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    Ken Harvey

    At yesterday’s pre-decision conference with the ACCC, Ian Haines, Bob Arnold, Carol Bennett and I argued that full disclosure of the relationship between therapeutic goods companies, physicians and other stakeholders is crucial.

    I mentioned a recent US Senate Finance Committee investigation that found the medical device company Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants, who were paid hundreds of millions of dollars by the company through royalties and consulting fees. See:

    The Committee Chairman, Senator Max Baucus, said Medtronic’s actions had “violated” patients’ trust. The president of the North American Spine Society, said, “If surgeons had known that the lead authors of the 13 original studies on InFuse (the Medtronic product) had received payments ranging from $1.7m to $64m from Medtronic and that its marketing employees were co-authors and co-editors, would they have been as eager to use this product on their patients?” Hence the need for full disclosure of such arrangements.

    This is just the latest in a series of scandals that has cost the U.S. therapeutic goods industry 15 billion dollars’ worth of fines over the last few years, see:

    My colleagues and I pointed out that if no changes were made to the ACCC draft determination, and the 17th Edition of Medicines Australia Code is authorised for another 3 years, then Australia will fall behind the level of transparency that will come into force in the U.S. next year as a consequence of the Physicians Sunshine Payment Act. This is unacceptable.

    I tabled our petition that currently has over 360 signatures and asked the ACCC to make the following changes to its draft determination.

    1. Reduce the period of authorization of the Code of Conduct to one year (2013).

    2. Request Medicines Australia to submit a revised Code to include arrangements covering transparency of relationships between the pharmaceutical industry and individual health professionals for authorization at the end of 2013.

    3. Request Medicines Australia increases the number of informed critics of their current Code regarding transparency matters on the transparency working group.

    I pointed out that while most of the signatories are Australian health professionals or concerned consumers a number of international people have also signed the petition, see:

    This is because Australian medicines policy is regarded as an exemplar in our region and there is international support for the ACCC to strengthen Medicines Australia Code along the lines requested.

    I noted that if no changes are made to the draft determination, aggrieved petitioners will ask for a review of this determination by the Australian Competition Tribunal on the grounds that the limited public benefits do not in our view (and on expert advice) outweigh the anti-competitive detriments of the deal.

    Medicines Australia argued that their members supported increased disclosure and their transparency working group was set up to explore various models whereby this might be achieved. However, they believed the issues were complex, the cost of compliance high and the benefits unclear. More time was required to find the right way forward.

    In response, I said that Medicines Australia concerns reminded me of the Saint Augustine’s prayer, “Oh Lord, give me chastity, but do not give it yet”.

    The ACCC is expected to make a final determination on these matters in a few weeks’ time. I’ll post the outcome.

    The petition is still available at

    More signatures are welcome in case we have to take this matter to appeal with the Australian Competition Tribunal.

    Dr Ken Harvey
    Adjunct Associate Professor
    School of Public Health,
    La Trobe University


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