Business Ethics Project 2013

Business Ethics Project

Suraj Chopda-129 Kushal Chaudhari-130 Kirankumar Dash-131 Varun Gurjar-137 Aditya Kadlag-141 Saurabh Patkar-164

Business Ethics Project 2013

Animal Testing Animal Testing or its also known as Vivisection is a practice of animal experimentation. Animal testing can be by administering drugs, infecting the animal with diseases, poisoning the animal for toxicity testing to see the effects of the chemical injected or being fed, brain damaging and other painful and invasive procedures. It can also include protocols that cause severe suffering, such as long-term social isolation, full-body restraint, electric shocks, withholding of food and water. Essentially, it is using animals in ways that cause distress and/or death in attempts to test the safety of drugs and biological products or of finding treatments, prevention, or cures for human diseases. Facts and Figures United States (2010) 1.28 million animals used in experiments (excluding rats, mice, birds, reptiles, amphibians, and agricultural animals used in agricultural experiments), plus an estimated 100 million mice and rats Canada (2009) 3.38 million animals used in experiments

145,632 animals subjected to severe pain near, at, or above the pain tolerance threshold of anaesthetized conscious animals

United Kingdom (2012) 4.11 million experiments on animals

2.95 million without anesthesia

2

Business Ethics Project 2013

However, results derived from the animal model are not valid or relevant for humans. Tens of millions (some estimate in excess of 25 million) of animals in the U.S. and around the globe suffer, die, or are killed each year in laboratories for biomedical experimentation, product and cosmetic testing, and for science education. Around the globe experimentation on animals is going on in the name of product testing, cosmetic testing. Many big pharmaceutical and cosmetic companies do it and try to hide it.

Business Ethics Project 2013

Business Ethics Project 2013

Business Ethics Project 2013

Company Name: Pfizer Inc

Company Description: Pfizer is an American multinational pharmaceutical corporation headquartered in New York City, and with its research headquarters in Groton, Connecticut, United States. It is one of the world's largest pharmaceutical companies by revenues Pfizer develops and produces medicines and vaccines for a wide range of conditions including in the areas of immunology and inflammation, oncology, cardiovascular and metabolic diseases, neuroscience and pain. Pfizer on animal testing: Following is what Pfizer says on animal testing on their Website, 1. Why Animal-based Biomedical Research? Pfizer is ethically and legally obliged to rigorously evaluate potential new medicines and therapies. Many of these evaluations can be, and are, accomplished by techniques that do not require the use of animals. However, given the present state of scientific knowledge, testing potential new medicines and therapies in animals is frequently critical to their
6

Business Ethics Project 2013

evaluation, and is required by regulatory authorities worldwide to ensure the quality, efficacy and safety of the medicines we discover.
2. Pfizers Commitment to Ethical and Humane Treatment of Animals

Pfizer accepts its responsibility to use animals in a humane and ethical manner and expects all Colleagues to treat animals with respect. We approach the use of animals in our business with a high level of humane and ethical concern for those animals. All use is carefully planned and conducted in such a way as to minimize or avoid pain, distress, or discomfort to the animals. Every proposed use is thoroughly evaluated before being undertaken as the health and well-being of all animals under our care is a primary concern. Similarly, we expect any third party organization we engage to conduct animal based research on our behalf to adhere to this Policy and to comply with all applicable laws and regulations.
3. Pfizers Commitment to Alternatives to Animal-based Biomedical Research

Pfizer is fully committed to the development and use of scientifically validated alternative testing methods that are acceptable to regulatory authorities and do not compromise patient safety or the effectiveness of our medicines. Pfizer continues to engage in and lead cross-industry efforts aimed at developing and refining new in-vitro testing and predictive informatics-based systems that hold promise for future reduction of animal usage. Pfizer works directly with regulators and through pharmaceutical trade organizations to increase the recognition and acceptance of alternative models where such alternatives can be used appropriately.
7

Business Ethics Project 2013

4. Policy

Pfizer embrace the principles known as the 3Rs of animal research first proposed in 1959 by Russell and Burch to describe the use of alternatives in animal research. Refer Appendix-1 for details on 3Rs and guidelines followed by Pfizer.

