MEPs to boost advanced therapies

A proposal to help the development of cutting-edge medical treatments and improve their availability is on a fast-track for EU legislative approval.

A vote by MEPs on the ‘advanced therapies’ regulation has been postponed from next Tuesday (13 March) to next month’s plenary session (23-26 April) to allow more time to negotiate a first reading agreement with the Council of Ministers, removing the need for a second reading.

Advanced therapies, including cell therapy, gene therapy and tissue engineering, could, it is hoped, one day offer a cure for disease from cystic fibrosis and cancer. It is already possible to use advanced therapies to generate new skin and cartilage.

There are currently no EU-wide rules for testing or registering advanced therapies. This leaves patients unsure of the safety of treatments and means that manufacturers have to register their products in 27 different countries.

Some member states, including Spain, France and the UK, were concerned that the proposed regulatory framework would impose complex changes on national health services. But ongoing ‘trilogue’ talks between the Council, European Parliament and Commission are reported to have brought all parties close to a deal.

"Agreement is not far off," said Walter Schwerdtfeger from the German ministry of health. "Everybody wants this. I don’t think there will be any blocking ­minorities in the end."

Germany has made an agreement on advanced therapies a priority for its six months in the rotating EU presidency.

An agreement now would signal a major about-turn for the Parliament. The assembly’s environment committee reached no decision on the proposal last September, citing ethical concerns over some advanced therapies.

The MEPs postponed a vote and in the meantime agreed that existing EU laws already control the use of the most sensitive therapies, including the modification of human genes, as well as the sale of human body parts.

But a rescheduled vote in committee on 30 January saw the regulation adopted by 55 votes to six, with three abstentions.

"MEPs realised the ­debate is not about ethics, but about safe products," according to one Parliament source. "The environment committee highlighted subsidiarity as the solution," he said, referring to the principle under which the EU may only act where individual member state action is ­insufficient.

"If Parliament stays with the amendment and the messages of the environment committee, a first reading agreement is ­likely," he concluded.

The regulation will set standard rules for the registration of advanced therapies but the final decision on whether to approve the therapies remains with individual member states.

Patient groups say agreement on EU-wide rules for advanced therapies is essential. "People with currently incurable diseases urgently need this," said Flaminia Macchia of patient group the European Organisation for Rare Diseases. The group says an ideal advanced therapies regulation would go even further than the text agreed by Parliament.

Macchia suggested that rather than allowing governments to choose which products should be available in their own country, patients and their families should have the right to accept or refuse advanced therapy treatment.

But opposition activists insist that ethical questions could not be excluded from the final text.

The Roman Catholic Church’s Commission of the Bishops’ Conferences of the European Community said that member states’ ministers and MEPs should not shy away from discussing ethics. It added it was not enough to rely on existing EU legislation to prevent the commercial sale of ­human body parts.

A proposal to help the development of cutting-edge medical treatments and improve their availability is on a fast-track for EU legislative approval.