BASIC NON DISCLOSURE AGREEMENT

Here's a simple nondisclosure agreement that a layperson or attorney can use when disclosing secrets to a contractor, a potential investor, or a prospective business partner. You can copy and paste it into your word processing program and use it for personal or business use. Your rights to use the agreement are limited by our terms and conditions. Consult an attorney if you need professional assurance that the information is appropriate to your situation. In general, a business attorney or intellectual property attorney can best guide you regarding NDAs.

BASIC NONDISCLOSURE AGREEMENT

This Nondisclosure Agreement (the "Agreement") is entered into by and between _______________ with its principal offices at _______________, ("Disclosing Party") and _______________, located at _______________ ("Receiving Party") for the purpose of preventing the unauthorized disclosure of Confidential Information as defined below. The parties agree to enter into a confidential relationship with respect to the disclosure of certain proprietary and confidential information ("Confidential Information"). 1. Definition of Confidential Information. For purposes of this Agreement, "Confidential

Information" shall include all information or material that has or could have commercial value or other utility in the business in which Disclosing Party is engaged. If Confidential Information is in written form, the Disclosing Party shall label or stamp the materials with the word "Confidential" or some similar warning. If Confidential Information is transmitted orally, the Disclosing Party shall promptly provide a writing indicating that such oral communication constituted Confidential Information. 2. Exclusions from Confidential Information. Receiving Party's obligations under this

Agreement do not extend to information that is: (a) publicly known at the time of disclosure or subsequently becomes publicly known through no fault of the Receiving Party; (b) discovered or created by the Receiving Party before disclosure by Disclosing Party; (c) learned by the Receiving Party through legitimate means other than from the Disclosing Party or Disclosing Party's representatives; or (d) is disclosed by Receiving Party with Disclosing Party's prior written approval. 3. Obligations of Receiving Party. Receiving Party shall hold and maintain the Confidential

Information in strictest confidence for the sole and exclusive benefit of the Disclosing Party. Receiving Party shall carefully restrict access to Confidential Information to employees, contractors and third parties as is reasonably required and shall require those persons to sign nondisclosure restrictions at least as protective as those in this Agreement. Receiving Party

shall not, without prior written approval of Disclosing Party, use for Receiving Party's own benefit, publish, copy, or otherwise disclose to others, or permit the use by others for their benefit or to the detriment of Disclosing Party, any Confidential Information. Receiving Party shall return to Disclosing Party any and all records, notes, and other written, printed, or tangible materials in its possession pertaining to Confidential Information immediately if Disclosing Party requests it in writing. 4. Time Periods. The nondisclosure provisions of this Agreement shall survive the termination

of this Agreement and Receiving Party's duty to hold Confidential Information in confidence shall remain in effect until the Confidential Information no longer qualifies as a trade secret or until Disclosing Party sends Receiving Party written notice releasing Receiving Party from this Agreement, whichever occurs first. 5. Relationships. Nothing contained in this Agreement shall be deemed to constitute either

party a partner, joint venturer or employee of the other party for any purpose. 6. Severability. If a court finds any provision of this Agreement invalid or unenforceable, the

remainder of this Agreement shall be interpreted so as best to effect the intent of the parties. 7. Integration. This Agreement expresses the complete understanding of the parties with

respect to the subject matter and supersedes all prior proposals, agreements, representations and understandings. This Agreement may not be amended except in a writing signed by both parties. 8. Waiver. The failure to exercise any right provided in this Agreement shall not be a waiver

of prior or subsequent rights.

EMPLOYEE NON DISCLOSURE AGREEMENT

The sole purpose of the Employee Nondisclosure Agreement is to make clear to an employee that he or she may not disclose your trade secrets without permission. Lawyers recommend that employers use such agreements prior to an employee starting work. If the agreement is with a current employee, we recommend that you give the employee something of value over and above normal salary and benefits. If you wish, you can include the language of this agreement in an all-encompassing employment agreement covering such additional issues as salary and duties. You may also want to require that if the employee creates anything on the job, it belongs to your company. If you want to include provisions you can add to this agreement to acquire ownership of any trade secrets developed by the employee, click here.

You can copy and paste this agreement into your word processing program and use it for personal or business use. Your rights to use the agreement are limited by our terms and conditions. This agreement allows you to choose alternative provisions. Be sure to eliminate those provisions you do not need. Consult an attorney if you need professional assurance that the information is appropriate to your situation. In general, a business attorney or intellectual property attorney can best guide you regarding NDAs. State laws may prohibit employees from stealing trade secrets even in the absence of nondisclosure agreements. State laws prohibit employees from improper disclosure of your trade secrets even without using an NDA. We advise you to use an NDA because it's possible to obtain additional benefits when suing over a broken contract including increased damages, payment of attorney fees and a guarantee as to where or how the dispute will be resolved.

BUSINESS ETHICS IN BIOTECH INDUSTRY Shaping the Indian biotech sector Biotechnology is called the technology of hope owing to its revolutionary promises in agriculture, healthcare, industrial processing and environmental sustainability. The technology offers so much hope that trade groups and governments are trying to make environments conducive to the emergence of this technology. Fuelled by aspirations of self-reliance and pressured to cope with poverty and underdevelopment, Indian Government is focusing on education and infrastructure to establish strong biotechnology capabilities. An Ernst & Young report identified 96 exclusive enterprises as biotechnology companies, making Indian biotech sector third largest in the Asian region after Australia and China. Though India is yet to introduce a novel biotechnology product, it has a strong science and the potential to generate revenue of $5 billion and a million jobs by 2010.
Ethics of biotechnology
Ethics are the rules or standards that govern the way people behave and their decisions on the 'right' thing to do. It asks basic questions about what is right and wrong, how we should act towards others and what we should do in specific situations. It is important to note that ethics relating to biotechnology and its applications are not fundamentally different from other situations. Ethics are practiced by everyone, every day. One common feature of ethics is that different people with different values often disagree on the right thing for individuals and society. One reason for this disagreement is that one thing may benefit some people but not others. An example is embryonic stem cell research. Some people see this as having great potential to develop cures for diseases. But, others object because it involves the destruction of human embryos that have the potential to become a human being. There is no clear right or wrong position in ethics. A persons individual experience and view of the world often guides the way they make ethical choices. For instance, someone who has a strong environmental outlook might see the use of genetically modified (GM) crops as unnatural. But, someone who has a strong scientificbased view of the world might see the use of GM crops as a natural extension of traditional crop breeding technologies.

