THE DRIVE TO INNOVATION: THE PRIVILEGING OF SCIENCE AND TECHNOLOGY KNOWLEDGE PRODUCTION IN CANADA

by

Laura Cauchi

A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Graduate Department of Theory and Policy Studies Ontario Institute for Studies in Education University of Toronto

Copyright by Laura Cauchi 2012

THE DRIVE TO INNOVATION: THE PRIVILEGING OF SCIENCE AND TECHNOLOGY KNOWLEDGE PRODUCTION IN CANADA Doctor of Philosophy 2012 Laura Cauchi Graduate Department of Theory and Policy Studies University of Toronto

Abstract

This dissertation project explored the privileging of knowledge production in science and technology as a Canadian national economic, political and social strategy. The project incorporated the relationship between nation-state knowledge production and how that knowledge is then systematically evaluated, prioritized and validated by systems of health technology assessment (HTA). The entry point into the analysis and this dissertation project was the Scientific Research and Experimental Design (SR&ED) federal tax incentive program as the cornerstone of science and technology knowledge production in Canada. The method of inquiry and analysis examined the submission documents submitted by key stakeholders across the country, representing public, private and academic standpoints, during the public consultation process conducted from 2007 to 2008 and how each of these standpoints is hooked into the public policy interests and institutional structures that produce knowledge in science and technology. Key public meetings, including the public information sessions facilitated by the Canada Revenue Agency and private industry conferences, provided context and guidance regarding the current pervasive public and policy interests that direct and drive the policy debates. Finally, the Innovation Canada: A Call to Action Review of Federal Support to Research and Development: Expert Panel Report, commonly referred to as The Jenkins Report (Jenkins et al., 2011), was critically evaluated as the expected predictor of future public

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policy changes associated with the SR&ED program and the future implications for the production of knowledge in science and technology. The method of inquiry and analytical lens was a materialist approach that drew on the inspiring frameworks of such scholars as Dorothy Smith, Michel Foucault, Kaushik Sunder Rajan, Melinda Cooper, and, Gilles Deleuze. Ultimately, I strove to illuminate the normalizing force and power of knowledge production in science and technology, and the disciplines and structures that encompass it and are hooked into it where the privileging of such knowledge becomes hegemonic within and by the regimes of knowledge production that created them.

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Acknowledgements

Thank you...friends and family for your ongoing words of encouragement, support and patience. Thank you...Professor Jamie Magnusson for always challenging me to look at the world critically and compassionately.

Thank you...Amgen Canada Inc., my employer for sponsoring me with the unrestricted grant for the pursuit of this degree and for encouraging my personal, professional and academic development.

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Table of Contents Abstract ........................................................................................................................................... ii Acknowledgements ........................................................................................................................ iv Dedication ....................................................................................................................................... x Chapter 1: Introduction, Background and Reflection ..................................................................... 1 Introduction and Background: SR&ED and HTA ...................................................................... 1 The Development of My Standpoint: Identifying the/My Disjuncture ...................................... 1 An Overview of the Dissertation Project Structure .................................................................... 6 Chapter 2: Theoretical Framework and Literature Review ............................................................ 9 A Brief Literature Review: The Presumed Primacy of the Scientific Research Method ........................................................................................................................ 9 Critique of Evidence Based Medicine Specifically as a Subset of the Scientific Method ...................................................................................................................... 12 Validity ..................................................................................................................................... 14 Bias and Objectivity.................................................................................................................. 16 EBM + RCT = Objectivity? ...................................................................................................... 16 Evaluation and Standardization of Knowledge Production ...................................................... 17 A Brief Literature Review: The Role of Public Scientific Literacy in Public Policy Development....................................................................................................... 21 A Brief Literature Review: The Role of Bioeconomics, Biopolitics and Biocapital ........................................................................................................................... 26 Theoretical Framework ............................................................................................................. 29 Chapter 3: Research Question and Method of Inquiry ................................................................. 32 Research Focus ......................................................................................................................... 32 What Is the SR&ED Program? ................................................................................................. 32 A Review of Online Resources: SR&ED Program................................................................... 33 The Program Itself: SR&ED in Brief........................................................................................ 34 The SR&ED Policy and the 2007 Consultation Process: The Primary Data Set ................................................................................................................ 36 Health Technology Assessment (HTA) Programs: An Overview ............................................ 38 The History of HTA Programs in Canada ................................................................................ 40 Generalized Structure of the Assessment of Evidence and the HTA Review Process ................................................................................................................ 41 Method of Inquiry and Analysis ............................................................................................... 42 Canada Revenue Agency Public Information Sessions: Participant Observation ............................................................................................................. 43 v

The SR&ED Public Consultation Documents: A Textual Analysis ......................................... 43 Public Consultation Process and Documents October 2007: The Process ............................... 44 The Role of HTA and SR&ED: The Canadian Landscape....................................................... 49 Clinical Research Conference: Participant Observation ........................................................... 57 Final Analysis: The Power of the Materialist Approach .......................................................... 60 Chapter 4: Data Narratives............................................................................................................ 61 Summary of Field Notes From Public Meeting ........................................................................ 61 Preamble to the Data Review of Appendix A: The Public Consultation Documents ........................................................................................................... 71 Chapter 5: Analyses and Discussions ........................................................................................... 74 Analysis and Discussion: Canada Revenue Agency Public Information Meeting and Public Consultation Documents........................................................................... 74 Analysis and Discussion: The R&D Global and National Landscape in Science and Technology as a Consequence of the Public Consultation Process ...................... 78 Analysis and Discussion: Health Technology Assessment and the Role of Evaluation ............................................................................................................................. 88 Health Technology Assessment: Relationship to SR&ED and Philosophical Consequences of Privileged Knowledge .................................................................................. 93 Analysis and Discussion of Public Conference: Clinical Research in Canada Conference ................................................................................................................... 96 The History of the Corporate Ideal and Human Capital: Precursor to the Innovation Discourse .......................................................................................................... 99 A Review of the Economics: Human Capital and Innovation ................................................ 101 Microeconomic Decision-Making Power VS Macroeconomic Needs ................................... 103 Application and Utilization of Human Capital: For Work and/or Citzenship? ...................... 104 Calculating the Human Capital Requirements and Knowledge Markets ............................... 105 The Duality Inherent in Human Capital: Disembodied Product and Consumer .................... 108 Chapter 6: The Current Situation and the Immediate Future ...................................................... 110 The Jenkins Report Recommendations ................................................................................... 112 The Current, Evolving Situation ............................................................................................. 122 Future Research Questions ..................................................................................................... 124 Concluding Thoughts .............................................................................................................. 125 References ................................................................................................................................... 128

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List of Tables

Table 1 Standardized Data Extraction Form ................................................................................. 44 Table 2 International Comparison of R&D Tax Incentives .......................................................... 81

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List of Figures

Figure 1. Basic schema: Knowledge production in science and technology in Canada. ..................................................................................................................................... 39 Figure 2. Registration information requested prior to attendance at SR&ED public information seminar (Canada Revenue Agency, 2011a). .................................................. 62 Figure 3. Algorithmic representation of SR&ED eligible claims. ............................................... 70 Figure 4. Schematic of the HTA decision-making process. ......................................................... 90 Figure 5. Proposed Model on Business Innovation advocated by The Jenkins Report (Jenkins et al., 2011). ...................................................................................................... 117 Figure 6. The innovation life force advocated by The Jenkins Report (Jenkins et al., 2011). .................................................................................................................. 120

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List of Appendices

Appendix A SR&ED Public Consultation Documents............................................................... 138 Appendix B Websites Consulted for Health Technology Assessment Information and References ........................................................................................................ 172 Appendix C Observation Field Notes From a 2011 Conference in Montreal, Quebec ........................................................................................................................ 173 Appendix D PowerPoint Slide Presentation From a Public Information SR&ED Meeting ......................................................................................................................... 180

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Dedication

This work and everything in my life is dedicated to my husband, Jean-Paul, and our children, Alexander and Michaela. You indulged every request to let mummy do her homework. Thank you for your patience and your love. Your support and sacrifice was the greatest of all and for that I will be forever grateful. All my love is yours.

Chapter 1: Introduction, Background and Reflection

Introduction and Background: SR&ED and HTA This dissertation project examined how science and technology knowledge production is privileged in Canada through very specific national economic, political and social programs. The focus of the research is the Scientific Research and Experimental Design (SR&ED) program. My entry point into the research is through my own experience as a knowledge production worker in the new economy. The legislation and the policy statements that govern this tax credit program will be shown to direct and guide how research and development in science and technology is completed and the parameters that privilege a certain type of knowledge; the innovation discourse. Overlaid and hooked into this is the analysis conducted by Health Technology Assessment (HTA) programs that specifically evaluate the medical therapeutic knowledge produced in Canada as a subset of knowledge produced in science and technology. These programs then allow certain types of knowledge to receive a privileged and powerful status in Canada. The economic, political and social implications of that privileged knowledge status will be critiqued as the basis of this analysis. The research method of inquiry will be outlined in Chapter 3. The concept for my dissertation project evolved over several years of graduate studies and my professional career as a knowledge production worker in the biotechnology sector. In my academic career, I have been focused on a critique of knowledge production that challenges the principles of democratizing knowledge (or rather, lack thereof) and the power structures and relations of ruling that support, maintain and privilege certain types of institutions and the resulting knowledge production. The Development of My Standpoint: Identifying the/My Disjuncture As I write the introductory chapter to this dissertation project, I find myself contemplating the organic and material processes that have led me to this place. In order to more fully and accurately capture the intent, purpose and spirit of my dissertation project, I believe it is critical to the process to document my personal motivation and standpoint for this project. It is 1

2 for this reason that I include the following reflective piece of personal writing. It is through this reflection that the social implications of the privileging of a positivistic ideology of knowledge production will be illuminated. Only then will the academic purpose and merit be apparent. My history in brief is presented as a traditional trajectory in education and career. I completed a Bachelor of Science (BSc) in Biology from the University of Western Ontario. I struggled in university after finishing first in my high school graduating class. In retrospect and upon reflection, I had given little thought to what I would study other than I did well in the sciences. So, of course, it made perfect sense to continue in university. At the end of the BSc, I was not accepted into the honours program, but I was not yet ready to leave university. I returned for 2 more years to complete the honours program in Anthropology. For the first time since I had entered university, the As were back. I thrived in the program and enjoyed writing essays and not lab reports. I wanted to talk about the possibilities and diversities of life and culture and not just about the perceived absolutes of science. I did not yet know the language and discourse of a critique of positivism, but that was the impetus for the path I was now inching along. I graduated again and went off to work to pay for my student loans. Life continued and I built a career, a marriage and a family. Ten years passes and the questions and uncertainties that had started to unfold at the end of my undergraduate career began to surface again. This is what led me to the Ontario Institute for Studies in Education at the University of Toronto (OISE/UT). I had built a successful career in the biotechnology industry managing the implementation and project management of clinical trials, but I was unconvinced that there was one acceptable way to produce, evaluate and transmit knowledge in science and technology. My professional life was dominated by a discourse that prioritized knowledge production by standards of evidence-based medicine, gold standards and quantitative methods that dismissed and negated any and all other methods as irrelevant and without credibility. This privileging of knowledge production by a few select methods is the disjuncture that began to surface for me. What I have been experiencing passively since leaving undergraduate studies and more acutely since beginning graduate studies at OISE/UT is an ongoing transformation away from positivism; situated for me within the context of understanding what truth is and whether an absolute truth in science is even possible. The mantra of science is predicated on the unbiased search for truth. Dei (2008, p. 11) proposes that, Sometimes the marker of difference is in what

3 is deemed science and not science or what is valid knowledge and what is not valid and the criterion for marking these determinants. I had spent the better part of my academic and professional life positioning science and technology knowledge within a positivist, transmission orientation where knowledge is right or wrong (data as a binary) and facts are presented in a logical and indisputable format from teacher to learner. I was now faced with challenging the notion that absolutes in knowledge were even possible and that learning could happen in more optimal ways for both teacher and learner in a collaborative way that honours multi-centric ways of learning and knowing and producing knowledge. I had begun to define a method and a process by which I could move beyond what Semali and Kincheloe (2000) describe as This modernist view of knowledge, this one truth epistemology (p. 27). Additionally, as part of this process, I must consider what Dei (2000, p. 8) proposes that Knowledge, experience and practice must lead to theory. This challenges my understanding of the role of theory in knowledge production where theory is the originating point. By design, the scientific method is rooted in theory as the basis for leading to experience which results in knowledge and consequently alters practice and behaviour. At its inception, the scientific method is reductionist and abstracted from the realities of the lives of individual people and populations. Once the binary opposition is embraced, we have to choose one and dismiss the other not only indigeneity and colonialism but also local knowledge or academic knowledge. (Kincheloe & Steinberg, 2008, p. 143). As Harding (1997) discussed, science sets a standard and the hegemony of the Eurocentric discourses blocks easy exit from their conceptual framework. All these scholars have challenged my understanding of the scientific method, the hallmark of positivism, as the preeminent methodology. However, similar to the conclusion in Harding (1997), the goal is not to revolt against modernity but to update and modernize cultural legacies. While on the surface this may seem to be an argument for the appropriation of alternative knowledges, rather, I see this as an opportunity to explore the intersection points. I would like to embrace the idea that this process can be knowledge creative and not knowledge destructive (Piatelli & Lechenby, 2009). Reids (2001) discussion and analysis of Joseph Schwabs theory of the learning environment highlighted for me the direct impact of the learning that is inherent, specific and automatic within a community and the inability to separate it from the community. I currently

4 work and study in two very dichotomous communities that provide diametrically opposed messages about how knowledge is produced and how one evaluates the importance, relevance and value of that knowledge. The positivistic world of biotechnology research and development is predicated on a research for-profit model where the importance of knowledge is judged by the breadth of its application, utility and financial profitability. A transformative, democratic method of inquiry is predicated on a search for all types of knowledge in an inclusionary way where the process and end result are always open to critique. A significant portion of my academic growth is the understanding that the community in which I associate will channel the direction of my journey to understanding. The collective notion of the community and the role of the individual are mutually interdependent. The individual is limited in the expression of their individuality by the learning that occurs within the community in which they function. That is to say, the individual is the product of the collective community. This may have been the key turning point for me in the deconstruction of my history. I did not like the product that I was becoming in my professional life. In the words of Dorothy Smith (2005, 2006), I was unaware of the relations of ruling that were coordinating not only my work processes but the way in which I was now thinking about how knowledge is produced. I was losing the ability to critically and independently appraise my role in this learning community and in the process of knowledge production. While there is a co-dependence between the individual and the community, there is an inherent dynamic nature of a community where knowledge and learning must be equally adaptable to the needs of the individual and the community. Challenging and critiquing my science education and professional life has been and continues to be a difficult process. It has required an understanding of the role of racism, colonialism, feminism and the industrial-military-biomedical complex. This self-reflection has challenged me to understand that science does not function in a vacuum that is devoid of external influences and effects. A key reading for me is Vandana Shivas (1997) Biopiracy: The Plunder of Nature and Knowledge. Her ability to position individuals as stewards of nature and the material effects of science and technology on individuals and societies is critical in my understanding that my role within a community is subject to my complicity. While my learning community may say and do one thing, I am still empowered as an individual to challenge,

5 disagree, diverge and subvert. In actuality, I have a moral obligation to do so. I believe this is critical to my evolving transformation as a biological and social scientist; two roles that are not mutually exclusive, contrary to popular belief. A transformative scientist understands that any science is a social construction, produced in a particular culture in a specific historical era. (Semali & Kincheloe, 2000, p. 45). I have contemplated this reading deeply in terms of my own understanding, the industrial community in which I work daily and the academy in which I critically evaluate all these processes. And so I am here now in this place and time. Is my history and standpoint relative? Clearly yes is the answer. Feminist standpoint theory outlines why that is so. Harding (1997) describes feminist standpoint theory as a postpositivistic, anti-internalist, socially located epistemology that allows for the identifications of conceptual practices of power which have been examined by Dorothy Smith (2005, 2006). At a lecture in the spring of 2002 at Boston College, Harding suggested that feminist standpoint epistemology questions and ultimately challenges the proposition that the social world is a fixed reality that is external to individuals consciousness. Standpoint theory is not relativism, rather if you start research from the standpoint of the subjugated, this will lead not to an objective truth, but rather to a less false, less partial, less distorted view. She believes that it should be the goal as researchers, not to justify truth claims but to enable different forms of knowledge to emerge that challenge power. She also challenges the value of objectivity as value neutral and argues that the relationship between researcher and participant must be engaged and not detached (Piatelli & Lechenby, 2009). It is from this standpoint and theoretical framework that I begin this dissertation project. My core interests and my standpoint are based on a critical assessment of the method and manner by which knowledge is produced in science and technology generally, and health care, specifically, between academia/public sector and industry/private sector. To that relationship, I would also add a third corner to create a triad which includes the government/nation-state/public sector institutions as a separate entity. My studies have evolved organically to consider the themes of academic capitalism, human capital theories, biotechnology as a nation-state bioeconomic and biocapital strategy, and, hierarchical critiques of evidence-based medicine as the standards of knowledge generation. On my journey to becoming and being a transformative

6 scientist, my critique must consider that knowledge is more than just evidence of fact. It is also a reflection of the individuals and their societies who actively produce that knowledge and the standpoint from which that production occurs and continues to develop. Consider Deweys (1938) Experience and Education and his discussion of experiences as a moving force of magnitude and direction. My journey to doctoral work was not a typical trajectory but there were seminal experiences that propelled my journey in specific ways and directions. I do not regret any experiences and accept that all knowledge, however produced, delivered and understood by me is framed by my ability to be in this place at this time and my ability to evolve further. How do I move beyond the privileged positivism of industry (and my own personal history) and develop a framework for an effective and democratic intersection of universal knowledge with multi-centric ways of knowing, understanding and teaching? It is through this lens that I wish for the reader to position her/him/self to understand the intention of this dissertation project and the critique which I intend to present. An Overview of the Dissertation Project Structure The dissertation project is structured with six chapters with several sub-sections contained within each chapter. Chapter 1 as the introductory chapter presents the thesis of the dissertation projection and an extensive reflective piece of writing. It is my intention that the materially reflective section of this chapter is a necessary and important component that will accurately present my standpoint development and the disjuncture from which the inspiring impetus for this dissertation project originates. Chapter 2 will explicate the theoretical frameworks and views from the literature that have influenced this dissertation project. The discourses of biocapital, a critique of evidencebased medicine and the role that public scientific literacy plays in the complicities of these discourses will be explored and critiqued. It is my intention to show that the innovation discourse that surrounds knowledge production in science and technology is dramatically affected by these discourses and influences the increasing positivistic nature inherent within the innovation

7 discourse. As a result, public policy programs such as the SR&ED and HTA programs are structured in such a way so as to privilege certain types of knowledge production and the methodologies that creates it. It is this hegemonic knowledge production methodology that will be analyzed and critiqued in greater detail in chapter 5. Chapter 3 will explicate in greater detail the specifics of the SR&ED and HTA programs. It will outline the method of inquiry that forms the basis of the data collection of this dissertation project and the methodological framework. I will introduce and explicated my method of inquiry: a materialist approach. Chapter 4 will be a detailed narrative of the data that was collected. Appendices A, B, C, and D will include detailed summaries of the data itself that was summarized from my participant observation field notes and the textual analyses. Summary of data collected: A. Appendix A will textually analyse and summarize the 48 public consultation submission documents from the SR&ED public consultation conducted in 2007 to 2008. B. Appendix B will list the key health technology assessment references and websites that were accessed for the HTA discussion that is included in Chapter 3. C. Appendix C will summarize the conference notes from the Clinical Research in Canada conference that occurred in Montreal, Quebec March 28 and 29, 2011. D. Appendix D will include the complete set of slides that were provided as a handout during the public information SR&ED meeting of the Canada Revenue Agency that I attended on September 20, 2011, in Toronto, Ontario. Chapter 5 will discuss the key findings from the data collections and the relationship to the innovation discourse as a national political, economic and social strategy of knowledge production in science and technology; including an analysis that incorporates human capital theory as part of the innovation discourse. The final chapter 6 will include a critique of The Jenkins Report (Jenkins et al., 2011) as a contemporary analytical tool that is expected to be used by the current Canadian government to

8 refine the SR&ED program and further privilege the production of science and technology knowledge production in Canada; all through the guise of the importance and criticality of the innovation discourse to national economic strategies. The Jenkins Report was publically released in October 2011 and represents a perspective that is likely to influence public policy decisions surrounding the innovation discourse in Canada in the coming years.

Chapter 2: Theoretical Framework and Literature Review

A Brief Literature Review: The Presumed Primacy of the Scientific Research Method The primacy of the scientific research method dominates in science and technology. The underlying message is that certain research methods and knowledge production is valued and rewarded over other types. Ninnes (2002) extends this discussion further in his review of space science. The process of applying a value and priority to one type of research necessitates that there is a hierarchy. By its very nature, that hierarchy of knowledge and knowledge production cannot be democratic. It will have a relative value, it will be prioritized, it will be disseminated and it will be normalized, and then, it will become powerful. As L. Smith proposes: The globalization of knowledge and Western culture constantly reaffirms the Wests view of itself as the centre of legitimate knowledge, the arbiter of what counts as knowledge and the source of civilized knowledge. This form of global knowledge is generally referred to as universal knowledge available to all and not really owned by anyone, that is, until non-Western scholars make claims to it. (L. Smith, 1999, p. 63) Foucault (1975) would propose that The Normal is established as a principle of coercion in teaching with the introduction of a standardized educationit is established in the standardization of industrial processes and productsLike surveillance and with it, normalization becomes one of the great instruments of power at the end of the classical age. (p. 184) The Western, global North ability to universalize, normalize and grant power to knowledge production and evaluation is a hegemonic system that requires vigilant challenge. Semali and Kincheloe (2000) expand on the power of normalizing knowledge by suggesting that, A key to comprehending the power of Western science involves its ability to depict its findings as universal knowledge (p. 29). Further on in their article they write that Knowledge in this context becomes centralized and the power to produce knowledge is concentrated in the hands of a limited power bloc. In this process one begins to understand that science is the most powerful cultural production of Western society (p. 31). There is a circular 9

10 logic that maintains the power relationship in knowledge production where universal knowledge becomes a standard, the standard becomes powerful by its ability to maintain the hierarchy of knowledge and continue to produce universal knowledge. By allowing for the diversity of multicentric ways of knowing and producing knowledge, there is a destabilizing force on the hegemonic structures that produce and propagate universal knowledge. Dei (2000) proposes that One may start to destabilize what constitutes valid academic knowledge by challenging the political economy of knowledge production that accords different cost and privileges to knowledge systems (p. 129). There is the perception of democratic knowledge in this process because the methodology of the scientific method is presumed to be validated by the hallmarks of quantifiable objectivity and utility and universality. However, the paradox of this methodology is that the results are presumed (erroneously in many cases) able to be extrapolated to the wider populations. It is important to realize and acknowledge that the marginalized are the many and not the few when one considers a global perspective and not a global north, western dominated world-view. As McTaggart (1991) proposes, there is no guarantee that the effects will be democratic, constructive, or equitable (p. 9). As a result, the lack of democratic knowledge is also accompanied by a lack of universality. The lack of democratic knowledge and universality in the process of knowledge production and standardization is a direct result of the power relationships that exist in the academic-industry research relationships that sponsor, produce and exploit knowledge production. There are economic, social and political implications for supporting and maintaining the gold standard as a means to reinforce the power relationships at the heart of bio-medical research. Evidence-based medicine as a methodology is a primary means to achieve this end. Consider the perspective of Gough (1998): If the knowledge produced by Western scientists is only consumed in cultural sites dominated by Western science, then their claim to its universality might be a relatively harmless conceit. But we are increasingly seeing attempts to generate global knowledge in areas such as health (necessitated, in part, by the global traffic in drugs and disease) and environment (e.g., global climate change) that draw attention to the cultural biases and limits of Western science. (p. 511)

11 Democratizing the processes of research and knowledge production will consider more than just the benefits of outcomes. Rather, by democratizing knowledge production there are challenges and considerations given to the very nature of research and the value to the communities as a whole and not just privileged individuals. It is the method by which marginalized citizens can be empowered to gain access to knowledge in order to stimulate social change and benefit for all (Brown, Bammer, Batliwala, & Kunreuther, 2003; Flicker, Travers, Guta, McDonald, & Meagher, 2007). However, the concept and ideology of the gold standard does not consider these elements. Rather, it is shrouded in the veil of detached objectivity and is supported by economic, political and social ideology that demands quantifiable and privileged knowledge, which is above and beyond reproach (Cauchi, 2007, pp. 1-2). Consider now the notion of binaries and dichotomies in positivism. Rather than allow a dichotomy to persist, Harding (1997) argues that cultural differences create possibilities to the expansion of knowledge about the world (p. 57). Instead of normalizing one methodology, the process of all knowledge production should be normalized which provides the opportunity for the diversity of knowledge production and could ultimately, lead to a more inclusive and democratic paradigm. However, there is a socially constructed challenge to the viability of this proposal. One of the universals of culture, it seems, is that each group regards its own knowledge system as the truth. For the Western powers, this inherent ethnocentrism assumes warrant and hegemony through the seductive power of the technology based on their scientific superiority. (Purcell, 1998, p. 267) The universality of science and universal knowledge is more than just the critical evaluation of data. It is rooted in the source of the data. An analysis of the source of the data, cultural and social differences, equity, race and gender issues, are all factors of the history and authority of scientific research and the privileged position that it holds within society and the academy. It is a privilege that extends to the products of research and the technologies that become elevated to the universal knowledge status. Pestre (2003) proposes that a process of nationalization has influenced science over the last 150 years to the extent that science has become central to national security, economic development and national identity. The management of the advancement of scientific research is

12 considered part of the normal duties of the state and regulatory authorities in association with industrial and academic partners. There has been a commodification of the products of scientific research; the emergence of a new regime of knowledge production linked to a new regime of social regulations (Pestre, 2003, p. 245). There is a normalizing force and power to knowledge production and the discipline that surrounds it. Authority is granted and maintained by all the methods of knowledge production, primarily rooted in the scientific method. The colonizing structures of knowledge production remain entrenched and are perpetuated by the regimes of knowledge production that created them. By problematizing the notion of who, what, where, how and why of knowledge production, this allows for other voices and possibilities to enter the discussion. Once knowledge is normalized, it becomes very powerful and potentially fixed. It is through the analytical frames of materialism and the power discourse that I will illuminate this problematic. There is valuable knowledge to be gained by inclusion rather than exclusion, challenge rather than status quo. I challenge the notion of the possibility of (absolute) truths and whether that possibility is a failure of knowledge production at the research level or knowledge dissemination at the classroom/community level or both. Critique of Evidence Based Medicine Specifically as a Subset of the Scientific Method Before examining the relationship between evidence-based medicine (EBM) and knowledge production, it may be beneficial to first discuss what it means to conduct good research in science and industry. Brickhouse (2005) examined this question and proposed that there are standards that must be met in order to ensure that research in science is classified as good and for critical evaluation of the research to be possible. The three criteria proposed include: 1. the evaluation of learning has important educational aims for science education, 2. there is careful and honest description about who is or is not benefiting in the science education studies and finally, 3. there is a potential for influencing policy and practice in science education.

13 Clearly, these criteria attempt to establish a methodology by which the research is useful, valid and beneficial. But is this necessarily a guarantee of good research? The goals and objectives of research are critical to understanding the value and applicability of science to education and society. If we accept the preface proposed by Brickhouse (2005) that standard research requires significant learning outcomes and that science should be framed and used to benefit, then there is an expected utility to the research in order to guarantee its evaluation as good. On the surface it appears that Brickhouse (2005) is arguing for evidence-based medicine as the standard methodology, however, she goes on to propose that, There are good reasons to believe that methodological diversity is an asset to educational research rather than a liability; Methodological diversity allows us to address a far greater range of questions than would be the case if we were to develop a methodological orthodoxy. (p. 6) While this may appear to be a generalized statement with application across many disciplines, I specifically place this quote here to illustrate that EBM is a firmly rooted methodological orthodoxy. Evidence-based medicine has evolved as the standard and privileged methodology in medical science research. The hallmark of evidence-based medicine is the placebo, controlled, randomized clinical trial (RCT) as the means of the research and the gold standard as the result of the research, which function together to support EBM as a universally accepted standard. The gold standard labeling arises from the perceived winner or superior result in the EBM research. Feinstein and Horwitz (1997) propose a definition for EBM where it is the proposed practice of evidence-based medicine, which calls for careful clinical judgment in evaluating the best available evidence from systematic research (p. 529). The key components of this definition include a review of the phrase best available evidence. The data or evidence will typically arise from randomized clinical trials and meta-analyses (hence EBM methodology). The evaluation of best available will have important implications for the individual patient. Results will be based on the average patient and average results. The best available evidence (i.e., the most legally defendable in courts of law for the cynics among us) for all may not be the best available for the individual.

14 This leads to the question about what is the real authority of EBM and its methodology. EBM is more than just randomized clinical trials and meta-analyses. It is also meant to encompass and include clinically relevant research from basic science, studies of diagnostic tests, prognostic markers, and, efficacy and safety of therapeutic, rehabilitative and preventive regimens (Feinstein & Horwitz, 1997). Theoretically, EBM was meant to have a more diverse approach to research but has evolved into the highly quantitative method that is the randomized clinical trial. The randomized clinical trial as the hallmark of EBM was introduced in the late 1940s for a tuberculosis-streptomycin study and became the standard by which the effectiveness of therapeutic agents were assessed (Feinstein, 1984). However, it has been proposed that the informal experiments conducted by James Lind in 1747 examining a treatment for scurvy were the first controlled clinical trials (Sacks, Chalmers, & Smith, 1982). The golden age of EBM began in the 1980s and continues to form the basis and authority of science research methodologies (Stirrat, 2004). A critique of the authority of the randomized clinical trial begins with an analysis of three key components: validity, bias and objectivity. Validity McKee et al. (1999) propose that the essential validity question is the extent to which results and evaluations can be externalized; that is to say, the extent to which the data and results are generalizable to all potential patients. Validity has two facets: internal and external validity. Internal validity refers to the certainty that the study findings are true for the study population and setting under examination. External validity refers to the generalizability of the study findings to other populations and settings. Clearly, external validity is reduced, if not impossible, when there is poor internal validity (Wells, 1999). One of the key challenges with increasing the validity of randomized clinical trials is that the study populations tend to exclude future, real-world patients that do not fit with the established study criteria. These are typically patients that have complicating co-morbidities that exclude them from the inclusion criteria. The ultimate conclusion is that a gold standard

15 treatment that results from this classic paradigm may have decreased safety and efficacy for all potential patients because of decreased external validity. Advocates of alternative and complementary medicine clearly assert that the EBM methodology and classic scientific method is either not applicable or not sufficient to fully evaluate some treatment regimens. These advocates propose that alternative research methodologies are better suited to alternative and complementary medicine. However, the challenge is still to ensure the validity of this data by whichever methodology. As Angell and Kassirer (1998) write, assertions, speculation and testimonials do not substitute for evidence (p. 841). Faraone and Tsuang (1994) examine this question from the perspective of how treatment decisions are arrived at when a variety of research methodologies do not yield a gold standard treatment. They specifically examined the situation in psychiatry where a cross-disciplinary approach is used when supplementary data about outcomes is considered along with family and medical history and laboratory studies. Clearly the model is a combination of evidence from classic EBM methodology where the external validity of data is increased by considering individual factors. However, this cross-disciplinary approach does not fit with the industrial model of one pill fits all gold standard medicine. True validity would be the result of a crossmatrix approach where a variety of research designs are considered to confirm the data and support any claims. A same or similar conclusion that is the product of various research methodologies from classic EBM with the randomized clinical trial to qualitative research methods, would lead to high external validity of the proposed standard. The hierarchy of research designs and methodologies is directly linked to the level of authority and, ultimately, privilege that is bestowed on evidence. Concato, Shah, and Horwitz (2000) propose that there is a clear hierarchy in science research designs with the randomized clinical trial (preferably double-blind, placebo controlled) at the top and qualitative observational studies at the bottom. It is presumed that non-randomized clinical trials have less validity and hence, decreased basis for generalizability. Grimes and Schulz (2002) are clear in their perspective that the randomized controlled trials are the gold standard in clinical research (p. 57). They feel that the randomized clinical

16 trial is essential to eliminating bias. Their primary argument is based on the belief that randomization is the only known way to avoid selection and confounding biases in clinical research and hence, reduces the likelihood of bias in determining outcomes. Abel and Koch (1999) are critics of the concept of randomization as a means to eliminate bias in unconventional therapies and surgery. They propose that the primary supporters of randomization as a methodology are found among internal medicine, biostatistics and regulatory agencies. Bias and Objectivity Consider now the issue of objectivity when assessing the authority of evidence from the randomized clinical trial. Holman (1993) proposes that the search for objectivity through reductionist strategies (i.e., randomized clinical trials and EBM) led researchers to express results in quantitative terms. This was viewed as the means by which validity could be increased, bias eliminated and objectivity assured. Historically, this is directly linked to the Science of Man Agenda outlined by Kay (1993) in The Molecular Vision of Life. The evolution of molecular biology and the data required to justify public policy surrounding issues of social control, was rooted in the reductionist, quantitative methodology. The empiricism required by the Science of Man Agenda was the precursor to evidence-based medicine. This methodology was the quantifiable rationalization required by academia and industry to advance science and technology and the social control agenda of the government and the industry leaders. Shrouded in the veil of objectivity, these reductionist research methodologies eliminated the notion and value of the individual. Hence, the person previously known as the patient was now referred to as the objective subject under study. Holman (1993) also argues that the focus and recognition of the quantitative EBM/gold standard methodology may have established flawed standards of clinical practice and research, which may have delayed the development of essential medical knowledge. He asserts, quite accurately, Good clinical thought requires recognition of the co-existence of generality and individuality (p. 35). EBM + RCT = Objectivity? Now what of the requirement for objectivity? One of the key criticisms of nonquantitative EBM/gold standard methodology is that it is too subjective and devoid of facts.

17 Malterud (2001) proposes as a defence that Qualitative research methods involve the systematic collection, organization, and interpretation of textual material derived from talk or observation (p. 483). How then is it possible to incorporate the perception and bias of the researcher while considering their own objective and subjective views? If we consider Haraway (1985) and her Cyborg analysis of situated knowledge, she proposes that there is no such thing as the neutral observer because the observer is always constrained and pre-determined by what is known and visible. Her argument proposes that there is a lack of objectivity in science regardless of the methodology used because science is always situated within a particular framework and according to certain power relationships that link the researcher, the sponsor and the benefactor of research. This perspective is also espoused by other feminist scholars including Dorothy Smith and Nancy Hartstock, and anti-racist thinkers such as Roxana Ng and George Seifa Dei. This section began with a critique of the primacy of the scientific method and the presumed authority of the randomized clinical trial as the hallmark of EBM based on the assumed superior methodology addressing validity, bias and, finally, objectivity. Quite clearly, there are flawed assumptions about the strengths and weaknesses of this methodology. The authority of the data and knowledge production that results and is elevated to the status of gold standard requires critical examination and skepticism. I will conclude this section with a final analysis by Feinstein (1984): Whether we like it or not, most of our future decisions about medical practice, health care, and scientific technology will have to be made without evidence from randomized trials. To acknowledge this reality requires no loss of reverence, allegiance, or respect for the primacy of randomized trials as a gold standard in scientific research. Furthermore, we commit neither sacrilege nor disloyalty by recognizing that randomized trials cannot always be done, that they do not always yield unequivocal answers when done, and that alternative scientific methods must be developed to get satisfactory answers to questions for which randomized trials are either impossible or inadequate. (p. 772) Evaluation and Standardization of Knowledge Production Feinstein and Horwitz (1997) propose that there are specific criteria by which evidence can be evaluated and, ultimately, constituted as evidence. Within the model of evidence-based medicine, they propose that knowledge production should be evaluated according to the following criteria:

18 1. Quality and scope of data. This criterion prioritizes the knowledge derived from evidence-based medicine and minimizes data from other sources. 2. The scope of topics. Randomized clinical trials target the average patient and then generalize the resulting data. Historically, the average patient was a healthy, white male population. The resulting information was then standardized across populations. 3. Prophylactic therapy for risk factor. Randomized clinical trials are unable to properly address challenges where the targeted research attempts to reduce risk factors and not disease states. This limits the scope of potential research. 4. The grey zones of practice where the results of randomized clinical trials are inconclusive. 5. Pathophysiologic principles. Individual medical and physical histories determine treatment and not a pre-determined standard that results from the randomized clinical trial. 6. Situations where the model of the randomized clinical trial is either not pertinent or possible. Clearly, the challenge with these criteria for evidence must address a satisfactory method by which to account for personal preferences, psychosocial factors, comfort and reassurance of the individual. This leads to individualization and not standardization. Consider then, the related issue of equivalence versus standardization. Equivalence of therapeutics or treatment modalities runs contrary to the notion of a gold standard which is based on superiority of one over another. Equivalence allows for choice and competition based on what is best for the individual and not what is the approved standard for all. The notion of equivalence appears to be in conflict with the emphasis on evidence-based medicine. Quantitatively, evidence-based medicine attempts to prove that a significant difference exists between therapeutic options. Ironically, there is no gold standard criteria to construct and support equivalence claims using clinically meaningful differences, or by extension, to determine whether the difference truly matters therapeutically (Green, Concato, & Feinstein, 2000).

