Licensing and further regulation of non-surgical procedures: business and regulatory impact assessment

Section 4: Additional implementation considerations

Enforcement/ compliance

Compliance with the Scottish Government’s proposals will be achieved through local authority enforcement of the licensing scheme, and through Healthcare Improvement Scotland (HIS) enforcement of the provisions set out in the Bill. These bodies have been consulted during the policy development process, and further engagement with them will be ongoing as proposals are implemented. Local authorities and HIS will be required to work with each other, building on existing links and connections, and will also continue to engage with other regulatory bodies, in particular the professional regulators for healthcare professionals, and the Medicines and Healthcare products Regulatory Agency (MHRA).

The Scottish Government expects that most businesses affected by the proposals will wish to comply. The Scottish Government also expects that the majority of consumers will wish to receive services from providers who meet all the relevant legislative requirements. HIS and local authorities are therefore expected to approach enforcement with an expectation that in most cases they will be supporting businesses to reach compliance.

In considering legislation it has been a priority to ensure that provisions are understandable, and in particular that drafting of offences is such that businesses will be well placed to understand which of their activities are affected. The Scottish Government has sought to ensure that proposals are clear, and as straightforward possible, and expects that most businesses considering the requirements will understand them. The sector that will be affected has been well engaged, as evidenced by high levels of participation in the consultation and survey, and it is clear from correspondence that there is a high degree of awareness around the proposals.

Where businesses do not comply with new requirements, this will leave them at risk of committing offences. In particular, the Bill introduces two new offences of providing a procedure (as regulated by the Bill) (a) on a person under the age of 18, and (b) outwith a permitted premises. HIS is being provided with some additional enforcement powers to complement its existing powers under the National Health Service (Scotland) Act 1978, to ensure that they are able to enter, inspect and collect evidence both from providers registered with them, and from premises where they have reason to believe an offence is being committed. The licensing scheme will be supported by penalties and enforcement powers contained in the Civic Government (Scotland) Act 1982 and adapted to the specific nature of the non-surgical procedures sector.

The penalties associated with the offences are fines up to level 5 on the standard scale, which is currently set in legislation as £5000. Prosecution will be by summary procedure. The level of penalty and the procedure are designed to be in keeping with the seriousness of the offences and the existing penalties for existing offences, including the offence of failing to register an independent healthcare service. Fines at this level are considered to be a meaningful deterrent, but the procedure is such that undue pressure is not likely to be placed on the court service. Local authority environmental health officers and HIS also have recourse to other powers to support compliance with the overall regime and any additional public safety measures that are required. These include requiring improvement activity and the option of putting in place additional requirements.

UK, EU and International Regulatory Alignment and Obligations

Internal Market/ Intra-UK Trade

The Scottish Government has considered the impact of proposals and legislation in relation to the proper functioning of the UK internal market and intra-UK trade. In doing so the Scottish Government has continued to engage with other administrations, and in particular with the Department for Health and Social Care (UK Government), which has indicated its intention to regulate the sector, although it continues to undertake further consultation and engagement.

As highlighted in Section 2 (UK/Devolved Administrations) the Scottish Government continues to consider the approach likely to be taken elsewhere in the UK, and the impact on the UK internal market will continue to form a part of those discussions.

The Scottish Government is satisfied that the proposals, as currently drafted, will not represent a barrier to internal trade or the movement of professionals or practitioners within the UK market. There is no evidence that the existing different regimes for the regulation of independent healthcare are preventing the free movement of either clients or practitioners in this sector. The proposals that will be legislated for through the Bill, and the proposed secondary instrument establishing a premises licence under the Civic Government (Scotland) Act 1982, will not prevent an individual from practicing in Scotland, as long as they comply with the requirement to work within a licensed or permitted premises.

The Scottish Government does propose to put in place restrictions on those providing procedures, set training standards for practitioners, and restrict certain procedures to appropriate healthcare professionals. The Scottish Government is continuing to develop these proposals and is considering the impact of Part 3 of the UK Internal Market Act (UKIMA), which makes provision relating to the regulation of professionals. The Scottish Government has engaged with both DHSC and the Department for Business and Trade (DBT) and is reassured that UKIMA is not intended to prevent public safety restrictions being made in line with our proposals. Further exploration the extent to which the activities being regulated by the Bill comprise the practice of a profession under Part 3 is ongoing. To understand the effect of the provisions in Part 3 also requires an assessment of regulation of relevant procedures in other parts of the UK, noting that the UK Government has recently announced its intention to legislate to regulate certain non-surgical cosmetic procedures. Provision to put in place qualifications or experience restrictions has not been made in the Bill, but instead an enabling power is taken, which will allow such restriction to be put in place at a future date. Similarly, the practitioner licence aspect of proposals for licensable activities will not be put in place at the same time as a premises licence.