Reality (Case let): Every year, Pfizer subjects huge numbers of animals to cruel and lethal experiments. In 2011, Pfizer experimented on nearly 50,000 animalsincluding 2,557 dogs, 1,159 primates, 452 cats, 7,076 guinea pigs, 31,560 hamsters, 5,512 rabbits, 1,680 gerbils, and 161 horsesin its own laboratories. More than 15,000 of these animals were forced to endure painful experiments, and more than 6,000 were denied pain relief. These numbers dont even include mice and rats or any of the animals tormented for Pfizer experiments in contract testing laboratories. According to a recent federal report, in just one Pfizer experiment, 13 dogs showed painful toxic effects. In another experiment, 81 dogs experienced varying degrees of lameness and pain, which was not treated. In an experiment involving cats, the report notes that 14 cats experienced varying degrees of lameness and pain, which was not alleviated through pain relief. One hundred eleven horses were repeatedly injected with snake venom and subjected to large blood draws. Such painful experimentation can cause horses to become ill, lose weight, and become anemic. No pain relief was provided.
8

Business Ethics Project 2013

In addition, federal inspections of Pfizers animal laboratories revealed multiple violations of animal protection regulations. Inside the laboratories, the body of a cat missing for nearly a month was found in a drain line, a dog was scalded to death by the automatic cage washer, and other animals endured stress and untreated infections in a laboratory reeking of excrement. Macaque monkeys had stress-induced hair loss on 50 percent of their bodies, and other animals, in their traumatized condition, chewed and pulled the hair out of their cage mates. Pfizer was also cited for the failure of its animal experimentation oversight body to ensure that experimenters who cut into animals had conducted a search for alternatives. Pfizer contracted out animal tests to Professional Laboratory and Research Services, which was shut down by federal authorities after a PETA undercover investigation revealed sadistic treatment of animalsincluding sick and injured animals being denied veterinary care; dogs and cats being slammed into cages, thrown, kicked, and dragged; and dogs and cats being pressurehosed with a bleach solution.

Business Ethics Project 2013

Company Name: Bristol-Myers Squibb

Company Description: Bristol-Myers Squibb, often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger of its predecessors Bristol-Myers and the Squibb Corporation. Bristol-Myers Squibb manufactures prescription pharmaceuticals in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis and psychiatric disorders. Its mission is to "discover, develop and deliver innovative medicines that help patients prevail over serious diseases."

Bristol-Myers Squibb on animal testing: Commitment to the Ethical Use of Animals in Research At Bristol-Myers Squibb our mission is to discover, develop and deliver innovative medicines to patients with serious diseases such as cancer, diabetes, hepatitis, HIV/AIDS, cardiovascular disease, and immune-system disorders like rheumatoid arthritis. We have both a legal and an ethical obligation to ensure the safety and efficacy of investigational medicines. Regulatory agencies around the
10

Business Ethics Project 2013

world, including the U.S. Food and Drug Administration, require that investigational medicines be thoroughly evaluated before approving them for use in human clinical trials. To fulfill these obligations, research or testing methods that include the use of animals are sometimes required, and will continue to be a component of our efforts to help patients prevail over serious diseases. Refer Appendix-2 for details

Reality (Case let): Each year, pharmaceutical giant Bristol-Myers Squibb (BMS) torments and kills tens of thousands of animalsincluding dogs, nonhuman primates, rabbits, hamsters, and guinea pigsin cruel and painful tests in which they have experimental drugs forced down their throats. According to annual reports filed with the federal government, some dogs and monkeys who are used in painful experiments at BMS are intentionally not given any pain relief at all. According to former Health and Human Services Secretary Mike Leavitt, nine out of 10 experimental drugs that appear promising in animal tests go on to fail in human clinical trials. A concerned insider at BMS recently informed PETA that callousness and negligence in the companys laboratories compound the animals suffering. The whistleblower reported that a monkey and rat endured terrifying and excruciatingly painful deaths when their cages were run through the companys boiling-hot cage washerwith the animals still inside. Another monkey hanged to death in her cage after she was clipped to the front of it to be weighed and left unattended. After PETA filed formal complaints with federal authorities, BMS was
11

