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

Section 3: Costs, impacts and benefits

This section provides an overview of the costs, impacts, and benefits anticipated for businesses as a result of the proposed regulation of non-surgical procedures. The section draws on evidence from extensive engagement and consultation as described in Section 2. In particular this builds on information drawn from the survey undertaken for businesses (see Section 2 “business engagement”). A summary of the responses to this survey is also included as an annex to this impact assessment.

The costs are based on the anticipated overall effects of the proposals set out in the consultation response published earlier this year. As described in Section 5, the Bill published ahead of this impact assessment will give effect to some elements of these proposals but not all. Where possible the impact of different elements of the publication are described, and where there are future decisions that give rise to uncertainty this is described.

This section identifies both financial and operational implications for a wide range of providers, from those already regulated by Healthcare Improvement Scotland (HIS) to businesses operating in unregulated settings. The costs and impacts will vary significantly depending on each business’s regulatory status and the scope of procedures offered. Many impacts will also depend on the way businesses behave, and on wider market effects that cannot be robustly predicted. This uncertainty is acknowledged.

This section acknowledges that there are a number of direct and indirect costs, some of which will be significant, especially for businesses who are not currently subject to HIS regulation and do not currently employ an appropriate healthcare professional. The Scottish Government considers that these impacts have been kept to a minimum and insofar as there will be significant disruption this is proportionate to the public safety aims of the policy, and the approaches taken are those which cause the least disruption whilst still being effective in achieving those aims. The Scottish Government also notes that the changes place providers of procedures on a more level playing field (with regulation for all parts of the sector), as opposed to the current unequal market, and will allow clients to access procedures with greater confidence.

Quantified costs to businesses

Most existing businesses offering procedures can be considered in two broad categories: those who are currently unregulated because the business does not employ one of the healthcare professionals that would mean the business comprised a clinic or other setting regulated by HIS, or independent healthcare settings which are already regulated.

Currently regulated businesses

Businesses already regulated by HIS operating with an appropriate healthcare professional(s) may face minimal to moderate costs. These are anticipated to be largely administrative – such as time spent understanding new requirements, adapting policies, or ensuring continued compliance. Some survey respondents suggested that there may be upfront administrative costs in the region of £250–£500, with possible additional costs for staff training or upgrades to premises (one respondent cited a one-off investment of £7,000 for such upgrades). The Scottish Government considers that these costs will not be overly disruptive to these businesses. Such businesses also already pay fees to HIS as detailed in the table below.

The maximum fees that may be imposed by HIS are set in the Healthcare Improvement Scotland (Fees) Regulations 2024. The fees above may increase to that point (or fees be charged for services such as variation or cancellation, which do not currently carry a charge), but cannot increase further without additional legislation.

Some currently HIS regulated businesses may not employ one of the professionals (doctor, dentist, or nurse or midwife prescriber or prescribing pharmacist) that will be required to work from a service in order for it to be a permitted premises for the purposes of procedures which will be regulated by the Bill. Such businesses will, if they intend to continue offering these procedures, be required to employ such a professional, the costs of which are discussed further in the section on currently unregulated businesses below. Such premises may also be able to meet the requirements of a permitted premises if a nurse, midwife or pharmacist working in such a setting were to train to achieve prescribing privileges. Such training may cost between £1500 and £2500 depending on provider, and the training requirements may reduce the availability of that professional during the time that this is undertaken. The Scottish Government understands, based on conversations with HIS, that there are few if any businesses delivering procedures regulated by the Bill who will be in this situation.

Businesses in this sector may also need to support training for employees and restructure their staffing based on the imposition of future training standards, restrictions of certain procedures to appropriate healthcare professionals and standards established for supervision of procedures. Such provision is not to be included in the Bill or other legislation anticipated within the current parliamentary session. The potential cost of such action for businesses will be considered before such standards and restrictions are put in place.

