Parliament agrees advanced therapies regulation

The vote Wednesday clears the way for a swift approval by national governments in the weeks ahead after expected approval of the new regulation by the Council of Ministers in the coming days.

Scientists and businesses alike have been calling for the law they say will boost Europe’s competitiveness in the most high-tech areas of medical research.

But some European Parliamentarians tried to exclude therapies developed using embryonic stem cells from the scope of the law for ethical reasons. Their attempt to limit the scope of the law sparked a last-minute lobbying frenzy by both sides in the argument.

The law covers gene and cell therapies and tissue engineering. These treatments offer hope to thousands of patients with conditions that are untreatable using conventional medicines. But until now approving the advanced therapies has been complicated because they aren’t covered by standard, Europe-wide pharmaceutical rules.

The proposed regulation would harmonise the market approval procedure for the new types of therapies across the Union, saving time and money for companies like Genzyme, an American biotech company specialized in developing gene and enzyme-based treatments for very rare conditions.

Defeat for ethical amendments

The outcome of the vote turned on whether or not parliamentarians would support a compromise package of amendments that specifically excluded all ethical amendments, and on whether the ethical amendments themselves were adopted.

The main aim of the ethical amendments, which were proposed by ultra conservative and staunch Catholic MEP Miroslav Mikolasik, and by Hiltrud Breyer, a Green Party member, was to prevent any therapies derived from embryonic stem cell research from getting pan-European authorisation, as they can under this new law – although it will still be up to national governments to decide whether such therapies should be marketed in their countries.

But the attempts to exclude stem cell research from the pan-European authorisation procedure failed. The compromise package was adopted with 403 MEPs in favour, 246 against and 11 abstentions, and all ethical amendments were rejected outright.

“We are delighted with the vote. It was the best possible outcome,” said Wills Hughes-Wilson, director of European healthcare at Genzyme, by telephone from the Parliament chamber in Strasbourg.

“Today is a big day for Europe’s biotech sector. We applaud the Parliament for taking this courageous decision,” she added.

The compromise package of amendments adopted is almost identical to a compromise text negotiated (but never agreed) between the European Parliament and the Council of national government ministers last month.