Official Report 595KB pdf
Under agenda item 2, we will continue taking oral evidence on the Non-Surgical Procedures and Functions of Medical Reviewers (Scotland) Bill, and I welcome to the committee Jenni Minto, the Minister for Public Health and Women’s Health, and her officials. Supporting the minister on part 1 of the bill are Rachel Coutts and Alison McLeod, who are both lawyers at the Scottish Government, and Owen Griffiths, who is the bill team leader. I invite the minister to make a brief opening statement.
10:00
I thank the committee for the opportunity to support its consideration of the Non-Surgical Procedures and Functions of Medical Reviewers (Scotland) Bill. I have some opening comments to make about part 1 of the bill concerning non-surgical procedures, and I also have some comments about part 2 of the bill. I hope that you are content for those to be made at a later stage, during the session when you consider evidence on that part of the bill.
I will start by reflecting on the issues that we seek to address through part 1 of the bill. The issue was brought home to me and a number of other members last year at a round-table meeting, organised by Miles Briggs MSP, where we heard some harrowing experiences from people who had been seriously injured after improperly carried-out procedures.
During the past few weeks, the committee, too, has heard evidence about exactly that. Although many Scottish people undergo popular procedures with little thought to potential consequences, the committee, like me, has heard that adverse consequences can include necrosis or vascular occlusion, burns or scarring and, in the worst cases, sepsis, blindness or death. I do not say that to be alarmist or to malign the many reputable providers of those procedures; I say it to remind us all that there are serious risks to the public, which the bill seeks to address.
The bill is robust but proportionate, and it seeks to ensure that those who choose to undergo non-surgical procedures can do so safely. The bill contains substantive provisions that will make the public safer. It does so by making it an offence to provide such procedures to those under the age of 18, which I hope we can all agree is a sensible and important step. It also makes it an offence to provide procedures outwith permitted premises. Permitted premises will be safe, hygienic settings that will be subject to regulatory oversight and from which healthcare professionals will provide or manage services. The involvement of healthcare professionals also supports safe and appropriate prescribing and will enable those healthcare professionals to intervene in the event of complications. If the bill becomes law, it will be an offence for procedures regulated by it to be provided, for example, in the back of a taxi, to be given to teenage children or to be delivered at a fizz and filler party in someone’s home.
Having discussed the main intent of the bill, I will highlight particular issues that might be of interest. I am, of course, happy to address any of the issues in more detail during questions.
I have said a lot about what happens when things go wrong, but I also want to reflect on some of the dedicated and highly trained practitioners, not just in the already regulated medical part of the sector but those in the broader beauty and aesthetics sector. I and my officials have met some of the practitioners who gave evidence to your committee. There is no doubt that many practitioners have invested in their own training and are committed to providing a safe and professional service to their clients. Many of you will have constituents who work in the sector and will know that the businesses are often small and female led. There is room for a thriving non-surgical procedure sector and an important continuing role for non-healthcare professionals in that sector but with some changes to current practice to support safety.
Although public safety is my priority, I have always been clear that we should not put a disproportionate burden on businesses. I am comfortable that the provisions in the bill are the least restrictive means of achieving the bill’s aims. Many experts and respondents to our consultation want to see a more restrictive approach than the one that is provided for in the bill.
In many countries where procedures such as Botox or dermal fillers have been regulated, those may only be carried out by doctors or, in some countries, by doctors, dentists or nurses. However, under our proposals, I consider it appropriate that non-healthcare professional practitioners can continue to provide procedures as long as they do so in permitted premises where services are provided or managed by a healthcare professional. I will come on to training and qualification standards shortly.
I have ensured that procedures are included in the bill only when it is absolutely necessary. Lower-risk procedures that do not require to be undertaken in a setting that involves a healthcare professional will be included in a local authority licensing scheme, akin to the scheme that is in existence for tattooing and skin piercing.
I know that the committee has heard evidence about the importance of training standards for practitioners. I am happy to reconfirm the Scottish Government’s commitment to establishing training standards for procedures that are in the bill. Unfortunately, legislation that sets those standards would engage part 3 of the United Kingdom Internal Market Act 2020. I am happy to discuss that in more detail but, for the time being, I assure the committee that, although the bill does not include such provisions, the Scottish Government is engaging with the UK Government with a view to implementing training standards in a way that will be effective and workable.
