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 setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 2001/83/EC

2000/0323 (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 setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 2001/83/EC

1. background

- Adoption of the proposal by the Commission: COM(2000) 816 - 2000/0323 (COD): 13.12.2000 [1]

[1] OJ C 154 E, 29.5.2001, p. 141 - Directive 89/381/EEC has meanwhile been replaced by Directive 2001/83/EC.

- Proposal forwarded to Parliament and to the Council: 26.01.2001

- Opinion of the Economic and Social Committee: 30.05.2001 [2]

[2] OJ C 221, 07.08.2001, p. 106

- Opinion of the Committee of the Regions: 20.09.2001 [3]

[3] Not yet published

- Opinion of the European Parliament at first reading: 06.09.2001 [4]

[4] Not yet published

- Date of the Commission's amended proposal: COM(2001) 692 of 15.11.2001

- Date of political agreement in the Council: 15.11.2001 (unanimity)

- Formal adoption of the common position by the Council: 14.02.2002

2. purpose of the commission proposal

This Proposal attempts to close the existing gap in Community legislation related to ensuring a high level of quality and safety of blood and its components and takes fully into account existing provisions in these areas. It seeks to ensure a comparable level of quality and safety throughout the blood transfusion chain in all Member States, bearing in mind the freedom of movement of citizens within Community territory.

The aims of this Proposal are to:

Close existing gaps in Community legislation with regard to the setting of standards for the quality and safety of blood and blood products used in therapy;

Strengthen requirements related to the suitability of blood and plasma donors and the screening of donated blood in the European Community;

Establish at Member State level requirements for establishments involved in the collection, testing, processing, storage and distribution of whole blood and blood components, as well as national accreditation and monitoring structures;

Lay down provisions at Community level for the formulation of a quality system for blood establishments;

Lay down common provisions at Community level for the training of staff directly involved in the collection, testing, processing, storage and distribution of whole blood and blood components, without prejudice to existing legislation;

and establish rules for ensuring the traceability of whole blood and blood components from donor to patient, which are valid throughout the Community.

3. comments by the commission on the common position

3.1. General remarks

The Commission notes with satisfaction that the Council has endorsed the general approach of the Commission's original proposal. The Council has also taken up two thirds of the amendments proposed by the EP and accepted by the Commission; even if in many cases not literally but in substance or in principle.

The Commission is particularly satisfied that all three institutions share the same view on most of the key issues to be addressed in this Directive, particularly as regards the scope, and the specific technical standards to be established.

Although it is not fully in line with the Commission's Amended Proposal, the Common Position covers all the issues considered essential by the Commission to guarantee a high level of health protection in the area of blood safety and quality. Furthermore, Council has included a provision on voluntary, unpaid donation, which must be considered a good solution to this sensitive problem.

The Common Position represents a carefully balanced compromise., without compromising the standards of quality and safety to be respected by blood establishments. In particular, it maintains the obligation for the Community to establish and update regularly specific technical requirements in all relevant fields.

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

- Integrated in the Amended Proposal and incorporated in full or partly in the Common Position:

Amendments: 2, 5, 10, 11, 13, 14, 15, 16, 17, 21, 23, 27, 28, 31, 32, 34, 35, 43, 45, 46, 48, 51, 54, 55, 56, 62, 63, 64, 65, 66, 67, 70, 71, 72, and 74.

- Integrated into the Amended proposal but not incorporated in the Common Position:

Amendments: 4, 9, 18, 24, 25, 29, 36, 49, 50, 52, 53, 57, 58, 59 and 68.

- Issues where the Commission's Amended Proposal differs from the Council's Common Position:

The changes in structure make it difficult in several cases to establish a precise correspondence between the Parliament's amendments, the Commission's amended proposal and the Council's Common Position. The Council has clearly taken up the main concerns of the European Parliament. It is remarkable that Commission and Council have mainly followed the position of Parliament on two of the three central issues of debate, and came as close as legally possible on the third:

- Scope: There is general agreement that the Directive should apply also to collection and testing of starting materials for medicinal products, as proposed by Parliament;

- Establishments of technical standards: All three institutions now share the view that most technical standards, listed in the technical annexes of the original Proposal, should not be discussed within the co-decision procedure, but be developed using a regulatory procedure, as proposed by Parliament; the annexes remaining in the Common Position should be acceptable;

- Voluntary unpaid donation: Council has included a provision on voluntary, unpaid donation, which is supported by both the Commission's and Council's legal services, and will not lead to shortages of supply of life-saving blood products. Nevertheless, it clearly identifies voluntary, unpaid donation as Community objective. Member States will have to inform the Commission about their actions to reach this objective. The Commission hopes that Parliament will be able to accept this compromise, which is at the limit of what is possible under Article 152.

However, the Commission regrets that the Council decided not to accept a number of amendments:

* Amendments 9, 52, and 53, which aim to strengthen the protection of donors and patients;

* Amendments 18, 24, 25, 49, and 68, which aim to clarify administrative provisions of the Directive;

The Commission maintains that these provisions would strengthen and complement the Directive, and are justified under the framework of Article 152 of the EC Treaty. However, as most of these standards are already fixed in national legislation in Member States, or can be established afterwards by the Commission using the"comitology" regulatory procedure, on balance the Commission is able to accept the approach put forward in the Common Position.

4. conclusion

As outlined above, the Commission considers the Common Position a good compromise, which takes on board most of the key amendments of the European Parliament, and is also in line with the Amended Proposal on all essential questions.

For the reasons outlined above, the Commission supports the Common Position adopted by the Council on 14.02.2002.

5. statements by the commission for the minutes

The Commission made three statements for the minutes, which are annexed to this Communication.

In its first statement, it confirms its intention to analyse actions taken to encourage voluntary and unpaid donations with a view to spreading best practices.

The second statement refers to the views of the Commission regarding two possibilities for implementing a traceability system.

The third statement indicates that the Commission will review a labelling requirement listed in Annex III.

Commission declarations to the Minutes

1. The Commission confirms its intention to analyse, in co-operation with the Member States and relevant organisations, actions taken to encourage voluntary and unpaid donations with a view to identifying and spreading best practices.

2. The Commission takes the view that in order to implement a traceability system at European level two possibilities could be considered.

The first would be setting up in the near future an information exchange system for tracing requests and results between Member States. The development of such a system is currently envisaged in the framework of the implementation of Article 14 and Article 28(a) of the Directive.

A longer term possibility could be the establishment of a common European identification system for blood and blood components, provided a cost/benefit analysis demonstrates an added value justifying the costs associated with implementing it

3. The Commission confirms its intention as a priority to examine the practical implications of the following labelling requirement listed in Annex III:

'The name composition and volume of anticoagulant and/or additive solution (if any).'

Based on the result of this review, the Commission will, if necessary, take the appropriate measures under Article 28 (1) of the Directive.