19 In some clinical trials, however, it is not expected that a new treatment will be superior to an existing standard. It may be realistic only to expect that a new treatment is in some sense equivalent to an existing established one, and it may be the objective of a clinical trial to provide adequate evidence of such equivalence. (Huson, 2001, p. 2) Perhaps an alternative methodology for assessing knowledge production is to consider knowledge along a spectrum of a continuum of increasing evidence. Currently, the standard for assessing knowledge relative to the RCT and EBM is through the phased therapeutic agent development process. A new therapeutic agent is assessed through a process that begins preclinically and passes through four phases of development (Campbell et al., 2000). Consider the following illustration of this process as an example. The pre-clinical phase is primarily the theoretical phase. Research at this phase theorizes about the potential safety margins between therapeutic and toxicity, reviews potential safety profiles across different species and attempts to hypothesize about optimal dose ranges, formulations and frequency of administration. Phase 1 is considered the human pharmacology phase where there is an initial introduction of the new therapeutic into humans. Typically, these are healthy volunteers and the resulting knowledge will provide guidance on preliminary safety screening, tolerance, adverse effects and metabolic and pharmacological action in small numbers of human. This is considered the modeling phase where the components under investigation will be defined. Phase 2 is the therapeutic exploratory phase where the goal is to confirm an acceptable and feasible profile of action of the therapeutic agent. Knowledge produced will yield preliminary efficacy findings in patients with the targeted disease or indication, the short-term safety profile, and, a potential optimal dose range. The end result of this phase using moderate numbers of patients (typically, 100-250 patients) is to justify future development and progression to large-scale phase 3 testing. The phase 3 stage is the definitive RCT where the end result is therapeutic confirmation. Large numbers of patients under examination will receive treatment in well-controlled studies (the hallmark being the randomized, double-blind pivotal clinical trial) where the purpose is to demonstrate short and long-term safety and efficacy while assessing overall therapeutic value.

20 The final phase 4 occurs after the therapeutic agent has received regulatory approval and attempts to yield information from long-term usage and implementation (Campbell et al., 2000). If knowledge production is assessed along a continuum, is it possible to push beyond the limit of the gold standard and propose that a platinum standard is possible? If the double-blind, RCT is accepted by the scientific community as the objective, scientific methodology which produces knowledge untainted by bias and, hence, considered the truth or the gold standard, is there a level of knowledge that is indisputable (Kaptchuk, 2001). The RCT cloaks itself as the embodiment of the ideal of the scientific method. Consider the space between the knowledge from the RCT and the discrepancies between knowledge produced from other, alternative scientific methodologies. Are there sub-phases to include between a traditional phased approach to medical drug development in the example outlined previously? Presumably, if all methodologies result in the same knowledge production and conclusions, the resulting standard assumes the highest position along the hierarchy of knowledge production and assessment. Is this then the pinnacle of objectivity? Haraway (1985) would still propose that this is simply not possible given the inherent lack of objectivity in science as situated within a particular framework and relative to certain, established power relationships. I would also extend this analogy with the Foucauldian perspective that objectivity is situated according to previously established normalized knowledge (Foucault, 1975). Historically, this has meant that science has a context and history that has excluded feminism, and challenges associated with critical pedagogy including (but not limited to), critical race theory, queer theory and post-colonial theory. As a result, objective truth is never possible and standardization is as irrelevant as it is impossible. There is value in the analysis of alternative methodologies that fly in the face of the RCT and EBM. Qualitative methodologies can help bridge the gap between scientific evidence and clinical practice. By contextualizing treatment regimens within real life situations, the knowledge produced by EBM can then be individualized (Green & Britten, 1998; Pope & Mays, 1995). In essence, gold standards for all become best options for the individual after careful, individual analysis and not in spite of it.

21 A Brief Literature Review: The Role of Public Scientific Literacy in Public Policy Development Consider now the role of society and individuals. I believe a critical point of analysis in this project is the role that the public plays in understanding and being complicit (consciously/unconsciously) in the validation of knowledge production in science and technology. Scientific literacy and the ability to understand and subsequently critique, is critical for an engaged public. The ability to make a choice begins with the ability to understand. However, defining what it means to have scientific literacy and what the expectation is for the general population is problematic. Consider this introductory quote by Jon Turney (1996): The scientists lament about public understanding of science is often heard. But scientific understanding is not merely a matter of scientific literacy; it also embraces issues of trust in scientists, doctors, and sources of information. People have an appetite for scientific information, and they are good at sifting the information relevant to their lives. Nonetheless, the onus will increasingly be on the scientist to explain scientific findings in ways that a range of publics can use. So, we need to improve the scientists understanding of the public. (p. 1087) Consider then that the definition of scientific literacy is two-fold: the ability of an individual to understand scientific concepts and the ability of the scientific community to disseminate information in an appropriate and comprehensible manner. Turney (1996) goes on to propose that the majority of scientific information is irrelevant to the average person and the general public. He suggests that a central problem is the ability on both sides of the definition to be able to distil what is critical and what is not in order to increase understanding. A Royal Society (1985, p. 6) report argued that scientific literacy can be a major element in promoting national prosperity, in raising the quality of public and private decision-making and in enriching the life of the individual. Clearly, scientific literacy is a desirable skill but what does it mean for the individual and for society? DeBoer (2000, p. 582) proposes that Scientific literacy is a term that has been used since the late 1950s to describe a desired familiarity with science on the part of the general public. Typically, a discussion of scientific literacy focuses on the successes or failings of the academic system to adequately educate a population in science education. An illiterate scientific public is considered a failing of the school system. However, this is too narrow a causality that negates

22 cultural and social differences where the priority of education is based on a hierarchy of certain subjects. Consider that the popular culture approach to education is based on the three Rs: reading, writing and arithmetic. Scientific education is peripheral at best in this model within the confines of mathematics. While understanding the downstream effects of scientific failings within the school system are a key part of the individual and public understanding of science, a detailed discussion is beyond the scope of this paper. Rather, this discussion will focus on what scientific literacy means and the effect it has on an individual and the publics decision-making. Historically, the surge in scientific education occurred in and around the end of World War II. Increasing a nations capacity in science and technology was politically and economically linked to increasing the domestic economy and creating national security through innovation and technological advances (DeBoer, 2000). In the period following approximately from the late 1950s to the early 1980s, the focus was on space exploration and the strategic use of science for society. What also followed was a more acute understanding of the responsibility that individuals hold with the creation and use of scientific knowledge. What was being ushered in was the age of the technological economy. It was a time of exploiting science for economic gain and a search for commercial applications of technology and not just scientific literacy. Scientific literacy was to provide a broad understanding of science and of the rapidly developing scientific enterprise whether one was to become a scientist or not (DeBoer, 2000, p. 586). What is the current age? DeBoer does not propose a historical framework for positioning the current age of scientific literacy but I would propose that we are in scientific overload. The mass uptake of email and the internet have allowed information to flow more freely than at any other time in history. This has challenges on several fronts: understanding the information, critiquing the source, challenging information, disseminating what is relevant and finally, decision-making and implementation. The mass amount of misinformation has created a propaganda machine that can counter the credible science with falsehoods. It is in this vein that I feel it is critical to include an analysis of the role of biocapital and biopolitics, alongside a critique of evidence-based medicine and the role of scientific literacy within societies. This creates a situation where if an individual, and ultimately, society, begins from a place of understanding that is rooted in the scientific failing of the education system (that is to

23 say, misunderstanding of science), they will not possess the necessary skills to continue to learn, understand and more importantly, challenge science. Consequently, the nation-states ability to convince the public of the importance of the innovation discourse in national economic and security policy development becomes of critical importance and effect. What should the goals of scientific teaching and understanding then be for a society? DeBoer (2000) proposes that there are nine distinct goals that a society should strive for. These include: 1. Teaching and learning about science as a cultural force in the modern world. Consider that science constitutes part of cultural understanding that should be passed from generation to generation where all members of a society have a responsibility to have a basic understanding of the natural world and how it functions. 2. Preparation for the world of work. Consider that understanding science and technology provides the basic skills required to succeed at all types of employment. Analytical and critical analyses skills are integral and desirable skills. 3. Teaching and learning about science that has direct application to everyday living. Consider that understanding such concepts as electricity, water purification and human anatomy and physiology are critical to an individuals personal health and well-being but also the ability of a society as a collective to make informed decisions. 4. Teaching students to be informed citizens; preparation for active citizenship. Consider that the ability to implement science-related social issues is predicated on a basic understanding of the science and technology that defines the issue. A successful democratic society is predicated on each individual member having the ability to speak out (and vote) against nuclear power and genetically modified foods because they understand and appreciated why they are wrong; should they choose. 5. Learning about science as a particular way of examining the natural world. Consider that understanding science and how scientific knowledge is created (the application of the scientific method) creates skills such as objectivity, subjectivity, understanding bias and the ability to critically assess.

24 6. Understanding reports and discussions of science that appear in the popular media. Consider that an individual should be able to critically appraise and disseminate relevant and credible scientific information. Central to this challenge is the issue of the expert and the ability of the individual to challenge the validity of the proposed expert. Within a democracy, the ability of the individual and the group to challenge the proposed expert knowledge is critical to making informed decisions. 7. Learning about science for its aesthetic appeal. Consider that there is incredible wonder and diversity in the natural world that should be celebrated and revered. An appreciation of Mother Nature and all her wonders leads to a greater respect and reverence for all the life that she creates and supports. 8. Preparing citizens who are sympathetic to science. Consider that the pursuit of science and technology are noble goals that usually result in beneficent results for society. By creating a democratic citizenry that appreciates science, it is a society that will support science and technology both politically and economically. 9. Understanding the nature and importance of technology and the relationship between technology and science. Consider that technology is the application of science to some commercial, social, economic or political end. The democratic citizenry is charged with the responsibility to critically assess the value of technology and its application within a society. Technology must be assessed for its social and environmental impact on individuals and a society. There is also a moral responsibility to consider the global impact of technology beyond the local and beyond the current generation. While DeBoer provides a robust framework for understanding the goals of scientific literacy, he focuses on this framework as a guideline for structuring scientific teaching and not on general public literacy and the relationship to decision-making. Young (2000, p. 8) proposes that The crux of the science-literacy problem is that, without the tools to assess the merits of various claims of scientific truth, the public may be unable to distinguish between revolutionary science from sheer quackery. Accepting that comprehension of information forms the basis of knowledge and that this is a prerequisite to understanding, decision-making and implementation

25 of change and action can only follow after this point. The motivation that compels an individual to action will be discussed shortly. Turney (1996) continues this discussion by placing the onus to increase the publics understanding on the shoulders of the scientific community. He proposes that there are two primary ways to accomplish this. Firstly, individuals are usually, primarily interested in health and biomedical information. Secondly, there is (blind) optimism in society that technology always provides good and useful things. The uptake of both these two topics areas is the path to increasing general scientific literacy. Augustine (1998, p. 1641) proposes that It has often been debated whether scientists need to be exposed to the liberal arts; a more compelling need, in my opinion, is for poets to be exposed to physics. The question is then why? Why a goal of widespread scientific literacy for all members of society? I think the critical answer to this lies in the individuals ability to determine a scientific fact or truth or falsehood or ambiguity. How this happens is two-fold. It requires a basic understanding of the information as it is was discovered and presented and how it is linked into all knowledge in a subject area. Secondly, it requires the ability to assess the validity of the expert. People will also bring to bear what they know about the sources of information their history, interests, and habitual veracity. That is, they use their own expertise about society and everyday life to decide who is trustworthy (Turney, 1996, p. 1089). Faulty or flawed decision-making can have deleterious effects for both the individual and all society. For example, there is a central tenet in the biomedical research complex where the written, informed consent of an individual is required prior to participation in any research. The ability of the individual to assess all possible risks prior to decision-making requires understanding of the science behind the research. Societal decision-making should follow this same framework where an assessment of all possible risks, including, personal, social, economic, political and physical, are weighed and considered accordingly. How skilled the individual and the public are produces debate. Normile (1996) summarized two studies produced by the Organization for Economic Cooperation and Development (OECD) Symposium on Public Understanding of Science and Technology. The first study assessed the publics interest in science versus the publics knowledge of science. In

26 the 14 OECD countries that were evaluated, all nations had a self-described interest in science ranging from approximately 25% of the population (Japan) on the low end to nearly 60% of the population (United States) on the high end. However, the same 14 countries averaged out at 10% of the population considering themselves to be well-informed. Hence, lots of interest, little knowledge. The second study assessed attitudes towards science and technology within young people of the same 14 OECD countries. The primary findings in that study indicate that young people are concerned more with technology and less with the physical sciences (the smartphone generation). As well, they were more interested in science and technology in instances where there was application to future jobs and careers (economic and utilitarian benefit). Macilwain (1998) proposes similar results produced by a National Science Foundation (NSF, US) study where Americans held an approval rating of nearly 70% for the scientific promise that they felt was possible with science and technological research. There was overwhelming positivity towards what science could accomplish which was attributed to successes in technology (primarily in telecommunications). However, the study found that there was little change in the publics ability to grasp basic science concepts where only 11% could explain what a molecule was; again, interest high, knowledge low. Holden (1995) reports similar results. In a study conducted by the University of Chicagos National Opinion Research Center (NORC), the topic of the survey was on the environment and 20 countries participated where they were asked 12 true or false statements about the environment. Canada scored the best on the survey with an average of 7.6 correct answers. The United States was 7th. I included the preceding section on scientific literacy as a key material construct that is necessary to deconstructing the role that a public understanding of science plays in the construction of the innovation discourse. While this was a brief overview, I see this as a robust area for additional exploration. A Brief Literature Review: The Role of Bioeconomics, Biopolitics and Biocapital Understanding the relationship of economics, politics and capital within the biological and life sciences is a critical intersection point where we can better understand the role that knowledge production plays in national economic and security strategies.

27 Sunder Rajans (2006) work on biocapital is a key text to analyse these intersection points. He brings together the literature on economics, politics and capital and the societal impact of the biological sciences in a critical and accessible way. He begins his discussion by positioning capitalism, generally, and biocapitalism, specifically as a dynamic process and not as a stable institution. This is the key to understanding his thesis: the life sciences represent a new face, and a new phase, of capitalism and, consequently, that biotechnology is a form of enterprise inextricable from contemporary capitalism. He goes on to explain this further, I conceive of the relationship of biocapital as a concept to contemporary systems of capitalism and to emergent scientific and technological horizons in the life sciences (Sunder Rajan, 2006, p. 3). His work is an ethnographic approach that focuses on the relationship between these intersection points and the relationship to the social and the coproduction aspects of science and technological development. He employs a Marxist analysis in his discussion. He argues that biocapitalism is a subset of capitalism and manifests its implementation differently and specifically across various global sites. He provides a working definition of biocapital as: Biocapital is a study of the systems of exchange and circulation involved in the contemporary workings of the life sciences, but is also a study of those life sciences as they become increasingly foundational epistemologies for our time. In the form register, it is indeed a subset or case study of contemporary capitalism; in the latter, it points to the specifically biopolitical dimensions of contemporary capitalism. (Sunder Rajan, 2006, p. 12) The notion of biopolitics was proposed by Michel Foucault. He proposed his theory of biopolitics as a form of social control where, discipline tries to rule a multiplicity of men to the extent that their multiplicity can and must be dissolved into individual bodies that can be kept under surveillance, trained, used, and, if need be, punished. And that the new technology that is being established is addressed to a multiplicity of men, not to the extent that they form, on the contrary, a global mass that is affected by overall processes characteristic of birth, death, production, illness, and so on. So after a first seizure of power over the body in an individualizing mode, we have a second seizure of power that is not individualizing but, if you like, massifying, that is directed not at man-as-body but at man-as-species. After the anatomo-politics of the human body established in the course of the eighteenth century, we have, at the end of that century, the emergence of something that is no longer an anatomo-politics of the human body,

28 but what I would call a biopolitics of the human race. (Foucault, 2008, pp. 242243) Sunder Rajan employs this analysis with the emergence of biotechnology and the sequencing of the human genome. The codes of life are used to exert micro-control on individuals towards the goal of macro-social control or massifying goals of social control. For both him and Foucault, Medicine is a power-knowledge that can be applied to both the body and the population, both the organism and biological processes, and it will therefore have both disciplinary effects and regulatory effects (Foucault, 2008, p. 252). Foucault goes on to clarify his definition. Biopolitics deals with the population, with the population as political problem, as a problem that is at once scientific and political, as a biological problem and as powers problem. And I think that biopolitics emerges at this time (Foucault, 1976, p. 245). The new biopolitics is the discussion proposed by Yu and Liu (2010). They propose that, The politicization of natural life has never ceased. The biotech revolution changes and reconstructs the Foucaultian concept of biopolitics from different dimensions, and declares the coming of the Age of Biocapitalism. This Age has opened a new pattern of modern power allocation in the area of life governance. In this neocapitalism, new biopolitics have gone beyond the forging, kneading and enslaving of bodies, and deep into the macro-level structure of nation, race and gender. It revolves around the biocapital to start a strong attack on traditional power politics and technical politics. (Yu & Liu, 2010, pp. 288-289) They complete their discussion with a call for merging ethics with the risks and responsibilities inherent in new technology and the resulting knowledge production. This responsibility rests, in their opinion, with the scientists who hold and control the knowledge and the biocapital. Consider now the relationship between commodification and biocapital. The commodification of knowledge is the theme focused on by Jacob (2009). He employs a Marxist analysis to analyse the concept of commodification of knowledge as a guiding principle in the scientific community and the role that academia plays/should play. He explores two issues: how

29 to explore commodification beyond the basics of monetary exchange and secondly, how commodification guides the governance of public science. He summarizes his approach as: By focusing on the commodification of science as a process and the elucidation of the properties of science as commodity, the paper connects the broad more case driven discussions about commercialization and commodification in science to the broader social theoretical discussion about commodification...Last but not least, by connecting commodification and governance at the macro policy level, it is hoped that the paper will make a contribution to starting a debate between those who do work on research and innovation policy and those who do higher education research. (Jacob, 2009, pp. 403-404) To conclude this section, I will draw on the analysis by Ruffolo (2008), where he draws on Foucault again to extend the analysis of bio-power and biopolitical production. The intersection of bodies and institutions is at the center of biopolitical productions that seek to normalize bodies through disciplinary practices. What is particularly relevant here is how these productivities result in the creation of multiple subjectivities within a single body: an individual is simultaneously a patient-subject. (Ruffolo, 2008, p. 2) The nature of biotechnology is that control is at the micro-level of social control of the individual as a binary: individual within a population. Why is it important to incorporate and intersect bio-economics, capital, and politics with a critique of evidence-based medicine and scientific literacy into this analysis? These three pillars of knowledge production in science and technology act in coordinated (sometimes), and often nebulous ways to privilege knowledge production. A critical appraisal and analysis of these theories in reference to the nation-state tools of the SR&ED and HTA programs will yield an explicated picture of the institutional structures and processes that create hierarchical privilege in knowledge production in science and technology. By incorporating the literature and theoretical frameworks of these intersections points, the analysis that follows will be more robust. I believe that these issues are critical to an understanding of the evolving role of the innovation discourse. Theoretical Framework When science and technology knowledge is produced and privileged, what does it do to other types of knowledge within society? The power of a materialist method of inquiry is that it

30 begins from the standpoints of individuals and their experiences of, or because of, these coordinating systems of knowledge production in science and technology. A theoretical approach does not ground the experiences adequately within the actualities of the experiences of knowledge workers or within the knowledge itself as an organic entity that is activated by the work of people and the texts that mediate its existence. Power acts upon/on/through individuals through their everyday/night work and life. It then becomes translocally and extralocally coordinated across individuals, then groups, and then industries, which are ultimately linked into the ruling relations that coordinate the actions and policies of those interlinked groups (D. Smith, 2005, 2006). There is a normalizing force and power to knowledge production and the discipline that surrounds it. Authority is granted and maintained by all the methods previously discussed. The research methodologies supported by evidence-based medicine and the resulting products, knowledge production, remain entrenched and are perpetuated by the regimes of knowledge production that created them. Foucault (1975) would propose that The Normal is established as a principle of coercion in teaching with the introduction of a standardized educationit is established in the standardization of industrial processes and productsLike surveillance and with it, normalization becomes one of the great instruments of power at the end of the classical age. (p. 184) It is power as a by-product of normalization and knowledge production that will anchor the discussion and analysis of this dissertation project and form the analytical frame of this materialist approach (to be further explicated in chapter 3). I firmly believe that linking the analyses from both a Materialist and Foucouldian perspective yields a much more robust and interesting analysis and I do not see these perspectives as mutually exclusive. While the ontology of evidence-based medicine, biopolitics and scientific literacy, when seen through a Foucouldian lens are technologies of power and normalization, the explication of the interactions are materially present in the daily lives of individuals through the implementation of policies. As a result, this analysis will be inspired by the works of scholars such as Kaushik Sunder Rajan, Melinda Cooper, Dorothy Smith, Michel Foucault, Gargi Bhattacharyya, Vandana Shiva and Gilles Deleuze.

31 This materialist approach as a method of inquiry will be further explicated and grounded in chapter 3 in terms of the methodological tools used following the introduction of the research focus and the background development of the SR&ED and HTA programs.

Chapter 3: Research Question and Method of Inquiry

Research Focus As previously presented, this dissertation project explores the privileging and normalizing power behind the ruling relations and the trans- and extra- local relationships between knowledge production in science and technology as a Canadian national economic strategy where science and technology knowledge production is systematically privileged economically, politically and socially. The project also explicates the ruling relations between nation-state knowledge production and how knowledge is then evaluated, prioritized and validated by systems of health technology assessment through the coordinating social relations in work and global processes. The basis of analysis will be the SR&ED program as the cornerstone of science and technology knowledge production in Canada and the HTA programs that are interconnected, overlaid and hooked into the process of knowledge production and coordinate the social relations that mediate these processes. There are significant process interchanges that exist at the interface of these different systems and programs. What Is the SR&ED Program? The basic tax structure of the federal income tax incentives for the SR&ED program was established between 1983 and 1985 (Tax Incentives for Scientific Research and Experimental Development Consultation Paper, October 2007) under three different federal government leadership regimes: Prime Ministers Pierre Trudeau 1980-1984 (Liberal), John Turner JuneSeptember 1984 (Liberal), Brian Mulroney 1984-1993 (Progressive Conservative). The SR&ED tax incentive program in Canada is the single largest federal program supporting business research and development in Canada. Annually, more than $4 billion dollars in investment tax credits are returned to more than 18,000 claimants of whom approximately 75% are small businesses (Canada Revenue Agency, 2011b).

32

33 The SR&ED program is a joint initiative from the Department of Finance and the Canada Revenue Agency. The Department of Finance sets the policy and the parameters governing the income tax deduction and the investment tax credits (i.e., incentives). The Canada Revenue Agency is responsible for administering the program. The administration of the program encompasses several aspects: 1. Providing program information 2. Responding to inquiries 3. Reviewing and processing claims 4. Developing and publishing forms, guides, applications policies and brochures 5. Delivering services i.e. Public information seminars, the pre-claim project review and the account executive service A Review of Online Resources: SR&ED Program The online resources and information for this program are found primarily through the Canada Revenue Agency publicly accessible website as a sub-topic (Canada Revenue Agency, 2011b). The following section will review the publically available information that is located at this website and related links. This will be based on information available, accessible and retrieved on June 22, 2011. The website home page begins with an introductory statement about the program and then lists ten sub-topics as hyperlinks. These hyperlinks form the basis of the website high-level organization. Each of the 10 sub-topics will be briefly described for their content and intent. 1. About our program: information about SR&ED, eligible applicants, application procedures and service standards. 2. First-time claimants: information targeted to assist first-time claimants. 3. Local information seminars: dates and registration screens for upcoming public information seminars across Canada. 4. SR&ED forms and publications: links to publications, guidelines and forms.

34 5. R&D links: links to various levels of government links on programs that support R&D. 6. Services and tools: a listing and links to tools and services that assist claimants. 7. Filing requirements: claim filing requirements for the program. 8. Subscribe to electronic mailing list: online form to receive email alerts on any changes or updates to the program. 9. SR&ED initiatives: links to previously conducted claimant surveys (2002 and 2005) and action plans. 10. SR&ED contacts: a city listing of the SR&ED offices across Canada and the contact numbers for queries. The cities included: Halifax, Montreal, Laval, Quebec, Ottawa, Toronto, Mississauga, Hamilton, Calgary and Vancouver. The Program Itself: SR&ED in Brief The SR&ED program was developed and designed to encourage Canadian businesses of all sizes and in all sectors to conduct research and development (R&D) in Canada that will lead to new, improved, or technologically advanced products or processes. The SR&ED program is the largest single source of federal government support for industrial research and development. (Canada Revenue Agency, 2010a) Generally speaking, qualification for the program and the tax credits is limited to a Canadian-controlled private corporation (CCPC) where the earned investment tax credit is 35% up to the first $3 million of qualified expenditures carried out in Canada and 20% on any excess amount. Other Canadian corporations, proprietorships, partnerships, and trusts can earn an investment tax credit of 20% of qualified expenditures for SR&ED work that is completed in Canada. A description and discussion of qualified expenditures will follow in the subsequent section. The goal of the program and qualifying work as stated on the departments website is: To qualify for the SR&ED program, work must advance the understanding of scientific relations or technologies, address scientific or technological uncertainty, and incorporate a

35 systematic investigation by qualified personnel (Canada Revenue Agency, 2010a). This statement will form the basis of the analysis and discussion in chapter 5. Qualifying activities and expenditures are outlined on the Canada Revenue Agency website (Canada Revenue Agency, 2010a). They include: 1. Experimental development to achieve technological advancement to create new materials, devices, products, or processes, or improve existing ones 2. Applied research to advance scientific knowledge with a specific practical application in view 3. Basic research to advance scientific knowledge without a specific practical application in view 4. Support work in engineering, design, operations research, mathematical analysis, computer programming, data collection, testing, or psychological research, but only if the work is commensurate with, and directly supports, the eligible experimental development, or applied or basic research The following activities are listed as not eligible for benefits under the program: 1. Social science and humanities research 2. Commercial production of a new or improved material, device, or product, or the commercial use of a new or improved process 3. Style changes 4. Market research or sales promotion 5. Quality control or routine testing of materials, devices, products, or processes 6. Routine data collection 7. Prospecting, exploring, or drilling for or producing minerals, petroleum, or natural gas 8. Development based solely on design or routine engineering practice

36 The analysis and discussion of what is included and excluded, as well as, the process and forms associated with submitting claims will be reviewed here generally but will be discussed in greater detail in chapter 4 and 5 in conjunction with a review of the participant observational research of the public meeting information sessions coordinated by the Canada Revenue Agency to members of the public. As a general overview, form T661 entitled Claim for Scientific Research and Experimental Development (SR&ED) in Canada must be completed in conjunction with either Schedule T2SCH31 entitled Investment Tax Credit-Corporation (for corporations) or, Form T2038(IND) entitled Investment Tax Credit (Individuals) (for individual applicants). All these forms must be submitted with the annual tax return forms or within 12 months of filing a tax return due for the year in which the potential SR&ED expenditure occurred (Canada Revenue Agency, 2010b). The SR&ED Policy and the 2007 Consultation Process: The Primary Data Set It is important to note that the program has a highly delineated policy that outlines the eligible activities, expenditures and rates and limits associated with each. According to the Tax Incentives for Scientific Research and Experimental Development: Consultation Paper (Consultation Paper),1 these include the following: Eligible activities: 1. Scientific or technological advancement: the work must generate information that advances the understanding of scientific relations or technologies. 2. Scientific or technological uncertainty: the possibility of achieving a given result or objective, or the way in which it could be achieved, must be unknown or indeterminable based on generally available scientific or technological knowledge or experience. 3. Scientific and technical content: there must be evidence that qualified personnel with relevant experience in science, technology, or engineering have conducted a systematic investigation through experiment or analysis.

|During my research in 2010-2011, the Consultation Paper had been available on the Department of Finance Canada website. As of July 2012, the URL I had used to retrieve it was no longer active. It appears that the Consultation Paper has been archived and would only be available through Access to Information.

37 Eligible expenditures: 1. Salaries or wages of employees directly engaged in SR&ED 2. The cost of materials consumed or transformed in SR&ED 3. Lease costs relating to machinery and equipment used all or substantially all (90% or more for SR&ED 4. Certain expenses associated with contracts to perform SR&ED directly on behalf of the taxpayer or payments to third parties where the taxpayer is entitled to exploit the results of the SR&ED 5. Overhead and administrative expenses may also be eligible under certain circumstances The Canadian government employs a variety of quantitative measures that are tax-based to evaluate the success of this program. Primary analyses currently evaluate: 1. Total tax expenditures 2. Statistics on program use 3. Evaluation of the SR&ED tax credit and realized economic benefits 4. International comparisons including analytical tools employed by the OECD for international comparison of R&D tax programs 5. Marginal effective tax rates on investments in R&D assets 6. Qualitative comparisons (methods, it is important to note, are not delineated in government literature) Primary data exists for items 1 to 5 above and is publicly available on the Government of Canada websites across three primary publicly available sources: The Department of Finance, the Canada Revenue Agency and Industry Canada. In 2007, the Canadian government under the Prime Minister Stephen Harper (Conservative Party of Canada) leadership regime began a public consultation program to elicit

38 feedback with a goal of improving upon the program. According to the Consultation Paper (see footnote 1, p. 35), the goals of the consultation were threefold: 1. To hear from stakeholders on how the SR&ED program assists research and development (R&D) in the business sector 2. Any challenges that business faces 3. Help the government identify priority areas while maintaining the integrity of the tax system The impetus for the consultation process was to increase the level of private sector R&D performed in Canada by improving the SR&ED program through cost-effective improvements and streamlining administration (Consultation Paper, 6, see footnote 1, p. 35). The consultation process proposed four general questions for public response on improving the SR&ED program: 1. How do the SR&ED tax incentives affect the performance of R&D in Canada, and how can they contribute to increasing private sector investment in R&D? 2. Are there features of the SR&ED tax incentives that impede the growth of small and medium sized innovative Canadian companies, and how? 3. How could more private sector R&D be leveraged? 4. Given the improvements already implemented or under study, how could administration of the SR&ED tax incentives be further improved and their complexity reduced? Public responses were invited as written responses only until November 30, 2007 to be provided to the Department of Finance. All responses received through this process were publicly posted to the Department of Finance website. Health Technology Assessment (HTA) Programs: An Overview At this point, it is important to introduce and incorporate an additional government apparatus (that is to say, ruling relation) that is currently being utilized into this analysis and has

39 various points of intersection with the SR&ED program and the process of knowledge production in science and technology within Canada. While the SR&ED program is clearly a tool of knowledge production, Health Technology Assessment programs (HTA) are a tool of knowledge evaluation and validation. HTA programs have historically been used by policy makers as a tool of the nation-state. With the exponential growth in medical innovation, available therapies and medical expenditures, there is a perceived ongoing need to systematically assess the available knowledge on efficacy, effectiveness and value to guide treatment decisions and/or make resource allocation decisions about scarce health care resources. HTA programs evaluate new technology through a very simple paradigm and lens: Does it work? At what cost? Is it worth it? And ultimately, is the nation-state willing to pay for it? This dissertation project will include an analysis of HTA programs (which assess medical therapeutic agents specifically) in relation to their concurrent and intersecting points of influence on the SR&ED program and the knowledge evaluated and produced through that program. While SR&ED privileges science and technology knowledge production generally, HTA examines medical technology as a subset of that knowledge. Figure 1 illustrates these related processes and programs in graphical form.

Figure 1. Basic schema: Knowledge production in science and technology in Canada.

40 The History of HTA Programs in Canada The first HTA program in Canada was established in 1988 in Quebec. With the trending increasing costs of health care in the late 1980s, there was a resurgence of interest in HTA programs across the globe. In Canada, it started with the Conseil dvaluation des technologies de la sant (CETS) and in 2000, was re-branded the Agence dvaluation des technologies et des modes dintervention en sant (AETMIS) with the mandate to evaluate the safety and efficiency of various health-care interventions. At the national level, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was formed in 1989 to conduct and prepare effectiveness reviews for medical devices and shortly thereafter added pharmaceuticals. In 1994, CCOHTA published Canadas first set of national guidelines for the economic evaluation of pharmaceuticals that grew out of a 1993 Canadian Collaborative Workshop on Pharmacoeconomics attended by international experts and representatives of Canadas provincial, territorial, and federal health-care systems. The initial mandate was simply the production of health technologies assessments, intended to counsel the Minister for Health and Social Services, and to, ultimately, disseminate any findings to key constituencies of the Quebec health care system (Battista, Jacob, & Hodge, 1994). Since 1988, HTA programs have been established across provincial, federal, academic and industrial jurisdictions in Canada. Further on in this chapter, several key HTA programs will be outlined and briefly described. Recall that health care delivery in Canada is the mandate of the provinces and territories. Public insurance systems are administered provincially and private insurance systems are also available to individuals through their employers or private purchase. The federal government is responsible for the national regulatory approval of pharmaceuticals, biotechnologies and medical devices. The provinces, territories and insurance systems (both public and private) determine whether they can and will pay for the new medical technologies. This is a key intersection point of HTA with knowledge production (Hailey, 2007). Policy decisions are then based on an analysis of HTA reviews. HTAs generally cover drugs, diagnostics, medical screening tools, educational interventions and any form of health care intervention. Occasionally, they will also analyse broader social issues such as organizational, social and ethical implications of medical technology. Internationally, governments evaluate each others HTA reviews and have a prioritized list of presumed

41 international expert programs. Canada is considered to have an internationally relevant and influential HTA which is the Common Drug Review (CDR). The anti-democratic influencers of this model will be further explored in Chapter 5. It is important to discuss the neo-colonialism and imperialism associated with the privileging of this type of knowledge by global north and western nation-states. Generalized Structure of the Assessment of Evidence and the HTA Review Process The centralized drug review process, which includes pharmaceuticals, biotechnological therapies and medical devices (that is to say, medically therapeutic agents), is a two-fold process. Firstly, the efficacy and safety of a new medical therapeutic agent is assessed for the clinical evidence that supports the medical claims for the medical therapeutic agent. How that evidence (knowledge) is created was outlined in brief in chapter 2 by the discussion on the phased system of medical research, as an example. Generally speaking, this assessment is aimed at clinical and economic evaluation to determine the probable impact of the product on patients health, drug costs, and the overall health care system, each relative to appropriate treatment comparators (Morgan, McMahon, Mitton, et al., 2006, p. 338). Secondly, the economic evaluations are typically part of an HTA program. Once the efficacy and safety of a new medical therapeutic agent is determined, the HTA program will assess that same agent from an economic standpoint. The assessment will result in recommendations including the following: should the medical therapeutic agent be funded, who should have access to that agent and under what circumstances. The assessment is ultimately about available resources and who is able to access those resources. As Morgan et al. (2006, p. 338) assert, Appraisal necessarily involves choices: In the face of limited resources, not all effective medicines can be funded. The implications of these limited resource based choices will be further discussed further in chapter 5.

