India balks at EU mention of animal welfare in trade pact

From ANIMAL PEOPLE, May 2009:
BRUSSELS, NEW DELHI–The government of
Indian prime minister Man-mohan Singh reportedly
objects to the inclusion of the phrase “animal
welfare” in the provisional edition of a recently
formalized protocol for negotiating a free trade
agreement between India and the European Union.
The European Parliament approved the
draft protocol for completing the EU-India Free
Trade Agreement on March 26, 2009, more than
five years after negotiations began with India in
November 2003.
The text that reportedly offends the
Singh government is scarcely provocative. Listed
tenth among 62 enumerated “General Issues,” the
sentence in question “Considers it important that
the Free Trade Agreement confirms the provisions
of the Agreement on Technical Barriers to Trade
and the Sanitary and Phytosanitary Agreement;
calls on the Commission in this regard to address
outstanding issues such as animal welfare.”
This would appear to be consistent with
Article 51-A[g] of the Constitution of India,
authored by Jawaharal Nehru, the first prime
minister of India, which states that “It shall
be the fundamental duty of every citizen of India
to protect and improve the Natural Environment
including forests, lakes, rivers and wildlife,
and to have compassion for all living creatures.”
However, reported the Financial Express
from New Delhi on April 15, 2009, “India has
opposed a reported move by the European Union to
include animal welfare issues in the World Trade
Organisation negotiations. Reacting to reports
of EU pitching for the inclusion of animal rights
in the WTO talks, official sources said these
were attempts by developed countries to block
exports from developing countries using these
standards.”
An unnamed Indian official told the
Financial Express, “These are non-tariff
barriers to curb exports,” which the official
projected would “throw many people out of jobs in
developing countries.”
Of most apparent concern to the Singh
cabinet are movement within the European
Parliament to strengthen standards for animal use
in laboratories and for livestock transport and
slaughter.
The European Parliament Agriculture
Committee on March 31, 2009 approved amended
rules governing animal experimentation which,
while much weaker than animal advocates had hoped
for, will be much stronger than a new Indian
regulatory regime introduced by the Singh
administration on March 5, 2009.
Explained online commentator Smita Joshi,
listed as information contact for Vivada
Chemicals PLtd., of Mumbai, “A proposal from
the department of pharmaceuticals now being
considered by Manmohan Singh seeks to make
comprehensive changes in the laws governing
research funding, drug discovery, clinical
trials, and approvals at different stages, so
that Indian drug makers can re-orient themselves
from being successful copiers of costly
multinational brands to owners of scientific
breakthroughs.

“Drug makers will get a new regulatory
regime that is more friendly for investing in
high-risk research, testing experimental drugs on
animals, and protecting the research data shared
with the regulators,” Singh said. “Faster
approval of various stages of animal and human
experiments is another reform planned. Specific
regulatory changes will be identified in a
detailed project report to be prepared within six
months after the Prime Minister clears the
project, said an official.”
Joshi indicated that the proposed Indian
regulatory changes are based on the
recommendations of “50 top executives of drug
makers such as Ranbaxy, Biocon, Wockhardt,
Pfizer, Wyeth and F. Hoffmann La Roche,” who
“identified the bottlenecks that hold drug firms
from inventing new drugs.”
Other developing nations have already
attracted considerable investment in animal
testing from the European Union and the U.S., by
offering the combination of well-educated labor
plus lax regulatory environments, but since 1964
India has had some of the strongest rules in the
world governing animal experimentation.
The Indian pharmaceutical industry began
a concerted effort to undo the rules after former
Indian federal animal welfare minister Maneka
Gandhi in January 2002 won rulings from the
Supreme Court of India that allowed her to close
five antivenin manufacturing firms for violating
animal care standards. An alliance of
pharmaceutical manufacturers with practitioners
of animal sacrifice in mid-2002 pushed Mrs.
Gandhi from office and in mid-2003 purged animal
advocates from the Indian federal body that
regulates animal research.
ANIMAL PEOPLE in April 2004 exposed the
Indian pharmaceutical industry strategy by
revealing the content of a leaked document
entitled Harmonization of CPCSEA [regulatory] Norms in India With International Norms &
Amendment of Breeding Rules With Regard to Import
of Animals for Experimentation. The author,
microbiologist S.C. Adlakha, Ph.D., was
identified as an animal health consultant for the
Animal Welfare Division, Government of India.
The exposé may have slowed the industry
momentum somewhat, but the proposed changes
outlined by Smita Joshi closely parallel
Adlakha’s recommendations.
The Indian government’s 11th Five-Year
Plan 2007-2012, published in January 2007,
anticipated both expanded animal experimentation
and more use of non-animal alternatives.
Addressing the first Indian Congress on
Alternatives to the Use of Animals in Research,
Testing and Education, Indian Council of Medical
Research senior deputy director general Vasantha
Muthuswamy simultaneously announced that a
National Cell Science Centre would be established
to pursue non-animal testing methods, and
disclosed that a 100-acre National Breeding
Facility to produce laboratory animals was in
development in Andhra Pradesh state.
Meanwhile the directive on animal
experimentation ratified by the European
Parliament Agriculture Committee will cover the
use of all vertebrate animals, cyclostome fish
such as hagfish and lampreys, cephalopods such
as octopi and squid, and decapod crustaceans,
including crabs, lobsters, and prawns. The
directive also governs the use of all
independently feeding larval forms of regulated
species, and embryonic or foetal forms during
the last trimester of their development.
As such, the proposed directive will
cast the broadest umbrella of any laboratory
regulatory regime now in effect.
The directive provides broad exemptions
for non-experimental standard practices in
agricultural and veterinary practice, including
animal husbandry practices such as artificial
insemination and embryo transplanting; methods
of marking animals such as ear-notching,
tagging, tattooing, branding, and
microchipping; and non-invasive practices.
Despite the expansion of regulatory
jurisdiction in the directive, Eurogroup for
Animals pronounced itself “deeply disappointed
with the results of the vote” wherein the
European Parliament Agriculture Committee
approved the directive. Eurogroup represents an
alliance of European animal welfare organizations
in lobbying the European Parliament,
Alleged Eurogroup, “The Agriculture
Committee have adopted amendments that will
remove important mechanisms for the protection of
research animals from the proposed text drafted
by the European Commission if these amendments
are also adopted in plenary,” in May 2009.

