Clear guidance on earned media crucial to pharma PR compliance

When the Medicines Australia Code Committee convened in November 2023 to assess a complaint from Astellas they found themselves in a tricky position.

Astellas had made complaint about a media statement from Bayer regarding its prostate cancer treatment Nubeqa. In short, the allegation was that a media statement on Bayer’s website about an expanded Nubeqa indication went beyond education and effectively promoted the product to the public. This, the complaint alleged, could potentially encourage patient-led prescribing.

There was however a complication.

The complication was that the committee was being guided by the recently ratified Version 19 of the code. This new principles-based version no longer included specific details or overt guidance about “product specific media statements”.

The committee was essentially on its own. Because no specific guidance on “product specific media statements” was contained in Edition 19 other than “the media” being listed (in general) as a stakeholder.

There was even discussion at the committee about which part of the Code actually guided this activity, especially as the media release was seen by the Code Committee as  “a mixture of a disease awareness campaign and promotional information about the availability of a new indication.”

The Code Committee eventually decided the media statement was in fact a breach. Thankfully they will have much clearer guidance in adjudicating similar complaints in the future. All the details and criteria for member companies who want to issue statements to media are now back in the newly released Version 20 of the Code, under section 10.1. (As explained in our previous blog here)

So why does all this matter?

All this matters because compliance around earned media turns on subtle issues like editorial ownership (of “the final output of media coverage” as the Code puts it), as well as tricky definitions of terms like “promotional” and “comparative”. It turns on what external experts say, what they are asked and (even more so) on how they are briefed and instructed.

As the history of the Medicines Australia Code of Conduct shows, questions around earned media and editorial relationships cannot be effectively managed via principles or the “vibe” or “intent” of what is going on.

Interestingly, despite what compliance professionals may assume, complaints about PR and editorial outreach are relatively rare. In all the complaints heard and reported by the Code Committee from 2023 to 2025, only the complaint of Astellas really focused directly on a media statement that aimed to drive earned media interest.

So best not to exaggerate the likelihood of a complaint.

Compliance teams are rightfully extremely diligent when it comes to reviewing and providing advice on consumer-facing media materials. The reality though is that most member companies are dealing with specialist health PR agencies who are well-versed in the provisions and restrictions of the MA Code.

Which I think goes some way toward explaining the low number of complaints in relation to PR and media statements.  But let’s not get complacent. That allegation of being ‘promotional’, ‘comparative’, or being designed to ‘encourage the use of a prescription product’ might be just around the corner. At least we’ve got the detail back in the Code now to help everyone navigate a clearer path.

You can read the full outcome of the complaint discussed here via the notes from the Code of Conduct Committee meeting here.