UK to hike transparency in drug regulation
Products Regulatory Authority (MHRA) and the pharmaceutical
industry operate more openly and transparently were announced late
last week by the country's Health Minister, Lord Warner.
Under the reforms, the Committee on the Safety of Medicines and the current Medicines Commission will be restructured into one body, and its chairman and members will not be allowed to hold interests in the pharmaceutical industry
The new Commission will also see its advisory panels restructured, with two lay representatives sitting on the committee, as well as patient representatives on every expert advisory group. The aim is "to give patients a greater involvement in the regulation of medicines, and monitoring their safety," said Lord Warner.
Moreover, the head of the MHRA, Prof Alastair Breckenridge, has written to pharmaceutical companies to demand more action on their agreement to publish their clinical trial data for medicines.
The move comes in the wake of a series of demands for the drug industry to make information on its clinical trials public, amid claims that firms only tend to disclose favourable studies.
This issue has been brought to the fore recently via the well-publicised lawsuit between GlaxoSmithKline and New York attorney general, Eliot Spitzer, which accused the company of suppressing important information about the safety and efficacy of the antidepressant Seroxat/Paxil (paroxetine) in children and adolescents.
GSK abnd others have since committed to full disclosure of trials, But the case reverberated around the world, and the MHRA itself came under attack on UK national television for its handling of the affair, with the Panorama programme alleging that the agency had failed in its duty to protect patients from the drug.
"It is important that the MHRA is open and transparent," said Lord Warner.
"To ensure we get completely impartial advice, experts concerned with the authorisation and surveillance of medicinal products will now have to prove that they have no financial interests in the pharmaceutical industry."
They will also have to declare any other interests, including any that they are aware of that members of their immediate family hold, and any other matter that affect their impartiality or could be perceived as affecting their impartiality.
Breckenridge noted that the Advisory Committee structure for medicines regulation in the UK has remained unchanged since the Medicines Act of
