Seòmar agus comataidhean

:Yes.

:The member raises a reasonable point. I suggest that such secondary legislation will not happen in this session of Parliament and that it would be for the minister who is in this position after the election to make those decisions and recommendations.

:I understand and support the intention behind the amendments in this group, which relate to the setting of standards and the establishment of clear guidance in the provision of a complaints process. They take a number of approaches to setting standards and have varying degrees of specificity.

I will start by confirming my approach to the amendments in this group that relate to guidance. I ask members not to press or move those amendments, for reasons that I will discuss shortly, but I am happy to engage in discussions in advance of stage 3 on a single amendment that could cover the topics that members consider important.

I note, for instance, Dr Gulhane’s amendments 106 and 118 and his concerns about body dysmorphia and other mental health conditions, and his amendment 79, which concerns guidance on complaints processes. I would expect responsible practitioners in regulated settings to already be aware of such matters, and I certainly confirm that Healthcare Improvement Scotland already requires providers of independent healthcare services to have a complaints procedure in place to provide an avenue for individuals to make an independent complaint.

Alongside that, healthcare professionals are already subject to their professional regulator’s complaints processes. The bill as introduced will deliver that intent, and it might not be necessary to reintroduce any further provision of that nature. However, I am open to the idea that difficult issues around mental health concerns, which Dr Gulhane mentioned, and how they affect those seeking procedures are matters on which even experienced practitioners and professionals may benefit from further guidance.

10:15

Fulton MacGregor’s amendment 75 is similar to Maurice Golden’s amendment 100. Amendment 100 would set out a general requirement for HIS to publish standards and guidance. Amendment 75 would require proportionate standards and guidance, and that

“Relevant permitted premises must meet only the standards set by HIS”

under the provision of the amendment. The amendments would effectively prevent some of the sensible guidance that HIS already has in place from applying and would require it to be duplicated in a new form. That is an overly complicated way of going about things. I do not see why, for instance, a complaint procedure that is suited to an independent travel clinic would not be suited to a cosmetic one.

I am pleased to support the principle of the need for guidance, but I propose to work with members ahead of stage 3 to introduce a single amendment that addresses all concerns. I urge other members to support that approach, too.

As this is the first group of amendments to be considered, I will make some quick general comments. I thank committee members for their consideration to date. This is a complex bill and I am grateful for your diligence in considering the issues. Today, I will be moving or supporting amendments that strengthen or clarify the bill without changing its fundamental character or the balance that it must strike to protect public safety without disrupting healthcare or causing unnecessary disruption to business.

I am grateful to those members who have lodged amendments. We are all committed to improving public safety. Some amendments seek to address concerns about the impact of the bill on businesses—especially rural, small and female-led ones. I want to be clear that, when I oppose such amendments, I understand the place that they are coming from. I will address my reasons in the relevant groups.

Amendments 5, 28, 30 and 34 provide a way to allow Scottish ministers to establish training and qualification standards for practitioners, working within the constraints of the United Kingdom Internal Market Act 2020. I shared our understanding of the effect of UKIMA with the committee through the correspondence that I directed to UK ministers. I have not yet received a response.

Part 3 of UKIMA establishes an automatic recognition principle whereby a professional who is qualified in one part of the UK is automatically treated as being qualified in another part of the UK. The effects of part 3 of UKIMA mean that the Scottish Government is currently unable to set standards for qualifications or experience for individuals providing non-surgical procedures in the bill in the way that we would like.

Section 26 of UKIMA provides a partial remedy to that. The individual assessment process under that provision would allow someone to have their existing training or qualifications assessed when they were different from those specified, to ensure that they were equivalent to those required in, or met the standards that we establish for, Scotland. We still need to work with the UK Government on a long-term solution, as that is a cumbersome one. Nevertheless, I want to take the available option, which would allow us to progress with setting standards by following that route.

We are pressing the UK Government to resolve the issues with UKIMA by repealing the act and replacing it with a more equitable, co-designed system built around the common frameworks approach.

I know that many members are pushing for training and supervision standards. To them, I say that this is a necessary first step. I urge members to support amendments 5, 28, 30 and 34.

I move amendment 5.