Many new technologies raise ethical concerns that might not be part of the world view held by those who develop the technologies in the first place. When it comes to developing products for commercial use, the goal is usually to increase sales and increase profits for shareholders. The decision for developing products can be seen as good for industry development, but perhaps not as good for individuals who do not have products developed to suit their needs when there is not enough company profit to be made. Also, in some areas of biotechnology development, the money needed to fund research projects is out of the range of individuals or small groups; it can only be undertaken by multinational or overseas companies. Some perceive this as acceptable, because it helps local researchers form links with wealthy larger companies. But others do not think it is not acceptable, because local research and development leave the community and are then controlled by international corporations. Many people believe that biotechnology products and applications should respond to and fulfil community needs. For example, some products may be of obvious social benefit (such as a drug that treats cancer), while others may be created by a business for attractive advertising and skilful marketing (for example, unusual-coloured flowers for the floral industry, or fluorescent fish for the pet industry). In a world with decreasing resources, where many people go hungry, is spending research dollars on developing a fluorescent fish acceptable or not? Your answer will differ depending on your world view. The right thing for one person may not be right for others. It can be very difficult to balance these conflicting views. There are particular ethical positions that are commonly shared. One of these is the view that all biotechnology products must be safe for humans and the environment. This is why Australia has developed a sound regulatory system. But, other ethical positions are diverse, such as an individuals rights to do what they want with their body. This interactive explores the ethics of gene therapy in more detail. There are many different ethical ways to view the world and none of these are inherently right or wrong. Ethics has many approaches, or frameworks. Some of these approaches are listed below: 1. Action-based (whether or not actions in a particular circumstance are ethical):

Principalism uses benefit-maximising and harm-reducing principles. Consequentialism is based on the greatest good for the greatest number. Non-consequentialism (deontology) refers to rights and responsibilities.
2. Agent-based (emphasis on the person rather than the action they perform):

Virtue-based can acknowledge character traits over consequences.

3. Situation-based (a broader perspective that takes into account other factors such as time, place and culture):

Casuistry considers each situation to be completely unique.

Feminist concentrates on communication, consultation and sensitivity. Geocultural focuses on relativity (cultural, special and time-specific contexts).

Ethical issues in biotechnology

New ethical questions have arisen from our ability to intervene in the structure of the genome. Responsible use of this technique requires ethical evaluation in which experts, potential beneficiaries and the general public should all participate. The examples of genetically modified food and of human genetics help to illustrate the issues involved. From the time when the earliest pioneers of medicine took the Hippocratic oath, the importance of ethical considerations in relation to actions affecting living entities has been recognized by professionals. The general principles are still of fundamental importance: respect for life and the need for a balance of benefit over harm resulting from any intervention. Contemporary features There are three particular contemporary features that account for the heightened public concern on the threshold of the 21st century. First, much of the current development in biotechnology results from a greatly enhanced understanding of the nature of genetics and the consequent ability to perform manipulations in the genomes of plants and animals. This power to intervene in what might be thought of as 'the fabric of life' raises the question of whether or not this, in itself, is an ethically questionable activity. Some feel that 'respect for life' implies that there should be no interference with it in this basic way. Conversely, the issue of the integrity of nature is itself complex and open to interpretation in an evolutionary world in which there is natural genomic plasticity. Moreover, the ethical does not simply equate with the natural. Heart transplants are as radically unnatural as gene transplants, but most people consider them to be ethically acceptable. Second, the pace of discovery in genetics-based biotechnology is very rapid and there is anxiety that a kind of technological compulsion ('if we can do it, let's do it') will drive developments ahead of proper ethical consideration of their propriety. Not everything that can be done should be done but, once technology is 'on the shelf', it is hard not to take it off. The moratorium on human germ-line therapy is an example of the recognition that there must be ethical restraints on the use of what is technically feasible. Part of the reason for this restriction is uncertainty about the long-term effects of such interventions. There is also considerable uncertainty about the environmental consequences of the genetic manipulation of plants. These issues are scientific questions that need to be answered before we have an adequate basis of knowledge for reaching final ethical decisions. Third, advanced technology involves processes that are only well understood by the experts who develop and use them. This places considerable power in the hands of the

companies that employ these experts. Currently, there is much public suspicion about the reliability and independence of this 'expert' advice. Some of this suspicion derives from a difficulty in understanding that absolutely certain answers often cannot be given to complex questions and that every element of risk can seldom be eliminated. It is also exacerbated by memories of unfortunate incidents, such as the bovine spongiform encephalopathy (BSE) crisis in the UK. There is also much suspicion of transnational corporations, which are perceived by many as wanting to maximize their profits by making users dependent on their products and then controlling availability. The ethical use of biotechnology clearly includes it being provided on a fair and just basis, neither denying reasonable reward to those who have undertaken the considerable expense and risk of R&D nor putting small-scale users in thrall to large-scale suppliers. Genetically modified foods These general considerations can be illustrated by the current controversy about the development and use of genetically modified (GM) organisms in the food chain. Selectivity Selective breeding has been used since agriculture began, with the development of cultivated crops from wild species and of domestic herds from wild animals. However, it is now possible to carry out gene transfers that could not occur in nature, even gene transfers from the animal kingdom to the plant kingdom. Some people have characterized this as 'playing God', with the implication that it is ethically unacceptable to interfere with nature. However, human beings are themselves part of nature and many religious people would see the responsible exercise of scientific skills as being the employment of God-given abilities. We have already seen that the natural-unnatural division is not in itself of intrinsic ethical significance, otherwise much of medicine, for instance, would be morally outlawed. Three particular points are notable.

