EU cuts deal on controversial gene-therapy rules

STRASBOURG - MEPs have approved new EU rules for testing and authorising modern medical therapies and rejected calls by conservative members to exclude ethically-sensitive medicines from the bill's scope.

The legislation passed on Wednesday (25 April) sets out the technical details on regulating at EU level so called "advanced therapies" - gene therapy, adult stem cell therapy and tissue engineering.

Stem cell therapy - which experts believe could in future be crucial for the treatment of blindness, spinal cord injury, as well as Alzheimer's and Parkinson's - is the most controversial as it can involve cells being extracted from human embryos.

The practice is currently legal only in a few countries, such as the UK, and the new rules uphold the right of individual member states to ban both research and sales of medicines developed from embryonic cells from human beings.

But MEPs did not support amendments promoted by the Slovak conservative deputy Miroslav Mikolasik - the parliament's main expert on the issue, who argued that the EU stamp should not be granted to products banned by some countries on moral grounds.

"Today's vote shows where Europe stands in terms of ethics," he said, adding "we could see a victory of purely utilitarian and absolutely commercial approach to what will be Europe's reality of tomorrow."

Mr Mikolasik maintains that once all products are registered at EU level, it will be difficult for national governments to prevent their spread.

Moreover, he believes that if companies producing controversial medicines took countries to the European court for blocking their products, member states would most likely lose the case on internal market grounds.

Deal-making in Brussels

But German socialist MEP Dagmar Roth-Berendt rejected the argument. "Countries like my own did ban embryonic stem cell research in the past and they will continue to do so as this legislation does not prevent them from it," she said.

The European Commission and German presidency expressed the same opinion and took the rare move of clinching a deal ahead of Wednesday's vote with MEPs from socialist, liberal and leftist groups, ignoring Mr Mikolasik.

The new rules are now set to enter a fast-track legal procedure and could go into force as early as mid-2008.

Bioindustry groups welcomed the decision, saying it will remove Europe's differences in rules on the authorisation of the new therapies, which hampers research.

"I know it's controversial in some countries but they should realise that for the sake of current and future patients research must go on - at least in those member states that allow it, even on cells extracted from human embryos," Stefanie Pingitzer from Europa Bio told EUobserver.

At the moment, there are no medicines based on embryonic stem cells available in the European markets, as none have been developed yet.