42 Method of Inquiry and Analysis The method of inquiry is what I consider a materialist approach. The inspiring framework will draw primarily on the work of sociologist Dorothy Smith and institutional ethnography. Smith (2005) suggests that a central problem for the institutional ethnographer is to escape from the objectifications of the ruling relations and the monologies of institutional discourse and find her or his way back to the actualities that are always there, always going on, and always ultimately more than can be spoken. (p. 123) While the approach is clearly materialist in nature, I borrow much in terms of methodological tools from institutional ethnography. Overlaid this analysis, I use a Foucauldian lens to illuminate the power relations and the normalization of privileged knowledge that are always at work. Policies of knowledge production have material presence in the everyday lives of individuals from the medicines that people are authorized by the nation-state to take, to the technologies that are commercialized, to the curriculum that is implemented in science and technology. Those material presences coupled with the power relations that place them there represent the explication of this analysis. A methodological orthodoxy for the purposes of this project would not have been sufficient or robust enough to fully illuminate and explicate the discourses. I have struggled with my entry point into this work given that the disjuncture of the problematic does not occur (necessarily) with this project at the level of individuals and their material work processes. Knowledge economy workers, in both the public and private sector, are actively involved in the process of the production of science and technology knowledge production. While I use as my entry point into this project, my own position as a knowledge worker in the knowledge economy, this project will not fully explicate the ways in which knowledge workers are consciously and unconsciously complicit in the production of privileged knowledge. Although, I believe that there is a significant amount of work yet to be done to deconstruct the work processes of knowledge workers. This project begins with the coordinating systems, policies and processes that guide and frame the manner in which that knowledge is produced. Those systems, policies and processes were captured in the 48 written responses to the public consultation process that began in 2007. The responses were submitted by knowledge workers (through their various

43 institutions in many cases) that are actively engaged in knowledge production in science and technology, represented by individuals, companies, consultants, and academics, to name a few. This represents an interesting and unusual situation where the experiences of individuals were captured by the individuals themselves in the written, textual responses which were made publicly available on the Government of Canada website. The responses were published exactly as they were submitted except for a font change for publication consistency on the website. They range from a one page response to 20+ pages. I propose that this is the entry point into the method of inquiry and subsequent analysis. The texts capture the words of the individuals and groups themselves, their lived experiences of the SR&ED program, and, the coordinating aspects of this program on their local work processes and the production of knowledge. This dissertation project and method of inquiry examines the following tools of inquiry and analysis. An ethical review was not required as all data is currently publicly available and not subject to the criteria required for an ethical review as required by the University of Toronto. Canada Revenue Agency Public Information Sessions: Participant Observation Public information sessions are hosted quarterly across the country by the Canada Revenue Agency to explain and promote the SR&ED program to companies. Their location and times are posted publically and open to attendance. I attended the session held on Tuesday, September 20, 2011 in Toronto, Ontario, Canada. Through a process of participant observational research employed during this public meeting, I will explicate the coordination of these meetings and the information that is provided to attendees as formal guidance on the use of the SR&ED program as a tool of research and development in science and technology. As Campbell and Gregor (2003, p. 83) propose, Explication of that actuality is the analytic practice that institutional ethnographers must learn...analysis is about making some particular meaning from the data. The SR&ED Public Consultation Documents: A Textual Analysis A textual analysis of the documents (public responses) that were submitted as part of the public consultation process (see Appendix A) will form the basis of the major data set. All the responses were published on the Government of Canada website through the Department of Finance and are publicly available. The textual analysis will examine the content and context of

44 the submitted responses and the authors, through the use of a standardized data extraction form developed for this dissertation project. To facilitate the textual analysis and data review of the 48 submission documents, I developed the following standardized data extraction form to capture key data points consistently across all the submission documents. See Table 1 for the template example. Scope and recommendations within each response will also be analyzed. Table 1 Standardized Data Extraction Form
Data extraction Title of submission Author(s) Bias (public, private, academic sector) Length of submission Format of submission Focus of response to consultation document Recommendations Critiques of current program Other notable comments Content

Public Consultation Process and Documents October 2007: The Process On October 5th, 2007 by the order of the Honourable Jim Flaherty, the Minister of Finance, and the Honourable Gordon OConnor, Minister of National Revenue (members of the minority Conservative Party of Canada government under Prime Minister Stephen Harper), a

45 public consultation process was launched to gather feedback on the SR&ED program. The process for the consultation process was outlined in a document entitled Tax Incentives for Scientific Research and Experimental Development: Consultation Paper: October 2007 (see footnote 1, p. 35). This paper is commonly referred to as the Consultation Paper. The stated goal of the consultation process in the press news release retrieved from the above location was listed as such: These consultations will advance the Governments longterm economic plan, entitled Advantage Canada, which includes establishing an Entrepreneurial Advantage by creating a business environment that unleashes private investment, and a Knowledge Advantage by creating the best-educated, most-skilled and most flexible workforce in the world. Submissions were invited to be submitted by a deadline date of November 30, 2007 to the Canada Revenue Agency (see footnote 1, p. 35) as listed in the Consultation document. The submissions were to be reviewed by officials in both the Department of Finance and the Canada Revenue Agency and made publicly available on the same website. The public consultation process was also intended to conduct a series of public meetings but no evidence of these meetings was found during the research for this dissertation project. The Consultation Paper (see footnote 1, p. 35) was a 19-page document that outlined the history and background of the SR&ED program, a basic description of the program requirements, an economic analysis of the current program and its usage, a basic description of international programs and measures of success, and finally, the questions to be addressed during the consultation process. On page 2 of 19 of the Consultation Paper, the goal of the consultation process was restated as such: In undertaking these consultations, the Governments main goal is to increase the level of private sector R&D performed in Canada by improving the SR&ED program through cost-effective improvements to the tax incentives and further streamlining the programs administration (see footnote 1, p. 35). The detailed questions outlined to be addressed by the consultation process included the following:

46 1. How do the SR&ED tax incentives affect the performance of R&D in Canada, and how can they contribute to increasing private sector investment in R&D? Among the specific areas that stakeholders may want to address are: a. The role that SR&ED tax incentives play in the R&D investment decisions of Canadas R&D performers; and b. How multinationals make decisions on the location of R&D activities, and how SR&ED tax incentives, and R&D tax incentives offered by other countries, play into that decision. 2. Are there features of the SR&ED tax incentives that impede the growth of small and medium-sized innovative Canadian companies, and how? Input is solicited on whether and in what way the legislated rules governing the SR&ED tax incentives create barriers to the growth of small and medium sized innovative Canadian companies, and on how firms currently manage the constraints. 3. How could more private sector R&D be leveraged? Stakeholders may wish to comment on, for example: a. Whether the structure of the SR&ED tax incentives could be improved to encourage more private-sector R&D in a cost-effective manner; and b. How the SR&ED tax incentives could best support public-private R&D collaborations, as highlighted in the S&T Strategy. 4. Given the improvements already implemented or under study, how could administration of the SR&ED tax incentives be further improved and their complexity reduced? Consistent with the Governments commitments in Budget 2007 to reduce the paper burden and the tax compliance burden on businesses, comments are welcome on: a. Whether there are provisions of the program that are difficult to access; how severe such difficulties are; and what effect they have on the compliance burden, or on the amount of support the firm receives;

47 b. Whether the Canada Revenue Agency processes claims consistently and what the Canada Revenue Agency can do to strengthen the level of consistency of the SR&ED claim review process; c. Whether there are areas of complexity within the program where the Government could improve/simplify the process for claimants while ensuring that the program is delivered as intended and that fiscal integrity of the program is maintained; and d. How the Government can improve the way in which information about the program is provided, better improve the services provided, and ensure that businesses are aware of the program (see footnote 1, p. 35). Written submissions to address these questions were invited to be submitted and were required to declare that that comments could be posted publicly on the website. While 48 written submission documents were retrieved from the website and form the basis of this chapter, it is possible that there were submissions made that did not allow public posting. If there were such documents, that information is not provided by the Government and access is not permitted. As such, the textual analysis and data review of the submission documents will only include the 48 submission documents that were posted and available publicly. The method of inquiry for the textual analysis is inspired and guided by the work of Dorothy Smith and Institutional Ethnography (IE). In Smith (2005), Chapter 5: Texts, TextReader Conversations, and Institutional Discourse, the chapter focuses on the way in which institutions become ethnographically accessible through the use of texts. She focuses on the ways in which texts act to transform the local particularities of people, place, and time into standardized, generalized, and, especially, translocal forms of coordinating peoples activities (p. 101). She discusses the idea that texts should not be considered as having inertia. Rather, they actively participate and coordinate peoples lives. She describes the dialogic or dual coordinating aspects of texts. She situates the text-reader conversation as central to institutional settings and the way in which institutional discourses become actualized. Smith (2005) outlines the five features of text-reader conversations on p. 107. The key point for this analysis was found on p. 111: Institutional discourses are central to the coordinating of the work that people do in bringing into being every day the institutional complexes embedded in the ruling relations.

48 This chapter allowed me to think about texts, generally, and the submission documents, specifically, in a few different ways. Firstly, texts are not static but rather they have a life and action of their own in the way that they coordinate peoples lives and work, translocally, extralocally and within a relation of ruling. There is a power associated with and embedded within texts as activators. Secondly, texts have boundaries that limit the information, actions, etc. that are permitted based on what is included/eliminated from the text. Thirdly, people disappear behind the information that is captured by the texts. To this I would add a fourth parameter and that is the ideology and power that permeates the often unstated goals of the text. It is this fourth parameter that I will attempt to illuminate through the textual data analysis of the submission documents within the context of the innovation discourse. This dissertation project is highly textually mediated. There are hundreds of pages of public consultation documents where people (often as representatives of institutions) documented their experiences with the Federal Government SR&ED program. As I have read and re-read those texts, the coordinating power of the boss texts of the Government (coordinated by policy and political ideology) became increasingly apparent. My entry point is through the words of the publicly submitted consultation documents. My challenge is rooted in how I link the public documents across each other and the different experiences embedded within those documents when I dont have access to those people but only their words that are now textually defined. In Smith (2005), Chapter 9: Power, Language, and Institutions, she introduces the concept and role of power in IE: The ruling relations are a complex and massive coordinating of peoples work. Intentions, desires, opportunities, impediments, blockages, and powerlessness arise within them. The texts that constitute and regulate establish agency, that is, textually specified capacities to control and mobilize the work of others. Textually sanctioned agency produces a power that is generated by the concerting and mobilization of peoples work. (p. 183) She positions texts as the central guiding and accountable power that coordinates peoples work. She also discusses the uses of regulatory frames as tools to guide the kind of work and texts that are captured and structure reality for people. Key to this discussion is the idea that texts are powerful tools that create the realities of an institution.

49 This chapter extended the discussion and analytical method for me about the power of texts to be dynamic regulators and aspects of peoples work. A text is not an inanimate, lifeless book or form or template or sign, etc. Rather, it is a dynamic tool that activates and guides the kind of work that people do. It also limits the activities within specified guidelines and limitations. The discussion of this chapter examines how texts become linked or hooked up to the relations of ruling and become embedded within those structures or institutions or policies. I have spent a significant portion of my academic studies thinking about power from a Foucouldian perspective. Previously I thought about power as a consequence of the normalizing force of societies that acts upon individuals and across populations through systems and policies. It was the theoretical aspects of how power came to be as a discourse. Now, from a materialist perspective, I need to think about how power becomes activated upon individuals through those same systems and policies that guide and limit the actions of people. Power acts on/upon individuals through their every day/night work and life. It then becomes translocally and extralocally coordinated across many people. For my project, power is clearly defined within the governmental policies that materially guide and limit knowledge production in science and technology. How this power is actualized and materialized at the individual level and manifests itself into the ideological coordination of knowledge production in science and technology requires further analysis and discussion. The Role of HTA and SR&ED: The Canadian Landscape An explication of the institutional structures and relations of ruling between the SR&ED program and the HTA programs that support knowledge production in science and technology in specific and privileged ways will be explored. I include this section here in order to allow the reader to understand the manner in which HTA and SR&ED are linked. I believe it is important for the reader to understand the ruling relations that exist through the framework of HTA and their role in the production of knowledge in science and technology in Canada. This section will review the specific HTA programs in place within Canada and a brief overview of their mandate. Beginning with the national Common Drug Review (CDR), I will provide a brief summary of the key HTA programs in Canada. Over the years the scope of the CDR has evolved. To reflect the larger mandate of promoting effective utilization of technology

50 at the federal, provincial, and territorial level, CCOHTA was rebranded in 2006 as the Canadian Agency for Drugs and Technologies in Health (CADTH). As part of heath care reform in 2003, a Common Drug Review (CDR) process was implemented by CCOHTA to increase the consistency and quality of the drug review process across the provinces. The national Canadian Expert Drug Advisory Committee (CEDAC) was established as part of the CDR to provide independent reviews of the manufacturer submissions and to make recommendations to provincial health-care systems for formulary listing (ODonnell, Pham, Pashos, Miller, & Smith, 2009). In addition to CADTH and the CDR, there is COMPUS, also known as the Canadian Optimal Medication Prescribing and Utilization Service. This program identifies the gaps between what is presumed known (from evidence provided through clinical trials and basic science research) and what typically occurs when prescribing drugs (during the post-approval process). This information can be used by health care providers, policy makers and consumers to choose the most optimal drug therapy based on the best available evidence. The issues associated with this type of hierarchical knowledge production and evaluation, and, the establishment of standards of care will form the basis of the analysis in chapter 5. It is presumed that by analyzing COMPUS key messages, health outcomes will be improved and limited health care resources will optimally utilized. COMPUS continually contributes to the re-assessment of a drug or a class of drugs. By evaluating drug therapies that have been in the market place, COMPUS investigates the evidence concerning their optimal use and patterns of use over time (COMPUS, 2010). The priorities for analysis by COMPUS were selected based on criteria such as large deviations from optimal utilization of prescription medications (over- or under-use), size of patient populations, potential impact on health outcomes and cost-effectiveness, potential to effect change, benefit to multiple jurisdictions, and measurable outcomes. COMPUS follows an established procedure to carry out its key objectives of: 1. identifying optimal drug prescribing and use by collecting and evaluating existing evidence

51 2. providing advice, tools, and proven strategies for jurisdictions and others to implement and support the adoption of optimal drug therapy by health care providers, consumers, and others involved in the prescription drug use continuum 3. developing and maintaining an inventory or virtual library of evidence-based and cost-effectiveness information on optimal drug therapy 4. linking and exchanging information with national and international parties active in optimal drug therapy 5. Identifying gaps in knowledge about optimal drug therapy through a range of sources, including linkages with federal, provincial, and territorial pharmaceutical management programs, which may guide research in the field. Leading experts from the scientific and medical communities, including clinicians, pharmacists, methodologists and economists, are routinely engaged to help COMPUS achieve its objectives of identifying and promoting optimal drug therapy (COMPUS, 2011). There are many other influential HTA programs and institutions in Canada. The following section will provide a brief synopsis and overview of the mandates of these key programs as listed below. The complete list of resources and the website links are provided in Appendix B: 1. The Medical Advisory Secretariat (MAS) 2. Drug Quality and Therapeutics Committee (DQTC) 3. Institute of Health Economics (IHE) 4. Ontario Health Technology Assessment (OHTAC) 5. Toronto Health Economics and Technology Assessment (THETA) 6. Centre for Health Services and Policy Research (CHSPR) 7. Chalmers Research Group (CRG) 8. Cochrane Collaboration's Bias Methods group (BMG) 9. Consolidated of Reporting Initiatives for Randomized Controlled Trials (CONSORT) 10. University of Ottawa's Evidence-based Practice Center (UO-EPC) 11. Centre for Evaluation of Medicines (CEM) 12. Programs for Assessment of Technology in Health (PATH)

52 13. Health Technology Assessment Program (HTAP) 14. Therapeutics Initiative (TI) 15. Drug Assessment Working Group (DAWG) 16. Health Policy Management and Evaluation (HPME) 17. Institute for the Clinical Evaluation of Sciences (ICES) 18. Health Care, Technology and Place (HCTP) 19. Alberta Foundation for Health Research (AFHR) 20. McGill University Health Centre (MUHC) 21. Centre for Health Economics and Policy Analysis (CHEPA) 22. Centre for Health Evaluation and Outcome Sciences (CHEOS) 23. Calgary Institute for Population and Public Health (CIPPH) In 2001, the Ministry of Health and Long-Term Care (MOHLTC, Ontario) established the Medical Advisory Secretariat (MAS) to conduct evidence-based analyses to help stakeholders make policy and funding decisions about health technologies (not drugs) in Ontario. The MAS, which is comprised of health care specialists including physicians, clinical epidemiologists, policy analysts and health economists, is committed to ensuring that residents of Ontario have access to the best available new health technologies that will improve patient outcomes. The MAS produces evidence-based analyses of health technologies that are then published in the Ontario Health Technology Assessment Series. Composed of stakeholders and experts, the Ontario Health Technology Advisory Committee (OHTAC reviews each analysis and makes recommendations to MOHLTC and the field. The MAS also performs a secretariat function for OHTAC. In recent years, the MOHLTC has become increasingly interested in reviews that have broader system impacts than those of single health technologies. As a result, MAS has increasingly been called upon to conduct mega-analyses. At the request of OHTAC, MAS oversees and funds field evaluations for technologies that appear promising, but for which there is inadequate evidence. Ontario has one of the largest field evaluation programs in the world. The MAS has forged important linkages with provincial experts and academic institutions, and also provides the interface with ministry-funded parallel programs that have been developed to support the work of OHTAC.

53 The Drug Quality and Therapeutics Committee (DQTC) was established in 1968 to provide independent and specialized advice to the Ministry of Health and Drug Programs Branch on drug related matters. The DQTC is directly accountable to the Minister of Health and LongTerm Care through the Drug Programs Branch and the Assistant Deputy Minister, Health Insurance and Related Programs. The DQTC has twelve members, including the Chair. Handling highly technical and scientific issues, the Committee includes experts in the fields of: medicine, pharmacology, health economics and evaluations of the interchangeability of generic drug products. The Institute of Health Economics (IHE) is a non-profit organization committed to producing, gathering, and disseminating health research findings from health economics, health policy, health technology assessment and comparative effectiveness to improve the delivery of health care and support a sustainable future (Institute of Health Economics, Alberta Canada, 2010). The Toronto Health Economics and Technology Assessment (THETA) Collaborative is a multidisciplinary research collaboration based out of the University of Toronto. Leading sources of expertise in health technology assessment (HTA), THETAs activities are focused in the following areas: 1. Providing decision support to government by designing, implementing and analyzing HTA studies for the Medical Advisory Secretariat (MAS) of the Ontario Ministry of Health and Long-Term Care (MOHLTC). 2. Advancing the scientific discipline of HTA through high-quality research. Engaging in knowledge translation to disseminate knowledge of HTA among researchers, policy-makers and health service providers. 3. Increasing HTA training and learning opportunities. (THETA, 2011) The UBC Centre for Health Services and Policy Research (CHSPR) propose that they are leaders of independent, policy relevant research and graduate training, we are dedicated to fostering visionary research within a collaborative and innovative research environment. Our work engages and informs health policy and issues that matter to Canadians (CHSPR, 2011).

54 CHSPR receives core funding and support from the BC Ministry of Health Services and the University of British Columbia. This enables the Centre to focus on research that informs health policy issues. The Chalmers Research Group (CRG) established in 1998, is an academic research group located in the Children's Hospital of Eastern Ontario Research Institute (CHEO RI), Ottawa, Ontario Canada and is affiliated with the University of Ottawa. It is engaged exclusively in evidence synthesis in healthcare and related methods research. CRG is committed to developing high quality systematic reviews and health technology assessments, and has garnered international recognition having conducted research for and training to local, provincial, national and international stakeholders. It is home to the international Cochrane Collaboration's Bias Methods group (BMG) and the international group for the Consolidated of Reporting Initiatives for Randomized Controlled Trials (CONSORT). It is also the coordinating base for the University of Ottawa's Evidence-based Practice Center (UO-EPC); a research program funded by the United States of America Agency for Healthcare Research and Quality (AHRQ) (CRG, 2011). The Centre for Evaluation of Medicines (CEM) has been in operation since 1992. It is an academic research and educational unit. The CEMs mission is to evaluate drug and technology use in the real world in order to improve patient health outcomes and policy decisions. It is affiliated with McMaster University and St. Josephs Hospital in Hamilton, Ontario, Canada. The CEM is housed within the Father Sean OSullivan Research Centre (FSORC) at St. Josephs Healthcare in Hamilton. Within the CEM there are four groups with special or focused research interests: Therapeutics group (THERAP); Program for Assessment of Technology in Health (PATH); Biostatistics group (BIOSTATS); St Josephs Health System Research Network (SJHSRN) (CEM, 2011). The Programs for Assessment of Technology in Health (PATH) Research Institute consists of multiple research programs in economic evaluation and health technology assessment (HTA). The Health Technology Assessment Program (HTAP) is a research program focused on the generation of HTAs to support federal and provincial government reimbursement decisions. Designated as a Partners in Health Technology Assessment (PIHTA) by the CADTH, PATH is the only official academic research partner with Canadas national HTA agency. HTAP conducts

55 systematic literature reviews and constructs original economic models to assess the clinical and cost-effectiveness of new and existing technologies (PATH, 2011). The Therapeutics Initiative (TI) was established in 1994 by the Department of Pharmacology and Therapeutics in cooperation with the Department of Family Practice at The University of British Columbia with its mission to provide physicians and pharmacists with current, evidence-based, practical information on prescription drug therapy. To reduce bias as much as possible the TI is an independent organization, separate from government, pharmaceutical industry and other vested interest groups. To fulfill its mandate the Therapeutics Initiative has established four working groups: the Drug Assessment Working Group, the Education Working Group, the Pharmacoepidemiology Working Group, and the Therapeutics Letter Working Group (TI, 2011). The Drug Assessment Working Group (DAWG) is committed to analyzing scientific evidence on the effectiveness and safety of drug therapies used in Canada. They systematically review and, when appropriate, critically appraise research relevant to new and existing drugs. Often the goal is to discover whether a new drug provides a therapeutic advantage over an existing similar drug therapy for a clinical condition. The Therapeutics Initiative has a dedicated team of researchers that is committed to the highest standards of research. In addition to reports on various new and existing drugs (see Appendix B), the DAWG also contributes to the federal Common Drug Review (CDR), a national program set up to reduce duplication, and provide equal access to high level evidence and expert advice, thereby contributing to the quality and sustainability of Canadian public drug plans. The DAWG has contributed to many of the CDR reviews (DAWG, 2011). Health Policy Management and Evaluation (HPME) Group brings together leading researchers from a wide variety of disciplines to develop and translate innovative ideas into evidence-informed practices that improve the planning, delivery and outcomes of health care. Responsible for more than $6.5 million in research funding each year, the Department is making significant contributions to knowledge in the fields of system design, performance management, comparative health systems, health policy and health economics, health services research, quality improvement, patient safety, observational and decision sciences research, clinical trials and knowledge transfer (HPME, 2011).

56 Established in 1992, the Institute for the Clinical Evaluation of Sciences (ICES) has played a key role in providing unique scientific insights to help policymakers, managers, planners, practitioners and other researchers shape the future direction of the Ontario health care system. They propose that their unbiased, evidence-based knowledge and recommendations, profiled in atlases, investigative reports, and peer-reviewed journals, are used to guide decisionmaking and inform changes in health care delivery (ICES, 2011). Health Care, Technology and Place (HCTP) is a strategic research and training initiative based at the University of Toronto. HCTP is funded by the Institute of Health Services and Policy Research at the Canadian Institutes of Health Research. CIHR provides funding opportunities for four themes of health research: biomedical, clinical, health systems services, and, social, cultural, environmental and population health (HCTP, 2011). The Alberta Foundation for Health Research (AFHR) founded in 1994 created a separate foundation in response to numerous inquiries about how to donate to health research. The AHFMR is a non-profit, charitable organization that supports only selected, top-quality health research projects according to the standards of excellence set by AHFMR (AFHR, 2011). The McGill University Health Centre (MUHC) is a single corporate structure including five hospital sites: the Montreal Children's Hospital (MCH), the Montreal General Hospital (MGH), the Montreal Chest Institute (MCI), the Montreal Neurological Hospital (MNH) and the Royal Victoria Hospital (RVH). The purpose and mandate of the MUHC is to advise the hospitals on difficult resource allocation decisions, using an approach based on sound, scientific technology assessments and a transparent, fair decision-making process. Consistent with its role within a university health centre, it will publish its research when appropriate, and contribute to the training of personnel in the field of health technology assessment (MUHC, 2011). Founded in 1987, the Centre for Health Economics and Policy Analysis (CHEPA) is a world-class interdisciplinary health research centre that is home to the largest concentration of health economists and health policy analysts in Canada. CHEPA researchers bring together a diverse set of intellectual resources to tackle complex health and health care problems from a variety of perspectives such as economics, political science, ethics and sociology (CHEPA, 2011).

57 The Centre for Health Evaluation and Outcome Sciences (CHEOS) is an interdisciplinary research collective founded to pursue excellence through the evaluation, interpretation and dissemination of health outcome information. CHEOS strives to contribute to preserving and enhancing the health care system and creating a healthier society. Based at St. Paul's Hospital in Vancouver, British Columbia, Canada, CHEOS is a centre of the Providence Health Care Research Institute. CHEOS is dedicated to working cooperatively with other health research organizations including those at the University of British Columbia and other institutions. CHEOS is committed to creating an inclusive, dynamic and cooperative work environment in which younger researchers are mentored, established researchers are supported, and all participants are encouraged to pursue personal and professional challenges (CHOS, 2011). The Calgary Institute for Population and Public Health (CIPPH) is a partnership between the University of Calgary and Alberta Health Services. The CIPPH came into existence in April 2009. The Institute has over 160 members, representing a wide range of disciplines and roles in health services, population and public health, research, policy-making and practice (CIPPH, 2011). All HTA references and information discussed in the preceding section are publicly available through the relevant websites listed and were accessed at various times between September 2010 and August 2011 for reference during the research and writing of this dissertation project. It is important to note that the nature of dynamic websites does not allow for references to remain static. The full list of websites is provided in Appendix B. Clinical Research Conference: Participant Observation On March 28 to 29, 2011, I attended a clinical research conference in Montreal, Quebec, Canada. The conference was titled Clinical Research in Canada: A Roadmap for Enhancing Canadas Global Competitiveness. It was organized by The Canadian Institute, a private organization that organizes conferences and professional development for the private sector across many diverse industries. The conference was billed with the following tagline in the promotional pamphlet: This highly interactive event brings together key stakeholders who are passionate about building Canadas competitive advantage in todays global market. My

58 attendance and fees at the conference was sponsored by my employer. The focus of the conference was to critically appraise the state of clinical research knowledge production in Canada, specifically, and globally. My field notes and the publicly available presentations and materials provided at the conference will form the basis of this participatory observational research and will clearly explicate how clinical research knowledge production, as a subset of science and technology, has a national economic, security and social strategy that privileges knowledge production. The advance public promotional materials and agenda list the keynote presentations and topic areas as: fostering collaboration, innovation and growth in todays highly competitive global marker, clinical trials global landscape and the new paradigm in Canadian clinical research from the perspective of Health Canada. Sponsorship for the conference was listed as being provided by Turning Technologies Canada, a private industry business that self-identifies as the global leader in audience response technology. The first choice of presenters everywhere, our simple, intuitive, polling products add engagement, encourage interaction, collect valuable data and provide instant feedback in meetings and events using RF or web-based devices. (Clinical Research in Canada A Roadmap for Enhancing Canadas Global Competitiveness, conference agenda, 2011), and the Canadian Research Association of Canada, a private industry business that self-identifies as a non-profit association whose mission is to provide a forum for discussion and exchange of ideas relevant to all aspects of clinical research in Canada. (Clinical Research in Canada A Roadmap for Enhancing Canadas Global Competitiveness, conference agenda, 2011). On the second page of the promotion material and agenda, there was a text box with the heading Who should attend. Listed under this heading were the following: Industry sponsors from Pharma, Biotech, Medical Devices Contract Research Organizations (CROs) and Site Management Organizations (SMOs) Clinical Research Investigators, Contract Research Associates, Site Coordinators, Monitors and Research Administrators Research Ethics Boards (REBs)

59 Research Institutions/Universities Clinical Site Facilities Contract Negotiators Agencies that fund research, including governments, research charities, and medical research councils Federal and provincial regulatory agencies Civil servants involved in federal/provincial initiatives to encourage clinical research in Canada Clinical Research consultants and solutions providers

The agenda was provided in advance of the conference and was included as part of the promotional material for the conference. It was a detailed agenda that opened at 9:00am with opening remarks from the Conference Chair. The schedule of lectures that was provided was accurate with the order in which the lectures occurred on the 2 days of the conference. Through participant observational research, I will detail in combination, the published materials that were provided in advance of the conference, comments that were captured during each of the lectures and discussions in my field notes, and, review the presentation materials that were provided either during the lectures or after the fact through public access on the website of The Canadian Institute through the use of a standardized data extraction form. The full summary of all the presentations is provided in detail in Appendix C. Given that the conference was a public event and my presence was indicated by my participation on the attendee list. I did not declare my presence as a student researcher. The Canadian Institute publishes all the presentations that were released publicly by each of the speakers through a disc that was provided on-site at the conference and additional supplemental materials are provided through the Canadian Institute website for a limited period of time following the completion of the event.

60 Final Analysis: The Power of the Materialist Approach Finally, the power of knowledge production as a nation-state economic, political and social policy is analyzed as a direct product of knowledge production relative to Canadian governmental policies and programs in chapters 5 and 6. Policy is also a tool of ideology and political power where the application of policy, procedures, work processes and the results of research, may be designed and coordinated in a particular way that privileges science and technology knowledge production and results in the innovation discourse as the public policy narrative in science and technology knowledge production. That discourse becomes materially present in the lives of individuals and societies through the application of those policies. What does this reveal and explicate about the position that science and technology plays in our economic, political and social processes? How do the ideological tools of positivism, such as the primacy of the scientific method and evidence-based medicine, become materially present in the lives of individuals and societies? What are the power relations that are always acting within and through these discourses? It is these questions that the reader is asked to continually have top of mind through the reading of this dissertation. The lens and the gaze will shift but this materialist approach will illustrate those discourses effectively.

Chapter 4: Data Narratives

Summary of Field Notes From Public Meeting On Tuesday, September 20, 2011, I attended the public information seminar on the SR&ED program that was organized and presented by the Canada Revenue Agency. What follows will be the summary of my field notes within this narrative and not within an appendix in order to more accurately illustrate the manner and tone in which the public is guided and directed by the Canada Revenue Agency on the SR&ED program. I have made this as a conscious choice to better situate the reader within the context of how the innovation discourse is manifest through the nation-state through the SR&ED program as a national tool. The public information seminar was held in the federal government building located at 1 Front Street West in downtown Toronto, Ontario, Canada in a lower level training room. Prior to attending the public information seminar, I was asked to complete an online registration form through the SR&ED website requesting attendance for that specific date and location (see Figure 2).

61

62

Registration * Mandatory fields for registration. To register: After giving the requested information, click on "Submit" at the bottom of the online request form..

* Name:

* Firm:

* Industry sector:

* Field of research:

* Telephone:

Fax:

* Email:

Figure 2. Registration information requested prior to attendance at SR&ED public information seminar (Canada Revenue Agency, 2011a).

63

When completing the online registration form, I declared my status as a student and my field of research as a doctoral student researching the SR&ED program. Approximately 1 week prior to the public information seminar, I received an email confirming my attendance, location of the public information seminar and a tentative agenda. When I arrived at the public information seminar, I identified myself as a doctoral student from the University of Toronto who was researching the SR&ED program for my dissertation. I said that my intention was to take detailed field notes on the seminar and reference my field notes and the presentation materials that were provided to the attendees. I was welcomed by the seminar facilitator (Research and Technology Officer, employed by the SR&ED program through the Canada Revenue Agency who said that my plan was acceptable and that there were no concerns since the seminar was a public meeting. I arrived at approximately 8:35amEST and took a seat in the fourth row. The public information seminar was being held in a lower level room identified as a training centre. It was a large, non-descript room located in the basement of the building. It appeared to be able to accommodate approximately 60 attendees. Tables and chairs were arranged in ordered rows and columns reminiscent of a classical classroom configuration. The Canadian flag was prominently displayed at the front of the room and throughout the room at various locations. Attendance was taken when entering the training centre. The ground rules were posted at the front of the room. They were handwritten and read: Please turn off all cell phones/set to vibrate or silent No recording devices please Timeline (approx.) o 9:00 10:45 o 10:45 11:00 o 11:00 12:00 o 12:00 1:00 o 1:00 1:30 science/technical break examples lunch Ontario

64 o 1:30 3:30 Financial

This agenda posted in the information seminar differed slightly from the agenda that was provided in the email confirmation letter prior to the meeting. The addition of the agenda item indicated by Ontario was not included in the confirmation letter. During the introduction, the facilitator indicated that a representative from the Province of Ontario was present and would review the available tax incentive programs available through the provincial government. Upon arrival, on my desk I found two documents. The first document was a printed copy of the slides that were to be presented. There were 127 slides in total and they were provided as an entire slide set. The slide set was tagged with a copyright notice labeled as 2005, Government of Canada. The complete slide set is attached as Appendix D, including those sides that were provided by the representative from the Province of Ontario. The second document was an evaluation form entitled Canada Revenue Agency SR&ED Seminar Evaluation Form. It was two pages in length. The public information seminar began promptly at 9:01 am. During the introduction, the facilitator introduced himself as a Research and Technology Officer (RTO) working for the Canada Revenue Agency in the SR&ED program. The RTO welcomed attendees, reviewed the ground rules that were posted at the front of the room and the agenda. He also reminded all attendees that the seminar was a public forum and to be conscious of disclosing any proprietary information to the group when asking questions. There were approximately 45 attendees present. Men appeared to outnumber women by a fourfold ratio. The attendees did not introduce themselves. The seminar began promptly following this basic introduction. The RTO continued and reviewed the first 6 slides provided in the handout. The 6 slides provided a basic definition of the SR&ED program, what the program offers, basic requirements and what types of claims are available. After this review, the RTO introduced the Research and Technology Manager (RTM) for the Canada Revenue Agency SR&ED program. She completed the remainder of the morning agenda that included the science/technical portion and examples section listed in the timelines posted at the front of the room.

65 The RTMs presentation began with slide 7 on page 2 of the slide set titled What Work Qualifies. She began by explicating the basic definition of SR&ED and stressed that the basis of the definition was rooted in a systematic investigation by a process of experimentation or analysis by scientific means. Ultimately, this definition implies that research is expected to be constructed by the tenets of the scientific method and evidence-based medicine (where applicable). I took note of two other statements that she ultimately returned to many times over the course of her talk. She stressed that objective, measurable testing is the key benchmark to consider when evaluating the validity of claims. As well, she established the key theme of her talk early in her introduction by introducing the concept that the SR&ED program was designed to encourage companies to achieve advancement in technology. She was very emphatic on this definition and returned to this statement many times to answer questions from the attendees and to stress a particular point. I began to take note of how many times she invoked this statement and was able to document 21 separate times in which she returned to this statement. An analysis of this key concept of the advancement of technology will be further explored in the analysis and discussion section of chapter 4. The presentation followed the slides directly. The RTM delineated the categories of knowledge produced and evaluated through the SR&ED tax credit program. She specified that the SR (scientific research) portion of the program included category A/basic research and category B/applied research. The ED (experimental development) portion of the program included category C/experimental development and category D/technical support work. According to the presentation slides and the verbal presentation, most claims in the program occur through category C claims. A percentage was not provided. Category D claims are only allowed in conjunction with one of the other three categories. The RTM went on to explicate the definition for each of the categories of SR&ED knowledge. The provided definitions are referenced in the presentation slides (see Appendix D). The following were the definitions that were provided for discussion. Please note that formatting including bolding and underlining was present in the original text in the presentation slides and is reproduced here directly.

66 A. Category A/Basic Research: work undertaken for the advancement of scientific knowledge without a specific practical application in view. B. Category B/Applied Research: work undertaken for the advancement of scientific knowledge with a specific practical application in view. C. Category C/Experimental Development: work undertaken to achieve technological advancements for the purpose of creating new, or improving existing, materials, devices, products or processes. D. Category D/Support Activities: work that directly supports and is commensurate with the needs of experimental development, applied research or basic research and is one of the following 8 specific types of work: engineering, design, data collection, computer programming, operations research, testing, mathematical analysis, psychological research. The RTM indicated that the remainder of her lecture would focus on Category C because it was considered the most problematic in the claims process. The slide 3 on page 3 of the handout includes a slide entitled Program Boundaries. The RTM discussed the map on this slide as a visual explication of the program boundaries for the SR&ED program where the middle, gray area (not visible on slides since they were provided as black and white slides but it was visible in the presentation screen) is problematic and sometimes unclear in the claims process and the evaluation of that knowledge. She emphasized that the boundaries are specific but that every situation is fact based between what is SR&ED eligible and earns investment tax credits (ITC) and other R&D that does not earn ITC. She made the point that ultimately it is the mandate of the Canada Revenue Agency to determine and set the boundaries, and ultimately, to interpret what is eligible or not. To emphasize this mandate, she used this juncture to advocate for the qualifications of the department that is responsible for the SR&ED program. She indicated that everyone in the department had, at minimum, a Masters graduate degree and most had a Doctorate degree. They were also not recruited to the department without more than 10 years of industry experience prior to joining the Canada Revenue Agency. While any RTO was qualified to review claims from any field, the Canada Revenue Agency did attempt to match RTOs to claims from their primary field

67 of expertise. No data was provided to support this claim and this information is not included in the slide deck provided. The RTM moved on to discuss the concept of technology specifically. According to the RTM, the Income Tax Act does not define technology in law. She provided her own definition on slide 6/page 3 of the handout. She drew on this definition from a dictionary definition but did not provide the source. In future guidance documents, the SR&ED program will be establishing an official definition. In the interim, the department considers this to be a guiding definition: Technology the systematic knowledge and application of tools, materials, processes and energy to the making of objects or for achieving other practical objectives. Further to this definition, the RTM provided a guiding definition for technological advancement: Technological advancement development of a characteristic, capability or know-how not previously existing or available. While providing these guiding definitions, she was very clear in the perspective that the application of known technology to solve problems is not SR&ED. The analysis and discussion will consider these definitions in greater detail within the framework of knowledge production in science and technology as a process and the role of innovation in that process of discovery. Under the title of Advancement and Uncertainty, there was a great deal of discussion around how these limitations and definitions are applied. The RTM explicated these definitions and challenges as follows: If a problem cannot be solved by the application of known technology, then experiments must be done to solve the problem and achieve an advancement of technology. This is work that is SR&ED eligible if the following conditions exist: Technically competent people (for the work being done) must apply a base level of technology that is known within a company that includes utilizing all of the available human capital sources and within the published literature that is available within the public domain that is reasonable accessible to the technically competent people. This will be subjectively judged as acceptable or not by the assigned RTO assigned to the claim by CRA. While the argument can be made that all research builds on what has gone before and could be referred to as advancing the technology, the RTM was very clear and focused on ensuring that the attendees understood that technological advancement is the basis of understanding the goal of the SR&ED program.

68 Interestingly, the RTM stressed that advancement is the capability or know-how and not a physical thing as referenced on slide 2/page 4. The point was made that innovation alone is not sufficient for SR&ED and that it must be in conjunction with overcoming a technological uncertainty and obstacle or limitation. Many questions and clarifications around these issues followed this part of the presentation. Attendees posed questions and examples about technical uncertainty and what would constitute technological obstacles or limitations. The RTM explicated this process as a problem that exists when known technology does not work and one must embark on experimentation to solve the problem. An interesting map was presented on slide 3/page 4 under the title of SRE&ED Does Not Equal R&D. Rather, SR&ED eligible work occurs at the points where a technological barrier is encountered and a series of experiments is required to overcome that technological barrier. Additionally, in the process of experimentation, several technological barriers could be encountered at various points and would each be considered and tracked separately as SR&ED eligible claims. This section of the lecture drew many questions from the attendees. Interestingly, knowing that the meeting was a public forum, the attendees tried to frame their questions and examples in such a way so as not to divulge their intellectual property or any proprietary information. From here, the lecture moved on to a discussion about what is meant by systematic investigation. Similar to technological advancement, the Income Tax Law does not define systematic investigation but it is defined in jurisprudence. The reference was not provided but the guiding principles of the definition used by the Canada Revenue Agency were provided on slide 5/page 4. Systematic Investigation includes the following steps: Hypothesis is formulated, Experimental tests, Analyses though physical, chemical, biological means, mathematical or computer simulations, Results, Deduction, Conclusion; Carried out by qualified individuals with suitable experience. While explicating this section, the RTM repeated 6 times that evidence must be shown to verify these claims and that the process of tracking of evidence must begin as soon as a technological barrier is encountered in order to be SR&ED eligible. There must be verifiable, dated examples of evidence. Retroactive documentation is not acceptable.