The genetic code is only significant when operating in the context of a living cell. In isolation, genes are simply complex chemicals. This has led some people to believe - to take the most ethically sensitive example - that if a human gene were transferred to a pig cell, it would, in that context, become simply a pig gene, although admittedly one of human origin. Other people do not accept this, but believe that the gene would continue to have the ethical status of a human gene1. Current gene transfers involve single genes or, at most, small gene clusters. They represent a highly accurate and targeted form of crossing. The creation of chimeras with substantial interspecies mingling would raise different and difficult ethical issues, including questions of animal welfare. There is a widely recognized obligation to use this new technology for serious and valuable means, not for speculative or trivial purposes. Obvious examples of responsible projects to choose include the generation of therapeutic proteins from transgenic animals and the modification of crops so that they can grow in and or saline environments.

Environmental effects One of the major concerns about GM crops is their possible environmental effects. Insect-resistant strains may reduce the use of insecticides, but will genes spread from herbicide-resistant strains to produce 'superweeds'? All interventions in nature run the risk of unanticipated upsets to its balance and, from the time that humans with stone axes began felling trees, agriculture has had significant environmental consequences. Even in the next millennium, our intellectual ability to foresee environmental effects is unlikely to be perfect. Some form of precautionary principle is ethically required, but it should not induce total paralysis. Because consequences are difficult to predict accurately, it is important that carefully controlled and monitored trials are used to gain the detailed knowledge on which ethically responsible decisions can be based. Moral duties It is predicted that the world population, currently approximately six billion, will rise to approximately eight billion by the year 2020. Present agricultural resources, if their produce was fairly distributed, could sustain approximately 6.4 billion people. Biotechnology offers considerable possibilities to help eliminate the anticipated shortfall. However, there is also considerable concern that small-scale farmers should not be exploited by large international companies. Moral perplexities often arise when there is a clash between two different ethically desirable goals. The possible use of 'terminator' genes (that make seeds sterile) illustrates this point. On the one hand, they would help to reduce the hazards of environmental dispersal; on the other, farmers in developing countries traditionally save seed from one season to the next and cannot afford to buy new supplies each year. If these problems are to be solved, there must be recognition of the common good, understood on a world-wide basis and calling for fairness in the policies of big corporations and in the international regulation of biotechnological trading. To these considerations must be added the universal ethical obligation to respect the duty of safety. With regard to food safety, GM products do not seem to raise issues or demand the monitoring of techniques, different to those employed to assess the effects of ordinary foods. Human genetics The use of biotechnology in relation to human beings is governed by the Hippocratic principle that interventions must be for the benefit of the individual person concerned. Controversy in this area is not generated by dissent from this principle but by disagreement about what constitutes a human person, with all the moral rights appertaining to that status. Some believe that this status is established at the moment of conception. If that is the case then no manipulation of the early embryo, other than for its own direct benefit, could be ethically justified. Others, however, take a more developmental view of the way in which a human foetus grows into a person, with the dawning of sentience and eventually of mentality. This latter view forms the basis of the legal restriction in the UK on research

using embryos to the 14-day period before the development of the primitive streak2. Currently, that research is also limited to projects investigating aspects of human fertility. However, it has recently been suggested3 that the scope of possible investigation should be extended to include the use of cell-nuclear-replacement (CNR) techniques to generate immunologically compatible tissue for therapeutic purposes and for the treatment of mitochondrial disease. At present, there has been no decision by the UK Government on whether or not to accept this recommendation. In the UK, GM embryos may not legally be implanted, so there is an absolute embargo on the use of CNR to generate cloned human beings. There is extensive ethical support for this legal position. The moral necessity to use new technology for acceptable means plays a determinative role in forming this view. Although the repair of damaged tissues in the ill or injured is seen as being highly desirable, the creation of a 'replacement person' is not so acceptable. Respect for the human person forbids this - not because there is an intrinsic human right to possess a unique genome (identical twins do not, but each is a human person) but because a human being is to be valued for their self and not used as a surrogate for another. The same moral intuition leads to an abhorrence of the idea of using genetic manipulation to produce 'designer babies' with qualities according to parental specification. Persons are never to be commodified: ethically, they are never means but always ends. The example of the regulation of human genetics in the UK provides an answer to the socalled 'slippery slope' argument. It is sometimes argued that to allow CNR for therapeutic purposes would soon lead to it being used for reproductive purposes. The ban on exceeding the 14-day limit and on implanting GM embryos shows that there are effective barriers in place to prevent this happening. Public debate Debates on the ethical issues raised by biotechnology will certainly continue into the 21st century. Science, by gaining knowledge, confers power; if that power is to be used to choose the good and refuse the bad then wisdom must be added to knowledge. This quest for judicious decisions will involve the participation of at least three parties:

the experts; the community of possible beneficiaries; and the general public.

Participation of the experts is essential, as only they can assess the potential risks and benefits of new developments. They have an ethical obligation to do this in as fair and as balanced a way as possible. Final decisions cannot be left to them alone, however, because their monopoly of expertise does not confer a monopoly of wisdom. They cannot be judges in their own cause, because the excitement of the research may cloud their judgement. The interest of the community of possible beneficiaries, whether it be sufferers from a particular disease or farmers on a marginal kind of land, is obvious - but, again, they cannot be judges in their own cause.

