Another fine mess

Decision “shows contempt for patients”, says patient group Eurordis

The talking shop that was attempting to find some sort of (workable) compromise to push through a single regulatory framework for advanced tissue therapies was liquidated last week when the chief negotiator Slovakian MEP Miroslav Mikolasik concluded he had no chance of reconciling the opposing forces and presenting an agreed technical report to the parliament in Strasbourg next week.

At issue were amendments that would have excluded products based on embryonic stem cell research.

Recriminations have followed. The strongest perhaps came from Eurordis, the organisation representing patients affected by rare diseases, which said it was astonished by Mikolasik’s decision to terminate the negotiation process between the Parliament, the Council and the Commission.

Based on religious beliefs

“This decision – based on personal religious beliefs – shows contempt towards European children and adults suffering and dying from incurable diseases and who are eagerly awaiting innovative, effective and safe therapies,” said Eurordis, in a statement.

Eurordis further accused Mikolasik of disregarding the plan agreed by the Parliament, the Council and the Commission to work together on the uncontroversial technical aspects of the regulation and leave ethics to the plenary vote.

EuropaBio, the European industry association, appeared on the face of it to be more measured, saying it was “Deeply disappointed by the breakdown in the informal talks between the Parliament, Council and Commission.”

But Europabio too, accused Mikolasik of underhand manoeuvres, in not keeping to the agreement to agree non-controversial technical matters and put ethical issues on one side until the plenary vote.

Johan Vanhemelrijck, EuropaBio Secretary General, called upon Mikolasik to continue with the approach that had been agreed. “Insisting on a short-term push to include these amendments into the compromise package creates the risk of losing out on the long-awaited objective to have advanced therapies regulated at European level for Europe’s patients, clinicians, researchers and industry.”

Agreement not dead yet

Mikolasik himself still thinks agreement is possible, though in the absence of an agreed technical report the machinations will now take much longer. “I’m very much disappointed and regret the delay we have to face now. It will have harmful consequences for the patients who are waiting for treatments,” he said.

But as EuropaBio pointed out, Europe has already spent a long time waiting for this legislation. The move to create a single approval procedure for advanced tissue therapies, operating along the same lines as the system for drug approvals, began five long years ago.

A further delay compounds the problems faced by companies in the field, while patients lose out as they wait in vain for treatments and Europe‚s competitiveness slides still further.

And so, advanced tissue therapies now joins patents, genetically engineered crops, a single market for services and energy markets, among others, where failure to agree a regulatory framework is ambushing the Lisbon objectives and damaging its citizens.