Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-06-11-Speech-2-058"
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"en.20020611.5.2-058"2
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".
Mr President, I would like to express my immense satisfaction at the adoption in committee on 23 April last of the directive setting quality and safety standards for blood, essentially without any significant shift from Parliament’s position and amendments. At last, I feel that a directive can be adopted at second reading which provides the greatest possible guarantees, particularly for patients and consumers, of the quality and safety of blood and its components in order to avoid infections and complications such as those which have caused so many scandals and disasters in the past.
The adoption of a new European directive laying down uniform quality standards for blood will, at last, allow the free movement of blood and its components throughout the countries of the European Union and the removal of unwanted restrictions on the movement of donors from one country to another. There will have to be high quality and safety standards for all the stages of the transfusion process, from donation to testing by means of specific, updated laboratory tests, to the collection, processing, storage, distribution and use of human blood and blood components.
As I am sure you will all remember, the point of the directive which was most critical and most disputed in our committee and in the House concerned what are known as ‘voluntary unpaid donations’. In my opinion, the common position adopted by the Committee on the Environment, Public Health and Consumer Policy resolves all the disputes over this point. Indeed, Article 4 states, according to the principle of subsidiarity, ‘This directive shall not prevent a Member State from maintaining or introducing ... more stringent protective measures .... In particular, a Member State may introduce requirements for voluntary, unpaid donations, including the restriction of imports of blood and blood components’.
The Committee on the Environment, Public Health and Consumer Policy deleted the clause ‘provided that the provisions of Article 30 of the Treaty are met’. A new amendment has now been tabled by the socialists to the effect that all the Member States may prohibit or restrict imports of blood and blood components to secure a high level of protection of health and to achieve the objectives laid down in Article 19(1), provided that the conditions laid down by the Treaty are met. This seems to me to be a good, acceptable compromise.
With regard to voluntary and unpaid donations, Article 19 of the common position lays down a number of specific provisions, including, in particular (Paragraph 1) that Member States are to encourage voluntary and unpaid donations and ensure that blood is in so far as possible provided from such donations. I feel that this is a very balanced provision and this position has already been endorsed in committee. Article 19(2) lays down in general terms that the Member States are to inform the other Member States and the Commission of the actions taken by them to achieve the objective set out in Paragraph 1. In this regard, I would like to table an oral amendment requiring the Member States to provide this information every three years instead of every two years, for this tallies with the text of a subsequent article.
In addition, still on the subject of voluntary unpaid donations, some of the Members called for the Council of Europe definition to be included in the text, particularly in Article 3. I broadly support the Council of Europe definition but I feel that it is sufficient for reference to be made to it in recital 23, precisely as it is currently worded, to the effect that this definition ‘should’ – not ‘must’ be taken into account by the Member States. I therefore oppose both Amendment No 7 and Amendment No 19, which seek to include a literal, rigid definition of ‘voluntary and unpaid donation’. Indeed, I feel that some flexibility is necessary in order to encourage donors. Commissioner, each Member State has a different attitude, different traditions and a different culture when it comes to the definition of ‘unpaid’, which I feel must be wholly respected.
It is not for Europe to impose rigid definition criteria on the individual Member States. The important thing is to have enough donors to achieve the most important objective, which is to avoid a shortage of blood and blood components.
Another point of controversy concerned the responsible person. In my opinion, there should be a compromise amendment giving Member States the freedom to choose the type of qualification required of the responsible person, in line with the principle of subsidiarity.
In conclusion, I hope that this directive will, at last, see the light of day and be adopted."@en1
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