The general public has an indispensable ethical stake in what is decided. If this general influence is to be exercised well, it will call for the development of informed and ethically sensitive public opinion. However, there are obstacles in the path to this happening. Much contemporary ethical debate takes the form of the confrontation of opposing single-issue pressure groups. One side claims that X is the best thing ever and we cannot have too much of it; the other, that X is the worst thing ever and we must avoid it at all costs. Whatever X may be, it is unlikely that either of these extreme positions is justified. It is important that society should seek to create forums in which ethical issues can be discussed in a truth-seeking and nonconfrontational manner. The issues that face us are too complex to be dealt with in slogan form. If this prospect of a rational debate about biotechnology is to be realized, a considerable educational programme will be required. It is clear that many people still lack the rudimentary degree of scientific understanding that is indispensable as the basis for reaching informed, ethical conclusions on these issues. A saddening but instructive example is provided by the case of irradiated food. Because 'radiation' is, in many minds, a sinister word, conjuring up the image of an invisible hazard, this effective way of improving food safety was rejected by the public, who simply refused to buy food so labelled. We must hope that the debates of the 21st century will be both scientifically better informed, and also ethically more subtle, than those of the past decade of the 20th century have often proved to be. 1 Biotechnology and Bioethics As has been described in other volumes of this series, modern biotechnology has had a great impact on medicine and agriculture. It can only be expected to have an even more dominating impact in future science and technology. It's impact is not limited to the technical impact that these advances have upon industry, medicine and agriculture, any technology influences society, and one can expect that life science technology potentially has the greatest impact. Biotechnology has also influenced the thinking of society, as will be discussed in this chapter, and we can expect further paradigm shifts to occur. These paradigm shifts include the switch to biodegradable products, industrial pressures to restructure scientific information sharing, the paradigm of sustainable and limited economic growth, and the paradigm of intervention in nature rather than observation and participation in it. Biotechnology has also been a catalyst to the consideration of bioethical issues (Macer, 1990), and the two words, biotechnology and bioethics, have coevolved. Before extending discussion it is essential to define what is meant by the words, biotechnology and bioethics. This in itself is no easy task because different people with different interests can broaden or narrow these concepts. In this chapter a broad meaning of biotechnology is taken; the use or development of techniques using organisms (or parts of organisms) to provide or improve goods or services. Bioethics is the study of ethical issues associated with life, including medical and environmental ethics.

2 Bioethics There are large and small problems in ethics; there are global, regional, national, community and individual issues. We can think of ethical issues raised by biotechnology that involve the whole world, and issues which involve a single person. A global problem such as global warming may be aided by global applications of biotechnology, for example to reduce net atmospheric carbon dioxide increase by reducing emissions or increasing biomass, however, excess consumption and energy use can only be solved by individual action, to reduce energy use. A regional issue is the risk presented by the introduction of new organisms or of an unstable genetically modified organism (GMO) into the environment, but it also involves individual responsibility to ensure that sufficient care and monitoring of the release is made. Other ethical issues arising from biotechnology that are thought of as individual issues such as genetic testing, or use of gene therapy, also have societal implications. We hardly need to ask why we need ethics, rather we need to ask what principles and factors are crucial for guiding decision-making, especially over such a diverse spectrum of issues. Medical ethics involves decision making on a personal level, it concerns the patient and the health care professional, especially the physician. At a further level away may be many others who will be indirectly affected by such questions as the cost of very expensive treatment that takes funds away from other patients. At this level higher policy-making is required, as in the case of issues such as environmental risk, or intellectual property protection policy. Some key principles of ethics are outlined below, with brief discussion of their relevance to biotechnology issues. We should balance the implications that arise from each principle to arrive at more ethical decisions. We may need to develop further principles, and bioethics is still being developed (Macer, 1990a). 2.1 Autonomy All people are different. This is easy to see, if we look at our faces, sizes and the clothes that we chose to wear. This is also true of the choices that we make. We may decide to play tennis, or golf, or chess, read a book, or watch television. These are all personal choices. In a democratic society we recognise that we have a duty to let people make their own choices. Above the challenges of new technologies, and increasing knowledge, the challenge of respecting people as equal persons with their own set of values is a challenge for all. This is also expressed in the language of rights, by recognising the right of individuals to make choices. 2.2 Rights Legal rights are claims that would be currently backed by the law if the case went to court, while human rights are critical to maintaining human dignity but may not have yet attained legal recognition. The recognition of human rights has changed the situation in many countries, and many countries in the world have signed the U.N. Declaration of

Human Rights (Sieghart, 1985), or one of the regional versions of this. This can be applied to many situations, for example, we all have a right to be involved in decisions about our country, the freedom of religion, or speech, to raise a family, to share in the benefits arising from scientific advances, and a right to a reasonable future. Respect for personal rights should change the nature of relationships between people in power and people without power from being characterised by authoritarianism or paternalism to becoming a partnership. Ethics is not the same as law. Ethics is a higher pursuit, doing more than the law requires. The law is needed to protect people and to set a minimum standard, but you can not determine good moral behaviour by settling cases in a court of law. We only need to think of medical litigation or environmental damage penalties, which can lead to huge sums of money being paid for accidents (or negligence) which cannot really be compensated by monetary reimbursement. The solution is to have more careful and moral physicians, companies, and politicians, and the replacement of monetary balance sheets by ethical values, as the primary motive of decision-making. 2.3. Beneficence One of the underlying philosophical ideas of society is to pursue progress. The most cited justification for this is the pursuit of improved medicines and health. It has often been assumed that it is better to attempt to do good than to try not to do harm. A failure to attempt to do good, working for people's best interests, is taken to be a sin of omission. Beneficence is the impetus for further research into ways of improving health and agriculture, and for protecting the environment. Beneficence supports the concept of experimentation, if it is performed to lead to possible benefits. The term beneficence suggests more than actions of mercy, for which charity would be a better term. The principle of beneficence asserts an obligation to help others further their important and legitimate interests. It means that if you see someone drowning, providing you can swim, you have to try to help them by jumping in the water with them. It also includes the weighing of risks, to avoid doing harm. Governments have a duty to offer their citizens the opportunity to use new technology, providing it does not violate other fundamental ethical principles. Just what the definition of fundamental ethical principles are may be culturally and religiously dependent, especially in the way that they are balanced when opposing principles conflict (see Sec. 3). Although different cultures vary, they all share some concept of beneficence and do no harm. People should be offered the option of using new technology in medicine and agriculture, and such applications should be made, providing internationally accepted ethical and safety standards are applied. Beneficence also asserts an obligation upon those who possess life-saving technology, in medicine or agriculture, to share their technology with others who need it. This is relevant to biotechnology companies also, who may hold patent rights on particular processes, beneficence would assert that they must share it with others, even if they