Other clinical settings

In addition to independent healthcare settings regulated by HIS, some other clinical settings offer non-surgical procedures, including community pharmacies and dental practices. GP and dental practices are not required to register with HIS if they have a contract with the NHS to provide relevant services, reflecting the role played by the NHS in assuring the quality of primary care services provided on their behalf. Community pharmacies are also not required to register with HIS, reflecting their ongoing role supporting primary care, and the established regulation of all pharmacy services by the General Pharmaceutical Council. In both cases this exclusion reduces the need for the same service to be regulated or assured in multiple ways. As set out in the consultation response the Scottish Government does intend that such premises should have parity with HIS regulated settings, and the majority of respondents to the relevant question in the public consultation agreed that such premises should have to register with HIS, even if this would not otherwise be required. If this was required, then such premises would have to pay the fees detailed above and may also have to meet other costs to comply with HIS’ wider requirements. Further consultation and consideration are required before any such change is made, and as such these premises have been included in the definition of a permitted premises for the purposes of procedures regulated by the Bill.

At a future date the Scottish Government may, by regulation, change the definition of a permitted premises such that these settings will be required to register with HIS, but until or unless such a decision is taken the Scottish Government does not anticipate any additional costs for such businesses.

There are other settings which are not required to register with HIS, but which will not be specifically included in the definition of a premises. This includes 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 procedures. The Scottish Government is not aware that procedures regulated by the Bill or intended to be included in a licensing scheme are carried out in such settings and as such no impact is anticipated.

Currently Unregulated businesses

Currently unregulated businesses, in which no healthcare professional is working may face greater costs depending on the procedures they currently offer, and whether they choose to offer these same procedures in future.

A business that offers procedures included in the proposed licencing scheme but not regulated by the Bill will be required to apply to the local authority for a licence for the premises. Individual practitioners will also be required to hold a practitioner licence, although these two licences are unlikely to both be implemented at the same time. The premises licence will take precedence. The cost of these licences will be set by local authorities but may be comparable to the current cost of a licence under the Civic Government (Scotland) Act 1982 (Licensing of Skin Piercing and Tattooing) Order 2006, which varies between local authorities but is typically less than £500 annually. The Scottish Government considers that these costs are unlikely to be disruptive to businesses and expects that local authorities will seek to keep these costs proportionate.

A business that provides procedures that are regulated by the Bill is likely to face greater costs if they intend to continue offering such procedures. Such a business will be required to employ an appropriate healthcare professional. Respondents to the business survey estimated costs of £85–£100 per hour, £200–£500 per day, £2,000–£4,000 per month, or £19,200–£70,000 per year to hire, employ or work with a healthcare professional such as a nurse prescriber. The wide variety of costs will depend on estimates of the number of hours that would be required but may also reflect different local market conditions. Businesses also estimated the following potential costs: one-off adaptation costs of £4,000–£15,000, additional staff training costs of £2,000–£15,000 (varies by scope and staff numbers); £1,000–£4,000 per annum for additional ongoing administrative activity; and an estimated 15–25% rise in insurance costs. Not all of these costs can be directly verified.

The Scottish Government is aware that these costs are significant and will represent a challenge to many businesses. Feedback from businesses is that many will not be able to accommodate such increased costs and will have to either adapt their business model significantly or close the business.

Steps taken to restrict costs to businesses

In direct response to feedback received during the public consultation, the Scottish Government has broadened the scope of the licensing scheme to include additional procedures, in particular including procedures known as electro-cautery or advanced electrolysis. This change will not benefit all businesses who raised concerns about the impact of the original proposals but does represent a significant change. The impact of this is that businesses providing these procedures will not be required to register with HIS and will therefore not be required to employ an appropriate healthcare practitioner. Feedback from businesses indicates that this will be a substantial and welcome saving in comparison to the consultation proposals consulted on in 2024/25, it will also mean that any businesses considering a change to the procedures they offer will have a greater range of possible procedures to consider. In all cases the Scottish Government has considered procedures and ensured they are in the least restrictive group that will allow appropriate mitigation of risks. This approach is discussed more fully in the consultation response, and the consideration of injectable procedures is discussed in more detail in Section 2 (Options Considered: Final Option – Supervision requirements for injectable procedures).

