[Ip-health] News: American Chronicle- INDIA: Trade Talks with EU Put Drug Manufacturers on Edge
Terri - Louise Beswick
Terri at haiweb.org
Thu Aug 5 08:57:30 PDT 2010
INDIA: Trade Talks with EU Put Drug Manufacturers on Edge
By Acharya, Keya
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
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
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
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 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
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
'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. (c) NoticiasFinancieras -
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