The report features the following recommendations -
1. The Private Health Facilities Regulation is amended to create an offence for a medical practitioner to provide prescribed services and treatments in an unlicensed facility.
2. The Ministry consult with stakeholders regarding whether any non-surgical cosmetic procedures should be required to take place in a licensed facility.
3. The Ministry keep the definition of cosmetic surgery under consideration to ensure that it continues to remains appropriate.
4. The Minister raise the issue of protecting the title “cosmetic surgeon” with the COAG Health Council.
5. That additional regulation be imposed for extreme body modification procedures relating to informing clients about the risks of the procedure, the measures taken to mitigate the risks and preventing body modification procedures being undertaken on minors.
6. The Minister write to NSW Fair Trading to raise consumer protection relating to cosmetic procedures.
7. That a new subclass of S4 medicines used in non-surgical cosmetic procedures in the Act should be created. This would allow regulations to tailor rules relating to the storage, use and administration of the medicines, as well as requiring additional consumer protections. This subclass could also apply to other S4 medicines that are prone to misuse or supplied outside of normal medical models of care.
8. That consultation occurs with stakeholders before the regulatory rules for the new subclass of S4 medicines are made.
9. That the penalties for breaches of the Poisons and Therapeutic Goods Act and Regulation be increased.It states
There are a large variety of cosmetic procedures that aim to alter or modify a person’s body or appearance and the procedures vary greatly in risk to patients or clients. High risk procedures include major cosmetic surgery and the use of certain scheduled medicines. On the other end of the scale, there are relatively low risk cosmetic surgery procedures (such as mole removal for a cosmetic purpose) and low risk procedures that do not involve the use of surgery or medicines, such as hair removal. There is a range of regulation affecting persons and premises carrying out cosmetic procedures. The review by the Ministry of Health has considered whether the current regulation of cosmetic procedures is appropriate to ensure the safety of patients/clients and makes a range of recommendations to improve the regulatory environment. However, the issue of the regulation of cosmetic procedures is likely to continue to remain an area of concern. As such, the Ministry will continue to monitor the issues, including implementation of the recommendations, and any other issues that arise following investigations that are currently underway, to determine if further action is necessary.It goes on to discuss the regulation of cosmetic surgery and facilities
Cosmetic surgery ranges from minor cosmetic surgical procedures that are carried out in a medical practitioner’s rooms through to high risk procedures, such as breast augmentation, that must be carried out in licensed private health facilities.
Regulation of facilities
The Private Health Facilities Act 2007 and Regulation 2017 requires facilities that carry out certain procedures to be licensed and comply with a range of licensing standards. These standards are aimed at protecting patients and relate to the safety of the premises (such as complying with the relevant sections of the Building Code of Australia and Australasian Health Facility Guidelines) and clinical care and patient safety (such as engaging with the National Standards and Accreditation Scheme, having procedures for the transfer of patients who require higher levels of care, minimum staffing requirements and appropriate equipment). While the Private Health Facilities Act provides extensive regulation in respect of licensed facilities, it only applies to facilities that carry out procedures that fit within one of the classes of private health facilities.
One of the relevant classes is the surgical class. However, the surgical class only requires facilities to be licensed if the surgery is undertaken using general, epidural or major regional anaesthetic or sedation resulting in deeper than conscious sedation..1 The use of general or major regional anaesthesia can create significant risks to patients. These risks can be associated with airway management (in the case of general anaesthesia) and/or risks associated with the immobility of the patient. These risks can be appropriately mitigated by way of licensing requirements.
Facilities that perform surgical procedures using local anaesthesia or conscious sedation are not required to be licensed in the surgical class2 as they are generally considered to be of lower risk and the facility in which the procedures take place is not seen as requiring licensing as generally professional standards, such as relating to infection control, can mitigate the risk.
The Royal Australasian College of Surgeons (RACS), the Australian and New Zealand College of Anaesthetists (ANZCA) and the Australian Society of Plastic Surgeons (ASPS) recently released a position paper on Day Surgery in Australia. The Colleges recommend increased standards for day surgery clinics that use intravenous sedation or significant amounts of local anaesthesia in day surgery clinics.
The Ministry of Health has considered the position paper and considers that the current licensing requirements for facilities under the Private Health Facilities Act and Regulation are generally appropriate.
Licensing requirements for facilities are extensive and impose a regulatory burden on business. Licensing requirements should only be imposed if there is a health and safety risk that can only be appropriately mitigated by way of requiring facilities to be licensed. All procedures that involve the use of sedation or local anaesthesia will carry a risk to patients. However, in some cases that risk can be mitigated by way of professional responsibilities and competencies required by the individual practitioner. For example, some minor cosmetic surgical procedures, using conscious sedation or local anaesthesia, can be safely carried out by a medical practitioner in an unlicensed private health facility eg mole removal for a cosmetic purpose. If multiple moles were being removed, it would be expected that a medical practitioner would assess the patient and whether or not adequate local anaesthetic could be administered safely in an unlicensed facility. This consideration would, among other things, take into account the cumulative toxicity of the local anaesthetic administration required for the multiple mole removals. Failure to properly consider these issues could be grounds for taking disciplinary action against the practitioner.