With regard to supervision, the Scottish Government intends to respond to the concerns raised by businesses about the cost of employing or working with healthcare professionals by making amendments to HIS regulations to clarify requirements around the presence of healthcare professionals on permitted premises. These amendments are not included in the Bill, but can be made, alongside other consequential changes in secondary legislation, under existing powers in the National Health Service (Scotland) Act 1978. Specifically, it is proposed that an appropriate healthcare professional, such as a doctor, dentist, nurse or midwife prescriber, or prescribing pharmacist, would only be required to be present during periods when relevant activities (either healthcare, or procedures regulated under the Bill) are actually being undertaken, rather than at all times clients are present.

This flexible approach would enable businesses for whom procedures regulated by the Bill comprise an important part, but not the whole of their business, to employ the necessary healthcare professional for only the relevant activity. This is intended to limit the costs of compliance with HIS requirements whilst still ensuring appropriate protection of public safety. This may not reduce the costs for all businesses, but for some businesses this may enable a viable business model. This may also address concerns around the availability of suitable professionals, as an appropriate healthcare professional could work with multiple businesses at different times. The Scottish Government hopes that this flexibility will enable some businesses in the currently unregulated sector to adapt their current model to meet the requirements of a permitted premises.

Potential business responses

A business is responsible for their own responses to the change in regulations, but the Scottish Government has given some thought to potential approaches that businesses may take, and some of the potential changes are discussed above. Given the highest impact identified is for currently unregulated professionals securing the services of an appropriate healthcare professional the Scottish Government considers that most business change will be focused on attempts to reduce or eliminate this requirement.

The requirement could be eliminated by changing the range of procedures offered to focus only on procedures that are not regulated by the Bill, including activities included under the proposed Licensing order or those that are not subject to any regulation. Where this is not a viable or attractive option businesses offering a range of procedures may be able to take advantage of the proposed easement discussed above and use careful scheduling of procedures to minimise the hours that an appropriate healthcare professional works in a setting, and hence reduce the cost faced, this may also increase the number of appropriate healthcare professionals available, if the role can be combined with NHS work, other independent healthcare roles, or be delivered by a person providing a similar service in a number of settings.

Businesses may also be able to consider their structure, combining with other similar businesses to share the cost of registering a setting with HIS, working with existing HIS regulated settings or ultimately in practitioners within such businesses seeking work in an existing setting.

The Scottish Government will continue to listen to views expressed by businesses, especially any discussion of ways in which businesses may be seeking to adapt to regulation. The Scottish Government may discuss any obstacles raised with it with HIS or other stakeholders.

Other impacts

The proposed regulatory changes may give rise to a range of other impacts on businesses. These cannot all be robustly identified or understood and cannot generally be quantified or associated with known costs. These impacts will also be subject to the behaviour of the businesses in question. Market impacts may have positive and negative effects. The benefits of the Scottish Government proposals are set out in the relevant section below.

As the Scottish Government implements its proposals, a business may choose to revise its business model, including adapting or narrowing the range of procedures it offers. Such changes could result in a shift toward other procedures, and it is possible that these procedures may be less lucrative or be procedures for which there is lower demand or heightened competition within the sector. During any transitional phase, businesses may incur additional costs from investing in new staff training or updating equipment to allow them to offer such procedures. These adjustments can also lead to opportunity costs, as capacity to deliver procedures may be temporarily reduced while resources are redirected toward implementing the necessary changes. Businesses which are currently offering licensed procedures may face increased competition from businesses that are refocusing on these procedures.

There may also be a negative impact on the desirability of procedures resulting from the implementation of the Scottish Government’s proposals, and the associated media attention on the issues. This is unlikely to be a substantial impact, especially if the proposals are seen to be making procedures safer and given there has already been regular negative press about these procedures. Consumer demand for procedures may also be affected if direct compliance costs lead to an increase in the cost of procedures. The pricing of procedures will remain a decision for individual businesses; however, reduced supply or reduced choice of business may lead to consumers being willing to pay higher prices.