:I fully support the amendments. The bill currently includes a list of acceptable forms of identification that allow providers to confirm that a person is at least 18 years of age and can receive a procedure. That approach has been taken in previous legislation.

As noted, in November 2025, the First Minister announced that an app will be launched in 2026. As that will at some point include digital proof of age, the bill should allow regulations to be made that can provide for that and other forms of ID. It is clear that such forms of ID might not be covered by the documents currently listed. The power to amend a list of documents does not therefore appear to be sufficiently future proofed. It is therefore prudent to remove the list of ID documents from the bill and give ministers the power to provide the list of acceptable forms of ID in secondary legislation in advance of offence provisions coming into force. I urge the committee to support the amendments.

:Only that I urge members to support amendments 29, 32 and 33.

Amendment 29 agreed to.

Schedule 2, as amended, agreed to.

Before section 15

Amendment 58 not moved.

Section 15—Interpretation of Part 1

Amendments 30 and 31 moved—[Jenni Minto]—and agreed to.

Section 15, as amended, agreed to.

After section 15

:I am pleased to speak to this group, which includes amendments on several issues relating to the fundamental definition of a non-surgical procedure. I will start by considering the amendments that relate to the healthcare exception provided by section 1 of the bill.

We have been clear throughout the process that the bill is not designed to regulate, restrict or interfere with the delivery of healthcare in any setting. The bill achieves that by providing that any procedure that is undertaken for, or under the direction of, a healthcare professional is not a non-surgical procedure. There should, for example, be no offence committed if a treatment for a healthcare purpose by a regulated healthcare professional is given to a child. As well as not interfering with healthcare delivery, we also want to ensure that we do not inadvertently capture under the bill’s provisions procedures carried out as part of clinical trials, which are already regulated elsewhere.

My amendment 6 will make it clear that procedures that are carried out as part of a clinical trial within the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 will not be covered by the provisions of the bill. That is required because certain procedures undertaken as part of such trials may not be covered by the existing healthcare exception in section 1(1)(b) of the bill. In a clinical trial, a person who has no illness may receive a procedure if, for example, possible side effects are being investigated.

Amendments 7 and 8 are technical amendments that correct and clarify references to the licensing of non-surgical procedures under the Civic Government (Scotland) Act 1982. I hope that they are uncontroversial amendments.

Sandesh Gulhane’s amendments 64 and 65 also relate to the healthcare exception. The amendments would remove the General Osteopathic Council and the General Chiropractic Council from the list of healthcare professionals who can undertake or direct procedures that would be considered exempt from the bill. Dr Gulhane has raised the issue in previous evidence sessions, and I am happy to reiterate some of my comments for the record today. This bill is not the place to judge what does and does not constitute healthcare, nor whether particular healthcare procedures are appropriate or effective in the treatment of disease. I can, however, inform the committee that both chiropractors and osteopaths use injections of hyaluronic acid as part of their practice. I understand that the committee has received correspondence on the matter. Whether that practice is effective or appropriate is between those professionals and their regulators.

I know that some committee members are concerned that the healthcare exception is essentially a loophole, so I wish to offer some reassurance on that point. In order to fall under the healthcare exception, a regulated healthcare professional carrying out a procedure regulated by the bill must have a healthcare purpose, and if a prosecution was brought against an individual, the presence of such a healthcare purpose may be considered by the courts. Such bad-faith activity is likely to lead to professional consequences as well. The Scottish Government considers that amendments 64 and 65 may raise concerns about their interaction with the reservation of the regulation of health professions in the Scotland Act 1998.

For those reasons I urge Dr Gulhane not to move those amendments, although I am happy to hear any views that he may have on the matter.

I will now turn to the amendments that relate to the power in section 1(5) to modify schedule 1. I remind members that amendment 35, in my name, which is to be debated under group 7, imposes a consultation requirement on all exercises of affirmative powers under the bill, including the power to modify schedule 1. I trust that that amendment will be supported, as it addresses the recommendations made by the Delegated Powers and Law Reform Committee at stage 1.

In the scenario where an entirely new procedure emerges, it is best that ministers can move fast and regulate such procedures quickly. If the advice that we receive is that such a procedure has a risk profile that is equivalent to procedures already included in the bill, it is reasonable, I think, that ministers should have the scope to list such a procedure in schedule 1, on the best evidence available at the time. That consideration would naturally form part of a policy note and any impact assessments.

