Katarina Klaric, Principal, Stephens Lawyers & Consultants

Health practitioners, individuals, businesses, and companies involved in advertising of health services will be subject to greater scrutiny by regulators.  Australian Health Practitioners Regulation Agency (AHPRA) and The Medical Board of Australia (Medical Board) have allocated additional resources to crackdown on advertising that is misleading or deceptive or uses testimonials which are banned. The regulators are deploying new technologies to audit websites, Facebook, Instagram, Tik Tok and other social media sites for illegal advertising of health services and therapeutic goods (medicines and medical devices)[i].

With the new Medical Board/AHPRA “Guidelines For Registered Medical Practitioners who Advertise Cosmetic Surgery” having come into effect as at 1 July 2023, the regulators will be focusing on advertising and social media used to promote cosmetic surgery.

Failure to comply with advertising laws can result in health practitioners being investigated, having disciplinary action taken, their registrations suspended or cancelled, being prosecuted for offences, and having penalties imposed.  Enforcement proceedings can also be taken against individuals, businesses or companies involved in advertising health services which are non-compliant.

Regulatory framework for Advertising of Health Services

Australia’s regulatory framework for advertising of health services is complex and requires compliance with a number of laws which are administered by different regulators. These laws include:

1. Health Practitioner Regulation National Law (National Law) which is administered by AHPRA and State and Territory Medical Boards. Section 133 of the National Law regulates advertising of a regulated health service, which is a service provided by or usually provided by, a health practitioner[ii].

Section 133 of the National Law prohibits the advertising of a regulated health service or a business that provides a regulated health service, in a way that –

  • is false or misleading or deceptive or is likely to be misleading or deceptive; or
  • offers a gift, discount or other inducement to attract a person to use the service or the business, unless the advertisement also states the terms and conditions of the offer; or
  • uses testimonials or purported testimonials about the service or business; or
  • creates an unreasonable expectation of beneficial treatment; or
  • directly or indirectly encourages the indiscriminate or unnecessary use of regulated health services.

A contravention of Section 133 of the National Law is a criminal offence which can result in prosecution in State or Territory courts. The maximum penalty which can be imposed by a court for each contravention of Section 133 committed by an individual is currently $60,000 and in the case of a body corporate is $120,000.

 

2. Guidelines for advertising regulated health service established under the National Law and published by AHPRA and the National Boards explain an advertiser’s obligations for advertising a regulated health service under section 133 of the National Law. The guidelines can be used by courts when hearing an advertising offence prosecution under section 133 of the National Law[iii]. The guidelines are not intended to provide advice about how to advertise and the AHPRA and National Boards will not approve advertising. The guidelines specifically state[iv]:

“These guidelines are not a substitute for legal advice. Anyone requiring advice about advertising a regulated health service should seek appropriate advice from their legal advisor or indemnity insurer.”

 

3.  Guidelines for registered medical practitioners who advertise cosmetic surgery came into effect on 1 July 2023 and were developed by the Medical Board of Australia (Medical Board) under section 39 of the National Law.  These guidelines were introduced in response to the “Independent review of the regulation of medical practitioners who perform cosmetic surgery” which made recommendations to improve patient safety in the cosmetic surgery sector including cosmetic surgery advertising.  The review followed the media coverage of adverse patient outcomes following cosmetic surgery at a number of clinics that were using Tik Tok and other social media to promote liposuction and abdominoplasty (tummy tucks) and other cosmetic surgery[v].

The review found that there were a lack of protective measures in the cosmetic surgery sector to direct consumers to qualified practitioners and to inform consumers about the risks associated with cosmetic surgery and procedures. The review was concerned about the advertising tactics used by some practitioners, particularly on social media with the use of models and influencers to promote particular cosmetic surgical procedures, actively encouraging people to pursue what is promoted as a socially accepted or perfect body type.  The review was particularly concerned about such advertising tactics on social media leading to increased incidences of body dysmorphia and other body image concerns (particularly among young women) as evidenced by research[vi].

The guidelines provide specific guidance for medical practitioners who advertise cosmetic surgery and are in addition to the Guidelines for advertising regulated health service and other guidelines and codes that medical practitioners are required to comply with.[vii] The guidelines set out what the Medical Board considers to be good practice in advertising:-

Good Practice cosmetic surgery advertising:

  • gives balanced and accurate information so the overall impression created by the advertising is not misleading
  • describes and/or show realistic results
  • presents the risks and recovery process of cosmetic surgery accurately
  • makes clear that outcomes will depend on the characteristics of the individual seeking surgery
  • presents normal body variations positively without pathologising normal appearance or encourage surgery to ‘fix’ normal variations[viii].

Although the guidelines focus on the advertising of cosmetic surgery which is performed for cosmetic and aesthetic reasons, the guidelines include a requirement that also applies to practitioners who are advertising non-surgical cosmetic procedures[ix], until such time as more detailed consideration and consultation occurs in respect of these procedures –

Advertising of non-surgical cosmetic procedures

  • Advertising should not glamorise cosmetic procedures, minimise the complexity of procedure, overstate the results or imply patients can achieve outcomes that are not realistic.

 

4. Therapeutic Goods Act and regulations and Therapeutic Goods Advertising Code

Where the supply of regulated health services also involves the use of therapeutic goods (such as medicines, cosmetic injectables, fillers, chemical peels, lasers, cryolipolysis and other medical devices), the service provider and advertiser of the services must also comply with the Therapeutic Goods Act and regulations and Therapeutic Goods Advertising Code. The Therapeutic Goods Administration (TGA) is the regulator responsible for compliance with the laws governing the importation, supply and advertising of therapeutic goods. There are also corresponding State and Territory laws that have to be considered which are administered by State and Territory Health Departments or Agencies.

