Conforming Intellectual Property and Privacy Restraints to the Right to Health and the Right to Information in Clinical Trials Data

93 Pages Posted: 2 May 2015

See all articles by Giulia Schneider

Giulia Schneider

Sant'Anna School of Advanced Studies; Bocconi University, International Law and Economics, Students

Date Written: April 30, 2015

Abstract

This paper aims to define a legal framework of clinical trials data, by testing international the European rules of data secrecy against the expanding demands for disclosure. We argue that information embedded in clinical trial protocols turn out to be a precious source for evaluation of drug's safety and efficacy, the awareness of which is thus to be considered essential for protecting patients' and consumers' health. However, clinical trials data do not only have an important public informational value, but also an intrinsic regulatory - and therefore commercial - value, being key to granting of drugs' marketing license.

We compare the general disclosure provision provided by art. 84 of the recent European Clinical Trials Regulation, establishing a publicly accessible European clinical trials database, with specific intellectual property measures, providing guarantees of exclusivity to clinical testing data used to obtain marketing approval.

Research-based companies aiming to protect their 'sweat of the brow' from the competitors' free-riding, have invoked art. 39.3 TRIPS and the European data exclusivity regimes, as a legal basis for regulatory agencies' non-disclosure obligation. Also privacy concerns have been called upon as a legal barrier to disclosure, due to the vast amount of personal data embedded in the results of test data.

Building on these premises, the paper illustrates that clinical trials protection rules or the privacy normative framework do not prevent drug's safety information disclosure. To the contrary we demonstrate a systemic justification for disclosure. In our analysis we read public interest of transparency and accountability in clinical trials information through the subsequent lenses of the human right to health as defined by International Human Rights Treatises and the Human rights case law, of public goods dimension of research and knowledge production, and finally of the legal framework protecting consumer rights as defined by the correspondent European Directives.

Keywords: clinical trials data, data exclusivity, privacy, access to information, health, competition, human rights, disclosure

Suggested Citation

Schneider, Giulia, Conforming Intellectual Property and Privacy Restraints to the Right to Health and the Right to Information in Clinical Trials Data (April 30, 2015). Available at SSRN: https://ssrn.com/abstract=2600921 or http://dx.doi.org/10.2139/ssrn.2600921

Giulia Schneider (Contact Author)

Sant'Anna School of Advanced Studies ( email )

Piazza dei Martiri della Libertà, 33
Pisa, 56127
Italy
3480369497 (Phone)

Bocconi University, International Law and Economics, Students ( email )

Milano
Italy

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