# CE2004078EN.01064401.xml

| 27.3.2004 | EN | Official Journal of the European Union | CE 78/644 |
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27.3.2004

EN

Official Journal of the European Union

CE 78/644

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(2004/C 78 E/0684)

WRITTEN QUESTION E-3763/03

by Christopher Huhne (ELDR) to the Commission

(11 December 2003)

Subject:   Clinical trials

Subject:

| 1. | Will the Commission indicate in table form the position in each Member State whereby charities and academic institutions researching into pharmaceuticals of limited market potential (for example, because of the small incidence of the condition or of its imminently life-threatening form) may enjoy special conditions for their clinical trials? |
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1.

Will the Commission indicate in table form the position in each Member State whereby charities and academic institutions researching into pharmaceuticals of limited market potential (for example, because of the small incidence of the condition or of its imminently life-threatening form) may enjoy special conditions for their clinical trials?

| 2. | Will it further state whether such conditions will be compatible in each case with the proper implementation of the Clinical Trials Directive? |
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2.

Will it further state whether such conditions will be compatible in each case with the proper implementation of the Clinical Trials Directive?

| 3. | Is any distinction made in any of the Member States for exemptions from Phase I, Phase II and Phase III? |
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3.

Is any distinction made in any of the Member States for exemptions from Phase I, Phase II and Phase III?

Answer given by Mr Liikanen on behalf of the Commission

(29 January 2004)

(29 January 2004)

The Commission and Member States discussed the responsibilities of the Member States to take into consideration the recommendation given in Directive 2001/20/EC (1), recital 14, for non-commercial trial.

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This recital reads: ‘Non-commercial clinical trials conducted by researchers without the participation of the pharmaceuticals industry may be of great benefit to the patients concerned. The Directive should therefore take account of the special position of trials whose planning does not require particular manufacturing or packaging processes, if these trials are carried out with medicinal products with a marketing authorization (...) and on patients with the same characteristics as those covered by the indication specified in this marketing authorization (...)’.

According to Article 22 of the above-mentioned Directive, the Member States are asked to inform the Commission on the national measures adopted with a view to transposing and complying with this text. The Commission is currently working together with the Member States in the preparation of the implementing guidelines of this Directive. The Commission is, therefore, confident that some of these concerns would be properly addressed during this preparation, both at Community level and at national level.

Moreover, to get an overall and conclusive view on the specific decisions taken by the Member States, the Commission will send out a questionnaire to the Member States to receive the information requested in a comparable format.

The Commission will publish the information received by the Member States.

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(1)  Directive 2001/20/EC of the Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1.5.2001.

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