Impacts on businesses other than direct providers of procedures

The impact of regulatory changes is likely to extend beyond direct providers of procedures. Training organisations, equipment manufacturers, and distributors or manufacturers who supply products or services to the sector may experience reduced demand if the number of compliant providers contracts, or if businesses reduce their activity during transitions.

If the impact of changes is to reduce the number of practitioners in this sector, then training providers may encounter a downturn in demand. The Scottish Government understands from survey responses and correspondence that some training providers are already seeing a reduction in demand as potential trainees defer investment in their own training while the level of regulation of the sector is still uncertain. The impact on training providers may be mitigated if the effect of proposals increases demand for training in the future, as businesses seek to meet any new standards.

If the impact of changes reduces the number of procedures being offered overall then this will have some impact on manufacturers, suppliers or distributors of products and materials used in the procedures. The businesses in this sector appear to largely be involved in the manufacture or distribution of a number of products with customers in the wider health or beauty sectors, and in markets beyond Scotland. As such the impact on these supplier businesses may not be considerable. The Scottish Government has not collected data or engaged with businesses in this sector.

Non-compliance, and “underground” businesses

The Scottish Government understands that the majority of the businesses currently operating in this sector are operating legally, and will continue to operate legally even as the regulatory environment changes. However, the Scottish Government also understands that a small minority of practitioners and businesses are not reputable, and may be willing to operate in deliberate, rather than inadvertent contravention of new regulation. Some businesses and other stakeholders have raised this concern, that some providers will choose to operate in a covert or “underground” manner, and provide services which are restricted by law. Some providers also raised a concern that such businesses would be less concerned with the safety of their clients than existing businesses and would undercut those businesses that were meeting the costs of new regulation. These businesses will not be attractive to many clients, but the Scottish Government does not discount the possibility that a minority of clients may be attracted by lower prices, or that underage clients may seek procedures that are restricted by age.

The Scottish Government notes this risk, and has considered it in the consideration of penalties for businesses. The Scottish Government will continue to keep the risk of non-compliance under review.

Scottish firms’ international competitiveness

The Scottish Government is not aware that these proposals will have an impact on international competitiveness, nor on the ability of Scottish business to attract inward investment. Robust standards may have the effect of improving the reputation of the relevant sectors in Scotland, which may enhance the attractiveness of such businesses for both investment and travelling clients.

The Scottish Government is aware that some clients do travel abroad to receive procedures, especially more expensive cosmetic procedures. There have been media reports of existing cross-border activity with younger recipients of procedures travelling out of England to Scotland or Wales to receive procedures that are no longer available to children in England due to the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, which makes it an offence to administer Botox^® or fillers to a person under the age of 18. However, this will cease to be possible as the Bill contains provision whereby it will become an offence in Scotland to provide non-surgical procedures to a person under the age of 18. Whilst consumers travelling outwith Scotland to receive procedures is clearly a possibility, the likelihood of this occurring in practice has not been raised with the Scottish Government.

Benefits to business

The policy offers several potential benefits to businesses. These are not directly quantifiable but have been raised in engagement with stakeholders and in responses to the survey of businesses. All businesses operating in the sector stand to benefit from increased consumer confidence, if the sector is perceived to be better regulated and hence safer. This may lead to increased demand for services, especially from potential clients who may have hesitated due to concerns about the risks of the sector. Insofar as some businesses stop offering procedures regulated by the Bill, or reduce the number of procedures they offer, other businesses may benefit from increased client numbers, and reduced supply may also allow for higher fees to be charged.

