Seòmar agus comataidhean

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.

:I thank Ms Mackay for lodging amendments 26 and 27. I am aware that concerns have been expressed about the level of penalties in the bill as introduced, and I thank the committee for its comments in the stage 1 report. It is vital that the bill has teeth and sets penalties that act as a meaningful deterrent to any practitioners who choose not to engage with the new regulatory scheme.

Having listened to the committee, I appreciate that the level of penalties set in the bill will not be a sufficient deterrent to businesses that could be earning up to £5,000 per day. Amendments 26 and 27 seek to allow the offences in the bill to be triable either under summary procedure or on indictment. In such circumstances, the penalty that could be imposed by the court would be a maximum fine of £20,000 on summary conviction or an unlimited fine on conviction on indictment.

As with any offence that is triable, either under summary procedure or on indictment, it will be for prosecutors to decide on the appropriate procedure based on the evidence provided to them. That represents a significant increase in the level of penalty that may be imposed, particularly in cases where more than one offence is committed—for example, providing a non-surgical procedure to a person under the age of 18 and outwith the permitted premises, or where repeat offences occur. In addition, no matter whether an offence had been committed under the bill, a person could still commit other offences if they caused harm, depending on the facts and circumstances of the case, and they would carry their own penalty. I therefore urge members to support amendments 26 and 27.

I recognise that Mr Golden’s amendments 56 and 57 and Mr MacGregor’s amendment 102 seek proportionality, transparency, good governance and accountability, but they also duplicate existing requirements on HIS and are therefore not required in the bill. With regard to amendment 56, I note that HIS inspections are based on publicly available standards, and it publishes its inspection reports for transparency purposes. It also has a complaints procedure, should providers not feel that those inspection reports are either fair or accurate.

In respect of amendment 57, HIS is required to comply with data protection legislation in relation to client information that it might obtain as part of its inspection processes. HIS also takes an improvement approach to support those whom it inspects to improve their services before it takes other action.

Like amendment 56, Mr MacGregor’s amendment 102 seeks proportionate enforcement. The Scottish Government is not aware of HIS having used its enforcement powers in a disproportionate way, but if Mr MacGregor or anyone else is aware of concerns in that respect, I ask them to raise those concerns directly with me. If those concern relate to proportionate penalties, I point out that there is discretion that the courts or prosecutors can use.

Dr Gulhane’s amendment 104 seeks to provide for a useful and insightful review. However, although I support the intention behind it, I consider that the asks that it makes could perhaps form part of a wider review provision of the kind that we will come on to when we discuss the group entitled “Review of Part 1”.

I ask Mr Golden, Mr MacGregor and Dr Gulhane not to move their amendments.

:I am grateful to members for the points that they have raised and I urge them to support amendments 9, 22 to 25 and 31. I ask Maurice Golden and Stuart McMillan not to move the remaining amendments in the group.

The amendments in my name are necessary to ensure that the “permitted premises” definition is as clear as possible for providers of non-surgical procedures and for HIS as the enforcing body. The other amendments in the group would undermine the core safety protections that the bill offers.

I will touch briefly on Dr Gulhane’s points about prescriptions. We are having conversations about those issues with the UK Government and the Medicines and Healthcare products Regulatory Agency. As you know, the matter is reserved. I acknowledge Dr Gulhane’s points and I am happy to discuss them further. HIS looks at such circumstances in its reviews and would refer any issues that it spotted to the MHRA.

I will repeat what I have said elsewhere, which is that I do not want to disrupt business unnecessarily, but nor am I willing to compromise on safety in order to reduce disruption. I am happy to continue to work with members on other approaches to mitigate the impact on businesses, including existing business support and any guidance that we can provide.

I want HIS to work with the Scottish Government to ensure that all its standards and requirements are appropriate to the services that it regulates and to consider any statutory standards in the same context. There is scope to make changes to regulations to better accommodate settings that do a mixture of procedures and other beauty treatments. I am happy to share more detail on that by correspondence.

In the lead-up to and during stage 3, I would be happy to hear any other suggestions from members on steps that might mitigate the impact on businesses.

Amendment 9 agreed to.

:This group of amendments relates largely to section 5, on the powers available to ministers to make further provision on non-surgical procedures.

I explained in my comments on previous groups why some matters needed to be dealt with under delegated powers. Our use of delegated powers was, of course, considered by the Delegated Powers and Law Reform Committee, and I was grateful to Stuart McMillan, who joins us today, for chairing that consideration. That committee recognised that certain matters were appropriate for regulations, but it also said that some additional safeguards were required in the exercise of that power.

As such, I turn to amendment 35, in my name, which requires Scottish ministers to consult in relation to all the affirmative regulation-making powers in the bill. I hope that all members will support that and agree that it is a proportionate approach to the issue identified by the DPLR Committee.

