MEP loses battle over EU gene therapy rules

STRASBOURG: MEPs voted to back a controversial compromise deal on the regulation of stem cell and other gene therapies, defying rapporteur Miroslav Mikolasik.

Ahead of the vote on Wednesday, Mikolasik once again condemned the decision by shadow rapporteur Dagmar Roth-Berendt to put forward a rival proposal.

“I strongly oppose the action of the shadow rapporteur and other colleagues, which is undermining the role of parliament.”

“Only three groups have backed the compromise, and I have not been informed by council that member states would back the deal.”

Roth-Berendt responded angrily, saying she had the democratic right to table what amendments she wanted, and that the text she had put forward was the one agreed with the European commission and member states which Mikolasik had chosen to reject at the last minute.

He wanted to exclude stem cell and other gene therapies from the scope of the rules, because such technologies are not permitted in many member states.

Roth-Behrendt, along with the commission and council, had argued to include all therapies but allow member states to opt out from using them, allowing centralised control without obliging countries to compromise their ethics.

In the end, MEPs gave their clear support to the ‘rebel’ report, voting 403 in favour versus 246 against.

Separate amendments from parliament’s legal committee, also designed to exclude controversial treatments from the scope of the rules on the grounds that they would fall foul of EU internal market rules, were also rejected.

Mikolasik was obviously disappointed that his report was rejected, but with both the commission and the EU presidency making it clear that they would not negotitate with arliament if his version was approved, failure was almost inevitable.

And Mikolasik’s statement to the hemicycle that he would back whatever MEPs decided showed that even he had little hope of winning through when it came to the final vote.

Commission vice-president Gunther Verheugen, who had told MEPs on Monday that they needed to move swiftly to a conclusion to allow new treatments to be developed, was quick to welcome the decision.

“I am very pleased that the European parliament approved the compromise package. Today’s vote paves the way for an early adoption of this eagerly-awaited regulation, which patients and industry have been waiting for too long.”

“With this regulation, we unleash the EU potential for innovation, often driven by SMEs, while respecting member states decisions on ethical concerns.”

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