Strasbourg, 25/04/2007 (Agence Europe) - The European Parliament has finally given way to demands from the German Presidency of the Council, the Commission and patient and industry groups and voted by a comfortable majority to put a stop to the manoeuvring of EP rapporteur, Slovak Christian Democrat Miroslav Mikolasik. Unless something unexpected happens, the President of the EP and the President of the Council will be able to sign legislation in June 2007 based on agreement in first reading against the recommendations of the rapporteur, the first time this has ever happened in the codecision procedure.
The rapporteur's views were totally rejected in Strasbourg on Wednesday by the European Parliament, which approved by 403 to 246 with 11 abstentions the compromise package of amendments tabled by three political groups (the PES, ALDE and GUE/NGL), thereby putting the Mikolasik report out of the running. By a majority of no less than 100 votes (260 to 360 with 17 abstentions), MEPs also rejected the two ethical amendments tabled by the Legal Committee. All other amendments were also rejected. The vote on the ethical amendments revealed that all political groups are divided on the issue. Votes in favour of the ethical amendments came mainly from members of the EPP-ED, UEN, ITS and IND/DEM. The vast majority of MEPs in the ALDE, GUE/NGL and PES groups voted against the ethnical amendments. In a last ditch attempt to rally a few extra votes, Miroslav Mikolasik asked to address the plenary before the vote. He said he condemned and opposed the behaviour of the MEPs who had tabled the compromise amendment package who, he said, had short-circuited the rapporteur to the detriment of the interests of the EP. He called for MEPs to reject the compromise package and vote through the amendments contained in the Mikolasik report. German Social Democrat Dagmar Roth-Behrendt told him that the compromise amendments matched the votes on the EP committee and the outcome of the informal negotiations with the Council and Commission that had been disrupted by Mikolasik. Knowing that his own group would not support him (some five dozen members of the EPP, mainly from the UK, France and Belgium, voted against the ethnical amendments even), Miroslav Mikolasik finally gave up in his attempt, announced the day before, to have the package sent back to the EP committee after the vote on the amendments.
After this first reading, the text to be submitted to the Council has been endorsed by the European Commission, explained Gunter Verheugen on Monday evening (see EUROPE 9413) and could be rapidly endorsed by the Council. It introduces a centralised authorisation process for marketing of new medicines made from stem cells and tissue engineering. A number of amendments tabled by the EP, using wording felt to be acceptable by the representatives of the member states on the working group that studied the Commission's draft legislation, provide useful details about the definition of products combining medical devices with biological material. The solution selected requires centralised authorisation every time pharmacological or metabolic action predominates. Other amendments aim to facilitate SME access to the centralised procedure by cutting costs and providing a solution for medicines prepared in hospital. The EP also provided details on the traceability and surveillance of products.
The German Presidency wants the legislation to be pushed through and is expected to put the issue on the agenda of the Health Council of 30 and 31 May. If member states continue to defend the same position at the Health Council, it may be able to formally adopt the text, which would then come into force in the summer of this year. Its application in the field would have to wait another year, until the EU Medicine Agency in London recruits experts and establishes structures and procedures to assess the new products. (oj)