- Crucial development on the presumption of confidentiality in the access to document saga (PTC Therapeutics v EMA and MSD Animal Health Innovation, Intervet v EMA)
- What are the practical implications of this case?
- What was the background?
- Background to EU jurisprudence on ATD to date
- The present case
- What did the AG opine?
- Case details
Life Sciences analysis: The saga of access to documents (ATD) cases in the European pharmaceutical legal landscape continues, this time with two promising opinions of Advocate-General Hogan. In summary AG Hogan found that the General Court had erred in law in its conclusions that (a) there was no general presumption of confidentiality and (b) access to the study reports submitted in a marketing authorisation application dossier at issue would not compromise the applicants’ commercial interests. Written by Marie Manley and Zina Chatzidimitriadou at Sidley Austin LLP.
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