Local view for "http://purl.org/linkedpolitics/eu/plenary/2001-09-05-Speech-3-434"
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". – Mr President, let me first say that I am very grateful for all the work on this important and ambitious directive. Important, as it constitutes our first directive based on the new and strengthened provisions in Article 152 of the Treaty, and ambitious, as a crucial element in our overall health strategy.
In addition, I have doubts about the legal basis for a provision determining the way donations should be carried out, and this issue was also raised by Mrs Doyle. Article 152 of the Treaty does not allow the Community to adopt measures which ‘affect national provisions on donation’. Whether an obligation to accept voluntary donation only can be justified in terms of increased safety seems questionable. Particularly in the field of plasma-derived products, safety nowadays depends far more on sophisticated screening tests and inactivation steps. Such a provision might therefore be challenged before the Court of Justice due to lack of an appropriate legal basis or on the grounds of subsidiarity.
For these reasons, I can only partly accept Amendments Nos 55 and 56. As already indicated, I am prepared to discuss any solution that would make it clear that a comprehensive application of the principle of voluntary, non-remunerated donation is a central long-term aim of the Community.
Amendments Nos 1, 3, 7, 8, 12, 60 and 61 aim to introduce declarations or requirements of enhanced ethical standards in one way or another. All of them are certainly worthwhile discussing and studying in detail, but from our point of view they are not really suitable for this directive, because they are either not directly linked with its objectives or do not have a legal basis in the Treaty.
Some of you said that remunerated donations have a greater risk from a safety point of view. Many of you referred to studies. All the advice I receive is that these are old studies. All of the modern studies run to the contrary. In view of the fact of what I said earlier in relation to other safety measures like screening tests and inactivation steps, these provide the degree of security that is necessary having regard to this particular debate. It was also suggested that if we did have a shortage of supply, that this could be replaced by imports, but I have to point out that the imports will be from remunerated sources, so this undermines the very purpose that people wish to achieve.
Mrs Ries also mentioned that she had been contacted by haemophiliac associations and indeed some others made the same point. I should say that my services and I have also been contacted by haemophiliac and other associations urging us not to go down the route of eliminating from the chain donations from remunerated supply. I would urge Parliament to take this very much to heart when considering voting on this issue tomorrow and to follow the views that I am expressing on this. I fully endorse and fully agree with the views of many of you who have already spoken on this issue.
The next issue I want to touch on is the scope of the directive. The last part of Amendment No 13, together with Amendment No 72, aims to extend the scope of the directive to the collection and testing of blood and blood components as starting material for medicinal products. The Commission can accept this in principle, but legal clarity has to be maintained as to the respective fields of application of this directive and Directive 89/381/EEC on blood and plasma derived products. Therefore, it will be necessary to review the wording of both amendments in the light of the final compromise to be agreed with the Council.
Other amendments introduce the term ‘blood derivatives’ into the text of the directive; this cannot be accepted, because it might lead to confusion with ‘medicinal products’.
Let me be clear: Everything made from blood and used in human therapy should fall under either this directive or the existing Directive 89/381/EEC. If any doubts exist the Commission will reconsider the definitions used.
The third point relates to the technical standards. The rapporteur has proposed to remove the technical annexes from the directive, and to adopt technical standards later by comitology.
I appreciate this approach and I am very grateful for the trust in the work of the Commission shown by this move. Members of Parliament will know that this is an issue that I have spoken on before in Parliament and I am particularly pleased that this approach has been adopted on this occasion. If the Council can accept this solution, my services will immediately start to draw up proposals for technical standards in order to ensure that they are adopted before the directive comes into force.
Before I turn to the details of the directive on the table today, let me pay tribute to the successful and valuable work of the Council of Europe in the area of blood safety. Our proposal for a directive builds on these achievements.
Let me also reassure you that my services will not try to reinvent the wheel when preparing the regular adaptation of the technical standards according to scientific and technical progress. We will fully use the pioneering work of the Council of Europe.
To add to and further complicate these procedures would not be feasible in an area where quick decisions may have to be taken to protect public health. For this reason, I can only partly accept Amendments Nos 68 and 71, and I cannot accept Amendment No 69.
