"I/A" Item Note and Statements for the Minutes: Proposed Directive on Standards for the Use of Human Tissues and Cells - Approval of EP Amendments at Second Reading

February 13, 2004

Brussels, 12 Feb 2004

Full text of Document 6160/04
Suite of documents 6160/04

Subject: Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
- Approval of EP amendments at second reading

1. On 20 June 2002 the Commission forwarded to the Council a Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells.1 This proposal was based on Article 152 of the Treaty.

2. The European Economic and Social Committee delivered its Opinion 2 on the proposal on 11 December 2002.

3. The European Parliament delivered its Opinion on the Commission's proposal on 10 April 2003 3. Following this Opinion, the Commission forwarded to the Council on 3 June 2003 an amended proposal on the matter4.

4. On 22 July 2003, the Council adopted its Common Position 5 in accordance with Article 251(2) of the Treaty, after having arrived at a political agreement in its meeting on 2 June 2003.

5. On 10 December 2003, the Permanent Representatives Committee gave a mandate to the Presidency to confirm in writing to the European Parliament the basis for an agreement at second reading.

6. On 16 December 2003, the European Parliament adopted at second reading a set of amendments to the Common Position, on the basis of the agreed texts. The Commission gave its positive opinion on the amendments.

7. Accordingly, the Permanent Representatives Committee is invited to suggest that the Council:

­ approve the amendments of the European Parliament, as an "A" item on the agenda of one of its forthcoming meetings, as contained in 16143/03 CODEC 1823 SAN 5. The Directive shall then be deemed to have been adopted in the form of the Common Position thus amended, in accordance with Article 251(3) of the Treaty;

­ decide to enter in the Council minutes the statements set out in the Addendum to this note;

­ decide that the above statements are published in the Official Journal of the European Union.

3 8305/03 .
4 10122/03 .
5 OJ C 240 E, 07.10.2003, p. 12.

* * *

Addendum to the "I/A" Item Note:
Full text of Document 6160/04 Addendum 01

Statements to be entered in the minutes

1. Statement by the Council and the Commission
"As illegal trafficking in tissues, cells and organs gives rise to serious concerns and can lead to significant health risks for both the donor and the recipient, efforts to combat such activities should be intensified".

2. Statement by the Council and the Commission
"In the absence of specific Community legislation on the processing, preservation, storage and distribution of tissues and cells intended for industrially manufactured products the Council and the Commission agree that the concerns raised by the Parliament in respect of the requirements to be determined for establishments operating in this field, such as the requirement to operate on a 24-hour basis, will be addressed in the development of the relevant technical requirements referred to in article 28 of the Directive".

3. Statement by the Council and the Commission
"The Council and the Commission agree that the concerns raised by the Parliament at first reading as regards the Annexes originally proposed by the Commission will be taken into account in the development of the relevant technical requirements referred to in article 28 of the Directive".

4. Statement by the Commission
"The important differences between organ transplantation and the use of other human substances such as blood, tissues and cells mean that a specific approach for organs in order to ensure safety and quality is necessary.

Such an approach in the current situation characterised by shortage of organs has to balance two factors: the need for organs' transplantation which is usually a matter of life and death with the need to ensure high standards of quality and safety. The Commission believes that before considering any proposal it is necessary to conduct a thorough scientific evaluation of the situation regarding organ transplantation. The Commission will present a report on the conclusions of the analysis it undertakes as soon as possible."

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