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So long 1 mm lowercase ‘e’ …

Are we ready for the new Medicines Australia Code of Conduct?

The next edition of the Medicines Australia Code of Conduct is due for implementation on 30 March 2020. Gone are most of the prescriptive details – from font-size specifications to the 10-patient-per-prescriber limit for Product Familiarisation Programs (PFPs) … in fact, gone are PFPs as we once knew them.

The Code has been culled from 96 pages down to a lean 36. But of all the things that have been stripped out, perhaps the most significant is the word NOT (as in ‘cannot’ ‘should not’ ‘may not’) - reduced from 375 instances in Code 18, to 98 in its new iteration.

This is big. At least for the those of us who have spent countless meetings in which, '...the Code doesn’t say we can't do it' was overtaken far too often by, ‘but the Code doesn’t say that we can – please check with the Code helpdesk’. You can’t blame companies for wanting to do the right thing – but in a heavily risk-averse industry, the more detail included in the Code, the more it constrained many companies to following the letter. Hopefully by pivoting to a more principles-based approach, companies can focus more on intent.

The details that remain in the Code include the $120 hospitality cap, and the requirements pertaining to claims, minimum product information, and transparency reporting – and brand name reminders remain firmly in the ‘Not’ bucket. There are also a few notable additions – including Scientific Exchange which is largely a consolidation of previous guidance, but nonetheless frames the necessary interactions between companies and healthcare professionals and researchers. Communications with Relevant Stakeholders is also a welcome addition – distinguishing between non-medical stakeholders who have ‘a role in the research, development, registration, listing or monitoring of a therapeutic good’, and the general public. There has also been a minor, but notable, adjustment to Patient Support Programs in the use of data beyond safety reporting. And this is where Code 19 shines – helping to elucidate what’s permissible where specific guidance does not exist elsewhere.

Existing leadership are well versed on the evolution of the Code and its intent to ensure successful compliance. However, long-term success will likely depend on how well new and future generations of industry professionals are mentored - and their understanding that maintaining the integrity of the industry comes not from doing what you're told, or not doing what you’re told not to – but from having strong principles and sticking to them.

The big question now is whether the Code Helpdesk will be any less busy once the guidelines are in effect?

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