Regulation and licensing of non-surgical cosmetic procedures: consultation analysis and response

3: Revised proposals

The consultation proposals published in December 2024 aimed to respond to public concerns about the safety and regulation of non-surgical cosmetic procedures. They aimed to build on the previous 2020 consultation with proposals for a robust framework that would balance the need to protect the safety of users of these services with proportionality in regulations. By moving from the proposal to license all procedures to one where some procedures could be restricted to certain settings and in some cases to healthcare professionals, the Scottish Government sought to recognise the range of different procedures and the need to mitigate different risks in different ways.

It remains the intention of the Scottish Government to introduce regulations that are robust enough to protect public safety, which is the most important concern of most respondents and stakeholders. However, the Scottish Government has also carefully considered the suggestion that in some cases the initial proposals went further, or were more onerous, than were required to deliver those public safety aims. On this basis the proposals were reviewed and modified. At each stage they were tested to confirm whether they would be effective in protecting public safety, that they would operate effectively within existing law, both UK and Scottish, and that they reflect a proportionate approach to regulation.

The questions asked in the consultation and what was said in response are included in the section above. This section outlines the refined proposals that the Scottish Government will now seek to implement. How these will be legislated for is described in more detail in the next section.

Grouping of procedures

The consultation proposed that procedures should be categorised into three groups. In the consultation background paper these were described as being separated by level of risk and level of invasiveness. It was proposed that each group required different treatment:

• Group 1: Should be carried out in a licensed premises by a licensed practitioner but may also be carried out in a clinic or other setting regulated by Healthcare Improvement Scotland (HIS).
• Group 2: Would be restricted to a clinic or other setting regulated by HIS, under the supervision of, or by, a healthcare professional.
• Group 3: Must only be undertaken only by an appropriate healthcare professional.

This element of the proposal is being maintained. As described in the previous section under questions 1-4, there appears to be broad support for some procedures to be carried out in a licensed setting (Group 1), and for some procedures to be restricted to healthcare professionals (Group 3). Support for Group 2 is more limited, but the group has been maintained to include procedures where the risks cannot be adequately mitigated in a licensed setting, but where it cannot be justified that they are restricted to healthcare professionals only. This reflects both the emphasis placed on safety by consultation responses, and the need to ensure that any regulation is proportionate. Restricting procedures to a HIS regulated or similar setting, with safeguards in place in terms of the initial consultation and supervision, appears to be a means of mitigating the risks of these procedures which is effective, but less disruptive than restricting these procedures to a healthcare professional.

More detail on how each of these groupings will work is set out below, including changes and refinements introduced because of the consultation feedback. Also included below are details of the procedures that are now proposed be included in each group, and information on how procedures were classified to ensure that the treatment of each procedure is appropriate. Considering the extensive feedback received, both on the proposed grouping and on the proposed licensing scheme and model of HIS regulation, more detail is being provided on how these will work, with refined proposals set out below.

Licensed settings and Group 1 procedures

Unless a business is a HIS regulated or clinical setting then in order to offer Group 1 procedures, that business will be required to seek a premises licence under a new scheme that will be established under the Civic Government (Scotland) Act 1982. As well as the premises licence, all the staff undertaking procedures in that business will be required to hold a separate practitioner licence.

Local authorities will be responsible for granting premises and practitioner licences, inspecting premises, and ensuring compliance with standards for hygiene, equipment, training, and insurance. This dual licensing model aims to balance public safety with minimal disruption to businesses, ensuring that all procedures are performed safely and responsibly. This model was strongly supported by respondents to question 5.

The premises aspect of this scheme will be similar to the current scheme in operation for skin piercing and tattooing. The premises licence will be the main means by which hygiene and other place-based standards will be enforced, as well as the means to ensure that appropriate materials and products are in use. A licensed premises may concurrently hold other licences, for instance to undertake tattooing or skin piercing, and wherever possible the requirements will be aligned, simplifying matters for businesses and local authority enforcement. Local authorities will also retain discretion about whether a vehicle can qualify for a licence, and in these cases the vehicle would have to meet the same standards as other premises.

