Clear relationships needed

 Ken Harvey

Dr Ken Harvey

First published on MJA Insight on 29 April 2013.






CONCERN about inducements to health professionals by the therapeutic goods industry is a worldwide phenomenon.

Such inducements can lead to uncritical uptake of newer, expensive and less well evaluated products, and underutilisation of more cost-effective drugs and medical devices. The cost implications to our health system are significant, as outlined by the Grattan Institute last week.

So, it is encouraging that the Senate is currently considering an amendment to the Therapeutic Goods Act. This provides an opportunity to debate various models of ensuring transparent and ethical relationships between health professionals and therapeutic goods companies.

Several countries have already addressed these concerns. The Dutch have a central register [PDF 560KB], managed by an independent foundation, to record the financial relationships between health care professionals and institutions and the pharmaceutical industry.

All financial relationships exceeding €500 (A$640) in total for 2012 were entered in the register at the start of 2013. The register was opened to the public last week.

The US Physician Payments Sunshine Act [PDF 935KB] became operational earlier this year. It requires pharmaceutical and medical device companies to report to the Centers for Medicare and Medicaid Services (CMS) all payments made to individual doctors and teaching hospitals that total more than US$100 (A$97) a year.

Companies must begin to collect the information by 1 August 2013 and report it to the CMS by 31 March 2014. The information will be posted on a public website on 30 September 2014.

The Australian Government prefers self-regulation.

Medicines Australia has set up a Transparency Working Group charged with incorporating similar disclose provisions to the US Sunshine Act into its self-regulatory code, and it is on track to releasing a final report mid year.

The group has developed principles applicable to all therapeutic goods companies and all health professions, not just doctors. These include providing access to information in a single, public repository, enabling the information to be audited and validated by health care professionals and companies, supported by an educational process to assist all parties to interpret the information in context.

If the group’s recommendations are adopted, member companies of Medicines Australia could start recording payments made to individual health professionals from the beginning of 2015 with public reporting starting in 2016.

Although Medicines Australia might take up the group’s recommendations, there is no compulsion on the other eight therapeutic goods industry associations to do so. Most importantly, non-members of industry associations escape self-regulatory codes yet they are often the worst offenders.

The Bill currently before the Australian Senate would, like the US Sunshine Act, include a clause making it compulsory to report. However, unlike the US Act, the Australian Bill only applies to pharmaceutical companies and doctors.

The Bill also allows details of payments to be split between a multitude of individual company web sites. This would make it very difficult to find out how much money a doctor was receiving and from whom. Regardless, the Bill has stimulated debate.

The Senate is currently considering submissions, which closed earlier this month.

Most of the 23 submissions posted oppose the Bill and support industry self-regulation (four industry associations, 13 pharmaceutical companies and the University of Sydney). One health professional and one consumer organisation support the Bill (the latter also wants it broadened to include all health professionals and all therapeutic goods companies).

Two health professionals have pointed out the limitations, both of the Bill and of self-regulation, and asked for broader debate about different models for ensuring ethical relationships between health professionals and therapeutic goods companies.

A late submission from the Department of Health and Ageing reinforces the government’s preference for self-regulation but fails to address its limitations.

Clearly, self-regulation cannot be effective unless the government introduces legislation to make compliance with codes of conduct a condition for obtaining approval to market therapeutic goods.

Self-regulatory codes should also have similar provisions to ensure a level playing field. Government support would allow access to information about relationships and payments from industry to health professionals in a single, public repository, such as the Australian Health Practitioners Regulation Agency.

A co-regulatory approach is required to ensure transparency in the relationships between health professionals and industry. I suggest we adopt the Dutch model.

Professor Ken Harvey is an Adjunct Associate Professor in the School of Public Health at La Trobe University.