Cosmetic medicine is a field marked by rapid advancements and evolving trends. This presents unique challenges for providers aiming to deliver safe, effective, and compliant cosmetic medical services. The Australian Health Practitioner Regulation Agency (“AHPRA”) and the Therapeutic Goods Administration (“TGA”) have set guidelines which seek to ensure providers of cosmetic procedures meet high standards. It is crucial that practices engaged in cosmetic surgery and non-surgical cosmetic services understand and adhere to these guidelines to ensure legal compliance, patient safety and professional integrity.
Understanding AHPRA
AHPRA oversees the registration and regulation of health practitioners across Australia, including those engaged in cosmetic procedures. AHPRA’s primary role is to ensure that registered health practitioners meet required standards of practice, maintain competence, and adhere to professional guidelines.
The AHPRA Guidelines
In July 2023, AHPRA published the Guidelines for registered medical practitioners who perform cosmetic surgery and procedures (“Guidelines”). The Guidelines represent the Medical Board of Australia’s additional expectations of practitioners that engage in cosmetic surgery and non-surgical cosmetic procedures. Serious or repeated infringements may result in deregistration. Accordingly, it is vital that medical practitioners and businesses providing cosmetic procedures understand the necessary obligations to:
Training, Qualifications and Continuing Professional Development
- Confirm practitioners have received adequate training, obtained appropriate experience and possess relevant qualifications.
- Ensure ongoing education to maintain knowledge and skills of the latest practices, technologies and techniques.
Patient Consultation, Consent and Privacy
- Explain the risks, benefits and alternatives of procedures. Adhere to relevant consultation and cooling-off requirements.
- Obtain clear, comprehensive and documented consent from patients.
- Maintain detailed and accurate patient records, including pre- and post-operative details, to support clinical decisions and ensure transparency.
Promotion and Advertising
- Ensure all advertising and promotional activity complies with the Guidelines for registered medical practitioners who advertise cosmetic surgery, the Guidelines for advertising of regulated health services, the Therapeutic Goods Advertising Code and relevant consumer law.
Understanding the TGA
The TGA regulates the availability, manufacturing and advertising of “therapeutic goods”. Therapeutic goods are those registered on the Australian Register of Therapeutic Goods (“ARTG”) and are usually characterised as either medicines, medical devices or biologicals.
The TGA does not regulate the practice of healthcare professionals nor the procedures or services they provide; however, TGA regulations become relevant where the advertising of services crosses into promoting the use and/or supply of therapeutic goods.
Cosmetic procedures may involve therapeutic goods that are widely available or prescription-only (i.e. relaxants, injectables, and fillers), and those with clear cosmetic uses (i.e., implants, laser devices, and liposuction systems) or more general uses (i.e., anaesthetics, surgical instruments, and equipment).
TGA Regulations
The TGA regulates the advertising of therapeutic goods in accordance with the Therapeutic Goods Act 1989 (“Act”) and the Therapeutic Goods Advertising Code (“Code”). Given the risk of significant civil penalties and/or criminal prosecution for infringement, businesses offering cosmetic procedures must understand the legal framework that applies to their promotional activity:
Advertising Generally
- “Advertising” has a broad definition that includes any statement, representation, or design intended to promote the use or supply of therapeutic goods. This includes direct and indirect promotion.
- Accordingly, the Code extends to the promotion of any ingredient or component of a therapeutic good and the promotion any procedure that involves the use of a therapeutic good.
Accuracy, Substance, and Objectives
- Advertising must be accurate, consistent with any current ARTG entry or public health campaign, and contain only substantiated claims.
- Advertising must not be misleading, directed to children, encouraging inappropriate use, causing alarm or distress, or representing goods as safe or effective in all cases.
Endorsements and Testimonials
- Any “endorsement” (i.e. show of support or approval) must disclose any receipt of payment or consideration.
- Any "testimonial” (i.e. endorsement that references personal use) cannot be provided in exchange for any form of consideration.
Prescription-only Goods
- Advertising prescription-only or controlled goods to the public is strictly prohibited.
- This includes advertising that promotes any procedure involving prescription-only goods.
- The use of any substitute term (i.e. ‘wrinkle reducing injections’ or ‘weight loss injections’) or inclusion of any pricing information will be taken to be advertising for these purposes.
Recommendations for Providers
It is vital that any businesses engaged in cosmetic surgery and non-surgical cosmetic services understand and appreciate their obligations with respect to AHPRA and the TGA. It may be appropriate to conduct an audit of your business to ensure adherence to AHPRA and TGA standards, including reviewing and updating the business website, and relevant business policies and procedures.
If you have any concerns that your business may be at risk of breaching AHPRA or TGA obligations, we encourage you to contact us to book a consultation with a member of our Commercial, Business & Private Client Services Division to discuss the application of the relevant legal frameworks in the context of your business, including any relevant practical advice your business can implement to ensure you are compliant.
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