Medicinal Cannabis

Jo Churchill Excerpts

Monday 6th September 2021 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

First, I congratulate the hon. Member for Edinburgh West (Christine Jardine) on securing this debate. I agree with colleagues’ comments: it has been incredibly helpful to have time to talk about this issue. As I sat on the Front Bench, the debate highlighted to me, first, the needs of these children and their families, and secondly, the complexity of the whole situation. We can make statements, but there are no easy solutions. This issue involves the medical profession, licensing and trials.

Let me thank all those who have contributed to the debate. In no particular order, so as not to upset anybody—I have met many of those who have contributed on numerous occasions—I thank my hon. Friends the Members for South Leicestershire (Alberto Costa) and for Windsor (Adam Afriyie), and the hon. Members for Strangford (Jim Shannon), for Gower (Tonia Antoniazzi) and for South Antrim (Paul Girvan).

I thank my right hon. and learned Friend the Member for Kenilworth and Southam (Jeremy Wright), who is not in his place but with whom I have met. As is the constituency MP for Hannah Deacon and Alfie, he has contacted me and spoken to me on several occasions.

I thank the hon. Members for East Kilbride, Strathaven and Lesmahagow (Dr Cameron) and for Inverclyde (Ronnie Cowan), to whom I shall not forget to wish a happy birthday.

As my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) said, we have known each other a long time and I have carried his bags on more than one occasion—

[Sir Mike Penning]

Not no more!

[Jo Churchill]

Not no more, but I understand where his passion comes from.

I can also see in their places the hon. Member for Manchester, Withington (Jeff Smith)—we have spoken about this matter—and my hon. Friend the Member for Reigate (Crispin Blunt).

At the heart of this debate for me are Alfie; Billy; Eddie Braun, who was not mentioned; Murray; Jorja; Maya; Bailey Williams, mentioned by the hon. Member for Gower; Sophia; and others. It is about those children. I have personally met several of the families and heard at first hand how it feels not to be able to have anything more. To be honest, as a mum of four, I can say that sympathy feels a bit useless when it comes to a mother who, in some cases, can watch their child fit 100 times a day. They have explained to me the relief that applying Bedrolite under the tongue brings to their children. They have spoken about the financial challenges, but I would like to use the time available to go over some of the challenges that I am trying to wrestle with to get to a solution.

We have had an accordion debate tonight. Initially, the hon. Member for Edinburgh West said that this debate was about access to NHS prescriptions. However, many others also spoke about how much this might benefit multiple sclerosis sufferers and those with chronic pain. Indeed, Lord Field in the other place has written to me on this subject and spoken about the relief of chronic pain that I think he himself gets from using a cannabis-based product. However, there does have to be an evidence base that is more than observational.

[Tonia Antoniazzi]

There has been a lot of talk about randomised control trials this evening, and I understand the difficulty that the NHS has with this. We have had numerous meetings with NHS England and with pharmacists on this. The issue is that the RCTs are a no-goer. They are just a no-goer. I would never take my child off a drug if I knew that it could possibly kill them in order to enable the NHS to prescribe. We have to overcome that hurdle. I would like to see a push from the Minister to make that change happen. We have seen it with covid and we have seen it with the vaccine. What the NHS has done is incredible. I would really love to have the Minister onside to be able to push the NHS forward to change its mind over the RCTs.

--- Later in debate ---

[Jo Churchill]

I understand that point and I have said to those parents that I would struggle. In fact I would probably find it impossible to offer my child something else when they were already gaining relief from something. However, as we have debated here today, there are probably two issues here: the treatment of those children who are already on Bedrolite; and the need for an evidence base, particularly when we start to talk about expanding the use of cannabis medicines for those suffering from a large range of other medical issues, be it MS sufferers and so on. This is where the challenge comes. Clinicians rightly want to prescribe based on the evidence so that they do their patients no harm. Many people have said that this is the place of last resort for these parents, but we have this difficulty.

[Sir Mike Penning]

rose—

[Jo Churchill]

I will go on to explain why after my right hon. Friend’s intervention.

[Sir Mike Penning]

I have two points. The first is that it is not all Bedrolite. A lot of these parents do not have Bedrolite. There are myriad specialist ones with different THC levels, but they have been prescribed by a consultant. I know what my hon. Friend said, but these are consultants, and they do want to prescribe the drug and they have prescribed it, but they are not allowed to put it on an NHS prescription unless you are Alfie, Billy or any of the others. It just does not make sense.

[Jo Churchill]

I agree that there are other medicines, but one of the challenges is how we treat people with ongoing needs as their conditions vary, if we do not have the ability to understand how the body is responding.

I will push on a little bit. Let me provide an update on Bedrocan oils from the Netherlands. As stated previously, the commercial agreement between Transvaal Apotheek and the UK special medicines manufacturer, Target Healthcare, is progressing. The Medicines and Healthcare products Regulatory Agency and the Home Office are working with those companies to ensure that all regulatory standards for manufacturing these medicines in this country are met. We continue to work closely with the Dutch Government, Transvaal, the Home Office and the MHRA—which I have met with and which says it will look at the international evidence—to ensure continuity of supply until domestic production has been established. We have had movement; I can sense the frustration in the House tonight, but we are moving forward. I will continue to keep the House informed of progress.

On the main topic of the debate, it is undeniable that it is incredibly hard for many of the patients and their families. As many Members have said, the challenges have done nothing but worsen during the covid-19 pandemic. The Secretary of State for Health and Social Care, my right hon. Friend the Member for Bromsgrove (Sajid Javid), when he was Home Secretary, changed the law to allow unlicensed cannabis-based products for medicinal use to be prescribed by doctors on the General Medical Council’s specialist register. This removed legislative barriers to legitimate use as a medicine. However, there is still caution across specialists in their ability and willingness to prescribe. [Interruption.] Indeed. However, with respect, if the prescribing of these medicines by a clinical specialist was that seamless, we would have more of it, but we do not.

The whole thing comes back to the fact that clinicians want to rely on an evidence base, and that includes clinicians in Scotland. We recently received a letter from the Scottish Government, outlining that Dr Rose Marie Parr, former chief pharmaceutical officer, had chaired a teleconference with key paediatric neurologists from specialist centres. The clinicians had a clear and united view that, following the GMC and British Paediatric Neurology Association guidelines, they would be unwilling to prescribe CBPMs containing THC, including Bedrolite, until there is clearer, published evidence available following a clinical trial.

[Tonia Antoniazzi]

rose—

[Dr Cameron]

rose—

[Jo Churchill]

All three Members rose at the same time. I will make my next point before I take interventions.

While the evidence base remains limited, I am sure that everybody, including clinicians in this place, will agree that decisions on whether to prescribe, as with any other medicine, have to remain clinical decisions. A doctor would not appreciate me in their consulting room telling them that they did not know their job as a doctor.

[Tonia Antoniazzi]

I thank the Minister for giving way again. I would just like to point out to her that that is not the case. There are three NHS prescriptions. If the law was changed, why are there those three NHS prescriptions? Either these medicines are safe or they are not. They must be safe. I understand what she is saying about the clinicians, but let us look at the risk-benefit for the particular group of children we are talking about. We know that “First do no harm” is how our clinicians treat their patients, but they have to move forward. Hannah Deacon is a classic example. She is continuing to campaign because she sees the unfairness and injustice that Alfie has his prescription but other children do not. Please, Minister, help us to move this debate forward.

[Jo Churchill]

Hannah has said those exact words to me. That is why I say that we have to look at this in a selection of doable, achievable pieces, because it is not possible to look at it for every condition. We are talking about those children with refractory epilepsy, and trying to find solutions there is my main focus currently.

[Christine Jardine]

I am not a medical person; I am a parent. I think back to the start of covid-19 when we were told that it would take years to do the clinical trials and to do everything that was necessary to have a safe vaccine, but now we have it, and a successful roll-out, because there was the will to do it—to think out of the box. I think for many people the frustration comes from the question of why the medical profession are not being encouraged to look at an alternative way of finding the reassurance that will enable them to be looking at the observational evidence from abroad and taking it on board. They will be looking to the Government to encourage them to do that.

[Jo Churchill]

I would like to reassure the hon. Lady that we do look elsewhere, but it fundamentally comes back to the fact that observational trials on very small cohorts are not the best way to develop the policy, going forward, to treat these individuals. That is notwithstanding the fact that the observations of all the parents I have met, and others who have seen their children benefit, are the foundation for making us try to put our shoulders to the wheel in order to do better. I think there is that tension.

Looking across other countries, my hon. Friend the Member for Windsor (Adam Afriyie) said, “If they can do it, why can’t we?” What is needed to support routine prescribing is the evidence base of safety and efficacy, public funding and cost-effectiveness. This is the system that we use in the UK for all medicines and medical devices, and it is really difficult to see a case for why cannabis should be treated differently from that on a broader spectrum, particularly when we take into account the comment by my hon. Friend the Member for Reigate (Crispin Blunt) that there is a need to look at how these medicines may help others suffering from chronic pain. I have been told that multiple sclerosis and palliative care are other areas, and so on. If we are going to broaden this, then we must look to do the job properly.

[Dr Cameron]

I thank the Minister for grappling with what is a very complex matter. I totally understand what she is saying. I can understand some clinicians’ reluctance because they do not want to prescribe something when they do not know what is contraindicated in relation to other conditions and they do not want to do harm. But this must potentially be done where the children are already benefiting from some kind of expedited process to ensure that they can have the prescriptions and that parents are not having to try to fund that in so many different ways, causing that stress. There must then be some kind of expedited clinical trial that shows that clinicians more broadly can have the confidence that they are prescribing medications that will support conditions, do no harm and would not be contraindicated or cost children or adults their lives if prescribed to the wrong individuals.

[Jo Churchill]

I thank the hon. Lady because she encapsulates in a nutshell what the challenges are. This is extremely difficult without that knowledge of what the contraindications are. I was trying to suggest, perhaps not as eloquently as I could have done, that we need these different bits in order to make the policy work. As the House has heard, the current Health Secretary was the Home Secretary when he changed the law, and at our very first meeting, he told me it was one of the things he was very keen to see us move forward on.

[Several hon. Members rose—]

[Jo Churchill]

I am going to make a little progress, because at this rate we will go up to the end of the time. I will come to my right hon. Friend the Member for Hemel Hempstead.

While saying that it should remain a clinical decision for doctors—indeed, that was very much what I took from the hon. Member for South Leicestershire, because it would be inappropriate for Ministers in Whitehall or the Scottish Government to influence individual prescribing decisions—with the exception of three licensed medicines, cannabis-based products for medicinal use are not first-line medicines and are not routinely funded. Most cannabis-based medicines are unlicensed medicines, and that means they are yet to have their quality, safety or efficacy assured by regulators here or, indeed, anywhere else around the world. Nor has their cost-effectiveness been decided by the National Institute for Health and Care Excellence, which is how we administer medicines. Those are the foundations of NHS decisions about routine funding. The cost of treatments sought privately remains the responsibility of the patients, and I am not cloth-eared to how difficult that is and why we need to try to find a solution.

[Sir Mike Penning]

rose—

[Tonia Antoniazzi]

rose—

[Jo Churchill]

I will give way first to my right hon. Friend.

[Sir Mike Penning]

The Minister is being very generous, although we have plenty of time. I think we have until half-past 10, Mr Deputy Speaker, should we or you wish. I have two questions. The hon. Member for Gower (Tonia Antoniazzi) asked a specific question: how is it safe on the NHS for three prescriptions to be given to three children, paid for by the NHS, but not any others? Is it safe, or is it not? The Minister referred earlier to clinicians not having the confidence to give the prescriptions. Is she aware that one of the clinicians was reported to the General Medical Council for writing a prescription and was exonerated? That is why they are scared; they are scared for their careers. How can it be safe for three children, but not the other children whose lives can be saved?

[Jo Churchill]

I thank my right hon. Friend. I have met clinicians, as well as the families. Like just about every other area of medicine, there is divergence in how they approach it. There are those who prescribe and those who do not. I have also spoken to Alfie’s general practitioner, who was very articulate in describing the benefits that Alfie saw from taking medicinal cannabis. However, it is still fundamentally the decision of the clinician who has the child as the patient. One thing that has been said to me is that it is important, as we try to move forward and do better, to ensure that private specialists also have conversations with those who are treating the children for other issues in their NHS care, because of contraindications and so on, as was referred to earlier.

[Tonia Antoniazzi]

I thank the Minister for being so generous with her time. The right hon. Member for Hemel Hempstead (Sir Mike Penning) has made a real point about there being a culture of fear within the NHS and with clinicians, who are too scared to prescribe because they do not know what the consequences are. The Minister has a role to play here in enabling them to have the confidence to prescribe and work with the drug that we refer to as cannabis. In this House, we should not be using the word “cannabis”, because it strikes that fear into the hearts of many, many people across the UK. Most other drugs have a single active ingredient; medical cannabis has many. If the Minister does not accept that randomised control trials are not applicable, we are in a Catch-22 situation and we are forever stuck. This is not acceptable.

[Jo Churchill]

I do not believe we are stuck, but we should proceed with caution. I think that is a totally acceptable way to go on. I think it was the hon. Member for Edinburgh West who asked why it is any different from insulin or the other drugs she listed. It is different, so we must proceed with caution.

[Christine Jardine]

On that point, will the Minister give way?

[Jo Churchill]

One minute. The cost of parents accessing private treatments remains the responsibility of patients. I am aware that the cost remains high and has brought immeasurable hardship to some families. However, the Government cannot stipulate what companies charge for these products. Furthermore, these are controlled drugs that are specially manufactured or imported for the treatment of an individual patient with an unmet clinical need. In such cases, there are also international treaties with which we have to abide, which mean that companies exporting or importing controlled drugs incur fees to support the necessary governance processes.

We have done an enormous amount within the constraints of the treaties to reduce the costs, making clear what the rules are about and how much can be imported under each notification, and allowing licensed importers to have a small additional supply so that children can get hold of a supply. The supply can be drawn from when a prescription is given by a specialist doctor, reducing the amount of time that a patient might wait for their medicine and helping to ensure continuity. However, the export of finished Bedrocan oils from the Netherlands is currently restricted under Dutch law, so the latter change does not apply to those products. The licensed cannabis-based products Sativex, nabilone and Epidiolex, for which there is clear evidence of safety clinical trials and cost-effectiveness, are provided routinely on the NHS for their licensed indications. Indeed, last month, the licensed indication for Epidiolex was expanded to those with tuberous sclerosis complex. I have heard from parents who have tried some of these drugs and found them not to be successful for their children, but it is important that as we build a better reference for cannabis-derived medicines, we have a suite of products that we can draw on.

[Christine Jardine]

I thank the Minister for giving way; she is being incredibly generous with her time. I would like to say, however, that when I referred to insulin and inhalers, I was not comparing medicine with medicine; I was talking about the principle of having to pay for something that makes such a fundamental difference to people’s lives, and how families are having to pay when, as other hon. Members have said, NHS prescriptions have been issued.

[Jo Churchill]

I apologise for the confusion; I misheard.

[Jeff Smith (Manchester, Withington) (Lab)]

Will the Minister give way?

[Jo Churchill]

One second. On the expansion of Epidiolex, NICE will work with the manufacturer to assess the clinical and cost-effectiveness of the medicine in the indicated patient group before making recommendations for routine prescribing and funding on the NHS. That is the proof. Where there is the will and investment in clinical trials, cannabis-based medicines can achieve the medicinal licence that is the gateway to routine funding. They have become a useful tool for clinicians in treating diseases where other licensed treatments have failed, but the licensing process also provides for the development of the evidence and information that doctors rely on to support their treatment decisions, as was laid out by my hon. Friend the Member for Reigate (Crispin Blunt). The MHRA is well equipped to provide advice to any prospective applicants wishing to conduct clinical trials or marketing authorisations. Indeed, there have been 13 trials ongoing in the UK in the past 12 months, and six other trials of this type of medicine have been completed.

On refractory epilepsy and the children we are specifically interested in tonight—that is not to exclude any other patient group—NHS England, NHS Improvement and the National Institute for Health Research have confirmed in principle support for two randomised control trials on early onset and genetic generalised epilepsy. These will compare medicines that contain cannabis oil, CBD only and medicines that contain CBD plus THC with placebos. While, like many other projects during the pandemic, there have been delays on commercial discussions, these are nearing completion. Once supply contracts have been finalised, the study team will be able to initiate the formal trial set-up process and confirm a date for patient recruitment. This is a pioneering area of research, and we are keen to support patients by progressing these trials as soon as possible. I feel keenly the frustration that they have taken so long, and I hope to be in a position to make a further announcement on these clinical trials in the next few weeks.

[Jeff Smith]

The Minister is being very generous in giving way, and I know she wants to find a solution to this problem. I tried to get in earlier when she referred to some parents who had used medical cannabis and found that some of it worked and some of it did not work. It sounds like an evidence base was being created there. I understand that she does not want to create a system for all our medical regulation based on observational trials, but there are many experts who say that randomised control trials will not work for cannabis and we need another way of getting the evidence. Given that we clearly have a system that is not working, is there not a case for this particular condition and this particular type of medicine being a special case? We need to find a different way of creating such an evidence base to give the clinicians comfort.

[Jo Churchill]

I will focus on the end bit. We do need to give clinicians comfort if they are going to prescribe medicines that help alleviate children’s pain. The challenge with the observational trial, as anyone who has been involved with medical trials will tell you, is that the smaller the cohort, very often the greater the problem is with the confidence intervals, and so on and so forth. There is a need to look at things by perhaps turning the telescope the other way up to see whether we can focus ourselves on approaching this in a different way to find solutions. However, the bottom line is that we need good evidence, because we have also been in this Chamber talking about drugs where the challenge to the patient has then transpired, and we later we have been here talking about the damage.

[Crispin Blunt]

Particularly in the light of what my hon. Friend has just said about turning the telescope around and thinking about this in a different way, this is not just about the United Kingdom; this is global. There is evidence all over the world that we can use, and we do have a terrible tendency of “not invented here” in some of this. There are other countries in which the authorities are finding a positive way to license this medicine. While obviously the focus is on these particular children now, behind them sit tens of thousands of people self-medicating on cannabis and making themselves criminals in the process. Behind them sit our 2,500 veterans who have untreatable trauma, who are being driven into the hands of dealers to find ways of managing that trauma. We are turning heroes into junkies because we are not advancing the science base as fast as we should.

We should be really supporting the research, which is why I am delighted to hear what my hon. Friend has just said. Let us really go for this. We can underpin the bioscience base of our country if we do so. We have just seen Dr Carhart-Harris, a leading researcher in the whole application of psychedelics, disappear from doing research in London to the United States. It is exactly the parallel argument with medicine from cannabis. We need to get behind the scientists and the researchers, and let them help our people and teach our medical profession what is available to them to help their patients.

[Jo Churchill]

That is true. However, people have to come forward with clinical trials designed in a way that is acceptable and gives us robust outcomes. We have discussed this and Psilocybin, and many other things, at some length in the past, and although tonight is not the time to carry that on I am sure we will do so again.

We take into account literature and evidence from other countries, and the guidelines published by the National Institute for Health and Care Excellence were developed in accordance with well-established processes based on internationally recognised and accepted standards. This ensures a systematic, transparent approach in identifying the best available international evidence within the scope of guidance at the time of the NICE evidence review. However, NICE found that current research is limited and of low quality, and that makes it difficult to assess just how effective these medicines are, and we need to make sure they are safe.

[Adam Afriyie]

I empathise with the Minister; this is tricky, because one does have to introduce medicines in a safe way according to a set formula and we have quite a good system.

I have two points. First, we were talking about prescribing to children untested or unvalidated medicines, yet in some treatments we are prescribing adult steroids to children. Will the Minister say something about that, as it seems slightly inconsistent? Secondly, there are patients, in particular children, who shortly will have no prescription whatsoever when the last specialist who can make these prescriptions retires. How are we going to cover that?

[Jo Churchill]

I am obviously very cognisant of the latter point, and my right hon. Friend the Member for Hemel Hempstead mentioned a court case. This adds to the need to find solutions to the problem. On adult steroids, that is a clinical decision by a doctor, and my hon. Friend would not expect me to comment on that, because we are dealing here with incredibly poorly children, and our heart goes out to them.

[Tonia Antoniazzi]

rose—

[Jo Churchill]

The hon. Lady is looking at her phone intently and jumping up again, so I will give way.

[Tonia Antoniazzi]

I thank the Minister for her generosity in giving way, and she is right that I want to make yet another observation.

One of the reasons why we all came into this House was to make change happen, and I know the Minister feels exactly the same. Maybe her hands are tied, but under the Health and Social Care Act 2012 the Secretary of State has the power to commission an investigation and research into new medicines. End our Pain has shown this to her officials several times; it has even been cited by a Queen’s counsel, whose opinion is that this is possible. This would be a great way to run an observational trial at no cost to parents; why will the Minister not take this option?

[Jo Churchill]

It is not in my gift to take that option, but I will take that comment back to the Health Secretary and have further discussions. As I said, in our very first meeting he highlighted this as an area where he wanted to see movement, and we are determined to get some movement.

We need the evidence base and we need trials to be ongoing to help inform future commissioning decisions. NHS England has also established a patient registry to collect uniform outcome data from licensed and unlicensed products. The refractory epilepsy specialist clinical advisory service has been established to provide expert impartial advice for clinicians treating complex cases while we await the outcome of clinical trials.

I hope I have managed to convey how committed I am, because I do believe that we ought to be able to find the solution for these children, and I was very aware of the hon. Lady’s point about what happens when they reach adulthood. My right hon. Friend the Member for Hemel Hempstead has spoken to me about the fact that as children move through and medicines gets better they thankfully survive longer, but then we have the added complexity of having to look at the system, which is why we want to make sure we find a solution. Finding the right solution is what we are after, because it will take time to generate further evidence and see the results of clinical trials. I do understand, however, that patients and families continue to access these medicines privately, and that the cost of doing so is very high. There are no easy or quick solutions, but I am committed that the Department will reconsider what action the Government may reasonably take with regard to access to unlicensed cannabis-based products for medicinal use where clinically appropriate.

The health of the children and adults dealing so courageously with these difficult-to-treat conditions is of paramount importance. I think it was Hannah who said to me that for every time Alfie does not end up in hospital having fitted repeatedly, there is a saving to the system.

[Alberto Costa]

Will my hon. Friend give way on that point?

[Jo Churchill]

Yes, finally, but then I am going to conclude.

[Alberto Costa]

My right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) made the point that the Government did supply the medication from a different Department, at no cost to the parents. I have suggested to the Minister that the Government, only on a temporary basis, should cover the cost for the very small number of children across the country who desperately need this medication, which they obtain through private prescription. Can she commit today from the Dispatch Box that she will at least try her best to find the money from her Department to cover those costs on a temporary basis?

[Jo Churchill]

I hope that I outlined earlier that a mixture of solutions is needed to crack this problem. We are not taking anything off the table. We are looking at every option that we can to ensure that we get the right support. Health is devolved, and the access to and funding of medicines is a matter for the relevant devolved nation. I hope, however, that hon. Members have seen that we are all trying to work on the challenge together, because there should not be a difference. As people have said this evening, this is not partisan; it is about making sure that we get the right care to the children.

I will commit that the health of children and adults is of paramount importance. It is of paramount importance to the Secretary of State and to me. I can assure hon. Members that I will carry on making sure, with my team, that we are doing as much as we can to try to get us to a solution that helps these children in the short term but also the long term, while having as the second strand of work the evidence base that we need to support the wider prescribing of any drug, because we need to make sure that we are doing it with care.

Question put and agreed to.