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

Executive summary

Issue and why it needs to be addressed

Non-surgical procedures, including cosmetic treatments such as dermal fillers and Botox^® injections, as well as the less common but growing range of procedures with wider lifestyle and wellbeing purposes, have become widely accessible to the public in a variety of settings, many of which exist outside the oversight of regulated healthcare environments.

While those procedures delivered within Healthcare Improvement Scotland (HIS) registered clinics must meet certain hygiene and training standards, there is currently no legal requirement for practitioners outside these settings to adhere to such protections. This regulatory gap puts the public at risk, with concerns ranging from substandard hygiene to unqualified individuals administering procedures without appropriate oversight, and a lack of adequate recourse for those experiencing complications. The need for intervention is further underscored by the overwhelming public support for regulation found in the 2020 consultation. The Scottish Government acknowledges that many people are receiving procedures in regulated and currently unregulated settings and have a positive experience with no ill effects. Unfortunately, however, this is not everyone’s experience.

As a result, the Scottish Government’s proposals, published in June 2025, aim to address this gap. This impact assessment considers the impact of those proposals on businesses, to ensure that the proposals are proportionate to their intended outcomes.

Intended outcomes

The principal goal of the proposed Bill and the wider legislative plans is to protect public safety by ensuring that all non-surgical procedures are carried out safely, by practitioners with appropriate training, and in hygienic environments regardless of location. The Scottish Government intends that a level playing field will exist between providers, in a sector with clear minimum standards for both premises and practitioners. The Scottish Government intends that this will lead to a reduction in adverse incidents and their broader impacts on both individuals and the health system, and an overall increase in client confidence in the safety of cosmetic and other treatments.

Options

During the policy development process, a number of regulatory approaches were considered. Given the strong public feeling, acceptance in the sector that further regulation of some sort is required, and the evidence of harm it was not considered credible to maintain the status quo. It was also not considered appropriate that such regulation as does exist – that certain settings are to register with HIS and meet their requirements – is dependent on the provider being a healthcare professional, and that as such providers with a healthcare background are subject to regulation, whereas other providers with no such background are unregulated.

It was also not considered that the use of voluntary, industry led, standards and guidance would be effective in addressing the issue. The Scottish Government noted that there are some voluntary registers established under the Professional Standards Authority. These registers may continue to have a valuable role in supporting high standards in the sector, but in the absence of statutory provision the incentives for practitioners to participate in these schemes are weak. The Scottish Government has engaged with the Professional Standards Agency and the organisations running existing registers and notes that the existing registers do not cater to independent practitioners operating without healthcare professional oversight. While there are many reputable practitioners in the industry there are also some practitioners whose actions do not give the Scottish Government any confidence that they would conform in future with a wider regime or a new professional register that did not have legal force.

As such the Scottish Government considered that a statutory model was essential. In considering that statutory system the Scottish Government considered first a licensing scheme operated by local authorities. The licensing model was consulted on in the 2020 consultation, and there was a strong positive response for this means of regulation, however there was a view expressed in responses, and then in subsequent engagement and correspondence, that this model was unsuitable for some procedures, where the risks were greater or were most appropriately mitigated through healthcare expertise and in a clinical setting. Environmental health officers(EHOs) also expressed a view that they would be ill placed to enforce a scheme whereby the full range of procedures undertaken were included in a licensing model, as they felt they did not have the training and expertise suitable for consideration of procedures that had more in common with healthcare than with existing licensable activities.

The alternative to procedures being undertaken in a licensed or an unregulated setting was for procedures to take place in an independent healthcare setting. HIS currently regulate certain settings such as independent clinics or hospitals where certain regulated healthcare professionals must work from if they wish to provide services, including non-surgical procedures. Requiring certain procedures to be undertaken in this context will therefore build on this existing model of regulation. In considering the advantages of this model the Scottish Government was also aware that this provides equality between the treatment of different types of practitioner in the sector. The Scottish Government also considered the view of most regulators of healthcare professions that prescription for cosmetic procedures should be undertaken following a face-to-face consultation. Such matters are rightly for the relevant regulators to comment on, but the Scottish Government considered that it was important that the model of regulation was coherent with existing professional regulation, and the reserved legislation governing the handling of medicines.

