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[e-drug] European Commission position on compulsory licensing

  • From: "Jérôme Martin" <jeromemartin@samizdat.net>
  • Date: Wed, 05 Sep 2007 21:36:10 +0200

E-DRUG: European Commission position on compulsory licensing
[This letter reflects the position of the European Commission (EC), the "government" of the European Union, on the issue of patents, IP and compulsory licensing.
Although not answering on Thailand, it is important to note that the EC makes a pledge that its Economic Partnership Agreements with developing countries will not undermine access to medicines or the flexibilities permitted in TRIPS and confirmed by Doha; this in sharp contrast to the USA which tries to make TRIPS-plus conditions in almost all of its "Free" Trade Agreements. WB]

Hello E-druggers,

Two weeks ago, Aides and Act Up-Paris wrote to European Commissioner
Mandelson about his letter to the Thai governement :


Please find below his "answer". Well, no answer at all on Thailand. You
will note the last sentence of the letter : EC Mandelson knows better
than the governments of the developing countries what's good for them.


Jérôme Martin / Miss Heat Stable
Act Up-Paris

Brussels, 3 September 2007

Act Up-Paris AIDES
Mr Emmanuel Château Mr Bruno Spire
Mr Hugues Fischer Président
Mr Jérôme Martin
Commission Internationale

Thank you for your letter dated of 22 August about access to medicines
and compulsory licensing of pharmaceutical patents.

First of all, I would like to underline that the Commission remains
supportive of the Doha Declaration on the TRIPS Agreement and Public
Health (which it had promoted), and fully recognises the right of WTO
members to grant compulsory licenses.

The Commission has been very active on patent issues in relation to
pharmaceutical products, including promoting an amendment to the TRIPS
Agreement to allow compulsory licensing for export of medicines towards
least-developed and developing countries. This amendment is pending
approval by the European Parliament. We have also made clear that we
fully respect the right of least-developed countries not to implement
the provisions of the TRIPS Agreement for pharmaceutical patents until 1
January 2016.

The use of compulsory licensing is an exception to the rights conferred
by a patent which should be used in the spirit of the 2001 Doha
Declaration and in the respect of the conditions of the TRIPS Agreement.
The use of compulsory licensing should not become a standard way of
doing business, because systematic recourse to compulsory licensing
would eventually be detrimental to the patent system, and so to
innovation and the development of new medicines. That is why the EU has
always made clear its preference for voluntary agreements between
potential licensees and patent holders on reasonable terms and
conditions, which the provisions of the TRIPS amendment can help facilitate.

It should also be borne in mind that the problem of increased access to
medicines, especially in poorest countries, needs to be addressed by a
wider package of national and international actions. The compulsory
licensing represents only one of the elements available for that matter.

The Commission supports, through technical assistance, the development
of the generic drugs industry in poor developing countries. Prevention,
treatment and care of HIV/AIDS, malaria and tuberculosis are one of the
objectives of a specific initiative dedicated to aid for poverty-related
diseases in developing countries for a combined 2005-2006 total of €
81.2m. Specific projects have also been funded in Africa and Asia.

The EU is also a major sponsor of pharmaceutical and
health-oriented/clinical research including health systems research and
capacity building in various sub-Saharan African countries through the
European & Developing Countries Clinical Trials Partnership (EDCTP).

During the period of implementation of the sixth Framework Programme for
Research (FP6 - 1999-2002), the Commission's support for R&D devoted to
poverty-related diseases amounted to more than € 455m. For the same
period, an additional € 78m were spent by the International Scientific
Cooperation (INCO) on various projects covering the fields of neglected
infectious diseases, health systems/policy research and reproductive
health. The Commission is fully committed to the success of these
research projects and innovative initiatives and will continue to do so
under the current seventh Framework Programme for Research (FP7 -

In the Economic Partnership Agreements with ACP countries and in other
future bilateral and regional agreements with developing countries, the
Commission is not asking, and will not ask, for provisions which could
affect access to drugs or undermine the TRIPS flexibilities contained in
the Doha Declaration on the TRIPS Agreement and Public Health.

It is also important to strike a balance between the need to provide
incentives for innovation and research and development and the need to
make existing drugs as available as possible at affordable prices, in
particular, in poor developing countries. It is well established that
patent protection provides incentives for innovation, transfer and
dissemination of technology and research and development into new drugs.

It is in the interest of developing countries themselves to adopt
appropriate patent protection in order to attract investment and develop
their own production capacities.

Peter Mandelson