ETD system

Electronic theses and dissertations repository


Tesi etd-03302016-095633

Thesis type
Tesi di laurea magistrale LM5
A European Transparency challenge: can commercial confidentiality in clinical trials data be overcome?
Corso di studi
relatore Prof.ssa Poletti, Dianora
Parole chiave
  • clinical trials data
  • data exclusivity
  • privacy
  • access to information
  • health
  • competition
  • human rights
  • disclosure
Data inizio appello
Riassunto analitico
The study aims to define a legal framework of clinical trials data, by testing international the European<br>rules of data secrecy against the expanding demands for disclosure.<br>We argue that information embedded in clinical trial protocols turn out to be a precious source for the<br>evaluation of drug’s safety and efficacy, the awareness of which is thus to be considered essential for<br>protecting patients’ and consumers’ health. However clinical trials data do not only have an important<br>public informational value, but also an intrinsic regulatory- and therefore commercial- value, being key<br>to the granting of drugs’ marketing license.<br>We compare the general disclosure provision provided by art. 84 of the recent European Clinical Trials<br>Regulation, establishing a publicly accessible European clinical trials database, with specific intellectual<br>property measures, providing guarantees of exclusivity to clinical testing data used to obtain marketing<br>approval.<br>Research-based companies aiming to protect their “sweat of the brow” from competitors’ free-riding,<br>have invoked art. 39.3 TRIPS and the European data exclusivity regimes, as a legal basis for regulatory<br>agencies’ non-disclosure obligation.<br>Also privacy concerns have been called upon as a legal barrier to disclosure, due to the vast amount of<br>personal data embedded in the results of test data.<br>We illustrate how drug’s safety information disclosure is not prevented by both clinical trials protection<br>rules and the privacy normative framework. To the contrary we demonstrate a systemic justification for<br>disclosure.<br>In our analysis we read public interest of transparency and accountability in clinical trials information<br>through the subsequent lenses of the human right to health as defined by International Human Rights<br>Treatises and the Human rights case law, of the public goods dimension of research and knowledge<br>production, and finally of the legal framework protecting consumer rights as defined by the<br>correspondent European Directives.