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RECOMMENDATION FOR SECOND READING     ***II
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24 April 2002
PE 290.142 A5-0141/2002
on the Council common position for adopting 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
(14402/2/2001 – C5‑0069/2002 – 2000/0323(COD))
Committee on the Environment, Public Health and Consumer Policy
Rapporteur: Giuseppe Nisticò
PROCEDURAL PAGE
 DRAFT LEGISLATIVE RESOLUTION

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 (14402/2/2001 - C5-0069/2002).

The committee had appointed Giuseppe Nisticò rapporteur at its meeting of 24 January 2001.

It considered the common position and draft recommendation for second reading at its meetings of 26 March 2002 and 22/23 April 2002.

At the latter it adopted the draft legislative resolution by 45 votes with 1 abstention.

The following were present for the vote: Caroline F. Jackson, chairman; Mauro Nobilia, Alexander de Roo and Anneli Hulthén, vice-chairmen; Giuseppe Nisticò, rapporteur; Emmanouil Bakopoulos (for Pernille Frahm), Jean-Louis Bernié, Hans Blokland, David Robert Bowe, John Bowis, Chris Davies, Marialiese Flemming, Karl-Heinz Florenz, Robert Goodwill, Françoise Grossetête, Cristina Gutiérrez Cortines, Jutta D. Haug (for Rosemarie Müller), Heidi Anneli Hautala (for Hiltrud Breyer), Hedwig Keppelhoff-Wiechert (for Martin Callanan), Christa Klaß, Eija-Riitta Anneli Korhola, Bernd Lange, Paul A.A.J.G. Lannoye (for Marie Anne Isler Béguin), Torben Lund, Jules Maaten, Minerva Melpomeni Malliori, Helmuth Markov (for Jonas Sjöstedt, pursuant to Rule 153(2)), Emilio Menéndez del Valle (for Phillip Whitehead, pursuant to Rule 153(2)), Jorge Moreira da Silva, Riitta Myller, Ria G.H.C. Oomen-Ruijten, Mihail Papayannakis, Paolo Pastorelli (for Horst Schnellhardt, pursuant to Rule 153(2)), Encarnación Redondo Jiménez (for Cristina García-Orcoyen Tormo), Frédérique Ries, Dagmar Roth-Behrendt, Guido Sacconi, Giacomo Santini (for Peter Liese), Karin Scheele, Inger Schörling, Bart Staes (for Patricia McKenna), Catherine Stihler, Astrid Thors, Antonios Trakatellis, Kathleen Van Brempt, Rainer Wieland (for Emilia Franziska Müller).

The recommendation for second reading was tabled on 24 April 2002.

The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session.


DRAFT LEGISLATIVE RESOLUTION

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive on 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 (14402/2/2001 – C5‑0069/2002 – 2000/0323(COD))

(Codecision procedure: second reading)

The European Parliament,

–   having regard to the Council common position 14402/2/2001 – C5‑0069/2002,

–   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 Commission's amended proposal (COM(2001) 692(3)),

–   having regard to Article 251(2) of the EC Treaty,

–   having regard to Rule 80 of its Rules of Procedure,

–   having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5‑0141/2002),

1.   Amends the common position as follows;

2.   Instructs its President to forward its position to the Council and Commission.

Council common position   Amendments by Parliament
Amendment 1
Recital 1

(1)   The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order to prevent in particular the transmission of diseases.

(1)   The extent to which human blood is used therapeutically demands that the quality and safety of whole blood, blood components and blood products be ensured in order to prevent in particular the transmission of diseases.

Justification

This amendment reinstates Amendment 5 adopted by Parliament at first reading but, instead of the term 'derivatives', uses the term 'blood products', which has been introduced and defined by the Council.

It must be made clear what products are covered by this Directive. Blood products, i.e. therapeutic products derived from human blood or plasma, are defined in Article 3(1)(c). It is therefore logical that reference be made to them here.

Amendment 2
Recital 19

(19)   It is important that when abnormal findings are reported to the donor, relevant counselling is also provided.

(19)   It is important that when abnormal findings are reported to the donor, relevant counselling is also provided. Member States shall ensure that all patients are informed in advance about possible adverse transfusion reactions.

Justification

This amendment reinstates Amendment 53 adopted by Parliament at first reading.

Amendment 3
Recital 21 a (new)
 

(21a)   Personal genetic data fall within the scope of the fundamental right to privacy and, consequently, access to and further use of such data by third parties, for instance insurance companies, employers or authorities, and by commercial and other interests, must be prohibited.

Justification

This amendment reinstates Amendment 7 adopted by Parliament at first reading.

Amendment 4
Article 1

This Directive lays down standards of quality and safety of human blood and of blood components, in order to ensure a high level of human health protection.

This Directive lays down standards of quality and safety of human blood and of blood components and products, in order to ensure a high level of human health protection.

Justification

This amendment reinstates Amendment 15 adopted by Parliament at first reading but, instead of the term 'derivatives', uses the term 'blood products', which has been introduced and defined by the Council.

It must be made clear what products are covered by this Directive. Blood products, i.e. therapeutic products derived from human blood or plasma, are defined in Article 3(1)(c). It is therefore logical that reference be made to them here.

