THE slow progress to open disclosure about the financial relationships between individual health professionals and the pharmaceutical industry moved one more step forward last week.
The Medicines Australia (MA) Transparency Working Group released two reports — Principles for transparency and Transparency model consultation and discussion document.
The reports resulted from pressure on the MA to further improve transparency after the Australian Competition and Consumer Commission (ACCC) approved amendments to the 17th edition of the MA Code of Conduct to improve transparency about pharmaceutical company payments to health professionals who act as consultants or are on advisory boards, but without naming individual doctors.
Further pressure on pharmaceutical company transparency came from proposed legislation that would have mandated the reporting of payments made to individual doctors. However, a Senate Committee recommended the bill be rejected, citing inappropriate timing given that the Transparency Working Group was about to report.
So what did the working group propose?
It did not achieve a consensus on all issues, which is not surprising given the disparate mix of members that included industry, health and consumer representatives, but it did agree that transparency principles should apply to all therapeutic goods companies, not just MA members.
The group also agreed that information about monetary transactions between a company and an individual health professional should: be readily accessible and meaningful to the public; be provided in a single, searchable, public repository; and be reviewed and agreed by health professionals and companies before publication. It also agreed that an educational process should be implemented to assist all parties in interpreting the information.
One principle not uniformly supported was to exclude business-to-business trading arrangements relating to the purchase of therapeutic goods, such as discounts provided by pharmaceutical companies or wholesalers to pharmacies.
Another proposal without unanimous support was that if the suggested model was expanded to the self-regulatory codes of other organisations, such as the Generic Medicines Industry Association and the Medical Technology Association of Australia, these transparency reports should be managed by a third party such as the Australian Health Practitioner Regulation Agency.
However, it was agreed that transparency reporting requirements would not be required if grants were made for continuing professional development, provided the program was an accredited event and the company did not select and/or directly pay the speakers or health professionals to attend.
A major area of dissension was the monetary threshold for reporting. One proposal was that amounts less that $25 to individual doctors not be recorded or reported, which would exclude low-level hospitality such as a pharmaceutical representative providing sandwiches to facilitate a GP clinic lunch-time meeting.
The alternative proposal was for a $10 recording threshold for individual doctors with reporting triggered on exceeding an annual cumulative total of $100, such as in the US Physician Payment Sunshine Act. However, unlike the US, Australian pharmaceutical company financial systems do not currently track low-level payments to individual health practitioners.
Other areas for debate included non-hospitality and non-travel costs to health professionals who attend a company-sponsored educational meeting; payments for clinical research; and whether a 45-day time frame was adequate for health professionals to review and correct information recorded about them.
MA is expected to call for submissions on the working group proposals later this year and conduct stakeholder discussion workshops.
The final model, as agreed by MA members, will then be added to the 18th edition of the code of conduct to be put to the ACCC in late 2014. If authorised, data collection would start in 2015 with public reporting in 2016.
There are several problems with this self-regulatory approach. As in previous code reviews, the final model is likely to contain the weakest options given that only MA members can vote.
There is no compulsion on the other eight therapeutic goods industry associations to follow MA’s path, let alone non-members. Not all industry associations have codes authorised by the ACCC, thus escaping the persuasive powers the ACCC exerted on MA.
The US Sunshine Act requires all pharmaceutical and medical device companies to collect data on payments made to individual doctors and teaching hospitals from August 2013, with reporting by March 2014 and public access by September 2014.
Australia should follow suit.
Dr Ken Harvey is adjunct associate professor at the School of Public Health, La Trobe University and was a member of the Medicines Australia Transparency Working Group. He can be contacted via medreach.com.au