E-DRUG: Shake-up for UK drug regulatory authority
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[Following on the Panorama investigations into Seroxat and drug licensing in the UK, a reform of the UK's Medicines and Healthcare products Regulatory Authority is now being proposed. These reforms are aimed at "strengthening of patient and lay involvement, tightening of the rules of interest and increased transparency" in the MHRA. Let's see what happens... LL]
Story from BBC NEWS: [copied as fair use; WB]
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/4002185.stm
Shake-up for drug licensing body
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.
'Secrecy'
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 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.
Impartial
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".
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, welcomed the increased involvement of patients, saying it would increase the agency's "expertise and strengthen its ability to take account of the public interest".
"I hope that following these reforms the MHRA will be more active in communicating with the public about its processes and decisions."
Published: 2004/11/11 10:57:48 GMT