Ethical issues related to animal experiments

1. Ethical issues related to animal experiments Dr. Navyug R. Singh Associate Professor Deptt. of Pharmacology GMC, Amritsar

2. Animal ethics: The Dilemma

3. Animals ethics: The dilemma • Why do our interactions with animals require ethical considerations? • How to deal with conflicts in human interests and animal welfare? • Are animal experiments indispensable? • Do we have an ultimate answer to these questions?

4. Different approaches to Animal Ethics • Contractarian view • Utilitarian view • Animal rights view • Nature preservation view

5. Different approaches to Animal Ethics Contractarianview Individual humans belong to a human-only moral contract that benefits individual and fellow humans.

6. Different approaches to Animal Ethics Utilitarian view Interests of not only humans but all sentient beings should be considered with aim to maximize pleasure and minimize pain of all and not individual beings (Best possible consequences).

7. Different approaches to Animal Ethics Animal rights view Sentient animals have right to life, liberty, fulfillment of natures (telos) and respectful treatment. These rights cannot be overridden to benefit others.

8. Different approaches to Animal Ethics Nature preservation view Protection of natural species, genetic integrity & natural processes are of moral significance. Noah’s Ark

9. So do these provide the answers…? • Contractarian view • Utilitarian view • Animal rights view • Nature preservation view

10. Blind Hens Challenge • A study conducted to analyze ethical concerns with keeping & breeding blind hens for egg production • More egg production • Less cannibalism & pecking • No direct pain afflicted • OK with Utilitarian View • Problematic with Rights View: Interference with natures (telos) of animals

11. Where to draw a line • Vertebrates : Invertebrates • Mammals : Non-mammals • Domestic : Wild • Sentient : Non-sentient How does one decide who is sentient and who is not? Indian guidelines provide an arbitrary scale of sentience Invertebrates < Birds < Rodents < Canines/Felines <Bovine/Equines < Primates

12. Animal Experiments

13. The Debate

14. The Debate

15. Attempts at regulation • Global efforts at legislating • American Animal Welfare Act, 1966 • Australian Animal Welfare Act, 2002 • Swiss Federal Law on Animal Protection , 1978 • British Performing animal Act, 1923 • British Animal Welfare Act, 2006 • Good Laboratory Practices • US-FDA • Organization for Economic Co-operation and Development (OECD) • WHO They say..them are trying to do something!

16. Indian Legislation • The Prevention of Cruelty to Animals (PCA) Act, 1960 (Amended in 1982) • Animal Welfare (AW) Act, 2011 (Would replace PCA Act, 1960)

17. PCA Act, 1960 • Provides for constitution of an Animal Welfare Board (AWB) for overall welfare of animals • Provides for a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) • Separate jurisdictions of AWB and CPCSEA • CPCSEA is mandated to form rules, get these ratified by parliament & be responsible for implementation

18. PCA Act, 1960

19. Penalties(Section 20 of PCA Act, 1960) If any person contravenes any order made or commits a breach of any condition imposed by the Committee under section 19 : When contravention has taken place in any institution, person incharge of institution shall be deemed to be guilty of offence and shall be punishable accordingly He shall be punishable with fine which may extend to Rs. 200

20. The Animal welfare Act, 2011(Major changes) • Section 21 (Replaces Section 14 of PCA Act) • No person or institution shall perform an experiment on animals unless permitted by CPCSEA • Section 28 (Replaces Section 20 of PCA Act) • A huge change in the quantum of punishment for contravention of rules as compared to present law

21. Penalties(Section 28 of proposed Animal Welfare Act) If a person contravenes section 21 or order made by Committee under section 27 • First offence • Fine: 20,000-50,000 OR • Imprisonment: 1 year to 3 years OR • Both • Subsequent offences • Fine: 75,000-1,00,000 AND • Imprisonment: 2 years to 5 years When breach takes place in an institution, person in charge of such an institution shall be jointly guilty of the offence, and shall be punishable accordingly under the Act

22. CPCSEA • Constituted in 1964 • Under Ministry of Environment and Forests • Central body for regulating experiments on animals • Works within ambit of PCA Act 1960 • Frames rules for implementation of act (Rules for Breeding and Experiments on Animals (Control & Supervision) 1998 amended 2001 & 2006

