BioWorld International Correspondent

BRUSSELS, Belgium - The European Parliament has given strong backing for Europe-wide rules that will offer a standardized approach to the development of advanced therapies.

A last-minute political compromise rescued the proposal from an ambush mounted by a small group of politicians who claimed that ethics would be compromised by the measure, and wanted to exclude stem-cell products from its scope. But the European biotechnology industry greeted the decision with relief, with senior executives describing the measure approved by the parliament as the best outcome they could have hoped for.

After weeks of uncertainty over the parliament's intentions, and after months of delay in getting to a vote, the debate was over quickly, and the vote delivered a clear result. A new fast-track regulation could become official within days, and apply across the European Union in less than a year. It establishes a robust centralized market authorization procedure for assessing the safety, efficacy and quality of advanced therapies.

That will pool expertise at the European level and provide direct access to the entire EU market, removing the hurdles of addressing 27 differing regulatory systems across Europe.

The measure creates the Committee for Advanced Therapies within the European Medicines Agency in London to advise and develop criteria and guidelines for evaluating products. Special incentives also will be given to smaller firms to develop new products, in terms of reduced fees for scientific opinion and marketing authorization.

On the contentious ethical aspects of advanced therapies, the regulation only seeks to ensure that products given to EU patients are safe and work effectively. But it does not take a position on whether products are ethically acceptable; that will be addressed by member states through their own national legislation. Member states remain free to accept or forbid some therapies on their territory. The regulation also specifies that donation of cells and tissues will be voluntary and unpaid.

"The European Parliament's vote opens the door for a much needed regulation to come into force this year if adopted by the council and ensures that patients will get quicker access to safe, advanced medical treatments," said Wills Hughes-Wilson, chair of the Advanced Therapies Working Group at EuropaBio, the EU association for bioindustries.

"It is a big day for European biotech and for European patients," said Johan Vanhemelrijck, EuropaBio secretary general. "The new regulation will put an end to the bewildering patchwork of guidelines, regulations and procedures that exist today."

"This is a very positive development and good news for Europe's patients, industry and research-base. The European biopharmaceutical industry now urges the council to finalize this important regulation and adopt it as rapidly as possible," said Carlo Incerti, president of the European Biopharmaceutical Enterprises.

Aisling Burnand, chief executive of the UK BioIndustry Association, said the vote "is tremendously significant for both patients and biomedical research across Europe. It will enable patients to access ground-breaking new therapies and ensure that these treatments fulfill high standards of safety, efficacy and quality."

Eucomed, the European Medical Technology Industry Association, also expressed satisfaction. "The vote is good news for European patients. Europe is one step closer to making a variety of cutting-edge treatments more widely available," said Maurice Wagner, director general of Eucomed.

European Commission Vice President Günter Verheugen, who is responsible for industry affairs in Europe, said the vote "paves the way for an early adoption of this eagerly awaited regulation, for which patients and industry have been waiting for too long. With this regulation, we unleash the EU potential for innovation, often driven by smaller firms, while respecting member states' decisions on ethical concerns."

Miroslav Mikolasik, the Slovak conservative member of parliament who had piloted the proposal through its committee stages, and who had argued in the end that the EU should not authorize any products banned by some countries on moral grounds, criticized the outcome as a genuflection to commercialism.

"Today's vote shows where Europe stands in terms of ethics," he said, describing it as "a victory of purely utilitarian and absolutely commercial approach."