Three rulings confirm EU regulator's approach to disclosure

The EU court has given a set of three rulings that strongly support the approach of EU medicines regulator, the EMA, to disclosure of documents.

Case 1 - Pari Pharma v EMA

German company Pari Pharma, a specialist in nebulisation technology for the treatment of respiratory diseases, challenged an EMA decision to disclose data about its clinical trials.

A Novartis group company obtained a marketing authorisation for its TOBI Podhaler product to treat pulmonary infections in cystic fibrosis patients. This product was authorised as an orphan drug and so benefited from 10 years of market exclusivity. Pari Pharma made its own version, Vantobra, arguing that it was similar to the TOBI Podhaler, and also clinically superior, so getting round the market exclusivity provisions in the Orphan Medicinal Products Regulation.

Novartis wanted to challenge the approval of Vantobra by accessing the CHMP assessment reports underlying the approval decision. Pari Pharma objected, saying that its confidential information would be compromised.

Case 2 -  PTC Therapeutics International v EMA

PTC Therapeutics, an Irish pharma company with an 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.

Case 3 - MSD Animal Health Innovation and Intervet international

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.

In each case, the EU court came down firmly on the side of the EMA, dismissing the arguments that the material should not be disclosed. The underlying principle that “the  public should have the widest possible access to documents” required proof of specific prejudice to an applicant for non-disclosure.

Strong support for disclosure

These rulings provide strong support for the EMA’s policy on the release of regulatory documents, and the more specific policy on the publication of clinical data. They also offer guidance on the circumstances in which confidentiality should be protected. An applicant faces a high bar. It would need, for example, to demonstrate that

“the compilation of those data which are accessible to the public and its assessments on those data provide added value — consisting of, for example, new scientific conclusions or considerations relating to an inventive strategy — giving the undertaking a commercial advantage over its competitors”

or

"the assembly of the publicly-accessible data together with the data which is not publicly accessible constitutes a commercially sensitive item of data whose disclosure would undermine its commercial interests"

in order to keep materials secret. 

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