Pharmaceutical Data Exclusivity in the Light of Access to Clinical Data: Is the EMA oversharing?

In the ever-evolving landscape of EU pharmaceutical regulation, this article unravels the complexities of regulatory data exclusivity and commercially confidential information (CCI). Examining EU legislation, CJEU jurisprudence, and EMA policies, it navigates the delicate balance between proprietary rights, transparency, and fundamental freedoms in the pharmaceutical industry. Central to the discussion is the conflict between safeguarding commercial interests and the public interest in clinical trials data disclosure. By offering nuanced perspectives, the article contributes to the ongoing dialogue, providing legal practitioners and pharmaceutical stakeholders with a concise understanding of the evolving regulatory landscape.