Revision of clinical trials directive could take two years

Pharmaceutical companies should not expect revision of the EU directive on clinical trials for at least two years, according to the European Commission.

Publication of this directive dates back to 2001 and it has come in for criticism from trial investigators who consider it makes trials more difficult to implement because it imposes too many formalities.

Nicolas Rossignol, an administrator within the directorate general for enterprise, said that review of the clinical trials directive was not in the Commission's programme in 2008 and was unlikely to be reviewed in 2009 since both Parliament and the Commission are due to be renewed that year.

The European political calendar is full for 2009 since there will be European elections and a new team of Commissioners will be installed in Brussels. As a result, although the issue of clinical trials is an important one, observers consider revision of the directive is unlikely to happen next year.

However, Rossignol said it was a two-fold issue, with problems relating to the directive itself and problems relating to its transposition.

He said he was willing to "take part of the blame because the Commission has the right of initiative" in drafting EU legislation. But he pointed out that the Council, which represents the Member States, and Parliament, which represents European citizens, had "co-decided" the directive.