Business Ethics Project 2013

cited for serious violations of the AWA. As a Fortune 500 company with annual revenues exceeding $19 billion, BMS certainly has the resources to ensure that animals do not suffer so egregiously in its laboratories: It would seem that the company simply doesnt care. Another instance of cruelty: An insider from pharmaceutical giant Bristol-Myers Squibb recently approached PETA with disturbing allegations about animals who suffered painful and gruesome deaths through negligence. The whistleblower reported that a monkey and a rat had been scalded to death when the cages in which they were each housed were carelessly put into the company's mechanical high-temperature, high-pressure cage washerwith the animals still inside. In a separate incident, the whistleblower reports that several monkeys were tethered to their cage doors to be weighed and then left unattended. When workers returned to the room, they found that one of the monkeys had strangled to death. In addition to these allegations of blatant neglect, from 2008 to 2010, Bristol-Myers Squibb tormented more than 20,000 animals in its laboratories, including more than 2,600 dogs and 3,400 primates who were imprisoned in cages, intentionally poisoned to death, and subjected to other painful and stressful procedures. Astonishingly, these numbers do not even include the thousands of mice, rats, and other animals who are not covered under the Animal Welfare Act , and they do not include animals used in experiments contracted out by Bristol-Myers Squibb to other laboratories, such as the notorious Covance.
12

Business Ethics Project 2013

Company Name: Merck & Co

Company description: Merck Sharp & Dohme, MSD outside the United States and Canada, is an American pharmaceutical company and is one of the largest pharmaceutical companies in the world. The company was established in 1891 as the United States subsidiary of the German company now known as Merck KGaA. Merck & Co. was confiscated by the US government during World War I and subsequently established as an independent American company. It is currently one of the world's seven largest pharmaceutical companies by market capitalization and revenue. Merck on animal testing: Laboratory animal research is indispensable to the discovery, development, manufacture and marketing of innovative medicines that treat and prevent disease. Further on the policy of Merck is given in detail in Appendix-3 Reality (Case let): Every year, pharmaceutical multinational Merck subjects tens of thousands
13

Business Ethics Project 2013

of animalsincluding dogs, monkeys, rabbits, hamsters, guinea pigs, sheep, rats, and miceto cruel and painful experiments in which they are poisoned, infected, mutilated, and killed. Animals are force-fed massive quantities of Mercks experimental drugseven though the U.S. Food and Drug Administration (FDA) admits that 92 percent of all drugs that are shown to be safe and effective in animal tests fail or cause harm in human trials. Merck is also one of a tiny handful of shameful places that continues to conduct invasive experiments on chimpanzees even though it is widely acknowledged by scientists worldwide that they are not needed to develop or test drugs to ensure human health. Merck has been cited repeatedly for abuse of animals in its laboratories, including caging highly social primates in isolation, using inadequate procedures for anesthesia, failing to provide veterinary care, and failing to consider alternatives to painful procedures on animals. Merck also failed to document whether pain relief was given to dogs who were used in painful experiments, and the company has even been cited for misrepresenting the number of animals used in painful experiments in a report submitted to the federal government. Merck contracted out animal tests to a company called Professional Laboratory and Research Services (PLRS), which was shut down by federal authorities in 2010 after a PETA undercover investigation revealed sadistic treatment of animals, including sick and injured animals who were denied veterinary care; dogs and cats who were slammed into cages, thrown, kicked, and dragged; and dogs and cats who were pressure-hosed with a bleach solution. Merck had contracted with this facility since at least 1996.
14

Business Ethics Project 2013

Company Name: Avon Products

Company description: Avon, is an American international manufacturer and distributor , household, and personal care products sold through representatives in over 140 countries across the world. As of 2012, Avon had annual sales of $10.7 billion worldwide. It is the fifth-largest beauty company and second largest direct selling enterprise in the world, with 6.4 million representatives. Avon on animal testing: Avon banned tests on animals in 1989 following PETAs very public Avon Killing campaigna play on the companys Avon Calling brand Reality (Case let):
For more than two decades, Avon had been one of the largest and well-known companies on PETAs cruelty-free cosmetics list. But PETA recently learned that when Avon decided to expand its business into China, the company started paying for tests in which chemicals are dripped into rabbits eyes and rubbed onto animals bare skin. Avon did not challenge the Chinese governments demand for painful animal tests which only duplicate safety information already gleaned from non-animal testsbut simply rolled over and paid for the tests. Moreover, Avon did not inform PETA or consumers that its policies had changed and continued marketing its products as cruelty-free.