Primate experiments

“Eurogroup is particularly disappointed
that the Members of the European Parliament have
allowed tests to be carried out on animals that
cause severe prolonged suffering,” the Eurogroup
statement continued. “The authorisation
procedure for determining what testing may be
carried out has also been weakened. Some MEPs
have even contradicted themselves,” said
Eurogroup, “by voting to make it easier to
experiment on primates, while in September 2008
they adopted a resolution calling for non-human
primate research to be phased out.”
The approved directive stipulates that
wild-caught primates, great apes, and members
of endangered species may not be used in
experiments except to help conserve their
species. Experiments using purpose-bred primates
may be “undertaken with a view to the avoidance,
diagnosis, prevention or treatment of
life-threatening or debilitating clinical
conditions in human beings,” including so-called
basic research which seeks to identify how
biological systems work, including how they
respond to injuries and disease. This tends to
be the most controversial branch of biomedical
research.
The directive reinforces the prohibition
on use of wild-caught primates by requiring that
primates used in experiments must be “the
offspring of non-human primates which have been
bred in captivity,” according to a phase-in
schedule based on the number of generations of
each type of primate who have bred in captivity
and are sufficiently abundant to fill anticipated
research demand.
Marmosets must be second-generation
captive-bred as soon as the directive takes
effect. Rhesus and crab-eating macaques must be
second-generation captive-bred by seven years
later. All other primates must be
second-generation captive-bred by 10 years from
the directive taking effect.
The directive forbids using
stray and feral domestic animals in experiments,
forbids using wildlife, and requires that any
mice, rats, guinea pigs, hamsters, gerbils,
rabbits, frogs, dogs, and cats used in
experiments must be purpose-bred. However,
exemptions to the purpose-bred rule for wildlife
and other commonly used species may be granted by
member states.
The directive also limits how
animals may be used if subjected to multiple
scientific procedures.
Animal-using scientific institutions will
be required to establish permanent ethical review
panels similar to the Institutional Animal Care &
Use Committees required in the U.S. since 1971.
The rules governing the use of
primates may inhibit the ambitions of some Indian
politicians and entrepreneurs to undo a 1978
prohibition on exporting primates for lab use.
Their argument, echoed by factions in Malaysia
and Indonesia, is that macaques in particular
are a common urban nuisance, especially since
street dog numbers have declined, enabling
macaques to push deeper into cities, and should
be “harvested” for economic use.
Scientists are mostly not eager to
use wild-caught primates, however, especially
in viral disease research, since wild primates
carry many viruses which could spread to humans
and in any event tend to complicate studies
involving human viruses.
Despite this concern, wildlife traffic
investigators suspect that many of the purported
captive-bred macaques imported into the U.S. and
European Union in recent years have actually been
caught in the wild. Of 27,905 monkeys imported
into the U.S. in 2008, 26,499 were crab-eating
macaques; 838 were rhesus macaques.
China, whose primate breeding industry
is suspected of “laundering” wild-caught
macaques, exported 18,074 monkeys to the U.S. in
2008. Another 1,920 came from Cambodia, and
1,800 from Vietnam, both nations where major
dealers are allegedly involved in
monkey-laundering.

