E-DRUG: INDIA Trade Talks with EU Put Drug Manufacturers on Edge
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By Keya Acharya
NEW DELHI, Aug 3, 2010 (IPS) - Their ongoing negotiations remain shrouded in secrecy, but there are already reports that India and the European Union (EU) will have a free-trade agreement ready by the end of August, and that they will be putting signatures to it before the end of 2010.
Yet it is a potential development that is causing more
nervous chatter than joyous jitters here in India, where
drug manufacturers in particular have raised concerns over
India's trade interests and intellectual property rights
(IPR) issues.
India's 7.5-billion-dollar drug industry is among the
world's top five bulk medicine producers. It is also among
the world's 20 top pharmaceutical exporters, with its export
business growing at 17.8 percent per year.
A large segment of its reasonably priced generic drugs,
including life-saving HIV anti-retrovirals and anti-cancer
drugs, are exported to other developing nations in Asia and
Africa. But now Indian drug exporters are worried that any
potential growth for their business overseas is bound to
disappear should India capitulate to several EU stipulations
in the trade talks.
The talks have drawn concern since they began in 2007,
especially since they integrate bits from other
controversial bilateral negotiations between industrialised
nations.
These include the Anti-Counterfeit Trade Agreement
(ACTA), the World Customs Organisation's Standards to be
Employed by Customs for Uniform Rights Enforcement (SECURE),
and the World Health Organisation's (WHO) International
Medical Products Anti-Counterfeiting Task Force (IMPACT).
ACTA, IMPACT, and SECURE have all drawn consistent
protests from developing countries for being formulated in
secrecy and without their consent.
More importantly, countries like India and Brazil say
that ACTA's definition of counterfeit drugs is ambiguous
enough to include generic drugs, while SECURE's IPR
enforcement allows Interpol to decide by itself, or by a
third party, what is counterfeit and seize it in transit.
As a result, they say, the definition of generic drugs
has become restricted, in turn allowing their seizure in
transit through EU countries. Essentially, such acts
override previous laws under the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) that allowed
patented drugs classified as 'essential' or crucial to
health to be manufactured in developing countries.
On its website, the EU says that "nothing in the proposed
agreement would limit India's freedom to produce and export
life-saving drugs in accordance with the TRIPS agreement…."
Officials at India's Department of Commerce, responsible for
dealing with the EU and WTO issues, for their part were
tightlipped when queried on the matter by IPS.
In June, however, India's Commerce and Industry Minister
Anand Sharma, in response to MP Maneka Gandhi's query in
Parliament on IPR and access to medicines in the India-EU
talks, said, "Final positions have not emerged and therefore
no agreement has been reached in any sector including IPRs."
Still, Gopal Krishnan, adviser to the Mumbai-based Indian
Drug Manufacturers’ Association (IDMA), notes, "What is
being agreed on needs to be seen. None of us in the field
have seen the document."
The concerns may not be unfounded. In 2009, the Mumbai-based
Indian Drug Manufacturers Association (IDMA), with over 600
small, medium, and large Indian pharmaceutical companies as
members, asked India's Ministry of Commerce to exclude the
EU's clauses on IPR since these were already included in TRIPS.
An issue dropped in the World Intellectual Property
Organisation (IPO), the EU's terms of 'patent linkage',
whereby one patent is applicable worldwide, had apparently
reappeared in the terms of the India-EU agreement.
In the meantime, cases of "fake medicines" have prompted
global trade regulators to formulate anti-counterfeit measures.
In 2009-2010, for example, several consignments of fake
anti-malarial medicines from China to Nigeria, labelled
'made in India', caused India take the issue up with China.
The latter country is reported to have 'apologise' to Nigeria.
K M Gopakumar of Third World Network in New Delhi, says,
however, that "the talks are extending the counterfeit
concept to all IPR." He asserts that the anti-fake
mechanisms have become more a means of market control by
richer nations.
Gopakumar adds, "If India 'gives in' to concerns we have
raised inside the FTA talks, what consequences will this
have for ACTA?"
Yet India has not been taking things sitting down. In May,
it filed a case against the EU in the World Trade
Organisation (WTO) dispute settlement court regarding
repeated seizures, on patent infringement grounds, of
generic drugs transiting through the Netherlands.
India says the seizures are illegal under TRIPS. Brazil,
Canada, Ecuador, China, Japan, and Turkey have since joined
in the case's consultations.
Prominent Mumbai-based IPR lawyer Gopakumar Nair feels
India's case at the WTO needs to be settled first before an
agreement on the FTA with the EU can be inked.
He also points out that in the early 2000s, the Substantive
Patent Law Treaty within TRIPS, which gave sweeping powers
on the patent system to WIPO and thus disempowered
developing countries from formulating their own systems, was
dropped due to opposition from the likes of India and Brazil.
"The key issue now," says Nair, who was once IDMA
president, "is that industrialised nations are bypassing the
dropping of this Substantive Patent Law Treaty, and the EU-
FTA provides an opportunity for this."
In June 2010, another international group of lawyers,
academics and health organisations signed the Berkeley
Declaration that called on all developing nations to
approach intellectual property enforcement and anti-
counterfeiting initiatives with caution.