The maximum penalty for breaching the Medicines Australia Code of Conduct won’t put a dent in pharmaceutical companies, says the college.
The maximum fine for breaching the Medicines Australia Code of Conduct is too small to deter pharmaceutical companies, says the RACGP.
For 60 years, the Medicines Australia Code of Conduct has set the standards for ethical marketing and promotion of prescription drugs in Australia.
Earlier this year, Medicines Australia opened its consultation into the latest edition of the Code, which came into effect in March 2020.
In its submission to the latest review of the Code (Edition 19), the RACGP raised concerns over the maximum fine for severe breaches — $200,000 — “which does not seem to be a deterrent of any impact for big pharmaceutical companies”.
College president Dr Nicole Higgins said members raised concerns over possible moves to avoid rules preventing the advertisement of prescription medicines and devices, in the name of informing the public of product availability or new indications.
“It is almost impossible to separate ‘informing the public’ from advertising,” she said.
“Information provided to the public should remain as a response to a query from a member of the public.”
Dr Higgins said that while there might be instances where it could be in the public interest to share information about a prescription drug, “for health promotion purposes”, it should be determined by a public health authority (state or federal).
“In such instances, educational information and disease awareness materials to the general public should be clear and accurate, and accessibility standards should apply and should be free from biases,” she said.
The college also raised concerns over the ambiguity of the code in regard to when pharmaceutical companies must declare funds used for “scientific exchange”, or the sharing of information in a non-promotional context.
“Funds shared with health organisations may remain unreported unlike funds shared with individual health professionals,” read the submission.
“Any funding exchanges between pharmaceutical companies and health organisations of any type, should be listed in the public domain.
“Additionally, conflicts of interest must be declared, when organisations and individuals that receive funding use this funding to produce educational content and position statements or guidelines that directly impact on accessibility, knowledge, and usage of the funder’s products.
“This should also be the case with respect to research partnerships.”
Discussion of unregistered products and off-label uses should be cut, added Dr Higgins.
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The college membership also raised specific concerns over the “unregulated cannabis industry”, which has seen the rise of one-stop-shop, online prescription services.
“Specifically, the marketing and opportunism of clinics, which are remunerated according to prescription numbers without proper history taking or collaboration with a patient’s regular GP,” read the submission.
Beyond industry, the college encouraged Medicine Australia to mandate that health professionals are not “spammed” with information and that communication should be paperless.
“Additionally, there should be quick and simple options provided for health professionals to personalise communications in terms of method and frequency,” read the submission.
“This would include ‘opt out’ areas as currently required by privacy laws.”
The latest edition of the Code can be found here.
Any updates will be proposed for formal adoption by specialist resolution at the next Medicines Australia Annual General Meeting in October 2024.