Provisions restricting procedures to those aged 18 or over (in effect, through the creation of an offence of providing procedures to persons under 18) may have an impact on the reported incidence of young people travelling to Scotland to receive procedures that they cannot currently receive in England due to the Botulinum Toxin and Dermal Fillers (Children) Act 2021. There is no robust evidence as to the scale of this movement, but alignment of the age-related restriction for those procedures captured by this Act represents a positive change to prevent young people in England bypassing the intentions of the UK Government, and potentially putting their own health at risk.

International Trade Implications

The Scottish Government does not consider that the proposals have the potential to affect international trade. No direct restrictions are put in place to prevent clients travelling from Scotland to receive procedures, or to prevent clients entering Scotland. Providers of procedures will be treated on a level playing field, and the decision as to where to seek a procedure remains one for consumers to make. The restrictions put in place may increase costs of procedures, as noted elsewhere, but it is considered unlikely this will be to such a degree that consumers will be incentivised to take on the cost of further travel to seek treatment outside of the UK. Similarly, the Scottish Government is not aware that Scotland is a destination for prospective clients, with most procedures regulated by the Bill or included in the licensing scheme assumed to be performed on clients who live in Scotland.

EU Alignment consideration

The Scottish Government does not consider that the proposals have any impact on alignment with the EU, or access to EU markets. The Scottish Government notes the variety of approaches to regulation of this sector across the EU, and that in many cases procedures in EU member states are more regulated or restricted than is the case in Scotland. Correspondents, survey respondents and some media have highlighted the perception that Scotland, and the wider UK, is “lagging behind” the EU and other comparable states. As such the further regulation of the sector will bring Scotland closer to the high standards of many EU states, whilst being appropriate to the distinct regulatory context, in an area that is largely outwith EU Commission competency.

Legal Aid

The proposals are not relevant to the provision of legal aid, nor to the ability of individuals’ rights to access justice through legal aid. Possible additional expenditure from the legal aid fund is possible if prosecutions are brought and those being prosecuted seek legal assistance. Financial impacts of the Bill, including the cost of court proceedings and costs that may be met by the Scottish Legal Aid board are considered as part of the Financial Memorandum, published separately.

Digital impact

The procedures affected by the Scottish Government’s proposals are delivered in person by a practitioner to a client. The Scottish Government does not consider that the proposals can be circumvented using digital technologies, or that digital technologies need to be explicitly accommodated in the proposals. However, there are related issues regarding the use, or potential use, of digital means to frustrate enforcement, or that businesses feel should be allowed, namely advertising and online prescribing / supervision.

The use of advertising through online means, especially through private groups on social media and private messaging apps, could provide a challenge to enforcement. It is possible that a provider may seek to evade regulation by advertising procedures through these means in a way which may not be visible to enforcement agencies. It is already illegal for providers to advertise the use of prescription only medicines to the general public in the UK.^[1]

Digital technology can also be used to facilitate virtual consultations, prescribing and off-site supervision. The Scottish Government is aware that this takes place and that some practitioners advocate for this being a suitable part of their business and practice model. Stakeholders who have raised this have generally done so in the context of the Scottish Government proposal that certain procedures should be restricted to a HIS regulated or other clinical setting where a healthcare professional should be present to undertake an in-person consultation and be available to support complication management.

The Scottish Government however notes a number of respondents to the consultation and correspondents with the Scottish Government hold the opposite view and emphasised the importance of in-person consultation to form a full view of a client, and the appropriateness of a given cosmetic or other intervention. In particular the Scottish Government is aware of the guidance offered by the professional regulators of healthcare professions that can prescribe medicines, especially that of the Nursing and Midwifery Council, which recently published revised guidance explicitly stating that remote consultations were not appropriate for the prescription of medicines for cosmetic purposes.

The Scottish Government proposals are not intended to in any way address the regulation of medicines, nor to interfere with the regulation of healthcare professionals, as areas of these are reserved matters, but these matters are considered with a view to ensuring the proposals are coherent with this regulatory context.

Business forms

The Scottish Government proposals will build on the existing HIS regulation of healthcare. The Scottish Government expects that the forms and processes for clinics seeking registration with HIS should be revised on an ongoing basis, including engaging with registrants and potential registrants to ensure the process is fit for purpose and easy to use.

Proposals for activities to be included in a licensing scheme require local authorities to develop the licence and support the application process. Local authorities will have flexibility to determine the form of the licence, and any forms that must be submitted in order to apply. The Scottish Government expects that local authorities will build on their experience of existing licensing schemes.