1960’s magazine ads promoting Valium to young women. Extravagant drug launch parties and fine dining. “Medical journals” owned and edited by pharmaceutical advertisers. Sales reps directed to target frequent prescribers in each zip code. FDA officials and a “Speakers’ Bureau” of experts on drug company payrolls.
Author Patrick Radden Keefe’s account of the history of Oxycontin’s Purdue Pharma in his book “Empire of Pain”1, paints a disturbing, and fascinating, picture of pharmaceutical marketing and its role in the US opioid epidemic, as well as the broader history of medical advertising throughout the 20th century.
Fast forward to 2022 and cross the globe to Australia, where the medical technologies and pharmaceuticals industry is experiencing rapid growth, supported by increasing investment and a strong culture of research and innovation.
Regulation, it seems, is also thriving with several self regulatory industry bodies joining the Therapeutic Goods Administration (TGA) and ACCC in regulating how companies can promote their products. From 1 January 2022, lanyards at educational events in Australia can no longer be branded with company or product names from pharmaceutical sponsors2. 1 January also saw the commencement of the new version of the Therapeutic Goods Advertising Code as well as Edition 12 of the Medical Technology Industry Code of Practice.
While the underlying rationale is hard to dispute, the regulatory environment can present a challenge for companies bringing new products to market and looking to promote them. This article reviews the current state of play for the promotion of medical devices and medicines in Australia as we turn the corner into 2022.
What is advertising?
Marketing these days can take many forms. Promotional activity is generally aimed either at consumers (patients) or healthcare professionals.
Advertising directed at consumers is covered by the The Therapeutic Goods Act 1989 (TG Act) and the Therapeutic Goods Advertising Code (TGAC)3. Promotions to healthcare professionals are governed by industry codes such as the Medicines Australia Code of Conduct (MA Code of Conduct)4 and the Medical Technology Association of Australia’s (MTAA’s) Medical Technology Industry Code of Practice (MTI Code of Practice).
The TG Act contains a broad definition of “advertisement”. In relation to therapeutic goods, this includes “any statement, pictorial representation or design that is intended whether directly or indirectly, to promote the use or supply of goods, including whether on labelling, packaging or any other information accompanying the package containing the goods”.5
A considerable grey area exists between the provision of information, and promotion. Educational information about disease awareness and prevention – for example – will not be promotional if it does not refer to particular products or treatments. However, if such information focusses on the benefits of a new, named product this may cross the line.
The new TGAC has commenced!
The 2021 TGAC took effect on 1 January 20226. The TGAC regulates the content of advertising material directed at consumers, including in relation to warning statements, endorsements and testimonials and scientific and clinical representations.
Below is an overview of the key changes in the 2021 Code, as compared to the previous 2018 version.
Simplification of mandatory statement requirements
- Reduction in the number of required mandatory statements.
- New mandatory statement for products that cannot be purchased by consumers.
- Distinction between products that can be physically viewed by consumers prior to purchase and those that cannot.
Clarification of rules around testimonials and endorsements
- Genuine unpaid testimonials remain permitted.
- Paid or incentivised testimonials cannot be included in advertisements.
- The prohibition on endorsements from health professionals extends to former health professionals.
The list of permitted product samples has been expanded
- To include face masks and gloves, certain sanitary products, hand sanitisers, certain nicotine replacement therapies and COVID-19 rapid antigen tests.
Rules regarding 'safe and proper use' have been expanded
- To prohibit an advertisement from causing undue alarm, fear or distress.
What about social media influencers?
If a person receives or is promised 'valuable consideration' for providing a testimonial about a therapeutic good, that testimonial must not be used in an advertisement. Valuable consideration essentially means anything of value, including the goods themselves if they are provided free of charge.
Social media influencers can often be offered goods or money in exchange for posting about the positive effects they experienced from a product. However, a social media post promoting a particular product is an advertisement and needs to comply with the TGAC advertising rules. Any comments about personal experience with a product are considered a testimonial, which is prohibited – noting also that the influencer is involved in marketing the goods.
