Ethical issues related to animal
experiments
Dr. Navyug R. Singh
Associate Professor
Deptt. of Pharmacology
GMC, Amritsar
Animal ethics: The Dilemma
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?
Different approaches to Animal Ethics
•
•
•
•
Contractarian view
Utilitarian view
Animal rights view
Nature preservation view
Different approaches to Animal Ethics
Contractarian view
Individual humans belong to a human-only
moral contract that benefits individual and
fellow humans.
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).
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.
Different approaches to Animal Ethics
Nature preservation view
Protection of natural species, genetic integrity
& natural processes are of moral significance.
Noah’s Ark
So do these provide the answers…?
•
•
•
•
Contractarian view
Utilitarian view
Animal rights view
Nature preservation view
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
Where to draw a line
• Vertebrates
: Invertebrates
How
does one decide
who is sentient and who is not?
•Indian
Mammals
: provide
Non-mammals
guidelines
an arbitrary scale of
sentience
• Domestic
: Wild
Invertebrates < Birds < Rodents < Canines/Felines
<Bovine/Equines < Primates
• Sentient
: Non-sentient
Animal Experiments
The Debate
The Debate
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 Cooperation and Development (OECD)
– WHO
They say..them are
trying to do something!
Indian Legislation
• The Prevention of Cruelty to Animals (PCA) Act, 1960
(Amended in 1982)
• Animal Welfare (AW) Act, 2011
(Would replace PCA Act, 1960)
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
PCA Act, 1960
Relevant Sections
SECTION 14
Performance of experiments on animals for
advancement of knowledge useful for saving life or
combating disease (by new discovery) not unlawful
SECTION 15
CPCSEA is constituted under this section
SECTION 17
CPCSEA empowered to make rules in this section (A
broad guiding framework of rules is also given)
SECTION 18
SECTION 19
Empowers CPCSEA for entry and inspection
Empowers CPCSEA to prohibit animal experiments
SECTION 20
Describes the Penalties in case of contravention of
section 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
institution
He shall be punishable
with of
fine
which may
shall
beto
deemed
extend
Rs. 200to be guilty of offence and
shall be punishable accordingly
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
Penalties
(Section 28 of proposed Animal Welfare Act)
If a person contravenes section 21 or order made by
Committee under section 27
When breach
takes
in an institution,
Subsequent
Firstplace
offence
offences
person
charge of such an institution OR
shall
Fine:in75,000-1,00,000
20,000-50,000
be AND
jointly guilty of 1the
offence,
and shall
Imprisonment:
year
to 3 years
ORbe
punishable
accordingly
under
Act
Both
Imprisonment:
2 years
to 5the
years
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
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
Breeding of and Experiments on Animals
(Control and Supervision) Rules, 1998
Rule 12 (amendment 2006)
“Registered establishments may undertake contract
• research
Rule 3: Norms
for breeding
animals
on behalf
of other of
agency
in accordance
• with
RulePrevention
4: Registration
of establishments
of Cruelty
to Animals Act, 1960 (59
• ofRule
8: and
Permission
of CPSCEA
required for experiments
1960)
rules made
thereunder.”
•
•
•
•
•
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
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
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
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.”
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”
Experiments in Educational Institutions
• Breeding of and Experiments on Animals (Control
and Supervision) Rules, 1998 seem to be in conflict
with the act
Rule 9 (g): “The experiment shall not be performed
for the purpose of attaining manual skill except in
schools, colleges & recognized training institutions.”
• But later amendments have rectified the issue
providing discretion to CPCSEA
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.”
Other Indian Guidelines
• Indian National Scientific
Academy Guidelines , 2000
• ICMR Guidelines, 2001
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
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
Replacements
• Other living systems:
– In-vitro systems
– Microorganisms
– Non-vertebrates
– Microdosing studies
– Epidemiological data
• Non-living systems:
– Chemical assays
– Mathematical models and Computer simulations
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..
Examples of current replacements
• National Commission for 3 Rs in animal Research, UK
• Lung on a chip: In vitro model developed at Harvard
MatTek Corporation,
•• EpiDerm:
Human skinUSA
3D-model (MatTek Corp., USA)
• EpiVaginal: Human vaginal ectocervical tissue
• Wyss Inst. for Biologically Inspired Engineering (US)
• ExPharm: Simulation software developed at JIPMER
(www.expharmpro.com)
• European Society for Alternatives
to Animal Testing
Thanks for listening..!