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Concerns raised over possible change to medicine advertising rules


Chelsea Heaney


20/05/2024 3:44:39 PM

The RACGP calls for greater transparency and larger fines for breaches in a review of Medicines Australia’s code of conduct.

Medications inside blister packs.
The consultation period for Medicines Australia’s Code of Conduct (Edition 19) ran from April to May 2024.

It has been nearly five years since Medicines Australia adopted its latest Code of Conduct (Edition 19) and its latest review has attracted more than 50 submissions.
 
In its own submission, the RACGP has made several recommendations, including raising concerns regarding the advertising of new products, scientific exchange with healthcare professionals, and improving dialogue in relation to complaints.
 
It also recommended engaging non-member companies in the complaints process, improving resources, and adapting to emerging trends in Australia and internationally.
 
RACGP President Dr Nicole Higgins wrote that members had voiced concerns about a potential move to ‘avoid the rules prohibiting the advertising of prescription medicines and devices’.
 
‘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.’
 
Bur Dr Higgins said there are instances where a state or federal public authority may share information with the public that is in the public interest.
 
‘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.
 
Chair of the RACGP Expert Committee – Quality Care, Professor Mark Morgan, said Australia’s current rules protect patients from direct advertising of prescription medicines and medical devices.
 
‘Unlike [the] USA where patients are bombarded by direct advertising,’ he told newsGP.
 
‘Often, if not always, there is bias in marketing messages. That might be okay for a particular brand of coffee – but it is not in patients’ best interest to have biased information for impactful decisions.’
 
He warned against this deregulated set-up as ‘almost all adverts overplay the benefits and often sell hope rather than reality’.
 
Dr Higgins says the concept of scientific exchange in Edition 19 of the Code of Conduct ‘needs more clarity’.
 
‘The Code includes examples of what is allowed but does not include what is not allowed,’ Dr Higgins said.
 
Furthermore, Dr Higgins wrote that references to unregistered products and off-label uses ‘are concerning and should be removed’.
 
Issues around transparency from pharmaceutical companies about funds used for scientific exchange were also raised.
 
‘Funds shared with health organisations may remain unreported, unlike funds shared with individual health professionals,’ Dr Higgins writes.
 
‘Any funding exchanges between pharmaceutical companies and health organisations of any type should be listed in the public domain.’
 
It was noted that anonymous complaints are not currently accepted, with the burden of proof lying with the complainant.
 
‘This is fundamentally different to how the Australian Health Practitioner Regulation Agency [AHPRA] operates its complaints process,’ said Dr Higgins.
 
The maximum fine of $200,000 for severe breaches resulting in patient safety implications was called into question.
 
Professor Morgan said it is hardly a deterrent when, in comparison, the top six pharmaceutical companies had revenues ranging ‘from over US$50–100 billion’.
 
‘[This makes] a $200,000 fine relatively tiny,’ he said.
 
In its final comments, the RACGP submission states that the patient support program section fails to address over-the-counter medicines and ends with Dr Higgins speaking to member concerns about the unregulated cannabis industry.
 
‘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,’ she said.
 
Professor Morgan said clinics providing medicinal cannabis scripts currently exist to ‘educate, prescribe, then sell’ product lines.
 
‘Medicinal cannabis is marketed for all sorts of conditions without much evidence of benefits over harms and without providing balanced advice about alternative treatment options,’ he said.
 
Medicines Australia says if the review finds that updates are needed, they will be put forward for formal adoption at the Medicines Australia Annual General Meeting in October. 
 
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