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Disclosure of documents held by the EMA – update on Advocate General Hogan’s opinions in appeals from General Court

Disclosure of documents held by the EMA – update on Advocate General Hogan’s opinions in appeals from General Court

Published By Ayesha Raghib

17/09/2019 16:14:55

Advocate General Hogan (‘AG’) delivered opinions last week in the appeals in cases C‑175/18 P and C‑178/18 P. Both cases concern access to documents by third parties pursuant to Regulation (EC) 1049/2001. The appeals have arisen from the earlier judgments of the General Court of 5 February 2018 (here and here) upholding the European Medicines Agency (EMA)’s decisions to release a clinical study report (CSR) for PTC Therapeutics’ human medicinal product ‘Translarna’ and toxicity study reports for Intervet’s veterinary medicinal product ‘Bravecto’. Both appeals turn on a question of great importance to the pharmaceutical industry that has not previously arisen upon appeal, namely, whether, in circumstances where the relevant Marketing Authorisation (MA) has already been granted, documents prepared and submitted as part of a MA application to the EMA for new medicinal products constitute commercially confidential information and should therefore not be disclosed to third parties on the basis that disclosure would undermine the protection of the commercial interests of MA holders.  
 
In both cases AG Hogan has concluded that the General Court erred in law in so far as it had concluded that (i) there was no general presumption that the documents should not be disclosed and (ii) the disclosure of the documents would not compromise the appellants’ commercial interests.  The AG proposes that the judgments under appeal should be set aside and the cases referred back to the General Court for judgment following a re-examination of the documents at issue in the light of the reasoning in the opinions.