Seòmar agus comataidhean

: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.

: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.

There is quite a lot in that question. Kym Kestell from the British Heart Foundation Scotland gave the committee good evidence on the research that the BHF is doing, which the Scottish Government is very pleased to support. We also have the Chief Scientist Office, which is in charge of research into health in Scotland, and the chief scientist is very open to receiving applications from organisations and universities to undertake specific research into heart conditions. Alongside the data, the research that we can undertake in Scotland, given our population, is really important.

That important question ties into a question that you asked at the previous meeting as well. I know that you recognise that local authorities know their communities and who the key drivers are in different parts of their communities, whether that is the more deprived areas or the less deprived ones. Partnership working is definitely happening, and COSLA is part of the Save a Life for Scotland partnership, as you know.

Another important thing, which Steven Short touched on, is that businesses are often willing to get involved in supporting fundraising, as is the British Heart Foundation. As I said, we are looking at a paper that was worked on at the most recent Save a Life for Scotland meeting, and we will be taking decisions based on that.

I absolutely agree. The targets will have been set with clinical advice and guidance. Targets should be a stretch, because we want people in Scotland to be healthy and to maintain healthy lifestyles. I know from the people who I have met who are living with stroke that some have had better journeys than others. That is how we learn. It is through sharing those stories widely among MSPs and more broadly across Scotland that change can happen. I was very heartened by the meeting that I chaired last week, because I heard a group of people who have the same determination to reach those targets.

We need to be aware that the FAST acronym is very well known. Bringing in the “BE”—the balance and the eyes—could produce some false positives, which we would be concerned might impact on clinicians’ ability to treat. That is why, in the additional training resource, we have been very clear that we are focusing on FAST, but we are also ensuring that people are aware that there could be other symptoms. The evidence and the discussions that I have had with the Stroke Association and Chest Heart & Stroke Scotland show that their views tie in with that.