The final point in relation to part 1 of the bill is the fact that, last week, a draft order was laid under the Civic Government (Scotland) Act 1982 for the Parliament’s consideration. If affirmed, the order will establish a licensing scheme for low-risk procedures that do not require to be carried out in a setting that involves healthcare professionals and, therefore, do not merit inclusion in the bill. The scheme that will be established by the order and the provisions of the bill are intended to work alongside each other to provide a comprehensive regulatory regime. The order sets a date after which businesses will have to comply with the licensing scheme. I have not previously provided a date on which we intend the offences in the bill to come into force, but I take this opportunity to set out my intention that the bill will come into force on the same day that the licensing scheme becomes operable, which is 6 September 2027.
I look forward to answering the committee’s questions.
We move straight to questions.
I declare an interest as a practising NHS GP, as stated in my entry in the members’ register of interests.
Good morning, minister. Thank you for coming to the meeting. I have quite a lot of questions for you. My first question is about the definition of regulated healthcare professionals and the list of councils that has been provided. Why have the General Osteopathic Council and the General Chiropractic Council been included in the list? Is that necessary?
When we were creating the list of professions that we felt were appropriate to include, we wanted to understand their qualifications in prescribing and whether they understood how to mitigate any negative impact of items that they could prescribe.
Would an osteopath be able to prescribe Botox?
It is not our understanding that osteopaths are currently involved in any prescribing activity. You are referring to the list of professions related to the healthcare exemption in the bill. The list has been broadly drawn to ensure that no—I hesitate to use the word “legitimate”—healthcare activity that you might expect to be associated with the list of professions is inadvertently excluded by being captured by the offences in the bill.
Are there any examples of procedures that osteopaths undertake that would be exempted?
We are not currently aware of any procedures that are being undertaken by osteopaths that would be captured by any provisions in the bill; we reconsidered that after the committee took evidence on it a few weeks ago. We can provide examples for some other healthcare professionals, such as members of the chiropractic council or the Health and Care Professions Council, but we are not aware of any current activity that osteopaths undertake to prescribe or administer injections or other procedures that might fall under the bill. However, if the osteopathic council were excluded from the list, further work would need to be done with the council to ensure that nothing was inadvertently excluded.
I am sure that my colleagues will come on to that, so I will move on.
The minister spoke about permitted premises being very important. When we took evidence from dentists, they mentioned the fact that not all practices are inspected by HIS and that the regime that applies depends on whether any private work is done in the practice. How will you ensure that dentists and dentists’ premises are captured?
As you point out, dentists’ practices that provide NHS services are covered by NHS regulations. Therefore, we would expect permitted premises to be hygienic and adequately staffed, in line with what we would expect of NHS inspected, registered and regulated premises.
The word “supervise” appears in the bill. A lot of us want to know what that means. For example, if a prescribing doctor is supervising people, do they need to be in the room during the procedure? How many people would it be appropriate for someone to supervise? Could one doctor supervise 100 people, for example, or is there a limit?
Thank you for raising that question, because I know from watching the evidence that the definition of supervision is playing on a lot of people’s minds.
As I highlighted in my opening statement, we have not included specific provisions on that in the bill, because we are still in discussions with the UK Government on the United Kingdom Internal Market Act 2020. It is the view of the Scottish Government that part 3 of that act would be engaged by legislation that set training standards in this area. We want to ensure that we have the right conversations and make the right decisions about training and supervision. That is covered under section 5 of the bill, which will allow us to make secondary legislation on such matters.
Do you think that you might be able to lodge an amendment in that regard at stage 2 or stage 3?
Our conversations and work with the UK Government have been progressing. Both the Department for Business and Trade and the Department of Health and Social Care are involved. I will write to the UK Government, probably later this week, to see how we can make progress. Sadly, however, one of the unintended consequences of UKIMA is that we can no longer make specific decisions on public health that we could have made when we were part of the European Union.
We heard about people going underground and doing things illegally—that is the whole point of going underground. Should practitioners who do not comply with the law be billed by the NHS for mistakes, errors or complications that they cause that force people to come to the NHS for help?
That is a really interesting question about an issue that has preyed on my mind since the first round-table meeting that I attended, when it was made clear that there is no way of specifying in records how an impact has occurred. For example, there is no part of a person’s NHS records that says that something was done specifically in response to a Botox injection or whatever. We did work to assess whether we could change that, but the whole reason for bringing in regulation in this area is to ensure that we have better records of the impacts, and that will be provided as part of the regulation work that Healthcare Improvement Scotland will do.
