Brussels Watch: Clinical Trials Directive - European Parliament Meeting

The European Commission has now adopted formally its proposed directiveon clinical trials, and sent it to EU governments and the European Parliament for them to discuss. The directive is supposed to harmonize the conduct of clinical trials in the EU, and recasts the ethics committee review part of the process.

At end-September, the European Parliament was the venue for a conference on clinical trials and ethics, which included representatives from industry, the Commission, the Council of Europe, and patient groups. Rolf Krebbs, chief executive of Boehringer Ingelheim and president of EFPIA, the European pharmaceutical industry trade association, stated that although the research-based drug industry welcomed the directive as it would allow for the harmonization of clinical trials in the EU, the industry was concerned that excessively stringent legislation would hamper, rather than encourage, research and innovation. In particular, increasing regulatory requirements for Phase I and Phase IV trials in Europe would significantly affect drug development.

For its part, the Commission stressed the need to ensure that guidelines are respected and implementation of ethical review procedures is administered in such a way that trial subjects are properly informed. Despite EU governments and the Parliament now starting to consider the directive in detail, member states are only now reviewing concept papers for guidelines to support and "complete" the Directive.