[Ip-health] IPS: (India) Trade talks with EU put drug manufacturers on Edge

Suerie Moon suerie_moon at yahoo.com
Tue Aug 3 19:42:42 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 talks.

   The talks have drawn concern since they began in 2007, 
especially since they integrate bits from other 
controversial bilateral negotiations between industrialised 

   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 

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 

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 

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 

   "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. 

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