Access To Information Held By Health Regulators – Transparency Versus Confidentiality

On 5th February, the EU General Court gave its ruling on three separate cases (PTC Therapeutics v EMA, Pari Pharma v EMA and MSD Animal Health Innovation v EMA) concerning decisions by the European Medicines Agency to give third parties access to certain documents contained in the registration dossiers submitted by Applicants for marketing authorisations (two for human medicines and one for a veterinary medicine).

We will not review here the detail of each of the cases in terms of the nature of the documents which were the subject of the third party access request or all of the arguments advanced by the applicants in support of why the access requests should be refused. However, the...