Scottish Cosmetic Interventions Expert Group Report July 2015

6. Options for regulation

Relevant existing regulation

Several regimes of regulation are pertinent to independent health services, including regulation of professionals (often through compulsory registration with professional bodies), the product (e.g. via the EU Directives) and service provision (the clinic) itself, including the premises, facilities available and clinical governance arrangements.

HIS are given legal powers in relation to independent health care services through amendments made to the National Health Service (Scotland ) Act 1978 ("the 1978 Act") by the Public Services Reform (Scotland) Act 2010. Provision is made for HIS to have powers in relation to the regulation of independent clinics but these powers have not been commenced - at least in part because the scope of the legislation was felt to be too limited. The definition of the object of regulation ('clinic') in the 1978 Act is as follows:

"independent clinic" means a clinic which is not comprised in a hospital and in or from which services are provided, other than in pursuance of this Act, by a medical practitioner or dental practitioner.

From the Act, 'provided' is defined to include managing a service but a medical or a dental practitioner must be present, so delegation of all services is not acceptable. Commencement of this provision would therefore exclude regulation of nurses who commonly act as independent providers of cosmetic procedures.

It is worth noting that regulation of many independent clinics which provide comparable services is already carried out by the Care Quality Commission (CQC) in England under existing legislation. Cosmetic surgery providers were included as part of CQC's recent consultation on their independent acute hospital inspection methodology.

Weighing up risk and financial/regulatory burden

In order to commence regulation of independent clinics in Scotland, an appropriate legal definition for 'independent clinic' is necessary. In keeping with the three existing spheres of relevant regulation, at least three different and non-exclusive ways of defining an independent clinic exist - on the basis of who provides the service, the types of services provided and where the service is provided.

There is an inherent tension between minimising risks faced by consumers and the regulatory burden (which incurs associated financial costs) required for such a governance arrangement. The most comprehensive inspection regime is likely to minimise risks of adverse events and may improve quality of care received. However, this may be achieved at a very high financial cost, may not be enforceable, may reduce business and may not be cost-effective.

Depending on whether the intention is to provide the broadest coverage, or ensure that inspection is targeting procedures with the greatest risks, a variety of approaches to the definition of an independent clinic are possible. Each of the three potential criteria for defining an independent clinic (regulation on the basis of the person, procedure and location) can be combined in three ways:

• Narrow remit: The service is regulated on the basis of both criteria being fulfilled e.g. an independent clinic exists if a service is provided by a doctor AND s/he is providing a dermal filler.
• Intermediate remit: The service is regulated on the basis of a single criterion e.g. an independent clinic exists if a service is provided by a doctor.
• Broad remit: The service is regulated on the basis of either criterion being fulfilled e.g. inspection if a service is provided by a doctor OR dermal fillers are being provided.

The first option results in the least regulatory burden but is likely to leave consumers with the least protection. In contrast, the third option will minimise risk but results in the greatest financial/regulatory burden. It is also worth noting that a very broad remit may result in the inspection capacity of HIS being overwhelmed so that inspections of the most 'at risk' clinics are not being conducted at an adequate frequency or with enough depth.

In their deliberations, the SCIEG and HQC expressed a desire to adopt a 'risk-based' approach to regulation of cosmetic procedures. The key features of such an approach included:

• Regulation (and inspection) of services on the basis of the anticipated likelihood of harms.
• Flexibility over time to add or remove procedures, in line with market changes and changing evidence base.
• Broad scope that could apply proportionately to all practitioners and providers.

A phased approach to regulation

In addition, it was noted that many of the most high-risk procedures are provided by health care professionals. However, considerable concerns existed about omitting regulation of cosmetic practitioners, with a need for regulation to protect consumers receiving dermal fillers noted.

Following extensive discussion by the HQC and SCIEG, a phased approach to the introduction of regulation to assure the safety and quality of cosmetic procedures was concluded as most appropriately balancing the needs for consumer protection and minimising regulatory burden. Such an approach has the advantages of building on existing legislation to allow timely action to be taken and facilitates a coordinated response to risk across the four nations.

Phase one: Commencing inspection of independent clinics

Phase one involves the commencement (through the use of Scottish Statutory Instruments legislation) of an existing power to allow the inspection of independent clinics. Given the rapidly evolving nature of the cosmetic procedures market, it was determined that defining an 'independent clinic' for the purposes of legislation on the basis of specific procedures was not appropriate. Similarly, the possibility of restricting the services subject to regulation on the basis of providing specific 'cosmetic' treatments or procedures was explored. However, this approach was viewed as unsatisfactory since defining specific procedures or treatments as 'cosmetic' within legislation could be difficult or impossible to achieve.

