Activites

• 2003/07/08 Final act published in Official Journal
  • Decision 2003/1209
  • OJ L 169 08.07.2003, p. 0001-0005
• 2003/06/16 Final act signed
• 2003/06/16 End of procedure in Parliament
• #2505
• 2003/05/13 Council Meeting
• 2003/05/13 Act adopted by Council after Parliament's 1st reading
• 2003/04/29 Modified legislative proposal published
  • COM(2003)0223 summary

    The Commission states that the Parliament's changes are in line with the approach proposed by the Commission. They provide useful clarification for implementing the programme. The Commission can therefore accept all of them.�

  • DG [{'url': 'http://ec.europa.eu/research/home.cfm', 'title': 'Research and Innovation'}],
• 2003/03/27 Debate in Parliament
  • Debate in Parliament
  • T5-0123/2003 summary

    The European Parliament adopted a resolution drafted by Gerard CAUDRON (EUL/NGL, France) made several amendments to the Commission's proposal. In order to fight HIV/AIDS in developing countries, participating Member States, together with Norway, are setting up a research and development programme entitled "The European and Developing Countries Clinical Trials Partnership" (EDCTP Programme). EUR 600 million is to be seen as a target figure, with the participating Member States contributing up to EUR 200 million. The programme will be administered by a partnership board, which will ensure a balanced participation of experts from the participating European States and from the developing countries involved in the programme. It will define the strategy of the programme to be approved by the common structure. The latter will have legal personality and be the recipient of the Community contribution. The arrangements for the financial participation of the Community and the rules relating to financial liability and to intellectual property rights will be adopted jointly by the Commission and the common structure, in accordance with the financial regulation applicable to the Community budget. Parliament insisted on a high level of participation of developing countries. Provisions relating to intellectual property rights aim to ensure that the people of developing countries have easy and affordable access to the research results produced by activities under the EDCTP Programme and to the products directly deriving from its results. The Commission must conduct an evaluation of the EDCTP Programme at the end of five years.�

• #X018
• 2003/03/03 Council Meeting
• 2003/01/23 Vote in committee, 1st reading/single reading
  • A5-0027/2003
• #2467
• 2002/11/26 Council Meeting
  • 2467 summary

    The Council held an exchange of views on the proposal for a Decision of the European Parliament and the Council on Community participation in a research and development programme aimed at developing clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries. Following the debate, the Presidency drew the following conclusions: The Council confirmed its intention to pursue this proposal as a pilot programme for the use of Article 169, it being acknowledged that further detailed discussions with the European Parliament will take place. In this context, Ministers: - underlined the importance of ensuring the commitment of financial and human resources at the national level, including, as appropriate, those of third countries, to carrying out these activities; - stressed the importance of associating very closely the developing countries with all aspects of the programme, including in the decision making process, and reinforcing current collaboration in this area as well as ensuring the establishment of the necessary modalities for effective coordination between the different actors in this field. Recognising the pioneering nature of this proposal, Ministers stressed the need for an in-depth examination of all aspects of this initiative and how best to link this programme to other activities in the implementation of the Sixth Framework Programme and the creation of ERA. Ministers stressed the need for establishing the appropriate structure and effective management arrangements for carrying out the programme, bearing in mind the need to provide for a similar level of scientific excellence and protection of Community financial interests as in other instruments implementing the Sixth Framework Programme. As to the way forward, therefore: - the Permanent Representative Committee should continue the examination of this proposal in close cooperation with the European Parliament, with particular attention to the modalities of the Community participation in EDCTP and also the question of liability of the participants; - the participating Member States should agree on the form of the legal entity and the common structure which will be responsible for the implementation and execution of the EDCTP activities, prior to the decision being taken by the European Parliament and the Council.�

• 2002/09/02 Committee referral announced in Parliament, 1st reading/single reading
• 2002/08/28 Legislative proposal published
  • COM(2002)0474 summary

    PURPOSE : to propose a new partnership between Europe and the developing countries for the development of new medecines and new vaccines agasint HIV/AIDS, malaria and tuberculosis. CONTENT : the European Commission has proposed to support a long-term partnership between Europe and developing countries by providing EUR 200 million for the development of new medicines and vaccines against HIV/AIDS, malaria and tuberculosis. This European and Developing Countries Clinical Trials Partnership (EDCTP) brings together EU Member States plus Norway, developing countries and industry in a joint effort to combat poverty-linked diseases. To adequately furnish the EDCTP programme with the necessary financial means, the European Commission has now proposed to contribute EUR 200 million of Community funds towards the EUR 600 million required for the total financial volume of the programme. Further EUR 200 million worth of activities stem from participating countries' national clinical research programmes that are brought together under a common objective. The remaining EUR 200 million will be acquired from other donors and industry. This initiative by the EU and participating European countries will allow for the rapid launching of a first set of urgent measures, once European Parliament and Council have given their green light. The vicious circle of disease and poverty causes a fundamental public health and economic crisis in developing countries, particularly in Sub-Saharan Africa. HIV/AIDS, malaria and tuberculosis (TB) alone account for more than five million deaths every year, 95% of these in the developing world. To respond to this emergency, the Commission launched already in 2001 its Programme for Action, based on three pillars: impact, affordability and research & development. The Programme for Action aims at combating HIV/AIDS, malaria and tuberculosis with the emphasis on poverty reduction. The EDCTP is a response for more and better research and development activities to fight the three diseases. To be successful, such a partnership initiative must evolve under the guidance of developing countries as the drivers of the real needs. Therefore, the EDCTP initiative has ensured that African clinicians and health system representatives took already part in this initiative at its very early stages, enabling them to assume a leading role in its further development. Similarly, to encompass the essential expertise that only industry can provide with respect to the clinical development of new drugs and vaccines. In practical terms, the EDCTP programme foresees: - central European and African management facilities; - measures for improved networking of European clinical research programmes and for global advocacy; - support for clinical research capacities in developing countries; - a training scheme for local researchers and clinicians that will strengthen the locally available human resources to guarantee the long-term sustainability of the EDCTP programme; - and, as its core mandate, support for prioritised clinical trials of new drugs and vaccine candidates that urgently await clinical testing. The present initiative, in line with the idea of a EuropeanResearch Area, is perfectly integrated within the activities of the 6th Framework Programme and represents the first attempt of a joined research programme between the European Union, Member States and associated countries. EU Member States and Norway will invest at national level more than EUR 1 billion for the years 2002-2007 in biomedical research to develop new clinical means to cure or prevent HIV/AIDS, malaria and tuberculosis. �

  • DG [{'url': 'http://ec.europa.eu/research/home.cfm', 'title': 'Research and Innovation'}],

Documents

• Legislative proposal published: COM(2002)0474
• Debate in Council: 2467
• Committee report tabled for plenary, 1st reading/single reading: A5-0027/2003
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T5-0123/2003
• Modified legislative proposal published: COM(2003)0223
• : Decision 2003/1209
• : OJ L 169 08.07.2003, p. 0001-0005

History

(these mark the time of scraping, not the official date of the change)