Amendment 5
Article 3, paragraph f a (new)
 

(fa)   ‘Adverse event’ shall mean any untoward occurrence associated with the collection, testing, processing, storage, distribution, and transfusion of blood and blood components and blood products;

Justification

This amendment reinstates the Commission text as amended by first-reading Amendment 19.

Amendment 6
Article 3, paragraph f b (new)
 

(fb)   Adverse reaction’ shall mean a harmful and unintended response in donor or in patient associated with the collection or transfusion of blood or blood components or blood products;

Justification

This amendment reinstates the text of the Commission proposal, as amended by first-reading Amendment 20.

Amendment 7
Article 3, paragraph k a (new)
 

(ka)   ‘Voluntary unpaid donation’ shall mean the donation of blood or blood components by a person of his/her own free will and without receiving payment in cash or in kind in return which could be considered a substitute for money. This also includes time off work reasonably required for donation and travel. Small tokens, gratuities, refreshments and the reimbursement of direct costs and direct travel expenses are compatible with the voluntary and unpaid donation of blood.

Justification

This amendment to a large extent reinstates Amendment 17 adopted by Parliament at first reading.

Amendment 8
Article 3, paragraph k b (new)
 

(kb)   ‘Haemovigilance’ shall mean a set of organised surveillance procedures relating to adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.

Justification

Reinstates the philosophy of Amendment 21 adopted by Parliament at first reading. It is logical that a definition of this practice should be provided, as the common position has introduced a new chapter on ’haemovigilance'. Moreover, there should be consistency with the terms used in Article 3 (g) and (h).

Amendment 9
Article 3, paragraph k c (new)
 

(kc)   ‘Inspection’ shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation, to identify problems;

Justification

Reinstates partially Amendment 18 adopted by Parliament at first reading, as recital 14 of the common position means that a definition of inspection is needed.

Amendment 10
Article 4, paragraph 2, second subparagraph

In particular, a Member State may introduce requirements for voluntary unpaid donations, including the prohibition or restriction of imports of blood and blood components which do not satisfy such requirements provided that the conditions of Article 30 of the Treaty are met.

In particular, a Member State may introduce requirements for voluntary unpaid donations, which include the prohibition or restriction of imports of blood and blood components, to achieve the objective set out in Article 19(1) of this Directive.

Justification

In its written answer to the various questions by Members of the European Parliament, the Commission asserts that there is no need to include a reference to Article 30 of the Treaty.

Member States have to be able to introduce measures that are consistent with the encouragement of voluntary unpaid donations, as set out in Article 19.

Amendment 11
Article 9, paragraph 2, point a

(a)   he/she shall possess a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;

(a)   he/she shall be a doctor with a specialisation in a field related to the work of the blood establishment, e.g. haematology, or in another relevant medical specialisation;.

Justification

The responsible person's duties, as set out in Articles 5(1) and 15(1) in particular, are not merely administrative but also include medical matters which require not only a doctor but one specialised in the relevant fields of the blood establishment. For example, while giving blood, the donor may show signs of fainting, develop a rapid or irregular heartbeat, a fall in blood pressure or even more serious medical problems. Medical care must obviously be on hand in such cases but the directive does not provide for it. It does not require the mandatory presence of a doctor, let alone that the person responsible for the blood establishment should be a doctor specialising in relevant fields.

Amendment 12
Article 14, paragraph 2 a (new)
 

2a.   Haemovigilance data shall be kept for at least thirty years.

Justification

This amendment reinstates Amendment 50 adopted by Parliament at first reading.

Amendment 13
Article 19, paragraph 2

2.   Member States shall inform the other Member States and the Commission of the actions taken by them to achieve the objective set out in paragraph 1.

2.   Member States shall report to the Commission on these measures every two years, for the first time two years after the entry into force of this Directive. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measure it intends to take at Community level.

Justification

The Member States must report to the Commission regularly. This amendment partly reinstates Amendments 55 and 75 adopted by Parliament at first reading.

Amendment 14
Article 20, first paragraph

Blood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV.

Blood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV. They shall take steps to ensure that tests are carried out in conformity with the latest scientific and technical procedures that reflect current best practice as defined by, and regularly reviewed and updated through, an appropriate expert consultation process. They must also take due advantage of scientific advances in the detection, inactivation and elimination of pathogens which can be transmitted via transfusion.

Justification

Reinstates in a modified form Amendment 62 adopted by Parliament at first reading.

It is essential that procedures for the testing of blood and blood components conform to the latest safety and technical standards and can detect viruses that may be present, so as to help ensure that finished blood products are completely safe.

Amendment 15
Article 24

The Commission shall meet regularly with the competent authorities designated by the Member States to exchange information on the experience acquired with regard to the implementation of the provisions of this Directive.

The Commission shall meet regularly with the competent authorities designated by the Member States, delegations of experts from blood establishments and other relevant parties to exchange information on the experience acquired with regard to the implementation of the provisions of this Directive.

Justification

It is important that all parties involved in the implementation of this directive be consulted in order to achieve a comprehensive level of information exchange.

(1)OJ C 72, 21.3.2002, p. 289.
(2)OJ C 154, 29.5.2001, p. 141.
(3)OJ C 75, 26.3.2002, p. 104.

Last updated: 21 May 2002Legal notice