Clinical Trial Data Transparency and GDPR Compliance: Implications for Data Sharing and Open Innovation

In: Katerina Sideri & Graham Dutfield (eds.), Openness, Intellectual Property and Science Policy in the Age of Data Driven Medicine, Special Issue of Science and Public Policy (2019 Forthcoming)

19 Pages Posted: 2 Jul 2019 Last revised: 19 Jul 2019

See all articles by Timo Minssen

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

Rajam N.

University of Copenhagen

Marcel Bogers

University of Copenhagen - Department of Food and Resource Economics (IFRO); University of California, Berkeley

Date Written: July 1, 2019

Abstract

Recent EU initiatives and legislations have considerably increased public access to clinical trials data (CTD). These developments are generally much welcomed for the enhancement of science, trust, and open innovation. However, they also raise many questions and concerns, not least at the interface between CTD transparency and other areas of evolving EU law on the protection of trade secrets, intellectual property rights and privacy. This paper focuses on privacy issues and on the interrelation between developments in transparency and the EU’s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines: (1) the genesis of EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR which are relevant in the context of clinical trials; and (3) the risk for tensions between the GDPR and the policy goals of CTD transparency, including their implications for data sharing and open innovation. Ultimately, we stress that these and other related factors must be carefully considered and addressed to reap the full benefits of CTD transparency.

Suggested Citation

Minssen, Timo and Neethu, Rajam and Bogers, Marcel, Clinical Trial Data Transparency and GDPR Compliance: Implications for Data Sharing and Open Innovation (July 1, 2019). In: Katerina Sideri & Graham Dutfield (eds.), Openness, Intellectual Property and Science Policy in the Age of Data Driven Medicine, Special Issue of Science and Public Policy (2019 Forthcoming). Available at SSRN: https://ssrn.com/abstract=3413035 or http://dx.doi.org/10.2139/ssrn.3413035

Timo Minssen (Contact Author)

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law ( email )

Karen Blixens Plads 16
Copenhagen, 2300
Denmark
+46 708 607517 (Phone)

HOME PAGE: http://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631

Rajam Neethu

University of Copenhagen ( email )

Nørregade 10
Copenhagen, København DK-1165
Denmark

HOME PAGE: http://https://twitter.com/JurRajam_N

Marcel Bogers

University of Copenhagen - Department of Food and Resource Economics (IFRO) ( email )

Unit for Innovation, Entrepreneurship & Management
Rolighedsvej 25
Copenhagen, 1958
Denmark

University of California, Berkeley

Garwood Center for Corporate Innovation
F402 Hass School of Business, #1930
Berkeley, CA 94720
United States

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