EU court blocks clinical data release, regulator appeals
The European Medicines Agency (EMA) has appealed two interim orders by the President of the General Court of the European Union, blocking release of documents containing regulatory information about two drugs.
In a statement the EMA said it appealed the decision to suspend the release of documents requested by third parties under its 'Transparency Regulation'.
The first order blocked the release of a clinical study report for PTC Therapeutics’ Translarna (ataluren), a centrally-authorised medicine for the treatment of Duchenne’s muscular dystrophy, until a final ruling is given by the General Court.
The EMA was planning to provide access to the clinical study report in response to an access to documents request, with appropriate redactions in accordance with the regulation.
The second order, issued at the same time, blocked the release of three toxicity studies for a veterinary medicine used to treat flea and tick infestations in dogs and cats.
The interim rulings were made as part of court cases brought by PTC Therapeutics and Intervet, respectively, to stop the EMA’s release of the documents in question.
Both companies argue that release of the requested documents would infringe their right to protect commercially confidential information contained in their dossiers.
They are challenging two distinct agency decisions to grant access to non-clinical and clinical information (including clinical study reports) previously submitted by companies as part of their marketing authorisation applications. In the EMA’s view, these decisions are fully consistent with the regulation.
For the last few years the EMA has been attempting to make all clinical trial information used to authorise medicines publicly available, with only information deemed commercially confidential redacted from documents disclosed.
Stefano Marino, the EMA's head of legal department, said: “A sort of 'blanket' protection from disclosure for documents supporting an authorisation for a medicine seems neither consistent with the legislation nor advocated by our stakeholders, including an overwhelming majority of pharmaceutical companies. We will welcome a clear indication on this point from the Court of Justice.”
Although the Agency’s approach to access to documents has been challenged previously, the Court of Justice has never released a judgment on the merits of those cases. In the past, similar orders were set aside by the Court of Justice and the marketing authorisation holders then withdrew the main cases. The latest cases are an opportunity to receive clarity from the Court of Justice as to whether the EMA’s approach is correct or not and to eliminate operational uncertainties for the Agency or the stakeholders using its system.
These two interim rulings come as the Agency is preparing for the release of the first clinical study reports under its ground-breaking policy on the proactive release of clinical study reports, planned for later this year.
The EMA has spent the last four years developing the new policy, facing pressure from both pharma companies keen to protect their intellectual property, and from campaigners, such as the doctor and journalist Ben Goldacre, who want all clinical trial information open to public scrutiny.
The two appeals filed are in line with its continued efforts to secure transparency on authorised medicinal products in the EU and on the scientific reasons supporting their approval, in the interest of patients and public health.
