Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law

Abstract

As indicated by the title and further explained in the Preface, the thesis explores if and under what conditions access to clinical trial data is granted and should be granted as a matter of research and innovation policy. Access to non-summary clinical trial data has been discussed in recent years, primarily from the perspective of data protection law and research ethics. Daria Kim’s thesis strives to provide a complementary view which conceptualizes clinical trial data as output of and input for innovative processes in medical and pharmacological R&D. Access to clinical trial data in the EU is highly topical for several reasons. First, EU data policy has recently shifted from the concept of exclusively held, proprietary industry data to an access paradigm which seeks to boost the European digital economy by access rights. The proposal for a European Data Act and the Digital Markets Act are the most prominent instruments. The thesis contributes to this more general discussion with a sector-specific exploration. Second, the COVID-19 pandemic has led to an unprecedented public awareness of the mechanisms of innovative processes in the pharmaceutical industry and the role of clinical trials for the success or failure of treatments and vaccines. This raises the question of whether access to clinical trial data may facilitate such innovative processes. Third, EU Regulation 536/2014 on clinical trials on medicinal products for human use and the recent European Medicines Agency (EMA) transparency policies represent a departure from the confidential treatment of non-summary clinical trial data which is still pursued by the US authorities and other regulatory bodies. This European approach of greater transparency has not yet been analyzed from an innovation policy perspective. Daria Kim’s thesis is therefore very well positioned at the crossroads of different legal and policy discourses.