22 November 2018

Cosmetic Surgery Regulation

The NSW Parliamentary Committee on the state's Health Care Complaints Commission has released its report on Cosmetic Health Service Complaints in New South Wales. The report follows the NSW Health Department's review of the regulation of cosmetic procedures earlier this year, noted here.

The Committee states
The cosmetic health services industry is a growing industry with an increasing demand for services. This inquiry has demonstrated to the Committee that there are a number of complexities that make regulating this area very challenging. There are various State and Commonwealth agencies and entities which play an important role in regulation or complaint handling. There are also a number of different State and Commonwealth laws which may be relevant, depending on the circumstances. Both registered and unregistered practitioners perform, or assist with, different kinds of procedures. In addition, there is no settled definition of what constitutes cosmetic health services. 
The Committee is concerned that complaints about these services may be underreported for a variety of reasons. We are also concerned about the corporate model of practice versus the traditional medical model of patient care and, in particular, the profits before patients focus of some corporate providers. We heard from a wide range of stakeholders that there is a lack of public awareness about various issues associated with this industry.  
The Committee has made 16 recommendations to address these and other issues of concern raised in this inquiry. Our recommendations are intended to ensure that:
  • legislative and regulatory frameworks are strengthened to better protect the public from potential harm
  • relevant and important information about the cosmetic health services industry is more accessible to the public so individuals can make informed decisions about procedures and practitioners and understand where and how to make a complaint if they are dissatisfied
  • the HCCC's powers and functions are robust enough to adequately address the complexities associated with the cosmetic health services industry (and the health services industry more broadly) and assist patients in resolving their concerns.
The Committee's recommendations are not just focused on the HCCC. We found that collaboration between the HCCC and other State and Commonwealth agencies and entities is important to inform the public and protect them from cosmetic health service providers that do not comply with the law or do not have satisfactory practices. Our recommendations will therefore involve work on the part of other NSW government agencies including NSW Health and NSW Fair Trading. We recognise that national cooperation and consistency on many of these issues is preferable. As such, we have recommended that the NSW Minister for Health raise certain issues of concern with the COAG Health Council with a view to achieving reforms that will apply across the country.
The Committee report comments
On 13 February 2018, the Committee resolved to conduct this inquiry into cosmetic health service complaints in New South Wales in response to concerns raised by the Minister for Health, the Health Care Complaints Commission (HCCC), the media and the community. The Committee’s concern was to investigate whether the HCCC and other Government regulatory frameworks could improve outcomes for the public who use cosmetic health services. The terms of reference for the inquiry are in Appendix One.   
A particular case that captured the Committee’s attention was the tragic death of Ms Jean Huang following a breast filler procedure at the Medi Beauty Clinic in 2017. The persons who performed the procedure were allegedly not registered health practitioners in Australia and have been charged with manslaughter. The HCCC is separately investigating the matter. The Committee has also followed matters relating to The Cosmetic Institute, which was investigated by the HCCC after two separate instances where women undergoing breast augmentation suffered cardiac arrest. A class action has also been commenced against The Cosmetic Institute alleging negligence during breast augmentation that left patients with lifethreatening complications. 
Prior to this inquiry, the HCCC issued public warnings in relation to the cosmetic health services industry. The NSW Minister for Health also:
  • raised with the Council of Australian Governments (COAG) Health Council the issue of protecting the title ‘cosmetic surgeon’ nationally to restrict its use to appropriately educated, trained and experienced health practitioners 
  • introduced regulations to require certain cosmetic surgical procedures, such as breast augmentation, to be carried out in licensed private health facilities  
  • requested a review of cosmetic procedures to consider the adequacy of the existing regulatory framework to protect the public.
The NSW Ministry of Health’s report made nine recommendations which have been, or are in the process of being, implemented. 
Complexities of the cosmetic health services industry 
The Committee learnt that the cosmetic health services industry is dynamic and complex. There are a number of issues that present regulatory challenges, such as those outlined below. No agreed definition of what constitutes cosmetic health services While the Medical Board of Australia’s definition of cosmetic medical and surgical procedures provides some guidance, there is no agreed definition of cosmetic health services or cosmetic procedures. The Committee believes that the lack of a clear definition presents regulatory difficulties. However, because new procedures are regularly being developed, the Committee acknowledges that any definition would need to adapt to this ever-changing environment.  
