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 documents included clinical study reports, toxicology reports and CHMP reports - all of which would be regarded as core documents in a registration dossier.

At the heart of the rulings, the court took the view that, whilst there could be a presumption of confidentiality to apply to a category of documents, there was no general presumption of confidentiality protecting the documents in question.

For a presumption of confidentiality to exist, there had to be a clear need for confidentiality to ensure that the procedures at issue - here, applying for an MA - would not be compromised, and that the relevant regulations ((EC) 726/2004; (EC) 141/2000; (EC) 507/2006) governing access to those documents could be construed as permitting the preservation of confidentiality.

The Court found that none of the regulations in these cases could be construed as restricting the EMA from giving access to these documents. The Court also decided that, where the documents contained (at least in part) non-confidential information, some added value must be evidenced for the whole document...