Amendments 36 and 37 would add to that and would make the exercise of the regulation-making power harder, preventing the Scottish ministers from acting quickly when required. In turn, that would have public safety implications and a negative impact for potential clients and practitioners alike. For those reasons, I ask Jeremy Balfour and Maurice Golden not to move the amendments in their names.

I now turn to amendments to schedule 1. Amendments 10 to 21, which are in my name, make several important changes, largely of a technical nature or where the effect of the schedule will be unchanged from its original intent. Amendments 10 and 16 remove the paragraph headed “Cellulite subcision” and insert a new one headed “Subcision”. The text and the effect are unchanged, but the amendment reflects the point that subcision can be used for other purposes, such as improving the appearance of pitted scars.

Amendments 11, 12 and 21 amend the schedule 1 entries for injectable or intravenous non-surgical procedures in order to limit them to those provided for a cosmetic or wellbeing purpose. A cosmetic purpose relates to a person’s appearance; a wellbeing purpose is one that provides an actual or perceived improvement in the person’s physical, mental or emotional wellbeing, their physical strength or stamina, their ability to concentrate or their mental alertness. The change provides additional clarity but continues to deliver the bill’s intent of regulating procedures undertaken for those reasons. It prevents any procedures or activities carried out for other purposes from being inadvertently captured.

Amendments 18 and 19, in my name, amend the definition of “substance” to make it clear that controlled drugs and psychoactive substances are not included. Those are not used in non-surgical procedures, so it is appropriate to exclude them from the definition of “substance”.

Amendments 13 and 17, also in my name, address the boundaries between schedule 1 to the bill and schedule 1 to the Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order 2026. That Scottish statutory instrument introduces a local authority licensing scheme that regulates lower-risk non-surgical procedures. A procedure, even if it would otherwise be low risk, becomes higher risk when a prescribed anaesthetic is used or when it is carried out on an intimate area. With the exception of intimate laser hair removal, such procedures are excluded from the SSI. Amendments 13 and 17 provide that those procedures are regulated by the bill instead. Those procedures carry additional risks, which are better managed in a permitted premises, where there will be healthcare professional involvement.

09:15

Amendments 14 and 15 clarify the definition of “microneedling” to ensure that a procedure that involves an injection or intravenous administration of a substance is captured by the relevant paragraphs, not paragraph 7. Amendment 14 provides that microneedling will include the use of

“one or more microneedles … multiple times on a single occasion”.

That definition will help to avoid confusion with other procedures, which might also use a fine needle.

Amendment 14 also provides that when microneedling, no matter the depth, is used to deliver radiofrequency electromagnetic radiation, that procedure is regulated by the bill. That is considered a riskier procedure because it carries increased risk of harm, including burns, excessive scarring and damage to nerves and blood vessels.

Procedures that are covered by the local authority licensing scheme under the Civic Government (Scotland) Act 1982 (Licensing of Skin Piercing and Tattooing) Order 2006, which extends to acupuncture, cosmetic body piercing, electrolysis and tattooing that are provided in the course of a business, are already exempted from the bill by virtue of section 1(1)(b)(iii). However, amendment 15 ensures that those procedures are also exempted when they are carried out in circumstances that do not require a licence under the 2006 order—for example, when not carried out as part of a business in someone’s home. It was never the intention of the bill to regulate those procedures, which did not form any part of the consultation process.

Amendments 38 and 39, in the name of Maurice Golden, relate to procedures such as skin boosters and mesotherapy. Mr Golden has made the case—which I, too, have heard—that those procedures carry less risk than other procedures considered in schedule 1. I should be clear that that is not universally accepted, and I am sure that Mr Golden would accept that that does not mean that those procedures are risk free. Any introduction of a substance into the body carries some risk. The substances that are used in those procedures are wide ranging, which makes that risk hard to assess.

I have also heard concerns that those procedures, especially skin boosters, use similar products and similar, if not the same, needles and other equipment as procedures such as dermal fillers. If amendment 38 is successful, there is a risk that it will make the work of local authority officers much harder in ensuring that licensed premises are carrying out only the procedures that they are entitled to carry out.

