E-DRUG: News from Australia: 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". See: http://tinyurl.com/mlczolk.
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 at: http://tinyurl.com/mu8xe3t.
If others wish to engage in this debate, see: http://tinyurl.com/nreuqwz.
Submissions close on August 1, 2014.
Dr Ken Harvey
Adjunct Associate Professor
School of Public Health and Preventive Medicine
Monash University
http://www.medreach.com.au
"Ken Harvey" <k.harvey@medreach.com.au>