The proposal for revision of the directive on clinical trials - COM(2012)0192 - initially welcomed by stakeholders, now seems to be creating concerns for some. The Standing Committee of European Doctors (CPME) regrets the total absence of ethical considerations in the text.
The long-awaited proposal - which repeals Directive 2001/20/EC - was presented on 17 July 2012. In fact, stakeholders are virtually unanimous in their objections to the 2001 directive. Patients' associations, pharmaceutical firms and researchers criticise it for imposing too cumbersome a regulatory framework, particularly for administrative formalities. Clinical research has declined in Europe (25% fewer trials between 2007 and 2011) and relocated to emerging countries.
The European Commission is aware that member states want to keep their prerogatives on the ethical aspects (if only because national sensitivities come into play on certain aspects like stem cells) and has taken care to point out that its text "does not interfere with the member state's internal organisation" and "does not regulate or harmonise the precise functioning of ethics committees". They are in fact not even mentioned. The CPME is interested in seeing the regulation state that authorisation for a clinical trial can be issued only if independent ethics committees have evaluated it positively.
Most large-scale clinical trials are multinational. The authorisation procedure for such trials involves two stages: the first is...