More details can be found in the TGA’s Tips for Social Media Influencers here.
Promoting to healthcare professionals
Offering doctors all-expenses-paid trips to pain-management seminars in places like Boca Raton was reportedly well worth the investment for Purdue Pharma. According to this New Yorker article, doctors who attended these seminars in 1996 wrote OxyContin prescriptions more than twice as often as those who didn’t. Could this strategy work in Australia?
The MA Code of Conduct and the MTI Code of Practice deal with promotions and inducements to healthcare professionals.
The guidance here is very broad. Both Codes refer to “ethical business practices” and “ethical undertakings” and preclude “inappropriate” influence or “inappropriate” inducements. Such general statements may be considered open to interpretation, however both Medicines Australia and MTAA have also provided some more specific guidance.
Our summary of the relevant principles, with some practical examples, is below.
The MA Code of Conduct:
- “Companies are committed to transparency in their interactions with healthcare professionals… to maintain trust and confident in the industry.”
- “Consistent with our ethical undertakings, nothing is offered or provided by a Company in a manner with conditions that would have an inappropriate influence on the approval, recommendation, prescribing and/or use of a product”.
The below education related items may be branded with company logo – not with a product brand name:
Moderate hospitality to healthcare professionals at events (up to $120 AUD in Australia as a guide). This includes reasonable travel and accommodation for educational events if necessary for attendance at the event.
Payment for consultancy, speaker fees or other services, where the payment is reported in accordance with transparency reporting requirements.
Promotional information to healthcare professionals that meets the Code requirements including being accurate, balanced, consistent with approved product information, referenced and not misleading.
Minimum product information must be included. Substantiating data must be available on request within 10 working days.
Items with the sole purpose of increasing awareness of the brand name of a product are prohibited.
Travel and accommodation for spouses or family of healthcare professionals.
Payments to healthcare professionals as an incentive for their attendance at an educational event or trade stand.
Financial support that is conditional on the use of a specific product.
Promotional content on social media that can be viewed by the general public.
Claims of clinical benefit beyond what is supported by evidence.
Using a healthcare professional’s identity or unpublished quotation without their documented approval.
PRESCRIPTION ONLY MEDICINES CANNOT BE ADVERTISED TO CONSUMERS, AND DOING SO IS AN OFFENCE UNDER THE TG LEGISLATION. SO HEALTHCARE PROFESSIONALS WILL GENERALLY BE THE TARGETS FOR PROMOTIONAL ACTIVITIES FOR THESE MEDICINES.
- The MTI Code of Conduct requires “ethical business practices and socially responsible industry conduct” in all dealings with healthcare professionals. A company must not “use any inappropriate inducement or offer any personal benefit or advantage to promote or encourage the use of its products”.
Company or product branding at educational conferences on items that serve a genuine educational purpose only.
“Modest hospitality” including refreshments at company sponsored education and training events. A monetary limit is not set as this will depend on context.
Company sponsored education and training in a clinical, educational or conference setting that is centrally located to the attendees.
Sponsorship of third party educational events, subject to the Code requirements.
Legitimate engagement of health practitioners as consultants, subject to the Code requirements.
Research or educational grants to organisations subject to the Code requirements.
Branded water bottles or coffee cups at conferences.
Branded mousepads or wall planners – even if they have conference dates marked on them.
Any other type of non-educational branded promotional item, even if the item is of minimal value.
Company sponsored training events at tropical islands or ski resorts where the destination is the main focus of the event.
Paying for travel and accommodation of health practitioners to attend third party education events.
Paying health practitioners to speak at third party educational conferences.
Education grants paid directly to individual health practitioners.
What inducements can doctors accept?
Medical practitioners are bound by their own professional code of conduct7 and have obligations to avoid conflicts of interest. The current Medical Board of Australia Code of Conduct specifically says that good medical practice involves:
- Recognising that pharmaceutical and other medical marketing influences doctors, and being aware of ways in which the doctor’s practice may be being influenced.