Finally, considering the licensed model and the model of moving procedures into HIS regulated settings, the Scottish Government considered that it would not be proportionate for all procedures, to be treated in the same way. Different procedures require different risk mitigation or have differing additional considerations (such as ensuring that procedures using medicines could be undertaken in a context coherent with professional and medicines regulation). It was due to this desire for proportionality, and to reduce the impact on businesses already carrying out these procedures, that the Scottish Government settled on a graduated model. In this model, procedures are grouped according to the most appropriate risk mitigation, and then either included in a licensing scheme or restricted to a HIS regulated setting. This approach was supported by consultation respondents, and is considered to be the most effective way of achieving the desired aim to improve public health and safety.

Sectors affected

The implementation of the Scottish Government Proposals will directly affect independent healthcare providers, beauty salons, and clinics offering non-surgical procedures. Impacts will also be felt by training organisations and the suppliers of these businesses. The clients who seek non-surgical procedures will also be impacted, benefiting from improved safety, but some may find that some procedures are less accessible, or more expensive.

Engagement completed, ongoing and planned

Development of the policy was informed by comprehensive engagement activities. The 2020 public consultation provided a strong mandate for regulation, and the more recent public consultation built on this with a detailed model for regulation and licensing. The more detailed model was developed with advice from the Scottish Cosmetic Interventions Expert Group (SCIEG) and following internal consultation and engagement with HIS and local authority EHOs. In addition to the public consultation the Scottish Government engaged with businesses and practitioners. Both the public consultation, and the results of these specific conversations, were essential in revising the proposals into the form that was published in June 2025.

Further engagement has taken place to support the drafting of the Bill, as introduced, and engagement will continue as a licensing order is prepared and the Bill completes its passage. Further engagement may also be required to support drafting of any guidance required and future legislation, building on the Bill and licensing order.

Anticipated impacts (intended and unintended, positive and negative) and mitigating actions

The anticipated positive impacts of these proposals include enhanced public health, a reduction in adverse outcomes, and increased consumer trust resulting from higher standards of training and hygiene. This may be paired by a reduction, at least in the short term, in the availability of some procedures in some areas, and the impact of reduced supply may lead to an increase in prices. The Scottish Government acknowledges that there will be some negative impacts on businesses, especially those that are currently providing procedures regulated by the Bill but are unable to meet the requirements of a permitted premises. The Scottish Government is comfortable that these impacts cannot be avoided without undermining the public health aims of the policy, and they remain proportionate to those aims.

Mitigation for negative impacts will take the form of a graduated implementation of proposals, in particular separating the place-based requirements and age restrictions of the proposals from the implementation of training and qualification standards. This will provide businesses the best chance of adapting their business models to the new regulatory system.

Enforcement/ compliance

Enforcement of the proposals will primarily be the responsibility of HIS and local authorities. Both will receive increased income through fees, and will have appropriate enforcement and inspection powers. Offences will be created with a penalty of up to level 5 on the standard scale, which is currently £5,000.

Recommendations/ implementation plans

The final recommendation is to proceed with statutory regulation, as outlined in the June 2025 proposals, but to undertake these in a staged way which allows businesses time to adapt and also allows the Scottish Government to resolve issues connected to the UK Internal Market Act 2020, which the Scottish Government is considering in relation to any impact Part 3 of that Act may have on the intention to put in place training and qualification standards, restrict certain procedures to appropriate healthcare professionals, or put in place supervision requirements. The Scottish Government will work with the enforcement agencies and businesses on the detail of implementation, and will provide further details on timing and other matters as legislation progresses or after the Bill has completed its parliamentary process.

Evaluation and monitoring of implementation/ review of BRIA

The Scottish Government will keep policy in relation to non-surgical procedures under review on an ongoing basis, and in particular as the proposals are implemented. This impact assessment may need to be reviewed or supplemented as further legislation is put forward putting in place elements of the proposals, especially if the approach taken diverges from that set out earlier this year and which are therefore assessed here. The Bill will bring a range of procedures into the scope of HIS regulation, and as such consideration of future policy in relation to these procedures may be partly combined with consideration in future of the wider regulation of independent healthcare, and HIS functions.