Opinion of the Economic and Social Committee on the "Proposal for 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 89/381/EEC"

(2001/C 221/18)

On 12 February 2001 the Council decided to consult the Economic and Social Committee, under Article 152 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 2 May 2001. The rapporteur was Mr Ribeiro.

At its 382nd plenary session of 30 and 31 May 2001 (meeting of 30 May), the Economic and Social Committee adopted the following opinion by 114 votes for with three abstentions.

1. Introduction

1.1. Progress in medical science has meant that blood has become more of a key issue in public health.

1.2. The use of blood in medical practice means that it is necessary to draw up rules to guarantee quality, safety and efficacy in the delivery of these services, particularly as regards the protection of donors and recipients.

2. Background

2.1. The Treaty of Amsterdam, in particular Article 152(4)(a) and (5), provided the Community with an opportunity to implement measures ensuring the quality and safety of blood and blood components when they are administered in medical therapy.

2.2. However, any Community legislation must take into account every step in the system for collecting and processing blood, and must respect the Member States' responsibilities for the organisation and delivery of health and medical care.

2.3. Previous Community initiatives in this area must be borne in mind, particularly the Council Recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (98/463/EC) and the Council Directive which lays down special provisions for medicinal products derived from human blood or human plasma (89/381/EEC).

2.4. In view of the Council of Europe's representativity and importance, its recommendations in this sphere ought to be taken into consideration. These include the following: R(96) 11, R(95) 15, R(95) 14 and R(86) 6.

2.5. Directive 98/79/EC, which covers diagnostic medical devices made for in vitro use, should now be supplemented because it does not contain requirements relating to the quality and safety of blood which may be used in the preparation of the above-mentioned medical devices.

3. Limitation of the application of this directive

The Community thinks, and rightly so, that the quality and safety requirements relating to haematopoietic cells must be dealt with in the framework of legislation to be published subsequently and incorporated in the standards relating to tissues and cells of human origin.

4. The aim of this proposed directive

This proposed directive is designed to supplement the Community's current system, guaranteeing an equivalent level of safety and quality for blood in all EU Member States, whatever its intended purpose.

This will go a long way to reassuring the public.

5. Strategy

The present proposal for a directive aims to guarantee the same conditions in all Member States for the system of blood collection and processing.

To this end it proposes to:

5.1. establish regulatory and administrative foundations which can be transposed into Member States' national legislation;

5.2. lay down an equivalent system for attributing responsibility in the Member States for the notification and approval of blood establishments, for the certification of good clinical and laboratory practice, for the accreditation of the staff involved and for the certification of the procedures and methodologies employed in all the establishments involved in the collection, testing, processing, storage and distribution of whole blood and blood components;

5.3. set up a committee of Member States' representatives, responsible for periodically updating the technical standards, and create a system to monitor adverse reactions and accidents associated with the collection, processing and use of blood and blood components (haemovigilance).

6. Content of the proposed directive

This proposal for a directive comprises nine chapters which can be divided into four distinct parts:

- 1st part - deals with general provisions (chapters I to IV)

- 2nd part - focuses on technical aspects (chapter V and annexes)

- 3rd part - establishes the requirements relating to data protection, exchange of information between the Member States, reports and penalties (chapters VI and VII)

- 4th part - regulates the consultation of committees, the adaptation of the annexes to technical progress and the implementation of the text (chapters VIII and IX).

7. General comments

7.1. The Economic and Social Committee notes that the proposed Directive aims to protect public health.

7.2. The Committee deems it necessary to highlight clearly the social, humanitarian and benevolent contribution made by blood donors and the civil society bodies which encourage blood donation. It underlines the altruism of blood donations which, because they are voluntary, anonymous and unpaid, warrant public acknowledgement.

7.3. The Committee approves the text of this proposal in general, subject to the general and specific comments below regarding some of the provisions it contains.

7.4. The Economic and Social Committee is generally critical of the fact that there are numerous detailed rules in the proposal, particularly in the annexes. It feels that the proposed directive should, in contrast, aim to lay down general principles and objectives. These rules should comprise only one annex with scientific and technical data which can be adjusted to reflect recognised scientific progress, proposed by scientists specialised in this area, meeting in an "ad hoc" committee. The updating procedure must not lead to formal changes being made to the directive.

7.4.1. In any case, doctors specialised in this area ought always to be properly represented on this committee. There must be maximum transparency in the appointment of these experts.

7.4.2. For this reason, the Committee has decided not to make detailed comments about the technical and scientific components of the annexes.

7.5. The Committee welcomes this proposed directive which consolidates equality of rights for people throughout the Community.

7.6. The Committee considers the wording of Article 4(3) to be ambiguous, since the internal movement of goods in Member States must comply with quality and safety aspects imposed within each Member State. Steps must be taken to ensure that it is not possible for blood or blood components to be used in a Member State unless they comply with any stricter national requirements which might apply in that country. The Commission will have to assess the potential legal impact of this conflict of objectives.

7.7. The Economic and Social Committee notes that this proposed directive respects the individual features of each Member State's health system, by advocating a uniform basis for quality and safety in the system for collecting and processing blood without blocking any ad hoc improvements which individual Member States might wish to introduce.

7.8. The Committee approves of the fact that in each Member State a system has been set up for the notification, approval, accreditation, inspection, monitoring and certification of blood establishments and the accreditation of the staff involved in the process.

