BRUSSELS, Belgium - The European Union finally adopted its new clinical trials rules. As this directive comes into effect - a gradual process over the next two years - it will align many of the national procedures on authorization and ethical approval for clinical trials across the 15 EU member states.
Biotechnology medicines are among the principal intended beneficiaries of the new rules. The high administrative and financial costs of coping with the currently divergent national rules are more of a disincentive to small companies than to multinational giants, the EU reasoned.
The main effects of the new rules will be to limit the scope of national authorities to block the start of clinical trials. Ethics committees will have to give their opinion on a proposed clinical trial in a maximum of 60 days. And regulatory authorities normally will have just 30 days to object to a proposed trial once they have been notified of a company's plans, although this can be extended by a further 30 days if the authorities say they need more time to assess an application. It still will be necessary to notify of a proposed trial in each country, but at least the new regime will establish a hierarchy at the national level among ethics committees. Therefore, when a multicenter trial requires approval by more than one ethics committee, one of those committees will deliver what will be designated as the principal opinion.
But the European pharmaceutical industry is not entirely convinced of the merits of the new measure, particularly for biotechnology products. The European Federation of Pharmaceutical Industries and Associations said the maximum of 60 days for national authorities to give their go-ahead to a proposed trial is twice what the industry considers acceptable. And for ethics committees, EFPIA always asked for a 30-day maximum to be competitive with the U.S. In addition, what was proposed as a mere notification of national authorities of the intention to conduct a trial has been turned in the final text into a formal request for authorization, which industry fears could be used by some EU countries to impose additional controls.
And for biotechnology products in particular, there are some special constraints. Ethics committees will be allowed an unlimited extension of the period for them to reach an opinion when a trial involves gene therapy and somatic cell therapy. And anyone planning trials of such products, or of any medicine containing genetically modified organisms, will have to obtain written permission from the national authorities before starting a trial.