- Recognising potential conflicts of interest in relation to medical devices and appropriately managing any conflict that arises in practice.
- Not asking for or accepting any inducement, gift or hospitality of more than trivial value from companies that sell or market drugs, appliances or devices that may affect, or be seen to affect, the way the doctor prescribes for, treats or refers patients.
- Not asking for or accepting fees for meeting sales representatives.
Companies promoting their products to medical practitioners should also keep the above in mind.
What are the consequences of an advertising breach?
While the majority of advertising complaints are dealt with by warning letters, infringement notices or advertising directions, serious non-compliance can result in Court proceedings and/or significant fines.
Recent examples include:
- Targin (opioid pain medication)8 – in December 2019 the TGA issued 24 infringement notices to Targin’s sponsor imposing fines totalling $302,400 for misleading, imbalanced or otherwise inaccurate advertising to doctors9. The TGA considered that statements in Mundipharma’s promotional material appeared to positively encourage the use of Targin for chronic non cancer pain. Mundipharma disagreed, but paid the fines.
- Peptide Clinics10 – in July 2019 the Federal Court imposed a $10 million fine for repeated contraventions of the TG Act by advertising prescription peptide medication in various forms on its website, Facebook, Instagram and via telephone in 2018 and early 2019.
In addition to breaching the general prohibition on advertising prescription medicine to consumers, the Court found the Peptide Clinics engaged in a deliberate marketing strategy involving numerous serious breaches. Further, aspects of the campaign gave consumers a false impression that the information in the advertisements was provided by medical practitioners acting in the consumer's best interests.
The significant fine in the latter case was said to be directed at general deterrence, with the Court commenting that it would send a "clear message that companies will not be able to profit from their wrongdoing".
So – pens but no sticky notes? Has the world gone mad?
Not necessarily. In the case of advertising targeted at medical practitioners, there have now been multiple studies indicating that drug promotion to medical providers impacts prescribing habits, including higher prescribing frequency and higher cost.11 And accounts, like this Washington Post article, from former pharmaceutical sales reps of their marketing strategies might well serve as cautionary tales.
There is certainly a case to be made for minimising the influence of marketing on clinicians’ prescribing, or product selection, decisions.
That said, while the basis for the regulatory environment is sound, companies may find themselves treading a sometimes difficult line between raising awareness of new - and potentially beneficial – developments and being in breach of advertising restrictions.
Fortunately some further guidance is available from the TGA here, from Medicines Australia here and from the MTAA here. If still in doubt, have a chat with your legal advisor. If nothing else, it pays to be across the regulatory detail before approving that order of branded mousepads.
1Radden Keefe P 2021, Empire of Pain: The Secret History of the Sackler Dynasty, Doubleday, US
2Note: under a “grace period”, if the lanyards were already organised, sponsored or produced as at 31 December 2021, they will be permitted
3As with all consumer goods, advertising and promotional material also must not constitute misleading or deceptive conduct or contain false or misleading representations as required by the Australian Consumer Law.
4While MA is an industry body, the MA Code of Conduct is relevant to all sponsors of prescription medicine (even non-members of MA), as compliance with the MA Code of Conduct is a condition of TGA registration.
5Section 3 Therapeutic Goods Act
6Subject to a 6-month period until 30 June 2022 during which both the 2018 and 2021 Advertising Codes will apply.
7Medical Board of Australia, “Good Medical Practice: A Code of Conduct for Doctors in Australia” (October 2020)
9The relevant statement was: Opioids should be used as part of multimodal pain management plan and in an ongoing trial, as they are associated with potential harms, including unsanctioned use, addiction and overdose. The TGA said opioids should not be represented as a core component of the multi-modal management of chronic non-cancer pain, and the decision to prescribe opioids should be approached with significant caution.
10TGA v Peptide Clinics Australia  FCA 1107
11A systematic review of 58 studies is found here: Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, Vitry AI. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLoS Med. 2010 Oct 19;7(10):e1000352.