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.