15

Business Ethics Project 2013

Animal Testing Regulations: United States In the United States, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA), which is enforced by the Animal Care division of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). The AWA contains provisions to ensure that individuals of covered species used in research receive a certain standard of care and treatment, provided that the standard of care and treatment does not interfere with "the design, outlines, or guidelines of actual research or experimentation." Currently, AWA only protects mammals. In 2002, the Farm Security Act of 2002, the fifth amendment to the AWA, specifically excluded purpose-bred birds, rats, and mice (as opposed to wildcaptured mice, rats, and birds) from regulations. Thus, relatively few animals used in research in the U.S. are covered by this legislation. The AWA requires each institution using covered species to maintain an Institutional Animal Care and Use Committee (IACUC), which is responsible for local compliance with the Act.

16

Business Ethics Project 2013

European Union

Asian Countries India- A complete ban on animal testing since late October 2013. China- Animal testing is must for cosmetics before it being approved from human use. Japan- The system in Japan is one of self-regulation; there are no regulations like Western countries, only the 3Rs principle are written into the Law for Humane Treatment and Management of Animals. This law was amended in June 2005 and enforced in June 2006. The Management of Animals is responsible for
17

Business Ethics Project 2013

administering the newly amended law. The amendment of this law was the conceptual idea of self-regulation and not being restricted by legislative constraints, it was approved by the members of the Japanese Diet who saw that care for laboratory animals and the use of laboratory animals are two different concepts that were concerned with science and animal welfare, respectively. This law requires those using animals to follow the principles outlined in the 3Rs. The principle idea behind the 3Rs was to insure that fewer animals were used; by following this principle, minimal distress and suffering could be achieved through monitoring and controlling the animals by the scientist themselves

18

Business Ethics Project 2013

World Map of Animal Testing

19

Business Ethics Project 2013

Companies which follow guidelines to reduce the damage on the ecosystem

VVF (India) Ltd

VVF (India) Ltd is one of the largest contract manufacturers of personnel care products in the world. With the client list of Johnson and Johnson, Amway, Pfizer etc it produces around 300000 metric tons of bar soaps annually.

20

Business Ethics Project 2013

The above diagram at the most primary level tells about the ingredients for the personnel care products i.e. Soaps, Shampoos etc. Soaps are nothing but fatty acids which are derived from Oils, again these oils could be vegetable oils (palm oil, mustard oil etc) or animal derived oils (tallow oil). To reduce the damage on the eco system, Sustainable Procurement has become need of the day. Many companies want their product to be developed from raw materials which are being produced in sustainable ways. Palm Oil Plantation and the social evils: As demand for palm oil increases, substantial tracts of tropical forests are often cleared to make room for large plantations. In the major palm oil producing regions of Indonesia and Malaysia, almost a third of forest loss in the last 10 years was due to the expansion of oil palm. When forests are felled and peat swamps drained, they are often also burnt, creating a haze that covers large areas, affecting peoples health and disrupting economic activities. At the global level, the impacts of forest loss are even more dramatic. As trees and vegetation go up in smoke or are left to rot, and as peat lands and swamp forests dry out, they release greenhouse gases into the atmosphere that contribute to global warming. Fifteen percent of all human-induced greenhouse gas emissions are caused by deforestation, forest degradation and peat land emissions.

