[English-language abstract, article in German.]
Abstract: The year 2014 was a turning point for transparency in clinical research. Two regulatory innovations comprehensively changed the rules in the EU. For one thing, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use (Clinical Trials Regulation – CTR) came into force, and for another thing, Policy 0070 of the European Medicines Agency (EMA) on the publication of and access to clinical data was published. While the policy has been occupying the pharmaceutical industry in practice since 2015, the requirements of the CTR came into effect at the end of January 2022.
The main innovation of the CTR is public access to the majority of documents and records that are created during the application process as well as during the course and after completion of a clinical trial. The special feature of Policy 0070 is the possibility for EU citizens to inspect the essential parts of a marketing authorisation application, such as the Clinical Study Report.
This contribution to the discussion describes the completely new challenges in the area of transparency that the pharmaceutical industry is facing as a result of the new requirements. In principle, transparency is to be welcomed in order to achieve the goals of the EU in the development and availability of medicines and vaccines. However, the protection of trade and business secrets of the pharmaceutical industry would be jeopardised. In the worst case, this could lead to a decline in investment in research and development within the scope of this regulation and to an international shift of clinical trials, including developing or emerging countries. Germany could lose more and more its leading role in conducting clinical trials in the EU.