MEP defends stance on EU gene therapy rule

STRASBOURG: Slovak MEP Miroslav Mikolasik has strongly denied suggestions that he is deliberately delaying the implementation of new rules on the approval of stem cell research.

“I refute these claims,” he told journalists in Strasbourg on Tuesday, responding to accusations from shadow rapporteur Dagmar Roth-Behrendt that he has tried to scupper negotiations with the European commission and member states on this sensitive issue.

Mikolasik, who wants to remove controversial stem cell technologies from the scope of the regulation, has been accused of making a U-turn in negotiations with the other two institutions.

Both the commission and member states have backed a compromise proposal put forward by Roth-Behrendt and two other MEPs that would oblige all gene therapies to be assessed at EU level but would allow member states to opt out of allowing them.

Identical rules are already in place across the EU with regard to contraceptives – all contraceptive treatments must meet agreed EU standards but member states are free to decide whether to allow them to be sold – Ireland, for example, maintains a ban.

Mikolasik said that his initial report had been backed by the lead parliament committee – the environment committee – and had been endorsed by the majority of his centre-right EPP-ED group, although he recognised that some of his own group would vote against the report.

He said that it was not acceptable that a compromise deal be put forward without his knowledge or approval, or that of the lead committee.

Mikolasik said that the compromise agreement would not be acceptable under EU internal market rules, and that a successful challenge of the rules at the European court would lead to a de facto approval of all gene therapies throughout the EU.

“This would mean that countries that currently ban stem cell and other genetic research would be obliged to allow it, a situation that is unacceptable,” he said.

He urged MEPs to back his proposal, denying suggestions that removing stem cell research from the scope of the regulations would leave them unregulated in the “wild west”.

But the European biotech industry, represented by Europabio, said that Mikolasik was clearly delaying the adoption of the vital new regulation by insisting on the ethical issue.

“At the press conference in February following talks with both commission and council, the rapporteur said quite clearly that he would not hold up the negotiations on ethical grounds,” a spokeswoman for Europabio told TheParliament.com.

“That is why Dagmar Roth-Behrendt is so angry, because these ethical issues have reappeared at the last minute and could scupper the whole negotiation.”

According to Europabio, parliament’s own legal services had highlighted two possible courses of action: strengthening the wording of the original proposal to allow member states to opt out of using gene therapies or removing them entirely from the scope.

But, crucially, they also recommended that the latter course of action should be avoided – a fact seemingly overlooked by Mikolasik and parliament’s legal affairs committee, which has backed his report.

“The amendments put forward by Roth-Behrendt include verbatim the first proposal from parliament’s legal services – merely rewording the original proposal as agreed by parliament’s environment committee to make it legally acceptable to member states,” the spokeswoman said.

Mikolasik told this website that member states would not be able to ban the use of stem cell technology on moral grounds – as suggested by Roth-Behrendt – but this also appears unfounded, the spokeswoman said.

“Article 95 of the EU treaties – which covers the internal market – states quite clearly that even if there are fully harmonised EU rules in one area, member states can still opt out on moral or environmental grounds.”

Concerns that allowing gene therapies would lead to the creation of animal-human hybrids, cloning or eugenics were also dismissed.

“These are already clearly banned under existing EU rules, so there is no risk that this could happen – you simply cannot get the permission to start this kind of research anywhere in Europe.”

“Most member states want the assessment of gene therapies to take place at EU level, because many don’t have sufficient expertise to do it themselves,” the Europabio spokeswoman said.

Roth-Behrendt repeated her claims that Mikolasik was deliberately delaying the new rules.

“The raporteur has given preference to his personal position against a European parliament unanimous decision,” the MEP said.

“With this irresponsible behaviour, the rapporteur has delayed the adoption of this important piece of legislation by at least another 12 months,” she said.

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