Explanatory Memorandum to COM(2000)816 - Standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components

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dossier COM(2000)816 - Standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood ...
source COM(2000)816 EN
date 13-12-2000
1. Among the myriad scientific advances that have taken place over the past century has been the augmentation of the life-sustaining role of blood. Now commonly accepted as an integral facet of health care delivery, its use and that of the products derived from it extends beyond medical emergencies to routine surgical procedures and prolonged quality-of-life therapies. The degree to which such products are used in medicine, however, demands that their quality, safety, and efficacy be ensured in order to prevent the transmission of diseases. It is this basic fact that underlies the Community's need for a coherent, consistent, and unassailable range of legal instruments in this field.

2. Whole blood is comprised of cellular components, including red blood cells, which carry oxygen; white blood cells, which fight infection; and platelets, which help prevent bleeding, suspended in the clear yellowish liquid portion called plasma. These components, which are known as labile blood products, are extracted from the whole blood donation, separated through centrifugation, and conserved for use together or separately to treat a patient. They may also be separated through apheresis (the process whereby whole blood is withdrawn and a desired component is separated out with the remainder of the blood returned to the donor). In addition to being used for transfusion, plasma can be fractionated into a number of stable industrially-prepared derivatives - albumin, clotting factor concentrates, protease inhibitors and immunoglobulins - and the cellular components can be used in the functioning of in vitro diagnostic medical devices. See diagram.

3. At present Community legislation does not address comprehensively the quality, safety and efficacy requirements to cover these different destinations for a blood or plasma donation. In effect, human whole blood and its components can be used for transfusion as well as serve as the starting material for manufacturing plasma-derived medicinal products and as essentials in some in vitro diagnostic medical devices.

4. In addition, Directive 98/79/EC i, which encompasses diagnostic medical devices intended by the manufacturer to be used in vitro, does not include requirements for the quality and safety of blood that may be used in the preparation of these medical devices.

5.


>REFERENCE TO A GRAPHIC>

In order to increase public confidence in the safety of the blood and blood products administered for therapy, it is essential, therefore, that Community provisions should ensure the quality and safety of blood and its components whatever the intended purpose.

6. Recognising that the blood transfusion process involves a considerable number of complex and interrelated activities, extending from the donor-suitability evaluation to the follow-up of transfused patients, any prospective legislation must take all steps into account, while respecting the responsibilities of the Member States for the organisation and delivery of health services and medical care.

7. The entry into force of the Treaty of Amsterdam, and in particular Article 152 (4)(a) and i, has provided the Community with an opportunity to implement binding measures laying down high standards of quality and safety for blood and blood components. It has enabled the Community to put into place a coherent legislative framework that will help to ensure a high level of safety for both donors and recipients of whole blood and its components on the one hand, and the quality and safety of this material when used for the preparation of medicinal products and medical devices on the other. It seems appropriate for technical reasons that quality and safety requirements for blood precursors (heamatopoietic progenitor cells from bone marrow, placental / umbilical cord blood, or peripheral blood) shall be established in the framework of specific legislation concerning quality and safety of tissues and cells of human origin to be proposed by the Commission subsequently, on the basis of article 152 of the Treaty.

8. Several initiatives have already been taken at Community level with the aim of ensuring a high level of quality and safety throughout what has become known as the blood transfusion chain as well as promoting Community self-sufficiency. The most recent of these was the adoption of Council Recommendation 98/463/EC i on the suitability of blood and plasma donors and the screening of donated blood in the European Community.

9. This Proposal attempts to close the existing gap in Community legislation related to ensuring a high level of quality and safety of blood and blood products 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. It proposes measures to ensure that the technical requirements and standards keep pace with scientific progress. To this end, a new Committee of Member State representatives is established. Members of this Committee will have to provide specific expertise in the fast moving field of quality and safety of blood, in order to regularly update the technical annexes of this directive, in particular in view of emerging risks of transmission of communicable diseases. This Directive also establishes a system to monitor adverse reactions and events associated with the collection, processing and use of blood and blood components in the Community.