However, the Ministry of Health also recognises that reliance on the level of anaesthesia and/or conscious sedation to determine licensing requirements will not always be a sufficient criterion for determining whether or not a facility should be licensed. This is particularly the case with cosmetic surgery where some procedures that carry high risks to patients can be carried out using local anaesthesia and/or conscious sedation.
As such, in 2016 the Private Health Facilities Regulation was amended to create a new class of private health facilities, being the cosmetic surgical class. Under the Regulation, certain cosmetic surgical procedures are required to be carried out in a licensed private health facility (or a public hospital). These surgical procedures are:
a) any cosmetic surgical procedure that is intended to alter or modify a person’s appearance or body and that involves anaesthesia (including a Biers Block), or
b) any of the following surgical procedures (however described):
(i) abdominoplasty (tummy tuck),
(ii) belt lipectomy, (iii) brachioplasty (armlift),
(iv) breast augmentation or reduction,
(v) buttock augmentation, reduction or lift,
(vi) calf implants,
(vii) facial implants that involve inserting an implant on the bone or surgical exposure to deep tissue,
(viii) fat transfer that involves the transfer of more than 2.5 litres of lipoaspirate,
(ix) liposuction that involves the removal of more than 2.5 litres of lipoaspirate,
(x) mastopexy or mastopexy augmentation,
(xi) necklift, (xii) pectoral implants,
(xiii) penis augmentation,
(xiv) rhinoplasty,
(xv) superficial musculoaponeurotic system facelift (SMAS facelift),
(xvi) vaginoplasty or labiaplasty, but does not include any dental procedure.
There are two categories of cosmetic procedures that are required to be conducted in licensed facilities:
cosmetic surgical procedures that use high levels of anaesthesia or more than conscious sedation; or
certain listed surgical procedures, regardless of the level of anaesthesia or sedation used.
Requiring certain listed procedures to be carried out in a licensed private health facility (or public hospital) recognises that there needs to be a broader consideration of risks of cosmetic surgery other than just the level of anaesthesia or sedation used.
The current list of procedures that are required to be carried out in a licensed private health facility was determined in 2016 following extensive consultation. Whether a cosmetic surgical procedure is required to be carried out in a licensed private health facility is based on the risks to the patient, being:
- The risk of the procedure itself (such as the inherent risks of the procedure eg risk of significant blood loss or other complications, whether there are significant risks the patient may need to be transferred to a higher level of care facility and whether the type of procedure is likely to mean that a patient would be non-ambulatory if they needed to be evacuated during an emergency), and
- the risk that the procedure will require high levels of anesthesia or sedation such that there is a significant risk of the patient inadvertently becoming unconscious and/or significant risk of local anesthesia toxicity.
The listed procedures are considered to be appropriate. However, a listed procedure is only required to take place in a licensed facility if the procedure is a surgical procedure. The Ministry is aware that some of the listed procedures, such as breast augmentation and penis augmentation, can also be carried out non-surgically. Such non-surgical procedures generally involve the injection of fillers (such as collagen) or, in some cases, a transfer of fat from one part of the body to another. All procedures, whether surgical or not, carry risks. As noted above, licensing requirements should only be imposed if there is a health and safety risk that can only be appropriately mitigated by way of requiring facilities to be licensed. If the listed procedures are carried out non-surgically, the risks are different than if the procedures are carried out surgically. Non-surgical procedures do not generally carry a risk that the patient will be non-ambulatory and the risk of the patient becoming unconscious due to high levels of anaesthesia or sedation is lower. However, if there is an incorrect administration of the filler, then there are risks of drug toxicity. Further, if a local anaesthetic is injected along with a filler, there is a risk of toxicity from the local anaesthetic if excessive doses are used.
There are risks associated with the use of all drugs and requiring any procedure and requiring procedures to be conducted in a licensed private health facility should only occur where a licensing requirement is proportionate to the risk.
In the case of non-surgical procedures involving the use of drugs, would be expected that the risks would be mitigated by way of professional responsibilities and competencies required by the individual practitioner and the normal regulation in relation to the use of medicines. It is noted that product information for prescription-only fillers provide detailed warnings about incorrect administration which all practitioners would be expected to consider and that medicines regulation limits who can access drugs. Therefore at this stage no substantive changes to the Private Health Facilities Regulation are considered necessary. However, as detailed later in the report, the Ministry recommends that additional regulation should be put in place in respect of the use of medicines commonly involved in cosmetic procedures. As part of the consultation on the detail about the additional regulation of medicines used in cosmetic procedures, the Ministry will also consult with stakeholders as to whether any non-surgical cosmetic procedures should be required to take place in a licensed facility.
