Self-regulation or government regulation of transparency?

In 2012, when edition 17 of Medicines Australia Code was released, the Australian Competition and Consumer Commission (ACCC) limited its authorisation to 2 years, rather than the 5 years sought, to encourage Medicines Australia to improve transparency around payments to individual health care professionals.

This was in accord with international developments such as the US Open Payments (the Physicians Payment Sunshine Act), which mandated full public disclosure of these relationships.

Edition 18 of Medicines Australia Code has now been submitted to the ACCC for authorisation. It “encourages” healthcare professionals to consent to disclosure. However, it also allows them to opt-out of disclosure while retaining the financial and related benefits of their interaction with member companies. As Senator Richard Di Natale noted, “The voluntary nature of disclosure makes the Code next to meaningless. It’s like making a breathalyser voluntary for drink drivers”.

Medicines Australia Code is weak because other therapeutic goods industry associations have not adopted transparency provisions in their own self-regulatory Codes and many have also opted out of ACCC Code authorisation (and thus being subjected to ACCC persuasive powers). In addition, there are increasing numbers of non-members of therapeutic goods industry associations (for example, the Indian generic company Ranbaxy Australia) who are not bound by any self-regulatory Code. Furthermore, Australian health professional organisations have also failed to address &/or incorporate transparency provisions in their own Code.  It’s therefore not surprising that many members of Medicines Australia were worried that attempting to force full disclosure would put them at a competitive disadvantage with other therapeutic goods companies, especially generic companies.

Medicines Australia argue that disclosing transfers of value from those health professionals who consent (and lumping together the total value of benefits received and the numbers of those who do not) is an incremental improvement (and public benefit) on the previous Code and thus their latest Code should be authorised.

The alternative view is that it would be to the public detriment to authorise a Code that fails to deliver on the key principles agreed to by Medicines Australia Transparency Working Group, including the key outcome raised by many interested parties in deliberations about edition 17 of the  Code: transparency on individual payments made to healthcare professionals (consistent with developments in the U.S.).

My own view is that the ACCC should not provide a fig-leaf of respectability to edition 18 of Medicines Australia Code by authorising the flawed outcome achieved. Rather they should defer authorisation and refer this mess back to where the responsibility lies: the Regulatory Policy & Governance Division of the Australian Department of Health, the Therapeutic Goods Administration (TGA) and the government, all of whom have failed to address the limitations of self-regulation.

A number of counties such as France, Portugal and Turkey have now embraced government regulation of transparency in addition to the USA. I also believe that Australian legislation should also make transparency (and other ethical considerations) a condition of market authorisation by the TGA.

My full submission (and others) can be found here. A (much) shorter version has published by MJA Insight.

If others wish to engage in this debate the ACCC is accepting submissions until August 1, 2014.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Pharmaceutical Promotion and tagged , , . Bookmark the permalink.

1 Response to Self-regulation or government regulation of transparency?

  1. Prof Harvey, whilst applauding your article in theConversation affirming the submission by the RACGP, I feel the strongest concerns have been overlooked. Those objections submitted by the Royal Aust & NZ College of Psychiatrists on 30th July addressing undue influence within institutional research were in accord with those submitted by myself on the day prior to your lodgement. Rather than abstracting principles, I’ve named & shamed within Monash in order to stress that misconduct is also overlooked.

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