69 The point was clearly made that the issue is never around the product that is produced. Rather, that is the result of the advancement of technology and any commercial costs associated with production must be separated from the experimental costs for the purposes of SR&ED. This portion of the lecture concluded with a review of the SR&ED Project Model on slide 2/page 6. This was a slightly different but similar interpretation of what constitutes SR&ED eligible work through the R&D process that was presented on the map on slide 3/page 4. The model specifies that SR&ED eligible activities are limited to those that can be classified as part of technological limitation, hypothesis, experimentation and advanced technology. The upstream and downstream activities outside of these activities are not eligible. The RTM concluded this portion of the agenda at approximately 11:00 am after speaking for approximately 1 1/2 hours. A 15 minute break began. During the break, I presented myself to the RTM and identified myself as a student from the University of Toronto, working on my dissertation on the SR&ED program. I stated that my presence was not subject to an ethical review because of the public nature of the forum and that I would be taking detailed field notes and referencing those and the slide deck in my dissertation. No issues were expressed by the RTM who was very welcoming and said super, great in response to my work. The public forum resumed at approximately 11:16am and the RTO indicated that the agenda was approximately 15 minutes behind schedule. The RTO continued with the agenda on slide 3/page 6 Claim Completeness and How to Write a Project Description. The taxation office that reviews these claims is located in Sudbury, Ontario and the deadline for submission of all documentation related to a claim is 18 months past the end of the fiscal year of a company. No claims will be accepted after this date. The RTO reviewed the technicalities of claim submissions at the taxation centre. He reviewed the claims process and the target timelines that are associated with the claims process. He indicated that the Canada Revenue Agency meets 90 to 95% of the time targets noted on slide 4/page but did not provided a reference to support this claim given orally. The most noteworthy comment made by the RTO during this discussion was that the claim forms

70 (Forms T661 Part 2) limit the project description describing the technological advancement to 350 words. The summary of work and explanation is limited to 700 words (see slide 4/page 8). The RTM returned to present the slides on Example Project Descriptions and Eligibility (slide 3/page 9). This section reviewed examples and case studies to illustrate the requirement of technological advancement. The RTM explicated that technological advancement must be presented as a method or process. A process of compare and contrast was used to illustrate examples and samples that outline the process and work that was done to achieve the technological advancement. She stressed that it is important to not use the jargon of the Income Tax Act but to clearly state the problem and the process. Ultimately to be SR&ED eligible, claims must achieve a technological advancement (T.A.) through systematic investigation (S.I.) by qualified individuals (Q.I.) and supported by evidence (E). Figure 3 represents an envisioned algorithmic representation of what I believe the intention of the presentation was designed to explicate.

T.A. + S.I (Q.I.) = E = SR&ED eligible

Figure 3. Algorithmic representation of SR&ED eligible claims.

The morning portion of the agenda ended at approximately 11:56am. The RTO concluded with a brief overview of the services offered by the Canada Revenue Agency to support the SR&ED program outlined on the website and he outlined the dispute resolution process that is available. The public forum took a lunch break from approximately 12:04pm until 1:00pm. Prior to resuming the afternoon session, I again declared my status as a student to the scheduled afternoon speakers including the RTO, a Financial Officer (FO) and the representative from the Government of Ontario, Ministry of Revenue (Sr Tax Revenue Specialist). These speakers confirmed acceptability with my presence and had no issues to declare. The RTO again stressed that is was a public meeting and I was welcome to document as I wished.

71 The afternoon session began with the Sr Tax Revenue Specialist for the Government of Ontario, Ministry of Revenue. She also provided a slide deck that included 34 slides. She began to speak at 1:00pm promptly. She outlined the 4 R&D tax incentives available to Ontario businesses. Her presentation focused on the technicalities and accounting of the tax credits. While the scope of these tax credits as tools of knowledge production and innovation are not within the scope of this project, it is important to note that there are several programs that run in parallel to the federal SR&ED program. The slide deck is provided for reference as Appendix D. She completed her review at 1:24pm and took a short question and answer period on the application of Ontario tax credits. Very few questions were posed at this time. At approximately 1:25pm, the FO began to speak. The first half of his talk (approximately 1 hour) reviewed the specific of the accounting around expenditures and tax advantage. The second half of his talk (approximately 1 hour, following a 15 minute break) reviewed the technicalities involved with completing the tax forms for efficient claims processing. He stressed two main concepts: the importance of maintaining proper books and records (textually mediated) and references to all or substantially all (ASA) as benchmarked at 90% or more as the tipping point in allowing claims. He ended the public forum by reviewing the accounting of a financial example of a case study entitled Case Study: T661 LTD. This portion of the public information meeting was clearly targeted at the accounting aspects of the SR&ED program; currently beyond the scope of this project. Preamble to the Data Review of Appendix A: The Public Consultation Documents Appendix A represents a highly textualized and data dense volume of documents to review as part of this analysis. In order to more fully prepare the reader for the volume of details and information contained within this analysis, an introductory section is necessary to lay the groundwork to better appreciate and process the ideological intent and purpose. What will emerge through the reading of the submission documents (see Appendix A) through the key data fields that were captured as part of the standardized data extraction form is an ideologically driven public and private policy mandate that is clearly in line with the neoliberal economic and political policy goals of the Canadian Federal Government. A prereading of the text Mobilizing Science and Technology to Canadas Advantage: Progress

72 Report 2009 (Department of Finance Canada, 2009b) outlines the key nation-state objectives for policy design for knowledge production in science and technology; driving the agenda of the innovation discourse. The document is a boss text that is a coordinated policy effort jointly produced by the Office of the Prime Minister (currently Prime Minister Stephen Harper, Conservative Party of Canada), and the ministries of Industry, Finance and State for Science and Technology. It outlines four key strategies as a means to achieve what is characterized in the opening message by Prime Minister Stephen Harper (Department of Finance Canada, 2009b, p. 1) as Our vision is to make Canada an even more attractive international destination for research, investment and work in the fields of science and technology. The four key strategic policy directives include the following (Department of Finance Canada, 2009b, p. iii): 1. Entrepreneurial Advantage making Canada a World Leader in Innovation through Science and Technology by a. Creating a competitive and dynamic business environment b. Strengthening public-private research and commercialization partnerships c. Increasing the impact and efficiency of Federal research and development assistance 2. Knowledge Advantage Positioning Canada at the Leading Edge of Global Science and Technology by a. Targeting world-class research excellence in areas of health, social, environmental and economic opportunity b. Maintaining Canadas G-7 leadership in public sector research and development performance c. Enhancing accountability and value for money from the granting councils d. Exploring new approaches to federally performed science and technology 3. People Advantage Growing Canadas Base of Knowledge Workers by a. Creating a competitive labour market environment b. Developing the next generation of science and technology workers c. Attracting the best minds from around the globe d. Expanding opportunities for Canadians in a changing economy

73 e. Fostering a strong science and technology culture 4. A Modern Approach to Science and Technology Management by a. Making Canada a world leader through stronger domestic and international partnerships b. Revitalizing our external science and technology advisory bodies c. Improving science and technology impact measurement and reporting Outlined within this strategic goal are four priority areas that were identified in the Executive Summary of the Progress Report (Department of Finance Canada, 2009b, p. 9). They include environmental science and technologies, natural resources and energy, health and related life sciences and technologies, and, information and communications technologies. The Progress Report expands on each of the four key strategies and the four priority areas throughout the report with an emphasis on the perceived, successful implementation of this strategy and augmented by examples from the private sector in terms of innovative commercial success. The Progress Report concludes with a statement that As part of the governments long-term plan to build a globally competitive economy, the S&T Strategy aims to help increase the prosperity of Canadians and improve their quality of life. More specifically, the Strategy provides a vision to create highly skilled job opportunities, a cleaner environment and healthier communities (Department of Finance Canada, 2009b, p. 45). A pre-reading of this document accurately lays the groundwork for understanding the policy and ideological directives that arise within the textual analysis of the submission documents that follow. What emerges is a coordinated hegemonic system and institutional structure that positions science and technology knowledge production as the key success factor for government policy directives for national economic and political strategies, and, private industrial, for profit interests. Emergent themes from this textual analysis and review include the innovation discourse, knowledge production as a neoliberal economic, political and social strategy in science and technology, and, the normalizing force and power of science and technology knowledge production by the nation-state. Further discussion on these themes will be developed in the major analysis in chapter 5 and 6.

Chapter 5: Analyses and Discussions

This chapter will include the analyses and discussions that resulted from the collected data: field notes and the submission documents. The intention is to clearly illuminate and position the SR&ED program within the global context, the current landscape for the global production of science and technology knowledge production, and, an analysis that explores the surplus value associated with the power of the innovation discourse. Analysis and Discussion: Canada Revenue Agency Public Information Meeting and Public Consultation Documents My impression, observations and analysis of the public meeting will centre on two main aspects: the attendees and the major themes that were explicated by the presenters. Firstly, my observation and impression of the attendees was determined by the types of questions that were asked and how they were posed to the presenters. Additionally, the counter responses in challenging the presenters in follow up questions and comments was also a key indicator of the goals of the public meeting. The attendees seemed to assume a more challenging or adversarial position in posing their questions. They wanted specific clarity over the definitions that were provided and the types of eligibility criteria that were listed and provided as guidance. They were very careful in posing their questions and responses to phrase them in such a way to be as close as possible to their actual example without revealing any intellectual property, proprietary knowledge or in some cases which industry they represented. The counter responses from the presenters from the Canada Revenue Agency tried to focus the discussion repeatedly on whether there was advancement in technology and not on the activities or work processes that the attendees represented. The discussions sometimes took on the tone of a cat and mouse game where the attendees were trying to phrase and re-phrase their questions in order to elicit a particular response or answer from the presenters. The presenters usually countered with the mantra of whether advancement in technology was truly achieved and how that milestone may or may not be defined by the Canada Revenue Agency.

74

75 This was clearly a point of contention for the attendees since technology is not defined by the legislation and is left to the subjective interpretation of the department officials. As previously discussed in the literature review, the notion of objectivity is a social construct that is ideologically determined and in this case is primarily determined by the methodological guidelines of positivism and the classic scientific method. It was interesting to note the dichotomy in this situation. A subjective interpretation of a scientific definition, in this case advancement of technology, is being constructed by individuals and applied to create the illusion of an objective measurement and method of assessment and evaluation. Ultimately, the application of this subjective interpretation results in a validation of the knowledge produced and whether advancement in technology was achieved is based on the primacy of the scientific method as the only approved research methodology. The definition excludes all other possible methods of inquiry and solidifies the ideology of positivism as the preferred (and only) research methodology. The second major area of discussion and analysis centred on the four major themes that emerged during the public information session and the post-meeting analysis of the field notes: 1. The definition of SR&ED 2. The concept of objective, measurable testing 3. The concept of systematic investigation 4. The requirement of an advancement in technology Firstly, consider the definition of SR&ED which was provided as a systematic investigation by a process of experimentation or analysis by scientific means (see Appendix D). Consider that this is essentially a definition of the scientific method. For projects directed towards the health sciences, this specifies the requirement of research in accordance with evidence based medicine guidelines. Secondly, the concept of objective, measurable testing invokes the language and discourse of evaluation and validity techniques (that is to say, the scientific method previously critiqued). Thirdly, the concept of systematic investigation is further extended as the required methodology and analytical process. Lastly, the mantra of advancement in technology is a key point in this discussion and analysis.

76 Taken together, all four of these themes provide a framework for a methodological approach that is firmly and ideologically rooted in positivism. Additionally, discussing the difference between advancement in technology and technological innovation as a discourse in science and technology is important to consider in this narrative and critique. What is the relationship between innovation and advancement in technology? Is innovation the same as advancement in technology or is one a subset of the other? While a detailed exploration of the relationship between innovation and advancement in technology is beyond the scope of this project, an explication is merited here as part of this analysis. However, consider the critique proposed by Sunder Rajan (2006), because biocapital is a techno-scientific enterprise, its component institutions are involved in the production of scientific fact, and in technological innovation (p. 111). Ultimately, the production of scientific fact and the resulting innovation are social constructs of ideological definitions of positivism based on the primacy of the scientific method as the only acceptable form of research methodology. However, there is an inherent dichotomy in this methodological approach and explication. The outcome of innovative experiments are by definition unknowable; the market inputs into these experiments, on the other hand, need to calculate and look forward to a return on their investment (Sunder Rajan, 2006, p. 111). In the case of the SR&ED program, the core requirement to achieve advancement in technology, ultimately, is a retrospective exercise. Did we achieve an advancement in technology versus will we achieve the same? The SR&ED program is designed around guaranteeing a particular goal. Encased within the goal of advancement in technology is the language and discourse of business and not science or ethics. The government program and the applicants to the program (as exemplified by the attendees to the public meeting), use such language as return on investment, business tax credits, amplifying the value of ROI when discussing the utility of the program and the value to their particular companies. Both stakeholders (government and private industry) are ultimately concerned with the maximum utility and commercial viability of their investment. The private industry most concerned with a product capable of mass commercialization and the government most concerned with increasing the gross national product through economic investment; a high return on investment, increased revenue earnings, and corporate growth value systems whose ideologies are increasingly globalizing and

77 homogenizing (Sunder Rajan, 2006, p. 113). Resources directed at technological gaps where economic return is minimal if not, non-existent (for example, orphan drugs for rare medical conditions), are not considered in this model; however great the technological advancement required to solve that unknown might be. Sunder Rajan (2006, p. 113) goes further to explain this dynamic: What brings therapeutic and commercial realization into proximity to each other is the ideology of innovation a high-risk, free market frontier ideology that is simultaneously particularly American and globalizing. Innovation is a qualitatively different (albeit related) concept from the Industrial Revolution or Marxian concept of surplus value generation. Indeed, it is the concept of innovation as an economic and social driver that is at the root of programs like the SR&ED program. The blurry assumption in this paradigm is that advancement in technology and innovation can be interchanged. The model is predicated on innovation leading to commercialization and, ultimately, economic success in a direct co-relationship. For the SR&ED program to be considered a success by the key stakeholders (government, private industry and citizen tax payers), advancement in technology must result in innovation which will lead to commercial utility and a return on investment for both the private enterprise and the government who represents the citizen tax payer. However, it is this smoke and mirrors approach to innovation as an economic discourse that conceals the true power of innovation as a mystical and magical generative force, the source of capitalisms power (Sunder Rajan, 2006, p. 113-114). The next stage to this normalization of the power and discourse of innovation is the solidification of the scientific facts associated with the innovation. The ideology of positivism assumes that the scientific methods, generally, and evidence-based medicine methodology, specifically, result in the production of scientific facts. Because of this paradigm, the life sciences also produce facts...and because they are facts (as opposed to, for instance, hypotheses, theories, or speculations), they operate with a certain authority (Sunder Rajan, 2006, p. 114). This is the value and power that is inherent in this methodological approach and because of it, a value-laden ideology such as innovation manages to be globalizing and apparently homogenizing

78 in its application but in fact calls into account different registers of salvationary and nationalist discourse and consciousness depending on the sites of its manifestation (p. 189). The media discourse is currently dominated by headlines that tout the concept of ideology of innovation as the next frontier of national economic salvation (Alvarez, 2011; McKenna, 2011, 2012). The idea is that innovation is an economic determinant and that nationstates must promote and create the environment required to produce innovation and ultimately, advancement in technology. Or, is it that advancement in technology will ultimately produce innovation? The discourse itself is unsure. Consider that: The overarching tension between, on the one hand, a consciousness of colonialism that sensitizes state policy regarding unequal exchange relations, and on the other hand the post-1990s determination to become a major player in the global market system, plays itself out at the level of everyday work practices; state policy statements, initiatives, incentives, and regulations...and the struggle between self-reliance and the use of science and technology to solve local problems...versus its use to leverage the global playing field. (Sunder Rajan, 2006, pp. 189-190) Returning finally to the public meeting under discussion, the over-riding mantra about advancement in technology is the key requirement of the program. There is an inherent juxtaposition in the SR&ED program where the focus has nothing to do with solving local, national or global programs through science and technology, but rather on creating technology that advances the discourse of innovation and knowledge production as an economic strategy through privileged methodological methods (i.e., EBM and the scientific method). This is ultimately a policy and program that inhibits innovation as a knowledge creative production process because of the blind fixation to advancement (and the innovation discourse) as the primary and sole requirement of success. Analysis and Discussion: The R&D Global and National Landscape in Science and Technology as a Consequence of the Public Consultation Process As a result of the public consultation process from 2007 through 2008 which solely included the submission of the public consultation documents reviewed in Appendix A, the only change instituted by the government was an increase in funding to the program and some minor

79 administrative changes to the administration of the program. Public and private spending on research and development in science and technology is widely believed to provide benefits throughout the economy and directly to the investor through a variety of mechanisms including lower prices, improved products and access to new technologies. As a result, it is a global practice for governments to provide assistance and incentives for private industry to invest in R&D (i.e., the SR&ED program in Canada). However, it is challenging to provide a true country to country comparison of R&D assistance and incentive programs across the globe because support can take a variety of forms including grants and loans, procurement and patent policies, taxation benefits, and, protection for intellectual property. Hence, the comparison to follow will be a relative comparison (Department of Finance Canada, 2009b). More than 30 countries have enacted R&D incentive policies at either a national, state or provincial level depending on the jurisdiction. Incentives are often delivered either in the form of credits (as in the case in the SR&ED program in Canada), tax deductions or direct cash refunds through tax refunds. Depending on the jurisdiction as well, R&D can be classified as one of the following: product development, process improvements and software development. At the multinational, industrial level, a cross-border global assessment of R&D incentives is an important policy consideration in the planning and distribution of R&D. Interestingly, the definition of R&D globally is quite similar and includes consistent activities. Essentially, R&D must include activities that include the following: 1. Scientific or technological advancement where there is a proposed technological advancement regarding a new or improved product, process, or design. 2. Scientific or technological uncertainty where there is uncertainty as to whether the project objectives can be achieved at all, or which of several paths to take to meet the desired expectations. 3. Scientific or technical content where this is a defined process of experimentation to eliminate the uncertainty (Department of Finance Canada, 2009a). Some of the key differences globally across different jurisdictions include the following considerations:

80 1. Whether R&D must be performed in the country that is offering the incentive. 2. Whether the R&D investor must assume the economic risk associated with the R&D activities. 3. Whether R&D must be performed by the claimant claiming the incentive or whether it can be contracted to a third party (i.e. a sub-contractor, an investor). 4. Whether R&D activities can be funded by a third party. 5. Whether the intellectual property that is developed must continue to reside in the country that grants the incentive (Department of Finance Canada, 2009a). The Organization of Economic Co-operation and Development (OECD) has developed a measure to estimate the tax subsidy for every additional dollar spent on R&D by companies. This method allows for international benchmarking of these incentives and comprehensive comparison of the attractiveness of various tax regimes globally. The model includes tax credits, cost allowances from taxable incomes, depreciation allowances and corporate income tax structures as the fundamental drivers for the benchmarking exercise. Canada currently ranks within the top ten most generous tax regimes in the world for both large and small companies (OECD, 2012). The following table 2 is a summary of various R&D tax regimes and incentives offered by selected nations globally. In the United States, the R&D tax credit expired in 2008 but Congress renewed the law in 2008, extending the credit through to December 31, 2011. The law includes three versions: traditional R&D credit, Alternative Incremental Research Credit (AIRC) and the Alternative Simplified (ASC) that provides benefit to companies that were unable to derive much benefit from the two other credits. Current US law also requires that the deduction for R&D expenses be reduced by the amount of any R&D credit and this drives the effective rate even lower. As a result, the United States R&D incentive appears to be less generous that those offered by other countries. In 2005, US-owned global companies spent $28.3 billion in R&D overseas, up from $15 billion in 1998 (a 47% increase). Even though in 2005 US parent companies spent $178.5 billion in R&D in the US, up from $140.1 billion over the same period, the R&D expenditures of US-owned global companies overseas continues to grow, most notably in Europe and Asia Pacific, that is China and India (Deloitte Consultants, 2011).

81 Table 2 International Comparison of R&D Tax Incentives

Country Australia R&D tax incentive Allows a 125% deduction for R&D expenses Plus a 175% deduction for R&D expenditures exceeding a base amount of prior-year spending. Comment The 125% deduction is the equivalent of a flat 7.5% R&D tax credit. In discussing its R&D-friendly environment, the Australian governments website (investaustralia.com) concludes, Its little surprise then, that many companies from around the world are choosing to locate their R&D facilities in Australia. The government also points out that 50% of the most innovative companies in Australia are foreignbased.

Canada

Offers a permanent 20% flat (i.e., first-dollar) R&D tax credit. Also, many provincial governments offer various incentives (e.g., refundable credits) for R&D activities conducted in their provinces.

In 2003, U.S. subsidiaries spent $2.5 billion on R&D in Canada, which has mounted an aggressive marketing campaign, including television and print advertisements, to lure more U.S. companies to locate R&D operations north of the border. Ontario print ad discusses R&D tax credits, among the most generous in the industrialized world and a cost structure which KPMG confirms as lower than the U.S. and Europe; the ad concludes, youll see why R&D in Ontario is clearly worth investigating.

China

Offers foreign investment enterprises a 150% deduction for R&D expenditures, provided that R&D spending has increased by 10% from the prior year.

The 10% incremental-increase threshold should not be difficult to meet for U.S.-owned companies growing start-up operations in China. Chinas Ningbo Economic & Technical Development Zone (NETD) invites global companies to enjoy a number of preferential taxation policies, as well as other benefits.

82

Country France

R&D tax incentive Allows a 40% R&D credit for R&D expenditures in excess of average R&D spending over the 2 previous years, OR a 10% flat credit on volume.

Comment France recently expanded the scope of eligible R&D expenses that serve as a basis for the computation of the credit. Beginning in 2006, taxpayers can take into account twice the actual amount of salaries paid during 12 months for the first employment of certain newly-graduated searchers; and can claim up to Euro 10M (up from Euro 8M) in research sub-contracting payments made to certain qualifying entities. This is the first time in our industry that Americans are coming to Europe to join the R&D of Europeans, Pasquale Pastore, President and CEO of STMicroelectronics, in The New France. Where the Smart Money Goes.

India

Companies carrying on scientific research and development are entitled to a 100% deduction of profits for 10 years. Automobile industry also is entitled to a 150% deduction for expenditures on in-house R&D facilities.

More than 100 global companies have established R&D centers in India in the past 5 years, and more are coming. As I see it from my perch in Indias science and technology leadership, if India plays its cards right, it can become by 2020 the worlds number-one knowledge production center, Raghunath Mashelkar, Director General, Council for Scientific & Industrial Research, India, in Science Magazine.

Ireland

Offers a 20% R&D tax credit, plus a full deduction, as well as a low generally applicable 12.5% corporate income tax rate. R&D grants also available, covering up to 50% personal and capital costs. Capital expenditures may also qualify for a separate flat credit. No stamp duty on transfers of IP into Ireland.

According to IDA Ireland, the government agency with responsibility for the promotion of direct investment by foreign companies into Ireland, The IMD World Competitiveness Yearbook 2007 ranks the investment incentives available in Ireland to foreign investors as among the best in the world. IDA Ireland is committed to supporting our clients to establish and grow R&D activities in Ireland. See IDA Ireland (2011) for further details.

83

Country Japan

R&D tax incentive Offers a flat 10% R&D tax credit (a 15% flat credit is provided for small companies), in addition to other incentives.

Comment In 2003, Junichiro Mimaki, an official from Japans Ministry of Economy, Trade, and Industry has reported to the Bureau of National Affairs that R&D and IT tax relief has created 400,000 jobs and boosted gross domestic product by 6.1 trillion yen ($55 billion) over 3 years.

Korea

Tax holidays, up to 7 years, are provided for high-technology businesses. In addition, a variety of tax credits are provided for R&D type expenditures.

Korea has been moving aggressively to attract foreign R&D investment, promoting not only tax incentives but also other benefits for foreign companies locating R&D in the Incheon Free Economic Zone (IFEZ).

84

Country Poland

R&D tax incentive Acquisition cost of the R&D results is tax deductible up to 150%. Entities having an R&D center can establish within the entity an innovative fund. Monthly contributions to this fund amounting to 20% of the given month revenue, are treated as deductible costs. Revenues from the R&D activities carried on in Special Economic Zones are exempt from corporate income tax up to 70% of investment cost or 2 years labour costs.

Comment Polands definition of R&D generally conforms to EU legislation and the OECD Frascati Manual that defines R&DC guidelines. The following R&D expenditures are eligible: Remuneration of personnel directly involved in R&D project Depreciation costs for equipment used in R&D activity Consultancy costs and other services linked to R&D Additional expenses incurred directly for the R&D activity In addition to tax incentives, there are EU and national budget grants up to 100% of R&D costs. There is also a technology credit with preferential interest rates (repayment of only 50% of the credit capital) this is designed to finance technology investments including purchase and deployment of new technology and production of new or modernized products based on this technology. It is permissible to combine various forms of the abovementioned incentives to get the best incentive opportunities in Poland, however state aid rules and regulations must be observed.

Singapore

R&D and Intellectual Property Management Hub Scheme offers U.S. companies a 5-year tax holiday for foreign income earned with respect to Singapore-based R&D.

According to Singapores Economic Development Board website, Singapore does not just welcome business ideas; it actively seeks and nurtures them. We play host to any shape and size of enterprise and innovation start ups with little more than the germ of an idea; global corporations with large R&D teams and complex production operations.

85

Country Thailand

R&D tax incentive Offers a 100% deduction on expenses, and Income tax exemption on R&D results

Comment The deduction is based on volume of R&D performed and the income tax exemption is based on R&D results up to R&D expenses.

United Kingdom

Allows a 130% deduction for R&D expenses, plus a 175% deduction for small and medium sized companies for R&D expenditures exceeding a base amount of prior-year R&D spending.

The UK leads the world in attracting R&D investment by U.S. affiliates U.S. subsidiaries spent more than $4 billion on UK-based R&D in 2003. The 125% deduction alone is the equivalent of a flat 7.5% R&D tax credit.

United States

Provides a maximum 10% credit for qualified R&D expenditures in excess of a 1984-88 base (measures R&D expenditures against gross sales receipts for the period). The Alternative Simplified credit provides a credit of 12% of R&D expenses that exceed 50% of average R&D expenses over the prior 3 years. The Alternative Incremental Research Credit formula combines a three-tiered fixed base percentage with a reduced three-tiered credit percentage. The business deduction for R&D expenses must be reduced by the amount of any R&D credit.

The US R&D tax credits are based on incremental spending of R&D according to specific criteria. Companies are able to elect one of 3 versions of the credit. There is also legislation to increase the ASC credit benefit from 12% to 20%. In 2006, Congress passed for the first time, a new Alternative Simplified Credit ("ASC") that does measure R&D activity against gross sales revenue for a 1984-1988 base period -- rather its formula reflects a companys research spending. The gross receipts formulation in the traditional credit has caused tremendous distortions for most companies and its benefit was limited for companies such as IBM, so IBM helped craft the ASC.

86 Consider now the philosophical frameworks that illuminate these global processes and regimes and how they are hooked into the material aspects of knowledge production and the implications for science and technology. Cooper (2008, p. 62), proposes that: Herein lies the idiosyncrasy of neoliberalism as a political practice: where welfare state nationalism saw the standardization of growth as a limit to be attained in some utopian future, neoliberalism confronts it as a historical limit to be deflected, no doubt because it is threatening to become all too attainable. Faced with declining levels of productivity, the neoliberal response is to blame the social state and its politics of national redistribution. The solution it proposes is simple: the state must divest itself of the burdens of social reproduction and redirect its energies toward the accumulation of capital beyond the boundaries of the nation. In this way neoliberalism declares war against the whole standardization of life that underlies the very idea of social-state nationalism. The truth it espouses and this is the crude truth of capitalism, according to Marx is that in the long run there is no mediation to be found between the rhythms of production and consumption, no progressive transition from third to second to first world that does not as some point enter into conflict with the blunt need to increase the production of relative surplus value. For this analysis, the expansion and exploitation of multi-national corporations to conduct R&D in science and technology in global markets is based on an assessment of the most highly favourable tax regimes that will allow them to extract the most surplus value from the products of their R&D. The knowledge produced from these market assessments and evaluations is based on the relative value of that knowledge if it were to be produced in differential marketplaces. This inequity in the production value of that knowledge is played out in a marketplace auction where the privilege of knowledge production goes to the regime that is willing to pay the most for it while the producer is trying to pay the least for that production. In the case of science and technology knowledge production in medical research, the relative value against human life becomes the differential between the cost of production and the relative value of the research. Cooper (2008) continues this discussion by a comparison of commodification versus/or financialization. In short, what is at stake and what is new in the contemporary biosciences is not so much the commodification of biological life that is a foregone conclusion but rather its transmutation into speculative surplus value. This is, in the first instance, an actual material process. ...However, there is nothing that predestines such promissory life forms to commercial ends. The transmutation of selfregenerative life into self-valorizing capital requires a decisive legislative

87 maneuver. ...the biological promise is recaptured within the form of an economic surplus value, value which is greater than itself. (Cooper, 2008, pp. 148-149) This is the essence of R&D and the characterization of how the production of knowledge is hooked into the economic policies of nation-states and the commodification process of industry. For the purposes of this analysis, knowledge production in science and technology has direct effects on life and the processes and activities of life. The drive to innovation in science and technology is predicated on progressive advancements in technology. Innovation in and of itself is a progressive self-valorizing process that inherently requires ever increasing amounts of surplus value. How financialization factors into this analysis is dependent on a working definition of the term. Magnusson (2012, p. 4) proposes that financialization [is] broadly [defined] as the increasing importance of financial markets in the sum total of international economic activity. The relationship to profit is complicated by the era of speculative financial markets where profit alone is only one aspect of the value of knowledge as a commodity. Sunder Rajan (2006) incorporates this discussion by introducing biocapital into the analysis. At the same time, because biocapital is a technoscientific enterprise, its component institutions are involved in the production of scientific fact, and in technological innovation. Biocapital is the articulation of a technoscientific regime, having to do with the life sciences and drug development, with an economic regime, overdetermined by the market. The life sciences are involved in fact production that enables the creation of new technologies and therapeutic products (innovation). The outcomes of innovative experiments are by definition unknowable; the market inputs into these experiments, on the other hand, need to calculate and look forward to a return on their investment. Therefore a speculative market place lends itself to innovation, while innovation breeds a speculative marketplace. (Sunder Rajan, 2006, p. 111) By examining the ideology of neoliberal surplus value and the innovation discourse, the process of R&D in science and technology creates an environment of exploitive development where the possibility of what might be produced is the result of both vision and hype. Sunder Rajan (2006) discusses the tools of vision and hype in the innovation discourse as a means to increase the surplus value of knowledge that is produced in science and technology.

88 This is a very detailed and extensive chapter that began with reference to the SR&ED public consultation documents (see Appendix A, to be read in parallel) and the emergent themes from that textual analysis, the current global landscape for R&D and the philosophical frameworks that explicate the relationship between knowledge production and the neoliberal frameworks of globalized knowledge production, the innovation discourse and surplus value accumulation. I will conclude this section with the following quotation from Rose (2007, p. 150): But the regulated political economy of health consisting of relations between the state apparatus, scientific and medical knowledge, the activities of commercial enterprises and the health-related consumption of individuals is being reshaped, as the potentialities embodied in life itself become sources of value. Ultimately, we must consider to what level we, as a society, are willing to accept for the continued progressive exploitation of the material surplus value of our life forms and the knowledge continued therein as commodifiable sources of value. Analysis and Discussion: Health Technology Assessment and the Role of Evaluation Previously, I introduced the concept of health technology assessment (HTA). I return to this again in this section to explore the history, structure, intent and goal of HTA and the relationship to the SR&ED program and how these parallel nation-state apparatuses are hooked into each other. Health technology can be primarily defined as an intervention or method that is used to accomplish one or all of the following goals: promote health, prevent, diagnose, or treat disease, and, improve rehabilitation and long-term care. Materially, these include things such as drugs, devices, diagnostic agents, equipment, procedures, and, systems that provide or deliver health care. Health technology can be described in three primary ways: what is the physical nature of the HTA (i.e., drugs, devices, procedure), what is the clinical purpose (i.e., prevention, screening, diagnosis, treatment, rehabilitation), and finally, what is the stage of diffusion (i.e., future, experimental, investigational, or, established, standard approach). The CADTH provides the following definition:

89 An evaluation of the clinical effectiveness, cost-effectiveness, and broader impact of drugs, medical technologies, and health systems, both on patient health and the health care system. During the assessment, data from research studies and other scientific sources are systematically gathered, analyzed, and interpreted. The findings from this process are then summarized in reports that translate scientific data into information that is relevant to decision making. (CADTH, 2011) Understanding the impact of this framework for this assessment on knowledge produced within science and technology (specifically medical research), and the subsequent application of hierarchies of privileged knowledge which impact on the nation-state decision-making process for approval and reimbursement will form the basis of this section. While a certain type of knowledge is produced through the SR&ED program and privileged economically through tax incentives, that knowledge is then filtered through the assessment mechanisms of the HTA programs in the country and that subset of knowledge is further privileged and exploited by hegemonic nation-state structures. There is an increasing power associated with this knowledge and the decision-making process behind it. Historically, the term HTA was first coined in the United States Congress in 1967 when the US Congressional Office of Technology Assessment (OTA) was established in 1972. The concept for HTA was a product of the OTA and had its origins in 1976 (Banta, 2003). The purpose of HTA was to establish and support an evidence-based policy and mechanism to assess the adoption of new health technologies, improvement of evidence on existing technologies, and, reimbursement of new technologies in an environment with scarce resources. Nation-states have embraced the establishment of HTA programs within their countries as a mechanism to manage the costs associated with health technologies and apply limited resources to those technologies likely to yield to largest return on investment from the perspective of public policy investment. As well, given the increasing rate of diffusion and knowledge production associated with new technologies, HTA provides a mechanism by which credible and scientific information about costs and consequences of health technologies can be thoroughly assessed (CADTH, 2011). The rationale for the utilization and purpose of HTA is often presented as a need to have more evidence before governments will be willing to provide reimbursement for the use of new technologies. The need for more evidence is often presented as the following model: a new promising intervention becomes available but sufficient evidence is currently not available (or

90 considered to be so by the decision-maker) and there is uncertainty regarding how it will be utilized in the healthcare system and the decision-maker is unable to make either a positive or negative decision about reimbursement. HTA is then positioned as the bridge between decisionmaking and research domains (Danish Centre for Health Technology Assessment [DACEHTA], 2011, p. 15). The following process map was retrieved from the Health Technology Assessment Handbook and outlines the process map for the potential utilization of HTA (DACEHTA, 2011, p. 15)

Figure 4. Schematic of the HTA decision-making process.

Draborg, Gyrd-Hansen, Poulsen, and Horder (2005) suggest that HTA has four distinct spheres of knowledge analysis that encompass aspects of clinical, economic, patient-related and organizational factors for decision-making. Each of these spheres includes many sub-factors for analysis which include the following: Clinical factors: efficacy, safety, effectiveness, indications, affected populations, other potential outcomes Economic factors: efficiency, costs, cost-effectiveness, cost-utility, cost-benefit

91 Patient-related factors: social impact, ethics, acceptability, psychological reactions, other patient parameters Organizations factors: diffusion, centralization or decentralization, utilization, accessibility, skills and routines, education and training Presumably, the more factors that are considered in the analysis, the more credible and scientific the HTA and the information presented on the health technology under review. As a result, that knowledge, filtered through the lens of an HTA mechanism, reaches a privileged position within the framework of the analysis. A typical HTA assessment proceeds in a gradated analysis with the following stages: 1. Identify the topic for assessment 2. Clear specification of the problem 3. Sources of research evidence for HTA/systematic literature review 4. Aggregation and appraisal of evidence 5. Synthesize and consolidate evidence 6. Collection of primary data (as appropriate) 7. Economic evaluation, budget and health systems impact analysis 8. Assessment of social, ethical, and legal considerations 9. Formulation of findings and recommendations 10. Dissemination of findings and recommendations 11. Monitoring the impact of assessment reports This positivistic approach to the assessment of science and technology knowledge produced through the lens of HTA, begins with a broader definition of a policy question that is driving the assessment. Primary identification and prioritisation of the topic for assessment, within the scope of a broader policy question, examines many possible questions including the following: 1. Is there a high potential to improve health outcomes or reduce harm? 2. Technology is expensive but promising?

