EU regulation progresses on clinical trials

Along with others, Germany has unanimously welcomed the revision of the EU directive on clinical trials. The change from mere guideline into a regulation valid in all member states, specifically aimed at making it easier to carry out multinational studies, is particularly welcomed, Bettina Döbereiner reports

Joerg Hasford
Joerg Hasford

However, the EU commission’s draft presented last summer was heavily criticised and the EU Committee on Public Health has since amended this, considering important points of criticism – but not all of them. In the first public reaction to the EU regulation, representatives of the German medical fraternity, of Ethics Committees as well as representatives from the former ruling- and opposition parties who heavily criticised the previous draft now positively stressed the fact that the EU parliamentarians will make a testing of study projects by ethics committees mandatory – and, unlike in the previous draft, have also stipulated this in the regulation.

The fear that sponsors – mostly pharmaceutical companies – could choose a country for studies that primarily look at the assessment of the cost-benefit ratio for multinational studies, and where testing standards are low, has also been allayed. In the current draft, the choice will be made based on an independent voting procedure.

The EU parliamentarians also agreed that – in correspondence with German law – minors and incapacitated adults are to be given special protection. People who cannot freely choose their domicile, such as prisoners or sectioned psychiatric patients, are now also adequately covered.

Also particularly welcomed are transparency specifications. Clinical study reports will have to be published 30 days after a drug has been licensed. ‘This is a first,’ said Professor Wolf-Dieter Ludwig, Chair of the German Medical Association’s Drug Commission. Cases where researchers had for years tried unsuccessfully to obtain clinical trial reports from pharmaceutical firms – e.g. for the flu medicine Tamiflu – will hopefully soon become a thing of the past, he said. Moreover, it will now also become mandatory to publish an easy to understand summary of study results within a year of the study completion – even in cases where a drug is subsequently not licensed. Violations of these regulations will incur fines, just as they do in the USA.

Advocates of the Commission’s draft also welcomed the Act of Parliament. The Chair of the German Society for Haematology and Oncology, Professor Mathias Freund, specifically welcomed the fact that, based on an OECD classification, a distinction will be made between clinical trials and low risk trials, with all trials involving medicines that have already been licensed, classed as low risk trials. These studies are to have shorter authorisation periods and will also be covered by the necessary insurance via a national compensation mechanism. This would represent a significant financial relief for mostly third-party funded academic therapy optimisation studies in the cancer research – particularly essential for rare cancers, e.g. acute lymphoblastic leukaemia or Hodgkin’s lymphoma.

However, critics said that in certain cases study participants in low risk trials no longer need to give specific consent for study participation, and that research on pregnant and emergency patients for the benefit of third parties would be permitted. Professor Joerg Hasford, Chair of the Germany’s Permanent Working Party of Research Ethics Committees, believes this is not acceptable and it is also problematic that, in the case of multinational studies, an ethics committee in the reporting country only needs to assess the first part of an application, i.e. the study protocol and the risk-benefit ratio. ‘This is not acceptable, because medical care standards in Member States differ significantly, which, from experience, also reflects in the study protocols,’ he said. The ethical justifiability of a clinical study can only be investigated on site – and not across borders.

Finally, Prof. Hasford also criticised the (still very tight) deadlines and the introduction of implied consent, which, in the case of non-adherence to deadlines, is assumed according to the draft.

What remains to be seen is to what extent the remaining criticisms still voiced in Germany will be considered for the new EU regulations. The parliamentary draft is currently being negotiated with the EU Council of ministers under the leadership of MEP Glenis Willmott to work out a joint compromise


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