Most respondents did not believe that vehicles should be licensable, but there was a concern about the disproportionate impact of restrictions on island and rural communities, and so the Scottish Government considered that some local authorities may wish to continue licensing such vehicles. A vehicle licensed in a local authority would only be able to provide services in that authority: a practitioner who wished to offer a mobile service across multiple local authorities will require separate licences.

The practitioner licence will be the means by which training standards are enforced. A practitioner may work in multiple licensed settings, but a practitioner working across local authority borders will require a separate licence for each local authority. It will be for local authorities to determine whether they wish to coordinate with each other in these situations. A practitioner licence will not be sufficient in itself to allow a person to perform Group 1 procedures. A person holding a practitioner licence will only be permitted to perform procedures in a licensed premises, or a HIS regulated setting (although the practitioner licence would not be required in the HIS regulated setting).

The use of a national register for practitioners was raised during consultation events, although it was not included in the Scottish Government’s original proposal. The Scottish Government investigated this as an alternative option, considering whether it would fulfil, in a more effective way, the requirements set out for the licensing scheme. It was, however, not possible to identify an appropriate public sector body, with relevant enforcement powers and operational experience, to undertake this role. Therefore, the practitioner licence model was retained as a more practical and cost-effective solution, capable of meeting public safety aims.

Group 1 procedures undertaken in different settings

The consultation asked whether a licence should be required for practitioners of Group 1 procedures in a HIS regulated or other clinical setting. The consultation (question 6) showed strong support by respondents for this approach. However, on this point the Scottish Government is proposing an alternative approach for the following reasons:

• Existing HIS regulations, specifically the Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011 already require HIS regulated clinics to only employ staff who have the qualifications, skills and experience necessary for the work they will perform. The Scottish Government consider this provides sufficient basis for HIS to enforce any training standard appropriate to Group 1 procedures, without the need for a practitioner licence in this setting.
• The practitioner licence would be an unnecessary additional burden, both for businesses and for individual practitioners.
• This would duplicate oversight across the local authority and HIS.

For the same reasons, no licence will be required for non-healthcare professionals undertaking Group 2 procedures (but under these proposals these will need to be undertaken in a HIS regulated or similar clinical setting as described below).

Group 2 and Group 3 procedures, and HIS settings

The consultation proposed that some procedures should be restricted to a HIS or other clinical setting (Group 2 and 3), and some procedures should be restricted to being undertaken by an appropriate healthcare professional (Group 3).

As noted in Section 2 in respect of Questions 1-4, there was strong support for the restriction of some procedures to an appropriate healthcare professional, but less support for the proposed inclusion of certain procedures in Group 2, where they would be restricted to HIS settings, but not restricted to being undertaken by a healthcare professional. On the other hand, some respondents did support the principle of HIS registration to ensure certain standards. Some of those disagreeing with the inclusion of procedures in Group 2 may have done so because of uncertainty around the concept of supervision, as related in the free text responses to question 4. The Scottish Government proposes that supervision can offer sufficiently robust protection and the detail below is designed to explain this. That protection will not be sufficient for all procedures, and the appropriateness of the group to the procedure is set out under the sub-heading “Procedures in each Group” below.

Standards of HIS settings

Most respondents to the consultation (Question 11) agreed that hygiene standards and standards of training should be enforced in HIS regulated settings. HIS already enforces such standards, and these standards are, for the most part, already provided for in legislation, including in the Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011. Where these standards in legislation exist, the Scottish Government does not propose to make any change, and so for procedures restricted to a HIS regulated setting, these standards will apply. The Scottish Government will engage with HIS to identify any requirements for guidance to strengthen these existing standards.

Attendance requirements

Some feedback received in engagement with business highlighted that the most onerous element of HIS registration would be the requirement for businesses to employ or otherwise pay for the services of a healthcare professional who could undertake the role of supervision (which is clarified below) or, where appropriate, to undertake certain procedures. We propose to ensure that a healthcare professional should only be required to be present when Group 2 or Group 3 procedures are being undertaken, not when Group 1 procedures, or services such as massage therapy were undertaken. This would reduce the burden on a business that offered group 2 or 3 services only on certain days or at certain times.

