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

(presented by the Commission)

EXPLANATORY MEMORANDUM

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 They may also be separated through apheresis (the process whereby whole blood is withdrawn and a desired component is separated out with the remainder of the blood returned to the donor).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 [1], 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.

[1] OJ L 331, 7.12.1998, p. 1.

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 (5), 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 [2] on the suitability of blood and plasma donors and the screening of donated blood in the European Community.

[2] OJ L 203, 21.7.1998, p. 14.

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.

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)

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)

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)

COMMUNITY INITIATIVES ON

BLOOD SAFETY AND SELF-SUFFICIENCY

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)

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)

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.

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.

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.

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).

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.

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.

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 (5) 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.

2000/0323 (COD)

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof,

Having regard to the proposal from the Commission [3],

[3] OJ C

Having regard to the opinion of the Economic and Social Committee [4],

[4] OJ C

Having regard to the opinion of the Committee of the Regions [5],

[5] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [6],

[6] OJ C

Whereas:

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

(2) The availability of blood and blood components used for therapeutic purposes is dependent on Community citizens who are prepared to donate; in order to safeguard public health and to prevent the transmission of infectious diseases by blood derivatives, all precautionary measures during their collection, processing, distribution and use need to be taken.

(3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or human plasma were ensured through 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 [7]; the specific exclusion of whole blood, plasma, and blood cells of human origin from that Directive, however, has led to a situation whereby their quality and safety, in so far as they are intended for transfusion and not processed as such, are not subject to any binding Community legislation. It is essential, therefore, that whatever the intended purpose, Community provisions should ensure that blood and its components are of comparable 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 establishment of high 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.

[7] OJ L 181, 28.6.1989, p. 44.

(4) In respect of blood or plasma as a starting material for the manufacture of proprietary medicinal products, Article 3 of Directive 89/381/EEC refers to measures to be taken by Member States to prevent the transmission of infectious diseases, comprising the application of the monographs of the European Pharmacopoeia and the recommendations of the Council of Europe and the World Health Organisation as regards in particular the selection and testing of blood and plasma donors. Furthermore, Member States should take measures to promote Community self-sufficiency in human blood or human plasma; and to encourage voluntary unpaid donations of blood and plasma. Consequently, these provisions cover blood and blood components collected and tested for the sole purpose of being used as starting material for medicinal products.

(5) In order to ensure that there is an equivalent level of safety and quality of blood components, whatever their intended purpose, technical adaptation of both Directive 89/381/EC and this Directive should be undertaken in accordance with the committee procedure provided for in this Directive. Directive 89/381/EEC should be amended accordingly.

(6) The Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community [8] identified the need for a blood strategy in order to reinforce confidence in the safety of the blood transfusion chain and promote Community self-sufficiency.

[8] COM(94) 652 final.

(7) The Council in its Resolution of 2 June 1995, on blood safety and self sufficiency in the Community [9], invited the Commission to submit appropriate proposals in the framework of the development of a blood strategy.

[9] OJ C 164, 30.6.1995, p. 1.

(8) The Council in its Resolution of 12 November 1996on a strategy towards blood safety and self-sufficiency in the European Community [10] invited the Commission to submit proposals as a matter of urgency with a view to encouraging the development of a coordinated approach to the safety of blood and blood products.

[10] OJ C 374, 11.12.1996, p. 1.

(9) The European Parliament in its resolutions of 14 September 1993 [11], 18 September 1993 [12], 14 July 1995 [13], and 17 April 1996 [14] on blood safety and self-sufficiency through voluntary unpaid donations in the European Communityhas stressed the importance of ensuring the highest level of blood safety and has reiterated its continued support for the objective of Community self-sufficiency.

[11] OJ C 268, 4.10.1993, p. 29.

[12] OJ C 329, 6.12.1993, p. 268.

[13] OJ C 249, 25.9.1995, p. 231.

[14] OJ C 141, 13.5.1996, p. 131.

(10) In accordance with the principles of subsidiarity and proportionality set out in Article 5 of the Treaty, the objectives of the proposed action, namely to contribute to general confidence both in the quality of donated blood and plasma 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, cannot be sufficiently achieved by the Member States and can therefore by reason of its scale and effects be better achieved by the Community. his Directive confines itself to the minimum required in order to achieve those objectives and does not go beyond what is necessary for that purpose.

(11) In elaborating the provisions of this Directive account has been taken of the opinion of the Scientific Committee for Medicinal Products and Medical Devices as well as international experience in this field.

(12) Blood and plasma used for therapeutic purposes or for use in medical devices should be obtained from individuals whose health status is such that no detrimental effects to their state of health will ensue as a result of the donation and that any risk of transmission of infectious diseases is minimised; each and every blood donation should be tested in accordance with rules which provide assurances that all necessary measures have been taken to safeguard the health of Community citizens who are the recipients of blood and blood components.

(13) 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.

(14) All necessary measures need to be taken in order to provide prospective donors of blood or plasma with assurances regarding the confidentiality of any health-related information provided to the authorised personnel, the results of the tests on their donations as well as any future traceability of their donation.

(15) Directive 95/46/EC of the European Parliament and the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data [15] requires that data related to the health of an individual be subject to reinforced protection. However, it covers only personal data and not that rendered anonymous so that the person is no longer identifiable. This Directive should therefore introduce additional safeguards to prevent any unauthorised changes to donation registries, or processing records, or the unauthorised disclosure of information.

