The study 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 the
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 the 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 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.
We illustrate how drug’s safety information disclosure is not prevented by both clinical trials protection
rules and the privacy normative framework. 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 the public goods dimension of research and knowledge
production, and finally of the legal framework protecting consumer rights as defined by the
correspondent European Directives