Supervision of Group 2 procedures

‘Supervision’ is the proposed approach to those procedures where it is important for a healthcare professional to be involved in a procedure, but not necessarily undertake it themselves. Concerns about this concept were raised on response to question 4, and in wider engagement by several different stakeholders. Some respondents also commented that it was unclear what supervision would mean in practice.

Feedback from responses to question 12 has been considered, alongside the existing requirements for staffing in HIS regulated settings. Having taken account of this, the Scottish Government is proposing that the risks of Group 2 procedures can be mitigated if:

• The supervising healthcare professional satisfies themselves that the procedure is appropriate to the client, and that the practitioner who will undertake the procedure can safely undertake it, having regard to their training and qualifications, and any complexities specific to the individual receiving the procedure.
• Undertaken with an appropriate professional remaining on site when the procedure is being undertaken so that they are available to support any complication management, and/or make out any prescriptions that may be required.

The Scottish Government expects that a supervising professional will exercise their professional judgement and will be working within the guidance and limits of their profession and training. Any professional undertaking this role would need to be suitably trained, qualified or experienced in the procedures being undertaken, in order that they can reasonably discharge the role. The Scottish Government proposes to work with professional regulators on this issue.

These requirements should reassure respondents that Group 2 offers robust protection for the relevant procedures. The supervision of an appropriate healthcare professional, when undertaken as defined, is a meaningful mitigation against a variety of risks. Accompanied by the need for the practitioner undertaking the procedure to demonstrate appropriate training, qualifications, and experience, it will provide assurance that clients do not receive inappropriate procedures, that the procedures are safely carried out, and that support is available to address any complications that may arise.

This clarification around the meaning of supervision may not address the concerns of those who believe the requirements of supervision are unduly onerous. However, this clarification should make it clear that these are considered necessary to meet the public health aim, which most people responding to the consultation stated was their main priority. These clarifications, in combination with the proposed changes outlined under “attendance requirements” above and the changes to the groupings of procedures outlined below, is how the Scottish Government is proposing to balance the need for safety with proportionate regulation for businesses.

Other settings

In general, in any setting outwith the NHS where specified healthcare professionals (medical practitioners, dental practitioners, registered nurses and midwives, pharmacists, pharmacy technicians and dental technicians) offer a service, they are required to register with HIS as an independent clinic (if they are not already classified as an independent hospital).

There are exceptions to this for services provided in schools, colleges and workplaces and in a first aid/emergency context, which are all settings unlikely to be suitable for the provision of non-surgical cosmetic procedures. However, there are some clinical settings where healthcare professionals deliver services, and which may be suitable settings for the provision of non-surgical cosmetic procedures, but which are also exempt from HIS registration. These include certain dental practices; community pharmacies, which are regulated by the General Pharmaceutical Council; and GP practices which provide NHS services. The Scottish Government is not currently aware of any GP practices offering non-surgical cosmetic procedures as a private service. Both community pharmacies and dentists offering a mixture of private and NHS services do offer such services, and entirely private dental practices would be required to register with HIS in any case.

In response to question 15, most respondents indicated that they felt that where non-surgical cosmetic procedures are offered, even if a setting would otherwise be exempt, then HIS registration should be required. In principle the Scottish Government agrees that there should be parity across all those delivering these procedures, and any standard that the Scottish Government sets in Scotland should apply wherever a procedure is offered.

However, the Scottish Government does not propose to prevent non-surgical cosmetic procedures from being offered in these settings (GP practices, dental practices or community pharmacies) at this time, nor to require them to register with HIS (with the exception of entirely private dental practices who are already required to register with HIS). Amending these exemptions would require further work with the relevant representative bodies. Mixed practice dental, pharmacy and GP settings abide to agreed rules as part of NHS contracts and the doctors, dentists and pharmacists working within them remain subject to their professional regulators. Pharmacy premises are similarly regulated by the General Pharmaceutical Council. It is therefore the Scottish Government’s understanding that the delivery of procedures in these settings is generally low risk. Considering bringing these settings under the scope of HIS regulation in the short term would also require substantial additional resource. This is not a priority currently, but the Scottish Government proposes to keep this issue under consideration as the wider proposals are implemented.

