Dr Ken Harvey: Doctors and drugmakers: are new laws the answer?

THE WAY drugs and medical devices are being promoted to doctors has become an issue of public concern in the last few years.

Public confidence in the medical system hinges on treatment options based on clinical evidence, not incentives.

Part of the problem is the way we currently regulate the relationship between doctors and the therapeutic goods makers.

A position paper on this topic, published in June, was commissioned by the Hon Mark Butler MP, the Parliamentary Secretary for Health.

It noted that the relationship between health professionals and industry is not regulated by the government but by an inconsistent system of self-regulation.

Seven different industry codes and numerous professional codes sought to cover this space, each with different requirements, application, enforcement and penalties.

So with this in mind, how do we reform the system based on the problems that Butler’s position paper identified?

A government Working Group on the Promotion of Therapeutic Products, of which I am a member, was set up to address this question.

The Group – which includes 15 representatives from industry, health and consumer organisations – has taken into account 36 submissions on the topic.

A strong theme has emerged: industry self-regulation is not enough. A major problem noted with the current model is a significant gap – non-members of industry associations do not need to consider acting in accordance with industry codes.

So what are the alternatives? Consumer and health activist groups are calling for a single industry code.

They want one efficient monitoring and complaints system and one set of effective sanctions for code violation.

This would be applicable to all therapeutic goods makers and administered by an independent agency.  Importantly, it would be underpinned by legislation that makes product registration dependent on compliance.

They want to see the system developed and operated co-operatively by all stakeholders, in accord with the partnership principle underlying the National Medicines Policy.

It is worth noting, however, that doctors are not off the hook on the issue, according to Butler. Butler calls on doctors to align with the standards expected of the therapeutic goods industry.

“Doctors and other health professionals should prescribe drugs or medical devices because of the benefit to their patients, not because they could receive an incentive or a gift”, he said in a media release in June.

In other words, it takes two to tango.

According to Butler, the government’s preferred position is that industry “strengthen and standardise self-regulation”.

But if it failed to do so, he warned, steps would be taken: “If the industry cannot provide the tough self-regulation that consumers deserve, the Gillard Government will have to bring in legislation.”

So where to now? Two meetings of the Working Group have been held; goodwill is apparent and progress is being made despite the government having been in caretaker mode.

Now that a minority Labor government has been confirmed, hopefully the Group will soon have much more to report.

Dr Harvey was a member of the expert group that drafted the World Health Organization’s Ethical Criteria for Medicinal Drug Promotion. He is currently a member of the Government’s Working Group on the Promotion of Therapeutic Products, an Adjunct Senior Lecturer in the School of Public Health at La Trobe University and Chair of the Governing Council of Health Action International, Asia Pacific.

Posted 13 September 2010