92 3. Size of population to be affected? What is the utilitarian scope of the technology? 4. Available information is uncertain but diffusion pressures are strong? 5. An established technology is associated with significant variations in utilization and outcomes. 6. Is it innovative or controversial or both? 7. Is there political pressure influencing the technology? 8. A critical step in this analysis, once the policy and topic foci are determined, is the evidentiary or systematic review of the literature. Within an HTA framework, a comprehensive search of the literature is based on a systematic, positivistic, methodological approach where there are two main types of resources relevant and essential to HTA: published literature and grey (also known as fugitive) literature. Evidence is categorized into two main types: efficacy evidence where benefits are considered under ideal or controlled conditions (i.e. placebo controlled randomized clinical trial), and effectiveness evidence where benefits are considered under general or routine conditions of use (i.e. real life conditions).2 Rotstein and Laupacis (2004, p. 177), propose that Differences between systematic reviews and health technology assessments: A trade-off between ideals of scientific rigor and the realities of policy making. Within this framework, there are several key factors to consider as part of this trade off. These include: methodological standards, repetition from previous studies, breadth versus depth of knowledge produced, inclusion or content experts and policy makers, performance of economic evaluation, making policy recommendations, and, active dissemination of that knowledge and analysis. Ultimately, HTA is best characterized by a method of inquiry that is rooted in a positivistic review of data and knowledge rooted in the primacy of the scientific method. The issue of quantifying and qualifying real world data is one of the most challenging aspects of HTA. This data is meant to supplement data outside of the large, placebo randomized
2

This information came from a PATH (Programs for Assessment of Technology in Health Research Institute) October 6, 2011, conference I attended in Mississauga, Ontario. The title of this presentation was The Importance of Health Economic & Biostatistics in Health Technology Assessment.

93 controlled clinical trials. This can include large simple trials, registry data, administrative data, health surveys and electronic health records and medical cart reviews. Additionally, assessment of the social, legal and ethical considerations attempts to include a holistic approach to the assessment by incorporating issues surrounding the prioritization of the technology being assessed (i.e., is it consistent with social values?), does the question being asked have relevant outcomes, what is the scope of the assessment and from which perspective is it being considered, has appropriate publication bias been considered during the collection of evidence and data, and, finally, have all appropriate access and equity issues been considered for the dissemination and implementation of technologies. Ultimately, it is important to consider that HTA is an iterative and dynamic process where newly available information, analyses, or revisions in technology, require ongoing and regular re-evaluation and re-prioritization. The incorporation of HTA into the discourse on how and what knowledge is produced in science and technology and the implications for the SR&ED program will be more fully explored in the coming sub-sections. Health Technology Assessment: Relationship to SR&ED and Philosophical Consequences of Privileged Knowledge Understanding the role of HTA and the relationship to the SR&ED program is necessary for this analysis to more clearly understand the hegemonic nation-state structures that influence and privilege the production of knowledge in science and technology. While the SR&ED program and HTA programs are mutually exclusive, they do operate in parallel to each other and the resulting knowledge that is produced in science and technology undergoes a progressive filtering that result in a highly privileged knowledge. This progressive and hierarchical approach to knowledge production is accomplished in a loosely coordinated (yet independent) fashion. As we have previously examined and established, the SR&ED program focuses on supporting the production of knowledge in science and technology that advances technology and is considered innovative. By the very criteria that define the SR&ED program, a specific type of positivistic knowledge is produced within a neoliberal economic and political environment where economic utility within the innovation discourse is the valued and privileged knowledge. This knowledge (or rather the agents of

94 production i.e. the private sector industry and the nation-state partners) is then further privileged with economic incentives (i.e., favourable tax structures). Once the knowledge passes the standards of acceptance outlined by the SR&ED program, it is then subjected to further evaluation through the HTA programs. The HTA programs would then apply their own standards of evaluation. However, rather than the goal of tax incentives that exist within the goals of the SR&ED program, the goal of a favourable HTA assessment is to ensure that the review of the technology results in a recommendation for society and governments to uptake that technology and to justify the costs associated with the new or revised technology. This privileging of knowledge, and credentialing by default, results in the establishment of gold standards; particularly within the health care sector. It is important to note that knowledge that is produced from R&D in science and technology that is not eligible as per the criteria of the SR&ED program can also be evaluated via an HTA framework. However, as previously discussed, it is likely that this knowledge does not meet the established standards, according to the government criteria, for either an advancement of technology or innovation. Consider then, what is the value of HTA? ODonnell et al. (2009, p. S1) propose that it is clear that HTA brings together public and private interests in a process in which there are potentially winners and losers, and the perception of outcome is highly contingent on each partys point of view. Critics charge that HTA has been used to restrict access to new health-care technology, whereas advocates underscore use of HTA to promote efficient resource allocation and to advance population-based health. These opposing dichotomous positions, interestingly, place the technology and resources at the centre of the debate. People and their access to use that knowledge or technology to their own personal advantage is not the goal of this debate. Rather, public access is shrouded in the debate around equitable distribution of available resources. The crux of decision making is on whether the technology is efficacious/beneficial/safe and whether the government is willing to use public funds to pay for it, and not, whether they should pay for it. While this argument may be semantic, the distinction is more pronounced. A favourable HTA decision is ultimately about the utility of the technology and the public funds available. Cheap technology that favours many will

95 easily be supported. Expensive technology that favours few or many will face many hurdles. There are resource allocation decisions here that are based in positivistic, utilitarian algorithms that categorize knowledge in ascending order or utility plus costs associated with their usage. ODonnell et al. (2009, p. S1) expand on this discussion more fully by the following: We see emerging...a set of common issues about the role of HTA in society, its effect on public health and access to care, its effects on innovation, and on the integrity and viability of publicly financed health care in general. We see HTA at the focal point of an ongoing struggle across a range of countries attempting to come to terms with expanding expenditures for health care, the availability of remarkable new innovations in healthcare technology, and constrained budgets. Ultimately, the goal is establishing a hierarchy of knowledge and making resource allocation decisions based on positioning within the hierarchy, regardless of equity issues. At its worst, there is the perception that HTA is simply the rationing of health care disguised as rigorous policy analysis (ODonnell et al., 2009, p. S3). However, at its best, ODonnell et al. (2009, p. S4), propose a more inclusive definition of the process and goals of HTA programs: HTA is not merely the application of good scientific evaluation methods-it must be that to be viable or successful. However, to be successfully implemented, the HTA process must consider the social or ethical context. That is, HTA must be applied with open and transparent consideration of the common good-as understood by the public and industry alike. ...Moreover, any investment in the scientific progress of HTA must be accompanied by investment in engaging the public directly. The social and ethical discussions must be accorded special attention. Transparency of the process is critical. Focused engagement of and active participation by all stakeholders is even more critical. The involvement of health-care professionals, patient advocacy groups, medical technology firms, and other influential bodies will be challenging and at times contentious. However, without positive social interaction along with the advancement of science, HTA will be as effective as proponents claim in improving the effectiveness and efficiency of health care. However, I would still argue that programs such as HTA and SR&ED still remain, at their core, socially constructed analytical tools and frameworks for producing, evaluating and disseminating knowledge in science and technology from the perspective and standpoint of a global north and western, positivistic paradigm of scientific knowledge. The implicit and explicit

96 pitfalls associated with this anti-democratic approach to knowledge production are clearly apparent. However, the obvious question is what are the alternatives? From a theoretically perspective, the alternatives are rooted in opening up these privileged spaces to alternative knowledges and ways of producing and learning. The challenge is overcoming the inherent bias in the discourse of knowledge production that there is a gold standard approach to producing knowledge and all privilege flows from the ontology of that methodological approach that is embedded in the discourse. In conclusion, while the SR&ED program and the HTA programs act independently, they are a coordinated effort with the ultimate aim of producing a hierarchy of knowledge in science and technology for dissemination into society. The knowledge that survives the filtering of both the SR&ED and respective HTA program favourably, assumes a place of great power and prominence in the economic, social, political and scientific domains. Challenging that position of power becomes a challenge against a paradigm shift. Analysis and Discussion of Public Conference: Clinical Research in Canada Conference Finally, I will conclude with the analysis and discussion of the public conference that I attended entitled, Clinical Research in Canada. Four major themes emerged during this conference and through the presentations provided. Refer to Appendix C for the full summary of each of the presentations presented. The emergent themes follow as such: 1. Innovation discourse as a national economic tool and leading indicator of globalized, neoliberal practices 2. Academic capitalism and the increasingly blurring interface between academia and industry as the driving force behind knowledge production and the innovation discourse 3. Biotechnology as a positivistic, progress driven science and tool of the innovation discourse 4. The exploitation of human capital as a national natural resource in the innovation discourse

97 Provided at the conference was a promotional pamphlet published by the Government of Ontario, Ministry of Research and Innovation (2010), entitled Ontarios Life Sciences Commercialization Strategy Bringing our Vision to Life. On the opening page of the provincial government publication in the introduction signed by The Honourable John Milloy Minister of Research and Innovation (cabinet member at the time for the Ontario Provincial Liberal Party McGuinty Government regime), the following quotation sets the agenda for both the promotional material and for the conference itself. Consider the following: To compete successfully in the global marketplace, we know that our industry needs to continue to attract and nurture great scientific minds, increase collaboration among all of the players academia, industry and government to accelerate the commercialization of research breakthroughs, and improve financing for innovative companies, particularly at the early-stage. (Government of Ontario, Ministry of Research and Innovation, 2010) Biotechnology and research and development in science and technology are positioned as a national economic tool for development. The language used by the nation-state promotional material describes this as a life sciences strategy, On page 2 in the section entitled The Opportunity the following statement is presented: Clearly, life sciences represent a huge and growing market, but with Ontarios share of the global bio-medical market currently at just 2 per cent, we have the potential to do much better. Problematic within these statements and the outlined strategy is the overt hegemonic position that the active, aggressive and ultimately, exploitative pursuit of life science research and development by governments with academia and private sector partnerships is a necessary economic strategy. The Ontario Governments Vision for the Life Sciences Commercialization Strategy is presented as the following: Ontario aims to be the best place in the world to take innovative bio-medical discoveries and turn them into new products and services that meet unmet patient needs by capitalizing on our world-class talent, research capacity and collaborative spirit. (Government of Ontario, Ministry of Research and Innovation, 2010) We will accomplish this by executing a Life Sciences Commercialization Strategy, which has three main goals: Promote even greater collaboration among government, academia and industry

98 Position Ontario as the go-to place for innovative multinational pharmaceutical and advanced health technologies firms looking to sources new technologies and test promising new therapies Grow our homegrown biotech industry, already the largest in Canada, to the point where it rivals those of leading centres in the U.S. and abroad.

To achieve these goals, Ontario is adopting a four-pronged strategy: Attract and nurture scientific excellence Facilitate greater collaboration Address financing challenges Improve international marketing and promotion (Government of Ontario, Ministry of Research and Innovation, 2010, pp. 11-16)

This strategy outlines the neoliberal ideological position for the commercialization of life. Cooper (2008, pp. 147-148) in Life as Surplus proposes, How should we define the particular form of commercialization at work in the biological patent? Are we dealing with the generalized commodification of biological life...or rather an entirely different kind of economic valuation? What is at issue, I suggest, is not simply the suspension and equalization of reproductive time, but a much more radical transmutation of lifes value and productivity. When patent law apprehends the value of the stem cell line, it is not in the first instance as an exchangeable equivalent (Marxs definition of the commodity) but as a self-regenerative surplus value, a biological promise whose future selfvalorizations cannot be pre-determined or calculated in advance. In this way it redefines the value of life as self-accumulative, both on the material level (cell line technology as a deliberate cultivation of the self-regenerative potentialities of living tissue) and a commercial level (the intellectual value of the cell line is not pregiven in the cell line in its unicity but accumulates and multiplies as the cell line is subdivided, expanded, and circulated among researchers). Essentially the argument is that the process of commodification determines the everchanging value of the products of research and development in science and technology. Market forces and utility drive the success and failure of life sciences commercialization strategies to the extent that there is sufficient surplus value in the products of R&D themselves. Sunder Rajan (2006) discusses this dynamic as the co-production of life sciences research and capitalism where he argues that the life sciences are overdetermined by the capitalist political economic structures within which they emerge (p. 6, italics in original).

99 Foucault, in a lecture delivered on March 14, 1979 as part of a series on The Birth of Biopolitics provided the following assessment of the neoliberal ideological position of relationship between innovation and capitalism (Foucault, 2008): We cannot halt at this problem of innovation and, as it were, trust in the boldness of capitalism or the permanent stimulation of competition to explain this phenomenon of innovation. If there is innovation, that is to say, if we find new things, discover new forms of productivity, and make technological innovations, this is nothing other than the income of a certain capital, of human capital, that is to say, of the set of investments we have made at the level of man himself. (p. 231) Consider now a discussion on human capital theory and the implications for knowledge production in science and technology, the seeping of academic capitalism and the impact on the innovation discourse. Traditional economic research and writing has focused on human capital theory as an economic model whereby the quantifiable value of a human being and their labour can be calculated. The central tenet in this model is that the human is a value-added product when education and skills are acquired and exploited. I will argue that there is a duality to this model that has all but ignored the notion of human as both product and consumer. I will focus on four main questions within the scope of human capital theory as a by-product of the higher education adoption of the corporate ideal and the movement towards academic capitalism: is education a commodity, what is the governments public policy interest in educational and knowledge markets, what is the utility of the acquisition of human capital, and, how is it possible to reconcile the intrinsic duality of product as consumer? The History of the Corporate Ideal and Human Capital: Precursor to the Innovation Discourse The history and analysis of human capital is a complex trajectory originating from roots in economic theory. Adam Smith proposed the initial theory of human capital during the time of the handicraft economy. It is unlikely that he could have foreseen the growth of the industrial revolution or the magnitude and complexity of the current knowledge economy (Spengler, 1977). The notion of human capital is neither new nor sophisticated. Defined by Langelett (2002), human capital is the know how of the workforce that increases the productivity of each worker (p. 1). The basic theory is that humans can have and acquire skills that can produce

100 wealth just as traditional capital can. Ambition, intelligence, entrepreneurship are but a few of the skills that, if utilized correctly, can produce wealth. Human capital is more than just the skills one is born with. Human capital can be acquired and increased by education and training. However, there is a cost to be borne. As Spengler (1977) stated, The reward of human capital must reflect the investment embodied in it even as does the return on other fixed capital. (p. 33). It is quite easy to envision the individual gain realized by the acquisition of human capital. Presumably, the greater ones skill and intelligence, it follows that the greater the ability to accumulate wealth. What is less obvious is the governments interest in increasing the aggregate human capital of its citizens and the resulting knowledge production; for our purposes here, in science and technology. Kiker (1966) proposes that there are distinct motives for treating humans as capital for the benefit of the government and nation-state. He proposes that these include: demonstrate the power of a nation, determine the economic effects of education, health investment and migration, propose tax schemes believed to be more equitable than existing ones, inform the public about the need for life and health conservation vis--vis the economic significance of an individuals life to their family and country, and lastly, guide courts and compensation boards in making fair decisions regarding compensation for injury. Beyond the economic benefits realized and utilized by a government of the aggregate human capital wealth, there is a symbolic power to increased levels of human capital as a leading indicator of the innovation power of a nation state. The power of human capital has macroeconomic implications for the nation-state and industry. Consider the histories outlined by Barrow (1990), Kaye (1993) and Brown (1979) where they propose that the increase in human capital, within the United States initially, and, globally secondly, was a strategic effort by capitalistic industrialists. The end goal was to guide higher education and create a workforce with the skills and intelligence required in a post-Fordist industrial world. Additionally, there was a need for increased and diversified resources and technology to continue to grow the empires and wealth of capitalistic industrialists like Rockefeller and Carnegie. Within the scope of their benevolent foundations, in partnerships with institutes of higher education, they engineered the structure and workforce required to usher in the age of neoliberalism and the resulting globalization, within a century.

101 A Review of the Economics: Human Capital and Innovation Besides positive economic growth, there are the inherent social benefits of an educated society. It is important to include this analysis within the context of furthering the analysis of the development of human capital as a biopolitocal strategy within the innovation discourse. It is here where I will explore the relationship between the government and the individual. Both have a vested interest in increasing human capital from both a macro and micro-economic perspective. Consider the summary provided by Doherty-Delorme and Shaker (2004). According to a study commissioned by the Higher Education Funding Council for England (HEFCE) graduates are less depressed, healthier, more likely to vote in elections and help with their children's education. The study, which was conducted by researchers at the Institute of Education, University of London, indicates that along with better jobs and higher pay, graduates also enjoy a number of other social and personal benefits. But in addition to having generally healthier lifestyles which cost society much less in security benefits and health care, and a higher sense of well-being, graduates are more likely to be involved in their childs educationboth in and out of schoolhave more tolerant attitudes, and volunteer in their communities more frequently. These benefits are evident across gender, age and social class. Clearly there are financial justifications for having a highly educated society graduates of university and college programs have enhanced earning potential and therefore spend more and pay more in taxes. In fact, evidence indicates that graduates pay several times over for the cost of society having educated them in a public system. But, in addition, there are other benefits which are tangentially financial, and still others that speak far more to broader social progression and the kind of society in which we wish to live. (Doherty-Delorme & Shaker, 2004, p. 4) To discuss education as a commodity, one must first define commodity in its basic format to understand its characteristics and application. Marx definition of commodity proposes that it is an external object, a thing which through its qualities satisfies human needs of whatever kind (Marx, 1990, p. 125). There is physicality to this definition that is focused on the uses and values of the physical nature of commodities. An analysis of education as a commodity will vary depending on whether the focus is the elementary and secondary school system or the post-secondary school system. My intuition is that education as a commodity applies to both systems. At the elementary and secondary school level, the systems are administered provincially but the product (i.e., curriculum and teaching standards) are expected to be uniform across all provinces and within all school districts. A

102 student who is in Grade 8 in Halifax should reasonably expect to be at the same level if s/he moves to Calgary mid-year. There is an expectation that the curriculum should have been standard and, with minor variations, the student will be at the same level of preparedness; no more or no less. In the same way, teachers should be expected to achieve the same teaching standards (within a narrow range of variation). The cost of educational administration should be the same as well. In this way, education certainly fits the definition of a commodity. The challenge is that consumers (parents and students) dont purchase education at this level (unless of course it is a private school). The government and local school boards provide the educational system. There is an expectation that there are standards across all boards to ensure that the same curriculum is being provided and that the economy is supported by a basic and common level of education across the province with assumed similarity between provinces. Higher education (colleges and universities) exist in a presumably, greater free market environment. Again, while the product is similar in terms of cost (negating private schools and unfunded programs), schools compete for students based on program offerings, scholarship options and perceived quality of institution (to name a few factors). This is particularly evident in professional programs (i.e., privatized MBA programs). Education as a commodity at the postsecondary level then becomes a question of accessibility. Who can afford to pay and where can they afford to go? Can they access the resources for payment or travel or support to attend an institution? It is quite clear that the government does have a public policy interest in creating and supporting markets in education and knowledge production for many reasons beyond the fact that government is the primary financier of education. Other reasons outlined in Cohn and Geske (1990) include: To assist in supplying market demands for a skill set (i.e., Currently too few doctors in certain jurisdictions to fill the demand; more funding required to educate more doctors and encourage (incentify) them to work in underserviced areas) To improve life within each social class and to help achieve social mobility (upward) (i.e., Education is for all classes and not just the elites)

103 To help individuals to discover and develop previously unknown talents through education, perhaps towards achieving social good. To help control population growth and maintain a sustainable and optimal level. (i.e., Evidence that greater education has a limiting effect on the birth rate) West (1970, as cited in Cohn & Geske, 1990) also outlines additional rationale including the state protection of minors, external neighbourhood effects (i.e., decreased crime), to ensure the success of democracy, to ensure equality of opportunity, to support a quest for common values and to support positive economic growth. The Goldin (2003) reading makes a very clear argument in the affirmative for this issue. The data was presented which clearly showed the positive effect on economic growth in the 20th century which the US experienced and the clear correlation with the policy of mass secondary and higher education; The twentieth century became the human capital century. An investment in developing and accruing human capital within its population yielded many economic returns which translated into monetary rewards for the state. She proposes that this occurred because of the increased use of science by industry, the proliferation of academic disciplines, a series of critical inventions and their mass use, the development of the corporation and the growth of retailing. All these factors created a demand for a more diverse workforce and an educational system to increase the human capital to fill that demand. Rockefeller and Carnegie would have been very proud indeed! Microeconomic Decision-Making Power VS Macroeconomic Needs The challenge with this issue is the principal-agent problem. How can the principal/government ensure that the agent/educational institute does what they want to achieve the goals outlined above when the principal does not own or operate schools? While funding formulae were designed to solve this problem, there are still issues. As well, human capital formation is a microeconomic decision with macroeconomic consequences (Langelett, 2002). The individual does the cost-benefit analysis and decides whether they will invest time and money in acquiring human capital. The government has a role in altering either the cost or the benefit but cant make the choice for the individual. Presumably, the individual does not make

104 this decision in isolation. There is a consequence and a sacrifice required by their family within the short-term. The notion of family capital theory requires some investigation as a subset of human capital theory. At the post-secondary school level, individuals make an investment in their education in the form of tuition payments and foregone income, which usually exceeds tuition fees. Presumably they want value in the form of a return on their tuition investment. Again, the choice is the individuals. Greater economic growth may be predicated on the acquisition of human capital but the micro decision of school attendance is beyond the control of the government. Also, attendance may not be as relevant at the post-secondary level if the individual benefits from economic signalling or screening in reference to the university or program which they graduate from (Langelett, 2002). If the student who only shows up to class twice a semester and still aces the exam, does anyone care when s/he is released into the workforce. Is the concern only that they graduated? As a result, let us consider education as a commodity again. What is the commodity? Education? Credential? The institution itself? Educated individual? Credentials, in and of itself, is not sufficient to qualify as additionally, acquired human capital. Application and Utilization of Human Capital: For Work and/or Citzenship? The connections between education and work are growing stronger. While many think that this is a relatively recent relationship, Fallis (2005) discusses how the connections between education and work were historically based. The early university was divided into arts, law, medicine and theology, where the liberal arts were the precursor to training in one of the other three departments. Education as a leisure activity of the elites is no longer the norm. The process of education is becoming increasingly utilitarian with the end goal of a good job and the increased buying power that ensues. The acquired human capital is expected to yield significantly on its return on investment. However, there are critical issues to consider with this model. Curriculum? Education vs. Vocationalism? Accessibility? Anisef, Axelrod, and Lin (1999) propose that there is an inherent danger in focusing higher education to meet assumed or expected market needs. They propose that this will result in higher education becoming an ineffective appendage of economic policy. One of the dangers with this model is the devaluing of a liberal arts education in favour of targeted curricula that

105 prepare students for specific jobs. Is there a real loss here? I would concur with Anisef et al. (1999) that there is cultural and intellectual value in liberal arts education. Employment and salary analyses have shown that graduates with a liberal arts education are not disadvantaged in the work force. The only exception may be fine arts graduates, but the contribution to the arts and cultural life cannot be discounted. While the data shows that liberal arts graduates are valuable employees because of their demonstrated ability to adapt, think critically and learn quickly, the focus in higher education is increasingly more vocational and technical training (Anisef et al., 1999). Academic capitalism as a policy directive is flowing into higher education where an implicit value is placed on different types of education. As Slaughter and Leslie (1997) propose, there is a hierarchy that is seeping into higher education that places technology, technoscience, the innovation discourse and managerialism in a position of privilege and greater status. This results in a re-structuring of the social relations of the research paradigm. Graduate employment outcomes are increasing in priority and are often linked to public and private funding. While it appears on the surface to make commonsense (pardon the pun and the reference to the Harris Government years in Ontario) that an efficient educational system will respond to market needs and produce graduates that are employable, there are inherent risks with this model. Burbules and Torres (2000) describe this as a dialectical process whereby the individual is both a self and a community member. Both roles have a vested interested in preserving the socializing and civilizing aspects of culture and community. Thereby, one of the principle purposes of education is to create a loyal and competent citizen that will value and support, culture, community and, I would add, the economy. Calculating the Human Capital Requirements and Knowledge Markets Manpower planning is an inexact science and it is difficult for higher education to anticipate long-term employment demands of different sectors of the economy. This is a model that is better suited to the community college system and the private training institutions. These institutes of higher education are better suited to responding and building programs that can respond to the economic needs of the marketplace in a more timely and efficient manner. The university and the curriculum should not be subject to the ebbs and flows of the demands of the

106 marketplace (i.e., industrial demands). Program changes should be based on long-term, strategic goals of incorporating current knowledge and paradigms. There is inherent value to the pursuit of knowledge alone because the learned and applied ability to think critically, to learn, to apply knowledge, to be creative are all valuable and applicable skills to the workforce. Berg (1970) examined the qualitative value of human capital development and the relationship between education and work. He found that the quality of education was important for three main roles: 1. the flow of ideas and the application to the economy, 2. the speed at which new skills could be acquired and applied to market production, and, 3. the effective development of the complex web of relationships and attitudes among consumers, workers and management. The relationship between credentials and ability is not clear which has the greater effect. Essentially, the value is in the education and the learned ability and not in the content of the curriculum. The inherent danger in the marketplace driving curriculum change is that the focus will be very narrow, utilitarian, highly vocational and constantly shifting. The university must be a space that supports the exploration of all ideas whether there is economic utility or not; if needed acutely, the marketplace can fill its own demand for a particular skill set. A prime example is the development of the private information technology (IT) training centres that were established in the late 1990s to satisfy the market demands of the knowledge based economy and tech boom. More recently, who would have known 5 years ago that oil patch technical skills would be in such high demand today? Did the education system anticipate this trend and build the capacity to provide this specific technical training? Did Canadians enrol in these training programs in time to complete the oil patch training to benefit from the energy boom? Will this training be worthwhile if the price of oil drops below $50/barrel? If the typical worker in the 21st century switches jobs many times, is this not an argument against the market driving curricula? Clearly, education is training for acquiring skills to work

107 and not training for a specific job or role. In this model, it is more critical to have the ability to apply and transfer skill sets. A liberal arts education has more value in this scenario. I think there is also the argument to be made that those who seek out professional schools and training also benefit from a liberal arts education. Perhaps this is an inappropriate amount of idealism but I believe that the acquisition of all human capital is good and only good can come from acquiring and developing different knowledge and promoting the aptitude for critical thought. Historically, this has been associated with a liberal arts education. Corson (2002) makes a very passionate argument about the applied privilege when a curriculum is altered and privileged to meet market demands. The natural question should be who suffers when privileged programs receive primary focus and funding? The obvious victims are the marginalized and minoritized groups whose programs will suffer when performance funding is linked to employability measures. The neoliberal ideology of globalization seeps into academia in a way that decreases equity for all students and value for all types of knowledge. Limiting diversity in any way in education (essentially an education orthodoxy) is a dangerous slippery slope that should be stemmed. The tail in this case is the evaluation and assessment process wagging the curriculum dog. Education as a product in the business model has little application or scope for a liberal arts education. The Usher article (2005) provides an interesting framework from which to discuss the opportunity costs and value of education and acquired human capital. In many ways, it is an indictment about the value that Canadians apply to education. The article showed that, if Canadians in general and low income Canadians specifically, over-estimate the cost of education and underestimate the realized value of education (i.e., salary and employment options), then the microeconomic cost-benefit analysis will be based on perceived (incorrect) knowledge. This will result in a decision to opt out of higher education. Clearly, the ability to succeed and complete higher education will not factor into this decision. Ideally, I believe that any student who has the ability and the desire should be allowed to participate in higher education. Due to information or misinformation, is the desire for education and acquiring human capital poorly developed? This is why society has a stake in ensuring that access to higher education is maintained through programs that provide economic options to pay for education and reverse the opportunity costs in

108 favour of education. Increasing national and global human capital is good for all, even if the individual reaps the greatest reward. The Duality Inherent in Human Capital: Disembodied Product and Consumer Perhaps the most remarkable feature of the concept of human capital is its narrowness in relation to the totality of human life. In human capital, economists have fashioned a concept that leaves no room for the traits of individuals that produce such ineffable outcomes as happiness, love, friendliness, humanitarian impulses, spirituality, knowledge for its own sake, and so on. (Douglass, 1977, p. 363) I would also propose that there is narrowness and a duality to the theory of human capital. Human capital theory, in and of itself, precludes the characteristics of humanity as outlined by Douglass (1977) while embodying a consumerism. There is a value that is assigned to, and extracted from human capital, generally, and from individuals, specifically. Deleuze and Guattari (1983) refer to this phenomenon as surplus value where, instead of simply representing the relations of commodities, it enters now, so to say, into relations with itself. It differentiates itself as original value from itself as surplus-value (p. 227). There is an inherent duality in the microeconomic application of human capital theory. As an individual acquires and builds on their own human capital, they are the product of their own labour and of the knowledge market that provided the education. This enables them to increase personal wealth and consume more. Investment [in human capital] is the act of committing resources to the production of producer goods rather than consumer goods (Douglass, 1977, p. 363). To be a product and a consumer in one is characterized by Deleuze and Guattari (1983) as the schizophrenic nature of capitalism run amok. How does one resolve this duality within the context of societal and individual goals? I do not think there is a resolution to be found. I think this duality (and contradiction so to speak) is a by-product of a capitalistic society within a neoliberal framework. Peters (2006) proposes that, education is the principal means of developing highly skilled and flexible human capital for effective competition in global markets (p. 64). Clearly, nation-state and industrial powers have created an environment that builds and exploits the surplus value within human capital; as a group and at the individual level. The individual is the cog in the wheel that ensures the

109 continuous movement (forward) of the capitalistic machine, perhaps, without ever realizing that they are the fuel that powers the innovation machine. I present these preceding ideas in order to better illustrate how individuals, and ultimately, societies, are materially complicit (knowingly and unknowingly) in the production and reproduction of this discourse.

Chapter 6: The Current Situation and the Immediate Future

During the writing of this dissertation, the following report was released to the public. This final chapter will review content and implications of The Jenkins Report (Jenkins et al., 2011). I did not include this information as part of my data set. Rather, I include it here in order to better position the evolving future nature of the SR&ED program and the innovation discourse as a national economic strategy. It is expected that public policy decisions at the federal and provincial government levels will follow some of the recommendations of this report. Certainly, the extent to which this is true will evolve over the coming months and years. I have endeavoured to include information as it becomes available up until the defence of this dissertation project. The panel was provided with the following mandate that was outlined in the Executive Summary of the report (Jenkins et al., 2011): The Panel was asked by the government to provide advice in respect of the effectiveness of federal programs to support business and commercially oriented R&D, the appropriateness of the current mix and design of these programs, as well as possible gaps in the current suite of programs and what might be done to fill them. The mandate specified that our recommendations must not result in either an increase or a decrease in the overall level of funding of federal R&D initiatives. Therefore, where we have identified opportunities for saving such as from some reduction in the refundability of the SR&ED tax credit we expect the government to reallocate the savings to provide funds for our other recommendations. The panel was composed of the following individuals: P. Thomas Jenkins (Executive Chairman and Chief Strategy Officer of Open Text Corporation), Dr Bev Dahlby (Professor and Fellow at the Institute for Public Economics at the University of Alberta), Dr Arvind Gupta (Professor of computing science at the University of British Columbia), Monique F. Leroux (Chair of the Board, President and Chief Executive Officer Desjardins Group), Dr David Naylor (President of the University of Toronto), and, Nobina Robinson (Chief Executive Officer of Polytechnics Canada). A full biography of the expert panel members is listed in Annex C of the full Jenkins Report. The consultation process was initiated in 2010 and concluded in October 110

111 2011 with the delivery of the report to the federal government and public release of the report. The mandate of the panel was under the jurisdiction of the Minister of State (Science and Technology). The methodology for this review was outlined on page E-7 of the Executive Summary and the summary is provided here to provide context for the mandate of The Jenkins Report: The year-long process culminating in this report began with foundational briefings from experts and decisions makers in both the federal and provincial governments. We implemented, in parallel, an ambitious agenda of research and program assessment. The latter encompassed a set of 60 programs (worth about $5 billion in the 2010-11 fiscal year) covering the gamut of federal initiatives to foster business R&D. Our extensive consultations included 228 written submissions [96 from companies, 80 from organizations, 38 from academic institutions, p. 1-4] in response to the release of our consultation paper in December 2010. These were supplemented by in-person group sessions in cities from coast to coast: Vancouver, Calgary, Winnipeg, Waterloo, Toronto, Ottawa, Montreal, Quebec and Halifax. We extended the scope of consultations beyond Canada to gather international perspectives on issues germane to this review. Meetings took place in Australia, Germany, Singapore, the United Kingdom and the United State, and with officials of the Organisation for Economic Cooperation and Development (OECD) and Tekes [Tekes is a Finnish funding agency for technology and innovation.] in Paris. Finally, we commissioned a survey of more than a thousand R&D-performing businesses representative of the range of sizes, sectors and provinces. (Jenkins et al., 2011) Interestingly, the scope of this review appears to have been more encompassing and inclusive than the official government public consultation process under discussion in this dissertation that occurred in 2007-2008. The written submissions in The Jenkins Report (Jenkins et al., 2011) represent nearly a 5-fold increase from those submitted in the public consultation process of 2007-2008. Additionally, The Jenkins Report included multiple sources of data including surveys, group sessions and global perspectives. On Tuesday, October 18, 2011, I attended a luncheon lecture at the Delta Chelsea Hotel in Toronto, Ontario. The lecture was sponsored by The Economic Club of Canada and my admission to the event was sponsored by my employer. The keynote speaker at this event was David Jenkins and was the public delivery of The Jenkins Report (2011) which had just been delivered to the federal government the previous day. Mr. Jenkins, with the other members of the expert panel in attendance, gave an executive summary of the full report to the crowd in

112 attendance which included members of the media. Approximately 350 people were in attendance at this lunch time event. Mr. Jenkins spoke for approximately 30 minutes and then took questions from the audience in attendance. All attendees were provided with a free copy executive summary of the report in English and French language. The link to the full report was provided in the executive summary. During his keynote, Mr. Jenkins chose to highlight the following points related to the full report and his own opinion on the state of innovation in Canada and current governmental support. Mr. Jenkins began his lecture by outlining some key perceived strengths in the Canadian economy including support for innovation, an established knowledge economy of tomorrow, a stable banking system, and, strong natural resources. However, he also outlined some current perceived issues including the following perceptions: falling behind innovation, investment is high but decreasing relative to other nation states, and, innovative R&D is not translating into commercial application and success. He suggested that by increasing innovation, it would have a direct impact on mobilizing business development. Interestingly, he did not provide a definition for innovation. Mr. Jenkins then went on to outline the six key recommendations outlined in The Jenkins Report (2011) for revamping the SR&ED program and stimulating R&D and innovation in Canada. Those recommendations will be outlined in further in this chapter. He concluded his lecture and answered a few questions from the attendees. After a brief lunch, the event concluded. The Jenkins Report Recommendations The executive summary of the report sets the direction with the following introduction: Canada has a solid foundation on which to build success as a leader in the knowledge economy of tomorrow. We have a strong financial sector and attractive corporate tax rates. We have a diverse, well-educated workforce and significant natural resource endowments. We have institutions that safeguard the rights of individuals and encourage initiative. Yet, despite these notable strengths, challenges remain. Studies have repeatedly documented that business innovation in Canada lags behind other highly developed countries. This gap is the ultimate source of the

113 long-term competitiveness of businesses and the quality of life of Canadians. The ability to conjure up new products and services, to find novel uses for existing products and to develop new markets these fruits of innovation are the tools that will ensure Canadas success in the twenty-first century. (Jenkins et al., 2011) Thus begins the report. The report is 148 pages and has an organizational structure similar to an annual business review. The major sections are divided as such: Executive Summary Motivation and Mandate The Context of the Review Overview of Programs to Support Business R&D Vision and Principles Program Effectiveness Program Mix and Design Filling the Gaps Leadership for Innovation Conclusions Annexes References

Six major recommendations are listed with several sub-suggestions provided with each recommendation. Recommendation 1 was to establish an Industrial Research and Innovation Council (IRIC). This IRIC was envisioned as an arms-length funding and delivery agency with the sharply defined mandate and focus on business innovation. The three key goals would be to facilitate commercialization activities, establish a national concierge service and web portal to act as an advising agent to industry, develop a federal business innovation talent strategy to focus on identifying and developing human capital, and, finally, to consolidate and evaluate programs that are currently underway in various provinces. Recommendation 2 focuses on simplifying the SR&ED program by basing the tax credit for small and medium sized businesses on labour-related costs only and re-direct funds to

114 support initiatives to help small and medium sized businesses grow into larger, more competitive global companies. They suggest that this can be accomplished by simplifying the compliance and administration of the program, creating a more predictable qualification process, become more cost effective by supporting the growth of businesses, create greater accountability within the SR&ED program, and, finally, adopt the outlined initiatives in a phased approach through a consultative process with industry. Recommendation 3 proposes that innovation must be considered a core business objective. The Jenkins Report suggests that this is possible by requiring that innovation is an objective of policy and program management, broaden the scope of innovative proposals by focusing on needs to be met or problem to be solved versus a technical list of requirements, create a demand-pull environment where government becomes the first-time user of innovative products or technology, create opportunities via Crown corporations for globally competitive capabilities, and, finally, working collaboratively across all levels of government to foster adoption of innovation products and technology that could increase efficiency and reduce public sector costs. Following the summary of recommendation 3, The Jenkins Report (2011) provides a summary statement of the rationale for increasing the public-private research collaboration on p. E-11. We believe that public-private research consortia in Canada lack the scale needed to have significant impact on the development of globally competitive Canadian companies. Consequently, Canada needs a fundamentally new approach to building such collaborations in areas of strategic importance and opportunity for the economy. The existing institutes of the NRC [National Research Council Canada] are a unique asset in terms of infrastructure, talent and sectoral and regional coverage. Consistent with the new direction being taken by NRC management, we believe that several of the institutes should be evolved to become a core national constellation of R&D and technology institutes mandated to collaborate closely with business in key sectors. The appropriate individual institutes could become focal points for the development of R&D and innovation strategies for key sectors, for major enabling technologies and for regional clusters of innovative firms and supporting services. Interestingly, they do not provide a definition of innovation or include the role of academia in this process of innovation or knowledge production.