Appropriate healthcare professional

The Scottish Government proposes that the supervision and undertaking of Group 2 and 3 procedures should be restricted to specific healthcare professionals. Considering the consultation responses to questions 13 and 14 the Scottish Government considers that the appropriate professionals would be:

• a medical practitioner (doctor);
• a dental practitioner;
• a registered prescribing nurse; or
• a registered prescribing pharmacist.

These professionals are expected to work within their competency and scope of practice and meet all training and qualification standards. As such, they would be expected to have trained in the relevant procedure being undertaken. The Scottish Government proposes to discuss this issue further with professional regulators.

Case studies/Illustration

Under these proposals if a business wants to undertake a Group 1 procedure, it must either be registered with HIS (or be another relevant clinical setting as discussed below) or both the premises and the practitioner must have a licence from the local authority. The standards met should be consistent between the two settings. Group 2 and Group 3 procedures can only be offered from a HIS regulated clinic (or other allowed setting). They cannot be offered from a licensed setting. If a business wishes to offer any procedures in these groups they will need to register with HIS and meet all the relevant requirements.

Enforcement of standards

The consultation (Questions 9, 15 and 16) demonstrated strong support for the principle that HIS and local authorities should have the powers they need to enforce the licensing scheme and registration requirements, and any standards set. The Scottish Government considers that the Civic Government (Scotland) Act 1982 provides a suitable framework for enforcement of the licensing scheme, and powers and provisions similar to those found in the 2006 Order relating to tattooing and skin piercing are appropriate. HIS also has substantial powers and the Scottish Government is considering with HIS whether there are any elements of these that will need to be revised to support the effective enforcement of any standards set in this context. The Scottish Government continues to consider the wider regulation of independent healthcare and will also consider wider enforcement powers in that context.

The Scottish Government fully expects that most businesses in the sector will seek to comply with any regulations to provide the safest and most reputable setting for their clients. Nonetheless, it is appropriate to ensure that there are legal penalties for individuals or businesses acting outwith the law. There are existing penalties for carrying out a licensable activity without a licence, and for failing to register a clinic with HIS where these are required. It is proposed that additional penalties will be required to prevent Group 2 or 3 procedures being carried out outwith a HIS regulated premises (or other allowed setting). The penalty will be set considering the existing penalties already mentioned in this section and may apply both to individuals and to businesses or business owners.

Procedures in each group

Considering the proposed separation of procedures into three groups and the treatment outlined above, the Scottish Government reconsidered all the procedures consulted on and reclassified them.

Whereas the consultation proposals were classified based on a combination of risk and level of invasiveness, the Scottish Government’s understanding based on the consultation feedback (question 4) and wider discussions and correspondence on this issue is that this way of classifying procedures was not considered to be helpful. As a result, the Scottish Government reconsidered the approach to classification and decided that it should focus on the most appropriate mitigation for the risks of a procedure rather than the level of risk itself, whether this was expressed in terms of likelihood or severity of adverse outcome.

The strong feedback received from businesses on the implications of the proposals on them was also carefully considered. The Scottish Government intends to only impose restrictions on businesses to the extent necessary to achieve the wider public safety aims, if those aims are effectively and proportionately met by doing so, and if it is not possible to achieve those aims in a less disruptive way.

It is appropriate to impose regulation that may in some case restrict businesses when it is in service of an appropriate aim and done in a proportionate way. Protecting public safety is an appropriate aim, and in proposing to impose these restrictions, the Scottish Government is following the wider precedent set by, for instance, the restriction of the use of sun beds, licensing of businesses undertaking tattooing and skin piercing, and the wider regulation of independent healthcare. The principle of proportionality means that any restriction should be effective in achieving the public safety aim, but that it should also be the least restrictive or onerous means of achieving that aim.

In deciding the appropriate group for each procedure, the Scottish Government considered the evidence from the consultation as well as other representations and tested each procedure against the criteria set out below.

The Scottish Government also considered existing devolved medicines legislation and the regulation of healthcare professionals, and this grouping is intended to be coherent with, and not in any way cut across these matters. Where relevant the groupings reflect existing requirements around medicines.