In the current market procedures are priced at a range of points by different providers. In some cases, providers with lower safety or hygiene standards are offering procedures undertaken with less training, using sub-standard products and in general meeting lower standards. A concern has been raised by some providers that this exerts a downward pressure on prices across the whole market. Providers in the currently regulated sector, in particular, highlight that they must meet HIS fees and standards for the setting whilst competing with providers who are not currently incurring these costs. A more level playing field between providers will mean that the prices of procedures may be able to more accurately reflect the costs of providing them. Some respondents to the survey and public consultation highlighted this effect in a negative sense, with a perception from some providers in the unregulated sector that regulation was being undertaken for the benefit of currently regulated providers.

Small business impacts

As described above (Section 1: Sectors/ groups affected), most providers in this field, in both the regulated and unregulated sectors, are small businesses. These include sole traders, or businesses operated by a practitioner of procedures that are to be regulated, working in a setting where other hair and beauty procedures are undertaken. Small or sole trader businesses do already operate in the regulated part of the sector. This suggests that HIS regulation does not prevent small businesses operating in the sector. Many small businesses also hold licenses for the existing licensing scheme for Tattooing and Skin piercing, and so, again, this licensing scheme is not likely to prove an insurmountable barrier for existing businesses. Nonetheless, any additional regulatory burden is likely to be felt more significantly by small businesses and sole traders.

Given the nature of the sector, being mostly comprised of small or sole trader businesses, specific exemptions for small businesses would frustrate the intentions of the policy. However, some measures have been taken to minimise the business impact, and these may be particularly beneficial to small businesses.

For those offering procedures regulated by the Bill the proposed easement to requirements for healthcare professionals to be present at all times of operation may benefit smaller businesses. If businesses offer a mix of procedures regulated by the Bill and other procedures, such as hair and beauty treatments, or procedures that will be included in the licensing scheme, allowing them to have a healthcare professional on site only when relevant procedures are offered, rather than at all times clients are present in a setting, will lower costs.

Under the licensing scheme, steps to mitigate the impact will be largely a decision for local authorities. However, it is proposed that local authorities will have scope to offer flexibility around the form of a licence and licence application, and that in particular sole traders will have the option of combining any practitioner and premises licence.

Overall, the impact on all businesses, and in particular smaller ones, may be mitigated through an implementation timetable that provides time for businesses to adapt. Careful staging of the imposition of specific training standards, or restrictions of procedures to particular professionals, may help to provide time for businesses to adjust their business models. In the licensing context the premises license will be put in place in advance of the practitioner licence to allow businesses to adapt to that element of the proposals. Exact timelines for implementation have yet to be agreed and continued engagement with practitioners will take place as the relevant decisions are made.

Finally, the Scottish Government will explore opportunities through Business Gateway and Skills Development Scotland to provide advice and support to businesses to help them undertake any transition or change to their business model as the proposals are implemented.

Investment

The Scottish Government is not aware that this sector is an important recipient of global investment. As such these procedures are unlikely to have a substantial impact on the ambitions of the Scottish Government in relation to investment.

In general, a better regulated, safer and reputable industry will be more attractive for global investment. The recommendations of the First Minister’s Investor Panel have been considered.

Workforce and Fair Work

The regulation of the sector will affect the workforce in several ways. The proposal that an appropriate healthcare professional will be required to support or provide procedures regulated by the Bill may create new job opportunities for those with advanced qualifications but may also negatively impact on non-healthcare practitioners unable to meet new standards or adapt their roles. (This proposal is not included in the Bill as introduced, but it a proposed use of the powers in the Bill.) Increased business costs could constrain the capacity of businesses to pay the Real Living Wage or invest in staff development, but conversely, insofar as the potential benefits to business highlighted above are realised, the opposite may be true. In general, the emphasis on higher standards should support a well-trained and higher paid workforce in the sector.

Climate change/ Circular Economy

No significant direct impacts on businesses’ ability to contribute to climate and circular economy targets have been identified. The proposals do not directly incentivise or require greater resource efficiency, reuse, or recycling, but the regulation of the sector through both the Bill and licensing scheme may provide opportunities to put in place guidelines encouraging best practices in waste management and environmental stewardship. Such guidelines would need to be put in place following further consultation with the sector to ensure that any requirements were manageable. This is not currently part of the Scottish Government’s plans. Wider impact is expected to be neutral.