VVF and RSPO: To avoid contributing to deforestation and social problems, buyers of palm oil can join the Roundtable on Sustainable Palm Oil (RSPO), an internationally
21

Business Ethics Project 2013

accepted certification scheme, which requires producers to apply strict environmental and social standards to their operations. The RSPO has set strict standards for responsible oil palm plantations, coupled with an independent system for auditing plantations, mills and the supply chain right up to the end users. To date, the level of awareness about Certified Sustainable Palm Oil is limited in India. As of 2011, four companies in India are registered as members of the RSPO Adani Willmar, Godrej, Kamani Oil Industries and VVF. Some companies within India have formed a Sustainable Palm Oil Coalition focused on advocating the government to support sustainable palm oil purchases move led by Hindustan Unilever, Godrej, Ruchi, VVF, Greenpeace as well as WWF India. More Details on RSPO in Appendix-4 Information shared by Harihar D Executive- VVF (India) Ltd

22

Business Ethics Project 2013

Godrej and Mangroves Soonabai Pirojsha Godrej Marine Ecology Centre The Western bank of the Thane Creek is the single largest mangrove belt in Mumbai. A substantial tract of mangrove land is adjoining the Godrej & Boyce Township, Pirojshanagar, in Vikhroli a suburb of Mumbai. Vast area under mangroves has been conserved by Soonabai Pirojsha Godrej Marine Ecology Centre. Well diversified and well protected, these are the lastquality mangroves in the city. The vast expanse of these mangroves serve as a second lung of the city only after the Sanjay Gandhi National Park which is under immense environmental pressures.

The mangrove flora of Pirojshanagar is well diversified. There are 16 species of mangroves and mangrove associates. The faunal composition in the area is also equally diverse. Apart from 206 species of birds, 30 species of reptiles, 13 species of crabs, 7 species of prawns and 20 species of fish have been identified so far in the area. Mammals like jackals and mongoose also were sited many a times This wetland acts as an important stopover for over hundred species of migratory birds including magnificent flamingos, gulls, terns, avocets & curlews.

23

Business Ethics Project 2013

Conservation Actitivities by SP Godrej Marine Ecology Centre The Soonabai Pirojsha Godrej Marine Ecology Centre has undertaken several measures to protect the mangroves locally. Some of the programmes undertaken are 1. Regular monitoring/ patrolling in creek side mangrove area conserved by SPG Marine Ecology Centre to check possible destruction of existing mangroves and protecting rare species of mangroves. 2. Ecological restorations of degraded mangroves by raising nurseries and replenishing degraded mangrove areas through artificial regeneration in different areas. 3. Establishment of Mangrove Interpretation Centre: Dissemination of the information regarding the importance of mangrove conservation through film/slide shows, seminars, nature trails/camps, poster exhibitions etc.

24

Business Ethics Project 2013

What can we do? Get acquainted with the mangroves near your area. Be vigilant towards activities happening in your surrounding areas and keep an open eye to note destruction in mangrove areas. Complain to the local authorities in case you observe any violation. Mangroves are now protected by law. If you find any kind of mangrove destruction, complain to the Forest Department or to the police. Both these authorities are equipped to take action under the Maharashtra Tree Felling Act and Environment Protection Act. Join organizations like the Mangrove Society of India, which are working specifically for the conservation of mangroves. Most importantly try to create awareness among as many people as possible. Participate in scientific plantations of mangroves flora at all possible areas.

25

Business Ethics Project 2013

Suggestions: Alternatives to Animal Testing Non-animal methods usually take less time to complete than the crude, archaic animal tests that they replace. In addition, they cost only a fraction of what animal experiments cost and are not affected by species differences that make applying test results to humans difficult or impossible. Effective, affordable, and humane research methods include sophisticated in vitro, genomic, and computer-modeling techniques as well as studies of human populations, volunteers, and patients. Thanks to this new understanding, many non-animal research methods are now being used around the globe. Here are just a few examples:

Pioneering contract research laboratory CeeTox uses human cell-based in vitro (test tube) toxicity screening to test drugs, chemicals, cosmetics, and consumer products. These humane tests replace cruel tests that involve pumping substances into animals stomachs and lungs and dripping chemicals into animals eyes or onto their raw, shaved skin. In a landmark 2007 report, the National Academy of Sciences confirmed that scientific advances can transform toxicity testing from a system based on wholeanimal testing to one founded primarily on in vitro (non-animal) methods.

Innovative biotechnology firm Hrel has developed a 3-D in vitro (test tube) human liver that scientists can use to study the breakdown of chemicals in the human body. This technology effectively mimics human organs and can be used to test cosmetics, drugs, and chemicals.

