Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-04-23-Speech-1-099"

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". Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner. I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds. Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January. Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur. I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday. In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic. I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells. As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States. As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation."@en1

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