Clinical trials insurance

Less protection of victims and additional costs for the state

Participants in clinical trials today are comprehensively insured against injuries which are caused by the medical tests. The European Commission plans to introduce a national mechanism of compensation for participants in every Member State. This would significantly reduce the protection of German participants.

The German system of clinical trials insurance provides comprehensive protection in case a participant suffers of an injury. This system of compensation was established 30 years ago – and it works very well. Harmonization with the implementation of a national system of compensation, as the European Commission proposes, would decrease the level of protection for the German participants. With the necessity of complete victim protection in mind, the GDV thus opposes this proposal.

Furthermore, the costs to be borne by the general public speak against the proposal of the Commission. Each State would not only have to pay for every injury which the compensation mechanism must cover. The public administration would also be burdened by the costs of building up and maintaining a functioning administration apparatus. These costs alone would be tremendous. There is no necessity to strain the public administration with these costs because a well-functioning and established mechanism is already in place – the clinical trials insurance.

The GDV’s complete position paper is available in the download section.