cannot pay for it. This may mean that companies share developments with developing countries, or give new drugs to individuals too poor to purchase them. 2.4 Do no harm The laws of society generally attempt to penalise people who do harm, even if the motive was to do good. There needs to be a balance between these two principles and it is very relevant to areas of science and technology, where we can expect both benefits and risks. Importantly, we must balance risks versus benefits of different and often alternative technologies, then apply these comparisons to our own behaviour, as well as in determining government policy. Do no harm is a very broad term, but is the basis for the principles of justice and confidentiality, and philantropy. It can also be expressed as respect for human life and integrity. This feature is found in the Hippocratic tradition and all other traditions of medical and general ethics. To do no harm is expressed more at an individual level, whereas justice is the expression of this concept at a societal level. Do no harm has been called the principle of nonmaleficence. Biotechnology and genetic engineering are providing many benefits, but there are also many risks. It is also unclear who will really benefit the most. It is important to see these benefits and risks in an international way because the world is becoming smaller and ever more interdependent. Biotechnology affects the lives of people throughout the world (Walgate, 1990). All people of the world can benefit if it is used well, through medicines, and more environmentally sustainable agriculture. However, biotechnological inventions that allow industrialised countries to become self-sufficient in many products will change the international trade balances and prosperity of people in developing and industrialised countries. If developing countries cannot export products because of product substitution the result may be political instability and war. This may in the end become the biggest risk. For example, the use of enzymic conversion of corn starch into high fructose corn syrup causes serious damage to the economies of sugar exporting nations (Sasson, 1988), and may already have caused political instability there. We need to remember national and international issues. Although we will continue to enjoy the many benefits to humanity, and we may hope for environmental benefits, the price of the new technology is that it may make us think about our decisions more than in the past. This is long overdue! International food safety and environmental standards should be speedily developed to ensure that all people of the world share their protection, and no country becomes a testing ground for new applications. 2.5 Justice Those who claim that individual autonomy comes above societal interests need to remember that the reason for protecting society is because it involves many human lives,

which must all be respected. Individual freedom is limited by respect for the autonomy of all other individuals in society and the world. People's well-being should be promoted, and their values and choices respected, but equally, which places limits on the pursuit of individual autonomy. We also need to consider interests of future generations which places limits on this generation's autonomy. We also need to apply this principle globally, as discussed above, no single country should pursue policies which harm people of any country. The key principle arising from the high value of human life is respect for autonomy of each individual human being. This means they should have the freedom to decide major issues regarding their life, and is behind the idea of human rights. This idea is found in many religions also. Part of autonomy is some freedom to decide what to do, as long as it does not harm others, also called individual liberty or privacy. Well-being includes the principle of "do no harm" to people, and to work for people's best interests. Internationally, the area of biotechnology patent policy should be examined in light of public opinion and the principle of justice. Shared genetic resources should not be able to be owned by any one individual or company. At the same time, some patent protection for specific applications involving biotechnology need to be protected to encourage further research, and to make the results of such research immediately open for further scientific research (see Sec. 7). 2.6 Confidentiality The emphasis on confidentiality is very important. Personal information should be private. There may be some exceptions when criminal activity is involved or when third parties are at direct risk of avoidable harm. It is very difficult to develop good criteria for exceptions, and they will remain rare. We must be careful when using computer databanks that contain personal information, and if they can not be kept confidential, the information should not be entered to such a bank. A feature of the ethical use of new genetics is the privacy of genetic information. This is one of the residual features of the existing medical tradition that needs to be reinforced. It is not only because of respect for people's autonomy, but it is also needed to retain trust with people. If we break a person's confidences, then we can not be trusted. If medical insurance companies try to take only low risk clients by prescreening the applicants, there should be the right to refuse such questions (Holtzman, 1989). The only way to ensure proper and just health care is to enforce this on employers and insurance companies, or what is a better solution, a national health care system allowing all access to free and equal medical treatment. We need to protect individuals from discrimination that may come in an imperfect world, one that does not hold justice as its pinnacle. 2.7 Animal Rights These above principles apply to human interactions with other humans. However, we also interact with animals, and the environment.

The moral status of animals, and decisions about whether it is ethical for humans to use them, depends on several key internal attributes of animals; the ability to think, the ability to be aware of family members, the ability to feel pain (at different levels), and the state of being alive. All will recognise, inflicting pain is bad so if we do use animals we should avoid pain (Singer, 1976). If we believe that we evolved from animals we should think that some of the attributes that we believe humans have, which confer moral value on humans, may also be present in some animals (Rachels, 1990). Although we cannot draw black and white lines, we could say that because some primates or whales and dolphins appear to possess similar brain features, similar family behaviour and grief over the loss of family members to humans, they possess higher moral status than animals that do not exhibit these. Therefore, if we can achieve the same end by using animals that are more "primitive" than these, such as other mammals, or animals more primitive than mammals, then we should use the animals at the lowest evolutionary level suitable for such an experiment, or for food production (which is by far the greatest use of animals). If we take this line of reasoning further, we conclude that we should use animal cells rather than whole animals, or use plants or microorganisms for experiments, or for testing the safety of food. Animals are being used for genetic engineering, for use as models of human disease, for use in the production of useful substances such as proteins for medical use, and in the more traditional uses in agriculture. Some of these uses, such as the production of mutations in strains of animal to study human disease will have human benefit, but are more ethically challenging because some of these strains may feel pain (Macer, 1989, 1991a). 2.8 Environmental Ethics Humans also have interactions with the environment, and in fact depend upon the health of the environment for life. The easiest way to argue for the protection of the environment is to appeal to the human dependence upon it. There are also human benefits that come from products we find in nature, from a variety of species we obtain food, clothing, housing, fuel and medicine. The variety of uses also supports the preservation of the diversity of living organisms, biodiversity. As we have learnt, the ecosystem is delicately balanced, and the danger of introducing new organisms into the environment if that may upset this balance is another key issue raised by genetic engineering. However, we have been using agricultural selection for 10,000 years, so the introduction and selection of improved and useful microorganisms, plants and animals is nothing new, and we should learn from mistakes of the past. The above arguments should convince people of the value of the environment, and that is a first stage. However, it appeals to our sense of values based on human utility. There is a further way to argue for the protection of nature and the environment, and it is a more worthy paradigm. It is that nature has value for itself because, it is there. We should not damage other species, unless it is absolutely necessary for the survival of human beings (not the luxury of human life). Nature has life, thus it has some value. Another paradigm for looking at the world is a religious view, that God made the world so the world has