[15] OJ L 281, 23.11.1995, p. 31.

(16) A common system of accreditation for blood establishments and notification of adverse events and reactions linked to the collection, processing, testing, storage, and distribution of blood and blood components should be established in Member States. Accreditation should be provided for a period not exceeding three years and be renewable only following a satisfactory inspection by the responsible authorities.

(17) Member States should organise inspection and control measures, to be carried out by officials representing the competent authority, to ensure the compliance of the blood establishment with the provisions of this Directive.

(18) Personnel directly involved in the collection, testing, processing, storage and distribution of blood and blood components need to be appropriately qualified and provided with timely and relevant training. The provisions laid down in this Directive as regards training should be applicable without prejudice to existing Community legislation on the recognition of professional qualifications and on the protection of workers.

(19) An adequate system to ensure traceability of whole blood and blood components should be established; traceability should be enforced through accurate donor, patient, and laboratory identification procedures, through record maintenance, and through an appropriate labelling system.

(20) The Commission should be empowered to adopt any necessary changes to the Annexes in order to take into account scientific and technical progress.

(21) It is necessary that the best possible scientific advice is available to the Community in relation to the safety of blood and blood components, in particular as regards adapting the provisions of this Directive to scientific and technical progress.

(22) Since the measures necessary for the implementation of this Directive are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [16], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

[16] OJ L 184, 17.7.1999, p. 23.

(23) In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalities to be applied by Member States.

(24) Responsibility for the organisation of health services and the provision of medical care should remain the responsibility of each Member State,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

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

However, when human blood and blood components are collected and tested for the sole purpose and exclusive use as starting materials for the manufacture of medicinal products as defined by Directive 89/381/EEC, the provisions of that Directive shall apply.

Article 2

Objectives

1. This Directive lays down standards of quality and safety of human blood and of blood components which are neither medicinal products within the meaning of Council Directive 65/65/EEC [17] nor reagents within the meaning of Directive 98/79/EC of the European Parliament and of the Council [18], in order to ensure a high level of human health protection.

[17] OJ 22, 9.2.1965, p. 369/65.

[18] OJ L 331, 7.12.1998, p. 1.

2. This Directive applies without prejudice to Directive 98/79/EC or to Directive 95/46/EC.

Article 3

Definitions

1. For the purposes of this Directive:

(a) 'Blood' shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing.

(b) 'Blood component' shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration, and freezing using conventional blood bank methodology.

(c) 'Blood product' shall mean any therapeutic product derived from human blood or plasma, and shall include both labile blood components and stable plasma derivatives.

(d) 'Blood establishment' shall mean any enterprise or body that is involved in any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion.

(e) 'Responsible person' shall mean an individual with relevant qualifications and experience for the scope of activities carried out in a blood establishment.

(f) 'Accreditation' shall mean formal acknowledgement of compliance with accepted standards for procedures, activities, or services following an inspection by an authorised institute or organisation.

(g) 'Inspection' shall mean formal and objective control according to adopted standards to identify problems and approaches to their resolution.

(h) 'Adverse event' shall mean any untoward occurrence associated with the collection, testing, processing, storage, distribution, and transfusion of blood and blood components.

(i) '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.

(j) 'Serious adverse event' shall mean an adverse event that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in or prolongs hospitalisation

(k) 'Serious adverse reaction' shall mean an adverse reaction that is fatal, life-threatening, disabling, incapacitating, or which results in or prolongs hospitalisation.

(l) 'Deferral' shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either of lifetime duration (permanent deferral) or for a fixed period (temporary deferral).

2. The terminology used in Annexes II to IX shall be as set out in Annex I.

Article 4

Implementation

1. Member States shall establish, or designate, the competent authority responsible for implementing the requirements of this Directive.

2. Member States shall ensure that the competent authority implements accreditation requirements and organises inspections and other control measures intended to guarantee quality and safety of human blood and blood components, in accordance with the provisions of this Directive.

3. This Directive shall not prevent a Member State from maintaining or implementing on its territory more stringent protective measures which comply with the provisions of the Treaty. Those more stringent measures shall be safety measures based on current scientific knowledge and shall not present an obstacle to the implementation of this Directive, in particular as regards the free circulation of labile blood products.

4. In carrying out the activities covered by this Directive the Commission may have recourse to technical and/or administrative assistance to the mutual benefit of the Commission and of the beneficiaries, relating to identification, preparation, management, monitoring, audit and control, as well as to support expenditure.

CHAPTER II

OBLIGATIONS ON MEMBER STATES' AUTHORITIES

Article 5

Accreditation of blood establishments

1. Prior to undertaking activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, the blood establishment shall apply for accreditation from the competent authority.

To this end, it shall deliver a notification to the competent authority, providing its name, address, telephone and fax numbers, as well as the name of the responsible person and the information listed in Annex II, Part A.

2. Where the responsible person is replaced, the blood establishment shall provide immediately to the competent authority the name of the new responsible person and his/her date of commencement.

3. The competent authority shall inform the blood establishment that it may only commence the activities for which it sought accreditation upon receipt, by the responsible person, of the competent authority's written approval and compliance with any conditions referred to therein.