115 The report continues from this point with the summary of recommendation 4. The reports recommends that the National Research Council (NRC) be transformed into a larger and more diverse agency with representation from industry, government and academia, and, secondly, to divert policy-related activities from the NRC to the relevant government department. Recommendation 5 proposes that high-growth innovative firms be provided with additional funding and risk capital at the start-up stage and at the late stage commercialization process. Finally, recommendation 6 suggests that a stronger federal strategy with engagement from the provinces is a necessary strategy to improve coordination and national, and ultimately, global impact. The Jenkins Report (2011) suggests that this can be established by establishing a federal ministry solely responsible for innovation, create an external Innovation Advisory Committee (IAC) to advise the government, and create a national dialogue on innovation (pp. E-13). The goal of this national dialogue on motivation, they suggest, would accomplish the following: Through the minister responsible for innovation, engage provincial and business leaders in an ongoing national dialogue to promote better business innovation outcomes through more effective collaboration and coordination in respect of program delivery, talent deployment, sectoral initiatives, public sector procurement, appropriate tax credit levels and the availability of risk capital. (Jenkins et al., 2011, pp. E-13) The suggestion that a national dialogue on innovation is a key recommendation and condition for R&D is central to the proposed motivation and mandate of The Jenkins Report (2011) that is outlined in chapter 1 of the report. Consider the following quotations lifted from The Jenkins Report: Being more innovative is also what is needed to take advantage of leading-edge technologies like biotechnology, nanotechnology and information technology. These are giving rise to entirely new markets and are providing novel approaches to the pressing challenges of our era such as how economies can continue to grow in ways that are environmentally sustainable, or how health care expectations can be met in ways that are fiscally sustainable. (pp. 1-1 1-2) The federal and provincial governments play an important role in fostering an economic climate that encourages business innovation for example, by

116 supporting basic and applied research and related training of highly qualified, skilled people, and by providing substantial funding through tax incentives and program support to directly enhance business R&D. (pp. 1-2) Research and development is a key ingredient in a great deal of business innovation and is also an essential contributor to Canadas international competitiveness and productivity growth. The fact that Canadas business R&D momentum stalled a decade ago and has not resumed is both alarming and unacceptable. It is urgent that business R&D in Canada start growing strongly again. (pp. 1-2) In a phrase, innovation means new or better ways of doing valued things (Innovation and Business Strategy: Why Canada Falls Short, 2009, p. 21). Innovation is not synonymous with invention, although the spark of invention or creativity is a necessary precedent for innovation. Business innovation occurs when a new or improved something a good, a service, a process, a business model, a marketing tool or an organizational initiative is put into practice in a commercially significant way. (pp. 2-1) The Jenkins Report (Jenkins et al., 2011) goes to great lengths to establish the link between innovation and economic development. Clearly the provided definition and framework for innovation and R&D outlined in The Jenkins Report supports the discussion on surplus value previously outlined in this dissertation. Interestingly, a discussion of innovation as a subset of knowledge produced in science and technology is not specifically outlined. However, a model is outlined in the report that is entitled A Firm-Centric Model of the Business Innovation Process (see Figure 5).

117

Figure 5. Proposed Model on Business Innovation advocated by The Jenkins Report (Jenkins et al., 2011).

Using this model as a proxy for the lack of specific discussion regarding the relationship between innovation and knowledge production, knowledge is a factor in this model as a precursor to inputs required for innovation activity to become stimulated. Knowledge and ideas, used by the appropriate human capital with the required institutional and infrastructure linkages, and capital support, lead to innovative products and activities. This model also illustrates a

118 movement away from Foucouldian discipline societies to a Deleuzian societies of control (Deleuze, 1992). He proposes that we are living in a generalized crisis where spaces of enclosure mould people into data dividuals. Consider then that: In the societies of control, on the other hand, what is important is no longer either a signature or a number, but a code: the code is a password, while on the other hand disciplinary societies are regulated by watchwords (as much as from the point of view of integration as from that of resistance). The numerical language of control is made of codes that mark access to information, or reject it. We no longer find ourselves dealing with the mass/individual pair. Individuals have become dividuals, and masses, samples, data, markets, or banks. [] The disciplinary man was a discontinuous producer of energy, but the man of control is undulatory, in orbit, in a continuous network. (Deleuze, 1992, p. 6) As the statement attempts to illuminate, Deleuze tries to understand individuals as agents of human capital, and their behaviour, in this analysis, the innovation discourse of knowledge production. In Societies of Control (Deleuze, 1992), Deleuze proposes a connection between politics and economy to problems of environmental control and ecological change. He explicates individuals and their moralities as products of the organization of control; ultimately, individuals are continuously and limitlessly controlled by systems of domination. Certainly, Foucault would see this as power domination where the agency of the individual is beyond the limit of their control. Knowledge production and the innovation discourse in this model thus is a product of the individuals/dividuals under the control of the institutions and networks that govern, guide and distort the behaviour. Deleuze was not an economic determinist, but he was interested in economic activities, particularly the functions of capitalism that affect our contemporary and current world. Coauthored with Felix Guattari, the two volumes of Capitalism & Schizophrenia (Deleuze & Guattari, 1983), explicated the ever-evolving function and role of capitalism. Foucault wrote extensively on how discipline power and bio-power were indispensable elements in the development of capitalism; but, what is the relationship between capitalism and disciplinary societies and control societies? Could both be part of the development of capitalism or is capitalism something beyond society? Or is this the mutation of capitalism? Consider then the notion of a mutation of capitalism and its effects within the whole social field; but in order for it to be even possible, the tools or material machines have to be

119 chosen (Deleuze, 1999, p. 39). To be chosen means that the social forms, and in this case, the innovation discourse of knowledge production is science and technology, the capabilities to produce and use them must be present, but also the power to accept, reject, distort or negate. The logic of choice is profit (the ultimate goal of capitalism and certainly linked closely to our previous discussions on surplus value). Deleuze and Guattari (1983) proposed that: An innovation is adopted only from the perspective of the rate of profit without this prospect, the capitalist will keep the existing equipment, and stand ready to make a parallel investment in equipment in another area (p. 233). Capitalism is not about production but about profit and the creation of ever increasing surplus value; the accumulation of capital, beyond the production of goods. Within this model, Foucault would describe disciplinary power as a new economy of power (Foucault, 1977, pp. 303-304) in societies. Clearly then, the mutation of capitalism, is a destructive process. As societies drift from disciplinary to control, a key characteristic reflected within the economic activities is that businesses dominate over factories. Deleuze wrote a vivid comparison about the differences between the factory and business. He wrote: the factory was a body of menbut in a control society businesses take over from factories, and business is a soul, a gas (Deleuze, 1983, p. 179). A factory is clearly a material and tangible, business is an abstract construct that is pervasive and hooked into many social institutions and constructs. Contemporary capitalism is driven by the notion that business is everywhere and hooked into all social processes and functions. Ultimately, as societies shift and drift from discipline to control, business becomes ubiquitous through the mutation of capitalism. In many ways, this is the process and goal of the innovation discourse; knowledge production run amok. Harvey (2010) discusses this process as the creative destruction of capitalism. Figure 6, lifted from The Jenkins Report (Jenkins et al., 2011), is a theoretical representation of this dynamic of the innovation discourse in an ever-evolving mutational pattern of knowledge production where the ubiquitous nature of capitalism pervades public, private, and academic interests with the end-game and goal of creating knowledge transfer and translation models to move innovation from theory to commercialization by increasing the margins of surplus value at every possible step. The Jenkins Report proposes this as an optimization of the

120 model of knowledge production and innovation and positions the SR&ED program at the crux of this dynamic between academic, public and private interests.

Figure 6. The innovation life force advocated by The Jenkins Report (Jenkins et al., 2011).

121

An additional analysis is provided by David Harvey in his discussions about the The Enigma of Capital and the Crisis this Time (Harvey, 2010). Harvey uses a Marxian framework to discuss capital and this notion of capitalism in crisis. Harvey interprets Marxs capital as a process of circulation and not a thing. He uses the following example to illustrate this point: Financiers lend money in return for interest, merchants buy cheap in order to sell dear and rentiers buy up land, resources, patents, and the like, which they release to others in return for rent. Even the capitalist state can invest in infrastructures in search of an improved tax base that yields greater revenues. But the primary form of capital circulation in Marxs view was that of production capital. This capital begins with money with is used to buy labor power and means of production which are then brought together in a labor process, under a given technological and organizational form, that results in a new commodity to be sold on the market for the initial money plus a profit...Capital is thereby committed to a compounding rate of growth. (Harvey, 2010, p. 2) The innovation discourse is firmly committed to this model of ever-increasing rates of growth and production. By continuously increasing surplus value and the potential for surplus value, the potentiality of the innovation becomes its own mutated form of capital. Harvey challenges the social, political and environmental implications of this form of mutated capital because he note[s] that the operative term here is profitable investment opportunities as opposed to socially necessary and socially valuable investment opportunities (Harvey, 2010, p. 2). Certainly the innovation discourse and knowledge production in science and technology is predicated on profitable utility and not on materially important or necessary innovation; they may or may not be mutually exclusive. Harvey also goes on to suggest that excessive innovation can generate crises by displacing labour too rapidly or rendering production systems obsolete well before investments have been amortized (Harvey, 2010, p. 6). Within the innovation discourse, it is a process that is both globally collaborative and competitive as nations and industries build on ever-increasing rates of surplus value and surplus knowledge to create the next economic inflection point. This is certainly challenged by the issue of where investment will continue to come from for this compounding growth. Harvey proposes that,

122 the time gap between yesterdays product and tomorrows reinvestment has to be bridged and this entails the use of money as money of account. The finance capitalists come back in as crucial players who operate not only at the beginning of the circulation of capital sequence but also at the end. For example, financiers lend to property developers who hire labour to build houses which are then purchased by the workers with a mortgage loan often from the very same financiers. Such a system is inherently speculative and prone to produce housing bubbles of the sort already noted. (Harvey, 2010, p. 8) For the purposes of this dissertation project, the SR&ED program is a proxy for the governmental financiers. The nation-state assumes this role as financier as a tool to feed and foster a speculative system to produce the advancement in technology previously explicated with a goal towards the ever-increasing surplus value of the capital and the knowledge produced. Within this hegemonic system of knowledge production in science and technology, capital circulation is a process that becomes disconnected from the needs of society and hooked into the drive for profitability; regardless of social implications. Harvey passionately is in agreement with the identification of this paradox; The central problem to be addressed is clear enough: compound growth for ever is not possible: capital accumulation can no longer be the central force impelling social evolution (Harvey, 2010, p. 15). The Current, Evolving Situation As of the writing of this dissertation, The Jenkins Report (Jenkins et al., 2011) and the implications for the SR&ED program is a situation that is currently in flux. From a governmental standpoint, the most recent legislative proposals status of the SR&ED program, dated December 31, 2011 (Department of Finance Canada, 2011) indicate that there are six provisions to the legislation that are currently under revision and awaiting governmental and Royal Assent at the federal government level. This current proposed legislation was drafted on July 16, 2010 (prior to the completion of The Jenkins Report). The six proposed revisions are summarized as follows: 1. Materials transformed in the process of R&D can be claimed under an alternative approved accounting methodology referred to as the proxy method. 2. The use of investment tax credits can be used against the cost of equipment.

123 3. Stock options can no longer be considered expenditures. 4. Ministerial discretion for late submissions beyond the 18 months can no longer be considered. 5. The French translation of the SR&ED program was revised to make it consistent with the English version. 6. The definition of contract payments was clarified in the section on investment tax credits. Interestingly, none of the key recommendations provided by the submission documents in the 2007-2008 public consultation documents were included in this proposed draft legislation. The media coverage on the SR&ED program pre- and post-Jenkins Report is quite extensive on the SR&ED program and the state of R&D in science and technology in Canada. A reading of the reports presents the view that the process of research and development and how it is funded and evaluated is inefficient and ineffectual in Canada. The overall perception is that the SR&ED program is grossly abused by fraudulent claims. Data to support this view is limited to anecdotal accounts of reviewers and accountants who are presented as informants in the articles. The following represent a snap shot of the media headlines and coverage from February 2011 to February 2012 in The Globe and Mail; a Canadian national newspaper: Dubious claims diminish R&D tax credit (McKenna, 2011, February 6) Flawed R&D scheme costs taxpayers billions (McKenna, 2011, March 11) John McDougall: Hungry for better return on research (McKenna, 2011, August 5) Study urges drastic cuts to federal R&D tax breaks (McKenna, 2011, October 14) A chance to fix our broken R&D model (McKenna, 2011, October 16) In health-care innovation, the future is already here (Alvarez, 2011, November 16) Canadas innovation window of opportunity (McKenna, 2011, November 19) Harper hints at R&D tax break overhaul (McKenna, 2011, December 16) A glaring need to determine whats legitimate R&D (McKenna, 2012, February 19) In McKenna (2011, December 16), the federal governmental response to The Jenkins Report (Jenkins et al., 2011) is included with a quotation attributed to Prime Minister Stephen

124 Harper indicating that in the next federal budget, the government intended to move ahead with some of the recommendations of The Jenkins Report. The next federal budget is due to be tabled in the spring of 2012. On March 29, 2012, McKenna, writing in The Globe and Mail under the headline of Tories target lagging innovation with funding overhaul, reports that the federal government budget intends to reduce the number of allowable tax credits in favour of providing direct grants to specifically chosen industries. The SR&ED tax credit portion of the program is expected to be cut by an estimated half a billion dollars with anticipated savings to be diverted directly into direct grants. This strategy was characterized in the article as they seem to be taking the subsidy approach of winner-picking by bureaucrats by Catherine Swift, chief executive of the Canadian Federation of Independent Business. However, Finance Minister Jim Flaherty is also quoted in the same article: The new approach will position Canada in the knowledge economy of the 21st century and help build globally competitive companies. Certainly that remains to be seen. Future Research Questions There is an extensive and robust literature on neoliberal frameworks for understanding capitalism. However, the nature of the innovation discourse within a neoliberal framework is currently evolving and I see this dissertation project within the scope of that body of work. I believe that future work in the specific area of knowledge production in science and technology, as a product of the innovation discourse (versus innovation as a subset of knowledge production), will more closely examine the relationship between competition, R&D, innovation and commercialization. There is a spectrum of overlapping relationships and linkages between these discourses that merit review with a view towards unpacking the intersection points of equity and democracy. Additionally, the notion of assessment and evaluation, albeit, measures commonly associated with a neoliberal framework of quantitative, positivistic measures of success should also be examined with a view towards incorporating alternative modes of knowledge production and a more inclusive understanding of the innovation discourse as a knowledge creative process. Coupled with this issue is the notion of scientific literacy. Earlier I introduced the concept of scientific overload, I return to it now as a research question that is materially important to

125 equipping citizens and societies to better critique the discourses that produce knowledge in science and technology. A critical pedagogical approach to teaching and learning would provide a framework for moving beyond positivism as the accepted standard in knowledge production in science and technology. I believe that scientific literacy within scientific overload is a key research question that will identify the intersecting links and institutions that continue to reproduce these discourses of technologies of power and normalization. An economic and, a parallel social analysis of the impact of an innovation discourse that constantly pushes the envelope of something new and better merits greater scrutiny to understand the impact on knowledge produced and the translation of that knowledge into commercialization. The hyper-focus on evidence and data to support the creation of this knowledge is hooked into the ever-evolving process to accumulate greater levels of capital: surplus value and otherwise. Finally, I will also suggest that as a practical extension of this project, an analysis of assumed implementations of revisions to the SR&ED program post-Jenkins Report will merit review to consider the impact on the economy, the process of R&D and the impact on the innovation discourse both at the national and global levels. Concluding Thoughts It is impossible to begin a project of this scope without diverging from the original path, perspective and standpoint. As this project has evolved and thoughts turned to written word, and that written word was re-written and revised, the goals and intention also underwent a similar evolution. That evolution, I am confident, was for the benefit of this dissertation and my own personal development. As I write these final words, I hope that the inspiring methodological and analytical lens of this project which I outlined as a materialist method of inquiry has become clarified for the reader. My intention was to illustrate how multiple gazes and analytical frames can be customized and utilized to explicate the message. As an evolving and transforming student and scholar, I remain convinced that an analysis is much more robust when an interdisciplinary approach is utilized. Many scholars contribute to my development. As I have embarked on this journey, the writings of Dorothy Smith, Michel Foucault, Kaushik Sunder Rajan, Melinda Cooper, David Harvey, and, Gilles Deleuze, have contributed to my understanding that the

126 possibilities for seeing and comprehending the world can be understood through many possible frameworks. Within this materialist method of inquiry, I attempted to marry the grounding of the materialist method by incorporating the effects on humanity and society and hooking that grounding into theoretical frameworks of power relationships. My intention with this project was to explicate and illuminate the privileging of knowledge production in science and technology as a Canadian national economic strategy where science and technology is systematically privileged economically, politically and socially. The focus of this analysis was the Scientific Research and Experimental Design (SR&ED) program; a federal tax incentive program that privileges the production of R&D knowledge in science and technology where innovation and advancement in technology are the key criteria. By textually analysing the publicly submitted consultation documents during 2007 to 2008, incorporating participant observational research of public meetings coordinated by the Canada Revenue Agency and The Canadian Institute, and, linking the process of knowledge production into the evaluation apparatus of the health technology assessment (HTA) programs across the country, my intention was to illustrate and illuminate the various, coordinated and parallel, systems that privilege the production of science and technology knowledge in Canada. Finally, The Jenkins Report (Jenkins et al., 2011) was incorporated to illustrate the current public and private interests that are guiding this knowledge production and the innovation discourse. It is a currently evolving situation and the public policy decisions that are likely to result from The Jenkins Report are likely to influence the direction and scope of knowledge production and the innovation discourse in Canada for many years to come. Key themes emerged during the analysis including the power of evidence-based medicine and evaluation regimes, the evolution of the innovation discourse as a tool of nation-state economic and social policy, the effects on human capital and ever-increasing amounts of surplus value on the production of knowledge, and, finally, the complicity inherent between academia, public and private interests in the production of knowledge in science and technology which ultimately results in commodification and commercialization. What is clear to me is that the goals of knowledge production in science and technology are driven by guidelines, goals and frameworks that are disconnected from the materialist realities of the societies from which they are generated. The neoliberal capitalist markets that

127 drive this production are hyper-focused on surplus value and profitability as the endgame with a view to an ever-increasing trend that is not sustainable. Information is precisely the system of control. (Deleuze, 1998, p. 16) My point is not that everything is bad, but that everything is dangerous. (Foucault, 1977, p. 236) Perhaps it is logical to conclude here and consider as a final thought that the process of knowledge production in science and technology is more than product generation. Foucault would say that the danger lies in the utility and usage of that knowledge. Deleuze would say that the danger lies in the system that controlled that knowledge production. Smith, Sunder Rajan and Cooper would ask us to begin with the individual and society. I ask you to consider that it is an iterative process (consciously and unconsciously, overtly and nebulously) that creates a hegemonic system of knowledge production generation and dissemination; knowledge production is a dangerous process when disconnected from either the individual or society.

References

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Appendix A SR&ED Public Consultation Documents

The following appendix includes all of the SR&ED public consultation documents, of which there are 48, which were publicly posted and available on the Canada Revenue Agency website with specific online locations noted in the first data extraction field of each submission table summary. The same standardized data extraction field was used for each of the submission documents. The submission documents are presented here in the alphabetical order they were listed as on the Government website. They were posted in the language and format they were received during the consultation process. They were all retrieved on April 15 and April 20, 2010 the Ministry of Finance, Government of Canada website located at www.fin.gc.ca/consultresp/. Submission 1
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_39-eng.asp Acorn Partners Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Acorn Partners Acorn Partners are a private industry consultancy firm who self-identify as Merchant Bankers to Emerging Canadian Business (Retrieved November 24, 2011 from http://www.acornpartners.com/pages/intro.php) On page 3 of 9 of the submission, they declare their bias as such: Where you stand depends on where you sit. ...Acorn Partners provides working capital products to a marketplace comprised of less than 45,000 Canadian firms with the highest growth rates. 9 pages, single-spaced The format reads like a review paper. It has a structure that begins as a review, followed by a summary section. It then goes on to a recommendation section that begins with what they call a central recommendation. There is a compare and contrast section that includes program strengths and weakness. The submission includes a series of recommendations that are divided into the following sections: 3 general recommendations 4 enhancements to the program 5 ancillary complementary changes to the investment tax act 6 recommendations specifically under program administration Key recommendations from which all others build from is to remove perceived barriers to entrepreneurial development and to re-assign the SR&ED program away from CRA and to the Minister of National Revenue Office. Their submission perceives that this change will allow the program to be more nimble and responsive to business needs and not subject to the bureaucracy inherent in CRA. The end goal would be that the Minister would have oversight with perceived political and not bureaucratic constraints. The key general recommendations outline the rationale for relocating the program, describing the ideal leadership and staff, emphasizing the need for collaboration between CRA and private industry and not an adversarial relationship. The enhancements include a call for increasing the allowable expenses to a fixed percentage, allowing claims for intellectual property protection, allow for funding of an intellectual property litigation fund and establish a procurement fund.

Author(s) Bias (public, private, academic sector)

Length of submission Format of submission

Focus of response to consultation document

Recommendations

138

139

Ancillary changes recommended include a variety of recommendations that adjust the accounting methodology that is currently used. Suggestions around program administration changes focus on additional activities that should be eligible under the program including: patentable activities, allow for some activities performed outside of Canada, remove the bargaining that can occur between CRA and the claimants, remove ambiguity and clarify expectations thus removing the interpretation of the individual CRA official. The general critique that permeates the submission is that SR&ED, as administered by CRA is a program that inhibits the innovative spirit of the private sector by being overly cumbersome and has an inherent conflict by being a tax collecting agency versus a tax credit granting agency. The first paragraph is striking in the characterization of the perceived goals of private industry and the government interests: Both Advantage Canada and the Science and Technology Review view Canadas entrepreneurs as modern alchemists instrumental in the transformation of technical advances into products and services successfully sold around the world. ...Entrepreneurship like democracy is a messy process. Like democracy it is laudable only when compared with the alternatives. For both their worst excesses need to be curbed.

Critiques of current program

Other notable comments

Submission 2
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_9eng.asp Association of Canadian Academic Healthcare Organizations Submission in Response to Joint Finance Canada, Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Association of Canadian Academic Healthcare Organizations (ACAHO) as represented by the 50 signatories to the letter in the Appendix that who represent hospitals and clinical research institutions across Canada ACAHO represents the academic sector and self-identifies as such The Association of Canadian Academic Healthcare Organizations (ACAHO) is the national voice of Teaching Hospitals, academic Regional Health Authorities (RHAs) and their Research Institutes. The Association represents more than 45 organizations, with members ranging from single hospitals to multi-site, multi-dimensional regional facilities (also known as "Research Hospitals"). (Retrieved November 25, 2011 from http://www.acaho.org/?who_we_are) 7 pages, single-spaced While this is a national organization with a head office based in Ottawa, it was submitted as a French document. It was posted in the language received and an English translation was not provided. However, I was able to source the English version of the template from their website in the archive of government submissions. It has the format of a review article that begins with an introduction of ACAHO, who they are, what their mission and mandate is. The focus of this submission document was on R&D as it pertains to health care professionals and clinical teaching sites located throughout Canada. Three key recommendations were listed in the submission document. These included: increasing the allowable expenditures from $2million to $10million and increasing the taxable threshold limits, allowing foreign ownership partnerships, and, expanding allowable expenditures to include pre-commercialization activities, including patenting, prototyping, product testing. No specific critique was levied other than to encourage the program to continue to evolve and support R&D throughout Canada in health research. Noted on page 2 of 9:

Author(s)

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140

Given the role that Canadas Research Hospitals occupy in the health research enterprise where 80% of all publicly-funded health research takes place and its important translational relationships with the private sector in terms of identifying, developing and introducing innovative goods and products to the marketplace, we have a critical stake in how the federal government crafts policy in this area. In other words, understanding that research, innovation and commercialization occurs within a health research ecosystem we need to ensure, as much as possible, that the structure, process and outcomes of government policy are closely (if not seamlessly) aligned.

Submission 3
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_6eng.asp Association of Canadian Community Colleges Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Association of Canadian Community Colleges (ACCC) As an academic stakeholder, the ACCC self-identify as such within the first paragraph of the submission document: As the national and international voice of Canadas 150 publicly-funded community colleges, institutes of technology, cegeps and university-colleges across Canada, a primary role of the Association of Canadian Community Colleges is to engage proactively in discussions and debate with respect to the role and capacity of these institutions in the nations economic and social development. 2 pages, single-spaced The format reads more like a business letter and less like a review or proposal. The structure also begins with the address and contact information for ACCC at the onset of the submission. The focus of this submission is that the SR&ED program does not currently benefit small and medium sized business. The submission states that 75% of businesses in Canada employ less than 5 employees and do not benefit from this program. No reference for data is given in their submission. The submission outlines 8 recommendations and observations of the SR&ED program. The recommendations focus on: increasing the scope and administration of the program, allow colleges and institutes to assist business in accessing the programs, increase the accessibility of the program through publicity and partnership with ACCC, allow academic research to be eligible for the program, provide direct cash to Canadian industry to develop infrastructure, provide additional incentives for private industry that partners with academia and include some activities that occur outside of Canada. The critique focuses on the idea that the vast majority of business because of their size and academic institutions are excluded from the program. Recommendations were briefly outlined and were not developed as a detailed proposal.

Author(s) Bias (public, private, academic sector)

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Recommendations

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Submission 4
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_5eng.asp AstraZenecas Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives AstraZeneca A private industry business that self-identifies as such: Improving health is one of

Author(s) Bias (public, private,

141
academic sector) the toughest challenges facing the world today. As a global biopharmaceutical company, AstraZeneca has a key contribution to make through the discovery, development, manufacturing and commercialisation of innovative medicines for some of the worlds most serious diseases. (Retrieved November 25, 2011 from http://www.astrazeneca.com/Home) 7 pages, single-spaced The format is structured like a traditional business letter. The salutation begins at the beginning of the submission and is addressed to the federal government employees responsible for receipt of the consultation submissions. The focus of the submission is on enhancing the use of the SR&ED program as a tool for local operating companies to advocate and attract business from the parent multinational corporation for business to be conducted domestically. The submission outlines 8 recommendations for consideration. These include: enhance incentives to continue to attract investment and research in Canada, allow for claims for research conducted outside of Canada by Canadians, re-define the definition of R&D to include social science work, extend refundability to nonCanadian controlled subsidiaries, include results meetings as qualifying expenditures, and, specify the approved list of medical associations qualified to conduct research and the mechanism for approval. The primary critique is that the current program has not kept pace with global programs and where once there was a domestic advantage, that advantage for local operating companies no longer exists. On the first page of the submission in the first paragraph of the background, the statement is made that AstraZeneca ...is one of the worlds top five ethical pharmaceutical companies The definition of social science work that they submit should be included: epidemiology, pharmacoepidemiology, health economics research, outcomes research and pharmacoeconomics. (page 3 of 7)

Length of submission Format of submission

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Critiques of current program Other notable comments

Submission 5
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_12-eng.asp Bateman Viner R&D Tax Specialists Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Bateman Viner A private industry business that self-identifies as such: ...an income tax focused firm combining uniquely specialized knowledge with a common goal to provide a high quality, personalized, professional, tax-oriented service, including planning, followthrough and optimal compliance. (Retrieved November 25, 2011 from http://www.vinerrnd.com/index-2.html) 3 pages, single-spaced The format is structured like a traditional business letter. The salutation begins at the beginning of the submission and is addressed to the federal government employees responsible for receipt of the consultation submissions. The focus of the submission is from an accounting perspective and outlines an alternatives tax rate structure based on a step-wise increase in expenditures. Key recommendations centre on increasing the allowable expenditure limit and not necessarily on what those expenditures are. As well, the submission advocates for an expansion of CRA through the hiring of additional reviewers and allowing for work conducted outside of Canada. The central critique focuses on expansion of the program because the program has not kept pace with similar programs that have been established in other countries. The perception is that Canada has now fallen behind in competitiveness.

Author(s) Bias (public, private, academic sector)

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142
Other notable comments On page 3 of 3, in the final section entitled Balance the opening sentence is: We recognize that our point of view is to enrich the program and the governments point of view may be to restrain costs.

Submission 6
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_3eng.asp) BDO Dunwoody LLP Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives BDO Dunwoody LLP A private industry business that self-identifies as such: BDO in Canada is the countrys fifth largest single national accounting and advisory partnership, with more than 3,000 partners and professionals. BDOs services run from assurance, accounting and taxation services to financial advisory and corporate recovery. (Retrieved November 25, 2011 from http://www.bdo.ca/about/index.cfm) 5 pages, single-spaced The format is structured like a traditional business letter. The salutation begins at the beginning of the submission and is addressed to the federal government employees responsible for receipt of the consultation submissions. The focus of the submission was on answering the 4 questions that were outlined as the goal of the consultation process. All of the recommendations were presented as part of the answers to the 4 consultation questions. Key recommendations focused on: increasing the cap on allowable expenditures and allowing for work conducted outside of Canada, easing the rules for establishing multi-national offices in Canada, clearer clarification of the rules to remove ambiguity and the subjective interpretation of the individual CRA officials, allowing claims by investors, allow for some commercialization costs, allow for expenditures between collaborators in and out of Canada, administrative consistency and simplification of the forms and processes for claimants. The key theme was that the SR&ED program had not kept pace with the global landscape of programs. Nothing noted

Author(s) Bias (public, private, academic sector)

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Submission 7
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_4eng.asp BIOTE Canadas Submission in Response to Joint Finance Canada -Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives BIOTE Canada A private industry business that is a registered lobbied group. It is self-identified as: Incorporated in 1987 as the Industrial Biotechnology Association of Ca nada, BIOTECanada serves as the national voice for industry leadership for Canadas biotechnology sector. Through our national network of partner organisations, we inspire our domestic and international community to recognize the value of biotechnology and to provide solutions to the challenges faced by biotech firms today. (Retrieved November 25, 2011 from http://www.biotech.ca/en/who-weare/overview.aspx) 7 pages, single-spaced The submission was structured similar to a businesss annual review document. It had a traditional structure with an Executive Summary followed by a more detailed explanation. Although the submission was submitted by BIOTE Canada, there were 13 different stakeholders as co-signatories to the submission who represent various

Author(s) Bias (public, private, academic sector)

Length of submission Format of submission

143
provincial jurisdictions, lobby groups and professional organizations, and they included: Ag-West Bio Inc. Bio Alberta BioAtlantech Bio Nova BIOQuebec Life Science Association of Manitoba LifeSciences British Columbia MaRS Discovery District Newfoundland and Labrador Association of Technology Industries (NATI) Ontario Agri-Food Technologies Ottawa Centre for Research and Innovation (OCRI) Prince Edward Island Bio Alliance The Biotechnology Initiative The submission focuses on increasing the competitiveness of the SR&ED program globally. They cite data that suggest that other G8 countries have established more competitive programs and Canada now lags behind. The submission provides 2 main recommendations and several other recommendations that build on the 2 main recommendations. 1. Easing the ownership rules for Canada businesses and allow for foreign ownership 2. Increase the allowable expenditures from $2million to $10million Additional recommendations focus on clarification of interpretation rules and eliminating the subjective interpretation of CRA officials, see the SR&ED program as a tool for creating jobs that maintain science and technology intellectual talent within Canada to secure Canadas future as a leader in the knowledge -based economy. The central critique is that the program requirements and processes have not been modernized since the mid-1980s (pre-NAFTA) and have not kept pace with global programs in other countries. Opening paragraph of the Executive Summary on page 1 of 7: Canadas 532 biotechnology companies, spending over $1.7billion annually, represent over 12% of the countrys business expenditures in research and development (R&D). It is critically important to the success of these emerging technology companies and to the health of the industry in Canada that the Federal Government continue to create an advantageous business climate to sustain and grow these R&D activities.

Focus of response to consultation document Recommendations

Critiques of current program Other notable comments

Submission 8
Data Extraction Field Title of submission Content Retrieved April 15, 2010 from http://www.fin.gc.ca/consultresp/sredResp_8eng.asp Business Council of British Columbias Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Business Council of British Columbia A private industry business that self-identifies as such: The Business Council of British Columbia, established in 1966, is an association representing approximately 250 major business enterprises engaged in business in British Columbia. Our members are drawn from all major sectors of the provincial economy, including forest products, mining, manufacturing, transportation, agri-food, telecommunications, information technology, financial services, energy, tourism, retail, construction, healthcare, education and professional services. The Business Council is the foremost policy and business advocacy organization in the province. Membership provides opportunities to participate in roundtable

Author(s) Bias (public, private, academic sector)

144
meetings, working committees, and conferences which will allow you to stay informed about current developments, and stay connected with other business leaders and government. With a 40-year track record, the Business Council is the most sought after business voice in the province. (Retrieved November 25, 2011 from http://www.bcbc.com/about_us/bcbc_intro.asp) 4 pages, single-spaced The submission was structured similar to a businesss annual review document. It had a traditional structure beginning with a Background and then followed 3 main sections that include a section on Innovation Policy and Wealth Creation, Issues of Program Design and Administration, and finally, Conclusion. The focus of this submission is on linking changes to the SR&ED program and innovation policy to increasing commercialization of the products of innovation and R&D. Key recommendations focus on: including support for commercialization, allowing access to the program for companies that dont meet the Canadian controlled ownership rules, stream-lining the application process and increasing the fairness of the program by moving it from the administration of CRA because of the inherent, perceived conflict of interest. The submission cites data from the OECD that rank Canada 15 th in what is referred to as business R&D intensity. The perspective is that SR&ED is no longer a globally competitive program. Noted in the conclusion final chapter on page 3 of 4: ...business innovation needed to enhance Canadas long-term economic prosperity in todays increasingly knowledge-drive global economy.

Length of submission Format of submission

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Critiques of current program Other notable comments

Submission 9
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_45e_.asp CAE Inc. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives CAE Inc. A private industry business that self-identifies as such: CAE is a global leader in modelling, simulation and training for civil aviation and defence. With annual revenues exceeding C$1.6 billion, the company employs more than 7,500 people at more than 100 sites and training locations in more than 20 countries. (Retrieved November 26, 2011 from http://www.cae.com/en/about.cae/home.asp) 1 page, single-spaced A short letter style submission signed by the company vice-president and CFO. The focus of the letter was on issues with the SR&ED program as they affect the aviation industry specifically. Two recommendations were in the submission: revision of the Income Tax Act to separate the Strategic Aerospace Defence Initiative from claw backs by the SR&ED program, and secondly, separate the provincial program tax credits from claw backs through SR&ED as well. Essentially to allow double-dipping of tax credits. No direct critique was provided except to encourage that the program should be enhanced and not amputated by different governmental levels. Nothing noted.

Author(s) Bias (public, private, academic sector)

Length of submission Format of submission Focus of response to consultation document Recommendations

Critiques of current program Other notable comments

Submission 10
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca.consultresp/sredResp_33-eng.asp Canadas Life and Health Insurers Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and

145
Experimental Development Tax Incentives Canadas Life and Health Insurers A private industry business that self-identifies as such: Established in 1894, the Canadian Life and Health Insurance Association (CLHIA) is a voluntary trade association that represents the collective interests of its member life and health insurers. The Associations membership accounts for 99 per cent of the life and health insurance in force in Canada and administers about two-thirds of Canadas pension plans. (Retrieved November 26, 2011 from http://www.clhia.ca/) 3 pages, single-spaced Submission formatted like a business annual review document. Since this group represents the insurance industry, recommendations were based on ensuring that the SR&ED program is accessible to this industry. The submission focused on 3 main recommendations: increasing access to the SR&ED program by easing the Canadian ownership rules of the program, modifying definitions of SR&ED including the requirement of technological advancement to be more broadly interpreted (particularly for software development), and, lastly, to reduce compliance burden and ensure consistent administration and interpretation across the national reviewers for CRA. Critiques focused on the restrictive nature of the program in the above 3 areas. Broadening the scope of the program to include work conducted in the financial services sector and not just in science and technology. Nothing noted.

Author(s) Bias (public, private, academic sector)

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Submission 11
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca.consultresp/sredResp_10eng.asp Canadian Association of Petroleum Producers Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Canadian Association of Petroleum Producers A private industry business that self-identifies as such: The Canadian Association of Petroleum Producers (CAPP) represents member companies that produce about 90 per cent of Canadas natural gas and crude oil. CAPPs mission is to enha nce the economic sustainability of the Canadian upstream petroleum industry in a safe and environmentally and socially responsible manner, through constructive engagement and communication with governments, the public and stakeholders in the communities in which we operate. (Retrieved November 26, 2011 from http://www.capp.ca/aboutUs/mission/Pages/default.aspx#JRFydppuTN7L) 6 pages, single-spaced The format is structured like a traditional business letter. The salutation begins at the beginning of the submission and is addressed to the federal government employees responsible for receipt of the consultation submissions. The submission focuses on issues that affect the oil and gas industry, specifically around clarifying and expanding definitions in the legislation and SR&ED program. The submission describes 2 main recommendations with several sub-points. 1. Improve administration of the program through join industry-government collaboration and re-establish the incentive culture, revise the appeals process, and, clarify documentation requirements 2. Restructure parts of the legislation through allowing SR&ED submissions after the 18month rule subject to penalty, institute partial refundability for nontaxable entities, restructure contract payment rules, expand the territorial limit to be consistent with the tax laws, and, re-write exclusions in the Income Tax Act to remove redundancies. The primary critique centres on the perceived lack of consistency in how the program is administered and how elements are defined in SR&ED by defined differently in other

Author(s) Bias (public, private, academic sector)

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146
pieces of legislation. The submission also stresses that the perception is that CRA has an audit mentality where this program should be one of collaboration and encouraging research and development. Noted on page 3 of 6, first paragraph under section 1b. The first stage of a redress process is rebutting the RTAs technical report itself. Our experience has shown that the technical reports virtually never state how the opinion of the RTA is supported by fact, legislation or policy and rather as of the tone of I do not feel it is SR&ED. The integrity of the program is lost if no due justification for disallowment of the claim is provided in the RTA report and thus no adequate basis for rebuttal by the claimant is possible. The SR&ED program has evolved to be one of an opinion of the RTA rather than a position based on fact, policy or legislation.