I know that time is short, so I will move on to my final question. When people go to the shops to buy paracetamol, they expect the drugs that they can buy—whether we are talking about Panadol or anything else—to essentially be the same thing. They are drugs that work and are regulated. However, we know that Botox is not always Botox, and people buy it from all sorts of different places.
We also know that people’s training is not the same. If you go to a doctor, pharmacist or nurse, you expect a basic level of training. I am keen for the bill to ensure that such training takes place. At one of our first evidence sessions, we heard about a practice that removes moles and skin lumps. The overriding regulator—the person who looks at those lumps and decides whether they are cancer—is not a registered nurse and certainly not a doctor. My fear is that those lumps are not being sent to a pathology lab. I did orthopaedics for many years, and I would not have been allowed just to whip out a lump on my own with no supervision or without the consultant knowing about it. I trained in surgery for a long time. You would not see somebody for a lump or mole who is not a professional and is not regulated. Is that going to fall within the provision to ensure safety and that people are not having cancers removed in that way?
10:15
The committee heard evidence from one of the practitioners that, if they were concerned that something could be cancerous, they would direct their client to their GP, which is the right thing to do. That situation absolutely falls under the public safety element of the bill. The committee took a lot of evidence about educating the public, and your question fits into that. You raise an important point, which I am happy to take away and think about. I will ensure that we have taken proper consideration of what you have said.
Minister, I go back to Sandesh Gulhane’s question about regulated professional bodies and the inclusion of the General Osteopathic Council and the General Chiropractic Council. My understanding is that neither osteopaths nor chiropractors in this country are medically trained—though they are in some other countries—and I am therefore not aware of their ability to prescribe pharmaceuticals, so their inclusion is unclear. When we asked which procedures they might be covered for, we were not given an answer.
I am really concerned that we have a potential loophole that could cause confusion. People might think that, because someone is regulated by the General Osteopathic Council or the General Chiropractic Council, they can perform the procedures that are outlined in the legislation. There is no reason for people to think that, so I ask you to consider whether those two bodies should be removed from the bill to ensure that it is as clear as possible.
I thank Mr FitzPatrick for pressing that issue. In drafting the bill, we have always been clear that there is a difference between healthcare need and the aesthetic wish to have certain treatments. If I go back to my past life, I used to work with the BBC Scottish Symphony Orchestra. Two of the players had specific issues that affected their ability to play, and both were prescribed Botox injections. Children living with cerebral palsy can also get Botox injections. Therefore, we must ensure that that element of healthcare is not lost. With regard to chiropractors, they can give a hyaluronic acid injection to reduce joint pain. That is another aspect. However, I am content to take the issue away, given that it has been raised by both you and Dr Gulhane.
I would appreciate it if you would do that. If someone has cerebral palsy and requires those injections, they should go to a medical practitioner to receive them. I would be concerned if people were routinely receiving medical treatment from people who are not medically trained.
I am not criticising the work that those bodies do, but neither of them have medically trained individuals. If we are inadvertently indicating to the public that they are somehow medical practitioners, I would be concerned about that. I am grateful for your agreement to look at that again and consider whether the two groups should be removed from the bill.
Given that the underlying aim of the bill is to protect public health, I am content to look at that.
On the back of the questions from Joe FitzPatrick and Sandesh Gulhane, I note that hyaluronic acid is a dermal filler that is registered as a medical device by the Medicines and Healthcare products Regulatory Agency, whereas the antidote, hyaluronidase, must be prescribed. There could be an issue with that. Osteopaths who are not medically trained do not prescribe, but they can give a device. Does that create a problem? If so, what work is being done with the MHRA to examine how we regulate that device? I note that it is not actually a device but a medication that has to be injected.
As you will know, Ms Harper, the MHRA is a reserved body, but you have highlighted the exact issue that we are trying to cover by saying that a healthcare specialist needs to be there in case something goes wrong. That has been the premise behind permitted premises with the right qualified staff and the regulations from Healthcare Improvement Scotland. As I said in my response to Mr FitzPatrick, I am happy to provide you with further information on that.
Does that mean that, if someone is going to administer a dermal filler, they will need to have the antidote on site? Time is critical if the blood supply to someone’s upper lip has been injected instead of the tissue around it. That would mean that the antidote would need to be readily available at whatever site is determined to be a Healthcare Improvement Scotland-regulated clinic.
If I have understood you correctly, you are saying that the antidote, because it is a separate prescription, needs to be held on the premises to ensure a timely intervention. That is exactly why we are saying that we need healthcare clinician specialists on site when the procedures are being carried out.
Owen Griffiths is champing at the bit to say something.
