A national, uniform approach to regulating the cosmetic medical industry is another step closer with the release of the Council of Australian Governments (COAG) Consultation Regulation Impact Statement (RIS).
Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is inviting stakeholders to comment on whether there is a sufficient case for government intervention based on the identified operator and consumer risks with the use of Intense Pulsed Light sources (IPLs) and lasers for cosmetic medical services or beauty therapy.
What is the latest update in regulating the cosmetic medical services industry?
Last month, in our article ‘Regulating the nip and tuck: cosmetic medical services growth expands’ we provided an update on the progress of the Australian Health Minister’s Advisory Council (AHMAC) overhaul of the cosmetic medical services industry.1
Since then, ARPANSA has taken the next step in achieving a nationally uniform regulation of lasers and IPLs and a national review of regulating unregistered cosmetic operators.
On 26 May 2015, ARPANSA released a Consultation RIS exploring options for the regulation and use of IPLs and lasers for cosmetic or beauty therapy.2
Why is it necessary to regulate the use of Lasers and IPLs?
Lasers and IPLs are instruments used for various cosmetic medical services such as for the treatment of:
- anti-ageing skin rejuvenation
- unwanted hair, tattoos and skin lesions
- acne and scar tissue
- vascular disorders
- hyperpigmentation including freckles, sun spots and birthmarks.
With the growing popularity of such treatments, the incidence of adverse outcomes appears to be increasing. Used for such purposes, the risks associated with lasers or IPLs include:
- missed or delayed diagnosis of skin cancers
- burns and permanent scarring
- permanent retinal damage.
What are the solutions suggested by ARPANSA?
The aim of ARPANSA’s Consultation RIS is to minimise the risks to operators and consumers of cosmetic laser and IPL services.
The Consultation RIS recognises that within the range of operators providing laser and IPL services are qualified health professionals as well as operators with limited or no training. Prices and availability of lasers and IPLs can also vary with many inexpensive devices easily purchased online. The result is that consumers may receive cosmetic services using IPLs and lasers from operators who may not have suitable understanding of the risks to the individual, the capacity of the device or the complexity of the procedure.
ARPANSA is exploring options to reduce these risks and has suggested the following options:
Status quo: no change to current practices
Option 1: educational awareness
Option 2: self-regulation by industry or an industry accreditation scheme
Option 3: licensing or registration of service providers based on prior qualification and training.
If the status quo is maintained, only some states would have regulation in place for the commercial use of lasers and IPLs for cosmetic medical services.3 This means consumers in the unregulated jurisdictions are under the notion of ‘caveat emptor’ or ‘buyer beware’ and limited to protections under the Australian Consumer Law4 with legal recourse often only available after an injury has been sustained.
Alternatively, Option 1 aims to educate and inform consumers of the risks associated with cosmetic medical treatments using IPLs and lasers. This would assist consumers to understand the importance of researching and selecting a service provider for IPL and laser treatments. ARPANSA is suggesting factsheets published by government agencies in order to provide reliable, objective information.
Under Option 2, industry leaders would develop a safety guide for the commercial use of lasers and IPLs. Standards may include requirements for training, limitations on treatments provided by certain qualified operators and medical clearance prior to treatment for some skin conditions. This option would have limited success unless the majority of operators are members of the designated regulating association.
Option 3 promotes the licensing of operators providing cosmetic medical and beauty services using IPLs and lasers. Furthermore, complex procedures such as skin rejuvenation and tattoo removal would be restricted to provision of service by a medical practitioner. Under this option, qualifications and training would form the basis of licensing.
When do you need to make your submission?
The Consultation RIS has been assessed by the Office of Best Practice Regulation under COAG’s best practice regulation guidelines and is now open for submissions until 31 July 2015.
The options presented in the Consultation RIS affect a number of stakeholders including commercial operators, franchisors and franchisees, medical practitioners, industry associations and education providers. If you are interested in drafting a submission and need our assistance, or if you require commercial legal advice about the impact of the proposed regulatory changes, we are happy to assist with your queries.
Our Consumer Markets and Franchising team has a variety of experience and a unique understanding of the issues in this industry. Our expertise in health, education, risk regulation, consumer markets as well as IT and technology places us in a position to provide solutions to assist businesses operating in complex regulatory environments.
1. Australian Health Ministers’ Conference, Cosmetic Medical and Surgical Procedures – A National Framework, 2011, http://www0.health.nsw.gov.au/pubs/2012/cosmetic_surgery.html
2. Australian Radiation Protection and Nuclear Safety Agency, INVITATION TO MAKE SUBMISSIONS Consultation Regulatory Impact Statement- Intense Pulsed Light sources (IPLs) and Lasers for Cosmetic or Beauty Therapy, 26 May 2015 http://www.arpansa.gov.au/publications/drafts/dr_ndrpIPL.cfm
3. Queensland, Western Australia and Tasmania would be the only jurisdictions to have any control over who provides commercial services with lasers for cosmetic or beauty therapy.
4. Schedule 2 of the Competition and Consumer Act 2010 (Cth).
|Stefanie Mackenzie| Lawyer
Tel +61 3 9258 3399