The non-compliance with the advertising requirements is a criminal offence which can result in warning notices, infringement notices and court proceedings being taken by the TGA and the imposition of substantial penalties. The Courts in imposing substantial penalties for non-compliance with the Therapeutic Goods Act and Advertising Code, have stated that anyone who is engaged in a business that involves the supply, use and advertising of “therapeutic goods” in Australia has a responsibility to be aware of the regulatory regime and to comply with the relevant regulatory requirements[x].

Case Example [xi]

The TGA issued five infringement notices totalling $13,320 to a West Australian registered health practitioner for alleged unlawful advertising of medicinal cannabis products on a website and through social media. The notices alleged that the health practitioner had advertised medicinal cannabis products:

  • that are not TGA approved, that is not registered on the Australian Register of Therapeutic Goods (ARTG)
  • that are prescription-only medicines and therefore cannot be advertised to consumers
  • using unapproved references to serious diseases or conditions, such as cancer and multiple sclerosis.

 

Case Example [xii]

The TGA issued 10 infringement notices totalling $133,200 to Mode Medical Pty Ltd (trading as Drip IV Australia) and 10 infringement notices totalling $26,640 to an executive officer of the company, for the alleged unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media.

 

5. Australian Consumer Law

All advertising of health services must also comply with the Australian Consumer Law. The Australian Competition and Consumer Commission (ACCC) is responsible for the administration and enforcement of the Australian Consumer Law, and has extensive investigative and enforcement powers.  Advertising of health services that is misleading or deceptive or likely to mislead or deceive consumers or contains false representation concerning health services or goods, will contravene sections 18 and 29 of the Australian Consumer Law.  The ACCC may take court action against the health service provider or advertisers seeking injunctions, compensation for the affected consumers and the imposition of substantial penalties.

Risk Management Strategies for Advertising of Health Services

The complex legal framework that regulates the advertising of health services and therapeutic goods in Australia exposes advertisers who do not have appropriate risk management systems in place to ensure compliance with advertising laws, to the risk of contravening the advertising laws. This could result in reputational damage, possible registration suspension or cancellation, court proceedings and penalties. Some of the strategies that health service advertisers could implement to manage risk of non-compliance include:

  1. Educating personnel involved in marketing of health services of the legal framework for advertising of health services and therapeutic goods.
  2. Review of all existing advertising including website and social media for compliance by legal experts.
  3. Review of all advertising by legal experts before it is published.
  4. Insurance cover.

Disclaimer:  This article is not intended to be a substitute for obtaining legal advice. 

© Stephens Lawyers & Consultants. 27 July 2023; Authored by Katarina Klaric, Principal, Stephens Lawyers & Consultants

For further information contact:

Katarina Klaric

Principal

Stephens Lawyers & Consultants

Melbourne Head Office

Suite 205, 546 Collins Street, Melbourne VIC 3000

Phone: (03) 8636 9100   

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Level 29, Chifley Tower, 2 Chifley Square, Sydney, N.S.W. 2000

Phone: (02) 9238 8028

Email: [email protected]

Website: www.stephens.com.au

All Correspondence to:

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[i] AHPRA & National Boards, “How Ahpra will implement changes to the Health Practitioner Regulation National Law” An Information Guide, October 2022,

[ii] National Law, s133 (4) defines “regulated health service” for purpose of s133.

[iii] AHPRA & National Boards, “Guidelines for advertising a regulated health service”, December 2020. p.4

[iv] Ibid, p.7

[v] Sydney Morning Herald (www.smh.com.au ) (Adele Ferguson & Lauren Day) “How the cosmetic cowboys ran free on the wild west of social media” October 30, 2021; ABC news (www.abc.net.au ) (Adele Ferguson & Lauren Day) “Cosmetic Surgeon Daniel Lanzer agrees to stop practising medicine days after 4 Corners investigation” posted Sat, 30 Oct, 2021/updated 1 Nov 2021; Sydney Morning Herald (www.smh.com.au ) (Kate McClymont) “Prominent cosmetic surgeon’s legal action to stop ABC’s 4 Corners program”  October 20, 2021

[vi] Overview of the “Independent review of the regulation of medical practitioners who perform cosmetic surgery” published by AHPRA & National Boards, 1 September 2022

[vii] Good Medical Practice: a code of conduct for doctors in Australia; Guidelines for registered medical practitioners who perform cosmetic surgery and procedures; Social Media: How to meet your obligations under National Law,

[viii] Medical Board/AHPRA – Guidelines for registered medical practitioners who advertise cosmetic surgery. Effective 1 July 2023. P5

[ix] Ibid, p3. The Guidelines have adapted the definition of “Non-surgical cosmetic procedures” from the Medical Council of New Zealand Statement on cosmetic procedures (2011).

[x] Secretary, Department of Health v Enviro Tech Holdings Pty Ltd (2022)  FCA 865 [76]

[xi] https://www.tga.gov.au/news/media-releases/west-australian-health-practitioner-fined-13320-alleged-unlawful-advertising-medicinal-cannabis.   Published 31 October 2023.

[xii] https://www.tga.gov.au/news/media-releases/mode-medical-pty-ltd-and-executive-officer-fined-almost-160000-alleged-unlawful-advertising-intravenous-infusion-products. Published 31 January 2023.