Decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States

Decision No 1209/2003/EC of the European Parliament and of the Council
of 16 June 2003
on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION
,
Having regard to the Treaty establishing the European Community, and in particular Articles 169 and 172, second paragraph, thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning the sixth framework programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002 to 2006)(4) (hereinafter referred to as "the sixth framework programme") provides for Community participation in research and development programmes undertaken jointly by several Member States, including participation in the structures created for the execution of those programmes, within the meaning of Article 169 of the Treaty.
(2) On 30 May 2001, the Commission presented a communication on the application of Article 169 of the Treaty and the networking of national programmes.
(3) The Council, in its Resolutions of 10 November 2000 and 14 May 2001, and the European Parliament, in its Resolution of 4 October 2001(5), underlined the gravity of the HIV/AIDS, malaria and tuberculosis epidemics and the need to step up efforts to increase aid at national, regional and world level, and endorsed the Programme for Action: accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction.
(4) In its conclusions of 30 October 2001, the Council called on Member States to select specific areas for pilot programmes, for which Community participation in research and development programmes undertaken at the initiative of several Member States within the meaning of Article 169 of the Treaty would be appropriate, if necessary in close collaboration with the Commission.
(5) In connection with its communications to the European Parliament and the Council of 20 September 2000 and 21 February 2001 the Commission has presented an action programme aimed at combating the global problem of HIV/AIDS, malaria and tuberculosis and identifying various strategies to be implemented. This action programme has various closely linked and interdependent parts: promoting prevention, encouraging treatment and making essential medicinal products more affordable and stepping up research and development. The research and development part is aimed, among other things, at developing, in coordination with the application of this decision, new clinical interventions to combat the three diseases through a long-term partnership between Europe and developing countries. In the design of clinical trials for new clinical interventions against HIV/AIDS, malaria and tuberculosis, coexisting infections should be taken into account.
(6) In their Decision No 36/2002/EC(6), the European Parliament and the Council decided that the Community would contribute EUR 60 million for the year 2001 to the global fund to fight HIV/AIDS, tuberculosis and malaria. As the Global Fund does not finance research and development activities, additional funds for research and development are required.
(7) Member States are undertaking individual research and development programmes or activities aimed at developing new clinical interventions to combat the global problem of HIV/AIDS, malaria and tuberculosis. These programmes or activities, the required funds for which have been granted, form part of long-term partnerships with developing countries.
(8) At present, the research and development programmes or activities undertaken individually at national level are not sufficiently coordinated at European level and do not allow a coherent approach at European level for an effective research and technological development programme to combat HIV/AIDS, malaria and tuberculosis in the developing countries or make it possible to find optimal treatments suited to conditions in the developing countries.
(9) Wishing to have a coherent approach at European level and to act effectively against HIV/AIDS, malaria and tuberculosis in developing countries, Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (hereinafter referred to as "the participating Member States") and Norway have taken the initiative, with developing countries, for setting up a research and development programme entitled "The European and Developing countries Clinical Trials Partnership" (hereinafter referred to as the EDCTP Programme) in order to obtain a critical mass in terms of human and financial resources and the combination of additional expertise and resources available in various countries across Europe and the developing countries.
(10) In the spirit of the sixth framework programme, the Community should have the right to agree the conditions for its financial contribution to the EDCTP Programme in relation to the participation therein of other countries, in the course of its implementation, in accordance with the rules and conditions set out in this Decision.
(11) The objective of the EDCTP Programme, for the total cost of which a target figure is estimated at EUR 600 million over a five-year period, is to accelerate the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in sub-Saharan Africa, and to improve generally the quality of research in relation to these diseases. The EDCTP Programme has been drawn up with a view to stepping up cooperation and the networking of European national programmes, accelerating clinical trials of new products, in particular drugs and vaccines, in the developing countries, helping to develop and strengthen capacities in the developing countries, including the promotion of technology transfer where appropriate and encouraging the participation of the private sector and mobilising additional funds to fight these diseases, including funds from the private sector. Because of the nature of the Programme, a significant part of the funding would be spent in the developing countries.
(12) A similar initiative could be launched at a later stage, including other neglected diseases which particularly affect poor people in the developing countries, provided that the Member States are implementing such programmes and that the Framework Programme has a corresponding research priority.
(13) The participating Member States have agreed to coordinate and implement jointly activities aimed at contributing to the EDCTP Programme for a proposed period of five years. The overall value of their national participation is estimated at EUR 200 million.
(14) Activities linked to obtaining additional funds, whether public or private, estimated at EUR 200 million, are provided for in the implementation of the EDCTP Programme.
(15) In order to increase the impact of the EDCTP Programme, the Community should participate therein by making a financial contribution of up to EUR 200 million.
(16) In order to increase the impact of the EDCTP Programme, the Community should aim at synergy effects with related Community initiatives in the field of improving public health in the developing countries, with a view to the latter enhancing their clinical, regulatory and community capacities necessary to play effectively their role in the EDCTP partnership.
(17) The participating Member States have agreed on a model of governance involving a Partnership Board, and a common structure to implement the EDCTP Programme. The Partnership Board will ensure a balanced participation of experts from the participating European States and from the developing countries involved in the EDCTP Programme and will define, develop and plan the strategy of the Programme to be approved by the common structure. The common structure is a legal entity which will guarantee the Community dimension in implementing the EDCTP Programme and will be the recipient of the Community financial contribution.
(18) Given that the EDCTP Programme meets the scientific objectives of the sixth framework programme and that the research field of the EDCTP Programme falls within the priority theme "Life sciences, genomics and biotechnology for health" of the sixth framework programme, the Community financial contribution should be taken from the budget appropriation allocated to that priority theme.
(19) It is essential that the research activities carried out under the EDCTP Programme conform to basic ethical principles, including those reflected in Article 6 of the Treaty on European Union and in the Charter of Fundamental Rights of the European Union, and apply the best clinical practices and follow the principles of gender mainstreaming and gender equality.
(20) It is also essential that research activities carried out under the EDCTP Programme meet the needs of developing countries and are coherent with the global European Union policy for improving health and combating poverty-related diseases in developing countries,