NEW DELHI - As India prepares to seal a
sweeping trade and investment deal with the
European Union (EU) in April, civil society groups
are campaigning to limit the deal's repercussions
within the local generic drug industry here on
which millions of people around the globe depend.
India's Commerce Secretary Rahul Khullar
is expected to be in Brussels from April 6-8 to
sign a comprehensive agreement that will lower
tariffs on a range of goods, liberalize investment
rules and expand the market for services.
The deal, in the making since 2006, is
between the world's largest economy and a
developing country that is about 8% of its gross
domestic product (GDP) size.
The EU's GDP was estimated at more than US$16.4
trillion in 2009 when India's stood at $1.3
trillion.
"We hope that Indian negotiators
will withstand pressures and ensure that the
existing intellectual property rights regime is
not tampered with to allow extension of patents,
especially as a number of drugs are going off
patent this year," said Mira Shiva, a member of
the All India Drug Action Network.
"The
World Trade Organization's TRIPS [Trade-Related
Aspects of Intellectual Property Rights] was bad
enough, but we are facing a TRIPS-Plus bilateral
deal which may prove even worse for public
health," Shiva told Inter Press Service (IPS).
If the India-EU free trade agreement (FTA)
introduces TRIPS-Plus measures, people on HIV
treatment, for example, may not be able to access
second-line treatment when they become resistant
to medicines they already are on, Shiva said.
By refusing to recognize patents and by
leveraging its large domestic market India has, in
the decades since 1970, been able to build up a
powerful pharmaceutical industry known for its
cheap and efficacious generic versions of patented
drugs.
After 2005, India has been
implementing changes mandated by the WTO, but
these are less stringent than the EU intellectual
property regime.
UNAIDS, the joint United
Nations programme on HIV and AIDS, notes that the
flexibility afforded by TRIPS has brought down
drug prices and helped lower the cost of
first-line generic anti-retrovirals (ARVs) by as
much as 99% in the last decade.
The EU can
be expected to demand data exclusivity on drugs as
it has done in the case of all its other FTAs,
said Shiva. Data exclusivity will allow drug
manufacturers a monopoly, based on clinical test
data generated on the safety and efficacy aspects
of a new drug.
"What this means," said
Amit Sen Gupta, public health expert at the Delhi
Science Forum, a voluntary organization, "is that
an Indian drug company planning to produce the
generic version of a patented drug will have to
conduct its own clinical trials before it can be
licensed and marketed."
"Fresh trials
would naturally add to the cost of the drug, and
delay its introduction into the market," Sen Gupta
said. The EU grants up to 11 years of exclusive
rights based on successful clinical trials and
other test data.
Indian regulators and
courts have refused to support international
pharmaceutical companies trying to stop generic
drugs being made by making token changes in the
formulation of drugs or by finding and adding new
uses for them.
In a celebrated case, the
Basel, Switzerland-based Novartis failed to obtain
patent protection in India for a new formulation
of its anti-cancer drug, Imatinib, also marketed
as Gleevec. In 2007, Novartis challenged India's
patent laws at the Madras High Court but found its
writ petition dismissed. The Supreme Court in New
Delhi is hearing an appeal.
Similarly,
US-based Abbott Laboratories could not to stop the
manufacture in India of generic, heat-resistant
versions of the anti-AIDS drugs, Ritonavir and
Lopinavir.
"The EU naturally sees India's
large and legal domestic market as well as its
drug manufacturing base as a threat," Shiva said.
Between 2003 and 2008 Indian generic
manufacturers provided more than 80% of drugs used
in internationally funded AIDS treatment programs,
including 91% of the pediatric ARVs, said Sen
Gupta.
Government programs to provide
anti-HIV treatment, such as those run in Brazil
and South Africa, have depended heavily on Indian
generic ARVs. Brazil's remarkable turnaround in
controlling the spread of HIV has been attributed
to the import of affordable generic ARVs from
India.
India's generic drug-makers play a
major role in the South African government's HIV
and AIDS prevention and treatment program. Last
year, when a $700 million tender was floated for
the supply of ARVs, the Indian manufacturer
Ranbaxy cornered a $131 million order. The UNAIDS
report for 2007 estimated that 5,700,000 South
Africans had HIV/AIDS - or just under 12% of the
country's population of 48 million.
Both
Brazil and South Africa also produce significant
amounts of generic drugs themselves and have
stakes in the viability of an industry threatened
by international intellectual property rights
regimes and FTAs.
Leena Menghaney, legal
expert and campaigner for the Paris-based Medicins
Sans Frontieres (Doctors Without Borders), said
the outcome of the India-EU deal was being closely
watched by Brazil, South Africa and other generics
manufacturing countries like Thailand.
Menghaney said compulsory licensing,
allowed under TRIPS, is threatened by
expropriation claims made under investment rules
in bilateral agreements. Compulsory licensing
would allow a government to override a patent in
emergencies such as an epidemic and arrange for
the manufacture or import of generic versions of
patented drugs.
"Pharmaceutical companies
have argued that compulsory licenses are indirect
expropriation and have resorted to claims under
provisions in bilateral FTAs," Menghaney says.
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