BioWorld International Correspondent

BRUSSELS, Belgium - The final and formal adoption of the European Union's new rules on advanced therapies have given the biotech industry another excuse for rejoicing - and they seized it with alacrity. Like hungry children in a candy store, they fell over themselves to applaud the compromise that was signed off by European ministers, after the European Parliament had given its approval April 25.

It was "exceptionally good news," "a landmark" and "a major milestone for Europe," bringing "new hope to patients suffering from severe conditions," were some of the enthusiastic words from Carlo Incerti, president of the European Biopharmaceutical Enterprises. He described it as a "much-needed framework for all companies, which have been investing heavily in the development of innovative therapies such as gene therapy or cell therapy-based medicinal products."

For Andrea Rappagliosi of Serono, a senior figure in EuropaBio, the EU association for bioindustries, the regulation "provides Europe with a great advantage to attract the leading companies researching and developing these innovative therapies and providing the scientific community, patients and industry with a predictable and clear legal framework."

Aisling Burnand, chief executive of the UK BioIndustry Association, said, "This regulation will enable patients across Europe to have access to safe and effective therapeutic treatments. It also will provide regulatory certainty for the biomedical research industry, currently developing some of the most ground-breaking medicines of our time." She predicted it would "strengthen the biotechnology sector in the UK and Europe."

The new regulation provides harmonized European safety standards and a single, integrated regulatory framework for the authorization and post-marketing vigilance of advanced therapy products. But because it is a compromise, it does not meet all the biotech industry's initial wishes. In addition, there also is much work to be done translating the text into the EU's 21 official languages, and then in developing secondary legislation and guidelines.

Some of the imperfections of the new legislation are demonstrated by the fact that Eucomed, the European association representing the medical devices industry, was equally ecstatic about the outcome - despite the fact that it had been locked in battle with the biotech industry throughout the months of discussion leading up to the final decision.

Eucomed said it is "good news" that the text adopted "appropriately excludes from the scope of the regulation tissue-engineered products containing or made exclusively from non-viable human or animal cells that do not act as pharmaceuticals." Fearful of seeing its domain carved up by the new rules, Eucomed had fought hard for those to remain covered by legislation based on the principles of the EU's medical devices directives.

And as further demonstration of the uncertainties left by the new rule, Eucomed said it believes "this could also be the case for some combination products associating a medical device [hip or dental implant, for example] and a coating made with human tissues or cells [added for biocompatibility and/or better integration]."

There remain even divergent views over when it will come into effect, and over exactly what it covers. While European Biopharmaceutical Enterprises believes it will be in force next fall, EuropaBio said the industry will have to wait until 2008. And while the biotech industry has been expressing relief that the rules do not embroil themselves with ethical considerations, German Health Minister Ulla Schmidt, who chaired the decisive May 31 meeting, said: "Appropriate attention is paid to ethical issues."