Livestock transport

The livestock transport issue may be at
least as sensitive to India as animal
experimentation, even though India neither
imports nor exports much livestock to European
Union nations, and would therefore not be
directly affected by pending EU proposals to
strengthen livestock transport regulations.
The concern for India is that the
European Union is responding to international
pressure from both animal advocates and health
agencies to much more closely regulate animal
welfare in transit. Illnesses including
hoof-and-mouth disease, Sudden Acute Respiratory
Syndrome, the H5N1 avian influenza, and mad
cow disease have spread not only from nation to
nation but continent to continent in recent years
via trade in livestock.
This is a difficult topic for India,
because while India nominally prohibits the
export of cattle and their progeny for slaughter,
India is in truth among the global leaders in
exporting cattle and buffalo to slaughter. More
than 17,000 buffalo and 500 cattle per day are
exported to slaughter from Punjab alone,
reported Varinder Singh of the Chandrigarh
Tribune in April 2008.
Stronger international treaties governing
animal welfare in livestock transport might
oblige the Indian government to acknowledge,
regulate, and supervise the clandestine traffic.
But that could be political suicide for the party
in power, since regulating cattle export for
slaughter could be portrayed as approving of the
slaughter of cows, the “Mothers of India,”
considered sacred by devout Hindus and Jains.
“Conscious that animal transportation has
always been a controversial issue, the European
Commission has nevertheless decided to return to
it and strengthen welfare standards for the 60
million cattle, goats, sheep, pigs, poultry
and horses moved each year in Europe,” reported
Luc Vernet of Europolitics on April 16, 2009.
“Before the European Parliament,” Vernet
said, “health commissioner Androulla Vassiliou
committed to make a proposal in this direction
before the [mid-2009] European elections. Her
services therefore developed a draft regulation
which anticipates establishing maximum load
densities on trucks, prohibiting the
transportation of animals to slaughterhouses
beyond a journey of nine hours, and limiting
convoys for other reasons.”
A 120-page impact study acknowledges that
the changes might produce a “slight increase” in
European meat prices.
“But according to Italian hauliers the
increase will be more than slight,” reported The
Pig Site. “Many member countries, including the
United Kingdom, argue that animal welfare could
be better served by enforcing the existing
regulations across Europe. Farming organisations
in Spain say that more important than journey
time is good animal management when loading and
unloading, and in supplying water. And they say
any reduction in density will simply mean wasted
fuel.”
Countering the industry opposition,
“Eurogroup For Animals has written to the
European Commission to express our concerns over
the half-hearted approach” of the draft
regulation, Eurogroup announced on April 24.
“Although we welcome the Commission’s
proposal to restrict the transport of animals
sent to the slaughterhouse to nine hours,”
Eurogroup specified, “the text allows for an
unrestricted number of exemptions that may be
granted by member states. An imprecise
definition of ‘slaughter animals’ will also allow
transporters to avoid journey time restrictions,”
Eurogroup alleged. “If they say the animals are
being transported for fattening, they will be
able to transport them longer.
“Eurogroup is also concerned that the
text does not make reference to a legal basis for
real-time checks on transport movements via a
global positioning unit–a clear necessity if the
proposed regulation is to be properly enforced,”
Eurogroup said.
The implications of Vassilou proposals
for India, however indirect, received
considerable attention from Indian business
media. The Statesman, for example, quoted
Vassilou, European Commission Animal Health &
Welfare Directorate advisor Michael Scannel, and
Czech agriculture minister Petr Gandalovic, who
currently holds the EU Farm Council rotating
chair.
“Animal welfare is gaining rapid
momentum, not only in the EU but worldwide,”
said Vassiliou, adding that animal welfare
requirements should be included as “non-trade
concerns” in World Trade Organization agreements.
Added Scannell, “Getting formal
recognition of animal welfare standards within
binding WTO agreements is crucial for unlocking
the United Nations and World Bank resources
needed to help the developing world raise its
animal welfare levels”