Concerns over proposed Clinical Trial Directive

The proposal for revision of the direc­tive on clinical trials - 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 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 would like to see references stating that authori­sation for a clinical trial can be issued only if independent ethics committees have evaluated it positively.

The CPME is surprised that the reg­ulation does not require the doctor to provide information on the objectives, risks and inconveniences of a clinical trial (to allow participants to give their informed consent or not). The organi­sation also regrets the very weak provi­sions on the publication of trial results. 

Sources:

Euractiv, Europolitics, EU Observer, EUROPA website, various NGO websites.