WRITTEN QUESTION E-3763/03 by Christopher Huhne (ELDR) to the Commission. Clinical trials.
Date: 2003-12-11
Institutions: European Parliament, Provisional data
Subjects: EU Member State, application of EU law, experiment on humans, pharmaceutical product, research body, voluntary organisation

C 78 E/644

Official Journal of the European Union

EN

27.3.2004

(cid:1) Municipality of Sienna, Italy:

(cid:1) in 2000 one project was not approved;

(cid:1) in 2001 one project was not approved;

(cid:1) in 2002 one project was funded (EUR 2 854);

(cid:1) in 2003 no projects were submitted.

The Honourable Member might also contact the relevant local authorities for more detailed information.

(2004/C 78 E/0684)

WRITTEN QUESTION E-3763/03

by Christopher Huhne (ELDR) to the Commission

(11 December 2003)

Subject: Clinical trials

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
its imminently life-threatening form) may enjoy special
the small
conditions for their clinical trials?

incidence of the condition or of

2. Will
implementation of the Clinical Trials Directive?

it further state whether such conditions will be compatible in each case with the proper

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

3.
III?

Answer given by Mr Liikanen on behalf of the Commission

(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.

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
The Commission is currently working together with the Member States in the preparation of
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.

(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.