The European Commission and the European Medicines Agency (EMEA) have acknowledged the nagging concerns about the implementation and impact of the EU’s Clinical Trials Directive by announcing a joint conference that will look at experience with the directive to date.
The conference on the “operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future” will be held at the EMEA in London’s Canary Wharf on 3 October 2007. The meeting is intended as “a stocktaking, involving the Member States and all major stakeholders, with a view to evaluating whether further work on the implementation [of the Directive] will provide opportunities to resolve existing problems and whether a revision of the Directive is necessary”, the EMEA said.
At its meeting on 5 December 2006, the European Commission’s Pharmaceutical Committee endorsed a report on the activities of the ‘Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use’, the EMEA noted. This report confirmed that “experience with implementation of the legislation varies between the Member States, and that it is not yet possible to fully assess the impact of some of the guidance prepared”.
Nonetheless, the agency added, “it appears clear that, unfortunately, some of the obstacles as regards the administrative burden and differences in implementation have not yet been overcome”.
According to the summary record of the Pharmaceutical Committee’s meeting last December, priority areas for attention identified in the ad hoc group’s report included approval times and procedures, specific national requirements, the definition of an investigational medicinal product, the conduct of non-commercial clinical trials, and the functioning and co-ordination with competent authorities of ethics committee activities.
Among the session topics for the conference on 5 October are:
- What aspects of Directive 2001/20/EC and its implementing rules work well?
- What does not work well?
- What can be remedied within the present legal framework?
- What should a new legal framework look like?
Academic researchers in particular have voiced concerns about the administrative and cost burdens of the Clinical Trials Directive, as well as the barriers put up by discrepancies in the Directive’s legal interpretation and regulatory application at Member State level. In a recent analysis published by PloS Clinical Trials, medical and regulatory affairs consultant Markus Hartmann and lawyer Florence Hartmann-Vareilles concluded that “the promises of the Directive have not been fulfilled”.
Among the obstacles highlighted as a particular bugbear for non-commercial trials were the need for single sponsorship of multicentre (including pan-European) studies; the definition of an investigational medicinal product (IMP), as opposed to background or supportive medication; the supply principle that requires trial sponsors to provide the IMP free of charge; the increased cost of insurance coverage and quality insurance systems; and the increased cost of submissions to ethics committees and national authorities as well as fees for Good Clinical Practice inspections.