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:I would be very happy to discuss that with Dr Gulhane in the lead-up to stage 3.

I am content to consider discussions with Mr Balfour on his amendment 37, because I absolutely understand where it is coming from with regard to the underlying issues.

I welcome the indication that Mr Golden will not be pressing his amendments in the group. However, if he decides to press them, I ask members not to support them, and I will continue discussions with him into stage 3.

09:30

I remind members that I already intend that a consultation requirement will be added to all the affirmative powers in the bill, so I hope that you all agree that it is unnecessary to put in place a further requirement, especially one that will prevent that power from being used effectively.

I urge members to support the amendments in my name, which are critical to ensuring that the bill captures the intended procedures but does not capture anything else and that it works effectively with the licensing statutory instrument.

I press amendment 6.

Amendment 6 agreed to.

Amendments 7 and 8 moved—[Jenni Minto]—and agreed to.

:I agree with Dr Gulhane’s points, and I will come to some of them later.

I note the concern about the impact on businesses, and I want to be clear that I am happy to consider taking other action. In the debate on the final group of amendments, we will talk about the time before key provisions in the bill come into force.

I also want the Scottish Government to work with HIS and engage with businesses so that it can carefully consider HIS’s requirements and determine whether any could be amended to ensure that they are suitable for the full range of businesses that HIS will regulate.

We must retain the requirement for a healthcare professional to be on site when procedures that will be regulated under the bill are being performed—I highlighted the importance of that in the debate on group 3. However, consideration is being given to removing the need for a healthcare professional to be present in a service when non-regulated procedures take place.

That said, there is no need to put in place a support fund such as the one that is envisaged by Sandesh Gulhane in amendment 105 and by the consequential changes that are proposed in amendments 117 and 119. As the convener and Dr Gulhane have noted, we will not be voting on amendment 105 today, given that there is no financial resolution and the Presiding Officer has determined that the cost of the amendment would exceed the threshold to require such a financial resolution.

There is also no need for a fund to be established to ensure that guidance is put in place. I refer members to the comments that I made in the previous group relating to standards, guidance and requirements for providers. I am willing to work with members on the inclusion of an overarching provision in the bill that requires the Scottish Government to produce guidance on a number of matters, given the number of amendments of that nature.

The final element of the proposed fund concerns direct financial support. Dr Gulhane is realistic about that element. Where businesses are concerned about on-going costs, for instance in relation to employment, it would not be reasonable or affordable to subsidise them using finite public moneys. Doing so would also be uncompetitive in a sector in which many businesses are already meeting the cost of HIS registration while receiving no such support.

10:30

Amendment 110 takes a different approach. I am grateful to Carol Mochan for lodging it. I note that it is one of a number of amendments concerning potential review provisions, including amendment 109, which is also in Ms Mochan’s name. The majority of those amendments are to be considered in group 11, so I will say more on them at that point. However, I say to Ms Mochan now that I would be happy to work with her on amendment 110 and with other members on how a single review provision can also consider the support available to businesses to ensure that the issues that Ms Mochan raises can be addressed.

Amendments 51 and 76 focus less on support for businesses and more on the imposition of costs on them. I must admit that I do not see the need for amendment 51 in Mr Balfour’s name. The Scottish ministers already have the power to set maximum fees for registration with HIS in regulations under section 10Z5 of the National Health Service (Scotland) Act 1978. Ministers are required to consult service providers before making regulations under the 1978 act, and HIS consults its registrants when evaluating those fees on an annual basis.

:My understanding is—I will correct the record if this is incorrect—that the Parliament votes on the instrument that sets the maximum fees every few years, so there is a check. I will get back to Mr Balfour directly on that, and I suggest that he does not move amendment 51.

I also urge Mr Golden to consider the provision in the 1978 act concerning the setting of fees. It requires HIS to set its fees—subject to a statutory maximum that is set by ministers in regulations—with regard to its reasonable expenses in carrying out its functions. That appears to me to be a very reasonable basis for fees to be set. Any alternative might prevent HIS from covering its own costs and open the prospect of the public purse subsidising the sector in perpetuity.

The other elements of amendment 76 compare costs incurred by businesses that are associated with enforcement and the level of penalties. I would welcome further discussion with Mr Golden on the costs associated with enforcement if he is aware of a concern about HIS inspection or other enforcement activity being burdensome for its current registrants. I note Dr Gulhane’s point regarding that, and I would be happy to discuss the situation that he mentioned with him.