Group 1 Procedures

Group 1 procedures should be those where the risks can be appropriately mitigated through the imposition of hygiene and training standards and by requiring the use of appropriate materials, which the Scottish Government believes can be achieved through a licensing scheme. As above, these may also be undertaken in a HIS regulated setting, which does not need to hold a local authority licence, and in these circumstances the practitioner will not need a practitioner licence.

This is the least onerous level of restriction proposed by the Scottish Government at this time. Procedures were only included in Group 2 or 3 where there was evidence that the mitigation in this group was insufficient.

As such, Group 1 procedures will be those that:

• Meet a basic definition of a non-surgical cosmetic procedure (a procedure that pierces or penetrates the skin in some way, for cosmetic or wider lifestyle reasons).
• Do not meet the criteria for inclusion in Group 2 or 3.

The following procedures meet these criteria:

• Microneedling to a depth of 1.5mm
• Laser and Light Treatments including:
• Laser hair and tattoo removal
• Laser treatments for acne scaring, sun damage and treatment of skin lesions, (but only non-ablative treatments)
• Photorejuvenation
• Fruit peel or glycolic acid chemical peels that effect only the viable epidermis or outer layer of skin
• Radiofrequency treatments
• High frequency ultrasound (for non-intimate use)
• Cryolipolysis
• Electrocautery, also known as advanced electrolysis
• Cryotherapy

IPL and LED therapies

The Scottish Government proposes to define these as licensable activities in relation to a scheme set up under the Civic Government (Scotland) Act 1982.

Group 2 Procedures

Group 2 procedures are those which are being restricted to a HIS or clinical setting, but which may be undertaken by either a healthcare professional or a non-healthcare professional practitioner.

Group 2 procedures should be those where:

• The initial decision to proceed requires the input of a healthcare professional, including, but not only, where a prescription is required.
• The risk of a complication that requires a prescription or the support of a healthcare professional to manage is sufficiently high, and there is no safe alternative management.

The first of these criteria is consistent with the proper handling of prescription only medicines under reserved medicines regulations, and the guidance of professional regulators. The Scottish Government considers that it is essential that the regulation of non-surgical cosmetic procedures is coherent with this wider regulatory background, and that the proper handling of prescription only medicines is a public good. This is also an appropriate mitigation of the risks of medicine use.

The Scottish Government considers that, apart from the use of prescription only medicines, an informed initial decision to proceed is important in any case where a substance is injected into the body. While these injections may not themselves be particularly complex, and the training required to perform the procedure is likely to be accessible to non-healthcare professional practitioners, the main risk comes from adverse reaction to or improper use of a substance, considering the nature of the substance and the particular client who is receiving it. The injection of a product is in some cases irreversible, or if not irreversible then less reversible than the application of a topical treatment (that is applied to the skin, such as a cream), and it is therefore important that the initial decision to proceed is well informed.

Considering all these factors, the Scottish Government has concluded that the decision to proceed with, and the safe application of, injectable substances, whether or not they are listed as prescription only medicines, requires specific pharmacological and/or anatomical knowledge, which will be part of the professional expertise of specific healthcare professionals. This does not ignore the expertise of non-healthcare practitioners, or the ability of such practitioners to train in the safe delivery of the procedure itself but complements it in an important way to provide a safer environment for these procedures.

The Scottish Government also considered whether a healthcare professional was required to screen moles or lesions for referral for investigation in laser and other procedures aimed at the reduction or treatment of such conditions. Following discussion with a range of stakeholders, the Scottish Government is satisfied that, with appropriate training, non-healthcare practitioners would be able to recognise cases where further medical investigation was required. Training is accessible to practitioners who are not healthcare professionals, which appropriately mitigates the risk that a skin complaint is treated cosmetically in advance of any required medical investigation. As such, this risk does not trigger inclusion in this group.