value, and we are stewards of the planet, not owners. This paradigm can make people live in a better way than if they look at the world only with the paradigm of human benefit. There needs to be examination of the view of nature that different people have, so that we can find what the commonly acceptable limits to modification of nature, plant and animal varieties, and human beings are. In the modern world any new science can easily spread, so researchers are accountable to all peoples of the world. There will be future possible applications of technology which are against "common morality", yet there is little research on what is acceptable. We need to know what these perceived limits of changing nature are, before we grossly change the characters of individual organisms, or make irreversible changes to the ecosystem and human society. On Eco-philosophy, see Chapter 11. Microorganisms are generally placed at the lowest end of the "scale" of ethical status, because the only internal character they have is the state of being alive. External factors from a human aesthetic viewpoint mean that the only argument usually applied to them is human utility. Biodiversity may have some value in itself, though it is yet to be defined in non-religious terms. If we want to preserve biodiversity, it is essential that we separate parts of nature on land and ocean as nature reserves or parks, away from the parts of nature which are agricultural areas. However, while we separate these areas physically we should not separate them psychologically as areas which we can abuse and areas which we protect. This applies both in terms of sustainable environmental protection and animal rights. In fact, agricultural biodiversity is of direct human utility, and we should attempt to stop its continued loss (Fowler and Mooney, 1990). 2.9 Decision-making To anyone who starts to try to apply these principles in their daily life or to decisions concerning biotechnology, it will very soon be apparent that there needs to be a balancing of conflicting principles of ethics. Different interests will conflict, so, for example, there are exceptions to the maintenance of privacy and confidentiality if many people or large environmental damage, are threatened. How do we balance protecting one person's autonomy with the principle of justice, that is protecting all people's autonomy. Many medical and scientific procedures are challenging because they involve technology with which both benefits and risks are associated, and will always be associated. Human beings are challenged to make ethical decisions, and to balance the benefits and risks of alternatives, they have to. The benefits are great, but there are many possible risks. In this regard utilitarianism, that we should attempt to produce the most happiness and benefit, will always have some place, though it is very difficult to assign values to different interests and to the degree of "happiness" or "harm". Although our life may become easier due to technological advances, so that it may appear that we don't need to make so many decisions, we are challenged to make more decisions than in the past. The more possibilities that we have, the more decisions that we make (Macer, 1990).

Standards of education are increasing, but it is another thing whether people are educated for decision-making. People need to be taught more about how to make decisions, and the education system should accommodate this need of modern life. Even if they are, this may still be no guarantee that the right decisions will be made. 3 Cross-Cultural Bioethics Any attempt to develop international bioethical approaches must involve consideration of the values of all peoples. We could call this cross-cultural bioethics. This means something different from universalism - attempts to define an international ethical code of what is ethical and what is not, or a table of acceptable and unacceptable risks based on consideration of ethical principles. Universalism is not currently possible in ethics, and we even have difficulty in universal recognition of basic laws such as those respecting human rights. However, the existence of international environmental laws, e.g. The Law of the Sea, and charters of human rights (Sieghart, 1985), is some encouragement for the future progress of limited universalism. We also see attempts within regions, such as by the Council of Europe, to devise a European Convention on Bioethics (EP, 1991, Mundell, 1992, Holm, 1992). Cross-cultural bioethics involves mutual understanding of various cultural, religious, political and individual views that people have. The diversity of individual viewpoints in any one culture appears to exceed the differences between any two. For example in any culture one can find people fervently opposed to induced abortion and those who support it as a "right" for women's choice. The opinions expressed in the responses to questionnaires that have been conducted on opinions about genetic engineering in Japan and in New Zealand (see Sec. 4), suggest that people in these diverse countries have a similar variety of reasoning. This type of research should be conducted in other countries, especially in developing countries, if we want further objective data in order to better understand the reasoning of all people. We may find that people in many countries do share the same hopes and fears, and if this is so, the call for international standards will be strengthened. If we look at declarations of ethical codes made by different religious groups, professional groups, and among different nations, we can see the principles of bioethics that were outlined in the above section in most. A key question in cross-cultural bioethics is how the concept of do no harm should be applied, and to what beings it applies. For example; At what stage of development should human embryos be legally protected, for in vitro research or abortion decisions? Which animals should be protected from which research or use? How do we balance justice within national boundaries with global distributive justice, and justice to future generations? How much individual liberty do we allow when individual choices affect society values and options for other people or beings? What is necessity and what is human desire or luxury? What is the level of acceptable risk of harm?

These are wide questions, and this paper will discuss some of them. For the purposes of this volume the discussion will be focused around the question of what ethical biotechnology is, and developing approaches that may allow us to better answer this question for policy development. 4 Perceptions of ethical biotechnology 4.1 "Moral" is not the same as ethical What we call "ethical biotechnology" cannot be decided just by public opinion. However, something which is morally offensive to the majority of people in a country, or region, or world-wide, is judged to be immoral and is likely to be outlawed. What is seen as immoral is often also unethical, though unethical practices are often tolerated by a society and thus our definition of moral, would say that they are "morally acceptable" because it is "common morality". For example, people living in industrialised countries enjoy the fruits of an economic system that is disruptive to people living in developing countries and the environment. By use of basic ethical principles of distributive justice, and justice to future generations who will have to live in a polluted and changed world, we would say it is unethical. However, this situation is "common morality" to a majority of the people living in the rich countries, though the proportion may be falling, and it is morally unacceptable to the poor of developing countries. It we draw our definition of morality at national or regional borders, we would see this mixed morality standard, but if we drew our morality from a global majority we would see it as immoral. Decisions may be made democratically in a country if a consensus supports them, if the rights of minority groups are not overtroden, and if it makes sense in the long term, both nationally and internationally. However, not all decisions made this way will be ethical, society can make unethical majority decisions and will continue to do so. In the area of biology and genetics, we should never forget the unethical compulsory eugenics that swept the world in the first half of this century, when more than 40 countries made laws to enforce mandatory sterilisation and selective immigration policies (Kelves, 1985), nor should we forget the environmental destruction that still continues today. We cannot say that these abuses are always based on ignorance, rather they are sustained by groups of people pursuing their own interests who can lead the public into following the pattern of living that will sustain the people in power in those positions. Usually appeals are made to the selfish side of human personality, that we all possess. Rather, we should be concerned with global sustainability and protection of the rights of all people. We must remember this distinction between ethical and moral when we look at public opinion. Law is often based on the so-called common morality of a country, and in the area of biotechnology we can see varying laws established by different countries, and even within Europe there are conflicting laws, for example in the area of assisted reproduction and the use of human embryo experiments for research, Germany prohibits research as a criminal offence (Deutsch, 1992), and Britain permits approved research until the embryo is 14 days old (Bolton et al., 1992). The laws on the contained use or