Registered and unregistered practitioners perform cosmetic health services 
Both registered and unregistered health practitioners provide cosmetic health services. Registered practitioners include doctors and nurses and unregistered practitioners could include beauty therapists. This presents challenges because patients do not always understand the distinction; there are differences in the applicable legislative, regulatory and complaint handling frameworks; and there was a perception among some inquiry participants that there is a lack of sufficient oversight of unregistered practitioners. The Committee mostly received evidence from, and about, registered practitioners. As such, the Committee has not made any particular findings or recommendations about unregistered practitioners. However, the Committee considers that the regulation of unregistered health practitioners could be the subject of a separate, dedicated inquiry in the future. 
Licensed facilities versus unlicensed facilities 
The public is also not always aware that some invasive cosmetic surgery procedures, such as breast augmentation, need to be performed in licensed private health facilities, which have more stringent standards with respect to the safety of the premises and patients and the standard of clinical care. Unlicensed facilities may still need to comply with other regulations such as in relation to local council requirements and public health. The Committee believes that raising public awareness about these differences is important. 
Corporate model versus patient model 
The Committee heard that the corporatisation of the cosmetic health services sector has caused some challenges. In particular, the Committee was very concerned to learn that some commercial operators put profits before patients which can conflict with patient interests. Others operate across borders which can cause difficulties for regulation and complaint handling. Some offer low-cost options by using counterfeit products or employing inadequately qualified staff. This can put patients at risk. The Committee acknowledges that State and Commonwealth agencies are collaborating to address these risks. It is essential that this work is continued and that emerging risks are identified and addressed quickly. In contrast, the Committee heard that under a medical or patient-centric model, the medical practitioner owes a duty of care to their patient, which requires them to consider the patient’s best interests including, in some cases, advising them not to proceed with a procedure. 
Under-reporting of complaints 
The HCCC received 94 complaints about cosmetic services in 2016-17. While this was a small number relative to other complaints they received, the overall trend is an increase. In 2017, NSW Fair Trading received 287 complaints about beauty services. Several inquiry participants claimed there may be an under-reporting of complaints because people are not aware that they can complain, feel too embarrassed or believe it would be a waste of time. It is important that the public are made aware that they can complain about these services and are encouraged to do so. Any barriers to making a complaint should be identified and removed. 
Demographics 
The Committee heard from inquiry participants that people who opt for cosmetic procedures are mostly women, often young women and women between 35-55 years of age. However, stakeholders also told the Committee that vulnerable patients from a financial, social and economic perspective are a target market and there has been an increase in men undergoing cosmetic procedures. The Committee also heard that some providers particularly target nonEnglish speaking communities seeking these services by advertising in non-English forums and on social media. The Committee believes that raising public awareness about cosmetic health services should be primarily addressed to these and any other identified groups. 
The Committee’s finding regarding collaboration between State and Commonwealth Governments 
The Committee heard that the legislative and regulatory frameworks in this area are very complex. There are a number of State and Commonwealth agencies and independent bodies that play a key role in regulation, complaint-handling and investigating complaints and offences. These include, but are not limited to, the HCCC, NSW Fair Trading, NSW Health, the Australian Health Practitioner Regulation Agency (AHPRA) and the Therapeutic Goods Administration (TGA). 
The legislative framework is also diverse and deals with issues such as the regulation of registered health practitioners (such as doctors and nurses), unregistered practitioners who provide health services and beauty clinics that carry out procedures involving skin penetration. There are also laws to regulate products such as botulinum toxin (Botox) and dermal fillers and private health facilities where some cosmetic surgery is carried out. Many of these State or Commonwealth laws have recently been amended, or are in the process of being amended or reviewed, to strengthen the legislative framework for cosmetic health services. 
Collaboration between agencies 
The Committee heard that State and Commonwealth agencies are currently collaborating to address risks in this area and inform the public through intergovernmental forums, joint operations, policy development and public education. The Committee supports these efforts and is interested to monitor whether they have the desired impact. 
Because of the complexity of the cosmetic health services industry, and the fact that some providers work across State and Commonwealth borders, the Committee finds that collaboration between the HCCC and other State and Commonwealth agencies and entities is important to inform the public and protect them from cosmetic health service providers that do not comply with the law or do not have satisfactory practices. The Committee considers that it is essential that this collaboration continues (Finding 1). In particular, the Committee believes the following areas of collaboration are important:  strong regulation and laws that focus on public safety and adapt as necessary to changes in the industry  compliance and inspection work of Government  public awareness  consumer and patient complaints are acted upon. 
The Committee’s recommendations 
The Committee has made 16 recommendations to address issues of concern that were identified in this inquiry. Not all of these recommendations are directed to the HCCC. This is because the issues of concern in the cosmetic health services industry require solutions that are broader than the HCCC’s role. 
