52000SC1293

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position adopted by the Council with a view to the adoption of a European Parliament and Council Directive 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

1. BACKGROUND

Date proposal transmitted to Parliament and Council: 1997 (document COM(1997)369 final-1997/0197(COD): 4 September 1997

Date of opinion of Economic and Social Committee: 28 January 1998

Date of opinion of European Parliament on first reading: 17 November 1998

Date amended proposal transmitted: 1999 (document COM (1999)193 final-1997/0197(COD): 27 April 1999

Date common position adopted: 19 July 2000

2. OBJECTIVE OF THE COMMISSION PROPOSAL

This proposal for a Directive aims to harmonise the scientific standards and rationalise the documentary and administrative procedures involved in the conduct of clinical trials on medicinal products for human use, while ensuring patient protection.

3. COMMENTS ON COMMON POSITION

3.1 Brief general observations on common position

The Council's common position differs from the Commission's amended proposal. It clarifies, expands on and adds to certain points and reinforces the subsidiarity principle but does not change the substance.

3.2 Parliament amendments on first reading:

- accepted by Commission and incorporated in common position:

the amendments accepted by the Commission have been retained in the common position, particularly the guarantees concerning protection of those taking part in the clinical trials: informed consent of the participants, clearly defined and stronger role of the ethics committee in the commencement and completion of these trials and in exchanges of information.

- accepted by Commission but not incorporated in common position:

none.

3.3 Any new provisions introduced by Council and Commission's position on them:

The Council's common position differs from the Commission's amended proposal on the points relating to the detailed organisation of the ethics committee for which the subsidiarity principle is applied, on the time limits which are clarified but extended, while remaining reasonable, on the various categories of authorisation which take account of the type of medicinal product involved, including the new therapies, and on the monitoring of the manufacture and importation of experimental medicinal products which takes account of the specific nature of this type of product.

The common position reflects the needs of the Member States particularly with regard to time limits but the Commission considers that the substance of its proposal has not been changed.

4. CONCLUSION

The Commission supports the common position. The adoption of Community legislation on the application of good clinical practice in the conduct of clinical trials on medicinal products will promote the conduct of such trials in the European Union.

5. COMMISSION STATEMENTS

None.