Procedure completed
Role | Committee | Rapporteur | Shadows |
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Lead | ENVI | CABROL Christian E.A. (UPE) |
Legal Basis EC before Amsterdam E 129
Activites
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1998/07/21
Final act published in Official Journal
- #2111
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1998/06/29
Council Meeting
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1998/06/29
End of procedure in Parliament
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1998/06/29
Act adopted by Council after consultation of Parliament
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1998/05/05
Modified legislative proposal published
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COM(1998)0290
summary
In its amended proposal the Commission accepted 16 of the 29 amendments adopted by Parliament and rejected 11. Among the significant amendments incorporated into the amended proposal, special reference should be made to the following: - CJD is taken into account in the recommendation, - establishment of national measures for the collection, analysis, publication and updating of epidemiological data using common definitions and criteria that are comparable throughout the Community, including data on viral markers, - assurance that the deferral criteria for blood donors are based on sound scientific evidence (where such evidence is not available the precautionary principle should prevail), - identification of prospective donors and data verification by means of a unique coding system, - use of the same types of screening tests for both blood and plasma donations. With regard to the questionnaire, the Commission accepted Parliament's amendments on: - the deletion from the questionnaire of a question concerning a spouse who is HIV positive and the sexual activity of a prospective donor in countries other than Africa, - the addition of questions on the sexual behaviour of the prospective donor outside the Community ( with the possibility of specifying which countries) and details of travel outside the Community, - the addition of questions on the sexual behaviour of the prospective donor that places them at risk of transmitting infectious diseases. �
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COM(1998)0290
summary
- #2086
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1998/04/30
Council Meeting
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1998/04/02
Decision by Parliament, 1st reading/single reading
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T4-0206/1998
summary
In adopting the report by Mr Christian CABROL (UPE, F) on the suitability of blood and plasma donors, Parliament asked that the Member States bring forward binding legislation for the Union with respect to blood products, donated blood and plasma by the end of 1998 and no later than the end of 1999. It also called for the establishment of a centralized single donor identification and registration system common to all Member States. Parliament also stressed the voluntary and unpaid nature of the donation and called for inclusion of a reference to the Council of Europe recommendations on the non-remunerated nature of the donation and the safety of blood products. It also wanted measures to be taken to take account of the risk associated with the new variants of Creutzfeldt-Jakob Disease, in particular by using imports of blood between Member States. Parliament also considered that there was a need to: - ensure that donors were identified by a single identification common to all countries and that this identification should be notified to a central body, - notify the list of donation centres to this central body and not to the Member States or the Commission, - ensure that epidemiological data on viral markers was regularly collected, analysed and verified, use being made of uniform definitions, and that the data was updated regularly, - ensure that the exclusion of blood donors was based on scientific evidence (where it existed) and where there was none that the precautionary principle should prevail. It also suggested that the same test should be carried out on blood and plasma samples. With regard to the questionnaire, Parliament called for the following questions to be included: - does the donor have a 'partner' (not 'spouse') who is HIV positive?; - has the donor travelled outside the European Union? (instead of outside 'Western Europe and North America'); if so when and what was the length of stay. However it rejected the amendment on whether the prospective donor had engaged in sexual activity in Africa (country, time involved and partner to be specified). The Commission text which refers to 'Sexual activity in Africa' in the list of questions remains. In the list of questions Parliament rejected the question on sexual activity in countries other than those in Africa. The question on 'Men who have unsafe sex' instead of 'Men who have sex with other men' remains in the questionnaire. Permanent deferral for blood donors applies to chronic alcoholics, intravenous drug users, prostitutes and those suffering from infectious diseases or immune-deficiency diseases (AIDS, hepatitis). Homosexuals are thus not automatically excluded from donating blood, as suggested by the report. �
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T4-0206/1998
summary
- 1998/04/01 Debate in Parliament
- 1998/03/18 Vote in committee, 1st reading/single reading
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1998/01/16
Committee referral announced in Parliament, 1st reading/single reading
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1997/11/17
Legislative proposal published
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COM(1997)0605
summary
OBJECTIVE : to lay down common rules concerning the suitability of blood and plasma donors in the European Union and practical tests for blood donation within the Community. CONTENT : In order to help ensure a high level of health protection of European citizens and achieve self-sufficiency in blood and plasma supplies, and given the differences in both the legislation and the practices of the Member States in this field, the Commission proposes to set out joint requirements concerning blood donations. The proposed recommendations aim to promote good practices in this field and to achieve a coherent blood donor policy throughout the Community. The recommendations principally concern the suitability (or unsuitability) of blood donors, the volumes of blood donated and the practical screening of blood donation samples, as well as the proper protection of data on prospective donors. More specifically, the recommendations: 1) propose a common terminology for blood and blood products, donors and the suitability of donors; 2) provide a list of information to be given to prospective donors (for example, measures to raise awareness of donors, confidentiality of information on their health, etc.); 3) stipulate certain items of standard information to be obtained from the prospective donor (including identification of donor, medical history by way of a written questionnaire, an example of which is appended to this proposal, donor's written consent to donate blood and, possibly, to export the blood donated); 4) provide for a registration of donors in order to make it easier to check regular donors and the source of the donation at a later date (Member States should establish a mutually compatible system of donor identification/ registration); 5) lay down exclusion criteria governing the suitability of blood and plasma donors (the physical criteria which donors must meet are given in the Annex: these criteria are common to all and relate to factors such as age, weight, donor's blood pressure, etc.) ; 6) lay down criteria governing the unsuitability of donors, including criteria governing the permanent or temporary exclusion of donors with the complaints listed in the Annex. Provision is made for exclusion files for registering excluded prospective donors; 7) ensure proper protection of data on prospective donors (in particular, in application of Directive 95/46/EC on the protection of personal data); 8) provide for measures concerning the volumes of blood donated (joint standards for maximum volumes of blood and maximum intervals between donations); 9) provide for "harmonised" tests on blood samples (joint requirements for testing blood samples, together with common rules for the interpretation of reactions to initial screening tests, are proposed in the Annex). The text also proposes measures to encourage voluntary, as opposed to paid, blood donation. �
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COM(1997)0605
summary
- #2013
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1997/06/05
Council Meeting
- #1961
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1996/11/12
Council Meeting
Documents
- Legislative proposal published: COM(1997)0605
- Committee report tabled for plenary, 1st reading/single reading: A4-0112/1998
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T4-0206/1998
- Modified legislative proposal published: COM(1998)0290
History
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