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REPORT     ***III
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6 December 2002
PE 287.615 A5-0442/2002
on the joint text approved by the Conciliation Committee for a European Parliament and Council directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
(PE-CONS 3652/2002 – C5‑0469/2002 – 2000/0323(COD))
European Parliament delegation to the Conciliation Committee
Rapporteur: Giuseppe Nisticò
PROCEDURAL PAGE
 DRAFT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT

PROCEDURAL PAGE

At the sitting of 6 September 2001 Parliament adopted its position at first reading on the proposal for a European Parliament and Council directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (COM(2000) 816 – 2000/0323 (COD)).

At the sitting of 28 February 2002 the President of Parliament announced that the common position had been received and referred to the Committee on the Environment, Public Health and Consumer Policy (14402/1/2001 – C5‑0069/2002).

At the sitting of 12 June 2002 Parliament adopted amendments to the common position.

By letter of 26 August 2002 the Council stated that it was unable to approve all Parliament's amendments.

The President of the Council, in agreement with the President of Parliament, convened a meeting of the Conciliation Committee on 19 September 2002.

In the light of a subsequent delegation meeting agreement was reached by exchange of letters of 26 September 2002 and 2 October 2002.

At its meeting of 26 September 2002 the Parliament delegation approved the results of the conciliation unanimously.

The following took part in the vote: Renzo Imbeni, Vice-President and chairman of the delegation; Charlotte Cederschiöld, Vice-President; Giuseppe Nisticò, rapporteur; Hans Blokland, John Bowis (for Caroline F. Jackson), Françoise Grossetête, Torben Lund, Minerva Melpomeni Malliori, Frédérique Ries, Karin Scheele (for Béatrice Patrie) and Catherine Stihler.

On 4 November 2002 the co-chairmen of the Conciliation Committee established that the joint text had been approved, pursuant to paragraph III.8 of the Joint declaration on practical arrangements for the new co-decision procedure,(1) and forwarded it to Parliament and the Council in all the official languages.

By letter of 7 November 2002 the President of Parliament informed the Council that it was necessary to extend the deadline for the work in the committee and the deadline for adopting the act, as laid down in Article 251(7) of the EC Treaty.

The report was tabled on 6 December 2002.

(1)OJ C 148, 28.5.1999, p. 1.


DRAFT LEGISLATIVE RESOLUTION

European Parliament legislative resolution on the joint text approved by the Conciliation Committee for a European Parliament and Council directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (PE-CONS 3652/2002 – C5‑0469/2002 – 2000/0323(COD))

(Codecision procedure: third reading)

The European Parliament,

–   having regard to the joint text approved by the Conciliation Committee (PE-CONS 3652/2002 – C5‑0469/2002),

–   having regard to its position at first reading(1) on the Commission proposal to Parliament and the Council (COM(2000) 816(2)),

–   having regard to the amended proposal (COM(2001) 692(3)),

–   having regard to its position at second reading(4) on the Council common position(5),

–   having regard to the Commission's opinion on Parliament's amendments to the common position (COM(2002) 479 ‑ C5‑0391/2002)(6),

–   having regard to Article 251(5) of the EC Treaty,

–   having regard to Rule 83 of its Rules of Procedure,

–   having regard to the report of its delegation to the Conciliation Committee (A5‑0442/2002),

1.   Approves the joint text;

2.   Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

3.   Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council to have it published in the Official Journal of the European Communities;

4.   Instructs its President to forward this legislative resolution to the Council and Commission.

(1)OJ C 72 E of 21.3.2002, p. 289.
(2)OJ C 154 E of 29.5.2001, p. 141.
(3)OJ C 75 E of 26.3.2002, p. 104.
(4)P5_TAPROV(2002)0300.
(5)OJ C 113 E, of 14.5.2002, p. 93.
(6)OJ C not yet published.


EXPLANATORY STATEMENT

Introduction

The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components (hereinafter only "blood") be ensured. In order to safeguard public health and prevent the transmission of diseases, all precautionary measures during their collection, processing, distribution and use need to be taken.

The availability of blood used for therapeutic purposes is dependent largely on Community citizens who are prepared to donate. Modern blood-transfusion practice has been founded on the principles of voluntary donor services, anonymity of both donor and recipient, benevolence of the donor, and absence of profit on the part of the establishments involved in blood transfusion services.

Community provisions should ensure that blood and its components are of comparable quality and safety throughout the blood transfusion chain in all Member States. The establishment of high standards of quality and safety will help to reassure the public that human blood which are derived from donations in another Member State meet the same requirements as those in their own country.

The objectives of this Directive are to contribute to general confidence both in the quality of donated blood and in the health protection of donors, to attain self-sufficiency at a Community level and to enhance confidence in the safety of the transfusion chain among the Member States.

The Directive will apply to the collection and testing of human blood, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.

First and second readings

The subject was addressed in the Giuseppe NISTICÒ (EPP-ED, I) report, adopted at first reading on 6 September 2001. It adopted a large number of technical amendments relating to the collection, testing, processing, storage, and distribution of human blood.

The Commission submitted an amended proposal on 15 November 2001, with changes relating to the scope of the Directive, the establishment of technical standards and voluntary and unpaid donation. The Council adopted its common position on 14 February 2002. It took up most of the amendments proposed by the EP, even if in many cases not literally but in substance or in principle.

On 12 June 2002, the EP adopted the NISTICÒ report at second reading with 8 amendments to the common position. These amendments covered in particular definitions, traceability, medical examination of donors, tests to be carried out in conformity with the latest scientific and technical procedures, and information of the European Parliament.

The Directive in conciliation

The Council formally decided on 26 August 2002 that it could not accept all Parliament's amendments: a conciliation procedure was therefore necessary. Even if Council accepted most of the EP amendments, it could not accept those on data traceability, medical examination of donors and tests carried out in conformity with certain procedures.

The EP delegation was constituted on 4 September 2002 and examined the Council position. The delegation accepted it with the exception of the issue relating to the "medical examination" of donors to be carried out before any donation of blood. Whereas Parliament proposed a "doctor" to be responsible for the assessment of the eligibility of donors, the Council considered that a "health professional" would be a sufficient requirement. Eventually both Parliament and Council agreed that a "qualified health professional" should be responsible for the examination of donors.

The conciliation procedure was opened at the meeting of the Conciliation Committee on 19 September in relation with Civil Aviation Security. Negotiations were concluded in writing through an exchange of letters between Parliament and Council which took place on 26 September 2002 and 2 October 2002. The joint text was formally approved on 8 November 2002.

Conclusions

The delegation regards the end result of conciliation as very satisfactory for Parliament, as the joint text has incorporated most of its amendments in full or in a reworked form. It therefore recommends that the House approve the text at third reading.

Last updated: 10 December 2002Legal notice