No general presumption of confidentiality for documents submitted to the EMA

We have commented before on court rulings over the attitude of the European Medicines Agency (EMA) to keeping regulatory filings confidential. In a move likely to concern applicants for marketing authorisation, appeals against two of those decisions have come down on the side of disclosure.

MSD Animal Health Innovation v EMA

Two Merck group companies, MSD Animal Health in Germany and Intervet International, objected to release to an undisclosed third party of a series of toxicology test reports that they had submitted to support the approval of Bravecto, a treatment for tick and flea infestations in dogs. Merck argued that confidential material in the reports meant that they should not be released.

PTC Therapeutics v EMA

PTC Therapeutics, an Irish pharma company with a conditionally approved product (Translarna) for the treatment of Duchenne Muscular Dystrophy, objected to the disclosure of the main clinical study report supporting the product’s approval. Translarna had been approved without comprehensive clinical data on the basis of unmet medical need for patients suffering from a life-threatening disease. An undisclosed third party had applied for access to the report.

No general expectation of secrecy

In both rulings, the European court emphasised openness in carrying out the work of Europe’s bodies and agencies as a “core EU objective”. It rejected the idea of a general presumption of confidentiality, saying that an applicant should identify specific passages that should be kept confidential and explain why.

The court also rejected an argument based on the international TRIPS Agreement which deals with intellectual property rights within the framework of the World Trade Organization. TRIPS Article 39(3) includes an obligation for signatory states to protect confidential material included in pharmaceutical and agrichemical dossiers. Again, without details of why disclosure of the material claimed to be confidential would harm the marketing authorisation applicant’s interests, the EMA should not be expected to keep it secret.

This is unwelcome news for applicants. The EMA will not have to accept general requests to keep material submitted to it confidential. Applicants will need to identify a “concrete and reasonably foreseeable risk” that the information could be used in a way that will harm its commercial interests.