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International Clinical Trials

Legal Instrument Plays Sweetly

Wim Van Velzen of Covington and Burling LLP examines the external review process of a clinical trials partnership seeking to piece together fragmented national research programmes

In 2000, Europe made a commitment to achieve the millennium development goals. The European Union (EU) adopted its new development policy based on poverty reduction. Despite increased efforts and resources, the number of people affected, infected and dying from HIV/AIDS, malaria and tuberculosis continues to rise. AIDS and tuberculosis are spreading rapidly, not only in Africa but in other regions such as Russia. In countries with large populations, for example China and India, infection rates are also increasing. Malaria poses a large burden, particularly on African countries, and sub-Saharan Africa continues to carry the largest burden of HIV/AIDS.

At the beginning of 2002, the European Commission developed a coherent European policy framework for external action to confront HIV/AIDS, malaria and tuberculosis. One of the instruments of this policy is to coordinate at EU-level a part of the research efforts of member states. It is clear that the EU considers it to be a major challenge to respond to the evolving nature of these three diseases and their geographical spread in developing countries.

Consequently, the EU and member states have made international commitments. In addition, specific regulatory steps have been taken to facilitate the availability of medicines in developing countries.

THE SIXTH R&D FRAMEWORK PROGRAMME

Today, member states are attempting to combat the diseases in question through their own R&D budgets. France, for instance, plans to spend ˆ1.4 billion between 2006 and 2008 on multilateral actions designed to tackle emerging and transmissible diseases. The German government spends ˆ300 million annually on the prevention and control of HIV/AIDS, malaria and tuberculosis and the development of health systems. The UK has committed to spend £1.5 billion on HIV/AIDS from 2005/6 to 2007/8 and has made millions available through global funds to tackle preventable diseases.

The US will provide $15 billion over five years to support international HIV/AIDS programmes. In comparison with the US, Europe follows a different strategy – its research efforts and actions are more fragmented – while the US National Institute of Health is fostering collaboration through its centre for HIV/AIDS vaccine immunology.


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Wim Van Velzen advises clients on European affairs, including the functioning of the European institutions, EU policy-making processes, development of EU legislation and accession of new EU members. In particular, he is involved in EU energy, telecommunications, information and communications technologies, and R&D policy. Since 1989 he has worked extensively across Central and Eastern Europe and more recently in Southeastern Europe, including the Balkans and Turkey. Wim served with distinction as a Member of the European Parliament from 1994 to 2004, where he was Vice President of the European People’s Party (EPP) and European Democrats Political Group, currently the largest party in Parliament.
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Wim Van Velzen
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