7.9. The Committee also welcomes the provisions relating to training and qualifications for professionals in the sector, especially since these will not prejudice legal requirements concerning mutual recognition of diplomas.

7.10. The Committee considers that one of the EU's priority objectives is to lay down the foundations for achieving high safety and quality standards for blood and blood components used within its territory. As a consequence it deems the provisions contained in this proposed directive to be positive, since, taking into account ethical and deontological principles as well as current international standards, they ensure that this objective will be met, necessarily covering the eligibility of donors and the collection, testing, processing, storage and distribution of whole blood and its components.

7.11. The Committee approves of the creation of a quality management and control system for blood establishments.

7.12. The Economic and Social Committee agrees with the establishment of a system for exchanging information on issues cropping up in the course of the system for collecting and processing blood, using a suitable labelling and filing system, so as to secure its traceability.

7.13. The Committee is pleased to see that the proposed directive creates mechanisms for continuous, rapid updates of the annexes, laying down the scientific criteria which determine the approach adopted by those involved in the system for collecting and processing blood.

7.14. The Economic and Social Committee does however feel that this proposed directive should state explicitly that it applies to both public, charitable and private establishments, irrespective of their size or the way they are organised.

7.15. The Committee recommends that it should in some way be made explicit in the proposal that tasks which might involve direct contact with donors or recipients of blood or its components should come under the exclusive technical responsibility of properly qualified health service staff with the appropriate back-up.

7.16. In view of the shortage of blood and given that blood donors make a humanitarian and benevolent gesture which is anonymous and unpaid, the Economic and Social Committee suggests that the Commission urge Member States to carry out more campaigns aimed at enhancing the public image of blood donors and thus providing the best incentive possible to give blood.

7.16.1. Self-sufficiency in the blood sector is one EU objective, which has to be secured. In line with the draft Directive, the Committee stresses how vital it is not to allow a mercenary, profit-oriented approach to blood donations to develop on the part of the establishments which collect and process blood.

7.17. The Committee notes that this proposed directive does not draw a clear distinction between homologous and autologous blood donations.

8. Specific comments

8.1. The Economic and Social Committee proposes that the following be added to Article 1: "the present directive does not cover the effective therapeutic use of blood and blood components".

8.2. The Committee suggests that Article 3(e) should read as follows: "responsible person shall mean a doctor specialised or with skills in transfusion medicine"(1).

8.3. Article 3(h) should read as follows: "Adverse event shall mean any untoward occurrence inconsistent with the procedural standards in force, associated with the collection, testing, processing, storage, distribution and transfusion of blood and blood components".

8.4. Article 4(1) should read as follows: "Member States shall establish, or designate, the competent authority, not involved in the process, which will be responsible for implementing the requirements of this directive".

8.5. Article 5(2) should read as follows: "Where the responsible person is permanently replaced, the blood establishment shall provide immediately to the competent authority the name of the new responsible person and his/her date of commencement. The competent authority must be informed of the name of the stand-in for the responsible person when the latter is temporarily absent".

8.6. Article 9(1) should read as follows: "the responsible person must be a doctor specialised or with skills in transfusion medicine1". (See point 8.2).

8.7. Article 10(1) should read as follows: "Personnel directly involved in collection, testing, processing, storage and distribution of human blood and blood components must be suitably qualified for their tasks and shall be provided with timely and relevant training".

8.8. Article 10(2) should read as follows: "additional training of the personnel shall be provided on recruitment ...".

8.9. Article 11(1) should read as follows: "The competent authority shall take all necessary measures to ensure that each blood establishment establishes and maintains a quality system for blood establishments ('QSBE') in keeping with current quality standards".

8.10. Article 12(2) should read as follows: "Member States shall take all necessary measures in order to ensure that access is provided to these documents for officials entrusted with inspection and control measures referred to in Article 8, without prejudice to the privacy of blood donors and recipients".

8.11. In Article 13(1), second paragraph, second line: "preferably computerised", should be inserted after the word "system".

8.12. At the end of Article 14(1) the following sentence should be inserted: "There will also have to be a procedure relating to 'look-back'".

8.13. Article 14(2) should read as follows: "The person responsible for the blood establishment shall notify the competent authority ...". The following should also be inserted:

a) The competent authority shall analyse and classify serious adverse reactions and events in order to introduce preventative measures.

8.14. In Annex II, Part A, first indent, the e-mail address should also be requested. The fourth indent should read as follows: "hygiene and safety requirements (e.g. protective garments, and compulsory compliance with accepted protection and hygiene standards in work area)".

8.15. Part B of Annex II of the original Commission document will have to include an additional indent, to read as follows: "Number of new donors per year". The following phrase should be added at the end of the current third indent: "and the reasons for this".

8.16. The following should be added to the first column in the table in Annex III: "Informatics experience applicable to this area".

The text in the fourth column should read as follows: "Training in human blood biology and chemistry".

The text in the fifth column should read as follows: "Specialisation or with skills in transfusion medicine (see Point 8.2)".

8.17. It is proposed that in Annex VI an introduction to a Part 4 be inserted, worded as follows: "4. Requirements relating to auto-transfusion

Auto-transfusion is not covered by these restrictive criteria and will be subject to specific requirements."

Brussels, 30 May 2001.

The President

of the Economic and Social Committee

Göke Frerichs

(1)

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