Strasbourg, 24/04/2007 (Agence Europe) - Just before the vote to be held in Strasbourg, the European Parliament remained very divided over the authorisation of new therapies resulting from cell and tissue engineering. On Tuesday evening, some groups still had to meet to seek to achieve the impossible, a common position. Such was the case of the EPP-ED in particular, although the rapporteur did state during a conference that his group had given its support. Miroslav Mikolasik trusts his report will be adopted together with the two ethical amendments - rejection of which, he said, would “automatically lead to promoting therapies derived from embryonic cells”. While denying that he wanted to delay adoption of the regulation, Miroslav Mikolasik announced that he would call for referral back to committee just before the final vote, if the compromise amendments, which have the endorsement of the Commission and Council, are approved by the plenary.
On Monday evening, the vice-president of the European Commission, Günter Verheugen, had, however, called on MEPs not to put off the procedure any longer, and to decide at once. It is a regulation that is long awaited, he said, speaking not only of patients' expectations but also of those of SMEs and the pharmaceutical industry. “I am pleased that three groups have suggested a compromise in order to reach a rapid agreement”, said Günter Verheugen, explaining that the Commission and Council can accept this compromise package as such. While acknowledging that ethical issues are sensitive, he recalled that “this regulation only aims to allow access to safe medicines” and that it respects subsidiarity for ethical matters. He went on to conclude by calling on the Parliament to support the package of compromise amendments submitted by Dagmar Roth Behrendt, Frédérique Ries and Adamos Adamou (EUROPE of 20 April).
Giles Chichester, who chairs the industry and research committee, said he was entirely in agreement with Mr Verheugen. The British conservative member does not agree with the rapporteur or with the two amendments of the legal committee which, he said, go along in an opposite and backward-looking direction. German Social Democrat member Dagmar Roth-Behrendt took the view that “it would be cynical, irresponsible and shameful to want to delay things”. She felt that a result was needed as swiftly as possible and that the Council and Commission had, during the informal trilogue, done everything possible to close the gap with the positions of the Parliament. Furthermore, nothing will prevent member states in future from banning a product on their territory for reasons purely related to public policy. Belgian Liberal Frédérique Ries pointed out that amendment 62 of the environment committee was validated by the legal services of the three institutions and guarantees subsidiarity for ethical aspects. “Each day, I receive letters from patients' organisations asking us not to put off the text any further”, said Adamos Adamou, Greek United Left member from Cyprus, urging for an agreement in first reading. Such an agreement is still possible if the Parliament only approves compromise amendments. “It is necessary for patients to have access to products without discrimination, to safe and effective products. Without European legislation, we would encourage discrimination and medical tourism”, said French UMP member, Françoise Grossetête, who supports the compromise amendments. “No-one calls on a member state to authorise or to ban anything”, noted Antonios Trakatellis, Greek Christian Democrat, before going on to add: “I do not understand this debate when patients' expectations are so high. We must not hinder therapies that would cure Parkinson's disease, diabetes or cancer. I am against the amendments of the legal committee”.
Slovakian Christian Democrat Miroslav Mikolasik, rapporteur, said the compromise amendments are “cut and pasted” from the Commission text with cosmetic changes here and there. Some compromise amendments do not have the support of the parliamentary committee responsible for substance, nor that of the legal committee or industry committee, he said, calling for his report and two controversial ethical amendments to be voted. He received the support of German Green member Hilrud Breyer, who mainly stressed the need for ethical amendments to be adopted, without which the Court of Justice would no longer allow a ban on the use of embryos. Konrad Szymanski, Polish member of the UEN Group, and Kathy Sinnott of Ireland, of the IND/DEM Group, also highlighted the need to safeguard embryos. German Christian Democrat Peter Liese accused Socialists and Liberals of being responsible for the six-month delay in adoption of the regulation due to the rejection of the first Mikolasik report in September 2006. He did not spare the Commission either, reproaching it for having dragged its feet on this proposal for three years. Hungarian Christian Democrat Peter Olajos gave his support to Mr Mikolasik, trusting that the Parliament would make a “pro-life choice”.
Speaking on behalf of the German Council presidency, Klaus Theo Schröder explained that decisive progress has been made in negotiations with the Parliament. “We have taken into account the EP's technical amendments. We have the basis for a good compromise with which the Council agrees”. “The important thing is the quality and security of therapies. On ethical aspects, we already have a directive on cells and tissue. It is a matter of subsidiarity. There is already an agreement on it. That is why the Council has not adopted the legal committee's amendments which would prevent agreement. This must be given a lot of thought when voting”, he said, calling on MEPs to think of the patients. (oj)