Press Release

30/03/2007

Advanced Therapies - 1st reading agreement not possible. Miroslav Mikolášik MEP

Today's informal trialogue meeting on advanced therapies has shown deep discrepancies between the positions of the European Parliament's main rapporteur Miroslav Mikolášik, MEP, together with some shadow rapporteurs, the Council and the Commission in this highly anticipated legislative proposal. After the meeting, Miroslav Mikolášik has announced that there will be no further negotiations with the Council and the Commission for a first reading agreement.

One of the main reasons is the fact that the two other institutions wanted to exclude the two amendments of the Legal Affairs Committee adopted under the Hughes procedure from the negotiations about a possible first reading agreement. JURI committee as a committee responsible for ethical questions relating to new technologies under the enhanced cooperation procedure has delivered an opinion on the proposal on advanced therapies. Two amendments were accepted by the leading Environment committee without a specific vote, but were adopted as part of the final report.

The informal trialogue discussions between the three EU institutions which started at the end of February have disclosed several problematic areas, particularly the question of the temporary national derogation from the European marketing authorisation, the subject of an amendment adopted by the ENVI committee but not supported by the Council. Other crucial points of disagreement were the two amendments by the Legal Affairs Committee. "It is absolutely unacceptable to neglect the position of the JURI committee which is a leading committee in the European Parliament in the matter of ethics in new technologies", declared Miroslav Mikolášik. "Colleagues who voted in favour of the report in the Environment committee have agreed on the inclusion of these two amendments in the final text. They are an inseparable part of the report", he added.

Consequently, the first reading vote on the report on advanced therapy medicinal products, on the agenda of the April plenary session, will now have to be followed by a second reading. "I'm very much disappointed and regret the delay we have to face now. It will have harmful consequences for the patients who are waiting for treatments. But I can't accept the non respect of the competence of one of the major parliamentary committees", stated Mikolášik. "And I can't accept the criticism about the delay from those who rejected my draft report in September of last year", he continued.


The first Mikolášik report has been rejected in the Environment committee largely by Socialists and Liberals in September 2006 because of ethically controversial matters related to this dossier. The second report has been adopted by a large majority last January by the same committee.

Advanced therapy medicinal products and related treatments which involve intervention in gene therapy, cell therapy and tissue engineering are of a major importance, having great potential in the treatment of diseases such as cancer, cartilage or bone diseases and injuries, repair of genetic disorders, repair of post heart attack damage or skin replacement in burned victims. The Commission's proposal introduces for the first time an integrated European regulatory framework for these products and lays down the rules for their European marketing authorisation, supervision and pharmacovigilance. The main objective is to ensure a high level of health protection within the EU, harmonise market access to treatments and foster the competitiveness of the European undertakings operating in this field.

The rapporteur continues to believe that the report as it will be presented in the next plenary session in Strasbourg represents a very good base for further discussions with the Council and the Commission after the first reading. "Lets wait for the outcome of the vote and then we will reopen the intensive exchange with the Council and the Commission in the view of the second reading", declared Miroslav Mikolášik.


For further information:
Office of Miroslav Mikolášik MEP, tel: +32-2-2847289