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A Transparency Challenge: Can Commercial Confidentiality In Clinical Trials Data Be Overcome?


Giulia Schneider

Information embedded in clinical trial protocols is essential for the evaluation of a drug’s safety and efficacy. However, clinical trials data does not only have a public informational value, but also has an intrinsic regulatory - and therefore commercial - value, as it is key to the granting of a drug’s marketing license. Research-based companies aiming to protect their ‘sweat of the brow’ from competitors’ free-riding have invoked Article 39.3 TRIPS and the European data exclusivity regime, as a legal basis for regulatory agencies’ non-disclosure obligation.
This paper illustrates how disclosure of a drug’s safety information is not prevented by the European intellectual property framework over clinical trials data. To the contrary, the paper demonstrates a systemic justification for disclosure.

Giulia Schneider, PhD in International Law & Economics, Bocconi University, Milan. Mail <>. The author would like to express her deep gratitude to Professor Giovanni Comandè of the Sant'Anna School of Advanced Studies in Pisa for his precious support and to Professor Yane Svetiev of Bocconi University in Milan for the valuable insights that made this contribution possible.


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