4. The competent authority empowered to grant the accreditation shall verify that the particulars submitted in the application comply with the requirements set out in this Directive.

5. The competent authority shall acknowledge the date of receipt of the information provided in paragraph 1, and within 90 days shall respond in writing to the responsible person, indicating either:

(a) that the information provided complies with this Directive and that the activities for which the blood establishment sought accreditation may proceed, or

(b) that the activities for which the blood establishment sought accreditation do not fulfil the conditions of this Directive and that the accreditation is therefore rejected.

6. For the purpose of calculating the period referred to in paragraph 5, no account shall be taken of any period of time during which the competent authority is:

(a) awaiting additional information which it may have requested from the responsible person, or

(b) carrying out any inspection or control measure in accordance with Article 4(2).

7. The accreditation shall be given for a maximum period of three years. The accreditation shall be renewable, in accordance with the provisions of Article 7.

Article 6

Provisions for existing establishments

Member States may decide to maintain national provisions for nine months after the date laid down in Article 30 so as to enable blood establishments operating under their legislation to comply with its requirements.

Article 7

Renewal of accreditation

1. For the purposes of the renewal of accreditation, the responsible person shall submit to the competent authority to which the original application was transmitted, not less than nine months before the expiry of the accreditation, a notification that contains in particular the information listed in Annex II, Part B and any relevant information listed in Annex II, Part A if modified since the first notification.

The blood establishment may only proceed with the activities for which it is accredited upon receipt of the written accreditation, and compliance by the responsible person with any conditions referred to therein, from the competent authority.

2. The competent authority shall respond in writing to the responsible person, within 60 days following receipt of the notification in accordance with the first subparagraph of paragraph 1, indicating either:

(a) that the information is in compliance with this Directive and that the activities for which it was granted an authorisation may continue; or

(b) that its activities for which it was granted accreditation do not fulfil the conditions of this Directive and that the accreditation is therefore suspended.

3. For the purpose of calculating the period referred to in paragraph 2, no account shall be taken of any periods of time during which the competent authority is:

(a) awaiting further information which it may have requested from the responsible person, or

(b) carrying out any inspection or control measure in accordance with Article 4(2).

4. The accreditation shall be renewed for a maximum period of three years.

Article 8

Inspection and control measures

1. The competent authority shall organise inspections and other appropriate control measures in blood establishments to ensure that the requirements of this Directive are complied with.

2. Inspection and control measures shall be organised by the competent authority on a regular basis. The interval between two inspections and control measures shall not exceed one year.

3. Such inspection and control measures shall be carried out by officials representing the competent authority who must be empowered to:

(a) inspect blood establishments as well as facilities of any third parties entrusted by the holder of the accreditation referred to in Article 5 with the task of carrying out evaluation and testing procedures pursuant to Article 18;

(b) take samples;

(c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of notification of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation.

4. The competent authority shall organise inspection and other control measures as appropriate in the event of any serious adverse reaction or event notified in accordance with Article 14 .

CHAPTER III

PROVISIONS FOR BLOOD ESTABLISHMENTS

Article 9

Responsible person

1. The responsible person shall fulfil the following minimum conditions of qualification:

(a) he/she shall possess a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology;

(b) he/she shall have practical experience for at least two years, in one or more establishments which are authorised to undertake activities related to collection and testing of human blood and blood components, or to their preparation, storage, and distribution.

2. The responsible person shall be responsible for ensuring that each batch of blood or blood components has been collected and tested, whatever its intended purpose, and processed, stored, and distributed, when intended for transfusion, in compliance with the laws in force in the Member State.

Article 10

Personnel

1. Personnel directly involved in collection, testing, processing, storage, and distribution of human blood and blood components shall be provided with timely and relevant training.

2. The training of the personnel shall be provided on recruitment, and then at regular intervals of at least once every year. It shall be repeated in the event of a transfer or a change of job, as well as following the introduction of any new technology.

It shall be assessed periodically and at least every two years (proficiency testing).

3. Training guidelines addressing the issues listed in Annex III shall be provided for personnel.

CHAPTER IV

QUALITY MANAGEMENT

Article 11

Quality system for blood establishments

1. The competent authority shall take all necessary measures to ensure that each blood establishment establishes and maintains a quality system for blood establishments ("QSBE").

2. The QSBE shall involve all activities of blood establishments that determine the quality policy, objectives, and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system.

3. The Commission shall establish in accordance with the procedure referred to in Article 26(2) detailed Community standards and specifications relating to the activities set out in paragraph 2 of this Article, to be carried out by a blood establishment.

Article 12

Documentation

1. Member States shall take all necessary measures in order to ensure that blood establishments maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms.

2. 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.

Article 13

Traceability

1. Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored or distributed on their territory can be traced from donor to patient and vice versa.

To this end, Member States shall ensure that blood establishments under the responsibility of the responsible person implement a donor identification system and assign a number to each donation and its products.

2. Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored and distributed on their territory comply with the labelling requirements listed in Annex IV.

Article 14

Notification of adverse reactions and events

1. Member States shall ensure that there is a system in place to collect, collate, and transmit information about adverse reactions and events related to the collection, testing, processing, storage and distribution of blood and blood components to the competent authority.

2. The responsible person shall notify the competent authority of any serious adverse reaction or event linked to the collection of blood and blood components.