More generally, as the definition of cosmetic surgery in the Private Health Facilities Regulation relies on a list of specific procedures, and the types of procedures may change over time (or the risks of the procedures can change) the Ministry will keep the definition under review to ensure that the list remains appropriate and, if necessary, changes to the Regulation can be pursued.It comments
The Poisons and Therapeutic Goods Act and Regulation places controls on the use, storage, administration, prescription and supply of poisons and scheduled medicines. The controls differ depending on the category of scheduled medicines. For example, Schedule 3 medicines are pharmacist only medicines, while Schedule 4 medicines can only be accessed with a prescription.
The Commonwealth also plays a role in regulating medicines, with the Therapeutic Goods Act 1989 (CTH) requiring that medicines to be registered on the Australian Register of Therapeutic Goods (ARTG) in order to be marketed and used in Australia. There are some exemptions which allow nonregistered medicines to be used with special authorisation or in other circumstances but these are not relevant to this review. The Commonwealth also places controls on the importation of medicines through regulations made under the Customs Act 1901 (CTH). Botulinum toxin and injectable hyaluronic acid dermal fillers are Schedule 4 (S4) medicines. The Act and Regulations currently provides that:
- As a S4 medicine, botulinum toxin and injectable hyaluronic acid dermal fillers need to be prescribed by an authorised practitioner (medical practitioner, dentist),
- A wholesaler can only supply S4 medicines to an authorised practitioner or other person authorised to possess the medicine,
- Any person who is assisting in the care of a person can administer botulinum toxin and injectable hyaluronic acid dermal fillers to a patient, in accordance with the authorised practitioner’s prescription. Injectable Schedule 4 medicines are not distinguished from medicines ingested or applied topically. It is a matter of professional responsibility for the medical practitioner who prescribes the Schedule 4 medicine to ensure that the person who is to administer the medicine is able to competently do so, and
- S4 medicines must be stored in a room or enclosure to which the public does not have access.
Based on a number of investigations by the Pharmaceutical Regulatory Unit, the Ministry is concerned as to whether medical practitioners who prescribe these medicines used in cosmetic procedures, such as botulinum toxin and injectable hyaluronic acid dermal fillers, have appropriate oversight over the receipt, storage, access, use and administration of these medicines at cosmetic clinics. In addition there are also concerns that certain cosmetic clinics are in breach of the Act and Regulation by importing medicines from overseas, without going through licensed Australian wholesalers. v Accordingly, there is a need for stronger regulation of certain types of S4 medicines that are used in cosmetic procedures. Stronger regulation will better ensure that medical practitioners who prescribe these medicines have appropriate oversight over the receipt, storage, access, use and administration of these medicines at cosmetic clinics and that appropriate action can be taken against persons who breach the Poisons and Therapeutic Goods Act and Regulation.
In order to strengthen regulation of the use of S4 medicines that are being used in cosmetic procedures, it is proposed to create a new subclass of S4 medicines, with regulations tailoring the rules relating to the storage, use and administration of the medicines, as well as requiring additional consumer protections. It would be expected that the exact regulatory rules would be subject to consultation with stakeholders but could include matters such as:
- Requiring that a medical practitioner or dentist who prescribes botulinum toxin and injectable hyaluronic acid dermal fillers must directly consult with the patient,
- Providing that botulinum toxin and injectable hyaluronic acid dermal fillers can only be accessed at premises when a medical practitioner is present during operating hours, and
- Placing limitations on who, such as a registered health practitioner, may administer the medicines in the course of providing a service.
The regulatory rules could also include matters relating more broadly to consumer protection, such as information given to patients. During consultation on the regulatory rules, consultation would occur with Fair Trading.
There are other types of S4 medicines that can be prone to misuse or supplied outside of normal medical models of care. Such medicines often provide for a lucrative business model, which can in turn fuel a black market. As such, similar concerns about inappropriate use arise and these medicines could be included in the new subclass. Examples of such medicines, include Sildenafil (Viagra), human growth hormone and injectable peptides (which can be used for performance improvement).
In addition, it is noted that the Poisons and Therapeutic Goods Act is 50 years old and the penalties applying to breaches of the Act and Regulation are not in keeping with the seriousness of the offences under the Act and Regulation. It is therefore recommended that the penalties in the Poisons and Therapeutic Goods Act be increased. It is noted that issues relating to penalties are being considered more broadly as part of the review of the Poisons and Therapeutic Goods Act.
The Ministry’s recent investigations have also uncovered concerns about the illegal importation of prescription medicines for use in cosmetic procedures the lack of appropriate labelling of hyaluronic acid dermal fillers product, which can contain lidocaine local anaesthetic. These are matters that concern the Commonwealth Therapeutic Goods Act. The Minister has already written to the Commonwealth Minister about these concerns. In addition, the Minister has already placed on the COAG Health Council agenda the issue of the use of medicines in cosmetic procedure so that other jurisdictions are aware of the issues.