26

Business Ethics Project 2013

VaxDesigns groundbreaking Modular IMmune In vitro Construct (MIMIC) system uses human cells to create a working dime-sized human immune system for testing the safety and effectiveness of HIV/AIDS vaccines. This in vitro method is faster than animal tests, can be used to test vaccines on the immune systems of many different human populations at once, and can replace cruel, ineffective tests on animals in which monkeys are infected with HIV-like diseases and forced to endure acute weight loss, major organ failure, breathing problems, and neurological disorders before they die excruciating deaths or are killed.

27

Business Ethics Project 2013

Appendix-1 For as long as it remains necessary to use animals in the discovery, development, evaluation and production of new medicines, we commit to maintaining high standards in the humane treatment of these animals. Significantly, we embrace the principles known as the 3Rs of animal research first proposed in 1959 by Russell and Burch to describe the use of alternatives in animal research. These are: 1. Replacement of animal experiments with non-animal experiments such as

mathematical models, computer simulations, and in vitro biological systems wherever appropriate; and where animals must be used; 2. Reduction of the numbers of animals used in each study, and of the

number of studies involving animals, to the absolute minimum necessary to obtain valid results and achieve our research objectives; and 3. Refinement of procedures involving animals to minimize the potential for

pain and distress. In addition to the 3Rs, and to further assure we maintain high standards for our animals, we have adopted the following guidelines: 1. When animal experimentation is necessary, great care is taken to choose

the most appropriate animal species for the research and to optimize the study design to ensure that the results will be as meaningful as possible. 2. Non-human primates will only be used when scientifically justified, for

example in cases where other species will not provide sufficiently close analogues to the biological pathways and responses expected in humans.
28

Business Ethics Project 2013

3.

All studies are carefully designed to gain the maximum information from

the fewest number of animals possible. 4. Each proposed use of animals is reviewed and approved by a panel of

objective experts prior to performing any experiments to ensure that the use of the animals is consistent with sound scientific practices and ethical considerations. 5. Our standards of animal care and welfare meet or exceed those required by applicable local, national, or international laws and regulations. 6. We regularly monitor our animals for signs of ill health or distress and take prompt action wherever appropriate. We make veterinary care available to our animals at all times. 7. Our veterinarians and scientists evaluate every proposed animal procedure with an emphasis on eliminating or minimizing any potential for pain or distress which may be experienced by the animals. 8. We train all Pfizer colleagues involved in the care, welfare and use of animals to ensure (a) that they are competent in the care of the animals and in the procedures required to complete the proposed work; (b) that they are aware of the ethical issues involved in the use of animals; and (c) that they demonstrate respect and humane treatment towards the animals in their care. 9. We expect our contract research organizations, collaborators and vendors to maintain similar high standards. Parties conducting animal based research for Pfizer at their facilities are required to adhere to this policy and to comply with all applicable laws and
29

Business Ethics Project 2013

regulations. We perform welfare audits of third party facilities in accordance with our quality assurance policies. 10. Because respect is a key tenent in our use of animals, we

have also established standards regarding the use of animals in the marketing of Pfizer products. If advertisements featuring animals are used, any animal shown should be healthy and in a natural or appropriate setting. Non-human primates should not be used in the advertising of Pfizer products, and other wild animals will also not be used unless they are shown in their natural setting or portrayed through animation or computer-generated graphics.

30

Business Ethics Project 2013

Appendix-2 At BMS, we are committed to reducing our reliance on animal testing methods, and promoting the development, validation and use of non-animal testing models. The company confers an annual Animal Welfare Award to scientists who have implemented innovative scientific methods or procedures that reduce the number of animals required in research while still obtaining valid results, refine research methods to eliminate or minimize impact to animals, or replace animal use in testing. Over the past two decades Bristol-Myers Squibb has moved to a research system that relies on a combination of in silico, in vitro and in vivo approaches. For example, Bristol-Myers Squibb has created a world-class imaging department that has allowed scientists to view the impact of experimental drugs on disease and assess the long-term effectiveness of a potential new treatment in a non-invasive manner. In addition, we have provided more than $1 million in funding to other organizations to support the development of alternatives to animal research. When the use of animals is necessary, Bristol-Myers Squibb is committed to providing the highest level of care. We ensure that the care and use of all laboratory animals meets or exceeds relevant local, national and international regulations, as well as our own internal standards of animal care.