10. The establishment of standards of quality and safety, therefore, will help to reassure the public that human blood and blood components that are derived from donations in another Member State nonetheless carry the same guarantees as those in their own country.

11. This Proposal, which aims to establish a high level of safety and quality level for blood, and blood components, while allowing the Member States to maintain or draw up complementary national measures, has indirect implications for the internal market. By ensuring that blood, and blood components, have the same level of safety and quality from one Member State to another, this proposal will facilitate indirectly their movement from one Member State to another. In addition, by establishing the same criteria regarding the collection of blood and blood components, in the Member States, this Proposal will help to remove uncalled-for restrictions on donors moving from one Member State to another.

12. In order to arrive at a high level of quality and safety of blood and its components, from one Member State to another, this Proposal requires the setting up of comparable national inspection and accreditation structures as well as equivalent training for the personnel involved throughout the blood transfusion chain. Accreditation granted by a national authority to a blood establishment would have the same status as a similar establishment in another Member State. In addition, the specific training provisions envisaged in this proposal are without prejudice to all the legislative requirements concerning mutual recognition of diplomas.

13. With respect to blood or plasma as starting material for the manufacture of proprietary medicinal products, present legislation, namely Directive 89/381/EEC (which extends the scope of Directives 65/65/EEC and 75/319/EEC and lays down special provisions for medicinal products derived from human blood or human plasma), will be periodically reviewed in order to ensure consistent and coherent standards of quality and safety for all blood donations, in particular as regards the suitability and testing of donors. The end result of this review will ensure equivalent and enforceable safety standards for blood and blood components, whether they are intended for transfusion, or for processing into medicinal products. In particular for the purposes of the review, the Commission will consult the relevant Scientific Committees before submitting appropriate measures to the Committee established in Article 26 of the present directive.

Contents

1.

14. COMMUNITY PROVISIONS APPLICABLE TO MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA


Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to medicinal products. (OJ 22, 9.2.1965, p. 369)

Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. (OJ L 147, 9.6.1975, p.1). Directive as last amended by Commission Directive 1999/83/EC (OJ L 243, 15.9.1999, p.

9)

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products. (OJ L 147, 9.6.1975, p. 13)

Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems. (OJ L 40, 11.2.1989, p.

8)

Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma. (OJ L 181, 28.6.1989, p. 44)

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use. (OJ L 113, 30.4.1992, p.

1)

Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use. (OJ L 113, 30.4.1992, p.

5)

Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. (OJ L 113, 30.4.1992, p.

8)

2.

Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use. (OJ L 113, 30.4.1992, p. 13)



Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. (OJ L 331,7.12.1998, p.

1)

Council Regulation No (EEC) 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. (OJ L 182, 2.7.1992, p.

1)

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. (OJ L 214, 24.8.1993, p.

1)

Council Decision 87/67/EEC of 26 January 1987 accepting on behalf of the Community the European agreement on the Exchange of Therapeutic Substances of Human Origin. (OJ L 37, 7.2.1987, p.

1)

Council Decision 1999/78/EC of 22 June 1998 on the conclusion of an Agreement on Mutual Recognition between the European Community and the United States of America. (OJ L 31, 4.2.1999, p.

1)

3.

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. (OJ L 193, 17.7.1991, p. 30)


Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to the analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. (OJ L 243. 15.9.1999. p.

9)

Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorised in accordance with the provisions of Council Regulation (EEC) No 2309/93. (OJ L 55, 11.3.1995, p.

5)

Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State. (OJ L 55, 11.3.1995, p.

7)

Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93. (OJ L 55, 11.3.1995, p. 15)

Commission Regulation (EC) No 1662/95 of 7 July 1995 laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorisations for products for human or veterinary use. (OJ L 158, 8.7.1995, p.

