Clinical Trials Registration and Results Reporting and the Right to Health

in I. Glenn Cohen, ed., The Globalization of Health Care: Legal and Ethical Issues (Cambridge (Mass): Oxford University Press, 213): 255-271

9 Pages Posted: 4 Jun 2013 Last revised: 6 Apr 2014

See all articles by Trudo Lemmens

Trudo Lemmens

University of Toronto - Faculty of Law

Candice Telfer

Independent

Date Written: March 1, 2013

Abstract

This chapter is a short, slightly revised and updated version of an article published in the American Journal of Law and Medicine (http://ssrn.com/abstract=1932436). The chapter discusses why access to information related to clinical drug trials can be qualified as a fundamental component of the right to health. This approach rejoins the claim of authors who characterize clinical drug trials as public goods. Yet, it offers also a legal and moral basis for the immediate implementation of transparency measures, regardless of more fundamental reform of drug regulation. Framing access to clinical trials data as a component of the right to health offers strong support against the argument that transparency measures may violate international trade obligations related to data secrecy and provides a basis for claiming that states have a duty to implement such measures.

The paper first provides an overview of the historical development of clinical trials and results reporting registries. It then analyzes the arguments invoked against mandatory trial registration and results reporting, zooming in on claims based on data secrecy obligations under TRIPS and TRIPS Plus agreements. The paper explores why registries can generally be justified under public interest exceptions in international trade agreements and how the existence of data exclusivity regimes already provides protection against ‘unfair commercial use’ of clinical trials data.

In the final section of the paper, the implementation of clinical trial and results reporting registries is situated in the context of the right to health. This not only promotes individual empowerment in requesting access to relevant health information, but also suggests that states have a duty to develop reliable and publicly accountable information systems. Such systems should enable independent medical research groups and civil society in general to contribute meaningfully to publicly accountable medical research and health product development.

Keywords: drug regulation, drug safety and effectiveness, clinical trials, access to information, data secrecy, intellectual property, TRIPS, human rights, right to health, transparency, governance of information, clinical trials, trial registration, commercial secret

JEL Classification: I18, K10, K20, K23, K32, K33, L52, L65, O19, O34

Suggested Citation

Lemmens, Trudo and Telfer, Candice, Clinical Trials Registration and Results Reporting and the Right to Health (March 1, 2013). in I. Glenn Cohen, ed., The Globalization of Health Care: Legal and Ethical Issues (Cambridge (Mass): Oxford University Press, 213): 255-271, Available at SSRN: https://ssrn.com/abstract=2273853

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

Candice Telfer

Independent

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