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Balancing the Privacy Right of Research Participants with the Public Interest in Access to Clinical Drug Trials Data in the Context of Rare Diseases


Faculty of Law, University of Toronto



Project Leader(s)

Trudo Lemmens


The topic of clinical trials and pharmaceutical data transparency has received significant attention across jurisdictions. While there is a growing consensus that increased transparency of clinical trials data is needed to strengthen the reliability of pharmaceutical research and safeguard public health, concerns have been raised about the privacy of human research participants, whose information is contained in clinical reports. Anonymization of data provides protection, but particularly in the context of rare diseases, some have suggested that it may not offer sufficient protection.

In this project, the researchers explore the questions how access to data can be balanced with protection of research participants’ privacy, particularly in the context of research involving rare diseases, where the number of research subjects participating in clinical trials is often small, and as a result, risks of re-identification arguably higher.

The project aims to clarify the privacy dimensions of data sharing initiatives, particularly in the context of rare diseases, and to stimulate discussion among stakeholders on these dimensions in order to facilitate coherent data sharing and privacy practices that are harmonized with new drug regulatory regulations, policies and guidance.

The project consisted of: 1) a literature review and discussion of the ethical, legal and social issues involved in data transparency in relation to rare diseases; 2) a review of transparency policies of Canadian pharmaceutical companies; 3) a comparative policy analysis of how the European Medicines Agency currently addresses the protection of privacy within its own transparency policies, and how the European Courts have interpreted the policies and treated privacy issues; and 4) the drafting of policy recommendations on the harmonization of data transparency measures and initiatives in the private and public sectors. This includes policy options for implementing transparency measures in Canada. The report also contains a policy brief outlining the main issues discussed in the report. Two scholarly publications are also coming out of the research.

Project deliverables are available in the following language(s):


OPC Funded Project

This project received funding support through the Office of the Privacy Commissioner of Canada’s Contributions Program. The opinions expressed in the summary and report(s) are those of the authors and do not necessarily reflect those of the Office of the Privacy Commissioner of Canada. Summaries have been provided by the project authors. Please note that the projects appear in their language of origin.

Contact Information

Professor Trudo Lemmens
Faculty of Law, University of Toronto
Jackman Law Building
78 Queen’s Park
Toronto, Ontario M5S 2C5
(416) 978-4201

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