My Lords, with permission, I shall now repeat the response to an Urgent Question on medicinal cannabis originally made by the Secretary of State for Health and Social Care:
“First, Mr Speaker, my sympathies go out to the patients and their families who are desperately seeking to alleviate their symptoms with medicinal cannabis. We are working hard to make the right approach. The law was changed on 1 November last year and it is now legal for doctors on the specialist register of the General Medical Council to prescribe cannabis-based products for medicinal use in the United Kingdom.
Whether to prescribe must remain a clinical decision to be made with patients and their families, taking into account the best available international clinical evidence and the circumstances of each individual patient. Indeed, there have already been prescriptions written for the products that the family attempted to bring into the country, and these have been supplied to patients. Without clinical authorisation, it is of course not possible to import controlled drugs, which is why the drugs were seized by Border Force on Saturday. However, we have made available the opportunity for a second opinion and the products have been held and not destroyed, as would usually be the case.
In relation to childhood epilepsy, the British Paediatric Neurology Association has issued interim guidance. NHS England and the Chief Medical Officer have made it clear that cannabis-based products can be prescribed for medicinal use in appropriate cases, but it must be for doctors to make clinical decisions in the best interests of patients. It is they who have the skill and the training to balance the risks and the benefits of any proposed treatment, including cannabis-based products, and to make a decision with patients and their families on whether or not to prescribe.
To date, research has centred on two major cannabinoids: THC and CBD. There is evidence that CBD may be beneficial in the treatment of intractable epilepsy, and over 80 children have already been supplied with CBD products in the UK on the basis of a specialist doctor’s prescription. I entirely understand how important this issue is to patients, and I have met and listened to the families and know just how frustrated they are. Therefore, after meeting the parents, I have taken the following actions.
First, I have asked NHS England to rapidly initiate a process evaluation to address any barriers to clinically appropriate prescribing. Secondly, to provide the evidence base and to get medicinal cannabis to patients in need, I have asked the National Institute for Health Research and the industry to take action to produce that evidence in a form that will support decisions about public funding. The NIHR has issued two calls for research proposals on medicinal cannabis, and I look forward to responses to those consultations. This is in addition to the training package being developed by Health Education England to provide every support to clinicians to enable them to make the best decisions with their patients.
This is a very difficult area, with some heart-rending cases. I look forward to working with all Members of this House to ensure that patients get the best possible care”.
My Lords, I thank the Minister for repeating the Answer given in the other place by the Secretary of State to the right honourable Member for Hemel Hempstead. While we are not talking only about children, children having up to 300 seizures a day must leave their parents distraught and desperate. The Government must act much more hastily to ensure people who can benefit from medical cannabis have the means to get access to it on prescription. Can the Minister set out for the House the timescale for the process evaluation announced by the Secretary of State yesterday? This issue has been going on for far too long and needs resolving finally in the next few days.
I thank the noble Lord for his question. The Secretary of State has asked NHS England to act with the utmost urgency and to bring responses forward quickly. I note that this comes in addition to the HEE training model and the NHS England and BSA system to monitor prescriptions for cannabis products. We expect results from that data this month, so we expect more action imminently.
My Lords, I thank the Minister for the action she is taking. I have some specific questions about what she said. Can she confirm that the second opinion she mentioned will come from a doctor with an appropriate understanding of the safety and effectiveness of these drugs, and that it will be available to all patients in the same situation? Secondly, she mentioned the British Paediatric Neurology Association’s interim clinical guidance, which was made very much as a snap judgment straight after the rescheduling last November; in effect, it just said, “No, no, no”. Can the Minister encourage the BPNA to consider further the massive amount of evidence from abroad and produce more considered guidance? Thirdly, she mentioned the 80 prescriptions for CBD medicines, but that does not strike me as making much progress, because you can get CBD legally on the internet; the only advantage of such prescriptions is getting the drug for free. The issue concerns medicines containing THC, which are the ones that patients desperately need. Finally, the Minister will probably find that trusts are stopping doctors who would like to prescribe these medicines from doing so. Getting the NICE guidance a lot sooner than next autumn would probably encourage trusts to allow their employees to do so. Can she encourage NICE to hurry up, please?
I thank the noble Baroness for her question, and I know that she has campaigned on this issue for some time. NHS England has clarified that clinical guidance does not remove or replace the clinical discretion of the prescriber to act. I know that the process review will look at the impact of clinical guidance, which will hopefully be helpful. We will also look at the role of second opinions. I hope that that has answered some of the noble Baroness’s questions; she made a number of points, and I will write to her on the rest.
