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Drug company transparency rules far from clear

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Pharmaceutical company payments to doctors of as little as $10 may be disclosed under model reporting guidelines prepared by the medicines industry.

Payments made by drug firms to individual practitioners could be publicly itemised and disclosed from mid-2016, according to draft proposals released by Medicines Australia (MA) earlier this month.

But the model guidelines, which are up for consultation and discussion during the next 12 months, are contentious.

The AMA, along with several other medical groups including the Royal Australian College of General Practitioners and the Royal Australasian College of Surgeons, have participated in a Transparency Working Group convened by Medicines Australia to thrash out ways to increase transparency surrounding payments made by pharmaceutical companies to individual doctors.

However, the MA reporting model is but one possible reporting structure, and does not reflect a consensus view within the Working Group.

While the AMA has supported moves to improve the transparency of relationships between the medicines industry and doctors, it is concerned that any information that is publicly disclosed is fair and helps inform patients in making decisions about their health care.

AMA President Dr Steve Hambleton has highlighted the importance of doctors being able to attend conferences and workshops to learn of the latest advances in medicines, particularly where they are able to interrogate manufacturers about evidence and efficacy.

Under the model guidelines, companies which made payments or other “transfers of value” would be obliged to record and disclose the name and location of the doctor involved, their registration number, the size, date and form of payments, and what they were for.

Medicines Australia has suggested two alternate thresholds for the disclosure of payments – $25 or $10, but the latter only if the aggregate reaches more than $100 in a calendar year.

The proposed code would be intended to include cash payments, in-kind items or services, or stocks, options or other ownership interests, and could be for consultation work, speaking engagements, honoraria, travel expenses, market research, education costs, royalties or license fees, grants or a charitable contribution.

Payments would be exempt from disclosure where they were made to cover the costs of attending a continuing professional development program which was accredited, and where the drug company was not involved in selecting those who would attend, nor any direct payments to them.

The impetus for increased transparency in the relationships between doctors and pharmaceutical companies has come largely from overseas, particularly the United States, where laws requiring the disclosure of drug company payments to individual doctors have come into force.

Medicines Australia Chief Executive Dr Brendan Shaw said the proposed transparency model was “similar” to the US Physicians Payments Sunshine Act.

Dr Shaw said his industry was keen to improve the transparency of the industry-doctor relationship.

“Medicines Australia members overwhelmingly support greater transparency so that the nature of their relationships with doctors is open to greater scrutiny,” he said. “Engagement with doctors is important and legitimate because patients want to be sure that their doctors know how to use the medicines they’re being prescribed.”

Consultations about the model will conducted over the next 12 months, and will be completed in time for Medicines Australia to submit its next industry Code of Conduct to the Australian Competition and Consumer Commission for approval by the end of 2014.