[Ip-health] Open letter from Médecins Sans Frontières President to Prime Minister of India on EU/India FTA

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Thu Feb 9 03:31:17 PST 2012

Dr Unni Karunakara, International President of Médecins Sans Frontières,
has written an open letter to Indian Prime Minister Dr Manmohan Singh,
setting out MSF's concerns over remaining provisions in the EU/India Free
Trade Agreement that would prove harmful for access to medicines:

The Honourable Dr. Manmohan Singh
Prime Minister of India
South Block, Raisina Hill
New Delhi -110 011

Geneva, 8 February 2012

*Honourable Prime Minister,*

Ahead of the India-Europe Summit on 10 February 2012, where a roadmap to
conclude the EU-India free trade agreement (FTA) is set to be agreed, the
international medical humanitarian organization Médecins Sans Frontières
(MSF) would like to draw your attention to specific harmful provisions in
the proposed intellectual property (IP) and investment chapters, that if
included would have serious implications for access to affordable medicines
in India and throughout the developing world.

MSF today relies overwhelmingly on affordable generic HIV/AIDS medicines
produced in India to treat nearly 180,000 people in 20 countries, as well
as using medicines from India to treat other diseases such as tuberculosis
and malaria. India has played a pivotal role in supplying affordable
generic versions of drugs used throughout the developing world.  It is
vital therefore that further barriers are not created that threaten the
supply of affordable generic medicines from India.

As such, the March 2011 official statement by Minister Anand Sharma,
against the introduction of ‘data exclusivity’ was welcomed by MSF and
others given the harmful effect it would have on access to affordable
medicines produced in India. We urge the Indian government to stand strong
in this and in future free trade agreements, such as the one currently
being negotiated with the European Free Trade Association countries of
Switzerland, Iceland, Norway and Liechtenstein.

*However the enforcement and investment provisions within the draft
agreement are still a matter for serious concern as unchanged they will
have significant negative implications for generic production critical for
ensuring access to affordable medicines in India and throughout the
developing world. *

We therefore urge India to take a similarly strong stand in relation to the
remaining harmful provisions, particularly:

*Enforcement provisions:**  *The European Commission’s proposed text is
broad in scope and goes well beyond what has already been agreed and
implemented by India under the TRIPS Agreement.  The EC had r*eproduced
some of the enforcement measures* contained in the Anti-counterfeiting
Trade Agreement (ACTA) over which the Indian government has raised serious
concerns at the WTO, stating that the agreement will “impede legitimate
competition and shift the escalated costs of enforcing private commercial
rights to governments, consumers and taxpayers”[1] <#13561e07d09ad167__ftn1>

The EU is proposing an ambitious enforcement agenda that:

   - *Widens the enforcement net so that life-saving legitimate medicines,
   under alleged trademark infringement, could be detained or destroyed at the
   border when being exported, simply because their label appears similar to
   the originator product.*  Although this is often justified on the basis
   of protecting the public from fake medicines, this issue is entirely
   separate, and will do nothing to improve medicines’ safety.  It would in
   fact have a negative impact on access to treatment, as is evident from the
   recent seizures of Indian generic medicines in EU countries. The impact
   of any such detentions will be felt directly by patients awaiting the
   arrival of crucial generic medicines in the many countries that do not have
   manufacturing capacity to produce medicines, and therefore rely on
   importing more affordable generics from India;

   - *Substantially increases the penalties *for alleged patent and
   trademark infringements.  On a mere allegation - and not proof –
   including allegations brought by a competitor, generic suppliers allegedly
   infringing a patent or a trademark may face a ban on production, delay or
   destruction of goods, disproportionate damages, and  potential


   - *Limits the Indian courts’ ability to balance commercial and public
   health interests and the Indian Constitution’s guarantee to the right to
   life*, by making use of a variety of alternative remedies rather than as
   the EU proposes, routinely granting provisional injunctions; and


   - *Extends liability to third parties*, thereby putting at risk of
   injunctions and provisional measures a wide variety of public health
   stakeholders, including: suppliers of active pharmaceutical ingredients
   used for producing generic medicines; distributors and retailers who stock
   generic medicines; NGOs such as MSF who provide treatment; funders who
   support health programmes; and drug regulatory authorities who examine
   medicines. This could act as a significant deterrent to anyone involved in
   the production, sale or distribution of affordable generic medicines.**

* *

*Investment Chapter:* The European Commission is also pushing for the trade
deal to be expanded in scope so that it covers investments, including
intellectual property, and supports an “investor-to-state” mechanism.

This would allow multinational drug companies to bypass the Indian
judiciary and take the Indian government to private arbitration courts over
investment disputes in relation to intellectual property, in order to seek
to reverse domestic health policies like tobacco warnings and measures to
reduce prices of medicines. Pharmaceutical companies must be given no
additional avenues to pressure India on policies and laws that promote
access to medicines. India is already reeling from multiple litigations
filed by companies like Novartis and Bayer against health safeguards
enshrined in India’s patent law.

In order to ensure that the EU-India FTA does not undermine access to
medicines, the additional threats posed by the enforcement and investment
provisions must be addressed. At a minimum, we would urge the Indian
Government to request the following safeguards are contained in the roadmap
to ensure that damage caused to people’s access to medicines is minimised:

   - The withdrawal of the IP enforcement measures, and as a minimum
   safeguard, the deletion of patents from the entire scope of the enforcement
   - The withdrawal of third party liability from the enforcement
   - The withdrawal of specific provisions dealing with injunctions from
   the enforcement provisions in order to preserve the existing flexibilities
   of the Indian judicial system;
   - Border enforcement should be limited to the requirements of the TRIPS
   Agreement and as such exclude exports and trademark infringements; and
   - The withdrawal of IP and the investor-to-state mechanisms from the
   scope of the investment chapter.

India has already shown that it’s prepared to stand firm against harmful
demands from the European Commission.  As the negotiations are reaching
their final stages we urge you to maintain your vigilance and commitment to
preserving the space for continuation of the generic production of
medicines that we and so many in India and beyond rely upon.

Yours sincerely,

*Dr Unni Karunakara*

*International President*

*Médecins Sans Frontières*

c.c. Honourable Minister of Commerce and Industry of India Shri Anand Sharma

c.c. Honourable Minister of External Affairs of India Shri S. M. Krishna


[1] <#13561e07d09ad167__ftnref1>

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