UK industry seizes initiative to head off call for new laws
pharmafile | January 21, 2005 | News story | |Â Â Â
The UK pharmaceutical industry has put forward new proposals to reform itself and its relations with regulators and patients in an effort to restore its reputation, which its leaders admit has been badly damaged in recent months.
The ABPI director general Dr Richard Barker and president Vincent Lawton and other senior industry figures presented a united front at the latest session of the Health Select Committee inquiry into the industry influence, hoping to set the record straight on a multitude of allegations made against it in previous hearings, and head off any recommendations from MPs that the sector needs to be more tightly regulated.
Announcing the new set of proposals, Dr Barker said: "The pharmaceutical industry is already extremely highly regulated and committed to the highest standards of ethical and business conduct. But we recognise that an issue of trust has arisen, and greater trust needs to be built on increased transparency."
The ABPI recommendations include:
Clinical trials
The ABPI has supported a new international agreement to publish details of all industry-sponsored trials. In addition, the ABPI has now recommended that all trials involving the NHS should include a requirement to publish as part of the contract.
Product safety monitoring
Doctors in acute medicine should be regularly assessed on their use of the Yellow Card adverse event warning system, and patients should receive greater encouragement to report adverse events themselves. The MHRA should receive more funds for increased monitoring, and should regularly publish Yellow Card data.
Reinforcing guidelines on industry-patient group relationships
Further guidelines on these relationships should be developed to reassure there is no inappropriate influence.
Ensuring uptake of NICE guidance
The ABPI says uptake of NICE guidance is still patchy, and that prescribing should be monitored to ensure recommendations are followed.
Better information for patients
The MHRA should introduce user testing of patient information leaflets about medicines to increase their usefulness to patients, and pharma companies should be encouraged to make scientifically reliable information available to the public.
The hearing attracted one of the largest audiences of press and stakeholders of the inquiry so far, but those expecting a combative performance from the MPs (one senior industry figure had feared 'the Spanish Inquisition') were confounded, with the industry representatives allowed to give their evidence in a non-confrontational atmosphere.
The evidence session was the seventh of the inquiry, and followed a fact-finding expedition by the MPs to Australia to visit GlaxoSmithKline and AstraZeneca facilities, completed by a visit to Pfizer's UK operations.
Dr John Patterson, a senior executive at AstraZeneca and former president of the ABPI told the committee he believed the industry image was being badly distorted.
Commenting on public perception and media representation of the pharma industry, he said: "I don't think there's a balance at the moment. In the last two to three years things have seemed to have got considerably out of balance."
Observing that health issues now figure much higher up the news agenda, he said that the portrayal of the industry's medicines was often over-simplistic: "It's either 'wonder drug' or 'killer medicine' and there's very little in between."
The ABPI's new proposals were contained in a second submission to the committee, which also included detailed rebuttals of the most serious allegations made by critics in earlier sessions.
Dr Patterson said ghostwriting was "absolutely not practised" at AstraZeneca, and said the company was like many others in having an extremely rigorous system for ensuring named authors have had appropriate input in papers bearing their name.
Another witness, GSK's UK general manager Eddie Gray, refuted claims that the industry indulged in 'disease-mongering' pointing out that drugs can only be licensed for conditions recognised by an International Classification Board.
Meanwhile, Dr Stuart Dollow, vice president of GlaxoSmithKline UK's medical division, said his company supported the idea of making greater use of the MHRA's General Practice Research Database (GPRD) as a pharmacovigilance system.
"We would recommend the GPRD is expanded to beyond the current section of the population that it currently covers. We would not only recommend expanding it but also getting people to put in adverse events and labelling them as adverse events."
The ABPI says the government must provide the regulator with more funding for it to increase its monitoring of adverse drug reactions.
The industry representatives also went on the offensive, pointing out that adoption of NICE guidance remained patchy, and that overall, uptake of new drugs in the UK remained one of the slowest in Western Europe.
These witnesses were joined by one dissenting voice – Simon Clark, chairman of the British Generics Manufacturers Association, who criticised the practice of 'evergreening' to extend the patent lives of major drugs and delay generic competition.
The next session will see the MHRA chairman Sir Alasdair Breckenridge giving evidence along with NICE chairman Sir Michael Rawlins. The MHRA has come under as much if not more criticism as the industry during the inquiry, including allegations of 'cosiness' with pharma and incompetence in handling issues such as the safety review of SSRIs.
The evidence sessions will conclude with questions being put to Lord Warner, the government minister in charge of overseeing the pharma industry.
The government is not obliged to follow any of the committee's recommendations, but will want to avoid a damning verdict on the MHRA and industry, hoping that changes already proposed will placate fears about pharma and its regulation.
