MEPs to clash over ethics in advanced therapies vote

MEPs are bitterly divided over a proposal to regulate emerging medical treatments which is scheduled for a vote by the full European Parliament on Wednesday (25 April).

An alliance of Catholic and Green MEPs is pushing for amendments which would exclude products that contain or are derived from human embryonic or foetal cells from the scope of the ‘advanced therapies’ regulation.

The regulation is intended to provide an authorisation process for new treatments through the European Medicines Agency whose decisions would apply across the whole EU.

A majority of Socialist, Liberal and far-left MEPs side with patients’ groups and pharmaceutical companies arguing that the ‘ethical amendments’ will delay approval of the EU-wide authorisation scheme and leave patients deprived of possible treatments.

They argue that the regulation would not prevent national governments that have outlawed certain treatments from excluding them from their national markets.

The Germany presidency of the EU has been trying to broker agreement between the European Commission, the Council of Ministers and the Parliament to get the regulation approved in a single reading.

After talks between the three institutions in February and March, they concluded that an agreement was close, based on dropping the ethical amendments which had been approved by the Parliament’s legal affairs committee last June but were not supported by the Parliament’s environment, public health and food safety committee.

But the Slovak MEP drafting Parliament’s position, Miroslav Mikoláöik, of the centre-right EPP-ED group, announced on 27 March that he would be including the ethical amendments.

Yesterday (18 April) a group of MEPs led by Belgian Liberal Frédérique Ries, German Socialist Dagmar Roth-Behrendt and Cyprus’s Adamos Adamou of the European United Left-Nordic Green Left put forward amendments to Mikoláöik’s report that would return it to what the Council wants.

Governments and the Commission had chosen to leave ethical questions out of the regulation, saying that EU law already allowed countries opposed to specific therapies to ban them.

Wills Hughes-Wilson of biotechnology umbrella group EuropaBio said that Mikoláöik’s decision to reintroduce the ethics questions had taken everyone by surprise. She said that the regulation was urgently needed to replace a complex patchwork of national rules, which were discouraging investment in European advanced therapies, used to repair skin and cartilage damage. It is hoped that one day they could offer a cure for diseases including cancer and cystic fibrosis.

Flaminia Macchia from patients’ group the European Organisation for Rare Diseases accused Mikoláöik of delaying his announcement in the hope of reducing the time available to build opposition to the amendments. She said that both Mikoláöik and German EPP-ED MEP Karl Heinz-Florenz had caved in to pressure from their Catholic colleagues.

On the legal affairs committee the ethical amendments were proposed by Green MEP Hiltrud Breyer, who won support from colleagues in the Green and centre-right EPP-ED groups.

The proposal will be debated on Monday and voted on Wednesday.

The deadline for proposing amendments was yesterday evening (18 April). At the time of going to print, it was unclear how many amendments were proposed. If there are more than 50, a plenary vote would be postponed for the environment committee to vote on the whole package.

If the ethical amendments are approved, the MEPs will set themselves up for a clash with the Council.

"At this stage it is impossible to predict how the vote will go," said a German diplomat, "but there is absolutely no way this amendment could be accepted by Council."

MEPs are bitterly divided over a proposal to regulate emerging medical treatments which is scheduled for a vote by the full European Parliament on Wednesday (25 April).