Competition Assessment

The Scottish Government considers that the proposals to be implemented through the Bill and the proposed secondary legislation will have an impact on competition, both by reducing the number of potential suppliers, which may reduce competition, but conversely by levelling the playing field for businesses operating in this sector (discussed further below). However, that reduction in competition is justified due to the need to achieve legitimate public safety aims. The measures that will have an impact on competition are proportionate to these aims, and the Scottish Government has aimed to form its proposals so that they are the least disruptive means of effectively achieving those aims.

The Scottish Government has considered the five Competition and Markets Authority competition assessment questions, and the answers to these are set out below, including further detail where relevant.

In considering these questions the Scottish Government considered primarily the “supply” of procedures that will be regulated by the Bill or included in the proposed licensing scheme. As in the sections above, also considered are impacts that this may have indirectly on other businesses, such as those who supply the sector with materials for procedures, or providers of training.

In considering the impact of these proposals the relevant baseline is the current situation. Currently suppliers of procedures who are certain healthcare professionals are regulated, through the National Health Service (Scotland) Act 1978 which requires independent healthcare services as defined in that Act to register with HIS. By contrast there is no requirement for businesses where procedures are not delivered by those healthcare professionals to register with HIS or to participate in any equivalent scheme. This has raised concerns that there is currently an unequal playing field between suppliers – and indeed that there is a perverse incentive as providers who do not have a healthcare background are subject to less regulation and are not required to meet quality standards. In some cases, this has resulted in charging lower fees and having an unfair advantage in competing for clients.

Will the measure directly or indirectly limit the number or range of suppliers?

The Scottish Government considers that its proposals are equivalent to “a licensing scheme, that will control market entry through quality standards” as described in the Competition and Markets Authority guidelines for considering Competition impact. In some cases, this is through the licensing scheme proposed to be run by local authorities. The scheme will require a premises operated by a business to meet certain mandatory conditions in order to hold a licence allowing procedures to be undertaken, and a practitioner licence establishing training and qualification standards. Similarly, the supply of other procedures is restricted in the Bill to permitted premises, which in most cases will be independent healthcare services registered with HIS where an appropriate healthcare professional provides services, or else an equivalent clinical setting. The Bill also delegates powers to the Scottish Ministers to make further provision restricting procedures regulated by the Bill, which may also have an impact on the competitiveness of businesses. These powers are intended to be used to restrict certain procedures to particular healthcare professionals and establish minimum training or qualification standards to practitioners.

The Scottish Government expects that the overall number of suppliers of procedures regulated by the Bill will contract, as not all of those businesses currently delivering the procedures will be able to meet the requirements of the Bill. This will be most visible regarding businesses providing “injectable” procedures such as dermal fillers and injections of Botox^®, which are currently widely available in a regulated and unregulated settings, but which will be restricted to permitted premises (regulated settings) by the Bill. Some procedures are much less commonly offered and may already be primarily offered by businesses who are already registered with HIS and so will already meet the requirements of the Bill. The supply of these procedures will not be substantially reduced.

Procedures that are proposed as licensable activities may continue to be offered with a licence from a local authority. The Scottish Government does not expect licensing to be an onerous requirement, especially if implementation is undertaken over a period of time allowing businesses to adapt their premises, or for individuals to meet training requirements once those are established. Supply of services, and so competition, may increase for these procedures if businesses currently offering procedures regulated by the Bill adjust their business model to focus on these licensable procedures.

The Scottish Government acknowledges that the impact of its proposals will be more strongly felt by some businesses than others, but this is a function of the currently unequal market, rather than any discriminatory or disproportionate treatment of any particular group of providers.