Amendments 54, 93 and 94 also seek to make consultation requirements, all of which are specific to the power in section 5. Amendments 93 and 94, lodged by Gillian Mackay and Sandesh Gulhane respectively, would require patient groups or those representing clients, clinical experts, regulators and enforcement bodies to be consulted. Dr Gulhane would add

“representatives of the beauty and aesthetics industry”

to the list and make other provision, which I will turn to shortly. Finally, amendment 54, in Maurice Golden’s name, also sets out consultation requirements, in this case with HIS, local authorities, and representatives of the industry and training institutions.

In respect of all those consultation requirements, I ask members to consider that the power in section 5 is capable of making very different sorts of provision. In fact, it is capable of making substantial provision, in which case consultation would be not only expected—and rightly so—but required to fulfil the range of duties on Scottish ministers in relation to impact assessment.

Amendment 35 strengthens that requirement. In such circumstances, some or all of the groups indicated might well be included in the list of consultees, but the power might also make quite small or technical changes, in which case targeted consultation would be more appropriate. Indeed, even more substantial matters might be of interest only to a subset of the groups that members have named. Again, it would be a better use of time if the Scottish Government were able to consult bodies that have an interest in the matter at hand. For that reason, I urge members not to press or move their amendments and to support the amendment in my name instead.

I note Maurice Golden’s amendment 53, which echoes some of the committee’s concerns and is unlikely to make the exercise of the regulation-making power in section 5(1) cumbersome. I do not consider the amendment to be necessary, as any Government proposing regulations would consider their enforceability, and I also expect the committee that scrutinises regulations to seek assurance in that respect. However, I am happy to discuss the issue further with Maurice Golden before stage 3.

On the other hand, I urge Mr Golden not to move amendment 55, which makes similar provision but also contains material that overlaps with a range of existing duties, including under the Equality Act 2010, and which is likely to make the regulation-making power more cumbersome and less capable of being used in a reactive way.

The next amendments that I will consider seek to impose certain requirements on ministers in exercising those delegated powers or restrain the way in which they may be used. In that category, I include amendments 48, 49, 52 and 90. Those amendments include different approaches to requiring transitional protections and ensuring that there are pathways for non-healthcare professional providers. The effect of amendment 52 also means that no provision can be made about training or qualification requirements for persons providing non-surgical procedures that does not also provide alternative routes to demonstrate competence, and provisions around continuing professional development, record keeping, audit, incident reporting and complications management. Those are not necessarily unreasonable matters to be considered, but putting those requirements against the whole exercise of the power would be cumbersome and often disproportionate to enact. They would remove the discretion to deal with issues in the most appropriate way, whether in regulations under this power, using other regulations, or in guidance.

11:30

Amendment 45 is relatively technical, as it seeks to amend section 5(2)(a) of the bill to prevent regulations made under section 5(1) from modifying sections 2, 3, 4 and schedule 1 of the bill once it becomes an act. The provisions in section 5(2)(a) are not unusual and are required to provide flexibility in how new provisions are written into legislation and be made as readable as possible. For instance, amendments making specific requirements in relation to the settings for the provision of a particular procedure may do so in stand-alone regulations, which would then need to be read alongside the bill provisions, or it may make sense to make modifications to section 4 of the bill to allow such matters to be included all in one place. For those reasons, the existing power in section 5(2)(a) is considered necessary.

Amendment 50, in Jeremy Balfour’s name, relates to creating a new regulatory scheme to facilitate certain categories of non-healthcare professionals to supervise procedures. That would be contrary to the strongly expressed views of consultees last year, who wish for supervision to be restricted to certain healthcare professionals. It would also conflict with the reasoning that I outlined in relation to group 3 around assurance of patient safety and dealing with complications. As such, I urge the member not to move amendment 50.

I return to amendment 94, in Sandesh Gulhane’s name. Like his amendment 97 in the previous group, amendment 94 would require certain material to be published before regulations can be made. In this case, the requirement is to publish training standards. I assure members that training standards are a priority, and it is a matter of great frustration to me personally that more progress has not been made on that issue. I am, however, hopeful that members will shortly approve my amendments on an individual assessment process that is a prerequisite to us resolving those issues.

As I have said elsewhere, it is still going to be necessary for the Scottish Government to work with the UK Government on those matters. It is also likely to benefit practitioners if, where possible, requirements in Scotland and England are aligned. That means that the timing of any standard of training is not entirely in the Scottish Government’s gift. On that basis, the requirement that Dr Gulhane has suggested in amendment 94 could prevent other matters being dealt with in a timely manner. On that basis, I urge Dr Gulhane again not to move the amendment.