[Ip-health] APM Health Europe: EU-India trade talks extend towards investment rules in bid to protect western medicines

Joanna Keenan joanna.l.keenan at gmail.com
Fri Apr 8 07:33:37 PDT 2011

APM Health Europe: EU-India trade talks extend towards investment rules in
bid to protect western medicines

BRUSSELS, April 7 (APM) - As trade negotiations between the EU and India
resume in Brussels Thursday, the question of Europe's rights to protect
pharmaceuticals from copying has again assumed prominence, this time with
moves to include protecting investment giving rise to yet another new area
of controversy. Indian officials came to Brussels this week for another
round of expert-level talks on the terms of the free trade agreement
currently under discussion with the EU.

Europe's bid to maximise protection of pharmaceuticals is, as before, high
on the agenda, and now the dispute has moved on from patents and data
exclusivity to questions of protecting investments. At the heart of the
disagreements is the conflict between brandname drug manufacturers in the
west, and generic medicine producers in India.

The EU - and the drug industry in Europe - is keen for a trade deal that
will open up the growing Indian market. But because of India's huge generic
medicines manufacturing sector - which supplies much of the developing world
- brandname companies in Europe want the deal to maximise protection for
their products against illicit copying. The discussions therefore have
turned to what is 'illicit'. The EU wants to see a tough Indian regime on
drug patents, with effective enforcement. It is also seeking some protection
for products through persuading India to accept the concept of data
exclusivity. And now the EU is also starting to exert pressure for
additional protection where a medicine that is not covered either by patents
or data exclusivity may still qualify, because it represents an investment
that would be eroded by copying. The approach is to push for greater
intellectual property protection as a part of the investment provisions of
the EU-India trade deal. The lack of clear definition of many of the terms
central to the discussion is a further complication.

Yesterday, the European Parliament waded into the debate on the Indian side.
In a resolution it adopted on future European international investment
policy, it demanded "a clear definition of the investments to be protected".
And in a passage related directly to the EU-India negotiations, it insisted
that where intellectual property rights are included in the scope of an
investment agreement, "the provisions should avoid negatively impacting the
production of generic medicines". It is not enough to focus on investor
protection, said the Parliament. The EU should also take full account of its
obligation "to exercise policy coherence for development".

Médecins Sans Frontières is also firmly opposed to the provision, which, it
says, "would allow EU pharmaceutical companies to sue the Indian government
if they feel their profit, or 'investment,' in India is under threat". MSF
says that if India decided to override a medicine patent, control the price
of a patented medicine, or take any action that would allow more access to
affordable generic versions of a medicine, "the government could be secretly
sued for millions of dollars".

It is incensed at the new EU move, since it fears a tough trade deal would
seriously damage supplies of cheaper medicines to poor countries. It is
calling for the EU "to remove 'intellectual property' from the definition of
investment it is pushing as a part of the free trade agreement".

The discussions on data exclusivity received a new twist when, at the end of
March, the Indian minister for commerce, Anand Sharma, told his parliament
that the government would not give way to calls for data exclusivity on
medicines. "India does not provide data exclusivity for pharmaceuticals and
agro-chemicals, which is in the paramount interest of our generic
pharmaceutical industry, as grant of data exclusivity would have
considerable impact in delaying the entry into the market of cheaper generic
drugs", he said.

Médecins Sans Frontières cautiously welcomed the statement. "We support
India in standing strong in the face of constant pressure from the EU
Commission on data exclusivity," said Leena Menghaney, manager of MSF's
Campaign for Access to Essential Medicines in India. "We urge minister
Sharma to stick to this position for this and for future free trade
agreements that India will negotiate". Another agreement is currently under
discussion now with the European Free Trade Association countries of
Switzerland, Iceland, Norway and Lichtenstein."

"This is a welcome statement from minister Sharma, but it is too early to
celebrate, because the EU has not made clear yet that they will stop pushing
data exclusivity in the free trade negotiations," said Michelle Childs,
director of policy/Advocacy at MSF's Campaign for Access to Essential

MSF and other campaigning groups are also concerned at what they see as
other attempts by the EU to maximise protection. MSF says the EU "is seeking
to introduce a completely separate category, that of civil trademark
disputes, into the EU-India FTA". It claims that the EU is seeking -
unfairly - to link civil trademark disputes and patent infringements with
counterfeiting, "for the purpose of targeting legitimate
generic competition/production".

"There is no place for patents or civil trademark infringement in a genuine
anti-counterfeiting treaty," says MSF.

Joanna Keenan
Press Officer
Campaign for Access to Essential Medicines
Medecins Sans Frontieres

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