3. The Community procedure for notifying these adverse reactions and events, referred to in paragraphs 1 and 2 of this Article, and the notification format shall be established by the Commission in accordance with the procedure referred to in Article 26(2).

Article 15

Record keeping

1. Member States shall take all necessary measures to ensure that blood establishments maintain records of the information required in Annexes V, VI, and VII, as well as the prevalence of viral markers in blood and plasma donors, and confirmed positive seroconversions.

2. The competent authority shall keep records of the data received from the blood establishments according to the provisions of Articles 5, 6, 7, and 14 .

3. The records shall be kept for a minimum of 30 years.

CHAPTER V

PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS

Article 16

Provision of information to donors

Member States shall ensure that all donors of blood or plasma are provided with information as outlined in Annex V, Part A.

Article 17

Information required from donors

Member States shall take all necessary measures to ensure that, upon agreement of a willingness to commence the donation of blood or blood components, all donors provide the information listed in Annex V, Part B to the blood establishment.

Article 18

Eligibility of donors

1. Blood establishments shall ensure that in order to protect the health of both the donor and the recipient, there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation set out in Annex VI are met.

2. Blood and blood components shall be collected from donors who meet the criteria for donation set out in Annex VI.

3. Any deviation in the age of donors, blood pressure, pulse, haemoglobin or haematocrit shall not go beyond the requirements listed in Annex VI.

4. The time interval between two donations for whole blood or for apheresis plasma and the volume given during each donation by the donors shall comply with the requirements of Annex VI.

5. If any of the diseases or symptoms listed in Annex VI are identified during the donation process, donors shall be deferred permanently.

6. The results of the donor evaluation and testing procedures shall be documented and any abnormal findings shall be reported to the donor.

Article 19

Testing of donations

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

Article 20

Storage and freezing conditions

1. Blood establishments shall ensure that the storage conditions of blood and blood components comply with the provisions listed in Annex VIII, Part A.

2. Blood establishments shall ensure that requirements as regards time of freezing of blood and blood components after collection are clearly identified according to Annex VIII, Part B.

Article 21

Quality requirements for blood components

Blood establishments shall ensure that quality requirements for blood components meet high standards in compliance with the provisions listed in Annex IX.

CHAPTER VI

DATA PROTECTION

Article 22

Data protection

1. Member States shall, in accordance with Directive 95/46/EC, ensure the confidentiality of sensitive medical information about donors, including information obtained according to Article 17.

2. Member States shall ensure that donors are informed about the protection of their personal data, including the guarantee of no unauthorised disclosure of the name of the donor, of information concerning his health, or of the results of the tests performed.

3. Member States shall take all necessary measures to ensure that all data collated within the scope of this Directive have been rendered anonymous so that the donor is no longer identifiable.

For that purpose, they shall ensure:

(a) that data security measures are in place as well as safeguards against unauthorised data additions, deletions or modifications to donor files or deferral registers, and transfer of information;

(b) that procedures are in place to resolve data discrepancies;

(c) that no unauthorised disclosure of such information occurs, whilst guaranteeing the traceability of donations.

CHAPTER VII

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Article 23

Information exchange

In order to facilitate the exchange of information associated with the collection, testing, processing, storage and distribution of blood and blood components, including information on adverse events or reactions, 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 measures for the protection of human health.

Article 24

Reports

1. Member States shall send to the Commission, commencing on 31 December 2003 and thereafter annually, a report on the activities undertaken in relation to the provisions of this Directive, including an account of the national measures taken in relation to inspection and control.

2. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, the reports submitted by the Member States on the experience gained in implementing this Directive.

3. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, every three years, a report on the functioning of requirements in the Directive, and in particular those relating to inspection and control.

Article 25

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, and dissuasive. Member States shall notify those provisions to the Commission by the date specified in Article 30 at the latest and shall notify it without delay of any subsequent amendments affecting them.

CHAPTER VIII

COMMITTEES

Article 26

Committee procedure

1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 27

Adaptation to technical progress

Annexes I to IX shall be adapted to scientific and technical progress in accordance with the procedure referred to in Article 26(2).

Article 28

Consultation of scientific committee(s)

The Commission may consult the relevant scientific committee(s) when adapting the Annexes of this Directive to scientific and technical progress, in particular with a view to ensuring a comparable level of quality and safety of blood and plasma used for transfusion and blood and plasma used as a starting material for the manufacture of medicinal products.

CHAPTER IX

FINAL PROVISIONS

Article 29

Amendment of Directive 89/381/EEC

The following Article is inserted into Directive 89/381/EEC:

"Article 6 a

In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products as referred to in Article 3, the amendments to the Annex to Directive 75/318/EEC as provided for in Article 6 shall be adapted to technical progress in accordance with the procedure referred to in Articles 26 and 28 of Directive ... /... /EC 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].

______________

* OJ L ... "

Article 30

Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 2002. They shall forthwith inform the Commission thereof.

When Member States adopt those provisions they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive.

