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

Daria Kim

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English

Springer Nature Switzerland AG
21 October 2022

International law; Medical & healthcare law; Clinical trials

Series: Munich Studies on Innovation and Competition

This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trialdata should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.

By: Daria Kim
Imprint: Springer Nature Switzerland AG
Country of Publication: Switzerland
Edition: 2021 ed.
Volume: 16
Dimensions: Height: 235mm, Width: 155mm,
Weight: 492g
ISBN: 9783030867805
ISBN 10: 3030867803
Series: Munich Studies on Innovation and Competition
Pages: 300
Publication Date: 21 October 2022
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

PART ONE: Setting the Scene.- Introduction.- The Context and the Problem in Focus.- Secondary Analysis of Clinical Trial Data - A Primer.- PART TWO: Analysis de lege lata,- Legal Sources of Control over and Access to Clinical Trial Data under the EU Applicable Framework.- Implications of IPD Disclosure for Statutory Innovation Incentives PART THREE: Analysis de lege ferenda.- Defining the Intervention Logic of Access-To-Data Measures - A Problem Analysis.- Access to Clinical Trial Data as a Case on R&D Externalities - A Theoretical Framework.- IPD as a Research Resource - Exclusively Controlled or Readily Accessible?.- Evaluating Legislative Options.- Final Conclusions and the Outlook.

Daria Kim is senior research fellow at the Max Planck Institute for Competition and Innovation (Munich), where she works on the topics related to the regulation of the data economy and life sciences. Prior to joining Max Planck Institute, she worked as a research associate at the Chinese University of Hong Kong. She holds MA (Indiana University of Pennsylvania), LLM (Munich Intellectual Property Law Center) and Dr. iur. (the University of Augsburg) degrees.