These measures are fundamental to the overall approach to improving standards, and address to some degree the unfair competition between providers that are currently subject to different regimes. In order to address public health and safety concerns in this market it is essential that certain minimum standards are imposed, and that the Scottish Government has the flexibility to impose further standards if needed. The Scottish Government is satisfied that it is appropriate to restrict some procedures to healthcare professionals, or contexts where a healthcare professional can offer input and supervision into a procedure. The Scottish Government has considered the range of procedures on offer, and only included, as a procedure to be regulated by the Bill, procedures where such input is essential to meet its public safety aims. Consideration of the grouping of procedures in this way was informed by consultation and is substantially discussed in the consultation response.

As noted earlier in this section, the Scottish Government also expects an impact on providers of materials and products for procedures, and providers of training. Both these sectors may see a contraction in demand. HIS requirements and any future requirements set out in mandatory licensing conditions or in future provisions made using powers in the Bill may further lead to shifts in demand for particular products. Insofar as the exercise of these powers is indeed expected to have such an impact, the CMA guidance will continue to be considered. Licensing conditions and HIS activity may also be used to ensure that products used in procedures are compliant with existing standards and complementary regulatory requirements. Future training standards may also have a limiting effect on the range of suppliers able to provide such training. Such impacts are again a matter for future decision making and have to be considered once that decision is made.

Will the measure limit the ability of suppliers to compete? Will the measure limit suppliers’ incentives to compete?

The Scottish Government considers that suppliers in the sector will still be able to compete, but they will be restricted by certain essential quality standards. Suppliers will have a framework for safe delivery of procedures, and consumers will be able to access services with confidence that safe delivery has not been compromised by any provider seeking a competitive advantage.

Suppliers of procedures to be regulated by the Bill may be required to increase prices in order to meet new requirements, especially to cover the cost of employing or paying for the services of an appropriate healthcare professional. Services which are currently regulated by HIS may not have to increase prices, but the change in the market may provide flexibility for them to do so.

Suppliers in the sector will still be in competition with one another and still have an incentive to compete and innovate on price and on the wider service offered. Such competition will not however extend to the ability to compromise on the safety or minimum standards of the service offered.

Will the measure affect consumers’ ability to engage with the market and make choices that align with their preferences?

It is anticipated that consumers will still be able to access services for the most part, although the impact on children and young people (to prevent access to this sector for under 18s), and on those living in remote and rural areas is likely to be more significant. This impact has been noted in the Children’s Rights and Wellbeing and the Equality Impact Assessments, and in screening for the Islands Communities Impact Assessment. Insofar as consumers’ access to the services has been restricted, this is considered to be proportionate to the improvement in public safety. In general, the Scottish Government considers that it is in the interest of consumers that they are able to access services with confidence that they meet appropriate standards. Consumers will still be able to choose between providers and choose between a range of different procedures.

Will the measure affect suppliers’ ability and/or incentive to introduce new technologies, products or business models?

As noted above suppliers will still have an incentive to innovate in order to compete for customers. Suppliers will still be able to innovate, and introduce new technologies, although the Scottish Government will have to consider novel technologies to ensure that any new risks introduced by such technologies can be safely mitigated. In legislation, procedures will only be defined in respect of broad essential characteristics allowing for innovation in technique, and in other details of the procedure within these categories. Suppliers of products and training will likewise remain incentivised to innovate in the products they offer, and to respond to that innovation by offering appropriate training.

Consideration of alternative approaches

The Scottish Government has thoroughly considered a range of alternative approaches, including the option of not intervening and maintaining the existing regulatory arrangements. However, it concluded that non-intervention would perpetuate a market that is known to be unsafe in some parts of the currently operating sector, and which is currently unequally regulated; where providers without adequate qualifications or oversight could continue to operate without meeting appropriate standards.

Other alternatives, such as voluntary accreditation schemes or less stringent licensing requirements, were also evaluated, as is discussed in the consultation response. These were found insufficient to address public safety concerns and the need for consistent quality across providers, as compliance could not be guaranteed and enforcement would be limited. Accordingly, the proposed measures offer the most effective and proportionate means of achieving the Scottish Government's aims of safeguarding public safety, ensuring fairness in competition, and raising standards across the sector.

