In Australia, the promotion of medicines to health professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry. The Code of Conduct overseen by Medicines Australia covers prescription drugs marketed by member companies. The latest version of Medicines Australia’s Code of Conduct (Edition 18) includes a requirement for greater transparency in the payments made to health professionals. The new requirements have been adopted reluctantly by the pharmaceutical industry and only following the lead of other countries, long-standing campaigns by medical and consumer organisations, and pressure from the Australian Competition and Consumer Commission (ACCC).
After several rounds of stakeholder consultation, the 18th edition of the Code was approved by the ACCC in April 2015. Approval was on the condition that all relevant ‘transfers of value’, either in kind or cash, such as speaking fees, advisory board fees, or sponsorships to attend conferences, would be reported and that the data would be accessible to the public.1 There was an ‘opt-out’ clause whereby health professionals could choose not to have their name publicly reported, but this will be terminated in October 2016 when the reporting of payments becomes mandatory.
Still in contention is the establishment of a searchable database of all companies’ payments to healthcare professionals that would allow members of the public to access information in a single location. From August 2016, data will only be available on each individual company’s website, but the ACCC has requested that Medicines Australia develop and implement a centralised database.
There are still a number of unsatisfactory points in the current transparency provisions. Not all payments have to be reported. The Consumers Health Forum of Australia was disappointed that the reporting of hospitality costs, which was required by Edition 17 of the Code, was discontinued. Instead there is a limit of $120 ($132 including GST) per meal provided. In practice, no company will ever have to record or report a doctor receiving their hospitality if they stay under this limit. This means that an important part of the industry ‘transfer of values’ to health professionals will not be captured in the new system. There should be ‘no free lunch’. Items of low monetary value could add up to a significant sum when aggregated over time, and have been shown to be extremely influential.2
The Society of Hospital Pharmacists of Australia also expressed concerns that the Code did not specifically address the relationship with healthcare organisations including support for professional development, sponsorship of national or international conferences and grants through third parties.3 Payments in relation to research work including clinical trials are not reportable although many post-marketing studies (phase IV trials) are mainly promotional in nature and are known as ‘seeding’ trials. Furthermore, involving opinion leaders in clinical research is a key promotional strategy for the pharmaceutical industry which cannot be ignored.4
The Department of Health is also pushing for increasing transparency, in particular with regards to making information on medicines available, for example by publishing companies’ submissions to the Pharmaceutical Benefits Advisory Committee. This proposal is fiercely opposed by the pharmaceutical industry which claims these data are ‘commercial in confidence’.
Another important concern is that the transparency provisions do not apply to pharmaceutical companies that are not members of Medicines Australia. Another industry organisation, the Generic and Biosimilar Medicines Association (GBMA), which has opted out of ACCC Code authorisation, has just decided to remove the requirement for members to report on educational events and non-price benefits such as access to training events or patient information sheets.5 In 2014–15 GBMA spent more than $2.2 million on non-price benefits to pharmacists and over $300 000 on educational events.6 This backward step is a real concern as the generic and biosimilar market is growing rapidly in Australia.
Companies do not always adapt to new regulations in good ways. GlaxoSmithKline has announced that it will end direct payments to health professionals for speaking or attending medical conferences, but will use this budget to hire a new team of medical experts working at the global, national and local level.* This strategy may provide more transparency, but still leaves medical education at extreme risk of being biased in favour of the company’s own products.
The growing trend of product familiarisation programs and patient support programs in Australia is a real concern with almost no public information available on these programs. For example, Novo Nordisk is currently enrolling the pharmacy workforce as well as prescribers in a patient weight-loss support program promoting the use of Saxenda (liraglutide) through ‘Saxenda Network Pharmacies’.7 This drug is not covered by the Pharmaceutical Benefits Scheme and pharmacists may be able to claim a professional service fee from the manufacturer. It is unclear whether this fee will be reportable.
There is no evidence that information provided by the pharmaceutical industry improves prescribing practices.8 Pharmaceutical promotion will always aim to influence the choice of prescribers towards newer, more expensive medicines and sometimes more risky medicines. In Australia, there is a wide range of independent sources of information on medicines including the Australian Medicines Handbook, Therapeutic Guidelines and Australian Prescriber that health professionals can consult.
A number of health professionals and organisations have already chosen to be independent from the pharmaceutical industry. Medical education in some hospitals such as Monash Health is now internally funded or funded by other organisations.9
The No Advertising Please campaign was launched by a group of health professionals and academics in 2014 and has won strong support from the Consumers Health Forum of Australia, the peak health consumer organisation in Australia. The campaign encourages doctors to avoid seeing drug representatives by pledging to not see them for one year.10 The campaign’s website also provides comprehensive information on research evidence showing that doctors who see drug representatives are more likely to prescribe more medicines, more expensive medicines and are less likely to follow clinical guidelines.
Transparency is good but independence from pharmaceutical industry is better for the health of patients and the healthcare system.
* NPS MedicineWise is conducting educational activities supported by an independent educational grant from GlaxoSmithKline secured by VentureWise, a wholly owned commercial subsidiary of NPS MedicineWise. NPS MedicineWise has designed and developed the content with complete independence and editorial control.
Conflict of interest: none declared
- Australian Competition and Consumer Commission. Applications for revocation and substitution of authorisations A91436–A91440 lodged by Medicines Australia Limited in respect of the Medicines Australia Code of Conduct edition 18. 2015 Apr 24. [cited 2016 Jul 1]
- Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth 2003;3:39-46.
- The Society of Hospital Pharmacists of Australia. Submission to the Australian Competition and Consumer Commission Medicines Australia Limited - Revocation and Substitution - A91436 - A91440. 2014. [cited 2016 Jul 1]
- Flicker L. The influence of opinion leaders. Aust Prescr 2012;35:74-5.
- Lam M. GBMA ends transparency reporting. Pharma in Focus. 2016 Feb 1. [cited 2016 Jul 1]
- Lam M. Generics spend $2.2m on pharmacists. Pharma in Focus. 2016 Jan 22. [cited 2016 Jul 1]
- Pharmacy key for Saxenda. Pharmacy Daily 2016 Feb 1. [cited 2016 Jul 1]
- Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians’ prescribing: a systematic review. PLoS Med 2010;7:e1000352.
- Dean J, Loh E, Coleman JJ. Pharmaceutical industry exposure in our hospitals: the final frontier. Med J Aust 2016;204:20-2. .
- .No Advertising Please. 2014. [cited 2016 Jul 1]