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 of the Council on the adoption of 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

2002/0128 (COD)

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 of the Council on the adoption of 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. BACKGROUND

Date of transmission of the proposal [1] to the European Parliament and the Council (2002/0128(COD)) // 26.06.2002

[1] OJ C 227 E, 24.09.2002, p.505

Date of the opinion of the European Economic and Social Committee [2] // 11.12.2002

[2] OJ C 85, 08.04.2003, p.44.

Date of the opinion of the European Parliament [3], first reading: // 10.04.2003

[3] Not yet published in the OJ.

Date of transmission of the amended proposal (10122/03 SAN 130 CODEC 779). // 30.05.2003

Date of adoption of the common position: // 22.07.2003

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The aims of this proposal are to:

- establish European Community legislation setting standards for the quality and safety of tissues and cells of human origin used for application in the human body;

- strengthen requirements related to the suitability of donors of tissues and cells and the screening of these donated substances of human origin in the European Union;

- elaborate at Member State level requirements for establishments involved in the procurement, testing, processing, storage, and distribution of tissues and cells of human origin, as well as national accreditation and monitoring structures;

- lay down provisions at Community level for the formulation of a register of accredited establishments;

- lay down provisions at Community level for the formulation of a quality system for establishments involved in activities related to tissues and cells;

- lay down common provisions at Community level for the training of staff directly involved in the procurement, testing, processing, storage, and distribution of tissues and cells of human origin, without prejudice to existing legislation;

- establish rules for ensuring the traceability of tissues and cells of human origin from donor to patient and vice versa, which are valid throughout the European Union;

- establish a system for the regulation of imports of human tissues and cells from third countries that ensure equivalent standards of quality and safety.

3. COMMENTS ON THE COMMON POSITION

3.1 General Remarks

The Commission submitted a proposal for a Directive on the quality and safety of human tissues and cells to the Council and European Parliament on 26 June 2002.

On 10 April 2003, the European Parliament adopted its report in first reading. The safety and quality aspects of the proposed Directive were very well received and its aims were fully endorsed. No major difficulties in these areas were raised.

Most of the Parliament's proposed amendments suggest the strengthening of the Directive's ethical provisions. Recognising their legitimacy, however, the Commission has given them careful consideration but is unable to accept their inclusion in the proposal as ethical aspects fall outside the scope of Article 152.

On the basis of the Parliament's report and taking into account the work in the Council, the Commission prepared and submitted an amended proposal on 30 May 2003 that took into account, wholly or partially, 35 of the 76 amendments.

The Commission notes with satisfaction that the Council has endorsed the general approach taken in its amended proposal. The common position has followed the same direction on the Parliament's amendments as that of the Commission - accepting the majority of those related to technical aspects and, given the absence of a legal basis, rejecting those dealing with ethics.

Although the common position differs on some particular issues from the Commission's amended proposal, it does cover all issues considered essential by the Commission to guarantee a high level of protection in the area of quality and safety of human tissues and cells.

The common position represents a carefully balanced compromise. In particular it maintains the Community's obligation to establish and regularly update specific technical requirements in all relevant fields. The common position has been adopted by unanimity.

3.2 Consideration of the amendments adopted by the Parliament at first reading.

- Integrated into the amended proposal and incorporated fully or in part in the common position.

The Council adopted - wholly or partly - 15 of the 35 amendments adopted by the European Parliament, which had been taken up, either wholly or in part, in the Commission's amended proposal. These amendments are useful clarifications to the proposal that strengthen the quality and safety requirements. It should be noted that amendment 21 widens the scope of the Directive to autologous cells to be used for medicinal products.

Amendments: 2, 11, 16, 21, 22, 23, 26, 33, 34, 35, 40, 49, 52, 53 and 54.

- Integrated into the amended proposal but not incorporated in the common position

Amendments: 12, 13, 20, 32, 38, 55, 56, 57, 58, 63, 64, 66, 69, 72, 74, 75, 76. 78, 80 and 85

It is important to note that amendments 63, 64, 66, 69, 72, 74, 75, 76 and 85 refer to the Annexes of the Commission's proposal, which, according to the common position, are referred in their entirety to the Comitology procedure.

Amendments 32, 56 and 57 are in essence covered by the common position.

Amendments 12, 13, 20, 78, 80 are useful clarifications and therefore the Commission has incorporated them wholly or partially into the amended proposal as they do not pose essential modifications to the proposal.

The Commission regrets that the Council decided not to accept amendment 38, which aims to strengthen the provisions on traceability, and amendment 55 that extends the experience required for the responsible person to three years. However, as the common position guarantees a high level of protection in the area of quality and safety of human tissues and cells, the Commission is able to accept the approach put forward in the common position.

- Not integrated into the amended proposal nor into the common position

Amendments: 3, 7, 9, 10, 14,15, 17, 18, 19, 24, 25, 28, 30, 31, 36, 37, 41, 42, 44, 45, 48, 51, 59, 60, 61, 62, 65, 67, 68, 70, 77, 81, 82, 83, 87, 89, 93, 94, and 95.