Other notable comments

Submission 12
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_1eng.asp The Canadian Chamber of Commerces Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives The Canadian Chamber of Commerce A private industry business that self-identifies as such: As Canadas largest and most influential business association, the Canadian Chamber of Commerce is the primary and vital connection between business and the federal government. It continually demonstrates impact on public policy and decision-making to the benefit of businesses, communities and families across Canada. Experience the power of a network of over 420 chambers of commerce and boards of trade, representing 192,000 businesses of all sizes in all sectors of the economy and in all regions. (Retrieved November 26, 2011 from http://www.chamber.ca/index.php/en/about-us/) 7 pages, single-spaced Submission formatted like a business annual review document. The submission had two main goals. Firstly, the submission spent nearly equal amounts of space critiquing the tax rates for business and personal tax (not a goal of the consultation process). Secondly, recommendations were provided for improving the SR&ED program. The submission also used several economic sources from the OECD to review GDP and business expenditures on R&D across G7 countries. Recommendations for the SR&ED program included: expanding refundability to all R&D performers across all industries, allow off-setting of tax credits, allowing for the program use across collaborating relationships between industry, academia and government, clarify and simplify forms and processes so that small and medium sized businesses will take advantage of the program, and finally, to publicize the program. The primary critique is that it is too limiting and discourages use because of the complex nature of the program administration. It also suggests that small and medium sized businesses do not adequately take advantage of the program. Nothing noted.

Author(s) Bias (public, private, academic sector)

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Submission 13
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_2eng.asp Canadian Vehicle Manufacturers Association Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Canadian Vehicle Manufacturers Association A private industry business that self-identifies as such: The Canadian Vehicle Manufacturers' Association (CVMA) is the industry association representing Canada's largest manufacturers of light and heavy duty motor vehicles. The CVMAs

Author(s) Bias (public, private, academic sector)

147
membership includes Chrysler Canada Inc.; Ford Motor Company of Canada, Limited; General Motors of Canada Limited; and Navistar Canada, Inc. The CVMA creates a framework within which member companies work together to achieve shared industry objectives on a range of important issues such as consumer protection, the environment and vehicle safety. The CVMA provides research, information, industry-government advocacy and other services aimed at building a better understanding of the importance of a healthy automotive industry to Canada's economic well-being and prosperity. (Retrieved December 1, 2011 from http://cvma.ca/eng/about/about.asp) 5 pages, single-spaced The submission is structured similar to a business letter with an opening address and contact information. The submission addressed each of the four consultation questions in order in the submission. The focus of the submission responses is on issues associated with manufacturing, production and commercialization. The recommendations focus on the following suggestions: expand criteria to allow activities related to product commercialization and productivity improvement initiatives, make the tax credits refundable, broaden the scope to include foreign owned companies, expanding eligible costs, allow for collaborative work conducted outside of Canada, allow for transfer of ITC between collaborating partners, once work is deemed eligible no further future justification to be required, allow claims to be submitted as groups as opposed to individual submissions. The primary critique is that the program has been overly focused on R&D and has excluded commercialization activities. As noted on page 2 of 5 of the submission: However, the automotive industry has long argued that the SR&ED eligibility criteria are biased in favour of organizations and activities focused on fundamental research and development versus the more important activities related to product commercialization and productivity improvement initiatives.

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Submission 14
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_48-eng.asp CATA Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Canadian Advanced Technology Alliance (CATA) A private industry business that self-identifies as such: The Canadian Advanced Technology Alliance (CATAAlliance) grows the revenues of its members by creating a collaborative edge -- a chain of expanding value that ripples across Canadas Innovators, Commercializers, Users, and Professionals. The largest high-tech association in Canada, CATAAlliance matches businesses with opportunities across almost every sector, so that we can all do business together. Reaching out from Canada, CATAAlliance members are connected with investment and partnership opportunities with the major global companies. As 80% are exporters, CATAs members are the arrow-head for global growth. Through its Innovation Nation program, CEOs come together to catalyze the development of the Canadian business environment. CATA is the foundation for commercialization, market research, networking, events, access to other associations, and professional development, across the nation. (Retrieved December 1, 2011 from

Author(s) Bias (public, private, academic sector)

148
http://www.cata.ca/About_Cata/) 6 pages, single-spaced Submission formatted like a business annual review document. The submission was primarily a critique of the current SR&ED program and included a list of 43 criticisms of the program ranging from the current tax structure to the administrative practices, qualifications of CRA reviewers, the client survey results, and the list continues and includes almost all aspects of the program. The recommendations were grouped into 3 main suggestions that were structured as an action plan. They include: clarification of the current legislation, a change in the administrative environment at CRA and simplification of the tax rate structure. The critique was extensive and addressed virtually all aspects of the program. Noted on page 1 of 1 in the Background section: Todays Challenge: Tax incentives are the preferred form of incentives but they must be truly world class for Canada to be an Innovation Nation.

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Submission 15
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_11-eng.asp Certified Management Accountants Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Certified Management Accountants A private industry business that self-identifies as such: CMA leads the advancement and integration of accounting, management and strategy. We develop professional accountants and resources to optimize enterprise performance. (Retrieved December 1, 2011 from http://www.cma-canada.org/index.cfm?ci_id=2412&la_id=1) 3 pages, single-spaced Submission formatted like a business annual review document. The focus of the submission was that the SR&ED program has not kept pace with market place business realities and on making a single recommendation to make it more competitive. The recommendation was to make the ITC full refundable and not as credits only as direct cash returns to the businesses. The primary critique is that it is not as lucrative to businesses and not sufficient to encourage R&D. The first paragraph of the Introduction section on page 1 of 3: Canadas Scientific Research and Experimental Development (SR&ED) program is a vitally important instrument of public policy aimed at attracting capital investment in research that will develop the technologies of tomorrow, encouraging innovation in our economy. Innovation is one of the key drivers of productivity, together with investments in human and physical capital.

Author(s) Bias (public, private, academic sector)

Length of submission Format of submission Focus of response to consultation document Recommendations Critiques of current program Other notable comments

Submission 16
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_35-eng.asp Deloitte & Touche LLP Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Deloitte & Touche LLP A private industry business that self-identifies as such: Deloitte, one of Canada's leading professional services firms, provides audit, tax, consulting, and financial advisory services through more than 8,000 people in 56 offices. Deloitte operates in Qubec as Samson Blair/Deloitte & Touche s.e.n.c.r.l. Deloitte & Touche LLP, an

Author(s) Bias (public, private, academic sector)

149
Ontario Limited Liability Partnership, is the Canadian member firm of Deloitte Touche Tohmatsu Limited. (Retrieved December 1, 2011 from http://www.deloitte.com/view/en_CA/ca/about-Deloitte/index.htm) 13 pages, single-spaced Submission formatted like a business annual review document. The focus of the submission was to respond to the consultation questions and the majority of recommendations were framed in reference to global programs. The submission was organized in a confusing layout and the same recommendation was repeated in several sections of the same submission document. The key recommendations focused on allowing foreign investors to be eligible for the program, introducing refundable tax credits, raise expenditure limits, eliminate taxable capital restrictions, introduce a multi-tiered tax system, allow contract payments to third parties, expand the definition of SR&ED, and, simplification of the current administration by CRA. The critique focused on the growing global competition of R&D programs, the mobility of R&D globally, impact of exchange rates on R&D investment by multinationals in Canada, increased competition for global jurisdictions where labour costs are lower and the increased complexity of the administration of CRA has become prohibitive. Nothing noted.

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Submission 17
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca.consultresp/sredResp_17-eng.asp Ernst & Young LLPs Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Ernst & Young LLP A private industry business that self-identifies as such: Ernst & Young is a global leader in assurance, tax, transaction and advisory services. We aim to have a positive impact on businesses and markets, as well as on society as a whole. (Retrieved December 4, 2011 from http://www.ey.com/CA/EN/About-us) 18 pages, single-spaced Submission formatted like a business annual review document. During the preparation of the submission, Ernst & Young conducted their own consultation by interviewing 50 corporations to gain their perspective and collate responses to include in their submission. The submission indicated that they did not interview current clients. The submission takes on the tone and scope of a policy document. All recommendations are presented within a framework that considers the efficiency, simplicity and equity that is proscribed into the recommendation. The following definitions are used and stated within the document: Efficiency: the extent to which the tax system distorts the allocation of resources in an economy in the absence of market failures. In a well functioning economy, taxes that distort market prices alter private resource allocation decisions which in turn lead to a sub-optimal level of economic output. To the extent that a tax on corporations corrects a market failure, such as those aimed at encouraging R&D activities, the allocation of resources may actually improve. Simplicity: this criterion addresses the extent to which a tax regime or incentive is easy to administer by the tax authorities and comply with by the private sector. Equity: a tax system, or incentive, is deemed to be equitable if it treats similar taxpayers on the same basis (horizontal equity) and the tax burden increases on the basis of taxpayers ability to pay (vertical equity). There are 3 main recommendations that are presented within the submission with several sub-points included within each of them:

Author(s) Bias (public, private, academic sector)

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Recommendations

150
Improving consistency and predictability through improvements in administration, clarification of the legislation and the interpretation left to CRA employees (ie. Subjectivity of each interpreter) 2. Refundability and a progressive ITC structure 3. Other policy and administrative issues that include a lack of recourse for claimants, fear of reprisal and legislative issues A significant portion of the submission critiques the current definition of SR&ED and challenges the notion of advancement of technology and the associated issues with that claim. The submission proposes that challenges exist primarily with how the interpretation is subjectively left to the interpretation of individual CRA RTAs and often results in claims being disputed. Interesting to note that this submission became essentially its own small consultation in response to the official consultation. 1.

Critiques of current program

Other notable comments

Submission 18
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_27-eng.asp Federation des chambers de commerce du Quebec (FCCQ) Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Federation des chambers de commerce du Quebec (FCCQ) The Quebec Chamber of Commerce Federation A private industry business that self-identifies as such: With its wide network of more than 150 chambers of commerce, the FCCQ represents more than 60,000 businesses and 150,000 business people involved in all sectors of the economy throughout Qubec. As the largest network of business people and businesses in Qubec, the FCCQ strongly supports its members interests in matters of public policy, thus promoting an innovative and competitive business environment. The FCCQs Board of Directors is representative of its diversity, both in terms of member companies as well as local chambers of commerce across Qubec. (Retrieved December 7, 2011 from http://www.fccq.ca/espace-anglais-philosophy.php) 5 pages, single-spaced The submission was submitted in French language. Submission formatted like a business annual review document. An English translation version was not provided and is not available on the website. As a result, this submission will not be included in this analysis.

Author(s) Bias (public, private, academic sector)

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Focus of response to consultation document Recommendations Critiques of current program Other notable comments

Submission 19
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_15-eng.asp Finding Common Grounds Inc. Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Finding Common Grounds Inc. A private industry business that self-identifies as such: Established in 1999 as a funding consultant company, Finding Common Grounds Inc. (FCGI) helps small to medium-sized companies in obtaining refunds through the SR&ED program. We specialize in delivering SR&ED claim preparation services efficiently, allowing you

Author(s) Bias (public, private, academic sector)

151
to concentrate on your business. Our mission is to ensure companies gain a competitive advantage in the industry by helping them recover development costs to reinvest in innovation and growth. (Retrieved December 7, 2011 from http://www.fcgi.ca/) 2 pages, single-spaced The format is structured like a traditional business letter. The salutation begins at the beginning of the submission and is addressed to the federal government employees responsible for receipt of the consultation submissions. The focus of the submission was on a specific technical accounting issue associated with reconciling the processing of the ITC. The recommendations associated with the focus of the submission included a simplification of the format of the notices of assessment and reassessment, easing access to the business enquiries line for questions and additional training for CRA staff on addressing questions. The critique was directly focused on this specific issue. Nothing noted.

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Submission 20
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_7eng.asp Forest Products Association of Canadas Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Forest Products Association of Canada A private industry business that self-identifies as such: The Forest Products Association of Canada (FPAC) is the voice of Canadas wood, pulp, and pap er producers nationally and internationally in government, trade, and environmental affairs. Canadas forest products industry is a $57.1 billion dollar a year industry that represents 2% of Canadas GDP. The industry is one of Canadas largest employers, operating in hundreds of Canadian communities and providing hundreds of thousands of direct and indirect jobs across the country. FPAC represents the largest Canadian producers of forest products. Our members are responsible for 66% of certified forest lands in Canada. Third-party certification of member companies forest practices is a condition of membership in the Association a world first. (Retrieved April 20, 2011 from http://www.fpac.ca/index.php/en/about-us/) 6 pages, single-spaced Submission formatted like a business annual review document. The submission is presented as a policy statement on behalf of the FPAC and addresses recommendations based on current challenges facing the forestry industry including the high cost of the Canadian currency and global competition from other jurisdictions. Two primary recommendations are presented. They include a call to make the tax credits refundable and not merely tax credits. Included is a suggested plan for a tiered approach to refundability. Secondly, there is a recommendation that advocates for clarifying the administration and regional interpretation of CRA staff and reviewers. The critique is based on the issue of refundability and how many forestry businesses are unable to take advantage of this program because the ITC are not useful and/or not worth the costs and challenges associated with applying for the SR&ED program. On page 4 of 6, noted in the final paragraph of the Conclusion section: A more effective SR&ED program would not only encourage and sustain private sector spending on R&D but enable Canada to improve its R&D and innovation performance.

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152 Submission 21
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_41e_.asp Friends of Canadian Institutes of Health Research Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Friends of Canadian Institutes of Health Research An public advocacy group that self-identifies as such: Friends of CIHR promotes health research and health research funding and communicates the benefits to society through various programs and activities, as follows: To support the goals and values of the Canadian Institutes of Health Research (CIHR) To communicate the significance of health research to the broadest possible public audience and to engage this audience in informed discourse. To facilitate a sharing of health care and health research knowledge through public forums. To attract and support health research trainees in their career development. To establish community-based partnerships to assist in the achievement of goals. (Retrieved December 7, 2011 from http://www.fcihr.ca/about)

Author(s) Bias (public, private, academic sector)

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7 pages, single-spaced Submission formatted like a business annual review document. The submission focuses on recommendations that will bring governmental support for health innovation in line with the support that has been in place to support development in the mining and oil and gas exploration and development. All recommendations are positioned relative too and in contrast to that which is available for this sector. Two primary recommendations are proposed within the submission. These include a change in the tax regime for health innovation sector to make it comparable to that for mining and oil and gas. Secondly, customizing the SR&ED incentives for the health innovation sector by allowing for different levels of tax credits according to innovation risk, increasing expenditure limits, relying on peer review as a means to qualify health innovation and allowing for ownership retention policies. The primary critique centres on challenging the presumed privileging of the mining and oil and gas industries tax programs. There were many notable comments in this submission related to the production of knowledge and health innovation. To be internationally competitive in health innovations we have to bridge the gap between the public and private sectors. Multinational health innovation firms might be ready to consider investing hundreds of millions of dollars in basic science partnerships and Canadian led disease management studies if we could bridge this gap. (page 1- 2 of 7) It is never easy for scientists: to shift their focus from intensely competitive grants or public budgets to commercialization; to extract even the most promising knowledge from the public sector research and clinical environments to protect intellectual property; to arrange for financing for the first proof of concept or animal models; to build a multi-disciplined team of colleagues and contractors; to finance the early stage formulation, toxicity, feasibility testing, pre-clinical or Phase 1 trials; and to obtain ethics review from multiple institutions. It takes a heroic effort. The preclinical development support capacity of the Canadian public and private sector is relatively scattered and weak, and government and NGO funding at this level is

153
rarely available. (page 2 of 7) Almost every month, the intellectual property of another very promising health technology is transferred out of the country for development by foreign investors....Every academic and research centre in Canada can provide examples of excellent research migrating to foreign owners for development. (page 3 of 7) Those who live in a risk-averse public sector silo are likely to become more aware of the exciting but high-risk opportunities of innovation and commercialization. Industry is more likely to co-locate with academic centres. Public awareness of the importance of health research will rise. Patients and health professionals will benefit immensely from new diagnostics, therapies, clinical trials, and methods of providing and administering health services. (page 5 of 7)

Submission 22
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_21-eng.asp Hydrogen & Fuel Cells Canadas Submission in Response to Joint Finance Canada Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Hydrogen & Fuel Cells Canada A private industry business that self-identifies as such: As the sectors collective voice, the CHFCA works to raise awareness of the economic, environmental and social benefits of hydrogen and fuel cells. We are a national, non-profit association providing services and support to Canadian corporations, governments and educational institutions promoting, developing, demonstrating and deploying hydrogen and fuel cell products and services in Canada. Our members cover most types of hydrogen and fuel cell technologies, components, systems supply and integration, fuelling systems, fuel storage, and engineering and financial services. (Retrieved December 9, 2011 from http://www.chfca.ca/itoolkit.asp?pg=WHO_WE_ARE) 2 pages, single-spaced Submission formatted like a business annual review document. The submission focused specifically on only the two recommendations listed. Two recommendations were proposed. They included allowing claims to be made by non-Canadian owned companies for work conducted in Canada and allowing transferability of unused tax credits to other corporate tax liabilities. Critique focuses on the SR&ED program as an effective tool to increase R&D in Canada but it is outdated in terms of economic conditions and reality and no longer maximally effective. Noted in the final paragraph: As capital has no citizenship, and the rest of the world has much more of it than Canada, we strongly recommend expanding eligibility criteria, raising credit limits, improving refundability in order to attract global capital to Canada.

Author(s) Bias (public, private, academic sector)

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Submission 23
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_53-eng.asp David N.H. Horler, Ph.D. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives David N.H. Horler President of Horler Information Inc. A private industry business that self-identifies as such as noted in the introduction of

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academic sector) the submission: It is important in a public consultation process to know who the respondents are, what they bring to the table and what their interests are. My interests and experience related to SR&ED are summarized in the Appendix. I have had continuous experience with the SR&ED program since its inception in 1985, as a claimant for 10 years, as a consultant to CRA for 5 years, and as a consultant to industry for 7 years. I am a scientist by training and I work primarily on the technological side of the SR&ED program. I also have a good working knowledge of the financial rules. My SR&ED experience is mostly in software and Information Technology (IT) claims. 9 pages, single-spaced The format is structured like a traditional business letter. The submission outlines that the focus will be on answering questions (d) of the consultation process with some input on questions (a) and (b). The primary recommendations include: clarifying inconsistent interpretation of SR&ED, CRA to follow defined policies, establish an effective appeal mechanism and develop corporate memory to learn from historical mistakes and precedent making decisions of previous assessments. The critique focuses on the presumed inherent conflict of interest between and audit culture and an incentive culture. The CRA as the administering body of the SR&ED program has competiting priorities when it comes to supporting the goals of the SR&ED program. Noted on page 3 of 9, ...the word truth, which might seem strange in this context. I am using the word to mean an absolute reference. Unfortunately, there is no completely factual or objective way of defining SR&ED.

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Submission 24
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_42e_.asp Intellectual Property Institute of Canada Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Intellectual Property Institute of Canada A private industry business that self-identifies as such: Founded in 1926, the Intellectual Property Institute of Canada (IPIC) is Canada's pre-eminent association of professionals who specialize in intellectual property: patents for inventions, trademarks, copyright, and industrial designs. IPIC is committed to the protection and promotion of intellectual property in the Canadian economy. IPIC's Objectives 1. 2. 3. 4. 5. Represent the interests of Canadian intellectual property practitioners; Influence the development of intellectual property laws to the extent they impact intellectual property matters in Canada; Be the recognized and visible authority on Canadian intellectual property law and practice; Ensure high levels of knowledge, training, and ethics in Canadian intellectual property practitioners; and Increase the level of intellectual property business in the Canadian economy. (Retrieved December 9, 2011 from http://www.ipic.ca/english/general/about.cfm)

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6 pages, single-spaced Submission formatted like a business annual review document. The focus of the submission is on the protection of intellectual property rights and the

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consultation document Recommendations inclusion of IP and patent costs as eligible expenses. The only recommendation discussed focuses on including patent costs as eligible expenses. The submission document focuses on this single recommendation and an extensive rationale for including these costs. The critique focuses on IP and patent protection as an integral feature of innovation and R&D and proposes that it has been excluded from the SR&ED program erroneously. Noted on page 2 of 6: If technological innovations created in Canada are not secured with intellectual property protection, they become freely available to the world at large. The result is a reduction of the commercial advantage to the innovator, and little, if any benefit to the Canadian economy as a whole. Although the technical focus of the Program is on scientific and experimental activities, the overall purpose of the Program is to enhance the Canadian economy by stimulating innovation, and not simply to fund pure research. It is noted that even universities recognize the importance of obtaining patents to protect their own technological innovations and to enable them to extract value from the same.

Critiques of current program Other notable comments

Submission 25
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_47-eng.asp KPMG LLP Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives KPMG LLP A private industry business that self-identifies as such: KPMG has offices in 32 locations across the country. The firm's more than 430 partners and 5,000 employees provide crucial services to many of the public and private business, not-for profit, and public-sector organizations in Canada. (Retrieved December 9, 2011 from http://www.kpmg.com/Ca/en/WhoWeAre/Pages/Default.aspx) 12 pages, single-spaced Submission formatted like a business annual review document. The submission begins with an extensive table of contents at the start of the submission document. KPMG conducted seminars across Canada to gain input and incorporate that information into this submission. They also conducted an electronic survey that consisted of 22 multiple choice questions about the SR&ED program The submission is very well organized and begins with an overview of the companies that most benefit from the program and the rationale. The focus is on how tax incentives affect company behaviour, investment and R&D. The balance of the submission considers the questions that were posed in the consultation process and proposes a series of options. Interestingly, they do not pose one single option but rather often multiple options. Key recommendations include: allowing for various refundability and ITC models, increase expenditure limits allowances, expanding the definition of experimental development, improving the collaboration between CRA and industry, allowing foreign ownership companies to be eligible, allow for third party contract claims, allow for work done at not-for-profits and universities through partnerships, allow for work done outside Canada, and, finally, proposals for improving several aspects of administration including culture, management and communication, accountability, consistency and appeals processes. The critique primarily focuses on the SR&ED program not having kept pace with programs globally. Noted on page 6 of 12:

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156

While we are not advocating the introduction of complex legislation to d efine what constitutes experimental development, we believe serious consideration should be given to elaborating on the existing definition of experimental development and supporting activities.

Submission 26
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_18-eng.asp Liberty Motor Company Inc. Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Wouter van Essen Liberty Motor Company Inc. A private industry business that self-identifies as such: Savaria is Canadas largest wheelchair van conversion company. In 2010, Savaria acquired Canadian manufacturers Liberty Motor Company and Viewpoint Mobility. The newly formed Savaria Vehicle Group offers a complete portfolio of products for rear, side and dual entry systems serving both personal and commercial needs. With its start in 2005 through Van Action, Savaria has been manufacturing wheelchair conversions for over 5 years, providing independence to hundreds of mobility challenged passengers and drivers. We sell van conversions through dealer resellers across Canada. In the U.S., our rear entry models are available through Mobility Works. (Retrieved December 9, 2011 from http://www.savaria.com/products/vans/index.php) 1 page, single-spaced The format is very short and structured similar to an email communication. Focus was on providing two basic recommendations. Two recommendations noted: simplify the claims process because it requires the use of outside consultants and costs 5-10% of total claim, and, allow for some work to be conducted outside Canada when there is not a comparable vendor in Canada. None noted None noted

Author(s) Bias (public, private, academic sector)

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Critiques of current program Other notable comments

Submission 27
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_13-eng.asp Mirak Communications Inc. Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Mirak Communications Inc. A private industry business that self-identifies as such: We are experts in small business research and development - from the conception, implementation and government funding, to exploitation of the results. Our three principals have over 75 years of front line experience in technology areas ranging from software engineering, information technology, robotics, optics, to audio visual processing and special effects. We have managed many successful R&D projects (as well as some failures). We have been successful in getting Canadian government funding for our R&D projects (through National Research Council support including the IRAP programme) and 10 years of SRED claims. (Retrieved December 9, 2011 from http://www.mirak.ca/profile.php) 1 page, single-spaced The format is very short and structured similar to an email communication. The focus is centred on proposing two recommendations.

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157
consultation document Recommendations

Critiques of current program Other notable comments

The two recommendations involve online communications. Firstly, establish a SR&ED exchange where companies can search for partnerships. Secondly, establish an online pilot project where collaboration between technical experts could be used to stimulate problem-solving. None noted Noted on page 1 of 1: The recent book Wikinomics: How Mass Collaboration Changes Everything by Tapscott and Williams boldly claims that much of the competitive advancement that organizations will gain in the future will be through wisdom of crowds type collaboration that will take place over the internet to solve problems and create innovation.

Submission 28
Data Extraction Field Title of submission Content Retrieved April 20, 2010 from http://www.fin.gc.ca/consultresp/sredResp_22-eng.asp MPB Technologies Inc. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives MPB Technologies Inc. A private industry business that self-identifies as such: MPB Technologies was started in 1977 by Dr. Morrel Bachynski and seven other employees when the Research and Development arm of RCA Canada closed its doors. The Company grew and eventually diversified to include works in Communications, Space, Fusion Technology, Electromagnetics, the Forest Industry, Robotics, and Lasers. The company won numerous awards along the way including the Financial Post Canada Enterprise Award for Best Start-up Business Plan, three Canada Awards for Business Excellence, and the Canada Export Award. (Retrieved December 9, 2011 from http://www.mpbtechnologies.ca/mpbt/mpbt_web_2009/_en/mpbt_frontPage/about/about.html) 1 page, single-spaced The format is very short and structured similar to an email communication. The submission focuses on making two central recommendations. The two recommendations include: making the ITC fully refundable to be re-invested back into R&D by the claimants, and, improving the competence of the CRA reviewers. The only critique mentioned is that the current program is facing increasing challenges from global programs in emerging markets. Noted on page 1 of 1: Therefore, it is recommended that the SR&ED tax credits be expanded to include protection of the resulting intellectual property and the development of foreign export markets. In this way, the tax credit system would address innovation and not just R&D which is only one component of innovation.

Author(s) Bias (public, private, academic sector)

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Submission 29
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_46e_.asp N.J. Robbins Consultants Inc. Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives

158
Author(s) Bias (public, private, academic sector) N.J. Robbins Consultants Inc. A private industry business that self-identifies as such: We are SR&ED research tax credit technical specialists. Since 1996, we have been quietly helping a growing group of technology-based companies obtain R&D tax refunds and organize their R&D work. Our client companies operate in diverse fields and include manufacturers, inventors, software developers and more. Forging comfortable, longterm business relationships with our clients, our approach is scientific but simple, rigorous but relaxed, accurate but advocating, strategic but sensible. As part of our work, we take much vicarious pleasure from our clients successes! (Retrieved December 9, 2011 from http://www.researchpays.com/fcontent/about_us/index.asp) 5 pages, single-spaced Submission formatted like a business annual review document. The primary focus of the submission centred on improving the administration of the program. There were 12 recommendations that all involved the administration of the program and the competency of the CRA reviewers. A critical assessment of the current competency of the CRA reviewers was included in the submission document. First line of submission: FOSTERING A TEAM CANADA APPROACH TO SR&ED Noted on page 2 of 5: We believe that the SR&ED program will operate best using a Team Canada approach. Unfortunately, the current approach can become somewhat adversarial, whereas our real adversaries are foreign interests. All of us working in the SR&ED field must work towards our common goal that of making Canada a more productive, technologically advanced and secure place to live and work.

Length of submission Format of submission Focus of response to consultation document Recommendations Critiques of current program Other notable comments

Submission 30
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_36-eng.asp Ottawa Centre for Research and Innovation (OCRI) Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Ottawa Centre for Research and Innovation (OCRI) A private industry business that self-identifies as such: The Ottawa Centre for Regional Innovation (OCRI) is Ottawas leading member -based economic development corporation for fostering the advancement of the regions globally competitive knowledge-based institutions and industries. OCRI delivers its economic development services through a unique partnership with the City of Ottawa, where the City and OCRI, through its members set the strategy and manage the programs that move Ottawas economy forward. OCRI is a non-profit organization that operates on an annual budget that comes from a variety of sources including: municipal, federal and provincial government; membership fees; professional development programs; and private sector contributions. OCRI aims to lead Ottawa into the future by actively listening to and openly communicating with membership, clients, staff, and stakeholders. Hallmarks of how OCRI does business includes successful event and program delivery; strategic relationship building; secure funding models; and professional HR talent. As a leader for the community, OCRI aims to excel at the anticipation and analysis of future trends and will be known for its ability to adapt to and harness constant change. (Retrieved December 9, 2011 from http://ocri.ca/what-is-ocri) 2 pages, single-spaced

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159
Format of submission Focus of response to consultation document Recommendations The format is very short and structured similar to an email communication. The submission provides a few recommendations but primarily calls on the government to initiate a comprehensive review of the SR&ED program. Recommendations include: a comprehensive review of the program with government and industry stakeholders, make ITC refundable, increase expenditure limit, include costs for protection of intellectual property and credits for equipment purchased and used. Critique is generally presented that the program has remained relatively unchanged for 20 years and has not kept pace with other global programs. Nothing noted

Critiques of current program Other notable comments

Submission 31
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_37-eng.asp PARTEQ Innovations Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives PARTEQ Innovations An academic research and business unit that self-identifies as such: PARTEQ Innovations was founded by Queen's University at Kingston, Ontario, Canada in 1987 to commercialize intellectual property (e.g. inventions) arising from universitygenerated research. A not-for-profit organization, PARTEQ provides Queen's researchers with the business and financial expertise that is needed to advance their discoveries to the public, while returning the proceeds from those activities to researchers and the university. Since its inception PARTEQ has returned more than $20 million to the university and its inventors. PARTEQ's day-to-day activities include the following: evaluating and protecting intellectual property; licensing technologies generated by research; and/or creating and managing new spinoff companies ("ventures") generated by research; attracting research support for projects with downstream potential; and managing an early-stage venture fund. (Retrieved December 13, 2011 from http://www.parteqinnovations.com/about.html)

Author(s) Bias (public, private, academic sector)

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Recommendations

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3 pages, single-spaced The format is structured like a traditional business letter. The submission document focuses the response based on the experiences of Queens University researchers and spin-off companies. It lists some of these companies and advocates for the continuation and expansion of the SR&ED program to continue to benefit these companies. Key recommendations include: expansion of ownership rules to allow for foreign ownership because of investors outside of Canada, raise expenditure limit and allow for increased capital expenditures on equipment, allow for patent protection, allow for work and/or consultations conducted outside of Canada. No specific critique is provided other than to challenge the discounting of the federal program by tax credits provided at the provincial level. Noted on page 1 of 3: The SR&ED tax incentives are an essential component in helping to successfully advance early-stage university research from the labs to the marketplace. Almost every one of the forty spin-off companies PARTEQ Innovations has formed over the past 20 years have utilized the SR&ED programs to finance research and

160
development in intellectual property licensed from PARTEQ Innovations and Queens University.

Submission 32
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_38-eng.asp PC Private Sector Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives PC Private Sector The authors self-identify in the submission document itself as: Formerly, we were the private sector members of Canada Revenue Agencys (CRA) Partnership Committee on SR&ED. Although the SR&ED Partnership Committee was discontinued in 2006 as a cost cutting measure, the private sector members have continued to meet on our own time and at our own expense to exchange information and points of view. 5 pages, single-spaced Submission formatted like a business annual review document. The focus of the submission was primarily a critique levelled at the current executive management and leadership of the CRA and what was referred to as the culturally inherent audit mentality. (page 4 of 5) Many recommendations were provided but were primarily about the delivery of the SR&ED program by the CRA and the lack of consistency, non-adherence to policy documents, closed door policy changes and improving the competence of reviewers and technical staff. The primary critique was that CRA did not see industry as a partner in this program and this was resulting in an adversarial relationship. As well, they propose that CRA was becoming increasingly insular in their administration of the SR&ED program. Noted on page 3 of 5: In our view, some senior Canada Revenue Agency executives have remained resistant to the concept of partnering with the private sector and have taken deliberate steps to dismantle the partnership and its influence on the delivery of the program. Without any broad consultation with stakeholders, CRA has taken the position that this is their program alone and that they will run and deliver it in accordance with other existing tax audit models. They seem unwilling to allow this incentive program its intended place as a key driver in our efforts to make our country a global leader in innovation, to improve Canadian society and help move Canada to the forefront of innovative nations.

Author(s) Bias (public, private, academic sector)

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Submission 33
Data Extraction Field Title of submission Content April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_24-eng.asp PH Farmer Consulting Ltd Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives PH Farmer Consulting Ltd A private industry business that self-identifies as such: PH Farmer Consulting Ltd. is an Atlantic Canadian business providing professional taxation and management accounting services. Our primary focus is geared toward supporting firms conducting R&D activities to access available financial support in order to reduce their net R&D costs. PH Farmer Consulting Ltd. was started by our President, Paul Farmer CMA, to address a clear need in Atlantic Canada for expert guidance, advice and support in the preparation of

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161
Scientific Research and Experimental Development (SR&ED) tax credit claims. Our Founder has been involved in the SR&ED program since the mid 1990s, having served for over 4 years in the SR&ED Review Section of the Canada Revenue Agency (CRA). After leaving the CRA Mr. Farmer accepted an offer of employment from one of the leading national Chartered Accounting service firms in Canada prior to starting his own consulting services company. As a result of the experience gained on both sides of the fence Paul has acquired unique insight into the claim preparation, review, negotiation and administration aspects of the SR&ED program. (Retrieved April 21, 2010 from http://www.phfarmer.com/aboutus.html) Length of submission Format of submission Focus of response to consultation document Recommendations 3 pages, single-spaced The format is structured like a traditional business letter. The focus of the submission is on continuing to improve the SRE&ED program so that it is seen as an incentive for foreign investment in Canada. Key recommendations include: allowing foreign ownership of companies, additional tax credits for R&D conducted in rural areas of Canada, increase expenditure limit, administrative changes including clarifying documents, ensuring compliance to CRA guidance documents by CRA RTO, ministerial discretion for documents received past the due date and date stamping of documents are local offices. The critique primarily discusses the lack of consistency by CRA staff to CRA guidance documents and the resulting inconsistency in application of policy. Noted on page 2 of 3: ...allow fees paid by Canadian corporations to purchase/license technology that has been developed by the Public or Academic Sectors (Universities, Community Colleges, etc.) to be considered eligible expenses for SR&ED. This would encourage more private companies to seek out more opportunities to partner with and/or purchase new intellectual property (IP) and other technologies from these institutions that could be further developed and commercialized. The Public and Academic Sectors have a major role to play in supporting and participating in the development of new technologies and in the enhancement of existing technologies, however it usually falls to the Private Sector to take the lead in commercializing it.

Critiques of current program Other notable comments

Submission 34
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_20-eng.asp Pinchevsky & Co Management Consultants Inc Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Pinchevsky & Co Management Consultants Inc A private industry business that self-identifies as such: Pinchevsky is now Alma Consulting Group Canada. Our goal is to simplify the claim process for our clients. Our value proposition is simple, maximise your SR&ED and technology tax credits, and minimize your resource cost and risk. (Retrieved December 13, 2011 from http://www.almacg.ca/) 4 pages, single-spaced Submission formatted like a business annual review document. The primary focus of the submission document is a list of criticisms levied about the administration and technical competence of the CRA reviewers. Recommendations that are provided are listed within the context of providing a list of criticisms of the program. Generally, the recommendations include: improving

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162
measures of program satisfaction, administering SR&ED as an incentive program, increasing consistency in program administration, increasing transparency and predictability, more timely delivery of the reviews, and, elimination of excessive burden in terms of requests to claimants. The critique primarily centres on the CRA administration and competency of the CRA reviewers. Noted on page 1 of 4: SR&ED is an incentive program and should be delivered as such.

Critiques of current program Other notable comments

Submission 35
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_25-eng.asp Raymond Chabot Grant Thornton Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Raymond Chabot Grant Thornton A private industry business that self-identifies as such: Our experts in assurance, taxation, consulting and Recovery & Reorganization are intent on partnering with you to encourage your growth. This approach has helped us become one of the largest networks of public accountants and management consultants. Today, Raymond Chabot Grant Thornton (L.L.P.) has more than 2,000 employees in more than 90 offices and is a member within Grant Thornton International. Grant Thornton International is one of the worlds leading organisations of independently owned and managed accounting and consulting firms. These firms provide assurance, tax and specialist business advice to privately held businesses and public interest entities. Member firms focus on helping the individuals who own the businesses they manage reach their personal and commercial goals by providing practical, customised solutions and identifying and pursuing business opportunities domestically and internationally. Grant Thornton member and correspondent firms operate in over 100 countries worldwide. They share a commitment to providing the same high quality service to their clients wherever they do business. (Retrieved December 13, 2011 from http://www.rcgt.com/en/about-us/) 9 pages, single-spaced Submission formatted like a business annual review document, including a detailed table of contents. Submission was submitted in French language and posted as such. A certified English translation was noted located through the company. As a result, this submission will not be included in this analysis.