All non-surgical cosmetic procedures where substances are injected into or under the skin meet these criteria. These would include:

• Toxins such as botulinum toxin (Botox®)
• Any prescription only medicine, including hayfever injections
• Dermal fillers (as far as they are injected for the purpose of smoothing or providing limited increased volume e.g. to the face or neck, not where they are used for body augmentation or procedures on the genitals or anus)
• Vitamin solutions

The Scottish Government proposes to restrict these procedures to HIS regulated or other clinical settings but does not believe that it is necessary for a healthcare professional to carry out these procedures, only to supervise.

Group 3 Procedures

Group 3 procedures will be restricted to a healthcare professional as discussed above. The procedures should be those where the risks of the procedure and the medical knowledge necessary to perform them correctly means they can only appropriately be performed by an appropriately qualified healthcare professional. This would be the case where:

• The training and knowledge required to undertake the procedure safely is sufficiently complex that the appropriate training is unlikely to be available and accessible to non-healthcare professionals, and/or needs to be accompanied by broad-based core pharmacological or anatomical knowledge most likely to be held by those with a healthcare background.
• The procedure itself is complex and there is a need for healthcare informed input and immediate decision making during the procedure.
• The management of any potential complication requires the direct support of a healthcare professional, possibly immediately, so that it would only be appropriate for the healthcare professional to undertake the procedure.

These criteria will be met by procedures which require:

• the use of any anaesthesia or sedation requiring a prescription-only medicine or any other product or technique likely to impair consciousness or undermine the ability of a pain response from the client (e.g., hypnosis, acupuncture);
• the safe handling of biological products such as blood for reinjection into the client; or
• intravenous procedures.

The following procedures meet this definition:

• Phenol Peels
• Platelet Rich Plasma and Biotherapy
• Injection Microsclerotherapy
• Injection Lipolysis
• Dermal Micro coring
• Microneedling where the needles used penetrate the skin to a depth greater than 1.5mm
• Use of dermal fillers to reshape or augment any part of the body, including any procedure where over 2ml of injectable substance is used in one site at one time e.g. Brazilian butt lifts, liquid breast augmentation etc.
• Ablative laser treatment
• Carboxytherapy
• Cellulite subcision
• Insertion of threads and cogs
• Any procedure listed in Group 1 or 2 where an anaesthetic is used
• Any introduction of substances (e.g. vitamin infusions) by IV
• Any procedure above, except hair removal, where the procedure is carried out on the genitals, anus or on an area around the genitals or anus.

The Scottish Government proposes to restrict these procedures to an appropriate healthcare professional.

Handling new procedures and changes in future

Several respondents to the consultation highlighted that it was important to have a means of responding to new procedures that are likely to emerge in coming years. It is also important to recognise that the nature of healthcare professions, the wider training landscape, and the evidence about the risks of non-surgical cosmetic procedures (and appropriate mitigations) are likely to change over time. The Scottish Government proposes therefore that Ministers should have powers that allow them to add new procedures to those that have been restricted, and to change the nature of those restrictions, for instance by moving a procedure from one group to another.

Other aspects of these proposals may be set in guidance that can respond, for instance, to changes in safe practice to accommodate new forms of training or to provide other clarity as the industry continues to develop.

Age restrictions

The Scottish Government notes the strong views received in response to proposals to restrict non-surgical cosmetic procedures by age, from practitioners, medical professionals and members of the public alike. The Scottish Government shares the widely expressed concerns about the appropriateness of some of these procedures for individuals whose bodies are still developing, as well as the potential influence of social media and peer pressure on younger people. These views were expressed both in response to question 18, and in the free text question concerning the impact on children’s and young people’s rights.

Based on the evidence received the current proposal is to implement an age limit of 18 years and over for all non-surgical cosmetic procedures. A graduated set of age restrictions was considered, which would depend on the nature or grouping of the procedure, but a single age limit ensures consistency, ease of enforcement, and clarity for clients. This approach is consistent with article 3 of the United Nations Convention on the Rights of Child (UNCRC), to act in the best interests of the child. A Child Rights and Wellbeing Impact Assessment (CRWIA) is, however, still in progress and the Scottish Government is seeking young people’s views specifically to ensure they are adequately considered in the final decision on age restrictions. As such the proposal remains provisional and may be revised in light of any new evidence that comes to light during that process.