Regulation and licensing of non-surgical cosmetic procedures: consultation background paper

3. Our proposal

The Scottish Government propose that private, non-surgical cosmetic procedures (NSCPs) should only take place either:

• In an independent clinic, or other healthcare setting regulated by Healthcare Improvement Scotland (HIS): or
• In a business premises that is licensed by the local authority.

We further propose that certain procedures should only be carried out in a HIS regulated setting, either by an appropriate healthcare professional or under their supervision.

Under this proposal practitioners in a licensed premises would be able to carry out lower risk, less invasive procedures, with more invasive, higher risk procedures carried out only in a HIS regulated setting. Wherever procedures take place we propose to establish standards (unless these are already established by virtue of the existing HIS regime) for:

• Training and qualifications;
• Insurance and indemnity;
• Premises’ hygiene and equipment;
• Materials, for instance disposable needles and consumable products used in procedures.

We have proposed three groupings of procedures:

• Group 1 procedures are the least invasive and lowest risk procedures. We propose that these can take place in a licensed premises by licenced individuals. Adherence to the standards referred to above will be a condition of obtaining and retaining a licence.
• Group 2 procedures are more invasive and higher risk. This category includes any procedure that uses a prescription-only medicine, or where such medicines are likely to be required as part of management of any complications arising from the procedure. We propose that these be restricted to HIS regulated premises, therefore meeting any standards set by HIS, and that there must be supervision by an appropriate healthcare professional, including a prescriber where prescription-only medicines are in use.
• Group 3 Procedures are those procedures which by virtue of either the complexity of the procedure, or the risk profile, we propose should only be undertaken by the appropriate healthcare professional.

The Annex to this paper contains full details of groupings and we are seeking views in this consultation on the procedures we have suggested belong to each group. Details are set out below covering our proposed licensing regime and how regulation within a HIS setting will work.

Because a premises will need to meet certain requirements, and be subject to inspection whether by HIS or the local authority (LA), it will not be possible for procedures to be carried out by practitioners working in hospitality venues, a client’s own home or any other location outwith a licensed premises or HIS regulated clinic. It may be possible for practitioners to work out of their own homes, but in that case the space will require a local authority licence, or to be regulated by HIS, meeting all the relevant requirements. It will be possible for the same practitioner to work in multiple locations, as long as these premises are covered by LA licence or HIS regulation. It will be subject to the discretion of the local authority or its officers whether it is possible for a vehicle to receive a licence in order to provide a mobile service, and any vehicle would again need to meet all the relevant requirements. We do not believe it is possible that a vehicle could meet the requirements for HIS registration.

It is not possible for this scheme to eliminate all of the risks of non-surgical cosmetic procedures, which vary from procedure to procedure. However, it is intended that these proposals will mitigate these risks. Our intention is to enable consumers to choose a provider of NSCPs with greater confidence than at present and that businesses and practitioners will have a framework for safe and responsible delivery of these procedures.

We also intend that these proposals remain proportionate. We anticipate that responsible and safe businesses will be able to continue to operate in both the clinical and non-clinical sectors. Any negative impact on businesses must be balanced against the need to eliminate risk of harm to clients. This is why it is important for us to seek views from the public, including business owners, practitioners and service users on these licensing and regulation proposals, and on the most appropriate form of regulation for individual procedures.

Licensing

The Scottish Government propose that procedures listed in Group 1 of the annex must be undertaken:

Either

• By a practitioner with a practitioner licence issued by the local authority in which they are practicing; and
• In a premises which is also licensed by the relevant local authority.

Or

• In a HIS regulated setting.

Under our proposals Group 2 and 3 procedures cannot take place under this licencing scheme. These procedures must only take place within a HIS-regulated setting (see below), it will also be possible for group 1 procedures to be carried out in a HIS-regulated setting.