My guiding principle has been that procedures should be included in the bill only when that is absolutely necessary to protect public safety. I would be happy to discuss those changes further, ahead of stage 3, with Mr Golden and other members.

I urge members to support amendments 6 to 8 and 10 to 21. I repeat my willingness to work with Mr Golden, and on that basis I ask him not to move his amendments until we have discussed them ahead of stage 3. I also ask Jeremy Balfour and Sandesh Gulhane not to move their amendments in this group.

I move amendment 6.

:This group of amendments reflects a range of different concerns. I am aware that not all members intend to press or move the amendments in the group, and I am grateful for the constructive comments that we have heard so far.

In the interest of safety, and on the grounds of certainty and continuity for business, I strongly resist amendment 111, because it makes provision about the expiry of part 1. However, it is reasonable that the Scottish Government be held to account on the effectiveness of that part of the bill, which will no doubt continue to be of interest in the next parliamentary session.

I turn to the remaining amendments. If amendments 59, 107, 108 and 109 were all pressed and agreed to, that would add significant pressure on Government and parliamentary time. If none of those amendments was pressed, the successor to this committee could open a programme of work reviewing any, or all, matters in relation to the bill. That could be done at a time of the committee’s choosing, and the committee could take evidence from the Scottish Government and any other bodies that it saw fit to speak to. However, given the strength of interest in a statutory review led by the Scottish Government, it seems appropriate that a review should be undertaken that is sufficiently broad in scope, and at a time that allows a full consideration of the operation of part 1 of the bill.

Amendment 109 in Carol Mochan’s name raises an important issue—and I appreciate her meeting me regarding it—but it appears too narrow, given the other interests that are appropriate here. Amendments 59 and 108 are both broader but I consider that, in each case, the specification that is currently offered is likely to make a report more cumbersome and less able to address the issues that emerge. I believe that the amendments also require a report at a stage that is too early for the impacts—positive or otherwise—of the bill to have fully emerged.

On the other hand, Stuart McMillan’s amendment 107 is sufficiently broad to allow all the issues that members raised to be considered and operates on a reasonable timescale, so that consideration could be as full as I am sure that members would expect. On that basis, I recommend that members support amendment 107.

I would be happy to discuss with members any other issues that they strongly feel need to be considered as part of the review, and I am happy to work together with Mr McMillan and other members on stage 3 amendments to the new section that Mr McMillan’s amendment would introduce.

:I will check that, but that is exactly the conversation that I think we need to have. You previously said one year, Stuart McMillan said five, so do we go down the middle and say three? I am happy to negotiate. However, if the review took place five years after the bill was enacted, that would be in the following parliamentary session.

:This is a complex and important group of amendments, so I will need a bit of time to address them all.

After consultation, we announced our intention to create three groups of procedures. Group 1 covers procedures that are undertaken under a local authority licence, and their regulation will be achieved when the SSI that was made on 12 February this year takes effect. Group 2 covers procedures that could be undertaken by non-healthcare professionals working in a clinical setting with supervision by a healthcare professional. Group 3 covers procedures that could be undertaken only by a healthcare professional. The bill covers procedures in groups 2 and 3, but it does not differentiate between them. It also does not specify who may undertake the procedures or what form supervision may take.

The bill provides key safety protections related to age and to ensuring that procedures are undertaken only in a regulated setting where we expect the right healthcare professionals to be available. Once issues relating to the United Kingdom Internal Market Act 2020 are worked through, we will put in place further regulations that will cover training requirements for practitioners and how supervision should operate and will restrict the riskiest procedures, so that they can be undertaken only by a healthcare professional.

I turn to the amendments. Dr Gulhane’s amendments 81 and 103 would put in place specific provisions for Botox. In many ways, the approach resembles the approach that we intend to take for group 3, with such procedures being able to be undertaken only by a healthcare professional. This matches the approach in a range of European countries and there was strong support for such provision in the consultation responses. However, I am also mindful that strong representations have been made in relation to non-healthcare practitioners being able to carry out the procedure safely. Given that Botox is a prescription-only medicine, it is necessary for a healthcare professional to make the initial prescription and to support consideration of whether Botox is right for the client, as well as to be available to manage complications. Complications can arise whoever the practitioner might be.