Bristol-Myers Squibbs research sites voluntarily seek and secure review and accreditation by an independent organization called the Association for the Assessment and Accreditation of Laboratory Care International (AAALAC), a private, nonprofit organization that promotes humane
31

Business Ethics Project 2013

treatment of animals in science and is internationally recognized as the gold standard for research programs.

The companys Animal Care and Use Committees review, approve and monitor all animal use, and perform monitoring audits, as well as semiannual facility animal care and use inspections and program reviews, to ensure the animals are healthy and cared for appropriately.

We ensure quality veterinary care is available at all times. We provide special training and development to all employees who work in any aspect of our animal research programs to ensure they demonstrate ethical and humane care and respect for all research animals. Safe and compassionate procedures for handling and caring for animals are in place at our facilities and disciplinary actions up to and including termination, can be taken against employees who do not comply with our standards and procedures.

Contractors who carry out research for Bristol-Myers Squibb are also expected to apply the same care and ethical standards, and accreditation requirements. We conduct an Animal Welfare Risk Assessment of contractors and regular inspections to ensure this is the case.

32

Business Ethics Project 2013

Appendix-3 Merck is dedicated to the ethical and responsible treatment of all animals used in the development of medicines and vaccines. Merck does not perform animal testing for its cosmetic products. Decisions regarding animal care, use and welfare are made by balancing scientific knowledge and regulatory requirements with consideration of ethical and societal values. Animal Research Oversight Animal research is highly regulated and monitored by the government. At Merck, it is also internally monitored by an animal-welfare oversight group. A veterinarian with expertise in animal welfare and laboratory-animal medicine manages the oversight group; as Mercks Institutional Official (IO) on animal welfare, this individual provides independent monitoring of animal research globally. The IO regularly communicates with senior management and the internal compliance committees on animal welfare. The IO also assists in the development of global policies and guidelines for animal research. All Merck sites hosting animal-based research have active and engaged Institutional Animal Care and Use Committees (IACUCs) or Ethical Review Committees (ERCs) that approve and monitor research studies. The committee membership includes veterinarians and scientists knowledgeable in animal-based research and often includes nonscientists and community members. Committees review all proposed animal studies, husbandry, and veterinary care facilities and investigate any research concerns. The IACUCs/ERCs regularly communicate with and sends status reports to the IO regarding animal welfare.

33

Business Ethics Project 2013

All Merck scientists involved with research animals must be trained to perform the duties required. Training includes review of regulations and policies, instruction on how to search for animal research alternatives, explanation of the role of the IACUCs/ERCs, and training on how to raise concerns of misconduct. Qualified veterinarians work with the scientific staff to consult and assist on all animal related research projects. Merck places high value on its animal-welfare stewardship responsibility; violation of these policies is grounds for employee disciplinary action, up to and including dismissal. Laboratory Animals Merck is dedicated to the ethical and responsible treatment of all animals involved in the development of medicines and vaccines. Decisions regarding animal use and welfare are made by balancing scientific and regulatory requirements with consideration of ethical, welfare and societal values. Additionally, any proposed study that may involve discomfort or distress, even if it is relieved, must perform a literature search to assure that there is no other viable alternative methodology. It is important to note that, as in most R&D programs, a large variety of in vitro (test tube) studies are performed at Merck prior to or instead of animal studies. Laboratory animals are only used to answer important scientific questions or fulfill a regulatory requirement. Laboratory animals involved in research within MRL are all specifically bred for research purposes. In Merck Research Laboratories, greater than 97 percent of the laboratory animals are rodents. The care and use of laboratory animals in biomedical research is highly regulated. In general, the regulations govern housing, feeding, veterinary care and research-project review by the IACUC/ERC, as well as
34

