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 to be treated as confidential. Again, it was not persuaded that that was the case here.
Finally, the Court held that the caveat in the first indent of Article 4(2) of the Transparency Regulation (protection of commercial interests) must be interpreted strictly so as to allow the public the widest possible access to documents.
In our experience, both the EMA and the MHRA have the approach of wishing to disclose information in dossiers submitted to it to obtain MAs, in order to ensure transparency and consistency. These recent cases and the Court's strict interpretation of Article 4(2) of the Transparency Regulation will give them some encouragement in this regard.
The decisions are a timely reminder to applicants for MAs who frequently assume that the registration dossier is, and will be regarded as, highly confidential. Of course, the dossier must be prepared primarily to ensure that the MA is granted, but it is important to have an awareness that parts of the dossier may be disclosed.
However, these decisions are quite fact specific. With different regulations, and perhaps more focused arguments around the added value of the information and its presentation, it may be possible to achieve wider redactions, or even a complete restriction of access.