Scottish Government Consultation on the Regulation and Licensing of Non-surgical Cosmetic Procedures

A consultation is underway into the regulation and licensing of non-surgical cosmetic procedures (NSCPs). The consultation only covers NSCPs for aesthetic and not healthcare purposes. The background paper has been released and responses to the consultation can be submitted up to 14 February 2025.

NSCPs are currently largely unregulated. Whilst independent healthcare clinics are regulated by Healthcare Improvement Scotland (HIS), meaning NSCPs in that context must adhere to certain standards, currently there are no legally required training or qualifications for NSCPs. An increasing percentage of the population is undergoing NSCPs and the rationale for regulation is that it will allow for NSCPs to be provided with increased public confidence and reduced risk exposure, and for providers of NSCPs to have a framework within which to operate safely.

What is an NSCP?

The paper defines NSCPs as procedures that have the purpose of enhancing or altering appearance without surgery and include procedures that penetrate the skin, either through a needle or blade, or that involve penetrating chemicals, radiation, sound or light. Make-up, facial treatments that do not penetrate the skin, and massage therapies are not considered NSCPs. The definition of surgery, however, has been left to professional regulators. Tattooing, skin piercing, acupuncture and electrolysis are not NSCPs and require a licence issued by a local authority under the Civic Government (Scotland) Act 1982 (Licensing of Skin Piercing and Tattooing) Order 2006, unless performed by a regulated healthcare professional.

Who carries out NSCPs?

At present NSCPs can be carried out by regulated healthcare professionals such as doctors, nurses or dentists, who are trained and subject to their own professional standards; by beauty therapists who may be highly skilled and can register with professional organisations such as the British Association of Beauty Therapy and Cosmetology (BABTAC); or sometimes by individuals who are not trained, supervised or licensed and may be using products which do not meet any suitability or quality standards. NSCPs can be performed in clinical settings such as hospitals and clinics, which are regularly inspected, or in beauty salons, hotels, vehicles or private residences which are not subject to inspection. Under the current legal regime, it is arguably not possible to determine whether non-regulated settings keep satisfactory standards of hygiene.

What regulation is proposed?

The existing regulations which could potentially apply to some NSCPs are:

• HIS regulation of independent healthcare;
• Professional regulation of healthcare professionals;
• Licensing and regulation of medicines and medical devices by the Medicines and Healthcare products;
• Regulatory Agency (MHRA); and
• Licensing of procedures including tattooing and ear piercing by local authorities.

Medicines also have their own regulations, and some Prescription-Only Medicines (POMs) are used in NSCPs such as Botox®, hyaluronidase and some injectable local anaesthetics. Dermal fillers are not POMs and are not regulated by the MHRA. POMs can be held in stock by treatment providers who obtained them via prescribers but are not themselves prescribers, and so may provide these POMs to clients without proper consultation or prescription.

The Scottish Government has proposed that private NSCPs should only take place either at an independent clinic or healthcare setting regulated by HIS or at business premises licensed by the local authority. In addition, the proposal is for more invasive, higher risk procedures to only be carried out in a HIS regulated setting, either by a suitable healthcare professional or under their supervision; and for lower risk, less invasive procedures to be performed also by practitioners in a licensed premises. Either way, there would be applicable standards for procedures regarding training and qualifications; insurance and indemnity; premises' hygiene and equipment; and materials such as disposable needles and consumable products.

There also proposals for procedures to be classified as follows:

• Group 1 procedures: the least invasive and lowest risk. They can be performed in licensed premises by licenced providers, with adherence to applicable standards referred to above, but also in a HIS regulated setting;
• Group 2 procedures: more invasive and higher risk. Procedures involving POMs, or where such medicines are likely to be needed for management of any complications which could arise from the procedure. These can only take place in HIS regulated premises and must meet the standards set by HIS, with supervision by a suitable healthcare professional, to include a prescriber where POMs are used.
• Group 3 Procedures: the most complex or high risk. They should only be performed by a suitable healthcare professional. Again, these NSCPs would be restricted to HIS regulated premises.

In respect of Groups 2 and 3, it is noted that NSCPs can at present be provided at GP, dental practices and community pharmacies that provide NHS services, which are not currently required to register with HIS, and the proposal is that any GP, dental practices and community pharmacies should also register with HIS if NSCPs are being provided. The paper contains an Annex which details which specific NSCPs should be included in each group, and views are being sought on that.

What change would this bring?

Since premises will require to meet certain requirements and be inspected either by HIS or the local authority, it will not be possible for NSCPs to be performed at hospitality venues, private residences or any other location that is not a licensed premises or a HIS regulated clinic. Providers could work at of their own private residences, but their workspace will require to be licensed or regulated by HIS, and therefore meet all the applicable requirements. The proposal is that it will be subject to the discretion of the local authority or its officers whether a vehicle can receive a licence for mobile services, provided such vehicle meets all the relevant requirements. However, such a vehicle could not meet the requirements for HIS registration.

It is proposed that the premises licence should be linked to practitioners' licences. Premises licences could potentially list all providers operating from the premises, to also include visiting or freelance practitioners, with a list of the procedures they offer. Likewise, a practitioner licence could name one or more premises and also list the procedures that the practitioner is qualified to perform. The premises licence holder should be responsible for ensuring that all staff working in the premises hold a practitioner licence, as well as for the condition of the premises, equipment and materials on the premises and that procedures performed at the premises are covered by insurance. It is proposed that a practitioner should only be able to obtain a licence if they demonstrate an agreed standard of training, and either the practitioner or the premises hold insurance in respect of the NSCPs they perform. Local authority officers would be responsible for assessment prior to issuing a licence in respect of both premises and treatment providers. Combined practitioner/premises licences could be offered. The local authority should conduct a fit and proper person check and see whether the practitioner has been disqualified from obtaining a licence. Local authority officers would have powers of inspection or enforcement as well.

Is there an age limit for NSCPs?

In addition, views are being sought on the extent to which children and young people should have access to NSCPs, and in particular whether age restrictions should apply, or protections should be established to limit the exposure of children and young people to the risks that may arise from NSCPs. The following two options are being considered:

• Whether to set age limits for NSCPs according to the type of procedure; or
• Whether to establish additional protections to make sure that young people are not receiving unsuitable procedures. This would mean that for people under a certain age all procedures, regardless of classification, should be considered a group 3 procedure in terms of being performed by an appropriately trained and qualified healthcare professional in a HIS-regulated setting. It would then be a matter of professional judgement and ethics whether the person can give informed consent or whether there are additional risks due to their age. This option provides greater autonomy for children and young people but is likely to increase the cost of NSCPs.

Responses

The closing date for responses to this consultation is 14 February 2025. If you wish to contribute, responses can be submitted here.

If you would like to find out more about the topics discussed in this blog, please get in touch with our Insurance team, or your usual brodies contact.