Directive 2002/98/EC of the European Parliament and of the Council
of 27 January 2003
setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
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 ,
Having regard to the opinion of the Economic and Social Committee ,
Having regard to the opinion of the Committee of the Regions ,
Acting in accordance with the procedure laid down in Article 251 of the Treaty , in the light of the joint text approved by the Conciliation Committee on 4 November 2002,
Whereas:
(1)
The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order to prevent in particular the transmission of diseases.
(2)
The availability of blood and blood components used for therapeutic purposes is dependent largely on Community citizens who are prepared to donate. In order to safeguard public health and to prevent the transmission of infectious diseases, all precautionary measures during their collection, processing, distribution and use need to be taken making appropriate use of scientific progress in the detection and inactivation and elimination of transfusion transmissible pathogenic agents.
(3)
The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use . 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 which are derived from donations in another Member State nonetheless meet the same requirements as those in their own country.
(4)
In respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, Directive 2001/83/EC 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 (WHO) 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 blood components and to encourage voluntary unpaid donations of blood and blood components.
(5)
In order to ensure that there is an equivalent level of safety and quality of blood components, whatever their intended purpose, technical requirements for the collection and testing of all blood and blood components including starting materials for medicinal products should be established by this Directive. Directive 2001/83/EC should be amended accordingly.
(6)
The Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community 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.
(7)
In its Resolution of 2 June 1995, on blood safety and self-sufficiency in the Community , the Council invited the Commission to submit appropriate proposals in the framework of the development of a blood strategy.
(8)
In its Resolution of 12 November 1996 on a strategy towards blood safety and self-sufficiency in the European Community , the Council 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.
(9)
In its Resolutions of 14 September 1993 , 18 November 1993 , 14 July 1995 , and 17 April 1996 on blood safety and self-sufficiency through voluntary unpaid donations in the European Community, the European Parliament stressed the importance of ensuring the highest level of blood safety and has reiterated its continued support for the objective of Community self-sufficiency.
(10)
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.
(11)
The nature of autologous transfusion necessitates a specific consideration in respect of how and when to apply the different provisions of this Directive.
(12)
Hospital blood banks are hospital units which perform a limited number of activities, storage, distribution, and compatibility tests. In order to ensure that the quality and safety of blood and blood components are preserved during the whole transfusion chain, while taking account of the specific nature and functions of hospital blood banks, only provisions relevant to these activities should apply to hospital blood banks.
(13)
Member States should ensure that an appropriate mechanism for designating, authorising, accrediting or licensing exists to ensure that the activities of blood establishments are performed in accordance with the requirements of this Directive.
(14)
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.
(15)
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, without prejudice to existing Community legislation on the recognition of professional qualifications and on the protection of workers.
(16)
Blood establishments should establish and maintain quality systems involving all activities 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, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system.
(17)
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 identification and labelling system. It is desirable that a system is developed in order to enable the unique and unmistakable identification of donations of blood and blood components in the Community. In the case of blood and blood components imported from third countries, it is important that an equivalent level of traceability be ensured by the blood establishments in the stages preceding importation into the Community. The same requirements of traceability which apply to blood and blood components collected in the Community should be ensured in the stages following importation.
(18)
It is important to introduce a set of organised surveillance procedures to collect and evaluate information on the adverse or unexpected events or reactions resulting from the collection of blood or blood components in order to prevent similar or equivalent events or reactions from occurring thereby improving the security of transfusion by adequate measures. To this end a common system of notification of serious adverse events and reactions linked to the collection, processing, testing, storage, and distribution of blood and blood components should be established in Member States.
(19)
It is important that when abnormal findings are reported to the donor, relevant counselling is also provided.
(20)
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.
(21)
All necessary measures need to be taken in order to provide prospective donors of blood or blood components 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.
(22)
According to Article 152(5) of the Treaty, the provisions of this Directive cannot affect national provisions on the donations of blood. Article 152(4)(a) of the Treaty states that Member States cannot be prevented from maintaining or introducing more stringent protective measures as regards standards of quality and safety of blood and blood components.
(23)
Voluntary and unpaid blood donations are a factor which can contribute to high safety standards for blood and blood components and therefore to the protection of human health. The efforts of the Council of Europe in this area should be supported and all necessary measures should be taken to encourage voluntary and unpaid donations through appropriate measures and initiatives and through ensuring that donors gain greater public recognition, thereby also increasing self-sufficiency. The definition of voluntary and unpaid donation of the Council of Europe should be taken into account.
(24)
Blood and blood components used for therapeutic purposes or for use in medical devices should be obtained from individuals whose health status is such that no detrimental effects 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 individuals who are the recipients of blood and blood components.
(25)
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 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. This Directive should therefore introduce additional safeguards to prevent any unauthorised changes to donation registries, or processing records, or the unauthorised disclosure of information.
(26)
The Commission should be empowered to establish technical requirements and adopt any necessary changes thereto and to the Annexes in order to take into account scientific and technical progress.
(27)
Setting of technical requirements and adaptation to progress should take into account the Council recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the EC , relevant recommendations of the Council of Europe and the WHO as well as indications of relevant European institutions and organisations such as the monographs of the European Pharmacopoeia.
(28)
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.
(29)
Tests should be carried out in conformity with the latest scientific and technical procedures that reflect current best practice as defined by, and regularly reviewed and updated through, an appropriate expert consultation process. This review process should also take due account of scientific advances in the detection, inactivation and elimination of pathogens which can be transmitted via transfusion.
(30)
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission .
(31)
In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalties to be applied by Member States.
(32)
Since the objectives of this Directive, namely to contribute to general confidence both in the quality of donated blood and blood components 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 at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.
(33)
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:
OJ C 154 E, 29.5.2001, p. 141 and
OJ C 75 E, 26.3.2002, p. 104.
OJ C 221, 7.8.2001, p. 106.
OJ C 19, 22.1.2002, p. 6.
Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 289), Council Common Position of 14 February 2002 (OJ C 113 E, 14.5.2002, p. 93) and Decision of the European Parliament of 12 June 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.
OJ L 311, 28.11.2001, p. 67.
OJ C 164, 30.6.1995, p. 1.
OJ C 374, 11.12.1996, p. 1.
OJ C 268, 4.10.1993, p. 29.
OJ C 329, 6.12.1993, p. 268.
OJ C 249, 25.9.1995, p. 231.
OJ C 141, 13.5.1996, p. 131.
OJ L 281, 23.11.1995, p. 31.
OJ L 203, 21.7.1998, p. 14.
OJ L 184, 17.7.1999, p. 23.