This model builds on the existing provision for tattoo parlours and skin piercing establishments, which is subject to licensing under the 1982 Act by virtue of the Civic Government (Scotland) Act 1982 (Licensing of Skin Piercing and Tattooing) Order 2006. The existing order does not specify that both premises and practitioner licences are required for these procedures, and practice currently varies between local authorities: some require premises-only licences and some require premises and practitioner licences.

We propose that the premises licence will be linked to practitioner licences. Premises licences may list those who are operating from the premises, including visiting or ‘freelance’ practitioners (i.e. anyone who is not a direct employee of the business), and the procedures they undertake; the practitioner licence may also name one or more premises. The premises licence holder will be responsible for ensuring that any staff working in the premises hold a relevant practitioner licence. We also propose that the premises licence holder is responsible for the condition of the premises, and ensuring that equipment and materials on the premises are appropriate. It will be a condition of the premises licence that any procedures carried out in the premises are covered by suitable insurance, whether held by the business in which the procedure is being carried out, or by the individual practitioner. In many respects the premises licence may be very similar to existing licences under the 2006 Order, and we will work with LAs and EHOs to maximise the benefits of any alignment to simplify administration.

We propose that a practitioner licence will list the procedures the practitioner is qualified to undertake. In obtaining the licence the practitioner will be required to demonstrate that they have met an agreed standard of training, for instance an SCQF NVQ at the appropriate level for the relevant procedure. CPD courses will not be an appropriate form of qualification in themselves. It will be a condition of licence that practitioners either hold appropriate insurance or that any procedures they undertake are insured through the premises they are operating in.

In determining an application for a premises licence, we propose that LA officers will visit the premises and assess them against specified conditions for the condition of the premises, and for equipment and materials being used to conduct procedures. The LA will also ensure that practitioners operating in the premises are licensed and that insurance is in place.

In determining an application for a practitioner licence, LA officers will review evidence provided by the applicant to ensure they meet the relevant training and qualification standards for the procedures they will undertake.

In either case the LA would be required to conduct a fit and proper person check and take steps to identify whether the individual has been disqualified from obtaining a licence. LA officers would have powers of ongoing inspection or enforcement, and be empowered to issue improvement notices or withdraw licences from premises or practitioners if licence conditions are not met or there is any risk to public safety.

The form of the licences would be a matter for the LA, at whose discretion simplified combined practitioner/premises licences (e.g. for sole operators) may be offered. Any such licence will have to provide the same level of assurance as for separate premises and practitioner licences. LAs will set the levels of fees for issuing, renewing and varying licences.

Regulation

We propose that the procedures listed in Group 2 and Group 3 must only take place in HIS-regulated settings. Currently HIS regulate independent healthcare services in Scotland including independent hospitals, clinics and medical agencies. An independent clinic is one where a registered doctor, nurse, midwife, dental practitioner, dental care professional or pharmacist or pharmacy technician provides a non-NHS service to the public. The vast majority of independent clinics regulated by HIS provide cosmetic procedures. These settings may also offer Group 1 procedures, as well as non-cosmetic services.

GP and dental practices that provide NHS services are not currently required to register with HIS, although we know that such practices can also provide private services. We are aware, for example from the General Dental Council’s response to the UK Government’s 2023 consultation, that a number of dentists currently offer NSCPs from their practices, but we are not aware of any NHS GP services that do this. The local NHS board is responsible for the NHS services provided in GP and dental practices, but they do not inspect or regulate other services offered in them. GPs and dentists who offer a wholly private practice are already regulated by HIS.

We propose to provide that where NSCPs are being provided by any GP or dental surgery they must be registered with HIS, even if this would not otherwise be a requirement, regardless of any overlapping regime of inspection or regulation which is in place.

Community pharmacies may provide private services alongside NHS services, and some also undertake NSCPs. The General Pharmaceutical Council (GPhC) inspects “registered pharmacies”, that is premises that dispense pharmacy medicines and prescription-only medicines to individuals, as the regulator for pharmacies, pharmacists and pharmacy technicians in Great Britain. Here again we propose to provide that where NSCPs are being provided by pharmacies they must register with HIS.