Regarding the level of penalties, I note that decisions regarding prosecutions are a matter for the Crown Office and Procurator Fiscal Service and that the appropriate level of fines to be applied following conviction will be a matter for the courts to determine according to the facts and circumstances of a particular case. I will say more about this under group 9, which relates to enforcement, but if a court considers it appropriate to set a stiff penalty for someone who has knowingly provided a high-risk procedure to a child, I do not want anything in the bill to prevent that.

For those reasons, I ask members not to press the amendments, as I am very happy to work with them to address some of the underlying concerns. In the meantime, I hope that my comments have been helpful and reassuring.

:I will take the intervention.

:The amendments are necessary to meet the ambition to set training standards in the future.

Amendment 5 agreed to.

:I have previously indicated my intention to commence the bill’s key provisions in September 2027 to align with the Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order 2026. Indeed, I have already made it clear that I do not intend to bring key sections of the bill into force until then.

Amendments 62 and 63, in Mr Balfour’s name, would imply a similar but not identical timeline, delaying commencement by a few months, depending on the date of royal assent. In practice, that would imply that key provisions, including offences, would come into force in early 2028. I am concerned that the current drafting of amendment 63 would not only delay the commencement of offences but prevent us from progressing any regulations under the bill.

:I will continue with my remarks, because I am going to address the point that Mr Balfour has just made.

I am concerned that a delay would mean that it would not be possible to progress work on a scheme under section 26 of the United Kingdom Internal Market Act 2020 and training standards in advance of the main provisions coming into force. I am of the view that bringing in regulations early will be better for businesses and enforcement agencies, even if those amendments can come into force only at the same time as the offences.

I am happy to work with Jeremy Balfour on an alternative approach that might be brought in at stage 3 to give businesses clarity about what they will need to meet the bill’s requirements. In return, I ask the member not to press amendment 62 and not to move amendment 63.

As for amendment 121, in Mr Russell’s name, I cannot support the length of delay that he has suggested, as it would prevent us from taking essential steps to improve safety in the sector. I do not believe that the amendment meets public concern on the matter, and I hope that other members will agree. Therefore, I urge that amendment 121 not be moved.

:This group of amendments goes to the heart of the bill. It contains amendments to section 4, which sets out the most important public safety provisions on where non-surgical procedures can be carried out and the need for healthcare professional involvement in those settings. Those are the issues that have been the subject of most of the correspondence and representations that I have received, and I must make it clear that I have listened carefully to all sides of the discussion.

I will start by discussing my amendments. Amendment 22 is the most substantial. It does not add to or remove any setting from the list of permitted premises, but it provides additional clarity about those premises. Amendment 22 will replace the existing sections 4(1) and 4(2) with a new section 4(1). The new subsections (1)(a) and (1)(b) provide new drafting so that the permitted premises for Healthcare Improvement Scotland-registered independent clinics and independent hospitals are those where the address is entered in the register that is maintained by HIS. Subsection (1)(a)(ii) makes it clear that an independent clinic can include a vehicle. Subsections (1)(c) to (f) are the same as provisions in the bill at introduction, but with minor technical drafting changes.

Amendment 25 will amend section 4(5) to include definitions that relate to new subsection (1). Amendments 9, 23, 24 and 31 make technical drafting changes that are proposed as a consequence of amendment 22. The changes address concerns raised by HIS in evidence to the committee about the clarity of those provisions.

The inclusion of vehicles might surprise some members, but, in the case of dental settings, mobile settings were included in the bill at introduction, and the inclusion is consistent with how those settings can already operate. In the case of a HIS-registered independent clinic, that has been made explicit, recognising that it is possible but not easy for a vehicle to be equipped in the same way as a traditional clinic. For example, such vehicles already provide dental scanning and blood donation services within the NHS. I assure members that independent clinics that are vehicles would be inspected by HIS and would be expected to meet the same standards as fixed premises in relation to the appropriateness of fixtures and fittings.

Amendment 22 also makes it clear that procedures must not be carried out from clients’ homes. It would, however, be possible for a clinic to be established out of rooms in a provider’s home or in a purpose-built outbuilding, because, again, such a setting can still be inspected by HIS and be held to the same standards as any other clinic.

I urge members to support all the amendments in my name.

I will now turn to other members’ amendments in this group and the clear themes that they fall under. Amendments in this group take a variety of approaches. Amendments 22D and 73 would create an additional category of HIS-regulated setting. Amendments 40, 44 and 61, amendments 68 and 71 and amendments 69 and 113 would amend requirements of existing categories of HIS-regulated settings.

