BioWorld International Correspondent

BRUSSELS, Belgium - The European Parliament will vote this week on proposed new rules on advanced therapies. The European biotech industry is hopeful that the parliament will unblock the long and slow legislative process to create a single market for those products across the European Union's 27 member states.

This would overcome the difficulties that companies face due to widely divergent national rules. Notably, there is no consensus in the EU on embryonic stem cell research, which is banned in Italy and Poland, while the UK and Ireland are among those who allow it.

The proposal envisions common European rules for advanced therapies, the creation of a new supervisory role for the European medicines agency and guarantees of high levels of health and safety. But the precise wording of the parliament's crucial opinion on the text will emerge only after the voting, since more than 150 conflicting amendments have been proposed - 87 of them in the days leading up to this vote.

In the debate leading up to the vote, opinions remained widely split among members of the parliament, with champions of research clashing with those who felt they were defending Europe's ethics. Parliamentarians opposed to unbridled research - particularly research with embryonic stem cells - argued that the proposal opened the door to a Frankenstein-like world, and that people might be driven by poverty to sell their own cells. But other members branded such views as reactionary, and claimed that it was essential for European patients to have access to advanced therapies - and without new legislation, access would remain uneven across the EU, and consequently unfair to patients.

European Commission Vice President Günter Verheugen, the senior European official responsible for industry affairs, made clear that advanced therapies offer a major opportunity for European patients and European research, and urged early adoption of the proposal.

The industry has been pressing hard for a rapid resolution of the divergences. As late as last week, there were fears that the vote might be postponed to later in the year, which provoked questions in the industry about how seriously leading parliamentary figures were taking the question. The best possible outcome for industry in this week's vote would be agreement on a text that guarantees clear and standardized rules for market access for advanced therapies - and which would avoid another protracted debate on the issue in the parliament later this year.