Consumer Duty

The Scottish Government considers that the proposals to be implemented through the Bill and the proposed secondary legislation will have a beneficial net effect on consumers. In particular, the proposals will enhance consumer health and safety. The impact of our policy on consumers of procedures has been central to the development of the policy and has remained at the forefront through the development of legislation. It will continue to be central as proposals are implemented, and insofar as future decisions will be made.

The primary consideration has been the reduction of harm to, and the protection of health of, consumers in Scotland. This policy directly responds to concerns that some people in Scotland have suffered serious harms as a result of procedures, and the risk of even more serious consequences. (Noting that one death in England has been reported in the media last year, and this appeared to follow the provision of a non-surgical procedure) The Scottish Government acknowledges that many have had positive experiences of the procedures being regulated by the Bill or brought into the scope of the proposed licensing regime.

The Scottish Government has also considered the principle that consumers should be reasonably able to access procedures, as long as they can do so safely. Some respondents to the consultations suggested that the numbers of people receiving procedures was too high, and that the procedures themselves were unnecessary, ineffective, or reflect poor priorities on behalf of their recipients. The Scottish Government takes no view on whether or not people should undergo procedures, or if they are effective or desirable. The Scottish Government considers the choice to receive a cosmetic intervention, or to undertake a lifestyle or wellbeing treatment of the sorts considered in the proposals, to be one to be made by individuals without the need for regulatory intervention. The exception is the consideration that children and young people should be prevented from accessing such procedures. This principle was endorsed broadly by respondents to the consultation and is considered further in the Children’s Rights Wellbeing Impact Assessment.

The Scottish Government is comfortable that, insofar as consumer choice may be limited through a reduction in the number of providers for some procedures, or where specific provision is being removed (the restriction of procedures from those aged under 18), this is appropriate and proportionate to the public safety aims being achieved. Specific impacts on groups are also considered in the appropriate impact assessments.

Costs, impacts and benefits conclusion

The Scottish Government recognises the costs outlined above, and that implementing the proposals will have an impact for current providers, especially those which are currently in the unregulated sector. Although these costs and impacts cannot always be clearly calculated, and although they are in some cases dependent on business choices and wider market effects, the Scottish Government does not underestimate these impacts. Businesses whose current practice involves the provision of non-surgical procedures without the involvement of an appropriate healthcare professional may choose to either adapt their business model or to meet the costs of employing an appropriate healthcare professional and registering with HIS. The Scottish Government recognises that neither of these options will be easy for businesses and that some will not be able to make the necessary changes while remaining viable and therefore that the proposals may lead to some businesses ceasing to operate entirely. No decision in this respect can be taken lightly. The proposals that the Scottish Government has made were made in full knowledge of these potential outcomes, and having reviewed this evidence the Scottish Government maintains that the proposals are appropriate.

The Scottish Government anticipates longer term benefits for those businesses whose model currently meets new regulations or can be adapted to do so. The Scottish Government notes that a reason some businesses will be more affected is because those businesses currently benefit from an unequal regulatory environment. Putting businesses onto a level playing field is likely to lead to some businesses closing, but with a more level playing field, the sector may continue to grow and continue to offer job opportunities and wider economic benefit.

The extent of business closure, and the impact on employees cannot be estimated robustly, businesses in the sector have in some cases given estimates of the impact on their own businesses and a number of those that do suggest that their businesses would cease to be viable (noting that businesses so affected are disproportionately likely to respond to a survey or contact the Scottish Government to this effect). This will be a subset of the total number of businesses that are currently in the unregulated part of the sector, but the numbers given for this in this impact assessment (1000-1500) are themselves an estimate, so no estimated number of businesses that may close can be give.

Ultimately the proposals are intended to secure lasting advantages for the public in terms of health and safety. The Scottish Government considers that it is essential that the proposed measures be taken to reduce the incidence of harms detailed in Section 1 of this impact assessment, that the costs are proportionate to that legitimate aim, and that they are the least possible consistent with achieving that aim.