New clinical trial laws increase workload, says French pharma

Pharmaceutical companies in France say they have been faced with added work to get approval for clinical trials and monitor them since new legislation came into effect. The new legislation on clinical trials, which implements European directive 2001/20/CE, came into effect in France at the end of August.

Industry clinical trial sponsors have found that two stages in the process especially - the preparation of the trial authorisation dossier and pharmacovigilance monitoring - have resulted in more work. 'The authorisation request dossier must now be more complete and must contain details about the manufacturing of the product,' said Claire Sibenaler, head of regulatory affairs, clinical trials and the environment, at French industry body Leem (Les entreprises du medicament).

Previously, sponsors only had to 'notify' a study launch. Now they must request authorisation from the competent authorities, with the support of a proper dossier.

Companies must also supply more complete pharmacovigilance data, at specific dates. The new rules include the obligation to draw up an annual safety report containing all adverse effects and events for each trial, according to Wyeth.

'We always used to monitor adverse effects carefully, but now we have to do this in a specific way, within a specific context,' said Sibenaler.

'We have had to set up special teams to prepare clinical trial authorisation dossiers, mainly at parent company level,' said Christian Rollin, head of Bristol-Myers Squibb's research department in France. 'Companies have had to create a department of 10 or so people in charge of compiling the dossiers.'

Clinical research departments also have an increased workload, especially from compiling dossiers for authorisation by French ethics committees (the Comites de protection des personnes , CPP). The new procedure of submitting requests by dossier has also increased spending for pharma companies.

'The initial amount is Euro 6,000, plus an extra fee for amendments, which represents a total cost of €7-8,000 per trial,' said Rollin. For a company like BMS France, which carries out between 20 and 30 studies annually, this means between €150,000 and €200,000 extra annual expenditure.

'This extra cost won't limit the number of studies launched, but it remains to be seen whether companies in France will remain competitive in terms of speed and efficacy, with these new procedures,' Rollin warned.

To measure the impact of the new legislation, Leem, in collaboration with the European Federation of Pharmaceutical Industries and Associations (EFPIA), is to launch a survey of its members, with results available at the end of 2007.