Business Ethics Project 2013

government inspections and voluntary AAALAC site visits. The animal facilities are staffed with veterinarians and professional animal care technicians. Contract Research Merck holds similar expectations for standards of animal care and use at our contract laboratories and animal vendors. Merck performs due diligence on and monitors external laboratories that perform in vivo studies on our behalf, and holds them accountable to the same regulations and standards that govern our internal animal research. Animal studies may not begin until a site has been approved by the Animal Welfare Group. All agreements with contract laboratories include terms regarding Mercks expectations for animal care and use as well as regulatory compliance. Additionally, in vivo research conducted at third-party laboratories is subject to protocol review by a Merck IACUC or an equivalent committee. Noncompliance with regulations or standards can lead to termination of the relationship. Support for Animal Science and Laboratory-Animal Well-Being Merck also advocates for the development of best practices and dissemination of information by supporting and participating with nongovernmental organizations such as the Scientist Center for Animal Welfare, the Institute for Laboratory-Animal Research at the National Academy of Sciences, and the American College of Laboratory-Animal Medicine Foundation. Merck is committed to the philosophy of using the best scientific methodologies and animal alternatives whenever possible or permissible by law.

35

Business Ethics Project 2013

To promote this commitment, we subscribe to the 3RsReplacement, Reduction and Refinementfor laboratory-animalbased research. Mercks Animal Welfare group collects, promotes and disseminates information on the principles and practice of the 3Rs. Training on the 3Rs is part of staff orientation for animal research. It is our responsibility to use the most appropriate methodology and to aggressively seek scientifically valid 3R approaches to animal research. Merck also has extensive in vitro expertise and investments, including an in vitro department that develops and utilizes non animal research methods (cell cultures) in the discovery and development of new medicines and therapies. We also provide funding to support 3Rs research at external organizations such as the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and the European Partnership for Alternative Approaches to Animal Testing (EPAA).As an example of the third R, Refinement, we have created world-class imaging department that allows scientists to view cancers and other pathologic diseases in animals and monitor the long-term effectiveness of new treatments in a noninvasive manner. Internal Merck Animal-Alternative Award To support the 3Rs philosophy, since 1994, Merck has presented an Animal-Alternative Award annually to the team or teams of Merck scientists that develop new techniques to support the alternative principle, and has published their work to share innovations with the greater scientific community. The 2011 Animal-Alternative Award recognized process refinement in bladder catheterization. The 2010 award was given for validation of an electrocardiogram-parameters model in a guinea pig model that replaced a canine model.
36

Business Ethics Project 2013

Appendix-4

Roundtable on Sustainable Palm Oil (RSPO) is an international non-profit initiative which brings together more than 500 palm oil growers, oil processors, manufacturers, retailers, NGOs and palm oil investors, who have one goal in commonpromoting the growth and use of sustainable oil palm. The RSPO has set strict standards for responsible oil palm plantations, coupled with an independent system for auditing plantations, mills and the supply chain right up to the end users. These standards include: 1. No conversion of primary forest or socially or ecologically valuable areas for plantations 2. Protection of endangered animals and plants 3. Protection of water, soil and air (including a ban on the use of fire for clearing land) 4. No child labor and the creation of educational opportunities for children living on the plantation 5. Inclusion and support of smallholders 6. Regular assessment of plantations by independent accredited certifiers Sustainable palm oil certified by the RSPO has been available since November 2008, and provides assurance that valuable tropical forests have not been cleared and that environmental and social safeguards have been met during the production of the palm oil. In addition, RSPO certification verifies the legality of production operations.
37

Business Ethics Project 2013

References: Vivisection: http://www.neavs.org/about/vivisection Pfizer Guidelines: http://www.pfizer.com/research/research_clinical_trials/laboratory_animal_care Pfizer, Bristol-Myers Squibb, Merck Inc Case let: http://www.peta.org/features/dirty-dozen-12-worst-ceos/#ixzz2nYN9623M Bristol-Myers Squibb https://secure.peta.org/site/Advocacy?cmd=display&page=UserAction&id=3971 Bristol-Myers Squibb http://www.bms.com/sustainability/environmental_performance/Pages/product_st ewardship.aspx Merck Inc http://www.merckresponsibility.com/focus-areas/access-to-health/researchdevelopment/animal-research/ VVF (India) Ltd http://www.vvfltd.com/home.html Godrej-Mangroves http://www.mangroves.godrej.com/index.htm Alternatives to animal testing http://www.peta.org/issues/animals-used-for-experimentation/alternatives-animaltesting/#ixzz2nXIvgomM
38