Under this proposal Group 2 procedures must be undertaken either by an appropriate healthcare professional or by a trained practitioner who is being supervised by a healthcare professional who will remain responsible for the procedure. The healthcare professional would be responsible for ensuring that the practitioner’s training and competence is appropriate to the procedure. HIS would consider the training and competence of both healthcare professionals and non-healthcare practitioners as part of their inspection.

By supervision we mean that an appropriate healthcare professional must be present on site, and undertake an initial face to face consultation for each procedure, including prescribing any prescription-only medicine for the procedure. The supervising professional will remain responsible for the safety of the procedure, satisfying themselves that the client is an appropriate candidate, is able to consent and understands any risks that may be associated with the procedure. They will also be required to be on site and available to answer any questions, or in the event of complications which require medical management, or if the practitioner undertaking the procedure requires support.

Under the current 2006 Order there is an exemption for the requirement for a licence for procedures such as tattooing and skin piercing where a procedure is undertaken by a regulated healthcare professional. We would propose to maintain this exemption for tattooing and skin piercing, and will further explore with HIS and LAs how best to ensure that the two regimes interact effectively, minimising duplication, while ensuring no gaps in the regulatory approach.

Group 3 procedures are those that we propose must be conducted by the appropriate healthcare professional themselves, and not delegated to a non healthcare-professional practitioner.

Where we refer to an “appropriate healthcare professional” the meaning of this will be dependent on the procedures being undertaken. Whether undertaking or supervising a procedure the healthcare professional will need to be working within their scope of practice, and have appropriate training and experience both in the procedure itself and in the management of any complications that may arise. The complexity of group 3 procedures is such that they will usually require advanced anatomical and medical knowledge so that we expect the appropriate professional to usually be a doctor or a nurse prescriber with advanced training, we will engage with professional bodies and HIS in establishing this in detail.

The registration of a setting that is offering NSCPs will be dependent on the setting demonstrating that:

• Practitioners are appropriately trained;
• Healthcare professionals are operating within their professional competence;
• Procedures are appropriately supervised where required;
• Group 3 procedures are being undertaken by a doctor or prescribing nurse with the appropriate competence (and not delegated);
• Appropriate insurance and indemnity is in place to compensate clients who suffer harm as a result of negligence or malpractice; and
• The setting meets HIS’ wider standards for the condition of the premises and any equipment or materials to be used.

Setting standards

The proposal in this consultation requires various standards to be set. These will be set in a variety of ways, for instance just as the current regime for tattooing and ear piercing includes detailed mandatory conditions in legislation for the condition of a premises the licensing scheme proposed in this consultation set such standards in legislation. However, Healthcare Improvement Scotland currently enforce hygienic and safe conditions for independent clinics without the relevant standards in legislation, and we are not aware of any issues with this approach in that context. We will work with LAs and HIS to ensure that standards are set in a way which is clear and enforceable, and the nature of these standards will reflect expert advice on the conditions appropriate for different procedures. We will also work with businesses in both the clinical and beauty sectors to ensure that standards are achievable and proportionate. Finally we will ensure there are mechanisms to keep any standards updated to keep up with developments in the industry and emerging evidence on safety and safety precautions.

Age restrictions

We are seeking public views on the degree to which children and young people should be able to access NSCPs, whether to put in place any age restrictions for NSCPs, or whether we need to establish protections to limit the exposure of children and young people to the risks that may be posed by these procedures. It is particularly important here to consider that the developing bodies of children and young people may be more at risk from these procedures than those of adults. Some stakeholders have called for a lower age limit to be set for recipients of NSCPs: this section sets out the context for any decision about restrictions to be made and provides options for respondents to consider.

