Clinical Trials Data Transparency & GDPR Compliance: What Are the Effects on 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)

Posted: 25 Apr 2019 Last revised: 18 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: February 1, 2019

Abstract

Recent EU initiatives and legislation considerably increases public access to clinical trials data (CTD). These are generally much welcomed developments for the enhancement of science, trust and open innovation. However, they also raise many questions and concerns. Many of these emerge at the interface of CTD transparency with other areas of evolving EU law concerning the protection of trades secrets, IPRs, and privacy. This paper focuses on the privacy issues by analyzing the interrelation between the transparency developments and the EU’s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines (1) the genesis of the EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR in the context of clinical trials; and (3) the practical difficulties and risks for tensions between the GDPR and the policy goals of CTD transparency and open innovation. Ultimately, we stress that such 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 Trials Data Transparency & GDPR Compliance: What Are the Effects on Data Sharing and Open Innovation? (February 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). Available at SSRN: https://ssrn.com/abstract=3360302

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

Register to save articles to
your library

Register

Paper statistics

Abstract Views
174
PlumX Metrics