The recommendations are intended to complement the work that has been done, and is in progress, at State and Commonwealth levels. The Committee believes that its recommendations will lead to a public that is better informed about cosmetic procedures; providers; risk; and options for seeking redress. The Committee’s recommendations will ensure that the HCCC’s powers and functions are robust enough to adequately address the challenges presented by this industry. The recommendations are also intended to further strengthen the legislative and regulatory frameworks to better protect the public. 
Reviewing the powers and functions of the HCCC
The Committee has recommended a review of the HCCC’s powers and functions, in response to stakeholder suggestions, to ensure the HCCC is able to sufficiently protect patients using health services and assist in resolving their concerns. 
In particular, the review is to consider whether the powers of similar bodies in other jurisdictions would be appropriate in New South Wales, including:
  •  empowering the HCCC to issue public warnings about specific health service providers and health organisations, in addition to more general warnings 
  • authorising the HCCC to make prohibition orders against specific health organisations where they pose a serious risk to public health and safety  
  • broader search and entry powers for the HCCC, so it can investigate operators it has concerns about more effectively, and is less reliant on partnering with Commonwealth or State agencies to benefit from their broader, or different, powers (Recommendation 1). 
The Committee did not receive much evidence about whether or not patients or practitioners are satisfied with the outcomes of the HCCC’s complaint-handling, investigation and prosecution functions. This is not surprising given evidence in other areas of the report that complaints may be underreported. However, this will remain an area of interest to the Committee in the future. 
‘Cosmetic surgeon’ and ‘surgeon’ – potentially misleading the public 
The Committee heard from a number of stakeholders that use of the title ‘cosmetic surgeon’ can be misleading to patients by implying that the practitioner has additional qualifications, experience and training. In fact, the title ‘cosmetic surgeon’ is not a protected or restricted title nationally. At present, a range of different kinds of doctors may use this title such as general practitioners, general surgeons and plastic surgeons. 
The Committee heard that defining the scope of practice of the title ‘cosmetic surgeon’ could assist the HCCC, the Nursing and Midwifery Council of NSW and the Medical Council of NSW in their complaint-handling and regulatory work. 
The Committee has recommended that the NSW Minister for Health continues to raise the issue of protecting or restricting the title ‘cosmetic surgeon’ at a national level. Patients could then better inform themselves about whether their ‘cosmetic surgeon’ meets certain minimum criteria in terms of education, training and experience. While the Committee prefers a national approach to this issue, if this cannot be achieved within a reasonable time, the Committee has recommended that the NSW Minister for Health consider whether to introduce legislation in the NSW Parliament to deal with this issue independently. In the Committee’s view, it is essential that this title be clarified to better inform and protect the public. 
The Committee also heard that the title 'surgeon' can be misleading to patients. While the Committee’s consultation has been limited to its terms of reference, the Committee questions whether confusion about this title is only limited to cosmetic health services. The Committee has therefore recommended that the NSW Minister for Health consider whether it would be in the public interest to support protections and restrictions on the use of the title ‘surgeon’, either at a national level or for doctors practising in New South Wales (Recommendations 2 to 4). 
Informing the public 
The Committee heard time and time again from inquiry participants that the public need to be better informed about various issues associated with cosmetic health services. The Committee was told that the public is confused about where and how to make a complaint and the complaints process. Some patients are reluctant to complain for various reasons. The public are also not well-informed about the range of health service providers, procedures and their associated risks, and differences between facilities. The Committee heard that advertising and the normalisation of cosmetic procedures have contributed to some of this lack of public awareness. 
The Committee acknowledges the work of agencies and regulators so far to raise public awareness of these issues. However, because this was an issue that was raised by most inquiry participants, the Committee has made several recommendations. 
In particular, the Committee has recommended that NSW Health and NSW Fair Trading take the lead in developing a targeted public education campaign to raise awareness about cosmetic health services. The HCCC should assist with this campaign, along with other relevant agencies. Various forms of advertising and media should be used, including social media. It is essential that the main demographics seeking these services are well-informed. 
The Committee has also recommended that the Minister for Health pursues with the COAG Health Council the establishment of a national one-stop-shop website and advice service to assist individuals considering making complaints about cosmetic health services. The Committee also considers that it would be beneficial to include information and advice of a more general nature for those persons considering cosmetic procedures. If this cannot be agreed to at a national level, the Committee has recommended that the Minister for Health looks at the NSW Government establishing the service (Recommendations 5 to 8). 