In many cases NSCPs are more appropriate to adults than to children, and many are specifically targeted at addressing signs of aging which are not present in children or younger adults. However, we also understand that there are circumstances where younger adults and older children may seek NSCPs to address conditions such as acne and scarring. Many providers of NSCPs will already have age restrictions in place for certain procedures. Providers should in all cases assess the suitability of a procedure for each individual, which should include age, and they may refuse to undertake procedures that they consider to be inappropriate or ineffective, or because they carry more risk for a certain individual.

When considering approaches for those under the age of 18 it is also important to consider the implications of procedures involving an intimate area, such as the genitals, anus, nipples or surrounding areas. The bodies of teenagers and young adults are continuing to develop and these areas are amongst those which may be especially subject to change during puberty. There are also additional safeguarding and ethical concerns related to the carrying out of procedures on intimate areas on children.

As well as this consultation we are also seeking specific feedback from stakeholders in this area. We will prepare a Child Rights and Wellbeing Impact Assessment in accordance with section 17 of the United Nations Convention on the Rights of the Child (Incorporation) (Scotland) Act 2024, and this will reflect both feedback to this consultation and the results of wider engagement.

Context

In considering any restrictions or protections we must also consider the emerging competence and capacity of young people to consent to procedures, and the framework offered by the Convention on the Rights of the Child (UNCRC) incorporated into Scottish Law by the United Nations Convention on the Rights of the Child (Incorporation) (Scotland) Act 2024) The UNCRC defines children as those below the age of 18, but also recognises the evolving capacity of children and the need for their views to be given due weight in accordance with their age and maturity. The UNCRC further recognises the role of parents or guardians in supporting decision-making by and about children. In Scotland the Age of Legal Capacity (Scotland) Act 1991, also addresses the question of age and capacity. This Act provides that a person over the age of 16 has legal capacity to enter into any transaction, but does not override other age limits or prevent them from being set.

In general older children are considered to have some capacity to give informed consent for medical procedures and are expected to make a number of consequential career and academic choices that may have a serious impact on their future life and livelihoods, however there are also times where the choices of young people are limited in legislation or in practice to protect their health and wellbeing.

Comparisons with other age restrictions may also be helpful. The Tattooing of Minors Act 1969 and the Public Health (Scotland) Act 2008 makes it an offence to allow anyone under 18 years of age to receive a tattoo (including microblading and semi-permanent make up) or use a sunbed. Piercing is currently restricted to those aged 16 and over, unless parental consent is in place in which case a piercing can be administered to a child of any age. In relation to NSCPs in particular the UK Government has made it illegal through the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 to provide Botox^® or dermal fillers to those under the age of 18 in England.

Options

In this context we are seeking feedback on how best to put in place protections whilst still respecting the competence of young people. We will use this feedback, along with specialist stakeholder advice, to make a final decision on which protections to put in place. We will need to demonstrate that any restrictions put in place are appropriate and proportionate.

There are two broad options for protecting children, although subject to feedback we may opt for a hybrid approach:

• We can put in place age limits for NSCPs which may be differentiated according to the type of procedure. This would be similar to the approach that exists for tattooing, sunbed use or skin piercing, and has the benefit of simplicity and transparency.

• We can put in place additional protections to ensure that young people are not receiving inappropriate procedures, whilst still providing flexibility. Here we would propose that for individuals under a certain age all procedures, even if they would usually be in groups 1 or 2, should be considered a group 3 procedure and therefore carried out by an appropriately trained and qualified healthcare professional in a HIS-regulated setting. It would then be a matter for professional judgement and ethics whether the individual was able to give informed consent or whether there was any additional risk posed by the age of the individual. This has the benefit that it will respect the competence of young people to make their own choices in relation to NSCPs, and is closer to the situation in relation to health care related decisions. This approach may however increase the cost, especially of Group 1 procedures, to young consumers.

Our consultation asks respondents to express a preference between these two systems, and subsequent questions ask about what limit should be set if an absolute age limit is put in place. A final question asks whether intimate procedures in particular should be limited to those of 18 years of age and older.