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Strict new conflict of interest rules for MHRA proposed

Published on 19/11/04 at 11:03am

Growing concerns about the independence and transparency of the UK medicines regulator have been met by a set of strict new conflict of interest rules.

The government has unveiled plans to reform the current system by barring chairman and members of MHRA committees from holding any interest whatsoever in pharmaceutical companies and, for the first time, bringing lay or patient representatives into each regulatory decision-making group.

If agreed, the proposals are likely to transform the culture of the MHRA and its committees, which critics have attacked as having a far too secretive and cosy relationship with the pharmaceutical industry.

These criticisms reached a crescendo this year over the safety monitoring of Seroxat and other antidepressants, with a number of groups accusing the regulator of failing to protect and inform patients.

The government has been preparing a revised code of practice for the MHRA since February this year, but the timing of the announcement is no coincidence. The Health Select Committee investigation into the influence of the pharmaceutical industry has heard evidence from the regulators and its critics, and is expected to publish a damning report in the New Year. Meanwhile, the MHRA committee investigating the safety of antidepressants, which has been dogged by controversy, is expected to publish its final report within the next few weeks.

Announcing the proposed changes, which will include a new Commission combining the work of the Medicines Commission and the Committee on Safety of Medicines, health minister Lord Warner said it was important the regulator was open and transparent.

"We want to give patients and the public a greater role in advising on safety of medicines by including strong lay and patient representatives on the new Commission and its bodies and groups," he said, adding that these greater powers were appropriate because of their growing knowledge of the healthcare they receive.

Richard Brook, chief executive of mental health charity MIND was one of very few lay representatives to sit on an MHRA committee. Invited to join the SSRI investigation, he resigned in protest, accusing its members of being afraid of being sued by the pharma industry and not interested in the patient's perspective.

He called the new rules a 'positive first step' towards a more open and independent regulator and said the government should be commended for listening.

"On the other hand, it is worth asking whether any of this would have come about without the huge amount of public pressure and negative publicity around drug companies' inappropriate behaviour with regards to aggressive promotion of certain antidepressants," he said.

He added that there was till a 'way to go' and called for clarification on whether the rules covered outside professional interests in the industry, for example the funding of academic research programmes.

Meanwhile, the government is pressing the UK industry to publish all of its clinical trials for marketed medicines. GlaxoSmithKline was heavily criticised for keeping data relating to the safety of Seroxat secret, and responded to pressure by announcing earlier this year its intention to make data on all its marketed products publicly available.

The ABPI set up a website 18 months ago, encouraging all companies to make such data available, but so far uptake has been disappointing and far from comprehensive.

Commenting on the demands, the ABPI says the issue requires global co-ordination.

"We are playing a leading role in what is an international movement towards greater transparency, the need for which is well recognised by trade associations and companies worldwide," said ABPI director general Dr Richard Barker.

Lilly and Forest have followed GSK's lead in declaring their own websites allowing access to full trial data, but the ABPI says it expects broader initiatives by the global industry over the next few months.

On the tightening of rules on conflict of interest, the ABPI said it believed the current system was totally impartial but conceded that "justice must not only be done but must be seen to be done".

But it warned: "It would be counterproductive if the new rules result in the regulator being unable to take advice from some of the leading experts in medicines."

The government's proposals acknowledged the limited pool of expertise available, and has exempted members of expert groups and sub-committees from the new stricter 'no-ties' rule, but declaration of interests will still be required in these cases.

Harry Cayton, the government's director for patients and the public welcomed the news saying: "The increased involvement of patients in the work of the MHRA will increase its expertise and strengthen its ability to take account of the public interest."

But he made his feelings on the MHRA's record to date on communication abundantly clear by concluding: "I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions."

Meanwhile, MHRA chairman Professor Sir Alasdair Breckenridge tacitly acknowledged the regulator was long overdue for reform, welcoming the news by pointing out that its committee structure had not changed in the 36 years since the Medicines Act of 1968.

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