Article 31

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

Article 32

Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

TERMINOLOGY USED IN ANNEXES

(1) Apheresis: process by which one or more blood components is selectively obtained from a donor by withdrawing whole blood, separating it by centrifugation or filtration into its components, and returning those not required to the donor;

(2) Buffy coat: a blood component prepared by centrifugation of a unit of whole blood that contains most of its leukocytes and, depending on the centrifugation, its platelets;

(3) Cell-derivative: a therapeutic product derived from a blood component (as derived from leukocytes - interferon, cytokines - or from outdated erythrocytes - haemoglobin solution);

(4) Cryoprecipitate: a blood component obtained from a unit of fresh frozen plasma and containing the major portion of Factor VIII, von Willebrand factor, fibrinogen, Factor XIII and fibronectin;

(5) Cytapheresis: an apheresis procedure intended for the collection of a cellular component of blood, such as red cells, leukocytes or platelets;

(6) Donor: a person in normal health with a good medical history who voluntarily gives blood or plasma for therapeutic use;

(7) Expiry date: the last day on which the blood or blood component is safe to use for transfusion;

(8) Granulocytes: a kind of leukocyte; also used as name for a blood component, obtained either by the separation of whole blood or by apheresis, and in which granulocytes are represented several times more than in whole blood;

(9) Granulocytes, apheresis: a granulocyte concentrate prepared by cytapheresis.

(10) Leukocytes: white blood cells also used as a name for a blood component obtained either by the separation of whole blood or by apheresis and in which leukocytes are represented several times more than in whole blood;

(11) Plasma derivative: highly purified human plasma protein prepared from pooled plasma under licensed pharmaceutical manufacturing conditions;

(12) Plasma: the liquid portion of anticoagulated blood remaining after separation from the cellular components;

(13) Plasma, cryoprecipitate depleted: the supernatant plasma removed during the preparation of cryoprecipitate. The content of albumin and immunoglobulins is comparable with fresh frozen plasma, factor VIII, von Willebrand factor, fibrinogen, factor XIII and fibronectin are reduced;

(14) Plasma, fresh frozen: plasma that has been separated from a unit of whole blood within a few hours of donation or selectively collected by an apheresis procedure, has been rapidly frozen, and stored at a temperature below -20°C (and preferably below -30°C);

(15) Plasma, recovered: plasma prepared from individual donations of whole blood;

(16) Plasma, thawed: plasma that has been thawed for clinical use after having been fresh frozen;

(17) Platelets (single unit): a platelet concentrate prepared by processing a unit of whole blood;

(18) Platelets pool (buffy coat): a platelet concentrate prepared by processing a pool of buffy coats obtained from different units of whole blood;

(19) Platelets, apheresis: a platelet concentrate prepared by apheresis;

(20) Platelets, cryopreserved: apheresis: a blood component prepared by the freezing of platelets within 24 hours of collection by apheresis, using a cryoprotectant and storing them at -80°C or below;

(21) Platelets: a blood component obtained either by separation of whole blood or by apheresis and suspended in a small volume of plasma from the same donation;

(22) Red cells in additive solution, Buffy coat removed: a blood component prepared by centrifugation of whole blood, removal of the buffy coat and most of the plasma, with subsequent addition to the red cells of an appropriate nutrient solution;

(23) Red cells in additive solution: a blood component obtained by centrifugation of whole blood and removal of most of the plasma, with subsequent addition to the red cells of an appropriate nutrient solution;

(24) Red cells, buffy coat removed: a blood component prepared by centrifugation of whole blood and removal of the buffy coat and most of the plasma;

(25) Red cells, cryopreserved: a blood component derived from whole blood in which red cells are frozen, preferably within 7 days of collection, using a cryoprotectant, and stored at -80°C or below;

(26) Red cells, deglycerolized: red cells that have been thawed and from which glycerol has been removed by washing;

(27) Red cells, frozen in 20% glycerol: red cells that have been stored continuously at -65°C or below, and to which 20% glycerol has been added before freezing;

(28) Red cells, frozen in 40% glycerol: red cells that have been stored continuously at -65°C or below, and to which 40% glycerol has been added before freezing;

(29) Red cells, frozen in glycerol: red cells that have been stored continuously at -65°C or below, and to which glycerol has been added before freezing;

(30) Red cells, frozen: red cells that have been stored continuously at -65°C or below, and to which a cryoprotectant agent such as glycerol has been added before freezing;

(31) Red cells, leukocyte-reduced: a blood component prepared by centrifugation of whole blood, removal of most of the plasma and reduction of leukocytes through filtration;

(32) Red cells, washed: a blood component prepared by washing centrifuged red cells with a volume of compatible solution in order to remove leukocytes, platelets and almost all of the plasma;

(33) Red cells: a blood component prepared by centrifugation of whole blood and removal of most of the plasma.

ANNEX II

INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT

TO THE COMPETENT AUTHORITY

Part A

* Identification of blood collection establishment (address, telephone & fax numbers, emergency numbers)

* Identification of responsible person, qualified personnel

* Number and qualifications of personnel; their responsibilities; written job descriptions

* Hygiene requirements (e .g. protective garments, hygiene in work area)

* Identification of products prepared

* Compliance of premises and equipment with regulatory requirements

* Disposal of infectious waste

* Standard Operating Procedures (SOPs) for donor suitability, testing, preparation, processing, distribution

* Storage requirements (time, temperature)

* Labelling provisions to be applied

Part B

* Total number of donors per year

* Total number of donations per year

* Number of donors/donations rejected

* Incidence of diseases in the donations

* Donor identification numbers

* Donation identification numbers

* Number of donations separated into components.

