Seòmar agus comataidhean

: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.

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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.

No. I am content.

I am pleased to join you this morning to consider the draft Food Supplements (Magnesium L-threonate monohydrate) (Scotland) Regulations 2026.

As the committee will be aware, food safety, standards and labelling are areas on which I am advised by Food Standards Scotland. Magnesium L-threonate monohydrate, as a novel form of magnesium, may be used to make food supplements only following approval under the novel food regime along with the approval of an SSI under the food supplements regime. Magnesium L-threonate monohydrate has been approved as a novel form of magnesium for use in food supplements in Scotland and, in the wider context, across Great Britain, having received a positive safety assessment by the food safety authorities.

The ministerial determination that approves the substance as a novel food was made on 7 January and will come into force at the same time as the draft regulations that the committee is considering today. The draft regulations will allow the substance to be used to make food supplements for sale to consumers in Scotland as intended, by amending the list of permitted mineral substances that is set out in schedule 2 to the Nutrition (Amendment etc) (EU Exit) Regulations 2019. The draft regulations will also set the purity criteria for the mineral substance, as required by the Food Supplements (Scotland) Regulations 2003 and in accordance with the novel food safety assessment specification.

I stress that the amendments are technical in nature and do not amount to a change in policy. They are necessary to ensure that this form of magnesium can be used in the manufacture of food supplements as intended. This is a business facilitative measure, and there is no negative impact on businesses or any other stakeholder group. In alignment with Scotland, comparable regulations have been laid in Wales and are expected to be laid in England in summer 2026.

I ask the committee to support the draft regulations. I am happy to take any questions.

I thank the committee for giving me the opportunity to speak on the Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order. The order is part of a suite of legislation to regulate non-surgical procedures—a sector that is currently unregulated. Such procedures can cause serious and lasting damage if they are not performed correctly, and this is one of two substantive steps that we are taking to reduce the potential harm to customers in Scotland across a range of procedures. The order sits alongside the Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Bill, which is currently at stage 1.

The order establishes a local authority licensing scheme for lower-risk non-surgical procedures that pierce or penetrate the skin. Such procedures do not require the input of a healthcare professional, as any risks can be appropriately mitigated through the imposition of hygiene standards and by requiring the use of appropriate materials. Procedures covered by the order include laser and light treatments that do not damage the skin’s surface; shallow microneedling; fruit and glycolic acid peels; and advanced electrolysis.

In contrast, the bill regulates a range of more invasive procedures where we believe healthcare professional input is required to ensure safe treatment. Taken together, the two pieces of legislation will allow us to provide a differentiated and proportionate approach to the range of procedures available.

The order sets out a number of mandatory licensing conditions relating to the hygiene of premises, equipment and processes, and it also requires that non-surgical procedures not be carried out on individuals under the age of 18. Those conditions are key to protecting the public, especially young people, and they will give customers confidence in the services that they are receiving.

As with the bill, the definition of a non-surgical procedure in the order does not include procedures that are undertaken by a person acting on behalf of the health service or by a healthcare provider for the prevention, diagnosis or treatment of illness or injury. Where the removal of skin lesions, for example, is carried out by a person acting for, or on behalf of, the health service or by a healthcare provider as part of the prevention or treatment of an illness, that will be exempt from the definition of a non-surgical procedure.

Again, as with the bill, the order does not include any provision for training or qualifications. That is due to the effects of the United Kingdom Internal Market Act 2020, which we have discussed previously. We continue to work with the UK Government on that issue, and we will legislate for training and qualifications when circumstances permit us to do so.

I welcome any further questions that the committee might have, and I encourage members to support the progress of this order.

We have taken a lot of advice and done a lot of work on this to ensure that we feel that the right procedures are being given the right and proportionate regulation. We expect local authorities to work closely with Healthcare Improvement Scotland to ensure that, if any questions arise on the procedures covered by the order that are being carried out in local authority-licensed premises, they get them right. As I said in my opening remarks, this is part of a suite of legislation to ensure that non-surgical procedures are given the right regulation.

Those are important questions. I know that the committee received thorough evidence in that regard from healthcare professionals and those who provide non-surgical procedures. We will clearly set things out in the guidelines, but it is fair to say that—this ties in with our promotion of the “Be the Early Bird” campaign on detecting cancer early—if someone has regular treatments, the beautician or whoever provides those treatments could advise that the person sees a healthcare professional if they notice any changes, as one would expect. Our guidelines will support that, because I recognise the importance of the issue and the questions that I was asked by the committee when we were talking about the Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Bill.

Before I bring in Owen Griffiths, I note that all the work that we have done to get to this stage has been clear. The consultation responses were clear on whether a procedure should be covered by the order or by the bill, and some changes have been made as a result of those responses. In schedule 1, we have laid out descriptions of each of the procedures that the order will cover.

In an earlier answer, I referred to work that was done by the skin piercing and tattooing working group. I am not ruling that in or out, but it is a suitable way of ensuring that those in local authorities have the appropriate training and understanding.