Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-04-23-Speech-1-121"
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"en.20070423.17.1-121"2
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"Mr President, essentially, the draft we are debating concerns the introduction of a centralised procedure whereby the European Agency for the Evaluation of Medicinal Products could issue authorisation for the marketing of advanced therapy medicinal products. The European Commission also wishes to ensure financial support for the firms manufacturing these products.
These proposals are worthy of support, or rather, they would be worthy of support if it were not for the fact that products that could be developed using controversial technologies have been included amongst advanced therapy products. I refer to products created using human embryos, or developed from animal-human hybrids or chimeras, and also to pharmaceuticals that change the genetic heritage of human beings.
Several European Union Member States such as Germany do not allow products developed using unethical methods onto their markets. The Commission’s proposal contains an exclusion which would allow these states to opt out of the principle of a common market in the case of these controversial products. It is now being stated that there is a legal error affecting both the draft currently under debate and the 2001 directive. Supporters of that view argue that pursuant to Article 95 of the Treaty, which aims at full harmonisation of the market, citing it as a legal basis for a draft regulation on advanced therapy products implies creating an open European market for these products.
The European Parliament therefore found itself in a situation in which it had to choose between going along with the European Commission’s draft or exercising caution and not condoning controversial experiments. Members of Parliament’s Committee on Legal Affairs were opposed to the idea of including unethical products in the regulation, arguing that regardless of Member States’ rights and despite rapid progress in certain areas no compromises concerning human rights can be permitted. They maintained that the principles banning the use of the human body for commercial purposes must be upheld, and that creating animal-human hybrids or chimeras amounts to an infringement of the principle of human integrity and an affront to human dignity."@en1
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