4)

Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93. (OJ L 286, 8.11.1996, p.

6)


4.

COMMUNITY INITIATIVES ON


BLOOD SAFETY AND SELF-SUFFICIENCY


5.

98/463/EC // Council Recommendation of 29 June 1998 on the Suitability of blood and plasma donors and the screening of donated blood in the European Community. (OJ L 203, 21.7.1998, p. 14)


95/C 164/01 // Council Resolution of 2 June 1995 on blood safety and self-sufficiency in the Community. (OJ C 164, 30.6.1995, p.

1)

96/C 374/01 // Council Resolution of 12 November 1996 on a strategy towards blood safety and self-sufficiency in the European Community. (OJ C 374, 11.12.1996, p.

1)

94/C 15/03 // Council Conclusions of 13 December 1993 on self-sufficiency in blood in the European Community. (OJ C 15, 18.1.1994, p.

6)


6.

COMMUNITY INITIATIVES RELATED TO THE


CONTROL OF COMMUNICABLE DISEASES


647/96/EC // Decision 647/96/EC of the European Parliament and the Council adopting a Programme for Community action on the prevention of AIDS and certain communicable diseases within the framework for action in the field of public health. (1996-2000)

2119/98/EC // Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community. (OJ L 268, 3.10.1998, p.

1)


7.

JUSTIFICATION



I. AIMS

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 components 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 (QSBE);

- 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;

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

8.

II. LEGAL BASIS AND PROCEDURE


The legal basis for this proposal is Article 152 of the Treaty, in particular (4)(a), which requires the European Parliament and the Council to adopt measures that set high standards of quality and safety of blood and blood derivatives.

The scope of Community legislative requirements relating to proprietary medicinal products, derived from Directive 65/65/EC, was extended by Directive 89/381/EEC to cover those derived from human blood or human plasma. The quality and the safety of blood components and plasma, in so far as they are intended for transfusion, are not subject to any binding Community legislation. The present proposal is intended to supplement the Community system, providing an equivalent level of safety and quality for blood and blood components, whatever their intended purpose.

9.

III. SUBSIDIARITY AND PROPORTIONALITY


In accordance with the principles of subsidiarity and proportionality, Community actions in the public health field should be undertaken only if their objective can be better achieved by the Community. This is reinforced in Article 152 which states that Community public health action shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.

Article 152, however, goes on to specify in (4)(a) that measures should be adopted setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives. In the light of this, actions should address issues that have a trans-national dimension, where common approaches are required, or where there is a need for effective co-operation and co-ordination.

The proposed measures set out in this Directive incorporate requirements for the collection, testing, processing, storage, and distribution of human blood and blood components. They do not prevent Member States from maintaining or introducing more stringent protective measures, in conformity with the Treaty, and do not affect national provisions on the donation or medical use of blood.

In contrast to existing Community procedures concerning the approximation of laws, regulations and administrative provisions relating to proprietary medicinal products, this Proposal does not have as its primary objective the placing on the market of blood and blood components. It will, however, mean that national provisions resulting from the transposition of this Proposal will result in homogeneity of technical requirements within the Member States once it has been adopted.

This Directive, in particular, establishes an equivalent system of notification and accreditation for establishments involved in the collection, testing, processing, storage and distribution of whole blood and blood components in the Member States. Although criteria for this system are laid down in this Proposal, detailed rules remain the responsibility of the Member States.

10.

IV. LEGISLATIVE AND ADMINISTRATIVE SIMPLIFICATION


The impact of this Proposal, once adopted and transposed in the Member States, will establish a minimum regulatory and administrative foundation that will facilitate the exchange of human blood and blood components in the Community and contribute to the attainment of Community self-sufficiency.

In ensuring an equivalent collection of data on any incidents arising during the collection, testing, processing, storage and distribution of human blood and blood components, this Directive will permit a simplification of the exchange of information in this field between the Member States (haemovigilance).

