E-DRUG: Question and Reply by EC- Access to medicines and ACP Countries
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QUESTION TO THE EUROPEAN COMMISSION by MEP David Martin (MEP- Chair of the
European Parliament working group on Innovation, Access to medicines,
Poverty related diseases) ACP-EU JOINT PARLIAMENTARY ASSEMBLY 18th session
- Luanda (Angola) 30 November-3 December 2009
Questions shall not be more than 100 words (Article 20(6))
Can the Commission outline what steps it is taking to ensure access to
affordable medicines in ACP countries? Can the Commission highlight how it
supports ACP countries to make use of TRIPs flexibilities to manufacture
or import generic medicines? Can the Commission further elaborate on
whether seizures of generic medicines in transit in the EU has affected
deliveries to ACP countries and, if so, what steps it will take to resolve
this problem?
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EUROPEAN COMMISSION'S REPLY TO QUESTION 17 BY DAVID MARTIN
Access to drugs is one of the oldest and main priorities of EC support to
health in developing countries. This support involved project and program at nearly all stages
of the continuum that goes from research to development and production, then to procurement and
to delivery, including quality control and counselling to patients.
Through bilateral support to countries, the EC has helped strengthening the drug procurement
system in a number of countries (central medical agencies established, equipped and
supported), and is still supporting this sector, either through direct funding for health, or
through budget support with a special attention to progress in health indicators.
On research and production, EC and EU have been very active in supporting Doha flexibilities on TRIPS (with EU having a regulation to allow EU countries to answer to request from developing countries). More recently, at the request of the European Parliament, the Commission engaged in a partnership with the special WHO/TDR program (€2 million in 2008, €5 million additional in 2009) to identify and to support research capacities in developing countries for new or more adapted drugs to neglected diseases.
This partnership falls under the framework of the Global strategy and plan of action for innovation, public heath and intellectual property that was approved by the World Health Assembly in May 2008. Similarly, the EC is supporting the WHO in identifying best practices, with the aim of defining possible future EC support to local production of good quality
drugs in Africa, an area also covered by the EU-Africa MDG partnership. In 2009 this support was extended to address the issue of vaccines and diagnostics production.
On procurement and quality; the EC is in a partnership with the WHO (essential medicines and pharmaceutical policies, €25 million for 5 years) for capacity building in African countries with regards to pharmaceutical policy (regulatory agencies, procurement process, quality control, etc;). This includes a direct support to the prequalification program of WHO.
But EC interest in supporting access to drugs is not limited to development policies.
Following its commitment topolicy coherence for development, the EC is currently assessing the impact that other EU policies, like the ones on trade or on research, have on access to drugs in partner countries.
Last but not least, the EC is engaged with some emerging economies countries in triangular cooperation for Africa with a special focus on access to drugs (recent agreement with Brazil,
and with South Africa, discussions with Egypt). Following some cases of retention of drugs in transit by customs authorities of some Member States, under suspicion of Intellectual Property Rights (IPR) infringement (Pursuant to Regulation (EC) No 1383/2003), the Commission reaffirmed its commitment to facilitating access to good quality, affordable drugs in developing countries, while
respecting the international agreements on IPR. In order to avoid any disruption of legitimate trade between third countries, the Commission provided Members States with a very detailed explanatory
note on this matter, and on the proper process to be followed when the breaching of patent laws is suspected in goods in transit in Europe. The Commission is maintaining close contacts with MScustoms authorities and with drugs manufacturers who are patent holders to see that EU regulations are implemented properly.
http://www.europarl.europa.eu/meetdocs/2009_2014/documents/acp/dv/772/772000/772000reven.pdf
Alexandra Heumber
EU & IP Policy Adviser
Medecins Sans Frontieres
Access to Essential Medicines Campaign
Rue Dupre, 94. 1090 Brussels
++32 (0) 2 474 75 09 (Dir off)
++ 32 (0) 479 514 900 (Mob)
++ 32 (0) 2 474 75 75 (Fax)
Alexandra HEUMBER <Alexandra.HEUMBER@brussels.msf.org>