The next version of the Medicines Australia Code of Conduct (Version 20) comes into effect on 30th March 2025.
Version 19 was reviewed during 2024 and attracted a wide range of submissions from various stakeholders in the health, medical and pharmaceutical sector.
When the initial edition of version 19 came out in 2020, I argued in Biopharmadispatch that it would create additional PR opportunities for earned media. This was because it was “principles-based” and the details about the circumstances in which pharmaceutical companies could conduct editorial media outreach about their prescription products and supply issues were less prescriptive than previous. Version 19 essentially listed “the media” as a stakeholder (with all the other stakeholders like healthcare professional associations, patient groups and political representatives) and provided some general principles-based guidance around not being promotional and helping people (like journalists) do their job within the general concept of the “quality use of medicines”.
The upcoming Version 20 winds back the clock in Section 10 because it copies and pastes the words from Version 18 (with some “minor amendments” as it says in the summary) to specify that contact with consumer-facing media should be restricted to new registrations, a new indication, a reimbursement announcement or an update on supply.
This is in line with submissions from medical groups like the Royal Australian College of GP’s who (apart from thinking $200K fines were a “drop in the bucket” for big Pharma) were concerned that companies might be doing some promoting of products in the name of “public information”. Or in the words of the RACGP, companies might seek to “ avoid rules preventing the advertisement of prescription medicines and devices, in the name of informing the public of product availability or new indications”
So the detail is back in. I suspect compliance professionals will join the RACGP in welcoming this.
Not that it will really make that much difference. Because most companies seem to have kept a tab open on Version 18 over the past few years and kept their consumer-facing media to the areas of new registrations and reimbursements. My prediction in 2020 that Version 19 would act as a trigger for a wave of new attempts to deal with consumer media as a stakeholder (in a more innovative or creative way) never really came true. The test for consumer facing media releases and PR centres on a genuine development (a PBS listing, TGA registration, NIP reimbursement etc). That’s always the conversation public affairs people will have with their compliance teams. Is this genuine news that can be communicated to consumers in a way that is “non-promotional”?
Supply issues are referenced in the Code so it might be possible to argue (under the principle of quality use of medicines) that consumer facing communications is appropriate in some supply scenarios – say the company has been out of stock, there’s some confusion, people are aware of that via the media and other sources. It would be fair for the manufacturer in these circumstances to put the record straight via the media in a non-promotional way.
The provisions in relation to disease awareness (Section 12.2) are largely unchanged so the test remains the same. Is the focus on the “therapeutic category” rather than on a “specific prescription product”. The direct to consumer communications needs to make sure it does not “unduly emphasise particular options or the need to seek treatment.”
So for example, a consumer facing communication that makes reference to the importance of vaccination in a particular therapeutic category could potentially be compliant in circumstances where the main focus is on the condition, vaccination as an option is not “unduly emphasised”, the call to action is to ‘speak to your doctor’ (rather than go and get vaccinated) and there are a wide variety of vaccines available for that condition (if there is only one vaccine available for the condition the focus of any disease awareness would need to be even more tightly on the disease, otherwise it may be interpreted as an attempt to promote a particular clinical pathway).
From a PR perspective for disease awareness, it’s largely “As you were”.
There are clearly still opportunities in the Code for manufacturers to play an important role in raising awareness about diseases and educating the general public about developments with their medicines, as they have done very successfully for decades.
It’s just a matter of having the right PR support, public affairs professionals and compliance teams to make sure it’s both impactful and compliant. Especially now that the detail is back in.