Other amendments would provide for new licensing or registration schemes, such as amendments 22A, 41, 42 and 60, on licensed non-healthcare premises, amendments 22B and 43, on community clinics, and amendments 22C and 112.

A number of these amendments seek to allow businesses to operate without healthcare professional involvement. In respect of the proposed licensing schemes, the Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order 2026 has recently been approved by the Scottish Parliament in order to introduce a local authority-run licensing scheme for lower-risk non-surgical procedures. It is intended that the licensing scheme under the order and the regulation of higher-risk procedures under the bill will both commence at the same time. As such, there is no need for any amendment that introduces a new licensing scheme.

I appreciate that all of these amendments seek to address business concerns around the impact of the bill, with the focus being the cost and practicality of having a healthcare professional always present in a setting. I will take this opportunity to explain why I believe that the presence of a healthcare professional is essential.

All the procedures currently described in schedule 1 to the bill carry some risk. Many of them require the use of a prescription-only medicine, and the remainder are all likely, in varying degrees, to require the use of a prescription-only medicine in addressing complications. We heard during the debate that these complications may not emerge immediately. However, I have clinical advice on and examples—some of which were shared in Parliament by Dr Gulhane—of complications emerging or being identified immediately and requiring immediate action to prevent serious adverse outcomes.

In these cases, someone needs to be available to assess the situation and have the ability to prescribe or administer the relevant medication. The setting needs to hold supplies of such emergency medication. Non-regulated settings delivering non-surgical procedures are not able to routinely hold supplies of prescription-only medicines without the involvement of a suitably qualified healthcare professional. I cannot endorse any proposal that could allow procedures to continue to be undertaken without access to emergency medicines.

With specific reference to amendments 44 and 61, which are linked with amendment 40, which seek to create a prescription-only medicine governance process, and amendments 69 and 113, which would require an arrangement for named prescribers to be attached to each permitted premises, there are concerns about the effect of these amendments on the reservation of the subject matter of the Medicines Act 1968 in the Scotland Act 1998.

There are other advantages to the presence of a healthcare professional in settings that provide non-surgical procedures. For example, a healthcare professional’s involvement in consultation can support fully informed consent and consideration of risks, particularly with regard to existing health conditions. A healthcare professional also offers the wider assurance of professional regulation. Complaints can be made against such professionals to professional regulators, with serious consequences if they are upheld. This is not the case for practitioners who are not healthcare professionals.

For all those reasons, I urge members not to move amendments that would in any way undermine the connection between a permitted premises and the presence of a healthcare professional.

Again, I urge members to support the amendments in my name.

I move amendment 9.

:Amendment 29 is a consequential amendment to reflect Healthcare Improvement Scotland’s extended role under part 1 of the bill in relation to non-surgical procedures. It will add reference to part 1 of the bill to sections 76 and 77 of the National Health Service (Scotland) Act 1978, so that inquiries can be held in relation to any matters arising under part 1 of the bill and orders can be made after any such inquiry in relation to any default by Healthcare Improvement Scotland in carrying out its functions in relation to non-surgical procedures. These powers are a last resort, but it is appropriate that any gap that is created where HIS acquires new functions is filled in a manner that is consistent with the approach taken where the powers were first included.

12:00

Section 17 of the bill amends section 18 of the Certification of Death (Scotland) Act 2011 so that medical reviewers will need to authorise cremation where deaths take place “outwith the United Kingdom”. Amendment 32 makes a consequential amendment to section 14(1)(b) of the 2011 act in consequence of the change to section 18 of that act that is to be made by section 17 of the bill.

The Hydrolysis (Scotland) (No 1) Regulations 2026 were approved by Parliament in a vote on 21 January 2026. The regulations ensure that medical reviewers will have the power to authorise hydrolysis in the same way as they authorise cremation; the regulations also change the title of section 18 of the 2011 act. Amendment 33 amends the cross-reference to the title of section 18 in consequence of the hydrolysis regulations.

I move amendment 29.

:I am grateful to members for their contributions to the discussion on this group, which covers some very important issues. The complexity of aspects of the discussion illustrates the importance of the power to amend schedule 1 so that we can ensure that the bill remains up to date, even as the range of procedures on offer changes. I welcome the support for my amendments.

With regard to Dr Gulhane’s point about amendment 6, on clinical trials, such trials are regulated by the 2004 regulations. Those regulations cover only regulated trials.

With regard to the point that Joe FitzPatrick made about Dr Gulhane’s amendments 64 and 65, I am content to continue to discuss those amendments—and any other amendments—with Dr Gulhane as we move to stage 3.