Author(s) Bias (public, private, academic sector)

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Submission 36
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_16-eng.asp RDP Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives RDP A private industry business that self-identifies as such: RDP Associates is devoted to providing your company with value-driven consultative services. In fulfilling this

Author(s) Bias (public, private, academic sector)

163
mission, we help you maximize your R&D tax credit or refund. Our dedication to this mission is best demonstrated by our personal commitment to quality service. The depth of that service is best expressed by those many clients and people we serve. RDP guarantees that there will be no charges to you for time or expense incurred if R&D refunds or credits are not recovered. (Retrieved December 13, 2011 from http://www.rdpassociates.com/) 4 pages, single-spaced The format is structured like a traditional business letter. The response focuses on listing issues that the consultants encounter and possible recommendations for resolution. Ten recommendations are listed: processing of claims by a financial review with support from a technical reviewer and not two concurrent reviews, issue refunds as certain aspects are resolved and set timelines for outstanding issues, allow for joint claims by partnered companies, allow for informal research relationships between collaborators, clarify issues and timelines associated with the start of SR&ED eligible activities at the R&D level, improve interpretation and consistency across reviewers by establishing training, evaluation and reward programs, allow application and offsetting of ITC to other taxes owing. Critiques are presented as issues with the recommendations listed above. Nothing noted.

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Submission 37
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_19-eng.asp Research Canada: An Alliance for Health Discovery Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Research Canada, representing 79 member groups listed on the first page of the submission which include public, private and academic research groups A collaborative public, private and academic collective that self-identifies as such: Working for all Canadians to improve health and build prosperity Research Canada is a national, not-for-profit organization whose mission is to improve the health and prosperity of Canadians by championing Canadas global leadership in health research. Working for all Canadians, its members and partners are drawn from all sectors dedicated to increasing investments in health research, including the leading health research institutes, national health charities, hospitals, regional health authorities, universities, private industry and others. (Retrieved December 13, 2011 from http://www.rc-rc.ca/) 5 pages, single-spaced Submission formatted like a business annual review document. The submission provides several testimonials of companies where the SR&ED program was highly effective. Additionally, recommendations were provided. Key recommendations included: allowing alliances with expert stakeholders, extending eligibility to more companies regardless of ownership origin, allowing for collaborative research relationships, allowing some pre-commercialization activities, improved administration and marketing of the program globally. The primary critique focuses on SR&ED as a program developed pre-NAFTA and should be modernized to meet the needs of a new North American and global economic order. (page 2 of 5) Noted on page 2 of 5: Taxation is critically important in shaping the perception of the country and

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164
signalling to the world that Canada is open for business. Unlike many other factors that influence the generation of knowledge and innovation, taxation falls completely within the domain of the government. A competitive and stable taxation policy has the potential to be an effective tool for the Canadian government to promote innovation and investment activity in the country. Noted on page 5 of 5: We consider that Canada can make a quantum advance in the design, understanding, and accountability of the innovation chain at this time that will result in the flexibility to meet new opportunities and will deliver increased international competitiveness.

Submission 38
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_51-eng.asp Research Support Services Inc. Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Research Support Services Inc. Represented by Mr William (Bill) Robinson A private industry business that self-identifies as such: Research Support Services Inc (RSS) is a Canadian consulting company located in British Columbia. We employ a staff of technology experts who assist clients to identify eligible SR&ED projects and who prepare science and financial reports for inclusion in a SR&ED tax claim submitted under the Canada Revenue Agency (CRA) Scientific Research and Experimental Development (SR&ED) Investment Tax Credit (ITC) program. Bill Robinson P.Eng, the CEO of the company, has been a SR&ED consultant since 1994. As well as providing consulting services, RSS will provide its clients a specialized SR&ED software application called ReCap. ReCap is designed to HELP THE CUSTOMER capture detailed research and trial information in a concise and consistent manner to directly support the SR&ED claim application. (Retrieved December 13, 2011 from http://www.researchsupport.ca/about.html) 37 pages, single-spaced, the longest submission document The format is structured like a traditional business letter. The consultation document submission presents each of the questions followed by a response, including examples and recommendations. After the initial recommendations, the submission lists the ideal characteristics of an incentive program which is a re-statement of the initial recommendations. From page 8 to page 37, an extensive appendix includes previously submitted documents, letters, published articles and public presentations conducted by the author on the topic of the SR&ED program. Key recommendations include: function as an incentive program and not an audit program, remove minimum limits on expenditures, increase total allowable expenditure up to $10 million, increased involvement of the Finance Ministry in the administration of the program, establish a tri-partite oversight body (CRA, Finance and Industry), clarify the science audit process, establish qualification and a training program of CRA reviewers, define responsibilities for Industry and Revenue Canada, commission an external advisory report. The primary critique is that the program is no longer an incentive program but is rather an audit driven bureaucratic system. Noted on page 2 of 37: If the SR&ED ITC programme was human, it would be diagnosed as severely schizophrenic. But the issue remains not with legislated rule; it remains with the interpretation of these legislated rules by the CRA in the administration of

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programme.

Submission 39
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_28-eng.asp Rye Management Consultants Inc. Submission in Response to Joint Finance CanadaCanada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Rye Management Consultants Inc. A private industry business that self-identifies as such: RMCI is a boutique consulting firm advising clients in the following areas: Strategic management, Succession planning, M&A, Government incentive programs, Government relations and International trade. (Retrieved December 13, 2011 from http://ryemci.com/) 1 page, single-spaced The format is very short and structured similar to an email communication. The four consultation questions were restated with brief responses offered for each of them in the form of recommendations. The main focus was on accounting elements of the program administration. Key recommendations include: increase the taxable income limit upwards, reduce the impact of previous years ITC on taxable income, eliminate taxing of credits, increase timeliness of reviews, and harmonize with provincial programs. No specific critique levied other than to emphasize that companies rely on the ITC to continually invest in R&D. Nothing noted.

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Submission 40
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_54-eng.asp Brian Hartman, R&D Funding Management Inc. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Brian Hartman, R&D Funding Management Inc. A private industry business that self-identifies as such: R&D Funding Management Inc. is a focused team of scientists, engineers and financial professionals that specialize in the Scientific Research and Experimental Development (SR&ED) tax incentive program offered by the Canada Revenue Agency. We have more than 300 years combined experience and are experts in unearthing eligible work and preparing successful applications. We also consult on many other government programs, pro bono, as a value added service. (Retrieved December 13, 2011 from http://www.rdfm.ca/) 1 page, single-spaced The format is very short and structured similar to an email communication. The submission document briefly outlines 6 recommendations. Key recommendations include: allow for foreign ownership of Canadian companies, allow for transferability of tax credits to other taxes owing, increase the consistency of SR&ED criteria and policies by CRA staff, increase taxable threshold limits, allow for claims by companies with collaboration contracts with other partners, and, establish a review board for an appeals process by claimants. No specific critique is presented Nothing noted.

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Submission 41

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Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_29-eng.asp Scitax Advisory Partners Submission in Response to Joint Finance Canada -Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Scitax Advisory Partners A private industry business that self-identifies as such: Scitax Advisory Partners LP is a Canadian professional services firm with specialist expertise in all aspects of planning, preparing and defending Scientific Research and Experimental Development (SR&ED) tax credit claims. We offer a multi-discipline team of engineers, chartered accountants and tax lawyers to ensure that your SR&ED issues are covered from every angle. While we normally work in concert with our client's existing accountants, our affiliated tax-dedicated chartered accounting firm Cadesky and Associates LLP is an expert resource for advice on any taxation matter such as may arise either during the planning and preparation of your claim or while dealing with CRA afterwards. In addition to planning and preparing new claims, we also engage on claims that are either being actively challenged by CRA auditors or that have received negative assessments on either scientific or expenditure eligibility issues. If CRA will not give satisfactory resolution at the local office level, with the help of our affiliated firm of tax lawyers we will appeal for a better settlement using either Notice of Objection or Tax Court of Canada procedures. (Retrieved December 13, 2011 from http://www.scitax.com/index.html) 2 pages, single-spaced The format is very short and structured similar to an email communication. The submission document immediately begins with 6 recommendations outlined and provides no other narrative. Six key recommendations are listed: expedite availability of tax funds through a timely process of review, clarify the rules and guidance of the SR&ED program, allow refundability and monetization in certain circumstances, federal and provincial programs should be mutually exclusive, better define acceptable record keeping, and, allow claims for fees for preparation. No explicit critique is provided. Nothing noted.

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Submission 42
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_23-eng.asp Stonecracker Scientific Law Office Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Stonecracker Scientific Law Office A private industry business that self-identifies as such: Stonecracker Scientific Legal Network is an international network of independent solicitors and their supporting firms. We are the ONLY law firms in the world that practice Research & Development Tax credit claim preparation. Our group of professionals understand the four areas of law that make up the Research & Development Tax Credit program; Corporate, Intellectual Property, International and Tax, in both Canada and the United Kingdom. We are focused on Research & Development Tax Credits - we are passionate about maximising your returns. We assist you and your business in making strategic decisions, mitigating risk and avoiding those areas that may negatively affect your claim. Through our network of solicitors and professionals, we provide you with high quality, personalized advice that relieves pressures associated with making business

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167
decisions pertaining to your R&D claim. We do not replace your company's current council or tax preparer, but rather work closely with them, ensuring everyone's expertise is utilized to maximise your tax credit. The Stonecracker Scientific Legal Network has the ability to see your claim through from beginning to litigation. Every claim has a team assigned to it; a solicitor, a technical writer and a financial analyst, to prepare your file. We have experience within a wide range of industries and sectors, servicing everything from small through large corporations. (Retrieved December 13, 2011 from http://www.stonecracker.com/) 5 pages, single-spaced The format is structured like a traditional business letter. As a law firm, this submission was prepared with a focus on the claims that were filed on behalf of clients and their own experiences as a legal representative of clients. The focus is on administrative related experiences and policy-related input. The opening comments specify that their experiences have also been that large multinationals will specifically evaluate the global landscape before choosing which jurisdiction to conduct R&D. Key recommendations include: allow refundability for publically traded companies, allow for collaborative research contracts between companies, clarify the requirements for documentation that are most appropriate to an industrial environment, allow for some pre-commercialization costs, allow for claims for costs associated with intellectual property protection, and, re-establish an atmosphere of assistance and incentive versus audit and compliance. The primary critique is that the current program and administration is not perceived as a partner in R&D in Canada with industry. Noted on page 1 of 5: That is to say that we have spoken to many former SR&ED program users whose experiences with SR&ED administration have been so exacerbating that they have chosen to stop performing R&D in Canada altogether, despite such activities possibly costing much more in other jurisdictions. The result is that the extremely valuable technical knowledge base and intellectual property may leave the country likely never to return.

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Critiques of current program Other notable comments

Submission 43
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_34-eng.asp Dmitry Shparbers Submission in Response to Joint Finance Canada -Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Dmitry Shparber A private industry business representative who self-identifies as such: Science Experts is a leading firm providing assessments of eligibility for a yearly government cash rebate for business involved with development of new procedures, products, or testing new materials. We provide consultation, technical writing and tax amendments services as per the needs of our clients. In addition we specialize in intellectual property protection. Patent will protect your product, composition of matter, machine, or a process. We conduct patent evaluation, search, and prepare Canadian, US and international applications. Before starting my own business I was involved in different projects in different industries. In 2000 Ive gone on to create my own intellectual property business offering creative consulting for government grants and providing intellectual property solutions for various industries. (Retrieved December 13, 2011 from http://ca.linkedin.com/in/dshparber) 1 paragraph

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Format of submission Focus of response to consultation document Recommendations Critiques of current program Other notable comments A short paragraph that proposes that R&D is not done in Canada by multi-nationals because of a more favourable taxation system in other jurisdictions. See above None provided The critique is that the current program is not currently competitive with other global programs. Nothing noted.

Submission 44
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_30-eng.asp Simon Sunatoris Submission in Response to Joint Finance Canada -Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Simon Sunatori A private industry business representative who self-identifies as such: Simon Sunatori (born January 10, 1959 (age 52)) is a Canadian engineer, inventor and entrepreneur, known for the invention of the HyperFeeder (a squirrel-proof bird feeder with concentric perching rings and a transparent globe), the MagneScribe (an auto-retractable ballpoint pen with an ergonomic cushion) and the Magic Spicer (a self-sealing auto-aligning magnetically-hanging spice dispenser with a continuouslyvariable hole-size selector). He obtained a Master of Engineering (Engineering Physics) degree from McMaster University in Hamilton, Ontario, Canada in 1983, and is a member of the Professional Engineers Ontario (PEO), a senior member of the Institute of Electrical and Electronics Engineers (IEEE) and a life member of the World Future Society (WFS). He is listed in Canadian Who's Who, published by the University of Toronto Press (UTP). (Retrieved December 13, 2011 from http://en.wikipedia.org/wiki/Simon_Sunatori) 2 pages, single-spaced The format is very short and structured similar to an email communication. The focus of the submission is on issues surrounding the concept of technological advancement and how to best identify what qualifies and what is included in allowable expenditures. Key recommendations: patentable work should automatically be considered technological advancement, fees associated with establishing a patent should be allowed, equitable treatment of small versus large corporations where smaller firms are perceived to be more micro-managed by CRA auditors. The primary critique centres on the perceived inconsistencies in administration of the SR&ED program. Noted on page 1 of 2 in the opening paragraph: I had a disagreement with a Scientific Auditor regarding technological advancement for the SR&ED Programme. I had assumed that one of my projects was eligible for SR&ED because it was a patentable subject matter, while the Auditor rejected it to be technological advancement because there were no equations! Noted on page 2 of 2 in the last paragraph: I had thought that the whole idea of the SR&ED Programme was to encourage innovation. However, a view graph in the SR&ED Seminar says: Innovation is not enough. Together with the Auditors discouraging comments: Thinking does not qualify, Trial and Error is excluded, and This programme is not for you (independent inventors) regardless of the context, it seems that the SR&ED Programme does not seem to encourage innovation in practice. To be fair, other

Author(s) Bias (public, private, academic sector)

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Advisors were open-minded to explore any possibility of SR&ED eligibility in order to encourage innovation.

Submission 45
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_52-eng.asp Technical Management Consultants Inc. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Technical Management Consultants Inc. As represented by Al Gordon A private industry business self-identified as such: Technical Management Consultancy Limited (T M C ), was founded in February 1995 to provide interim management and consultancy at senior manager level in technically based projects and companies. In 2004 a Psychology Division was added to the company following collaborative work on psychological attitudes to business and project risk. Company staff and associates have worked in a wide range of industry sectors including; defence, nuclear energy, construction, mining, oil and gas, rail, Occupational Health, HR, the National Health Service, Civil Service, Law Firms and Local and National Government. The company focuses on applying systems engineering and psychological principles to projects and businesses through the disciplines of Programme Management, Risk Management, Change Management and Requirements Engineering. (Retrieved December 13, 2011 from http://www.tmclimited.com/) 1 page, single-spaced The format is very short and structured similar to an email communication. Submission document only provides 3 recommendations and no other narrative. Three key recommendations listed: allow for refundability, provide consistent and extensive training for CRA reviewers to ensure equitable application of the program across the country, and, reintroduction of partnership committees to allow for collaboration and consultation on an ongoing basis between government and industry. None explicitly listed. Nothing noted.

Author(s) Bias (public, private, academic sector)

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Critiques of current program Other notable comments

Submission 46
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_14-eng.asp TELUS Corporations Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives TELUS Corporation A private industry business that self-identifies as such: TELUS (TSX: T, T.A; NYSE: TU) is a leading national telecommunications company in Canada, with $10.1 billion of annual revenue and 12.4 million customer connections including 7.1 million wireless subscribers, 3.7 million wireline network access lines and 1.2 million Internet subscribers and more than 400,000 TELUS TV customers. Led since 2000 by President and CEO, Darren Entwistle, TELUS provides a wide range of communications products and services including data, Internet protocol (IP), voice, entertainment and video. In support of our philosophy to give where we live, TELUS, our team members and retirees will, by year-end 2011, have contributed $245 million to charitable and not-for-profit organizations and volunteered 4.1 million hours of service to local communities since 2000. Ten TELUS Community Boards across

Author(s) Bias (public, private, academic sector)

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Canada lead TELUS' local philanthropic initiatives. TELUS was honoured to be named the most outstanding philanthropic corporation globally for 2010 by the Association of Fundraising Professionals, becoming the first Canadian company to receive this prestigious international recognition. (Retrieved December 13, 2011 from http://about.telus.com/community/english/about_us/company_overview/strategy_%2 6_values) 6 pages, single-spaced The format is structured like a traditional business letter. The focus of the submission is on the telecommunications industry and challenges with the SR&ED program. The initial part of the submission outlined the significance of the telecommunications industry to the Canadian economy and the successes that TELUS had experienced over their history. The submission also outlined the historical challenges that the telecommunications industry had experienced with the SR&ED program. Key recommendations include: remove the SR&ED program from the Income Tax Act and re-assign responsibility to another government agency due to the adversarial and inconsistent approach employed by CRA, improved transparency, timeliness and consistency with the administration of the program, improved clarity of the SR&ED program, improved dispute resolution process, and, revision of rules related to investment tax credits. The primary critique centres on the adversarial nature of the audit experiences of TELUS with the CRA. The tone of the letter is quite accusatory and uses the opportunity to list the negative experiences with the SR&ED program. Nothing noted.

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Recommendations

Critiques of current program Other notable comments

Submission 47
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_44e_.asp Tembec Inc. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives Tembec Inc. A private industry business that self-identifies as such: Tembec is a leading integrated forest products company, with operations in North America and France. With sales of approximately $2 billion and some 4,300 employees, it operates over 30 market pulp, paper and wood product manufacturing units, and produces silvichemicals from by-products of its pulping process and specialty chemicals. Tembec markets its products worldwide and has sales offices in Canada, the United States, China, Korea and Japan. The Company also manages forest lands in four Canadian provinces in accordance with sustainable development principles and has committed to obtaining Forest Stewardship Council (FSC) certification for all forests under its care. (Retrieved December 13, 2011 from http://www.tembec.com/public/A-propos-de/Apercu.html) 4 pages, single-spaced Submission formatted like a business annual review document. Submission was submitted in French language and posted as such. A certified English translation was not located through the company. As a result, this submission will not be included in this analysis.

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Submission 48
Data Extraction Field Title of submission Content Retrieved April 21, 2010 from http://www.fin.gc.ca/consultresp/sredResp_31-eng.asp TesProTM Equipment Inc. Submission in Response to Joint Finance Canada-Canada Revenue Agency Consultation Improving the Scientific Research and Experimental Development Tax Incentives TesProTM Equipment Inc. A private industry business that self-identifies as such: TesPro Equipment Inc. is a high-tech designer and manufacturer of state-of-the-art testing equipment and production equipment. TesPro Equipment Inc. is at the forefront of innovation in designing and manufacturing customized specialty products. TesPro Equipment Inc. incorporates mechanical, electrical, pneumatic, hydraulic, computer controlled and computer monitored components in many of our products. (www.tespro.net) (Retrieved December 13, 2011 from http://www.list-company.com/companyinfo/4028809a13dd74c80113dd78fc635c38/TesPro-Equipment-Inc-TestMeasurement.shtml) 3 pages, single-spaced The format is similar to an email communication. The focus of the submission document centres on answering the consultation questions only and provides no additional narrative. Key recommendations include: improve the timeliness of the review process to allow for claimants to budget appropriately for the SR&ED review, improve awareness and education of the SR&ED program for all companies, improve public-private R&D collaboration, improve the consistency of CRA reviews, simplify the areas of complexity and forms, and, improving the website. The primary critique centres on a lack of consistency with program administration. Noted in the last paragraph, page 3 of 3: Reducing time-frames in all processes of the program by streamlining each component will ultimately result in more innovation and technological advances by Canadian-controlled private corporations that happen sooner rather than later.

Author(s) Bias (public, private, academic sector)

Length of submission Format of submission Focus of response to consultation document Recommendations

Critiques of current program Other notable comments

Appendix B Websites Consulted for Health Technology Assessment Information and References All Health Technology Assessment references and information discussed are publicly available through the relevant websites listed below and were accessed at various times between September 2010 and August 2011 for reference during the research and writing of this dissertation project: http://www.ihe.ca/ http://www.path-hta.ca/Home.aspx http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html http://www.health.gov.on.ca/english/providers/program/ohtac/ohtac_mn.html http://www.health.gov.on.ca/english/public/pub/drugs/dqtc.html http://www.inahta.org/INAHTA http://www.thecem.net/ http://www.theta.utoronto.ca/ http://chspr.ubc.ca/publications http://www.ti.ubc.ca/ http://www.chalmersresearch.com/home.html http://www.ispor.org/HTADirectory/Index.a http://www.hpme.utoronto.ca/site3.aspx http://www.ices.on.ca/webpage.cfm http://www.hctp.utoronto.ca/Welcome.asp http://www.cihr-irsc.gc.ca/e/37788.html http://www.cadth.ca/index.php/en/help/federated-search http://www.ahfmr.ab.ca/about.php http://www.mcgill.ca/tau/objective/ http://www.ispor.org/HTADirectory/Index.a http://www.chepa.org/Home.aspxspx http://www.cheos.ubc.ca/ http://www.chaps.ucalgary.ca http://www.ucalgary.ca/cipph/

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Appendix C Observation Field Notes From a 2011 Conference in Montreal, Quebec

The following tables represent a summary of my participant observation field notes from the Montreal conference that I attended on March 28 to March 29, 2011 in Montreal, Quebec. A standard data extraction form was used to summarize and analyze each of the presentations listed on the agenda. Most presenters also provided handout slides to all the attendees of the conference. Day 1 (March 28th), the schedule of lectures and discussions was as follows:
Time Title Speaker Credentials of Speaker 9:15am to 10:15am Clinical Trials Global Landscape Kenneth A. Getz, MBA Senior Research Fellow, Assistant Professor Tufts Center for the Study of Drug Development, Tufts Medical School Owner/Founder, CenterWatch Founder and Board Chair, The Center for Information and Study on Clinical Research Participation (CISCRP) Overview of the current operating environment and its impact on sponsors, CROs and investigative sites Solutions implemented to transform R&D, accelerate drug development and reduce costs New approaches and opportunities to improve development performance and efficiency New initiatives to raise public awareness and rebuild pubic trust in clinical research A significant portion of this presentation focused on the costs associated with R&D in drug development and the relative return on investment by sponsor companies. Interestingly, he proposed that there are currently three factors that are affecting the R&D conditions globally: a low point in the innovation cycle, regulatory conservatism and public discontent. As well, he proposes that in the period between 2011-2020 that there will be an Innovation Platform where: Rapid growth of open, global innovation platforms and communities Growing integration and coordination of partnership networks Ample operating inefficiencies requiring incremental improvements Baby boomers start turning 65 Expanding and maturing emerging market economies As a result of these factors, he proposes that there is a new network model of innovation where there are open and integrated platforms supporting autonomous, coordinated teams. Essentially, innovation and R&D will be a collaborative effort between large pharma, academia, biotechs/small pharma, CROs/other partnerships and partnerships with patients. Interestingly, he does not see a role for government in these innovation networks. 10:30am to 12:00pm Sponsors Perspective on Canadian Clinical Trials: Challenges and Potential Solutions (a panel discussion) Moderator: Kenneth A. Getz (as above) and a panel of commentators from government and industry as listed below 5 Panelists:

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Speaker Dr. Shurjeel Choudhri, Chief Medical Officer and Head Medical and Scientific Affairs Bayer Inc. Sandra Gazel, M.Sc. Associate Director, Clinical Operations, Medical Division Abbott Canada Stanislav Glezer, MD, MBA VP, Medical Affairs sanofi-aventis Canada Inc. Jean-Jacques Rousseau, MBA (A) Manager, Life Science Programs Ontario Ministry of Research and Innovation Manon St-Pierre, Director of Research, Innovation and Knowledge Transfer Quebec Ministry of Health and Social Services Topics to be discussed include: Why are we at a crisis point? What are the main causes? What are the consequences? What are some potential solutions? Having launched the Life Sciences Commercialization Strategy, the Ontario Ministry of Research and Innovation will discuss what steps it is taking to streamline ethics review and contracting to help maximize its share of global clinical trials activity The Ministry of Health and Social Services initiative regarding the negotiation of research contracts between the academic hospitals and pharmaceutical and/or device companies: o Background: the origin of the Quebec initiative o Solutions: why reinvent the wheel? o Particularities to consider in Quebec o Other initiatives in Quebec and Canada: the need for dialogue The panel discussion became very focused on government programs and initiatives. The representative from the Quebec provincial government faced a great deal of opposition and questioning on the central provincial ethical review process known as the MSSS process. A significant amount of criticism was levied about the lack of efficiency and transparency associated with this process. Unfortunately, English was her second language and the questions were filtered to her through her personal translator and the dialogue on this issue was not productive since many comments and questions were lost in translation. Additionally, the representative from the Ontario government used the opportunity to promote current government initiatives and programs and investment in innovation in the province of Ontario. The panel discussion was primarily focused on questions directed towards these two government representatives. Time Title Speaker Credentials of Speaker 1:15pm to 2:30pm Canadian Clinical Trials SWOT Analysis: Diagnosis Before Prognosis (a panel discussion) Each of the following speakers gave a brief presentation followed by a question and answer period with the attendees and panel discussion 4 Panelists: Ayman Chit, HBsc, M.Biotech Scientific Advisor and Health Outcomes Scientist, Vaccines GlaxoSmithKline (Canada) Ron Fehst IRB Services, Former Senior Regional Research Manager Eli Lilly Canada Inc. Ronald Heslegrave, PhD Member, Expert Panel on Research Integrity Senior Scientist, Research Ethics University Health Network, University of Toronto Dominique Johnson, PhD Director, The Montreal Heart Institute The presentation will offer an analysis on Canadas strengths, weaknesses, opportunities and threats (SWOT) concerning clinical research in todays competitive global market. The presentation was opened with the following quotation attributed to William Pollard: Learning and innovation go hand in hand. The arrogance of success is to think that what you did yesterday will be sufficient for tomorrow.

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The format of the presentation was less of a SWOT analysis and more of a summary of global initiatives and commentary on the state of innovation and R&D globally in science and technology. They provided the quotation below as a summary of their perspective on the core issues challenging R&D in science and technology in the life sciences. Tear down this wall: The academia/industry business interface. The business interface between universities and companies is an area in crying need of more standardization. Oneoff deals have high transactional costs, and yet the parties are reluctant to adopt the best practices of others. Successful models of university-industry collaboration in places like University of California San Francisco where the focus is on high-value research moving from universities into development at companies, rather than on royalty revenue for either party need to be spotlighted, studied and replicated. And universities need to significantly rethink their internal reward structures to value industry collaboration and patents, not just government grants and publications. Who best to lead the charge here? (Anderson, 2011). Time Title Speaker Credentials of Speaker Topics 2:30pm to 3:15pm Clinical Trials and the Personalized Medicine Landscape Dr. Philippe Bedard, MD FRCP(C) Assistant Professor, Department of Medicine University of Toronto Principal Investigator and Medical Oncologist Princess Margaret Hospital The growing use of biomarkers in cancer clinical trials Methodology and the use of prognostic multi-gene signatures in early-stage breast cancer Genomic selection of patients for early phase clinical trials How Canadian clinical trials are impacted by personalized medicine The presentation reviewed the increasing use of biomarkers in cancer clinical trials and the issues associated with the patient consenting process, the ethics review process, privacy and storage of data issues, and, the utility of biomarker data in innovative genetic research. He used a case study approach using examples from current clinical programs. 3:30pm to 4:15pm Research Integrity in Canada: Enhancing Transparency and Accountability Ronald Heslegrave, PhD Member, Expert Panel on Research Integrity Senior Scientist, Research Ethics University Health Network, University of Toronto At the request of Industry Canada, the Council of Canadian Academies conducted an assessment examining the key research integrity principles, procedural mechanisms, and appropriate practices, for their application across research disciplines and institutions in Canada. This presentation will focus on the results of the assessment and share insights into how clinical research will be impacted going forward. Key discussion points include: The role of the newly proposed Canadian Council for Research Integrity (CCRI) The key research integrity principles, procedural mechanisms and practices appropriate in the Canadian context that could be applied across research disciplines at institutions receiving funds from the federal granting councils The four key gaps identified in Canadas Policy Framework and how they will be addressed through the CCRI How Canada is different and how we align with emerging global standards The state of research integrity and misconduct policies in Canada and what actions would be considered to constitute research misconduct in a Canadian context What are the roles and responsibilities of all those involved? How could a common research integrity definition foster a research culture of high ethical standards and instil public confidence?

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Comments and Observations A significant portion of the presentation focused on issues of unethical conduct in R&D. He provided several examples of global cases of misconduct and their subsequent impact on research design and standards of good clinical practice. Key quotation in the presentation: Innovation and overall progress is dependent on the results of research. He proposes that in order to foster a positive environment for R&D, the key components include: a research integrity definition that is laden with values and principles and managed by principles of promotion, prevention and sanctions. He proposes as a definition of research integrity: coherent and consistent application of values and principles essential to encouraging and achieving excellence in the search for, and dissemination of, knowledge. These values include honesty, fairness, trust, accountability, and openness. Time Title Speaker Credentials of Speaker Topics 4:15pm to 5:00pm National Initiatives and Innovation in REB Review in Canada Sharon Freitag Director, Research Ethics Office, St. Michaels Hospital President, Canadian Association of Research Ethics Boards (CAREB) Tips for ethical review approval for clinical research Challenges with adverse event reporting How multi-centred trials in Canada are impacted by ethics review The presenter outlined the current landscape of the ethical review process by province and national programs and initiatives that are currently in development. The presentation was advocating for the establishment of a national ethical review process and standardized process.

Comments and Observations

Day 2 (March 29th), the schedule of lectures and discussions was as follows:
Time Title Speaker Credentials of Speaker Topics Comments and Observations 9:15am to 10:15am Fostering Collaboration, Innovation and Growth in Todays Highly Competitive Global Market Peter A. Brenders President and CEO, BIOTECanada Keynote address BIOTECanada is a national lobby organization on behalf of the biotechnology sector in Canada. This presentation focused on the current landscape of R&D in biotechnology in Canada and the relative amount of investment by the government relative to other global jurisdictions. Quotation within presentation: World leaders are looking to biotechnology as a source of increased revenues, new companies, increased employment and a hedge against off-shoring. With human capital as its primary resource, nations do not have to be rich in natural resources to be players in biotechnology. The presentation outlines 4 primary reasons that governments would invest in biotech. These include: 1. Global economies desire the economic and social benefits e.g. high value products 2. Biotech generates high paying jobs 3. Biotech impacts health, nutrition, energy and the environment 4. Biotech innovates traditional industries

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He goes on the quote research commissioned by BIOTECanada and conducted by Nanos Research that reports that 9/10 Canadians see biotech as important to Canadas future economic prosperity when asked the question Do you believe that the biotechnology industry is a very important, somewhat important, somewhat unimportant or very unimportant part of Canadas future economic prosperity? When biotechnology was defined as ...a term that describes the controlled use of biological substances to make a wide variety of products in our everyday lives. Biotechnology innovations can create special drugs or vaccines, healthier crops that do not need pesticides, can turn waste into energy, can find new ways to make foods or can even convert plant matter into new products like car parts. The second half of the presentation outlined the funding and financing challenges associated with biotechnology firms to conduct their R&D and the examples of collaborative programs between industry and academia, and through mergers and acquisitions of private industry businesses. Time Title Speaker Credentials of Speaker Topics 10:30am to 11:15am Tracking Phase 1 Trial Participants Khaled El Emam, PhD Associate Professor, Canada Research Chair in Electronic Health Information Faculty of Medicine and the School of Information Technology and Engineering CHEO Research Institute and the University of Ottawa An overview of professional phase 1 trial participants and the risks they introduce Privacy challenges and potential solutions The role of technology to drive this success This presentation outlined the challenges with the use of health volunteers in phase 1 clinical trials. These people were referred to as Professional Guinea Pigs and throughout the presentation; they were referred to as PGPs. He outlined an algorithmic program for screening out professional volunteers while still maintaining confidentiality and research integrity and outlined some of the initiatives globally. The presentation generated many challenging questions from the attendees who seemed generally uncomfortable with the content, ethics and tone of the presentation. There were challenges to the ethics of his proposal; including his suggestion that biometrics might also be captured in this database. 11:15am to 12:15pm Implementing an Adaptive Design: Increasing Efficiencies and Improving ROI Joint presentations by two speakers: Jack Corman and Pierre Gervais Jack Corman President IRB Services Pierre Gervais, B.Pharm., M.Sc. President, Research Director, Q&T Research, Sherbrooke; Research Director, Q&T Research, Outaouais and Chicoutimi The goal of Adaptive Design is to speed drug development by increasing efficiencies and identifying best candidates with the right does earlier, or conversely knocking the poor candidates out quickly with the goal to doing fewer long and costly studies in Phase II and III. This presentation will focus on key strategies for implementing a successful Adaptive Design including: Strategies to improve the success rate of convention clinical trials with Adaptive Design Maintaining access to patients with complex design studies How to streamline organizations and structures study schedule, data entry, queries, volume of supplies Steps to overcoming adaptive design challenges for ethics review boards Ethical review during a trial is this necessary for each new development? Opportunities for keeping lines of communication open

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Comments and Observations This presentation focused on the statistical and ethical design challenges and questions associated with an adaptive design clinical program as a new paradigm. It was a highly technically drive presentation that focused on the implementation of this kind of methodological design. 1:30m to 2:15pm The New Paradigm in Canadian Clinical Research: A Health Canada Perspective Agnes V. Klein, MD Director, Center for Evaluation of Radiopharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate Health Canada Division 5, the new regulations of Clinical Trials (CTs) have been implemented for over 5 years now. The implementation was fortuitous because it arrived at a time when the costs of studies had increased and when quality and timeliness of the evaluation, as well as the conduct of these studies, became critical. Five years later, HC has conducted several interactive consultation workshops in order to evaluate the benefits of the new regulations. This presentation will look at: Various perspectives on the new regulations The effect they had on the conduct of trials and on the review of proposals Provide insight into new endeavours that would enrich the CT-scape in Canada Current status and future directions in CTs Relative competitiveness of Canada in the CT field Concerns related to the conduct of CTs The benefits of the Canadian health care system in terms of CTS The benefits of CTs to the health care system A discussion of current hot issues and areas This presenter did not provide their slides to the attendees. The presentation focused on the interpretation of Division 5 and how Health Canada sees the application of Division 5 to the design and evaluation of clinical trials in Canada. I am unable to reference specifically the presentation since it was not provided to the attendees. 2:30pm to 3:30pm Top 10 Dos and Donts for Clinical Research Sites Joint presentation by two speakers: Raffi Chamlian and Sonja Mitrovic Raffi Chamlian, BPharm Clinical Research Manager, International Centre for Therapeutic Research Canada, Servier Canada Inc. Sonja Mitrovic, BSc., MD Manager, Regional Research Eli Lilly Canada Inc. To assure Canadas position in the global arena, we must select high performance sites to maximize patient recruitment performance while preserving quality. This presentation will cover: How are institutions, sites and investigators identified? How do they get on the short list? How do they get into the final group? What metrics are used to make this decision? Proactive engagement strategies for optimal site selection Opportunities for creating greater collaboration between industry sponsors and site investigators How to keep the research team motivated and committed to their recruitment target This presentation focused on the factors and processes associated with conducting feasibility assessments in Canada by sponsor companies and the selection of clinical sites for participation in R&D. It was more practical than theoretical and outlined a standard process for conducting this evaluation of clinical protocol and clinical investigative sites. 3:30pm to 4:30pm

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Title Speaker Credentials of Speaker Social Media and Its Impact on Clinical Trials Joint Presentation by two speakers: Karine Cote and Deirdre Cozier Karine Cote, RN, BSc. Adm. Associate Director, Patient Recruitment Specialist Q&T Research Sherbrooke Deirdre Cozier Manager, Regulatory Operations, Policy and Clinical Trials sanofi-aventis Canada Inc. Patient recruitment, retention, advocacy and knowledge Transparency, integrity, confidentiality, privacy and oversight Are there social media guidelines in place? How do you triage adverse events if reported online? How will you manage negative feedback about the study? Global trends; successes and failures This presentation outlined the use of social media to recruit patients into a study and publicize a study. Process, guidelines, ethical considerations and privacy issues all need to be considered with the evolving use of social media in R&D. These presenters did not provide their slides to the attendees and as a result, I am unable to reference their slides.

Topics

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References Anderson, M. (2011, January 20). Top 10 medical research trends to watch in 2011: Tear down this wall: The academia/industry business interface [no. 8 on list]. Retrieved from http://www.huffingtonpost.com/margaret-anderson/top-10-medical-researcht_1_b_810829.html Council of Canadian Academies. (2009). Innovation and business strategy: Why Canada falls short (Report of the Expert Panel on Innovation). Retrieved from http://www.scienceadvice.ca/uploads/eng/assessments%20and%20publications%20and% 20news%20releases/inno/%282009-06-11%29%20innovation%20report.pdf Nanos Research. (2009, September 21). Canadians regaining confidence in strength of economy [NANOS REPORT, Nanos Economic Monitor]. Retrieved from http://www.nanosresearch.com/library/polls/EconIndex-F09.pdf

Appendix D PowerPoint Slide Presentation From a Public Information SR&ED Meeting

Copied on pp. 179206 is the full set of slides that were provided as handouts during the Canada Revenue Agency public information SR&ED meeting (Scientific Research & Experimental Development: What It Is and How It Works) that took place on September 20, 2011.

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