The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation.
The first order blocked the release of a study report for PTC Therapeutics’ Translarna (ataluren), a Duchenne’s muscular dystrophy treatment, until a final ruling is provided. EMA says it was planning to provide access to the 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 Intervet’s Bravecto (fluralaner), a veterinary medicine used to treat flea and tick infestations in dogs and cats.
PTC Therapeutics and Intervet both filed the cases to stop EMA from granting access to the non-clinical and clinical information (including clinical study reports), arguing that the release of the requested documents would infringe their right to protect commercially confidential information contained in their dossiers.
“Our approach to transparency has been welcomed by many of our stakeholders and these court cases are a good opportunity to test our rules on making available to the general public the documents on which EMA’s scientific opinions on medicines are based,” said Stefano Marino, EMA’s Head of Legal Department. “Our position that clinical reports are not confidential per se was confirmed by the adoption of the recent Regulation on clinical trials. They may contain some residual commercially confidential informationwhich should be redacted. However, 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.”
The transparency regulation entered into force in 2010 and it opens up the opportunity to obtain documents containing information about authorized drugs.
In February, a team of researchers found that the EU’s transparency regulation did work in obtaining some documents, though there was “great variability in time to receive an initial decision from the EMA (1 to 13 weeks).”
And as the number of requests continued to grow -- EMA says it has released over two million pages of regulatory data -- from 20 requests per month during the first two years to nearly double that (although those requests have since gone down), EMA has had to expand its capacity and in September 2013, launched a 12-person team to deal with the additional requests.
The agency’s approach to allowing documents to be accessed has been challenged previously, though EMA notes that the Court of Justice has never released a judgment on the merits of those cases.
The latest cases are an opportunity to clarify whether EMA’s approach is correct or not and to eliminate operational uncertainties for the agency or the stakeholders using its system, EMA says.
The two interim rulings also come as EMA is preparing for the release of the first clinical study reports under a 2014 policy on the proactive release of clinical study reports, planned for later this year.