Source: EURLEX
Language: en
Format: md

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| 13.3.2004 | EN | Official Journal of the European Union | CE 65/235 |

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(2004/C 65 E/250)

WRITTEN QUESTION E-2869/03

by Margrietus van den Berg (PSE) to the Commission

(26 September 2003)

Subject:   European and Developing Countries Trials Programme (EDCTP)

The EDCTP will support the implementation of clinical trials and strengthen collaboration between European and developing country scientists. How will intellectual property rights for products that emerge out of such collaborative research be managed/shared?

Answer given by Mr Busquin on behalf of the Commission

(24 October 2003)

During the discussions in the Parliament and in the Council, leading to the adoption of Decision 1209/2003/EC[(1)](#ntr1-CE2004065EN.01023501-E0001) of 16 June 2003 on Community participation on the EDCTP programme, a balance was sought between on the one hand encouraging the involvement of industry by providing adequate protection of intellectual property rights and on the other hand seeking an easy and affordable access to the results of the research activities for the population of developing countries. Article 2(g) reflects this compromise:

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|  | The Community contribution shall be conditional upon: 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 an easy and affordable access to the research results produced by activities under the EDCTP Programme and to the products directly deriving from its results. |

This provision is taken up by the new structure (a European Economic Interest Grouping — EEIG) created on 27 June 2003 in the Netherlands, which will implement the EDCTP programme.

The statutes of the EEIG already include dispositions reflecting Article 2(g) and the contract between the Commission and the EEIG will impose the same requirements. It is the responsibility of the EEIG to make sure this provision is implemented on a case by case basis for each of the clinical trials that it will be funding.

The Commission will closely monitor the implementation of Article 2(g) by the EEIG.

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