Local view for "http://purl.org/linkedpolitics/eu/plenary/2001-09-05-Speech-3-422"
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"en.20010905.15.3-422"2
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"Mr President, Commissioner, first of all my sincere thanks to the chairman, Caroline Jackson, for giving this report preferential passage. Equally sincere thanks go to all the shadow rapporteurs for the optimum cooperation there has been, and thanks, too, to the Commission officers, the representatives of the various associations and all those Members who have contributed to improving this important and sensitive directive with excellent amendments.
As regards imported blood – Amendment No 43 – it should be specified that the criteria this amendment refers to relate to the quality and safety of the blood.
In conclusion, Mr President, the guarantee of high standards of quality, effectiveness and safety of blood provided for in the directive will mean greater peace of mind for European Union citizens about any treatment with blood, as well as greater confidence in the European institutions and the national authorities.
The directive fills a void which has existed in Europe up to now around standards of blood quality and safety. The objective of this directive is primarily the protection of donors and patients, finally making it possible for all the Member States to have the same standards which ensure the maximum possible level of quality and safety of blood and blood components, not only for blood available in the countries of the European Union but also for blood imported from third countries.
The directive provides for continuous updating, at least annually, of laboratory tests to identify bacterial or viral pathogens and other infective agents, as well as upgrading to the most sophisticated technology for safer and more effective sterilisation of blood and blood components. There are also recommendations to the Member States to strengthen scientific research in the sector. The existence of a new European directive which provides for the same standards of quality in the individual Member States will facilitate the free movement of blood from one European Union country to another and remove uncalled-for restrictions on donors moving between countries.
High standards of quality and safety must apply during all stages in the transfusion chain, from donation to inspection by means of specific laboratory tests, collection, processing, storage, distribution and utilisation of whole human blood and its components.
The quality and effectiveness guarantees must therefore cover the suitability of blood donors, plasma and their components, the transfusion structures, the qualifications and training of medical, technical and nursing staff and the checking, inspection and control mechanisms, as well as a system for ensuring the traceability of blood from donor to recipient. The European Parliament provides for the person responsible to have a qualification in medicine, preferably with a specialisation in haematology or transfusion medicine or related medical specialisation.
In order to gain a better understanding of the importance of monitoring each stage in the process, it is worth considering the unfortunate, terrible, adverse reactions which have occurred and which we hope will never occur again, for example AIDS, hepatitis B and C and other, sometimes fatal infections, like anaphylactic shock or endotoxic shock.
The Commission has accepted the rapporteur’s proposal to delete the annexes, as they cover extremely complex technical matters. They should be updated periodically by a simple and flexible mechanism.
Finally, the principle by which all donations should take place on a voluntary non-remunerated basis has been strengthened by numerous amendments from Parliament. However in my opinion, Commissioner, the priority is to safeguard the needs and requirements of patients. In fact, in view of the sadly limited number of donors still, and Europe’s lack of self-sufficiency in blood, if all forms of incentive for donors were immediately banned it would create enormous, even fatal, difficulties for patients. The shortage of blood and plasma is a well-known problem in Europe.
That is why I hope the House will approve the amendment by the Group of the European People’s Party (Christian Democrats) and European Democrats and the Group of the European Liberal, Democrat and Reform Party which upholds the principle of free and voluntary donation on the one hand, but allows a transitional phase for achieving that principle on the other. An oral amendment by Mr Lisi states that by the end of December 2008 all donations must be voluntary and non-remunerated. Individual Member States must encourage the achievement of that principle, but sufficiently gradually to avoid any possible catastrophic effects on the public."@en1
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