Dr Gulhane’s amendments 81 and 103 would restrict the practice of non-healthcare professionals in an unnecessary way. In addition, by creating an offence in relation to the provision of Botox, a prescription-only medicine, the amendments would make provision on a subject matter that falls under the Medicines Act 1968. That is a reserved matter under schedule 5 to the Scotland Act 1998. Therefore, amendments 81 and 103 appear to be outwith our legislative competence, so I urge Dr Gulhane not to move them.

However, the points that Dr Gulhane has raised are important, and we will highlight them in our on-going discussions with the UK Government.

Amendments 58, 84, 87, 92, 95 and 97 cover supervision, which is an issue that the Scottish Government intends to resolve through future regulations. The principles of supervision might change over time, and they will be closely impacted by, for example, the training standards that are set.

The broad principles that are set out in subsection (1) of Mr Golden’s amendment 58 are likely to be features of future regulations. The amendment might also overlap with or duplicate existing requirements under professional guidance or elsewhere. I appreciate that Mr Golden’s amendments are largely focused on making practice easier for non-healthcare practitioners, but I note that he is proposing a model of remote supervision, which I do not think would be appropriate. That would weaken safety protections and would not provide the flexibility that practitioners are looking for. The cost of a professional observing a procedure using technology would need to be factored in. In-person partnership is a more effective approach to safety and allows professionals to work in parallel in a setting. I am very concerned that amendment 58 would undermine the fundamental safety intentions of the bill, which I covered in the debate on group 3. Therefore, I cannot support it and urge Mr Golden not to move it. If he does, I ask members not to support it.

Dr Gulhane’s amendment 97 asks ministers to ensure that a definition of “supervision” is in place before regulations are made under section 5. I am happy to confirm that specifying the basis on which procedures can be undertaken, as part of the section 5 regulations to ensure that procedures are carried out safely, is a priority, alongside providing training standards and restricting the highest-risk procedures to healthcare professionals. I cannot say which matters will be resolved soonest—that is a matter for ministers after the election. If regulations on other matters were ready first, I certainly would not want them to be delayed. Therefore, I cannot support amendment 97.

Dr Gulhane’s amendments 87, 92 and 95 relate to supervision because they replace ministers’ ability to make regulations to specify who may provide, or supervise the provision of, a non-surgical procedure, with a list of individuals who may perform procedures unsupervised. That list includes an advanced medical practitioner—a health and care practitioner with a qualification encompassing clinical practice, leadership and management, and education and research. It appears that amendment 92 may be outwith legislative competence, as a result of the medicines reservation in the Scotland Act 1998.

Mr McMillan’s amendment 84 also addresses supervision, suggesting minimum staffing ratios. There are concerns that this amendment may also be outwith legislative competence because the regulation of the health professions is reserved under schedule 5 to the 1998 act and because of the effect of the amendment in relation to the medicines reservation in the 1998 act.

We do not yet have a definition of supervision, at least in part because we are still working through the implications of the United Kingdom Internal Market Act 2020, which does not allow us to set training and supervision standards for Scotland which would operate in the manner in which the Scottish ministers would like them to. Now is not the time to specify who can or cannot perform procedures without supervision. This is a matter for future regulation, as soon as it is practicable, so I cannot support amendments 84, 87, 92 and 95.

Amendments 77 and 78, in the name of Dr Gulhane, seek to impose direct requirements on providers in relation to insurance and indemnity, as well as aftercare information. These are entirely reasonable requirements, but I can reassure Dr Gulhane that insurance and indemnity requirements already form part of HIS’s regulation of the settings that are registered with it. The appropriate place for these matters is in HIS guidance, or in the requirements placed on HIS-registered settings through regulations under the National Health Service (Scotland) Act 1978. Similarly, aftercare information should be a basic part of practice in this sector and, again, guidance would be an appropriate place to address it. Therefore, I cannot support amendments 77 and 78.

Amendments 80 and 115, in the name of Fulton MacGregor, seek to impose direct requirements on providers in relation to training requirements. The bill already makes provision for the Scottish ministers to make regulations setting out training or qualification standards and, once the issues surrounding the internal market act are resolved, it is the intention to set training and qualification standards for providers of non-surgical procedures. Fulton MacGregor’s amendment 96, in the next group, which I will be urging the committee to support, also addresses this issue. I hope that that addresses the member’s concern and I note his comments regarding his amendments.

