Proposal on clinical trials welcomed
By Ophélie Spanneut | Wednesday 18 July 2012
All players applaud the proposal, presented by the European Commission on 17 July (see
Europolitics4467), that will change the nature of legislation on clinical trials from a directive to a regulation, thus avoiding diverging transposition. “With the directive, member states divert rules and often add a layer of constraints,” commented Philippe Juvin (EPP, France).
While the European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the measure, it nonetheless has concerns about its feasibility given the confusion of competences. The Commission will have to juggle with EU competences and those that fall to member states, since elements related to civil and criminal liability rules and ethical aspects (such as informed consent) remain a national competence. Juvin proposes a “national unification system” based on the idea that the opinion of ethics committees should be valid at national level. In certain member states, like Italy, such committees are regionalised and researchers have to obtain the approval of all the regional committees where trials are conducted. According to Juvin, there is reason to deal with ethical matters at national level since sensitivities (eg on stem cells or abortion) are strongly country specific.
The Commission was careful to point out that its text “does not encroach on member states’ internal organisation,” nor does it “regulate or harmonise the detailed functioning of ethics committees”. This is seen as a signal to the Council, since member states brandished the argument of subsidiarity in the negotiations with Parliament and the Commission in 2000 on the directive currently in force.
Introduction of the concept of ‘low intervention clinical trials’ is also welcomed. Thom Duyvené de Wit of the European Hematology Association recognises the need to make a distinction between regulatory constraints in terms of the risk involved in clinical trials. The European Cancer Patient Coalition (ECPC) notes that, since 2005, the share of non-commercial clinical trials has dropped from 40% to 14%. Such trials test the effectiveness of using lower doses of medicines already on the market, for example.
With respect to the transparency demanded by NGOs (4440), Health Action International (HAI) notes that “the EU database described in the Commission’s proposal has the potential to open access to clinical trials data”. HAI cautiously adds that for such a base to be effective, however, it “needs to include all raw data, be governed by clear and limited definitions of exceptions to disclosure and be easily searchable”.
The UK-based association Cancer Research hopes that the proposed changes will “make it easier for cancer patients and the public to take part in world-class research”.