ANNEX III

GUIDELINES FOR TRAINING To Be Provided For Personnel Directly Involved in the Collection, Testing, Processing, Storage and Distribution of

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Whole Blood and blood components

ANNEX IV

LABELLING REQUIREMENTS

Component // The label on specimen receptacles and containers should contain at least the following information

GENERAL LABELLING REQUIREMENTS

// Specify

// * Nature of whole blood or component (or intended component)

* Volume of component

* Unique numeric or alphanumeric donation identification

* Producer's name and address (clear text or code)

* ABO group

* Rh (D) group, specifying "Rh (D)-positive" if D positive or "Rh (D) negative" if D negative

* Date of collection and expiry date

* Temperature of storage

* Name of anticoagulant (not required for frozen, deglycerolized, rejuvenated, or washed red blood cells)

* Approximate volume of blood collected from the donor

* That the blood or component must not be used for transfusion if abnormal haemolysis or other deterioration is evident

* That blood or component must be administered through a 170-200 ìm filter

SUPPLEMENTARY SPECIFIC LABELLING REQUIREMENTS

// Specify

Plasma, fresh frozen // * Whether component is from whole blood or apheresis donation;

* Volume and composition of anticoagulant used;

* Whether quarantined or virus inactivated

Platelets: apheresis // * Volume of content and average number of platelets; if unit does not meet recommended standard, actual number of platelets to be specified;

* Whether leukocyte depletion has been carried out

Platelets, recovered // * Donation number (if platelets are pooled, labelling system must allow identification of original donations);

* Whether or not leukocyte depleted;

* Composition of anticoagulant solution

Red cells // * Name and volume of component;

* Composition of anticoagulant or additive solution

Red cells, cryopreserved // * Date and time of preparation and expiry;

* Composition and volume of suspending solution;

* Extra caution should be applied in identification of frozen bag units

Red cells, buffy coat removed // * Composition of anticoagulant solution

Red cells, in additive solution // * Composition and volume of additive solution

Red cells in additive solution, buffy coat removed // * Composition and volume of additive solution

Red cells, leucocyte-depleted // * Composition of anticoagulant solution

Red cells, washed // * Time of preparation and expiry;

* Composition and volume of the suspending solution

Whole blood // * Volume of preparation;

* Composition and volume of anticoagulant solution

ANNEX V

INFORMATION REQUIREMENTS

A. INFORMATION TO BE PROVIDED TO DONORS ACCORDING TO ARTICLE 16

1. Accurate but generally understandable educational materials about the essential nature of blood, the products derived from it, and the important benefits to patients of blood and plasma donations;

2. The reasons for requiring a medical history, physical examination, and the testing of donations; information on the risk of infectious diseases that may be transmitted by blood and blood products; the signs and symptoms of AIDS, and the significance of 'informed consent', self-deferral, and temporary and permanent deferral;

3. Information about protection of personal data: No unauthorised disclosure of the name of the donor, of information concerning his health, and of the results of the tests performed;

4. The reasons why they should not donate which may be detrimental to their own health;

5. The reasons why they should not donate which put recipients at risk, such as unsafe sexual behaviour, HIV /AIDS, hepatitis, drug addiction and the use and abuse of drugs;

6. The option of changing their mind about donating prior to proceeding further without any undue embarrassment or discomfort;

7. Information on the possibility of withdrawing or self-deferring at any time during the donation process;

8. The opportunity to ask questions at any time;

9. The undertaking that if test results shows evidence of any pathology, they will be contacted by the blood collection centre;

10. Specific information on the nature of the procedures involved in the donation process and associated risks for those willing to participate in apheresis programmes, whether for plasma or cellular components.

B. INFORMATION TO BE OBTAINED FROM DONORS ACCORDING TO ARTICLE 17

1. Identification

Appropriate means of identification, providing

- name (first and surname),

- address,

- date of birth,

or alternative means allowing the donor to be uniquely identified.

2. Health history

Health and medical history

- any relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to themselves or a risk of transmitting diseases to others, by way of a written questionnaire addressing the criteria listed in Annex VI and a personal interview with a trained health care staff member;

3. Signature

- Signature, on the donor questionnaire, countersigned by the health care staff member conducting the interview under the responsibility of the responsible person, or subject to the approval of this responsible person

- Signature on a separate attestation,

- to acknowledge

- that educational materials provided have been read and understood,

- that opportunity to ask questions has been presented, and

- that satisfactory responses have been received.

- to agree that his / her blood or plasma donation could be used for patients needing transfusion or blood products in the country where the donation is made or in another country, to which it would be transferred in accordance with the provisions of the legislation of the country where the donation is made, particularly with regard to the destination of the donation; and

- to indicate his / her informed consent of the wish to proceed with the donation process.

