arketing prescription medicines, and how this is done, is more often than not a contentious topic. Although marketing prescription medicines is recognized as an important influence on how medicines are used, getting the right balance between the provision of information and education about prescription medicines on the one hand and inappropriate marketing on the other continues to challenge stakeholders.

Different stakeholder perspectives on this topic can be influenced heavily by the prevailing national health, regulatory, and industry arrangements. In Australia, all aspects of medicines availability and use are captured in our National Medicines Policy. The aim of this policy is “to make sure:

• All Australians have fair, timely, reliable, and affordable access to high-quality medicines and medicines services.
• Medicines are used safely and correctly. People have the information they need to make informed choices, and healthcare is well organised and based on their needs.
• There is support to encourage world-class innovation and research. This includes research that results in new treatments, medicines, and medicine services in Australia.”

The first two points above describe Australia’s national aspiration to achieve Quality Use of Medicines (QUM).

How does Australia approach “appropriate” marketing of prescription medicines?

In 1960, Medicines Australia, the prescription medicines industry association, established its “Code of Conduct.” Medicines Australia aspires to “set[s] a standard that ensures the Australian pharmaceutical industry acts with integrity and honesty to improve patient care.” Medicines Australia further states that “The Code of Conduct supports the Therapeutic Goods Act and regulates how industry communicates about prescription medicines.”

On March 27, 2025, Medicines Australia released the 20th edition of this code after wide consultation with patients, health professionals, industry, government, and other stakeholders, marking 65 years of development in support of Medicines Australia’s mission.

The code has delivered significant direct and indirect benefits since its inception and contributed significantly to achieving the aims of Australia’s National Medicines Policy. One strength of the code is that it is self-regulating but is underpinned by the Therapeutic Goods Regulations and the Therapeutic Goods Act, which means that legal avenues or remedies independent of the code process are available to parties in dispute over alleged breaches of the code or act. All prescription medicines companies are obliged to adhere to the Code of Conduct’s principles, to participate in the dispute-resolution process, and to accept the code’s verdicts. A pharmaceutical company may occasionally disagree with the outcome sufficiently strongly to take separate legal action, but this is an unusual occurrence. Although membership in Medicines Australia is voluntary, the Therapeutic Goods Administration (TGA) applies a range of conditions to all sponsors whose prescription medicines are registered in Australia, such as disease education, and requires that any “promotional activities comply with the Medicines Australia Code of Conduct.”

How are disputes adjudicated? Disputes typically involve claims for an advantage of one product over a competitor product that misrepresent the evidence. A codes complaints committee meets monthly if needed.

One important feature is the composition of the Code Committees. The chairs are independent lawyers experienced in competition and consumer law. Member companies without a conflict in the matters on the agenda provide senior employees, most often from medical departments, to serve on these codes complaint committees. These individuals are generally very familiar with the regulations around pharmaceutical advertising and promotion as well as the Code of Conduct. Independent consumers, specialist and general medical practitioners, and pharmacologists or clinical pharmacologists are sourced from their professional associations through a transparent process to provide expert, independent input to deliberations, and all members serving over a triennium are listed on the Medicines Australia website. The TGA provides an observer without voting rights.

Complaints are accepted from any individual or organization, but most emanate from pharmaceutical companies; fewer come from health professionals and are rarely received from the public. Because Australia does not allow direct-to-consumer advertising of prescription medicines, complaints from consumers are unusual. Rival pharmaceutical companies are quite alert to competitors’ claims that could breach the code principles and therefore play an effective “watchdog” role.

Medicines Australia member companies are obliged to undertake “intercompany dialogue” prior to submitting a complaint to the Medicines Australia Code for adjudication. These are invariably high-level interactions led by senior company personnel up to the chief executive, or medical or marketing directors. The minutes of all meetings are confirmed by both sides and then submitted with the complaint. Both parties submit their detailed case around specific aspects of the code that are claimed to have been breached. Their arguments are commonly supported by detailed evidence, often from pivotal clinical trials that post-date the information in the official product information (label).

The committee’s discussion is generally complex and involves critical appraisal of trial designs, statistical analyses, generalizability of results and, most importantly, the impact on the propensity of prescribers to write prescriptions for the medicine in question based on the disputed claims.

Should a complaint be upheld, the committee considers whether the advertisement or advertising campaign breach presents a risk to patients’ safety, giving particular weight to the opinions of the practicing physicians (especially those most likely to be the main prescribers—more often than not, primary care physicians [general practitioners]) on the committee. Substantial fines, corrective letters to all recipients exposed to the information in breach, and withdrawal of offending materials/presentations are recommendations available to the committee. Although these penalties exert significant material damage, the reputational impact, amplified by publication of the results of code deliberations by Medicines Australia, is also considerable. An appeals process, similar to the complaints process but with different committee members adjudicating, is accessed a few times annually.

The evolution of the Code of Conduct over 65 years has been an important component of Australia’s National Medicines Policy, with principles that reflect the changing nature and complexity of pharmaceuticals, our increasing understanding of the mechanisms of disease, and shifting societal expectations. The regular testing and evolution of our regulation of pharmaceutical promotion through a transparent, inclusive, and largely collegial case-based process that educates participants and stakeholders throughout has been a valuable contributor to achieving better and safer outcomes for citizens needing prescription medicines in Australia.