BRUSSELS, Belgium - Continued disagreements within the European Union over how to handle advanced therapies are condemning the biotech industry to further delays in its push for legislation.
The key figure in the European Parliament's discussions of the draft rule, Czech physician Miroslav Mikol ik, has concluded that the gap between parties is too wide for him to win approval for his report when it comes up at the Parliament's plenary session later this month.
He has abandoned attempts at brokering an early compromise among the rival schools of thought. Mikol ik was speaking after a meeting between EU officials, diplomats and politicians, convened to smooth out the remaining differences in order to speed adoption of the draft rule. Among the outstanding problems are rivalries among the EU institutions over who has the authority to decide on ethical questions, with member state governments flatly rejecting some late inclusions into the parliament's report.
"It is absolutely unacceptable to neglect the position of the legal affairs committee, which is a leading committee in the European Parliament in the matter of ethics in new technologies," Mikol ik said. "These two amendments are an inseparable part of the report," he insisted.
There also are disagreements over the determination of some member state governments to obtain national derogations from the EU-wide authorization procedures envisioned for advanced therapies.
"I'm very much disappointed and regret the delay we have to face now," Mikol ik said. "It will have harmful consequences for the patients who are waiting for treatments. But I can't accept the nonrespect of the competence of one of the major parliamentary committees."