Amendments Nos 39 and 41, which refer to another directive or ISO standards as reference for standards introduced under this directive, cannot be accepted. When proposing updated standards, the Commission will take into account all relevant external and EU standards by default. To mention some at the expense of others could cause legal problems in the application, or force the Community to apply standards established outside its legal framework.
We are also unable to accept Amendment No 22 introducing a definition of traceability, which in my view is not only too general but also not covered by the Treaty. Amendment No 44, introducing a universal donor identification system, which is both costly and over ambitious and unnecessary, is not acceptable either.
Finally, the qualifications of blood establishment staff. Amendment No 33 would restrict the qualifications of the ‘responsible person’ to that of a medical doctor. This is too restrictive and cannot be accepted. The ‘responsible person’ is, according to the proposal, charged with administrative and management tasks in relation to the application of the directive, and does not have medical responsibilities
. But again Member States are free to impose further demands as to the qualifications of the ‘responsible person’.
In summary, for the reasons I have set out, 19 amendments are not acceptable. These are Amendments Nos 1, 3, 6, 7, 8, 12, 19, 20, 22, 30, 33, 39, 41, 44, 47, 60, 61, 69 and 73. 52 amendments are acceptable in full or in part.
The following 23 amendments are acceptable in part: Amendment Nos 2, 5, 10, 13, 14, 15, 17, 21, 27, 28, 32, 35, 43, 46, 55, 56, 62, 66, 67, 68, 70, 71 and 72. The remaining 28 amendments can be accepted in full, including Amendment No 75, the so-called ‘compromise amendment’.
Let me, finally, repeat my appreciation for all the constructive work done by the rapporteur and the committee and indeed all of you present. Many of the amendments will improve the proposal. And for those elements where difficulties remain, the Commission is ready and willing to assist in finding solutions quickly. Indeed, the fact that the Commission can accept in whole or in part 52 of the 71 amendments shows our willingness to take on board Parliament’s substantial policy contributions and our confidence that together we will be able to bring forward this important objective and have it adopted as quickly as possible.
This new directive will cover blood and blood components not considered medicinal products in so far as it will ensure a comparable level of quality and safety throughout the blood transfusion chain in all Member States. In addition, the directive lays down provisions at Community level for a quality system for blood establishments and for the training of blood establishment staff.
I am pleased to note that the amendments debated today in general are very supportive of the basic approach of the Commission to issues related to blood safety and the way these should be addressed at Community level. I appreciate the very valuable contribution of the European Parliament. A greater part of the amendments constitutes improvements, clarifications, and useful additions to the text and I thank Mr Nisticò and all his colleagues for their contribution.
We can accept in full 29 amendments. There are in addition a further 23 amendments which include valuable ideas that we can endorse, but which, as drafted, are not fully acceptable. This is either because they contain specific points of substance which conflict with the approach of the directive, or because they raise legal or technical difficulties.
With so many amendments. it is not feasible for me to make specific comments on each of them. I will therefore concentrate on four key areas, where there are several amendments which we cannot accept, and where I believe that some clarification of the Commission’s position will be helpful.
First, ethical questions. We all agree that the principle of voluntary, non-remunerated blood donation is of a very high ethical value. As Mrs Stihler said, the EU charter of human rights demands that no financial gain shall be made from parts of the human body as such. Therefore I welcome, and will actively support, any contribution the Community can make to achieve comprehensive application of this principle. But we have to carefully analyse all aspects of the issue.
I am determined to ensure that this new directive will not unwillingly contribute to shortages of life-saving therapies. The supply of blood and blood derivatives, such as plasma-derived drugs, is a matter of life and death for many patients, as many of you have said. Much of the plasma used for these drugs in Europe does not come from donations which can be considered ‘voluntary, non-remunerated’ in the strict sense of the words, and it is difficult to see how these donations could be replaced in the short term. There is a clear danger that a ban on them might result in severe shortages of these products.
Consequently I consider it premature to effectively ban any donation which is not fully in line with the definition of ‘voluntary, non-remunerated donation’ provided for in Amendment No 17 and to this extent I agree with Mr Nisticò and with the contributions from Mrs Ries, Mrs Müller, Mr Bowis and Mrs Doyle. I endorse their views and I accept what they said in relation to this issue."@en1
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