11.

V. CONSISTENCY WITH OTHER COMMUNITY POLICIES


This Proposal is complementary to the range of Community legislation relating to the quality, safety, and efficacy of blood and blood components as source material intended for manufacturing into medicinal products, and is intended to ensure the same level of quality, safety, and monitoring of blood and blood components, not processed as such, intended for all uses.

In addition, the inspection and monitoring measures set out in this Proposal dovetail perfectly with those set out in the proposal for a Directive on good practices in the processing of source materials for medicinal products and in the inspection of manufacturing firms.

12.

VI. OUTSIDE CONSULTATION


This Proposal takes account of the most recent progress made and agreements attained at international level, particularly within the World Health Organisation and the Council of Europe.

In addition, there have been a number of consultations with competent technical experts and with representatives of the Member States in the preparation of this Proposal.


13.

PRESENTATION



The object of this Proposal is to establish a legislative foundation for the Community setting a high level of quality and safety of human blood and blood components. The provisions envisaged deal with the greater part of the blood transfusion chain from pre-donation to the distribution of these substances for therapeutic use. It excludes, however, the actual therapeutic use of blood and its components reflecting this aspect of the legal basis (Article 152 i of the Treaty).

The proposed measures are presented in nine chapters as well as nine technical annexes, including one delineating the terminology used.

The nine chapters can be divided into four distinct parts. One comprising provisions of a general nature (chapters I to IV); one dealing with aspects of a technical nature, which include the annexes, applicable for the collection and testing of donations, and for the processing, storage and distribution (chapter V); a part regulating data protection requirements, exchange of information between the Member States, reports and penalties (chapters VI and VII); and finally a part regulating the consultation of committees, the adaptation of the annexes to technical progress and the implementation of the text (chapters VIII and IX).

The scope of this Proposal covers human blood and its components. The definitions used in this Proposal are presented in Article 3 of the enacting terms, while the terminology used in the technical annexes are listed in annex I in order to streamline the text. The definitions as well as the terminology are widely accepted and used.

An obligation is introduced, in Articles 5, 6, 7 and 8 of the Proposal, requiring Member States to set up a notification system including accreditation and inspection and control of blood establishments. It is necessary that a competent authority be set up within the Member States to ensure effective implementation of the Directive's provisions, once adopted.

In order to maintain a high level of quality and safety for the collection, testing, processing, storage, and distribution of whole blood and its components, it is necessary that provisions on staff training and the adoption of a quality control system be established in these centres. These elements are envisaged in Articles 9 to 12 of this Proposal.

In addition, specific provisions are set out in Articles 16 to 21 referring to the technical annexes, which ensure a high level of safety and quality covering the eligibility of donors, the testing, collection, storage, and distribution of whole blood and its components. These specific provisions take into account international standards (e.g. Council of Europe, World Health Organization, American Association of Blood Banks, and national standards), and the provisions of the Council Recommendation of 29 June 1998 on the Suitability of blood and plasma donors and the testing of their donations in the European Community, as well as the advice of experts from the Member States.

As a contribution to ensuring safety and quality throughout the blood transfusion chain, an information exchange system needs to be established between Member States. To be effective, this system has to rely on traceability of blood throughout the transfusion chain using suitable labelling as well as using a system of conservation of the files. This labelling, as well as the information exchange system and the adoption of provisions concerning the maintenance of the files foreseen in Articles 13 , 15 and 23 , will facilitate any action that may need to be taken upstream in the chain in the event of downstream incidents and will highlight any event occurring, after donation, in the transfusion chain.

Lastly, in view of rapid scientific developments related to the safety and quality of blood and its components, continual and rapid adaptation of the Proposal's annexes to technical progress has to be foreseen. A committee procedure is envisaged in Article 26 to address this. Such adaptations will be carried out on a solid scientific basis.