ANNEX VI

REQUIREMENTS CONCERNING THE SUITABILITY OF BLOOD AND PLASMA DONORS AND THE SCREENING OF DONATED BLOOD

1. Requirements for the protection of blood and plasma donors

a) Physical acceptance criteria

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b) Donation criteria

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2. Permanent Deferral Criteria

a) For protection of donor

* Auto-immune diseases

* Cardiovascular diseases

* Central nervous system diseases

* Malignant diseases

* Abnormal bleeding tendency

* Fainting spells (syncope) or convulsions

* Severe or chronic gastrointestinal, haematological, metabolic, respiratory, or renal disease not included in preceding categories

b) For protection of recipient

Prospective donors who have, or have a history of, any of the following:

* Auto-immune diseases

* Infectious diseases - persons suffering or having suffered from

- Babesiosis

- Hepatitis B (HBsAg confirmed positive)

- Hepatitis C

- Hepatitis, infectious (of unexplained aetiology)

- HIV/AIDS

- HTLV I/II

- Leprosy

- Kala Azar (leishmaniasis)

- Q fever

- Syphilis

- Trypanosoma cruzi (Chagas' disease)

* Malignant diseases

* TSEs (or history thereof in genetic family)

* Alcoholism, chronic

* Cornea/dura mater transplantation recipient

* Diabetes, if treated with insulin

* Intravenous (IV) drug use

* Pituitary hormone of human origin (e.g. growth hormone) recipient

* Sexual behaviour that places them at high risk of transmitting infectious diseases, including persons who have had sex in return for money or drugs

3. Temporary Deferral Criteria

Whether for protection of the donor or recipient: should take fully into account Recommendation 98/463/EC.

ANNEX VII

TESTING REQUIREMENTS

AS REGARDS WHOLE BLOOD AND PLASMA DONATIONS

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* Not required for apheresis plasma intended only for fractionation.

ANNEX VIII

STORAGE AND FREEZING

A. STORAGE

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B. FREEZING

Blood product // Time of freezing

Plasma A // Frozen within 6 hours of phlebotomy

Plasma B // Frozen within 24 hours of phlebotomy

Plasma C // Frozen after 24 hours of phlebotomy

Platelets // Frozen within 24 hours

Red cells // Frozen within 7 days

ANNEX IX

QUALITY REQUIREMENTS FOR

BLOOD COMPONENTS

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FINANCIAL STATEMENT

1. Title of operation

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 .

2. Budget heading(s) involved

B3-4308, B3-4308A

3. Legal basis

Article 152 of the Treaty establishing the European Community.

4. Description of operation

4.1 General objective

The objective is to permit the funding of activities aiming at implementing certain provisions of this Directive, once adopted.

- Standards and specifications to be included in the Quality System for Blood Establishments;

- Format and procedure for the notification of adverse reactions and events;

- Adaptation of the Annexes to technical progress.

4.2 Period covered and arrangements for renewal

These activities will be carried out during a two year period beginning on 1 January 2002 for the two first items listed in paragraph 4.1.

There is a need for continuous adaptation of the Annexes to technical progress. A first adaptation of these Annexes is to be foreseen by 2003. The corresponding preparatory work will therefore have to be completed by the end of 2002. A second adaptation can be foreseen by 2004. The corresponding preparatory work will therefore have to be completed by the end of 2003.

5. Classification of expenditure or revenue

5.1 Compulsory/Non-compulsory expenditure

Non-compulsory expenditure (NCE)

5.2 Differentiated/Non-differentiated appropriations

Dissociated credit (DC)

5.3 Type of revenue involved

6. Type of expenditure or revenue

- Service contracts and subsidies for joint financing of studies and reports with other sources in the public and/or private sector. A general rule will be to limit the Commission's participation to 50% of the total cost of the subsidised project, and 100% of the costs for a service contract.

7. Financial impact

7.1 Actions are financed under:

Proposal for a decision of the European Parliament and of the Council adopting a programme of Community action in the field of public health (2001-2006) (COM(2000) 285 final) [19].

[19] Financial breakdowns are in line with the indicative amounts in these texts.

Proposal for a Decision of the European Parliament and of the Council extending certain programmes of Community action in the field of public health adopted by Decisions No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC, No 1400/97/EC and No 1296/1999/EC and amending those Decisions (COM(2000) 448 final)1.

7.2 Itemised breakdown of cost

Commitment appropriations EUR million (at current prices)

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7.3 Technical and administrative assistance and support expenditure included in Part B of the Budget (B3-4308A)

Commitment appropriations EUR million (at current prices)

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7.4 Schedule of commitment and payment appropriations

EUR million

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8. Fraud prevention measures

All proposals for subsidies will be assessed for technical content and financial criteria which include adequacy of own resources, sound finances and financial management, past record of performance or reliability as regards the capability of fulfilling the terms of subsidy, relationship between partners in a given project and potential for effective accounting and control. These also apply in cases of service contracts.

Requests for final payment must be accompanied by an evaluation of the operational and financial status of the project concerned.

- Specific control measures envisaged

Checks in situ will be carried out using appropriate selection criteria (scale of subsidy, interim report, results of on-going monitoring, information on progress with the execution of the relevant work-plan). In cases where there are reasons to believe that the performance of a project that has received a subsidy, or that of a service contract, is seriously being compromised, an urgent check will be carried out and, if there are remaining suspicions, the service concerned will refer the matter to the relevant audit services and the Anti-fraud Service.

9. Elements of cost-effectiveness analysis

9.1 Objectives; target population

- General objectives: links with the overall aim

The overall aim of the directive is to make a contribution towards the attainment of a high level of health protection by directing action towards improving public health, preventing human illness and diseases, and obviating sources of danger to health.

- Specific and quantifiable objectives

Complete and implement the framework on high standards of quality and safety for the collection, processing, storage and distribution and use of whole blood and blood components;

Develop and operate a haemovigilance network and prepare guidelines on the optimal use of blood.