As I understand it, what you have described is standard practice in HIS-regulated settings. Where dermal fillers are being provided for cosmetic reasons, it would be usual for the provider to hold stocks of hyaluronidase and, where HIS is regulating that, it would expect somebody who is capable of making that prescription to be available on site when the procedure is being carried out. That is standard in the regulated setting, and the bill brings the procedure into that regulated setting so that it can continue to happen.
I will just backtrack to one of Sandesh Gulhane’s questions, which was on supervision. I might have missed the answer, but I am not clear on that. Sandesh Gulhane asked how many people a healthcare professional can supervise. I am keen to hear the answer to that, because several witnesses have raised the issue with the committee. What exactly does the term “supervise” mean?
As I said to Dr Gulhane, we are still in discussions with the UK Government to understand what we can do as a result of the United Kingdom Internal Market Act 2020. When HIS is regulating specific businesses, there is a provision in legislation that says that those businesses need to be staffed appropriately. Our work on supervision runs in parallel with Healthcare Improvement Scotland and with the work that we are doing on UKIMA.
At this time, I cannot say how many people would be required to be supervised. That will be worked through once we understand the level of training and qualifications and the regulations that Healthcare Improvement Scotland deems appropriate to ensure the proper, robust regulation of those businesses.
As things currently stand—from what you and Owen Griffiths have said—if a dermal filler or Botox procedure is carried out in a HIS-regulated setting, a prescriber will be there who can step in and prescribe an appropriate treatment if things go wrong; however, if a single practitioner is carrying out such procedures in a room in a beauty salon or a hairdressing salon, or in their own home, they will not have access to a healthcare professional to prescribe something. Do you anticipate that, if the bill is passed as drafted, a sole practitioner would not be able to become HIS regulated and carry out those procedures?
There are a few things in that question. HIS regulation will also look at the premises, to make sure that they are safe and hygienic.
I appreciate that. I am sorry for interrupting you, minister. My question is specifically about the supervision element. I am just trying to get my head around whether there would need to be someone on site who could prescribe an antidote or a remedy to relieve a complication.
As Owen Griffiths said, that is currently the situation with HIS-regulated premises. We are currently looking at whether that would be the requirement in this instance. It is about striking a balance and ensuring that each place to which people can go for such treatments is as safe as possible.
Last week, the committee heard that only wholly private dental practices are HIS registered, whereas oversight by NHS boards applies only to practices that provide NHS dental services. How will the bill ensure the consistent regulation of schedule 1 procedures that are delivered in dental practices and, if HIS oversight cannot be assumed, what measures can the Government take to ensure that there are no gaps in assurance?
That is a really important question, and we will be discussing it in more detail with HIS. A key element of the bill is that premises are properly regulated, hygienic and safe. That is the work that we are currently doing with HIS.
Good morning. My question is on training and training standards. You will be aware that a lot of stakeholders have called for minimum training standards and mandatory qualifications to be set for all practitioners—medical and non-medical alike. What is the Government’s response to those calls?
I am sorry, I did not hear your question; you were speaking from behind your hand.
I apologise. There have been calls for minimum training standards and mandatory qualifications for all practitioners. What is the Government’s response to those calls from stakeholders?
I agree that appropriate training standards are needed. As you will know, the bill’s contents do not include standards or supervision requirements. It is really important that we get the right training for people and that they become properly regulated. I see that as important for the Government.
10:30
I agree with that. From a practical perspective, we heard a lot about the ability of a person to take a course for a day or a couple of days, after which, all of a sudden, they are qualified. Over time, could the bill eradicate that kind of inadequate training?
One area that I am clear on, which is part of our conversation with the UK Government about the United Kingdom Internal Market Act 2020, is that we need to have a proper standard for qualifications. According to the evidence that was provided to you, the University of South Wales provides a course; we have not yet engaged with it, but we are planning to do so. We also understand that a couple of universities in Scotland are looking to provide better courses—regulated courses—that would help to ensure that the people who offer such treatments have the right training and qualifications.
How would you define approved training providers and what the curriculum would be? How do you plan to provide that? Is there a role for the Scottish Qualifications Authority in setting the standards that are related to the bill?
That may well be a role for the SQA, but it may also be for specific universities.
One risk or potential unintended consequence of the bill is that practitioners with high-level aesthetic qualifications may be prevented from practising, whereas a nurse with no Office of Qualifications and Examinations Regulation-recognised training would be permitted to carry out regulated procedures. How does the Scottish Government intend to mitigate that risk?
It came very clearly through the evidence that you have taken and the meetings that I have had that practitioners are qualified up to scottish credit and qualifications framework level 7. We will therefore be looking at how to shift credits from such training and how that would fit in with the regulated training and qualifications that we have just been talking about.
Will that be included in the bill, or will you do that under secondary legislation?
Currently, the plan is to do it under secondary legislation.
You mentioned work with the UK. What sort of consultations have you had with other UK nations on the mutual recognition of training and qualifications, so that there is a level playing field?
That is part of our conversations with the UK Government. Owen Griffiths and other Scottish Government officials have been speaking directly to its officials, so that we understand the impact of ensuring that qualifications can be as consistent as possible across the four nations and reach the standards that are appropriate to ensuring public safety across the UK.
Good morning, minister. We have heard evidence on public awareness, which you have spoken about in the past. What needs to accompany the bill in order to raise public awareness about the dangers of such procedures and how to identify reputable practitioners?
When any legislation comes in, there must be appropriate public messaging and engagement. That was made very clear through the evidence that you received on communication from Douglas White.
We have not set out a specific communication plan. Clearly, we will work on that if the bill is passed, to ensure that the right people get the information. I was asked if I would front the announcement of the consultation. I did not think that somebody in their late 50s would be the right person to do that, so we have to ensure that we target any information to the public in the right way, using channels that people can access.
Similarly, how can we combat advertising and marketing that perhaps trivialises the procedures and makes it seem like they are not medical procedures? Do we have a plan for that?
I have met the Advertising Standards Authority regarding other parts of my portfolio to talk about advertising on social media around smoking, vaping and suchlike. As you will know, advertising standards are reserved, so advertising on procedures is an issue on which we would be looking to work with other Governments across the UK.
Great. That partly answers another question that I was going to ask. I know that you have committed to doing that in the past, which is really helpful.
You indicated that we know that younger people are sometimes attracted to non-surgical procedures. The bill sets an age limit of 18. Will we need campaigning to ensure that younger people are aware of the pros and cons of such procedures? It has been suggested that a register of licensed practitioners should be created. How would that work and how would we ensure that people were made aware of it?
Public awareness is one of the most important things that every one of us, as elected representatives in Scotland, can support the Scottish Government and the public with. It is important that people understand the possible negative outcomes of receiving such treatments from unregulated practitioners, which I will certainly focus on if the bill is passed.
Good morning. I just want to follow up on the questions about public awareness and perhaps draw out a little more the Government’s attitude to the balance between the public sector’s responsibility to provide public awareness information and providers’ responsibility to provide information.
When we talk about other products on sale that have some health harms, we do not simply say that there is a public health awareness campaign and we do not simply say that providers have to give information—we say both things. I am not quite clear whether the Scottish Government is saying that it wants to regulate the information on risks that providers of such procedures have to make available. I recognise that advertising is reserved, but regulating the provision of information about risks is surely a public health matter and therefore devolved.
That is a really interesting question, Mr Harvie. I envisage that any messaging that comes from a public health perspective will display the negative aspects and the risk of doing something.
I am just thinking back to our work on the UK Tobacco and Vapes Bill with regard to ensuring—this is perhaps what you are getting at—that the onus is on manufacturers to provide such information on their packets. It is a really interesting concept and a way forward that we can certainly explore.
Tobacco is an interesting comparison, because we require information to be provided not simply in text form but through images that are sometimes deliberately shocking.
They are graphic, yes.
Do you expect to explore that approach in relation to non-surgical procedures?
I am certainly content to do so. Seeing the impact of bad procedures has shaped my own thoughts on the matter.
Good morning. My questions are on the impact on businesses. How will the Scottish Government ensure that there is clear guidance for practitioners and businesses on the compliance requirements set out in the bill?
That is key to ensuring that the bill works—we must ensure that businesses are absolutely clear about the requirements. The businesses that are currently regulated by Healthcare Improvement Scotland make it clear on their websites and their premises that they have that additional regulation.
If the bill is passed, what is the timeline for bringing in its provisions?
As I said in my introduction, we have just laid an SSI on the licensing for group 1 of the procedures, and the date set out in that instrument is 6 September 2027. We envisage that, if the bill is enacted, the provisions will come into force then, too. Therefore, on the assumption that the bill will be passed, businesses will have more than a year to comply with the regulations and to ready themselves for them.
What work has the Scottish Government undertaken to assess the financial impact on, and the viability of, small businesses as a result of the bill? What practical, financial or advisory transitional support will be available for practitioners to help businesses meet the new requirements under the bill?
We have engaged a lot with small businesses, because we recognise that the regulations will have an impact on certain businesses that are carrying out certain listed procedures, and we have also been speaking to various areas within the business elements of Government to see what support could be provided. There is a bit more work that we can do in that area to consider what support businesses might need—perhaps through, say, the Federation of Small Businesses. Those conversations are on-going, but I do recognise that we have to get the balance right.
How will the Scottish Government ensure that implementation of the bill does not push treatments underground, with the associated risks of reducing safety and choice?
That is always a concern when bringing in regulations. I have been asked whether we are introducing the regulations too late, and my response has been that, when it came to driving safety, it was not too late to bring in rules on wearing seat belts in cars. It is important to recognise the need to regulate in this area in order to improve public health and safety, but we need to enforce it well, too, and that is why we have been working with Healthcare Improvement Scotland and environmental health officers.
Do you have timescales for when you expect businesses to comply with the new regulations?
We have said that we will bring the act into force on 6 September 2027. I have not had any conversations with officials on whether there will be a phased introduction, but I am happy to come back to the committee on that.
So, that is something that you might consider.
With regard to enforcement, will the Scottish Government adopt an improvement-first approach, rather than immediate punitive measures for non-compliance on the part of businesses?
10:45
I think that I am right in saying that the evidence that you received from Healthcare Improvement Scotland described the process, which would involve inspection, making recommendations and then re-inspection. That is an appropriate way to move forward, with the caveat that it would all depend on what had gone wrong and what was being investigated.
If an improvement notice was served to a business, how would that business be supported to improve its standards?
My understanding is that Healthcare Improvement Scotland is there to give support.
Are you confident that Healthcare Improvement Scotland has the capacity to do that?
You had evidence from Healthcare Improvement Scotland last week about the capacity that it might or might not have. One of our on-going conversations that we are having with it is on how it will provide the regulation and enforcement work that we envisage arising from the bill. When businesses register, they will pay a one-off registration fee and then a regular fee every year after that. Our aim is for Healthcare Improvement Scotland to become financially self-sustaining as a regulator. Those are, as I have said, the on-going conversations that we are having with it.
Following on from enforcement, I want to focus on the unregulated aspects that we know will be created here. We have heard concerns that the bill might not give HIS sufficient powers, systems or resources to undertake effective enforcement in unregistered settings. What additional resource and support will Healthcare Improvement Scotland receive to enforce the bill’s provisions effectively, given the scale of expectations? That relates both to the regulated setting as well as settings outside of that, where there might be underground rogue traders.
The bill gives HIS the powers to enter unregulated settings if specific complaints have been made or if evidence has been given to it. With regard to resourcing, we expect, as I said to the convener, Healthcare Improvement Scotland’s regulatory services to be financially self-sustaining—that is part of our on-going conversations.
I do recognise your point—an unregulated business would not be paying for the regulatory people. Therefore, I am content to look at that and bottom it out if we get through stage 1 and move towards stage 2.
What do you foresee as the balance between the proactive and reactive approaches that Healthcare Improvement Scotland will take? How much of its work will involve going out and having regular inspections or reacting to intelligence, and how will that balance be struck?
As you know, Healthcare Improvement Scotland is independent of Government, so the intention is that it will work out the best way of ensuring that it inspects regulated premises as often as it needs to. Food Standards Scotland and environmental health officers have similar models to ensure that premises are properly regulated.
Thinking about all the players that need to be involved in counterfeit products—you mentioned environmental health officers in relation to licences—I wonder whether there is a role for Police Scotland here, too. We know that these things already happen, but what will happen with regard to the black market and unregistered premises?
I expect all health and safety agencies, including Police Scotland, to work together. Food Standards Scotland has had a number of successful forays with regard to unregulated food products on the market, and they have been carried out very much in partnership with Police Scotland.
It would be helpful to have a route map published and on the record in the lead-up to the regulations coming into force. Are you content to do that? After all, it would be good for the industry to have a staged understanding of what is expected and at what point. There might even be an element of education in the scaled-up improvement notices that are expected. Are you content to look at that?
There has to be a route map towards full implementation with any new piece of legislation that comes in. I would be content to consider including education for businesses and the general public in the process and to think about whether we need phased implementation.
Enforcement might sit on one side of this, but incentives sit on the other, and I want to ask about them. Practitioners have raised concerns about the burden of training costs. Could an incentive scheme be created by offering supportive grants to enable small business owners to access training and accreditation if they are to meet any new mandatory requirements or standards? That could have a positive, as well as negative, effect.
Paul Sweeney makes a really good point about how we ensure that good businesses can reach the right standard and undertake the regulatory regime that we are introducing.
As I said in reply to an earlier question—which might have come from the convener—we have been actively looking at support for businesses while we have been drafting the bill. We will continue to do so and will take on board the point about incentives.
I just want to follow up on the enforcement theme. The bill would create an offence of providing procedures outwith permitted premises, but it does not include an offence of offering those procedures in those circumstances. Are there any existing offences that would come into play in relation to offering procedures in that way and which could play a role in enforcement? The powers to inspect premises, including powers of entry, come into play where there is a reasonable belief that the offence of carrying out the procedure has been, or is being, committed. Is there another way of allowing enforcement authorities to exercise that power of entry where procedures are being offered, or where the offer to make them available can be demonstrated, but there is no evidence that a procedure has actually happened?
I will ask Rachel Coutts to answer that from a legal perspective.
The offence relates to providing the procedure. Under criminal law, it is where the offence happens that will determine what stage you are at with regard to whatever is happening, so it will all depend on the facts and circumstances of the case. We might need to go away and look a bit further at the issue of where the actual offence happens.
If someone makes an offer on social media, perhaps even within a friendship group, to provide procedures outwith permitted premises, is there anything in the bill, or under the current law, that will allow enforcement action to be taken?
That would depend. I would have to go away and look at the specific detail of where the two elements of the offence would happen. At the moment, it is about the point where provision takes place.
If anything further could be provided in writing before the bill progresses, that would be helpful.
I will suspend the meeting briefly for a changeover of witnesses to allow for scrutiny of part 2 of the bill.
10:54 Meeting suspended.
We will now continue our evidence-taking session with the Minister for Public Health and Women’s Health on the Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Bill. In this part of the meeting, we will be focusing on part 2, and supporting the minister are Katrina McNeill, team leader, burial and cremation team, and Lucy Orren, lawyer, Scottish Government.
Minister, I believe that you have a further statement to make.
Thank you. I am pleased that, in the bill, we are also considering two amendments to the Certification of Death (Scotland) Act 2011, to extend the right to request an interested person review and to amend the provision concerning the authorisation of cremation in Scotland when the death has occurred elsewhere.
The extension of the interested person reviews set out in the 2011 act represents an important step in strengthening public confidence in the death certification process by allowing all relatives equal standing in being able to request an interested person review. Medical reviewers already undertake randomised reviews to improve the quality and accuracy of medical certificates of cause of death, but where such a review has taken place, an interested person review cannot then be carried out. The amendment allows individuals with a legitimate connection, such as family members, healthcare professionals or funeral directors, to request a detailed review where they believe further scrutiny is warranted. It will mean that interested persons can request a review, irrespective of whether a medical certificate of cause of death has been randomly selected for review already.
11:00With the bill enabling further targeted reviews, all bereaved families will have the same right to request a review. The system will be more transparent and responsive, ensuring that specific issues can be examined thoroughly and sensitively. Ultimately, this amendment will enhance accountability and provide an additional safeguard to reassure the public and professionals who are involved in end-of-life care.
On the other amendment set out in the bill, section 18 of the 2011 act currently applies to deaths that occur “outwith Scotland”. That includes deaths that occur in other parts of the UK, thereby creating a legal requirement for medical reviewers to authorise cremation in Scotland where a person has died in England, Wales or Northern Ireland. Other UK nations have robust procedures in place for death certification and apply relevant checks, and it is appropriate for those procedures to be respected in cases in which it is intended for the deceased to be cremated in Scotland. The amendment set out in the bill will remove the need for medical reviewers to authorise cremation where a death occurs in another part of the UK, thus recognising the reciprocal checks in other parts of the UK and avoiding unnecessary duplication of work.
The extension of interested person reviews and the amendment to section 18 of the 2011 act reflect our continued commitment to clarity, transparency, and public trust in the death certification process. The changes will not only strengthen safeguards for families and professionals but ensure that our legislation recognises existing robust checks and procedures and is responsive to real-world practice.
I therefore propose that the committee recommend the extension of interested person reviews and the amendment concerning the authorisation of cremations in Scotland where the death has occurred outwith Scotland, and I look forward to answering any questions that the committee might have.
Thank you, minister, for those further remarks. We will move straight to questions.
What resources will the Government put at the disposal of registrars and the death certification review service to ensure that they have sufficient capacity to handle what will clearly be an additional workload?
I will pass that question to Katrina McNeill.
There is currently a low number of interested person reviews—indeed, only six in the past year—and the death certification review service has confirmed that it does not expect any huge increase if this amendment to the 2011 act is passed, and that any increase can be absorbed into its current workload.
That was helpful. So, you do not envisage there being any additional workload or any effect on the timeliness of burial in such cases.
No, we do not.
Okay. On what timeframe does the Government expect to be able to publish clear criteria and guidance for accepting or rejecting review requests, to ensure that misuse and delays are prevented?
That is an operational question for the death certification review service. Its random reviews are normally done within one day. Interested person reviews are done quickly, too—in maybe one or two days. We would not issue guidance on how it would do those reviews; it already knows how to do them, so it will not need any further guidance.
Has the Government considered a transparent appeals process for declined review requests?
I am not aware of any process to decline reviews.
Okay. To reinforce confidence in certification, would the Government, as part of these reforms, reconsider the current exemption of medical certificates of cause of death from review where the death has been investigated by the procurator fiscal?
Do you mean the current exemption from interested person reviews?
Yes—the exemption of MCCDs from review where the death has been investigated by the procurator fiscal.
We could do that, but we are not aware of any call for it. The Crown Office can investigate the much wider circumstances around a death than those relating just to the MCCD. However, if there were a need to do that, we could certainly consider it, and we would be happy to engage with you further if you wanted to discuss it.
Okay. That will be helpful when the committee comes to think about that.
What practical steps are you thinking of taking with regard to national guidance on and appropriate public communication of these changes to the provisions on interested person reviews?
There is death certification review service statutory guidance, which is published. If the amendment in the bill is passed, we could update that to ensure that it is clear in what circumstances an interested person review can be requested.
Is there some public interface that members of the public can use in order to understand the changes?
Yes. It is on the Health Improvement Scotland website.
Thank you.
On the theme of public awareness of the right to ask for a review, how do you propose to ensure that that right is more widely known?
As I said in my introductory remarks, there will be no change to the fact that people can have reviews. That has always been the case, and people should be informed of that and aware that they can do that. The change just ensures that, if a case is randomly chosen for review, it will not stop a connected person—whether it be a member of the family or a healthcare professional—asking for a further review.
The ability for people to have a review is already there. However, what I am taking away from this is that it is, perhaps, not known widely enough, so we should probably take the issue away and look at it.
I think that you are correct, minister, that it is not widely known. The proposed change to the legislation might be small, but it would provide an opportunity for that information to be disseminated more widely, so that members of the public—and healthcare professionals and funeral directors, in particular—could become more aware of that part of the legislation. Of course, it might have the knock-on effect of there being more requests for reviews.
I agree with you on both points, convener.
With regard to the provisions in the bill on cross-UK cremation authorisation, how confident is the Scottish Government that the bill ensures clear, consistent processes for authorising cremations for deaths that have occurred outside Scotland?
As I noted in my introductory remarks, each of the four nations has robust procedures. We are taking note of them and operating in a way that provides consistency across the four nations.
Are you confident about that?
Yes, I am.
What data-sharing and governance arrangements would the Scottish Government expect to be in place across the UK jurisdictions to protect privacy and ensure accuracy?
The Scottish Government has clear guidelines for funeral directors on those areas, but Katrina McNeill can add a bit more on that.
Information sharing between the organisations, such as the death certification review service in Scotland and the Office of the Chief Coroner in England and Wales, will comply with data protection legislation. The Scottish Government, including our office, does not actually see any of that information—we do not see personal medical records.
Do you foresee the DCRS handling exceptional cases, such as repatriations, and ensuring that equivalent checks have taken place elsewhere?
Yes.
Yes.
You have both made that very clear.
How will the Scottish Government monitor and evaluate implementation, quality and timeliness across jurisdictions? Do you have plans for data gathering and report publishing?
I am a member of the DCRS management board, and we discuss all of those issues at its quarterly meetings. We also have six-monthly meetings with DCRS about its operational procedures, where we engage on all those points.
Do you envisage those meetings continuing if the legislation is passed?
Yes.
Yes.
That ends our questioning this morning, minister. I thank you and both sets of your officials for attending today.
As this is the final meeting of the Health, Social Care and Sport Committee in 2025, I want to take the opportunity, on behalf of the committee, to thank everyone who has contributed to our work this year and to wish everyone a happy and restful festive period.
11:10 Meeting continued in private until 11:34.Air ais
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