Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-06-11-Speech-2-073"
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". – Mr President, it was in 1628 that Doctor William Harvey first postulated his theory on the true nature of blood circulation. It took about 200 years, however, for this theory to be fully accepted. Thankfully, it has taken a significantly shorter period of time, less than a year and a half, for the Council and Parliament to consider the Commission's proposal presented in January 2001 for a directive establishing quality and safety requirements for blood and blood components.
The issues presented in Amendment No 24 have all been taken into account in the modifications to Article 15 of the common position, together with a new definition of "haemovigilance" presented in Amendment No 27, which the Commission can accept.
Amendment No 26 has to be rejected. The establishment of any deadline for the introduction of binding requirements relating to voluntary unpaid donations cannot be considered at a time when Member States are facing difficulties in securing an adequate supply of blood – a point made by many of the speakers here this morning.
All other amendments are acceptable to the Commission, either in full or in part. Amendments Nos 1, 9, 12, 15, 17, 19, 25, 27 and 28 are fully acceptable.
Allow me to elaborate briefly on those amendments that the Commission is prepared to accept in part. These are: Nos 2, 3, 5, 6, 10, 13, 14, 16, 18, 20 and 21. Amendment No 2, as drafted, clearly is not in line with the limitations of Article 152 of the Treaty. The wording would need to be substantially revised to comply with the Treaty. However, it would be a far better solution to drop the amendment entirely.
With regard to Amendments Nos 3 and 21, in relation to personal genetic data, the Commission fully supports the idea behind the proposal, but the examples given for potential misuse of data might be too specific. Amendments Nos 5 and 6 would only be acceptable if the word "products" were to be deleted for the reasons I have already given in my comments on Amendment No 4.
Amendment No 10 would cause major problems. We believe that in Article 4(2), on restrictions of imports among Member States a reference to the Treaty is clearly necessary in order to avoid any misinterpretation of this sensitive text.
The wording in the compromise Amendment No 20 by the shadow rapporteur provides this reference but the suggestion that voluntary unpaid donations alone can ensure a high level of health protection is scientifically doubtful.
A revised wording indicating that voluntary unpaid donations can contribute to a high level of public health, as already stated in recital 23, would be acceptable. We are prepared, however, to accept the deletion of the specific reference to Article 30 of the Treaty.
Equally problematic is the proposed reference to Article 19(1), which establishes a Community objective but not a legal requirement. Therefore it cannot, as such, be used to justify trade restrictions among Member States, which are generally only acceptable for very substantial reasons.
The danger here is that this provision might be vulnerable to legal challenge, which could lead to the directive being annulled.
The proposed amendments before you today are the culmination of considerable efforts on the part of the Council in reaching its common position, the Environment Committee in proposing amendments to that position, and the rapporteur, in cooperation with the Spanish Presidency, in trying to reach a compromise.
The Commission fully agrees with the principle of regular reporting by Member States on the issue of voluntary unpaid donations, as proposed in Amendment No 13. However, this reporting requirement should be brought into line with the reports that Member States have to submit every three years on the overall implementation of the directive. I note what Mr Nisticò said in his own contribution on this issue a moment ago.
Amendment No 14 can be accepted in a modified form. It would be necessary to make reference in Article 20 to quality management, coupled with a new recital which could include all the extra detailed explanations required by the current amendment.
The cross-reference to Article 11 would provide safeguards for testing to be always carried out in accordance with good practice, while the new recital would provide an explanation for the principles behind the procedure.
With regard to Amendment No 16, the Commission is ready to accept the first part, referring to genetic analyses, but not the second part because patents cannot be regulated under Article 152.
The idea behind Amendment No 18 can be accepted in a slightly modified form within the first paragraph of Article 23.
To conclude, it is the Commission's opinion that, with regard to the 28 amendments, agreement between all three institutions remains within our grasp. The European Parliament is now at a critical juncture where it must make its decision on whether the proposed compromises are acceptable. This decision will either further the debate in the context of the conciliation procedure or enable the directive to go forward for final adoption at the forthcoming Health Council.
Of the 28 amendments proposed by Parliament, eight must be rejected by the Commission. These are Amendments Nos 4, 7, 8, 11, 22, 23, 24 and 26. I will briefly give our reasoning on each of these. Amendment No 4, refers to "products", a term that covers, in this context, any therapeutic product derived from blood or plasma, including medicinal products based on blood constituents and prepared industrially. The latter are covered by Directive 2001/83, where technical requirements are specified in detail. As the term "products" in this amendment could lead to legal difficulties, it needs to be omitted.
This also applies to Amendments Nos 5 and 6 and, to a certain extent, to Amendment No 1, which is acceptable on balance but is somewhat superfluous without Amendment No 4.
With regard to Amendment No 7, the Commission accepts the view that the definition of "voluntary non-remunerated donation", as defined by the Council of Europe, should appear in the text of the directive. The discussions in Council, however, have clearly demonstrated that this definition is not sufficiently precise to be included in the enacting terms of a legally binding directive. For these reasons, the Commission prefers this definition to be incorporated in recital 23. We therefore reject Amendment No 7 and accept the compromise proposal put forward by the shadow rapporteur in Amendment No 19.
Amendments Nos 8 and 27 propose two slightly different definitions of "haemovigilance". We accept Amendment No 27 and reject Amendment No 8 because Amendment No 27 reflects more closely the directive's provisions on this issue.
Amendments Nos 11 and 22 propose a preference for the responsible person to be a haematologist.
As the tasks of the responsible person are managerial as well as technical, such a specialist may not always be required for this post. Furthermore, it is not opportune to mention in a Community legal text specific qualifications that are not harmonised at Community level.
Member States, however, have the freedom to impose stricter requirements if they so wish. I recommend instead voting in favour of the compromise Amendment No 28 by Mr Nisticò. Amendment No 23 has to be rejected because it is not appropriate to modify the title of an article so that it no longer corresponds with its content."@en1
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