Hansard

: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.09:15Amendments 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.