Wednesday, October 08, 2008

Cleaning the stables - words don't move sh*t

The pharmaceutical industry is addressing the need to develop a “more mature” relationship with doctors, but the medical profession has so far failed to do so, even though many doctors have abused industry hospitality, a meeting in London has heard.

The General Medical Council (GMC) – the registration body for doctors in the UK - must take more of a lead against such wrongdoing by doctors, according to Dr Des Spence, a general practitioner (GP) who works with No Free Lunch, a group which is highly critical of pharmaceutical industry promotion.

Dr Spence, who was speaking at a debate held in London last week to mark the 50th anniversary of the Association of the British Pharmaceutical Industry (ABPI)’s Code of Practice for the industry, said that the key issues of inappropriate behaviour by companies relate to hospitality, not promotion materials, and that the problem with the Code now is a lack of policing and implementation.

One improvement could be the introduction of spot checks on pharmaceutical reps’ activities, he suggested.

William Harbage QC, chairman of the Appeal Board of the Prescription Medicines Code of Practice Authority (PMCPA) - which administers the Code at arm’s length from the ABPI – agreed that awareness is key. “If industry reps are doing something they shouldn’t, there will be someone at the receiving end,” he pointed out.

But Mr Harbage disagreed with suggestions that companies should be fined for serious breaches of the Code. Financial Times journalist Andrew Jack had told the debate that the bad publicity arising from such wrongdoing causes internal turmoil at companies, but that the ultimate sanction is money. Mr Harbage stressed that the public aspect does hurt – no company wants to see its name hauled through the mud, and jobs, appraisals and bonuses are all at stake.

Moreover, there are serious issues of practicality; for example, how big should such fines be?

“You’d have to go a long way up to hurt Big Pharma,” he warned, adding that companies would counter the threat by bringing in teams of lawyers and the result would be full-scale civil litigation.

Self-regulation, on the other hand, deals with these issues speedily – certainly by the standards of the law courts – and it seems to be working. It “has teeth with naming and shaming,” and the Medicines and Healthcare products Regulatory Agency (MHRA) can step in if an individual act of wrongdoing is covered by the Medicines Act rather than the Code, said Mr Harbage, who emphasised: “these things are well worth holding onto.”

Dr June Raine, director of the Vigilance and Risk Management Division of the MHRA, said that she would not rule out the introduction of fines for breaches of the Code, but these must be proportionate and not “telephone numbers.” Regulatory oversight is now focusing more on public health issues, such as new medicines coming to market, she said, and reminded the debate that the Agency has powers to bring criminal actions. “The statutory nature of this is that we are at the ready,” she said.

APBI president Chris Brinsmead said the Association is proud of the Code, whose requirements are stricter than the law’s, and he forecast that it will continue to evolve over the next 10 years. And at that time, added Dr Raine: “the regulator will still be there, with niftily-applied teeth.”-

The Royal College of Physicians (RCP) working party convened in September 2007 to examine relationships between doctors and the industry was due to present its findings by the end of this year. However, a RCP spokesman told PharmaTimes that the group’s report is not now expected before next February.

By Lynne Taylor
PharmaTimes

No comments: