Cannabis-based Products for Medicinal Use

The final item of business is a members’ business debate on motion S6M-03233, in the name of Collette Stevenson, on access to cannabis-based products for medicinal use. The debate will be concluded without any question being put.

Motion debated,

That the Parliament welcomes the Home Office’s rescheduling of certain cannabis-based products for medicinal use (CBPMs) in 2018; notes the reported improvement in some children with treatment resistant epilepsy who take CBPMs, such as Cole Thomson, from East Kilbride, who it understands receives Bedrolite on private prescription; acknowledges the reported financial pressure that these prescriptions can place on families; further acknowledges the reported hesitancy of NHS consultants to prescribe unlicensed CBPMs due to the lack of robust evidence; notes the view that the rescheduling does not go far enough in assisting some patients, and the calls for a change in rules to allow GPs, who consider it appropriate, to prescribe unlicensed CBPMs where a non-NHS consultant has initiated that course of treatment; understands that the British Paediatric Neurology Association published its updated Guidance on the use of cannabis-based products for medicinal use in children and young people with epilepsy in October 2021, which, it considers, outlines concerns around the lack of randomised control trials demonstrating a product’s safety, quality and efficacy; acknowledges the Scottish Government’s reported commitment to collaborate with NHS England and the National Institute for Health Research to support research trials into medicinal cannabis in order to give NHS consultants the assurances that they need to consider prescribing CBPMs on the NHS; understands that, once a medicinal product has undergone clinical trials, it could be considered by the Medicines and Healthcare products Regulatory Agency for licensing and that this could lead to further consideration by organisations such as the National Institute for Health and Care Excellence, the Scottish Medicines Consortium and NHS Scotland; notes the calls for industry to run observational and clinical trials; believes that an increased evidence base offers the best opportunities for expansion of the range of CBPMs available from the NHS; welcomes the reported plans by Target Healthcare, which operates in East Kilbride, to produce CBPMs in Scotland, and notes the calls on the Scottish and UK governments to work together to find solutions on these issues.

I am grateful to members who supported my motion. I will try to cover as much as I can in seven minutes.

First, I thank Rona Mackay and Pauline McNeill, the co-conveners of the cross-party group on medicinal cannabis. This area is complex and wide ranging, so the work that they and the CPG are doing is a very welcome contribution.

When the Home Office rescheduled certain cannabis-based products for medicinal use in 2018, many people were relieved. Under the current set-up, doctors can prescribe a medicinal product that has a valid marketing authorisation but, for unlicensed products, there is a restriction in place whereby only a subset of doctors—generally consultants—can prescribe. The only other access routes for patients are as participants in a clinical trial or through private prescriptions.

Medicinal cannabis has been proposed as a treatment for a range of conditions, including multiple sclerosis—[Interruption.]

I would like to move on, thank you.

Those conditions include multiple sclerosis and epilepsy. In the latter case, one product, Epidiolex, is now available on the national health service for some patients.

The Multiple Sclerosis Society provided a useful briefing for today’s debate, in which it mentioned another product, Sativex, which might get rolled out on the NHS. That would be good to see. The MS Society carried out a survey and found that 22 per cent of people with MS in the United Kingdom had accessed

“illegal forms of cannabis to treat their MS symptoms.”

There is a common theme. It was public knowledge that parents of young children with epilepsy from right across the UK had to resort to accessing products illegally, and that is what really forced the legislative change.

As I have said in my motion, I have a constituent who currently receives a medicinal cannabis product. Cole Thomson, aged nine, has drug-resistant focal epilepsy. He used to have daily seizures and has spent a lot of time in hospital over the years. Since he started taking Bedrolite three years ago, however, he has been doing well. His mum, Lisa Quarrell, is in the public gallery today, and I acknowledge the work that she has done in campaigning for access to medicinal cannabis and her efforts to fundraise for Cole’s medicine. Lisa shared a video on Facebook the other day, with Cole doing taekwondo and playing the drums. I can only imagine how proud of Cole and how relieved she is, given the prognosis just a couple of years ago.

We could argue that Cole and the few other children who are in a similar situation are a success story, but that would probably downplay the trials and tribulations facing parents such as Lisa. For a start, Cole’s Bedrolite is sourced through a private prescription and costs more than £1,200 per month. Lisa has found it impossible, so far, to meet an NHS consultant who would prescribe Bedrolite.

I understand that many doctors are hesitant to prescribe cannabis-based products that do not have a marketing authorisation, because those products often do not have a rigorous evidence base behind them, as licensed products are required to have. Furthermore, medical societies develop specific guidance for their members, and some of them have raised concerns about the lack of clinical trials to demonstrate safety, quality and effectiveness. Patients, policy makers and clinicians are entitled to expect manufacturers to provide evidence, so I appreciate that point, but I would challenge scientists, medics, pharmaceutical companies and any other relevant parties to consider the different ways in which evidence can be gathered.

The most recent meeting of the CPG focused on the role of evidence in widening the use of medicinal cannabis. We heard about the potential for conducting observational trials involving patients who are already on a product. I welcome the Scottish Government’s commitment to collaborate with NHS England and the National Institute for Health and Care Research to support research trials, so that we can give NHS consultants the reassurances that they need in order to consider prescribing more cannabis-based medicines.

I understand that NHS England is involved in discussions on two clinical trials for adults and children with epilepsy, and that Scottish patients will be eligible. That is very welcome. However, when it comes to treatment-resistant epilepsy and patients like Cole, who has been doing well on a cannabis-based product, we have to be aware that certain research methods would not be acceptable to all patients. With the go-to randomised control trial option, participants could end up on a placebo or on a different medication. Clearly, some patients and their loved ones would be reluctant to take part in such trials on that basis.

I would be interested to know more about a few other aspects of CBPMs. Perhaps the minister, in closing, could touch on how the chief medical officer has worked with doctors since the rescheduling to get feedback and develop protocols or guidelines; what role the CMO and the chief scientific officer can play in supporting, encouraging and facilitating relevant research; whether shared-care guidelines are under development; and whether the Scottish Intercollegiate Guidelines Network could develop general or condition-specific guidelines.

We should consider the role of general practitioners, too. I understand that some GPs have indicated that they would prescribe unlicensed cannabis-based medicinal products if they could, in particular when treatment has been initiated by a relevant consultant or when they have seen at first hand the benefits to an individual patient. I call on the Home Office and relevant stakeholders to consider such options, in consultation with patient groups, GPs and others.

I am delighted to have kicked off this debate—the first in Scotland—on access to medicinal cannabis products. It is such a wide-ranging topic, and I wanted to spend some time talking about Cole Thomson from East Kilbride. Getting more evidence is key to widening the use of such products, and I want to see movement on that as soon as possible. I hope that I have given a flavour of just some of the opportunities and challenges in this area, and I look forward to hearing other members’ contributions.

As we have heard, this debate on access to medicinal cannabis is a first for this Parliament—a very important first—and I thank my colleague Collette Stevenson for bringing it to the chamber.

As a co-convener of the cross-party group on medicinal cannabis, I know that a debate on the issue is long overdue. We have heard Collette Stevenson’s heart-rending account of her constituent Lisa Quarrell and her son Cole. As a mother, I cannot imagine the stress and heartache of having to fight every day to keep my child alive and facing the constant worry of how to pay for private prescriptions for the drug on which they depend. About 40 other mothers in Scotland have children who have severe epilepsy and, like Lisa, they have to do that every day. That is not to mention the thousands of chronic pain sufferers and those with conditions for which cannabis can relieve the worst symptoms.

Cannabis is the oldest medicine in recorded history—there is evidence of its medicinal and religious use for more than 4,000 years, so it is not a new drug. However, it is clear that there is stigma around the use of it. I think that it is the psychoactive aspect that scares people, but medicinal cannabis has very low levels of tetrahydrocannabinol, or THC, which is the psychoactive component, so the benefits of its use far outweigh the element of risk regarding side effects.

I make it clear that cannabis for medicinal use is not about people looking to chill out and have a good time; it is about giving people quality of life and pain relief when other drugs have failed to do that. Why should sufferers be denied that simply because of ill-informed prejudice?

The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 allow for cannabis-based medicines to be legally prescribed for any condition. Thomas Mulvey of the MS Society Scotland has for some time been calling on the Scottish Medicines Consortium to approve Sativex. Cannabis-based Sativex has been shown to be hugely beneficial in treating symptoms that are associated with MS, and it will be considered by the SMC later this year.

As my colleague Collette Stevenson said, the MS Society’s UK-wide report into Sativex found that 22 per cent of people living with MS had accessed “illegal forms of cannabis”.

As Ms Mackay and Ms Stevenson have pointed out, there is a licence for Sativex for the treatment of moderate to severe cases of multiple sclerosis. However, the manufacturer has not yet made a submission to the SMC and, as a result, Sativex is not yet recommended for routine use on the NHS in Scotland.

The SMC remains in discussions with the manufacturer of Sativex regarding its plans for submission, but the decision on, and the timing of, a submission will be up to the manufacturer. Members might want to encourage the company to make a submission, but until it does so, there is nothing that we can do. I want to let members know that that is the case with regard to this very important issue.

I thank the minister for that clarification. That is really interesting, because the MS Society’s report found that 22 per cent of people living with MS had accessed

“illegal forms of cannabis to treat their ... symptoms”,

which I find outrageous. I understand that Sativex gained Medicines and Healthcare products Regulatory Agency approval 10 years ago, and that MS sufferers are being forced to break the law to gain access to it, so I hope that the situation changes quickly.

Why are we not prescribing such a demonstrably effective drug? In Scotland, there are currently no NHS patients receiving CBPMs, and, in the UK, there are only three. The international data tells a different story, but I do not have time to outline that.

The barriers to prescribing include the National Institute for Health and Care Excellence guidance, which, as I understand it, is not legally enforceable in Scotland and is not legally challengeable by Scottish patients. That is typical of the legal confusion that surrounds the prescribing of cannabis-based drugs. However, NICE has clarified that healthcare professionals in England should not feel

“prevented from considering the use of unlicensed ... products”

if it is appropriate for individual patients.

Although powers relating to the regulation of medicines and medicinal products are reserved, funding for cannabis-based products through NHS prescriptions is a devolved issue. Only specialist doctors on the General Medical Council’s special register can prescribe unlicensed cannabis-based products for medicinal use. GPs cannot, or will not, prescribe them. Around the world, prescribing is done mostly through primary care, but for some reason the UK has gone down the route of allowing only specialists to prescribe.

Weak clinical evidence is also cited as a barrier, but I would argue that the thousands of patients whose lives have been immeasurably improved by such products are evidence that they should be prescribed. There is also the fear factor among clinicians, along with a lack of awareness and training. The GMC, which is responsible for overseeing medical practitioners in good prescribing practice, is working with clinicians on the prescribing of CBPMs. However, it would appear that many NHS clinicians fear being struck off if they prescribe such products.

I believe that it is possible for Scotland to lead the way on cannabis research. My time on the cross-party group has been a huge learning curve for me. The issues around prescription are embedded in a legal minefield, but I am optimistic that that will change soon. The Cabinet Secretary for Health and Social Care is liaising with the UK Government on the need to build the evidence base for CBPMs, and he believes that the UK Government and the Scottish Government could work together to achieve that.

In conclusion, I urge the minister to ensure that the issue is taken forward and clarified in Scotland without further delay, and to look at international evidence, get the trials under way and sort out the legal complexities. The lives of thousands of patients—old and young—depend on it.

I welcome the opportunity to speak in the debate, and I congratulate my friend and colleague Collette Stevenson on securing it. I thank my office manager, Scott McElvanney, for his assistance and research that helped me to prepare. It has been interesting to hear directly about the impact on Cole’s life, and about Lisa’s experience, and it is important that the debate is being held.

Just as synthetic drugs can help some conditions and not others, it is important to note that cannabis is not a one-size-fits-all line of treatment. In addition, when it comes to discussing the legalisation of cannabis, it is important that we make the distinction between recreational purposes and medical treatment. In legalised forms of medicinal cannabis, the benefits come from chemical elements in the plant. I absolutely recognise and agree with Rona Mackay about the stigma that is associated with that. It is important that we highlight the medicinal effects—not the THC effects that other people might seek.

The benefits are becoming more evident through proper clinical trials and research, both globally and at the University of Glasgow. The research suggests that the benefits of cannabis come from some of its compounds, which are cannabinoids such as cannabidiol—CBD. Interestingly, Hilltop Leaf Ltd, which is a private medicinal cannabis cultivation and extraction business that aims to provide a plant-based clinical treatment as an alternative to synthetic pharmaceuticals, has opened a site in Dumfries and Galloway with South of Scotland Enterprise funding, and is growing cannabis for medicinal research and use.

Those compounds can translate to multiple physical benefits. When I worked as a post-anaesthesia care nurse, pain management and pain relief were a critical part of my job, whether I was giving, intravenously, morphine, diamorphine or paracetamol. That was acute pain management. However, a lot of those drugs are also used in chronic pain management, so I was interested in the evidence from the various clinical trials, which has generally agreed that medicinal cannabis reduces pain, by altering pain pathways in the brain.

The evidence from the studies shows the benefits of cannabis-based drugs for patients with arthritis, fibromyalgia, endometriosis and migraine. In some instances, those drugs are reported to help to replace the long-term use of non-steroid anti-inflammatory drugs—NSAIDS—such as ibuprofen, which also have negative side effects. That means that CBD can help to reduce inflammation. Clinical trials have been carried out for patients who live with Crohn’s disease and irritable bowel syndrome and rheumatoid arthritis. In every one of those studies, cannabis-based medication decreased inflammation and led to increased independence, and greater wellbeing for patients—which we should absolutely support and pursue.

Due to the effects on the limbic system, research is being carried out—including, in Scotland, by the University of Glasgow—on the ability of cannabis-based medication to treat anxiety, epilepsy, multiple sclerosis, Parkinson’s disease, post-traumatic stress disorder and even Tourette’s syndrome, and insomnia. Clearly, there is a body of international evidence on the benefits of medicinal forms of cannabis, and we should be further exploring regulated forms of medicinal cannabis for prescription here in Scotland.

Following the changes to the misuse of drugs legislation in 2018, cannabis-based products can be prescribed in cases of special need. I am aware of three products: Epidiolex, Sativex and Nabilone. Epidiolex is recommended for prescription in Scotland, but we there have been difficulties from general practitioners about the way that the drugs can or cannot be prescribed.

The Royal College of General Practitioners says that it has been pressurised into prescribing unlicensed medicinal cannabis products.

That happens because patients with life-limiting conditions read social media posts about the benefits of medicinal cannabis products. The RCGP has shared its concerns about the lack of availability of medical cannabis products. I encourage the minister to support GPs by taking forward clinical guidance and by looking at the education that is available to patients and clinicians about those products.

I am conscious of time. I agree that medicinal cannabis compounds and products have many benefits and I encourage the Scottish Government to continue supporting clinical research into those products to improve the outcomes for folk whose health conditions are totally life-limiting.

I thank Colette Stevenson for lodging her important, comprehensive and fairly balanced motion, and I congratulate her on securing the first ever debate on the issue. She deserves plaudits for that.

Members have related the experiences of families who find themselves in painful and distressing circumstances, trying to do the best for their children. We have heard from many members how families have used their own money to access cannabis-based products through private prescriptions, and the further pressure that that has placed on already stretched family finances.

I thank all members for the tone of the debate, which I think is important as we move forward on the issue. I am sure that all of us can only have enormous sympathy for any family or any patient who finds themselves in this extremely difficult position, and we will all understand their desire to explore any avenue to help families or their loved ones.

I want to reflect briefly on what the Scottish Government has powers over in this area, the situation now and what we are seeking to do to try and help. At the moment, the regulation of medicines is a UK Government responsibility, which is undertaken by the Medicines and Healthcare products Regulatory Agency. Before a medicine is marketed, the manufacturer must demonstrate its safety, quality and efficacy. Applications for a marketing authorisation, also known as a licence, must include data demonstrating the medicine’s quality, safety and efficacy. The MHRA will consider that data before a licence is granted. I should also note that, when the law changed in 2018, it did not relate directly to providing such products in the national health service.

The rescheduling of products under the Misuse of Drugs Act 1971 did not alter the role of clinicians in deciding what treatments to prescribe to patients. Clinicians make those decisions on a case-by-case basis, taking account of the specific needs of the individual. Government ministers cannot and—I am sure that everybody agrees—should not intervene in those clinical decisions.

Again, that is a difficult area. The Government is, of course, very well aware that families have spent substantial sums on private prescriptions for cannabis-based products. I hope that the Parliament will understand that the cost of treatment that has been sought privately must be met privately and must not consume funding that would otherwise be made available to the NHS.

However, we should strive to move the situation forward by underlining the importance of new products being developed and fully assessed, so that they can then be licensed and considered for general availability on the NHS here in Scotland. That is what we would all want to strive for, and that is what we should do.

In my speech, I will try to explain how we plan to move forward on all of this. I do not have very much time left, Presiding Officer, so I hope that you may be a bit lenient with time, for what I do not cover in this speech, I will write to individual members about, on the issues that they have raised.

Since the changes in UK regulations, doctors on the specialist register of the General Medical Council have been able to prescribe an unlicensed cannabis-based product for medicinal use if that is clinically appropriate for their patients. Many members have spoken about GPs today. GPs may prescribe licensed cannabis-based medicines, subject to any restrictions under the product’s licence, but the law also allows GPs to prescribe unlicensed products, under the direction of a specialist as part of a shared care arrangement.

In Scotland, as was highlighted earlier, the only licensed cannabis-based product for medicinal use is Epidiolex, which is licensed for severe epilepsy. That drug has been through randomised controlled trials and assessed by the MHRA and the Scottish Medicines Consortium. That means that, unlike other cannabis-derived products, it has been assessed for quality, safety and efficacy, as well as clinical and cost-effectiveness.

I will give a bit of time back to the minister.

I do not think that that is quite right. I will get back to Ms White with some of the specifics. There is a huge amount of information in front of me about what GPs can and cannot do. I am not going to have time to read all that out today in the chamber. However, I will write to all members who have taken part in today’s debate to outline how that works, if that would suit members.

Our clinicians are professionally and clinically responsible for any medicine that they prescribe, and the responsibility when prescribing an unlicensed product is greater than when prescribing a licensed medicine. That is why a clinician must be satisfied that there is sufficient evidence or experience of an unlicensed product’s safety and efficacy before prescribing. If a clinician feels that it is not appropriate to prescribe a particular product, they do not have to. When the evidence base remains limited and there is not full clarity about the risks or harms, it is right that doctors are cautious about prescribing such products.

I will move on to some recent clinical guidelines, which demonstrate a clear need for more evidence on the safety, quality and effectiveness of unlicensed medicines to support routine prescribing on the NHS. That, as members know, is why access on the NHS remains limited and prescribing of such medicines happens almost entirely within the private sector. It is also why the Government continues to support the development of new clinical trials.

Current evidence for the medicinal use of unlicensed cannabis-based products is from small, low-quality observational studies and patient-reported outcomes. I hope that members understand that it would not be safe to allow for general access on the basis of such limited data. In the UK, in the past, we have, unfortunately, learned about the dangers of allowing new medicines to be given to patients before thorough testing of safety and efficacy. That is why we support the establishment of clinical trials led by NHS England and the National Institute for Health and Care Research.

It might have been Emma Harper who asked about the chief scientific officer’s involvement. He has been in discussions on those issues, too—[Interruption.]

The minister needs to conclude.

Those randomised control trials will involve two groups of patients—adults with epilepsy and children with epilepsy. For each group, there will be three arms: one with cannabidiol, which is known as CBD; one with tetrahydrocannabinol—commonly referred to as THC—which is the principal psychoactive constituent of cannabis; and one with a placebo. I understand that the study team will announce the plans for the trials as soon as possible, including when patient recruitment is expected to commence and when the trials will be complete.

It is essential—this was touched on earlier in the debate and in my response to Rona Mackay—that manufacturers come with us to conduct the research. Despite repeated calls, some in the cannabis industry have largely failed to invest in clinical trials, although GW Pharmaceuticals stands as a noteworthy exception.

I want to assure the Parliament that the Government has been clear and unambiguous in its support for exploring solutions in what is a very difficult situation. We are more than willing to work on a cross-party basis to ensure that we move forward on that. We are committed to working with clinicians, the UK Government and regulators. Crucially, we need manufacturers to take the steps that are needed on clinical trials, so that patients and families can get the help and support that they need as quickly as possible. If we can build an alliance across the chamber, we might be able to work well together to persuade those manufacturers to do exactly that.

Thank you, minister. That concludes the debate. The minister referred to writing to each member who participated in this evening’s debate. I request that he ensures that the Scottish Parliament information centre receives a copy of that so that the information is in the public domain.

Absolutely.

Thank you, minister. With that, I close the meeting.