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Last Updated: Thursday, 11 November, 2004, 10:57 GMT
Shake-up for drug licensing body
Seroxat pill
Panorama said trials showed Seroxat could be addictive
A reform of the way drugs are regulated has been outlined by ministers to make the system more independent.

A new code of conduct has been drawn up for the Medicines and Healthcare products Regulatory Authority (MHRA) body responsible for licensing.

It proposes not allowing the members of the body, the Commission for the Safety of Medicines (CSM), to hold interests in the pharmaceutical industry.

It also calls for more patient involvement in the process.

Two lay representatives will sit on the CSM, the new name for the Committee for the Safety of Medicines, as well as patient representatives on every expert advisory group under the plans.

The MHRA has also written to pharmaceutical companies to demand more action on their agreement to publish their clinical trial data.


The move comes after heavy criticism at the way the MHRA operates.

On Wednesday in a Westminster Hall debate Dr Ian Gibson, chairman of the Commons science and technology select committee, said the MHRA had an image problem.

He said it was "gaining a reputation for not giving out information".

I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions
Harry Cayton, the patients tzar

"I think it is time the culture of secrecy was addressed.

"The damage done by the public believing they have been lied to or defrauded is difficult to repair.

"It is the only regulatory agency that is fully industry funded.

"It is a difficult task to convince people that a regulatory body entirely funded by the industry is impartial."

Last month BBC's Panorama programme criticised the MHRA over its handling of anti-depressant drug Seroxat.

The Panorama investigation claimed vital information relating to Seroxat was overlooked.

It suggested the drug could be addictive and increase suicidal feelings in young adults.

Health Minister Lord Warner said it was important the MHRA was "open and transparent".

He said the changes meant that "everyone can be confident in the impartial and independent expert advice given on the safety of medicines".

'Public interest'

Professor Sir Alasdair Breckenridge said: "Proposals for the new commission incorporating strengthening of patient and lay involvement, tightening of the rules of interest and increased transparency will move the MHRA forward in its aims of improving public health."

And Harry Cayton, the government's patients tzar, said: "I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions."

Richard Brook, chief executive of mental health charity Mind, who resigned from an MHRA expert group over concerns it was being compromised by the influence of the large drugs companies, said the announcement was "great news and a positive first step".

He added: "It is worth asking whether any of this would have come about without the huge amount of public pressure and negative publicity around drugs companies' inappropriate behaviour with regards the aggressive promotion of certain antidepressants."

Wendy Garlick, principal policy adviser at Which?, formerly the Consumers' Association, welcomed the changes but said ministers needed to go further.

"For the public and healthcare professionals to have any confidence in the system, the government needs to go further and establish an independent regulator who is up to the job of vetting drug adverts."

Dr Iona Heath, of the Royal College of GPs, also took issue with advertising, accusing drug fimrs of "disease mongering", where people were told about diseases they had never heard of.

She said she had patients at her surgery every day asking about osteoporosis, cholesterol and blood pressure.

"I am supposed to make people better, not spend my life working with people who are hell bent on making themselves feel worse."

But the Association of the British Pharmaceutical Industry maintained the current system was impartial.

ABPI director general Dr Richard Barker said: "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."

Medicines watchdog 'under fire'
03 Oct 04 |  Health
'Seroxat saved my life'
30 May 03 |  Health
Q&A: Medicines regulation
03 Oct 04 |  Panorama


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