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
1. In implementing 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) (hereinafter referred to as "the sixth framework programme"), adopted by Decision No 1513/2002/EC, the Community shall make a financial contribution to the research and development programme entitled "The European and Developing countries Clinical Trials Partnership" (hereinafter referred to as "the EDCTP Programme") undertaken jointly by several Member States (hereinafter referred to as "the participating Member States").
2. The Community shall pay a financial contribution to the common structure amounting to a maximum of EUR 200 million for the duration of the sixth framework programme.
3. The Community financial contribution shall be paid from the budget appropriation allocated to the priority theme "Life sciences, genomics and biotechnology for health" of the specific programme of the sixth framework programme entitled "Integrating and strengthening the European Research Area (2002 to 2006)".
The Community financial contribution shall be conditional upon:
(a) the carrying out of the activities under the EDCTP Programme described in Annex I to this Decision; and
(b) the implementation and coordination of the research and development programmes and activities undertaken at national level by the participating Member States;
and also upon:
(c) the establishment by the participating Member States, or organisations designated by participating Member States, of a structure with legal personality (for the purposes of this Decision referred to as "common structure"), which shall be responsible for the implementation of the EDCTP Programme and for receiving, allocating and monitoring the Community financial contribution;
(d) the establishment of the governance model for the EDCTP Programme in conformity with the guidelines set out in Annex II to this Decision;
(e) ensuring a high level of involvement of developing countries;
(f) ensuring a high level of scientific excellence and observance of ethical principles in accordance with the general principles of the sixth framework programme; and
(g) formulation of the provisions relating to intellectual property rights in such a way that they also aim at ensuring 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 arrangements for the Community financial contribution and the rules relating to financial liability and to intellectual property rights shall be adopted jointly by means of an agreement to be concluded between the Commission and the common structure, in accordance with the Financial Regulation applicable to the general budget of the European Communities.
The Commission and the Court of Auditors may, through their officials or agents, carry out all the checks and inspections needed to ensure proper management of the Community funds and protect the financial interests of the Community against any fraud or irregularity. To this end, the participating Member States and/or the common structure shall make all relevant documents available to the Commission and the Court of Auditors.
The Commission shall communicate all relevant information to the European Parliament, the Council and the Court of Auditors. The participating Member States are invited to forward, through the common structure, to the Commission any additional information required by the European Parliament, the Council and the Court of Auditors concerning the financial management of the common structure.
This Decision shall apply to Member States joining the common structure.
The conditions for the Community financial contribution in relation to the participation, in the EDCTP Programme, of any country associated with the sixth framework programme or, where essential for implementing the EDCTP programme, of any other country, may be agreed by the Community on the basis of the rules set out in this Decision and of any implementing rules and arrangements.
The annual report on the sixth framework programme presented to the European Parliament and the Council pursuant to Article 173 of the Treaty shall include a summary of the activities of the EDCTP Programme undertaken. This summary shall also be part of the regular progress report on the Community Programme for Action: accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction.
At the end of the five-year period, the Commission shall conduct an evaluation of the EDCTP Programme. Results of this evaluation shall be presented to the European Parliament and the Council.
This Decision is addressed to the Member States.
Done at Luxembourg, 16 June 2003.
For the European Parliament
The President
P. Cox
For the Council
The President
G. Papandreou
(1) Proposal of 29 August 2002 (not yet published in the Official Journal).
(2) OJ C 133, 6.6.2003, p. 93.
(3) Opinion of the European Parliament of 27 March 2003 (not yet published in the Official Journal) and Decision of the Council of 13 May 2003.
(4) OJ L 232, 29.8.2002, p. 1.
(5) OJ C 87 E, 11.4.2002, p. 244.
(6) OJ L 7, 11.1.2002, p. 1.
Supplementary provisions
ANNEX ISupplementary provisions
Description of the activities of the EDCTP Programme financially supported by the Community
In cooperation with developing countries, the participating Member States have set up the EDCTP Programme.
There are several types of activities under the EDCTP Programme to which the Community makes a financial contribution in accordance with the procedures to be laid down in the agreement between the Commission and the common structure:
1. Activities linked to networking and coordination of:
(a) European national programmes;
(b) the activities carried out in the developing countries.
These activities are aimed at strengthening the two main components of the EDCTP Programme: programmes/activities in Europe on the one hand and in the developing countries on the other.
2. RTD activities linked directly to the development of new products and the improvement of existing products against the three diseases (HIV/AIDS, malaria and tuberculosis), suited to the specific requirements of the developing countries, i.e. that they are effective, easy to use and as affordable as possible:
(a) support for clinical trials in the developing countries, taking into account, in the design of the trials, coexisting infections and giving due consideration to sexual and reproductive health;
(b) strengthening of capacities in the developing countries.
3. Activities planned to ensure the development, visibility and sustainability of the EDCTP Programme:
(a) activities to promote the EDCTP Programme to ensure a high profile at European or international level;
(b) activities linked to obtaining the necessary funds, including those from the private sector, to enable the EDCTP Programme to develop as planned, including beyond the period covered by this Decision;
(c) regular reporting on the implementation of the EDCTP Programme with special emphasis on its public-interest value.
4. Basic activities for the EDCTP Programme such as secretariat services and the management of information concerning clinical interventions against the three diseases (HIV/AIDS, malaria and tuberculosis).
ANNEX II
Guidelines for the model of governance of the EDCTP Programme
This model should comprise the following:
1. A "Partnership Board" which should define, develop and plan the implementation of strategy to be approved by the common structure. The Board should include a balanced contingent of experts from the participating European States and from the developing countries involved in the programme. It should also include representatives of the Commission and experts from the public or private structures involved in the programme and from other international programmes/organisations, such as the WHO, where appropriate.
2. The "common structure", set out as a European Economic Interest Grouping (EEIG) as established by Council Regulation (EEC) No 2137/85(1). The EDCTP EEIG will be the executive structure and manage the programme through its secretariat. It will comprise two main bodies:
(a) the "EEIG Assembly", which should be the highest authority within the EEIG; and
(b) the "EEIG Secretariat", which should provide administrative support for the work of the Partnership Board and the EEIG Assembly.
(1) OJ L 199, 31.10.1985, p. 1.
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.