release of, genetically engineered microorganisms vary between different countries, due partly to different public perceptions of risk (see Chapter 1 and 2). Whenever we consider the results of opinion surveys we need to remember the axiom, "Lies, damn lies and statistics". Nevertheless, they are an important gauge of public opinion, and when combined with the results of methods that allow the thinking behind such results to be determined, they are important in sociological study. Governments and companies involved in biotechnology research have become careful in their monitoring of public opinion, for in the case of governments it can mean they are not reelected, and public opposition to companies can be expensive in terms of time delays and lost sales. Most people receive information via the mass media, especially the newspaper and television. The media have a large responsibility to communicate science issues well, and scientists should also inform people about science. The media has a responsibility to present balanced information, on the benefits and risks of alternative technologies and to do this independently of commercial interests. Public opinion can be influenced by groups who have a special interest, such as political groups, and other groups, whose members spend time to publicise their opinions, and who can get media coverage of their views. Interference with nature or "playing God" There were also significant proportions of respondents who thought that genetic manipulation was interfering with nature, or that it was profanity to God, or said that they had a bad feeling about it. Also many saw genetic manipulation, especially of humans and animals, as unethical (Table 2, Sec. 4.3). These respondents may see these techniques as unacceptable, regardless of the state of technology and regulation. In the US survey, 46% said that we have no business meddling with nature, while 52% disagreed (OTA, 1987). Although many scientists react to people with these views as irrational, it is noteworthy that about 16% of the scientists and teachers in New Zealand and Japan who found these techniques unacceptable also shared these views, and these reasons were also cited regarding genetic manipulation of microbes. The questions about food also illustrate this concern. In Japan 12-16% of the public who were concerned about concerning products made from GMOs, said that such foodstuffs or medicines would be unnatural, while in New Zealand the values were much higher (Table 5). While rationally we can say such foods are just as natural as foods made from any modern crop or animal breed, 10-12% of scientists also said this. In a 1988 public opinion survey in Britain, 70% agreed that "natural vitamins are better for us than laboratory-made ones", while only 18% disagreed (Durant et al., 1989). In fact the use of varieties bred using genetic engineering should allow the avoidance of chemical pesticides and preservatives during crop growth, food storage and processing, which could actually make such foods "more" "natural". We have yet to understand what people believe nature really is. It is a changing concept and varies between individuals, religions and cultures. As societies become urbanised

they lose touch with nature. However, there is also a recent trend to buy products from "organic farming", or preferences for "free-range eggs" over eggs from battery farmed chickens. All people have some limit in the extent to which they support changing nature, or the application of technology. Bioethics still needs to be developed in order to approach this abstract area of thinking. In the meantime, scientists as well as the public, perceive limits to what is acceptable, or "ethical", biotechnology, and further research is needed to determine what these limits are. By reducing the use of chemicals in agriculture, food processing, and medicine, biotechnology may actually be able to make these areas more "natural". Also, if efficiency of agriculture is increased, and genetic diversity increased, biotechnology may allow some agricultural land to revert to more random natural vegetation. The potential is there, if society demands it. However, increased use of microorganisms for industrial and environmental processes may lessen the use of chemicals in these applications, would this also lessen people's concern - or raise it? Bioethics versus business: a conflict? In short, the answer is yes, the reason is that ethical concerns rely on principles such as just distribution of wealth and equality, and on factors such as beneficence. However, the goal of business is to make profit, and many businesses aim at economic growth and high profits. Biotechnology may allow production of consumer goods from renewable biomass sources, however, energy is still required to transform raw materials into finished products, thus economic growth requires continual energy input. The economic policies, based on Schumpter Dynamics, are not compatible with sustainable development (Krupp, 1992), therefore if biotechnology aims to be ethical it must use a different economic theory. When businesses consider raw materials they may attempt to use the lowest cost materials, which may mean that international common assets such as environmental resources are used, the so-called problem of the commons. They may also ignore the future costs of pollution caused by the production and use of technology. Much of the new wave in biotechnology research is being performed by private companies. These companies are being encouraged to perform research in their countries' national interests, including the hope of more export earnings from the sale of products and/or technology (OTA, 1991c). See also Chapter 6, 7 and 17. Some of the conflicts relevant to ethical biotechnology are discussed below. 7.1 Intellectual Property Protection There are several forms of intellectual property protection, and they are outlined in Chapter 17 of this volume. There continues to be much controversy regarding the patenting of plants and animals, and of genetic material form living organisms, especially humans. There is less controversy regarding patenting of microorganisms. Patents and variety rights are supported to act as incentives for technology development, consistent with beneficence. However, should there be subject matter which is exempted