23. CPCSEA Functions • Inspection & Approval of Animal House Facilities • Registration of Institutional Animal Ethics Committee (IAEC) for animal experiments or breeding • Appointment of CPCSEA nominees in IAECs • Permission for experiments on large animal • Inspection & prohibition of experiments, if violations • Action against establishments, if non-compliance

24. Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 • Rule 3: Norms for breeding of animals • Rule 4: Registration of establishments • Rule 8: Permission of CPSCEA required for experiments • Rule 9: Detailed norms for performance of experiments • Rule 10: Norms for transfer and acquisition of animals • Rule 12: Prohibits contract experiments on animals • Rule 13: Describes composition of IAEC • Rule 14: Power to suspend or revoke registration Rule 12 (amendment 2006) “Registered establishments may undertake contract research on behalf of other agency in accordance with Prevention of Cruelty to Animals Act, 1960 (59 of 1960) and rules made thereunder.”

25. CPCSEA guidelines: 5 Principles • Principle 1 Justification of animal testing • Principle 2 Reduction & replacement of animal testing • Principle 3 Minimization of pain and suffering • Principle 4 Rehabilitation and Euthanasia • Principle 5 Housing, handling and veterinary care

26. Institutional Animal Ethics Committee • Composition and registration with CPCSEA mandatory for animal experimentation • Has representation of CPCSEA (nominated member) • Empowered to approve small animal (up to rodents) experiments on its own • Responsible for monitoring & implementation of CPCSEA norms & regulations

27. Experiments in Educational Institutions • PCA Act 1960 does not effectively address the issue Rule 17 (2d) “That experiments on animals are avoided where possible; e.g. in medical schools, hospitals, colleges and like, if other teaching devices such as books, models, films may suffice.” Rule 17 (2F) “That, as far as possible, experiments are not performed merely for purpose of acquiring manual skill.”

28. Experiments in Educational Institutions • AW Act, 2011 does not differ fundamentally & just elaborates on the kinds of educational institutions “…including undergraduate medical colleges, pharmacy colleges, zoology and other degree and diploma colleges and universities”

29. Experiments in Educational Institutions • Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 seem to be in conflict with the act • But later amendments have rectified the issue providing discretion to CPCSEA Rule 9 (g): “The experiment shall not be performed for the purpose of attaining manual skill except in schools, colleges & recognized training institutions.”

30. Experiments in Educational Institutions • Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 as amended 2006 Rule 9 (g): “The experiments shall not be performed for the sole purpose of attaining manual skill except in schools, colleges and programs duly scrutinized and permitted in registered establishments by the Committee.”

31. Other Indian Guidelines • Indian National Scientific Academy Guidelines , 2000 • ICMR Guidelines, 2001

32. Can we do away animal testing..? • Ethical concerns regarding human use of medicine and medical procedures gave rise to animal testing • It is difficult to avoid the animal experiments as long as • Regulatory authorities continue to demand toxicological and pharmacological data for license • Suitable and reliable alternatives are not available

33. Alternatives to animal experiments • Modified animal use 3 Rs (4 Rs) • Reduction: Data sharing, Improved designs & stats, Shared controls, Repeated use (!) • Refinement: Reducing pain, mortality and morbidity • Rehabilitation: Appropriate rehabilitation • Replacement: With other systems

34. Replacements • Other living systems: • In-vitro systems • Microorganisms • Non-vertebrates • Microdosing studies • Epidemiological data • Non-living systems: • Chemical assays • Mathematical models and Computer simulations

35. Hopeful future..!: Virtual twin(National Centre for 3Rs in Animal Research, USA) • Digitized virtual twin of each individual at birth • Completely mimics individual’s biological systems • Updated as the age advances • Could totally replace animal testing..!!! Wow..

36. Examples of current replacements • Lung on a chip: In vitro model developed at Harvard • EpiDerm: Human skin 3D-model (MatTek Corp., USA) • EpiVaginal: Human vaginal ectocervicaltissue • ExPharm: Simulation software developed at JIPMER (www.expharmpro.com) • National Commission for 3 Rs in animal Research, UK • MatTek Corporation, USA • Wyss Inst. for Biologically Inspired Engineering (US) • European Society for Alternatives to Animal Testing

37. Thanks for listening..!