For these reasons, the SCIEG recommends that the definition of an 'independent clinic' for the purposes of commencing inspection and regulation of cosmetic clinics be based on the health care professional providing a service. Following consultation with a range of professional representatives, the following groups were deemed most likely to perform cosmetic procedures or other specific high-risk procedures that necessitated regulation:

• Doctors
• Dentists, & dental care professionals
• Nurses
• Midwives

In making a judgement, the SCIEG gave consideration to likely trends in future provision while being cognisant of the need to ensure regulation would be proportionate to the potential risks imposed. There was also recognition that this service is additional to current HIS activities and must be based on a cost-recovery mechanism. In addition it is recognised very small numbers from other health practitioner groups provide some cosmetic interventions and may wish additional accreditation in due course (see phase three).

Phase two: Regulation of cosmetic providers

Phase one as described above would allow regulation to be commenced for independent clinics being provided by (or on behalf of) specific regulated health care professionals. This would bring regulation in Scotland into closer alignment with existing protections afforded to clients using similar services in England. However, its coverage would not include non-surgical cosmetic procedures being provided by independent cosmetic practitioners who are not members of a statutory register. For example, services being provided by beauticians, hairdressers or similar therapists would not be subject to regulation. At present, many cosmetic practitioners will have received training at further education colleges or similar settings which are often necessary for insurance purposes.

Phase two would allow regulation of these services to be introduced in a manner that is proportionate and risk-based. The introduction of regulation in a second phase has a number of important advantages:

• Timely: Commencement of phase one could be achieved without primary legislation whereas introducing regulation of cosmetic practitioners would be best achieved through proportionate primary legislation. A longer period of time is required to introduce primary legislation, both for the preparatory work required and its introduction to the Scottish Parliament.
• Risk-based: Many services provided by cosmetic practitioners carry lower risks than those provided by regulated health care professionals. Compulsory registration and inspection by HIS could therefore be viewed as disproportionate to the risks presented and may be more likely to be subject to legal challenge.
• Coordination across the four nations: During the SCIEG's deliberations, plans are being considered to introduce regulation of cosmetic practitioners in England. Awaiting the outcome of such discussion will allow greater coordination of regulation to be achieved across the four nations. Harmonisation of regulation was viewed favourably to mitigate the risk of cross-border tourism.

Three options were considered for introducing primary legislation to regulate cosmetic practitioners providing cosmetic procedures. First, regulation of the cosmetic practitioner providing the service could be achieved through a coordinated UK-wide policy. If the UK government decide to introduce legislation which requires specific cosmetic procedures to be only provided by regulated health care professionals, or on their behalf, similar provisions could be introduced in Scotland. Since health care professionals would have some responsibility for the actions of cosmetic practitioners to whom they delegate, this would introduce the expectation that all those providing specific procedures had met the minimum training requirements, such as those set by HEE.

Second, local authorities currently require certain services to be provided subject to the acquisition of a license. While detailed information about licensing was not available to the secretariat, the following summarises initial information gathered but may be subject to revision following further investigation. For some businesses (such as tattoo parlours, petrol stations and riding stables), meeting minimum standards is necessary prior to receiving a license. For other businesses (such as food outlets), licenses must be applied for from the local authority but are automatically dispensed. There is currently no licensing requirement for hairdressers or beauty parlours but premises that have tanning facilities are required to hold a license from local authorities in many areas.

In both licensing options, the local authority would hold a complete list of all businesses providing the service of interest and could take action to address reported concerns by clients or others. It is worth noting that licensing can be either compulsory for all local authorities or discretionary (which may result in large variation in implementation across different local authorities). Local authorities can operate a cost recovery scheme for the registration process but are not allowed to charge for the costs of enforcement to address poor practice. Therefore the introduction of a licensing scheme would have financial implications for local authorities which would need to be explored further.

Lastly, it may be possible to combine the two approaches above i.e. to restrict provision to health care practitioners, either directly or on their behalf (and hence introducing the expectation of adherence of training standards, for example such as those set by the HEE training requirements), in combination with a compulsory local authority licensing scheme. The SCIEG expressed a preference for this third option, noting that a lack of available data on the provision of cosmetic procedures represents a major challenge for evidence-based policy and ensuring appropriate safeguards for consumers choosing to undertake cosmetic procedures.

Phase three will be to consider the voluntary or legislative options for any additional health care professionals who provide services and wish to be accredited. The aim is to ensure options for any other specific individuals who are providing services to be allowed entry into the regulated group. This may include for example, any clinical scientists who are supervising and performing aesthetic laser procedures can be regulated as independent clinics in their own right if necessary.