By Martin Banks - 8th June 2010
I am recommending that the EMA disclose the documents
Nikiforos Diamandouros
European ombudsman Nikiforos Diamandouros has called on the European Medicines Agency (EMA) to grant access to clinical study reports and trial protocols for anti-obesity drugs.
His demand follows a complaint from Danish healthcare researchers who wanted to conduct an independent analysis of the drugs.
In 2007, the researchers, from a health and information centre, asked to see clinical study reports and corresponding trial protocols for two anti-obesity drugs.
They explained that they wanted to conduct an independent analysis given that, in their view, biased reporting on drug trials was common.
The researchers said that concerns for patients' welfare should be given priority over concerns for the commercial interests of the drug industry.
The UK-based EMA refused their request for access to the documents on the grounds that disclosure would "undermine" the drug producers' commercial interests.
During his investigation, the Strasbourg-based ombudsman inspected the relevant reports and protocols and concluded that their disclosure would not affect any commercial interests.
The Greek-born official said, "I am recommending that the EMA disclose the documents or else give convincing arguments as to why access cannot be given."
Diamandouros criticised its refusal to grant access to the reports and protocols, saying it amounted to maladministration.
EMA has now been told to submit a detailed opinion by 31 August.
The agency, based in London, evaluates and supervises medicinal products placed on the EU market, with a view to protecting public health.
It receives clinical study reports and trial protocols from drug producers seeking to obtain marketing authorisation.
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