Brussels, 19/04/2007 (Agence Europe) - No fewer than 159 amendments have been brought forward ahead of the first reading in the European Parliament of the draft regulation on a centralised authorisation procedure for the marketing of medicines derived from cell and tissue engineering. All the signs point to a hard-fought battle next week in Strasbourg between the supporters of a European mechanism to control the quality and safety of the products which could help patients throughout the EU, and those who are ready to shoot down the regulation simply to block development of treatments which use, even very indirectly, human embryonic stem cells.
To thwart the position of the rapporteur, Slovakian Christian Democrat Miroslav Mikolasik (who, in September 2006, drafted a report introducing ethical considerations which led to its rejection by the Parliamentary committee, then interrupted negotiations with the Council, which were about to bring an agreement), German Social Democrat Dagmar Roth-Behrendt, Belgian Liberal Frédérique Ries and Cypriot GUE MEP Adamos Adamou have presented a package of 75 amendments aimed at allowing the Parliament to return to the provisional outcome of negotiations with the Council and Commission. This “counter-report” brought an immediate reaction from Mr Mikolasik who is now threatening to call for the issue to be returned to committee, which would mean the whole procedure would have to be begun again.
Mr Mikolasik, however, has opponents even in his own group. In the face of his strategy of obstruction, French UMP MEP Françoise Grossetête added her signature to those of Ms Roth-Behrendt, Ms Ries and Mr Adamou on a letter calling for the rejection of the ethical amendments contained in the Mikolasik report without having been put to the vote in the appropriate committee, and to approve the package of amendments which would bring a swift agreement with Council on this key issue for patients (see EUROPE 9409). Even before the plenary session (the debate will be on Monday evening, and the vote on Wednesday), the battle has already begun within the ranks of the EPP-ED group, which will have to decide on Tuesday, whether it will instruct its members to vote for the ethical amendments, as Mr Mikolasik called on it to do, or tell Mr Mikolasik to return to his pipedreams. (oj)