from patent protection, such as plant and animal varieties are exempted in the clause 53(b) of the European Patent Convention? There is also a question of what is novel, when gene sequences consist of information that is already existing in nature - even though this information can be shuffled into new vectors. Another question that is important for the future of biotechnology patents and for gene sequencing patents is whether the application of robotic sequencing methods is non-obvious. The policy should be made considering all the economic, environmental, ethical and social implications, and it should be internationally consistent. In 1991 a controversy arose when a a single patent application for 337 human genes was made in the USA, and in February 1992 a further application for patents on another 2375 genes was also made by the NIH (Macer, 1992a). Modern technology has the ability to sequence all of the 100,000 human genes within several years. However, there is no demonstrated utility so this type of broad application is expected to fail, regardless of ethical or policy issues. The patents were applied for on behalf of the US National Institutes of Health, though many inside the NIH are against it (Roberts, 1992). This government body may sublicence particular US companies to pursue research on these genes in an attempt to "protect" the US biotechnology industry from international competition. Researchers in Britain, France and Japan are also obtaining many gene sequences (including some of the same genes and sequences), so a patent war may begin, and international scientific cooperation in the human genome project will be seriously damaged. The US Patent Office is expected to make a relatively quick decision on the validity of such patents, but more applications are expected just in case a patent office recognises such applications. Government action to prevent such patents on random cDNA fragments has been widely called for (Kiley, 1992). The French government, and Japanese genome researchers (Swinbanks, 1992), have announced that they will not apply for similar patents because of ethical reasons. England's Medical Research Council (MRC) has applied for a similar patent on more than 1000 genes, though England is joining France in calling for an international agreement to waive any of these patents if they should be granted (Aldous, 1992). The human genome is common property of all human beings, and no one should be able to patent it (Macer, 1991b). Public opinion could force a policy change regarding the patenting of genetic material, even if it is judged to be legally valid. People in Japan and New Zealand were asked if they agreed whether patents should be obtainable for different subject matter (Macer, 1992a, 1992b). 90-94% of all groups agreed with the patenting of inventions in general, such as consumer products. There was less consensus on the patenting of other items, though the same relative order of items was followed in all groups in Japan and New Zealand. There was less acceptance of patenting new plant or animal varieties than of inventions in general. Only 51% of the public agreed with patenting of "genetic material extracted from plants and animals" in New Zealand, but even less, 38%, in Japan. There was even lower acceptance of patenting "genetic material extracted from humans", in Japan only 29% of the public agreed, while 34% disagreed. In all groups more people disagreed with the patenting of genetic material extracted from

humans than those who agreed with it. Among scientists however, company scientists were much more supportive of patents then government scientists.
ETHICAL ISSUES IN BIOTECH
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Because it is grounded in the use of living organisms to produce drugs and food, the biotech industry has been grappling with several ethical issues, as more and more products become available. Remarkably, the nascent industry proactively moved to regulate itself as early as the 1973, shortly after Drs. Herbert Boyer and Stanley Cohen successfully recombined DNA by forming the Recombinant DNA Advisory Committee (RAC) to explore the consequences of this achievement and to investigate the risks involved in conducting research in this area. During the next decade, as basic research moved toward product development, the industry again acted proactively by formulating and adopting safety standards for industrial manufacturing using organisms derived using recombinant DNA technology. Today, work on stem cells, cloning, and the development of genetically modified crops are the main sources of controversy. Stem cell research The stem cell controversy derives from the potential power of these undifferentiated embryonic cells to become differentiated into virtually any type of cell found in the human body. Scientists have the ability to maintain and focus the development of such cells to replace existing cells that are either cancerous or which have lost their capacity to function normally due to accidents and/or disease. Thus, in addition to cancer, patients suffering from diabetes, stroke, brain and spinal cord injuries, and diseases associated with aging can potentially have a new source of healthy cells. The consequences of successfully implementing this vision have raised enough questions that the NIH issued a policy in 2000 that would allow some research under strict federal oversight. In August 2001, the Bush administration restricted the policy somewhat but permitted continued federal funding. Subsequently, the NIH has issued update guidelines to the industry to implement the new policy. Cloning Cloning refers to the laboratory replication of genes, cells, or organisms from a single entity, meaning that exact copies of genes can be made. Although the National Bioethics Advisory Commission (NBAC), with industry agreement, has acknowledged the moral, ethical, and safety consequences of this activity, there is, nevertheless, one strand of cloning research that is supported by the industry. Therapeutic cloning or somatic cell nuclear transfer (SCNT) refers to the use of undifferentiated cells that are genetically identical to those of a patient, and hence have no potential of incurring rejection. Such cells can develop into new tissues targeted to replace diseased tissues and offer promising new treatments for Alzheimer's, Parkinson's, heart disease, and many cancers. Food and agriculture controversy with the European Union Perhaps the most heated debate, however, surrounds the development and marketing of genetically altered crops. Agricultural scientists have long experimented to develop varieties of crops - among them soy, corn, cotton, etc. - that are hardier, more disease and pest resistant, and more nutritious. Success in this area has been remarkable: by 2002, a full 74 percent of the total US soybean crop acreage, 71 percent of cotton, and 32 percent of corn used biotech breeding methods. Biotech has also produced fruits and vegetables (e.g., tomatoes and raspberries) that are longer lasting, less prone to disease, and have delayed ripening.

Aquaculture has produced salmon and other fish that breed faster, cost less, and is more sustainable than fishing in the wild. Overall, the biotech food market is estimated to expand 18 percent to $5 billion by 2005. Yet despite these advantages, concerns remain both at home and abroad. In July 2003, critics took to the streets in Sacramento, CA, decrying the use of "terminator" genes and raising the possibility that crosspollination of genetically altered foods with those grown in the wild will harm plant diversity and pose unknown health dangers to humans who consume them. Also in July 2003, the European Union (E.U.) recently ended the 5-year moratorium on genetically altered crops it imposed in 1998 to have time to study health and safety concerns and to develop a system of tracing and labeling biotech foodstuffs. The E.U. requires such crops have clear labels. The US, along with Argentina and Canada, formally requested a panel of experts from the World Trade Organization (WTO) to rule the E.U. guidelines illegal. The U.S. and its allies claim that the guidelines are cumbersome, difficult to implement, and constitute a trade barrier. American farmers claim they lost some $300 million per year in lost corn exports. Furthermore, the U.S. wants full and unconditional acceptance of biotech-based foodstuffs.