L’accès à l’information et le droit à la santé : La transparence des essais cliniques comme une obligation dans le contexte des droits de l’Homme (Access to Information and the Right to Health: Transparency of Clinical Trials as a Human Rights Obligation)
Louise Lalonde, ed., Le droit, vecteur de la gouvernance en santé? Défis théoriques et enjeux pratiques de l’accès aux soins de la santé (Sherbrooke: Éditions Revue de Droit de L'Université De Sherbrooke, 2012) pp. 131-167
38 Pages Posted: 9 May 2013
Date Written: July 1, 2012
This chapter is a short version in French 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 a detailed 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.
Note: Downloadable document is in French.
Keywords: drug regulation, drug safety and effectiveness, clinical trials, data secrecy, TRIPS, human rights, right to health, transparency, governance of information
JEL Classification: I18, K10, K20, K23, K32, K33, L52, L65, O19, O34
Suggested Citation: Suggested Citation