These amendments mainly address the following:

- a request to the Commission to submit shortly (mid 2003) a legislative proposal in the field of organ transplantation (62);

- widen the scope of the Directive to include research with tissues/cells not intended to be applied in humans (7, 19, 87);

- the use or non-use of certain type of tissues/cells or some processes (i.e. embryos, cloning). (Amendments 9, 14, 30, 31, 51,68, 93, 95),

- ethical issues such as voluntary and unpaid donation (Amendment 41); non-profit procurement (Amendments 14, 15, 44, 77, 81); consent (Amendments 14, 48, 82); or ethics in general (18, 36, 37).

Both the Commission and Council are of the opinion that these amendments are either out of the scope of the proposal or do not have a legal basis under Article 152.

With respect to Amendment 51, the Italian and German delegations included declarations, which are annexed to the report of the common position, supporting its inclusion.

Amendment 51 aims to prohibit the use of 'cells derived from cloned embryos' for 'transplant' - so-called 'therapeutic cloning' - using cells with genetic features identical to an existing cell or organism. Such applications are controversial ethical issues, with no consistent opinion in Member States and no likelihood of one being reached in the near future. In the opinion of the Commission, therefore, the Directive should not interfere with decisions to be made by each Member State concerning the use or non-use of any specific type of human cells or tissues, as was foreseen in the Commission's amended proposal. A solution that sets safety and quality requirements in cases where the use of such cells is permitted in a Member State is the preferred option.

- Amendments rejected by the Commission but taken up in the common position

Amendments 4, 5 and 6 were accepted wholly or in part.

Amendment 4 proposes the inclusion of a recital on the need to promote information and awareness campaigns with the specific theme 'we are all potential donors'. In the Commission's view such a detailed provision is definitely not appropriate for a Directive. However, as the Commission is not against the essence of the amendment, its amended proposal introduces a new recital (10) promoting the donation of tissues and cells of high quality and safety, in a more general way.

Amendment 5 addresses the desirability of having worldwide standards, and amendment 6 the importance of the regulation of organ transplants. The Commission could accept these amendments with the new wording of the common position.

- -Issues where the Commission's amended proposal differs from the Council's common position

1. Accreditation requirements for tissue establishments (Article 6)

The accreditation requirement not only for the establishments dealing with tissues and cells, but also for the procedures that they perform has been strengthened by the common position. As this was the intended approach by the Commission in its original proposal, and as the text of the common position clarifies and improves the amended proposal, it can be accepted.

2. Publicity or promotion activities in this field (Article 12(2))

The Council has reaffirmed in this case the Member States' competence in implementing the Directive, given the scope of Article 152 of the Treaty.

3. Deletion of Article 25 of the Commission's amended proposal on access to human tissues and cells.

The first paragraph of Article 25 has been deleted and consequently amendment 58 of the Parliament has not being taken on board, on the basis that it goes beyond the scope of Article 152. This paragraph intends to prevent discrimination in the access to tissues and cells for all kinds of establishments (public and private). The Commission recognises that with the new and wider definition of tissue establishment, Article 25 is no longer necessary. However, the Commission is of the opinion that, for clarification purposes, the words 'public or private' should be reintroduced in the definition of tissue establishment, as they were in the Commission's amended proposal.

The second paragraph has been incorporated in Article 11(2).

4. Reference of the Annexes to the Comitology procedure (Article 28)

The Council has considered it appropriate to refer the matters treated by the annexes in the Commission's proposal to the regulatory committee procedure. The Commission could accept the Council's common position view on this issue.

Some new provisions have been added to the list of the technical requirements (Article 28):

(a) Elaboration of requirements for the accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes,

(b) Requirements for the determination of conditions for the selection, evaluation and procurement of cells used for reproduction purposes, and

(c) Requirements for the direct distribution to the recipient of specific tissues and cells.

5. Other significant changes

A new recital was adopted (Recital 9) clarifying the legal status of cosmetic products. This is a useful clarification.

Two definitions were deleted - tissue bank and tissue procurement team - as they do not appear in the text or are covered by other definitions. Two new definitions have been incorporated - donation and storage. The Commission agrees that these definitions clarify the proposal.

'Inspection for procurement' has been substituted for 'putting in place the appropriate control measures'. The Commission can accept this change in wording.

The requirement for the notification of serious adverse events and reactions (Article 11(2)) is extended to all personnel involved in the process. The Commission welcomes this new provision as it improves the quality and safety aspects.

With regards to the quarantine of tissues and cells, minor modifications have been introduced. The Commission considers that when developing the technical annexes particular attention should be paid to the specific nature of autologous cells for quarantine purposes.

4. CONCLUSION

The Commission considers the common position to be a good compromise, which takes on board key European Parliament amendments, while still being in line with the Commission's amended proposal on all essential questions. The common position has been adopted by unanimity.

For the reasons outlined above the Commission supports the common position adopted on 22.07.2003.