- Target population:

The general population and target population sub-groups are the ultimate beneficiaries of the actions being undertaken.

The direct beneficiaries of the Community's financial contribution are governmental or quasi-governmental agencies and institutes competent in the area of blood and blood components, associations of health professionals and learned institutions, and representative NGOs active in the field of health information, prevention of diseases and health promotion.

9.2 Grounds for the operation

- Need for Community financial aid, with particular regard to the principle of subsidiarity

The present proposal for a directive by the European Parliament and the Council pursuant to Article 152 of the EC Treaty is adopted in an area where the Community does not have exclusive competence. The objectives cannot be sufficiently accomplished by the Member States because of the complexity, trans-national character and lack of complete control at Member State level over the factors affecting quality and safety of blood and blood components.

- Choice of ways and means

The actions to be implemented have tangible aims and measurable outputs benefiting all the Member States and they will yield added value in a number of ways:

* They would lead to the setting up of sustainable procedures and structures, in particular networks, and the production of data and information necessary for the assessment of Community policies and activities in the area of the safety and quality of blood and blood components;

* They will foster and underpin policy formulation at Member State and Community level and may lead to the preparation of legislative instruments;

* They would support activities that expand and consolidate efforts already undertaken by Member States;

* They would enable the production of reports and the conduct of analysis on a unique and large scale and quality in the Community.

- advantages over possible alternatives (comparative advantages)

The action programmes undertaken in the past suffered from a lack of flexibility to handle new or re-emerging threats and could not allow the re-deployment of resources.

9.3 Monitoring and evaluation of the operation

- Performance indicators selected

* output indicators (measurement of resources employed and efficiency)

The New Programme on Public Health (COM(2000) 285 final) provides for quantifiable deliverables, annual work plans and on-going monitoring of actions undertaken using as indicators the number and quality of networks to be established, guidelines and reports to be issued, ad hoc surveys on health status, health systems and public perceptions, effectiveness of strategies and quality of information, and up-take, emulation and multiplier effects in Member States by competent authorities and local groups and associations.

* impact indicators (measurement of performance against objectives)

The programme is subject to evaluation, especially on performance, including effectiveness against objectives for each of the action involved, by Commission staff and by independent experts using direct, i.e. health-related indicators and indirect measurements (e.g. setting-up and proper operation of mechanisms and procedures for health improvement).

- Details and frequency of planned evaluations

The Commission submits evaluation reports mid-way and at the end of the programme in which the effectiveness and added value of the actions will be evaluated.

- Assessment of the results obtained (where the operation is to be continued or renewed)

In the light of the evaluations mentioned above, the Commission may propose an extension of the programme, if appropriate.

10. Administrative expenditure (CHAPTER III, Part A of the budget)

Human resources and administrative means are to be covered by the appropriations already allocated to the managing service.

10.1 Effect on the number of posts

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10.2 Overall financial impact of human resources

EUR

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The amounts given must express the total cost of additional posts for the entire duration of the operation, if this duration is predetermined, or for 12 months if it is indefinite.

10.3 Increase in other administrative expenditure as a result of the operation

EUR per year

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IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

Title of proposal

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.

Document reference number

No 2000/191

The proposal

Taking account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main 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 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 (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.

The impact on business

Who will be affected by the Proposal-

This Proposal will have an impact on the activities carried out within the framework of the blood transfusion chain, particularly those extending from prospective blood and plasma donors to the delivery of the blood and blood components for therapeutic use. The blood establishments directly concerned by the provision of this Proposal vary from mobile donation units, to large blood services, to hospital blood banks. The Proposal will have indirect implications on the plasma products industry.

What will business have to do to comply with the Proposal-

In most Member States, responsibility for the provision of blood services is overseen by a national authority. This Proposal will not add any further administrative constraints on these institutions and, in certain cases, will lead to their simplification. For those that will have to set up such a national system, an administrative burden will be imposed on blood establishments. In the case of blood precursors, as administrative responsibility may not be so clearly defined in some Member States, this will have to be clearly ascertained.

The collection, testing, processing, storage, and distribution of blood and blood components is viewed not as a business but as a service. The businesses that support this service, however, may have in some cases to invest resources in order to comply with the requirements foreseen in this Proposal.

What economic effects is the Proposal likely to have-

In establishing a notification system for blood establishments as well as an inspection and control system, this Proposal may introduce an administrative burden on those establishments in the Member States where such systems are not already in place. On the other hand, common high standards for the quality and safety of whole blood and blood components that are set up under this Proposal may help to reduce costs associated with adverse events and effects related to blood transfusion, facilitate the circulation of blood and plasma across the borders, and encourage advancement of the goal of Community self-sufficiency, and lead to positive economic effects.

Does the Proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc.)-

No specific provision is envisaged for small and medium sized firms in this Proposal.

Consultation

List the organisations which have been consulted about the proposal and outline their main views.

Organisations invited to Stakeholders meeting.

Association of the European Cancer Leagues (ECL)

European Association of the Plasma Products Industry (EAPPI)

European Group for Bone Marrow Transplantation (EBMT)

European Haemophilia Consortium

European Plasma Fractionation Association (EPFA)

European Research Project on Cord Blood Transplantation (EUROCORD)

International Federation of Blood Donor Organisations (IFBDO/FIODS)

There is general support for the initiative being taken by the Commission.