Activites

• 2003/02/08 Final act published in Official Journal
  • Directive 2002/98
  • OJ L 033 08.02.2003, p. 0030-0040
• 2003/01/27 Final act signed
• 2003/01/27 End of procedure in Parliament
• 2002/12/18 Decision by Parliament, 3rd reading
  • T5-0618/2002 summary

    The European Parliament adopted a resolution approving the joint text by the Conciliation Committee. (Please refer to the document dated 08/11/02).�

• 2002/12/17 Debate in Parliament
  • Debate in Parliament
• #2476
• 2002/12/16 Council Meeting
• 2002/11/04 Joint text approved by Conciliation Committee co-chairs
  • 3652/2002
• 2002/10/02 Final decision by Conciliation Committee
• 2002/09/26 Report tabled for plenary, 3rd reading
  • A5-0442/2002
• 2002/09/19 Formal meeting of Conciliation Committee
• 2002/08/26 Parliament's amendments rejected by Council
• 2002/06/12 Decision by Parliament, 2nd reading
  • T5-0300/2002 summary

    By adopting this draft recommendation for second reading by Mr Giuseppe NISTICO (EPP-Ed, I), the European Parliament approved the common position in principle subject to some amendments. The Parliament proposes to introduce a number of definitions, including "adverse event", "adverse reaction", "haeomovigilance" and "inspection". It also wants haemovigilance data to be kept for at least 30 years. An amendment was adopted which enables Member States to introduce requirements for voluntary unpaid donations, which include the prohibition, and restriction of imports of blood and blood components to ensure a high level of health protection. In addition, Parliament adopted another amendment demanding that a medical examination, comprising at least an interview and blood pressure check by a doctor, shall be carried out before any donation of blood or blood components. The doctor shall be responsible for giving donors the necessary information and gathering information from donors, and shall, on the basis thereof, assess the eligibility of donors. They shall take steps to ensure that tests are carried out in conformity with the latest scientific and technical procedures that reflect current best practices. They must also take advantage of scientific advances in the detection, inactivation and elimination of pathogens which can be transmitted via transfusion. Lastly, the Parliament called for Member States to report to the Commission every two years on the measures taken under the directive.�

• 2002/06/11 Debate in Parliament
  • Debate in Parliament
• 2002/04/23 Vote in committee, 2nd reading
  • A5-0141/2002
• 2002/02/28 Committee referral announced in Parliament, 2nd reading
• #2408
• 2002/02/14 Council Meeting
  • 14402/1/2001 summary

    The Council has taken up two thirds of the amendments proposed by the EP and accepted by the Commission even if in many cases not literally but in substance or in principle. The Council carried out a relatively extensive revision of the text of the proposal in order to better structure and clarify its provisions and to address more fully and systematically certain key issues of particular concern to the Member States. The Council introduced the following main changes: - Scope: there is a general agreement that the Directive should apply also to collection and testing of starting materials for medicinal products; - Hospital blood banks: the Council introduced a definition of hospital blood banks and an Article specifying which provisions of the Directive would apply to them; - Designation, authorisation, accreditation or licensing of blood establishments: the Council extended the concept of accreditation to cover all different modalities of recognition of a blood establishment existing in the Member States; - Responsible person and personnel: the Council considered that the question of appropriate qualifications and timely, relevant and regularly updated training is to be dealt with according to the principle of subsidiarity; - Voluntary unpaid donation : No provision on this issue was included in the Commission's proposal, as the Commission considered that such a provision is not compatible with the Treaty. The Council included instead a provision for the encouragement of voluntary and unpaid blood donations by Member States. The Council has added a provision on information thereon to the other Member States and the Commission as well as a recital referring inter alia to the Council of Europe's efforts in this area. Furthermore, the Council has added an explicit reference to the possibility for a Member State to maintain or implement more stringent protective measures, and in particular, to introduce requirements for voluntary unpaid donations, including the prohibition or restriction of imports of blood and blood components which do not satisfy such requirements. - Structure and content: the Council considered it useful to maintain a number of the Annexes originally proposed by the Commission, albeit in a simplified form, in order to set key reference points defining the framework for the implementation of some important provisions of the Directive which constitutes the basis of the quality and safety system at Community level. Lastly, the Council deleted the Article on clinical tests to be carried out before blood donation and new recitals were added, clarifying certain rpovisions relating to autologous transfusion, hospital blodd banks, quality system and traceability of imported blood and blood components.�

• #2384
• 2001/11/15 Council Meeting
• 2001/11/15 Modified legislative proposal published
  • COM(2001)0692 summary

    The Commission has made a number of amendments to its original proposal bearing in mind parliamentary amendments proposed following the first reading. The main amendments have been grouped into three categories namely, scope of the Directive, establishment of technical standards and voluntary, unpaid donation. Concerning the first category, scope of the Directive, this has now been extended to the collection and testing of blood and blood components for all purposes, including the manufacturing of medicinal products. Council Directive 89/381/EEC has been amended accordingly. In terms of the establishment of technical standards new solutions have been introduced as far as technical implementing provisions are concerned. Rather than including a list of technical annexes to the Directive, the Commission shall develop and up-date the technical implementing provision through the use of a regulatory committee procedure. Lastly, a new amendment has been included which urges Member States to encourage the voluntary and unpaid donation of blood and blood components.�

  • DG [{'url': 'http://ec.europa.eu/dgs/health_consumer/index_en.htm', 'title': 'Health and Consumers'}],
• 2001/09/06 Decision by Parliament, 1st reading/single reading
  • T5-0443/2001 summary

    In approving this report drafted by Mr Giuseppe NISTICO (EPP-ED, I), the European Parliament adopted a large number of technical amendments relating to the collection, testing, processing, storage, and distribution of human blood and blood components. (Please refer to the previous text).�

• 2001/09/05 Debate in Parliament
  • Debate in Parliament
• 2001/07/11 Vote in committee, 1st reading/single reading
  • A5-0272/2001
• 2001/02/12 Committee referral announced in Parliament, 1st reading/single reading
• 2000/12/13 Legislative proposal published
  • COM(2000)0816 summary

    PURPOSE : to increase public confidence in the safety of the blood and blood products administered for therapy by establishing Community provisions ensuring the quality and safety of blood and its components whatever the intended purpose. CONTENT : 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; - to 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, testng, processing, storage and distribution of whole 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 through the Community.�

  • DG [{'url': 'http://ec.europa.eu/dgs/health_consumer/index_en.htm', 'title': 'Health and Consumers'}],

Documents

• Legislative proposal published: COM(2000)0816
• Committee report tabled for plenary, 1st reading/single reading: A5-0272/2001
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T5-0443/2001
• Modified legislative proposal published: COM(2001)0692
• Council position published: 14402/1/2001
• Committee recommendation tabled for plenary, 2nd reading: A5-0141/2002
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 2nd reading: T5-0300/2002
• Report tabled for plenary, 3rd reading: A5-0442/2002
• Joint text approved by Conciliation Committee co-chairs: 3652/2002
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 3rd reading: T5-0618/2002
• : Directive 2002/98
• : OJ L 033 08.02.2003, p. 0030-0040

History

(these mark the time of scraping, not the official date of the change)