To better inform future policy, regulation and education programs relating to cosmetic health services, the Committee has recommended more research into the behaviours of, and influences on, consumers seeking the services. Inquiry participants provided some insight into this area, such as the potential influence of the media on decisions about cosmetic procedures, especially social media, reality television and celebrities. However, the Committee believes more rigorous research in this area is needed (Recommendation 9). 
Regulation of Laser and IPL devices for cosmetic purposes 
The Committee learnt that there is no specific regulation of laser and IPL (Intense pulsed light) devices for cosmetic use in New South Wales. Some other states regulate this issue and proposed national guidelines have been issued. The Committee heard about patients who have suffered burns or other complications from the incorrect use of these devices. The Committee is concerned about this regulatory gap in New South Wales but would prefer a national regulatory approach so the Committee has recommended that this be pursued. However, if this cannot be achieved, the Minister for Health should consider whether to introduce legislation in New South Wales to provide minimum standards for cosmetic health service providers offering these services. Ensuring that operators have appropriate training and experience to use laser devices and IPL devices for cosmetic procedures will minimise patient complications (Recommendations 10 and 11). 
Issues with therapeutic goods used for cosmetic purposes 
The Committee heard of various issues associated with therapeutic goods used for cosmetic purposes such as botulinum toxin (Botox) and dermal fillers, for example:  illegal importation of these products from overseas  administration of Botox and dermal fillers by unregistered persons when they should be administered by a doctor, or a nurse under the supervision of a doctor  tele-consulting, for example a nurse administers Botox or dermal fillers in one location and is supervised by a doctor from another location via Skype 
The Committee acknowledges the work of State and Commonwealth agencies to identify and seize therapeutic goods which have been illegally imported. NSW Health is working on regulations to better manage therapeutic goods for cosmetic purposes. The Committee looks forward to an assessment of these changes to identify whether further initiatives are required. The Committee notes concerns about the use of teleconsulting to consult on cosmetic procedures. We note that it is a service permitted under the Medical Board of Australia's guidelines and can play a beneficial role in other areas of health care such as reaching people in remote regions. The Committee is concerned that restrictions placed on this service could impact negatively on these communities. 
The Committee is of the view that broader evaluation and consultation on the effectiveness of the current guidelines, beyond the scope of this inquiry, would be required before suggesting any changes to this particular practice in relation to cosmetic procedures. 
Upselling and commissions 
The Committee was surprised to hear that some corporate operators offer nurses or other employees incentives such as commissions to encourage them to sell patients other procedures or more of the same procedure. The Committee acknowledges the detrimental impact such a model could have on patients who may be persuaded to have procedures that are not in their interest and unaware that financial incentives are behind these tactics. 
The Committee has recommended consideration of whether individuals providing these services, or their employees, should be required to disclose any incentives, commissions or other payments they receive for upselling. This would provide more transparency for patients and give them the opportunity to reconsider a procedure (Recommendation 12). 
Increasing the role of General Practitioners in assisting patients with decision-making 
The Committee considers that General Practitioners (GP) can play an important role in providing independent advice to patients considering cosmetic procedures, particularly those that are invasive, as GPs are aware of a patient's broader medical history. The Committee has recommended that the NSW Minister for Health raise with the COAG Health Council whether patients seeking invasive cosmetic surgery be required to consult their GP. The Committee believes that national consultation on this issue will identify potential benefits and impacts. A national approach is also preferred to prevent patients from crossing borders to places with more relaxed standards. The Committee has also recommended that the New South Wales public education campaign about cosmetic health services ensures that patients be encouraged to seek advice from their GP (Recommendations 13 and 14). 
Reviewing the current cooling off periods 
The Committee learnt that Medical Board of Australia guidelines, which apply to doctors, set out cooling off periods for certain cosmetic health services. The Committee believes that cooling off periods are important after a patient had a consultation and been informed of the risks of a procedure. This gives the patient an opportunity to seek further advice or reconsider the procedure. 
The current cooling off period for adult patients is seven days for major cosmetic procedures. There is no cooling off period for adult patients seeking minor cosmetic procedures. There are other specific cooling off periods for young people seeking major or minor procedures. 
Given the concerns raised about cosmetic health service practices as part of this inquiry and in the media more broadly, the Committee has recommended a review of the current cooling off periods in the Medical Board of Australia guidelines to ensure they sufficiently protect consumers in New South Wales. The review will also consider whether it is appropriate to require cooling off periods for some cosmetic procedures provided by unregistered practitioners as the Committee is concerned that this may be a gap in regulation which could put the public at risk (Recommendation 15). 
