[Ip-health] Trade talks with EU put drug manufacturers on edge

Leena Menghaney leena.menghaney at geneva.msf.org
Fri Aug 27 01:32:31 PDT 2010

Trade talks with EU put drug manufacturers on edge
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

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 'apologised'
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
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.


Leena Menghaney
Medecins Sans Frontieres
Campaign for Access to Essential Medicines  (India)
C 236 Defence Colony, New Delhi, India
Tel: +91 11 46573731, +91 11 46573730

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