Source: EURLEX
Language: en
Format: md

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| 20.3.2004 | EN | Official Journal of the European Union | CE 70/237 |

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(2004/C 70 E/256)

WRITTEN QUESTION E-3215/03

by Christopher Huhne (ELDR) to the Commission

(30 October 2003)

Subject:   Clinical Trials Directive

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| 1. | With regard to the transposition of Directive 2001/20/EC[(1)](#ntr1-CE2004070EN.01023702-E0001), the provisions of which must be in place by 1 May 2004, will the Commission confirm whether certain Member States are seeking exemptions for non-commercial clinical trials? |

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| 2. | Will the Commission confirm whether it has been contacted by the UK Government to seek such an exemption? |

Joint answer

to Written Questions P-3209/03 and E-3215/03

given by Mr Liikanen on behalf of the Commission

(12 November 2003)

The concerns regarding potential hurdles to research have been taken on board and were discussed during a Pharmaceutical Committee meeting held on 15 May 2003 between Member States and the Commission.

The Commission and Member States discussed the responsibilities of the Member States to take into consideration the recommendation given in Directive 2001/20/EC[(2)](#ntr2-CE2004070EN.01023702-E0002), recital 14, for non-commercial trial.

It is clearly not the intention of the Commission that the implementation of the clinical trials directive in national law should have a prohibitive effect on prospects for European research.

On the contrary, it is the intention of the Commission to strengthen a European clinical trials environment in the interests of the European Research Area and the European citizens as stated in the G 10 recommendations.

The Commission understands the researchers' concerns but has at this stage no intention to propose a modification to Directive 2001/20/EC.

The Commission is currently working together with the Member States in the preparation of the implementing guidelines of this Directive. We are therefore confident that most of these concerns will be addressed during this preparation.

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