German medics challenge new EU clinical drug trials
- 25 September 2012
- From the section Europe
German doctors have voiced concern about EU plans to speed up clinical drug trials and streamline testing procedures across the 27-nation bloc.
The German Medical Association (Bundesaerztekammer) said the proposal would undermine the safety mechanism provided by ethics committees, which do prior assessment of clinical trials.
The EU Commission wants a new EU draft regulation to take effect in 2016.
Bureaucracy is hampering human drug tests in Europe, the Commission argues.
After World War II Germany tightened up ethical standards in medicine, shocked by the abuses committed by Nazi doctors.
The new EU regulation would replace the 2001 Clinical Trials Directive.
Health Commissioner John Dalli, who presented the proposal on 17 July, said "800 million euros [£637m; $1.03bn] per year could be saved in regulatory costs and boost research and development in the EU, thus contributing to economic growth".
He insisted that patient safety would not be compromised.
The Commission says the current directive has been applied in diverse ways in the EU, leading to a big regulatory burden. That contributed to a 25% fall in the number of clinical trials conducted in Europe in 2007-2011, it says.
The new proposal cannot become law until EU health ministers - grouped in the EU Council - and European Parliament have approved it.
The Commission aims to make it easier to conduct multi-national clinical trials in Europe, by introducing one authorisation procedure, simplified reporting procedures and more transparency.
The proposal also calls for checks by Commission specialists on the conduct of clinical trials in the EU and other countries, to make sure the rules are properly supervised and enforced.
The news website Nature says the current directive has been criticised by many medical experts as excessively bureaucratic. They have also blamed the directive for the transfer of medical research to some non-EU countries where oversight of clinical trials is less strict.
German MPs are set to examine the new EU proposal this week.
The German Medical Association - the main ethical watchdog for doctors in Germany - says it wants the role of ethics committees in clinical trials to be made explicit in the EU proposal. It also says that rejection of a clinical trial by an ethics committee must mean that the trial is ruled out.
The proposal must also allow for member states to conduct their own checks in cases where a clinical trial is pioneered by one member state, the German doctors say.
The proposal also undermines German clinical trial safeguards for minors and for people incapable of giving consent, the association says.