Ken Harvey: Transparency hurdles

MEDICINES Australia has submitted edition 18 of its self-regulatory Code of Conduct to the Australian Competition and Consumer Commission for authorisation.

The outcome will be interesting.

In 2012, when edition 17 of the Code was released, the 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 Physician Payments Sunshine Act), which mandated full public disclosure of these relationships.

Medicines Australia responded by establishing a Transparency Working Group, with representatives from member companies, and from a diverse range of health professional and consumer groups. By May 2013, the group had agreed on a set of transparency principles applicable to all therapeutic goods companies.

These included collecting details on all monetary transactions between a company and an individual health care professional, and reporting these transactions on a single, public website that is readily searchable.

As I wrote in MJA InSight last year, a transparency model consultation and discussion paper included various implementation options on which the group had failed to reach a consensus, including the levels of payment to be recorded and reported.

The revised Code, agreed solely by members of Medicines Australia, has two major flaws. First, it provides no assurance that information about transactions will be transparent for many individual health professionals as it allows them to opt-out of public disclosure while retaining the financial and related benefits of their interaction with member companies. This is Clayton’s transparency.

Second, it fails to implement the concept of a single website for consolidating information about transactions provided by different companies. Without this, those interested will have to trawl the websites of all Medicines Australia member companies to collate their own list from those doctors who have consented to make this information available.

The main reason why the Code is so weak is because other therapeutic goods industry associations (eg, the Generic Medicines Industry Association) have not adopted any transparency provisions in their codes and have also opted out of ACCC code authorisation (and thus being subjected to ACCC persuasive powers).

There are also increasing numbers of non-members of therapeutic goods industry associations (especially generic companies based in India) not bound by any self-regulatory 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.

All of which highlights the problems of self-regulation raised in 2010 by the Working Group on Promotion of Therapeutic Products. This working group provided principles to harmonise the disparate therapeutic goods industry codes and addressed the need for non-members to adhere to codes as a condition of gaining marketing approval by the Therapeutic Goods Administration (TGA).

The federal government’s response in 2013 was merely to set up a Codes of Conduct Advisory Group to assist industry to implement the recommendations of the working group. There is only one report from this group currently in the public domain and it is unclear what, if any, progress has been made.

Self-regulation is incapable of delivering the outcomes required, which has led the US, France, Portugal and Turkey to embrace government regulation of transparency. In Australia, it is time to revisit the Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013. A revised Bill should make transparency (and other ethical considerations) a condition of market authorisation by the TGA.

Meanwhile, the ACCC should not provide a fig leaf of respectability by authorising edition 18 of the Medicines Australia Code. Rather, they should defer authorisation and refer this mess back to where the responsibility lies — the Regulatory Policy and Governance Division of the Department of Health, the TGA and the government, all of whom have failed to address the limitations of self-regulation.

The ACCC has called for submissions about the code, which close this week (1 August). It is an opportunity to have your say on the proposed arrangements.
 

Dr Ken Harvey is adjunct associate professor in the School of Public Health and Preventive Medicine, Monash University. He represented the Consumer Health Forum on the government’s Working Group on Promotion of Therapeutic Products and Medicines Australia’s Transparency Working Group and Code Review Panel.