The European Medicines Agency (EMA)’s refusal to allow researchers access to trial documents relating to two anti-obesity drugs is “an instance of maladministration,” the European Ombudsman has ruled this week.
In his second decision against the EMA on data access issues in two months, Ombudsman Nikiforos Diamandouros has called on the EMA to grant the researchers access to the clinical study reports and trial protocols, which relate to orlistat (Roche’s Xenical and GlaxoSmithKline’s over-the-counter product Alli) and rimonabant (Sanofi-Aventis’ now-withdrawn Acomplia), “or provide a convincing explanation as to why no such access can be given.”
The case dates back to 2007, when researchers at the Nordic Cochrane Centre for research and information in Denmark asked the Agency for access to the documents on the two drugs. They said this was “essential” in order for an independent analysis to be conducted – given that, in their view, biased reporting on drug trials was “common.”
However, the EMA refused their request, on the grounds that granting access to the data would undermine the commercial interests of the drugs’ manufacturers.
The researchers responded that it was unlikely that clinical study reports would contain anything that could undermine the protection of commercial interests and asked the Agency to explain, if it were to uphold its initial decision, why it considered that commercial interests of the drug industry should override the welfare of patients.
In its reply, the EMA confirmed its decision. It added that its current policy was not to disclose original data submitted as part of an application dossier for marketing authorization but also pointed out that the outcomes of its assessments of such data appear its website.
The Danish researchers then brought their case to the Ombudsman, who was told by the EMA that the public interest in disclosing the requested documents had to be balanced against the interests of the companies submitting data to it. The researchers responded that, as a likely consequence of the Agency’s position, patients would die unnecessarily and would be treated with inferior and potentially harmful drugs.
Following his investigation, Mr Diamandouros concluded that the documents at issue did not contain information on the composition of either orlistat or rimonabant, or any other commercially confidential information. Therefore, he ruled, their disclosure would not undermine commercial interests.
The EMA had not provided sufficient reasons for its refusal to grant access to the documents requested, and its failure to do so amounted to an instance of maladministration, he said, and called on the Agency to grant the complainants access to the requested documents, or provide a convincing explanation as to why no such access can be given.
The Agency is required to submit a response by August 31.
– In May, the Ombudsman again criticised an access decision by the EMA, after it refused to provide Irish citizen Liam Grant with documents concerning suspected adverse drug reactions (ADRs) associated with Roche’s acne treatment Accutane (isotretinoin). The Agency’s refusal was based on its belief that EU transparency rules did not apply to reports of serious ADRs, but Mr Diamandouros disagreed, stating that the transparency rules do in fact apply to all documents held by the Agency, and called for the EMA to respond to his decision by July 31.