Section 5 of the bill will confer on ministers a power to regulate to make further provision about non-surgical procedures. Altogether, 23 amendments have been lodged that change or add to section 5 and a further five amendments would make additions immediately after section 5. Not all of those amendments are to be debated in this group, but I hope that members will appreciate that it would not be possible to accept such a high number of overlapping and sometimes conflicting amendments.

In this group, amendments 83, 46, 47, 91, 84, 87, 92 and 95 all in some way restrict or direct the use of section 5 powers by ministers, seeking that the Scottish ministers must consider or make provision for a whole range of issues, such as provision about consultation and consent, record keeping, the traceability of injectables and aftercare.

Maurice Golden’s amendment 91 would prevent any restriction to providing non-surgical procedures being made based on the professional status of an individual. That would prevent ministers from restricting who can provide even the highest-risk body augmentation procedures. I cannot support the amendment. There are times when it will be right to restrict the carrying out of certain procedures based on the professional status of the provider. I suspect that the member would agree that such a blanket limitation was not his intention.

Maurice Golden’s amendment 46 requires that any regulations made under section 5 must make provision for the classification of non-surgical procedures into categories of risk and potential harm, having regard to available evidence on harms and complications. It would be a significant undertaking to categorise procedures in more detail than we have done, each time that regulations under section 5 are made. It would also limit the Scottish Government’s ability to react quickly to novel procedures or to changes in how existing procedures are delivered. In my amendment 35, the requirement to consult on regulations, which will be subject to the affirmative procedure, will take account of the risks and potential harms of procedures in relation to any changes that the regulations make. Therefore, I cannot support amendment 46.

11:00

Maurice Golden’s amendment 47 provides that regulations must make certain requirements of providers, and although the matters discussed are appropriate, I again want to maintain flexibility for such matters to be addressed in guidance or regulations as appropriate, and to avoid anything that would duplicate existing requirements elsewhere. Therefore, I cannot support amendment 47.

I will now consider amendments 83, 88 and 89, in the name of Gillian Mackay, which seek to address the heightened risk of non-surgical procedures to clients with pre-existing conditions such as prior surgeries or altered anatomy. Amendment 83 sets out that the Scottish ministers “must have regard to” the need to protect individuals at greater risk of harm when making regulations under section 5, whereas amendments 88 and 89 provide that ministers “may” exercise their powers to make provision for different or additional requirements and ensure that providers carry out documented pre-procedure assessments and informed consent procedures.

The requirement for the procedures that the bill covers to take place in settings where a healthcare professional is available takes account of scenarios such as those set out by Gillian Mackay in amendment 83, in which clinical input is required to determine whether a procedure is suitable for a client. If any further provision is required in this respect, it may be provided in guidance. However, I do not think that any duty is required for the Scottish ministers to ensure that these matters are considered; instead, such a duty would encumber the exercise of the power.

Amendments 88 and 89 are also not strictly necessary, but I would understand if the member wished to move and press them as a further signal of the types of matter that we may need to consider in future. In the spirit of compromise, I would be happy to support these amendments. That is because, unlike amendment 83, amendments 88 and 89 would not encumber the wider use of the power. I ask the member not to move amendment 83.

I will turn to the final amendments in this group: amendment 98 by Gillian Mackay and related amendments 99 and 120 by Dr Gulhane. The amendments offer two very similar approaches to ensuring additional protections to high-risk clients and require guidance to be produced. I have already discussed guidance. I do not think that it is helpful for the bill to contain multiple guidance provisions, so I refer members to my comments during the debate on group 5 and ask them to work with me, and each other, on a stage 3 approach to the issue.

This has been a substantial group, and it demonstrates the level of care that members have put into considering safety and risk issues. There is time before stage 3, if members are willing to work with me, to agree approaches to concerns that can be endorsed on a consensual basis, whether or not that requires anything to be included in the bill.

For the time being, I repeat my support for amendments 88 and 89 and urge other members not to move their amendments. If they do, I would ask that members do not support them.