Revision surgery data collection 
The Committee heard concerns about the costs to, and diversion of resources from, the public health care system when patients are admitted following cosmetic surgery complications. The Committee has recommended that the Minister for Health considers the feasibility of collecting data on cosmetic revision surgery in the public health system to guide future policy and decision-making. The data may also be valuable to the HCCC as adverse outcomes from cosmetic procedures will not always result in complaints to the HCCC (Recommendation 16).
The Committee's Findings and Recommendations are
The current framework to protect the public 
Finding 1 The Committee finds that collaboration between the Health Care Complaints Commission and other State and Commonwealth agencies and entities is important to inform the public and protect them from cosmetic health service providers that do not comply with the law or do not have satisfactory practices. It is essential that this collaboration continues. 
Reforming the HCCC's powers 
Recommendation 1  The Committee recommends that the Minister for Health reviews the powers and functions of the Health Care Complaints Commission to ensure the Commission is able to sufficiently protect patients using health services. In particular, the Committee recommends the Commission should have the powers: a) to issue public warnings about specific health service providers and health organisations; b) to issue prohibition orders in relation to specific health organisations; and c) for search and entry to apply to all complaints and allow authorised persons to enter premises if the premises is a public place and the entry is made when the place is open to the public. 
Titles of medical practitioners 
R2 ...  that the Minister for Health continues to make representations to the COAG Health Council to protect or otherwise restrict the title 'cosmetic surgeon' at a national level under the Health Practitioner Regulation National Law. 
R3 ... that, if the COAG Health Council does not protect or otherwise restrict the title 'cosmetic surgeon' within a reasonable timeframe, the Minister for Health considers whether separate legislation should be introduced in the NSW Parliament to place restrictions on the use of the title 'cosmetic surgeon' in relation to doctors practising in New South Wales. 
R4  ... that the Minister for Health considers whether it is in the public interest to support protections and restrictions on the use of the title 'surgeon' either at a national level or for doctors practising in New South Wales 
Informing the public 
R5  ... that the Minister for Health and the Minister for Innovation and Better Regulation develop a targeted public education campaign to raise awareness about cosmetic health services, the risks involved in procedures and where to get relevant information. 
R6  ... that the public awareness campaign use various forms of advertising, media (especially social media) and other resources to target the main demographics seeking cosmetic health services in terms of age, gender and cultural background. 
R7  ... that the Minister for Health pursues with the COAG Health Council the establishment of a national one-stop shop website and advice service relating to cosmetic health services to: a) provide relevant information about procedures, practitioners and facilities to individuals seeking these services, and b) direct individuals who are dissatisfied with a service or provider to appropriate complaint pathways including, for New South Wales, the Health Care Complaints Commission, NSW Fair Trading and NSW Health. 
R8 ... that, if the COAG Health Council does not agree to establishing a one-stop-shop website and advice service for cosmetic health services, the Minister for Health looks at the NSW Government establishing the service. 
R9 ... that NSW Health research behaviours of, and influences on, consumers seeking cosmetic health services to inform future policy, regulation and education programs in this area. The Minister for Health could recommend to the COAG Health Council that it consider this as a priority for research funded through the National Health and Medical Research Council (NHMRC).  
Protecting the public 
R10  ... that the Minister for Health pursues the issue of national regulation of the use of intense pulsed light devices and laser devices for cosmetic health service procedures with the COAG Health Council. 
R11  ... that the Minister for Health examines whether legislation should be introduced in New South Wales to regulate the use of intense pulsed light devices and laser devices used for cosmetic health services. 
R12  ... that the Minister for Health and the Minister for Innovation and Better Regulation consider whether individuals providing cosmetic health services, and employees of those persons, should be required to disclose any commissions, incentives or other payments they receive for encouraging patients to agree to procedures, more of the same procedure or additional procedures. 
R13 ... that the Minister for Health raises with the COAG Health Council the issue of whether patients seeking invasive cosmetic surgery be required to consult their General Practitioner and pursue national consultation on this issue. 
R14 ... that, as part of the New South Wales public education campaign about cosmetic health services, the Minister for Health encourages patients considering invasive cosmetic surgery to seek advice from a General Practitioner. 
R15  .... that the Minister for Health and the Minster for Innovation and Better Regulation review whether the cooling off periods provided for in the Medical Board of Australia's Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures, 1 October 2016, are sufficient to protect consumers in New South Wales. The Ministers should also consider whether it would be appropriate to require and regulate cooling off periods for some cosmetic health services provided by non-registered practitioners. 
R16  ... that the Minister for Health considers the feasibility of collecting data on revision surgery in the public health system, to correct cosmetic health procedures, to inform future policy and decision-making in this area