My Lords, I want to come back to the point about NICE made by the noble Baroness, Lady Walmsley. My understanding is that, at the moment, the evidence on which doctors can base a decision to prescribe these medicines is very limited. Clearly, relying on the NICE guidance is one way through. My problem is that, if we look at another area such as cataract operations, we see that despite NICE guidance many patients are now being denied treatment that has absolutely proven to be effective. My concern is that the Government seem to be trying to find a way round the evidence relating to these medicines when, up and down the country, patients are being denied interventions that we know will be successful and that can help thousands of people. Can the Minister comment on that?
The noble Lord is right that it is important that guidance is provided. The point of bringing the guidance forward is to look at the most up-to-date evidence available across the country. The challenge with medicinal cannabis is that the evidence base is developing. Currently, more than 100 clinical trials are ongoing worldwide. We are bringing the NICE guidance forward in the autumn to take all that clinical evidence into account in the most up-to-date guidance, so that patients can benefit and clinicians can have more confidence in prescribing. The NIHR call for clinical trials has been brought forward so that the evidence base can be strengthened even further as we go forward because, in the long term, the only way for us to move from an unlicensed prescribing route, which is where we are now, to a licensed route is through clinical trials and a greater evidence base. That is what the Government are keen to encourage.
Do the Government recognise that, whenever patients take part in a clinical trial, there will also be some patients who access the medication outside that trial? Are the Government establishing a confidential database to monitor the outcomes of every child who is prescribed a cannabinoid to look at its efficacy and any harms reported, so that we can get a cross-population database of the effects that could then feed into the evidence-accruing processes? It may be that a royal college such as the Royal College of Paediatrics and Child Health would be able to assist the Government by providing a confidential haven for such clinical data to be collected.
I thank the noble Baroness for her comments, and I know that she is expert in this area. Proposals for an observational trial and the collection of observational data have been put forward. I think that the concern is that, at the moment, there is a lack of confidence in the data. What is needed is the highest quality clinical data because, while a large amount of observational data for medicinal cannabis is available, data at the level of randomised controlled trials is required so that there is confidence not only among clinicians to prescribe but also for the funding system to fund within the NHS. At this point, it is that level of data which needs to be gathered, and that is why the NIHR is bringing forward public funding for it and why the Government are encouraging the industry to fund such trials as you would expect in any other area of the pharmaceutical industry.
My Lords, I declare an interest in that my grandson has intractable epilepsy, so we have been through the whole process, and I have some understanding and experience of this issue. He has recently been prescribed Epidiolex after a long struggle for him to be allowed to use it. Over the past few months, we have seen some incredible benefits from it. Does the Minister accept that rather unfair barriers have been put in place as regards access to this drug for children? I have heard of other cases where the British Paediatric Neurology Association, which she has mentioned, has said that Epidiolex, which is manufactured without THC, could be used for the treatment of childhood epilepsy as long as all other treatment avenues have been explored, including brain surgery and VNS. My grandson has had this treatment, where a device is attached to the spinal cord. These are incredibly invasive, dangerous and risky procedures. Surely it would be better to allow Epidiolex to be tried out rather than insisting on other routes? One mother told me that they are insisting that her child has brain surgery first. That cannot be right.
I thank the noble Baroness for her comments and for setting out her personal experience. She obviously has expertise in this area which few of us in the Chamber can claim. The reason NHS England has put forward is that individual clinical expertise relating to an individual patient is of the utmost importance, even where the guidance might seem to contradict that judgment. That is why in the autumn we will be bringing forward NICE guidance that will look at the most up-to-date evidence which should, we hope, be of assistance. It is also why we are bringing forward the NICE process review in order to understand what barriers may be in place and to encourage clinically appropriate prescribing and try to assist with cases such as these.
My Lords, what Mrs Emma Appleby has done—and I praise her courage—is to show that, whatever relaxation there appears to have been or modification, which we all thought was likely to produce some positive results, in fact that really is not happening. People are being denied medication, with incredibly debilitating results. I have an interest in this because I have a young family member with stage 4 terminal brain cancer. He suffers from sickness as a result of chemotherapy which nothing else is able to help. He has been refused cannabis. The consultant will not prescribe it because he feels that there is not enough information from the Department for Health and Social Care for him to feel that he is justified in doing so and he does not know what the implications might be. I understand from another consultant that the BMA is in fact advising medical professionals not to prescribe it. What is the alternative for desperate relatives? Is it to buy cannabis off the streets not knowing what the quality is and facing the prospect of a criminal conviction? Speed is of the essence here, certainly for my family member. I hope that the Minister can say a little more about the way in which this is likely to progress and the speed with which it will do so.
I thank the noble Baroness for her question and for describing her personal experience. I emphasise that we must allow clinical decision-making in this. We have tried to encourage more experience in the system by putting out guidance through NICE based on the latest evidence, by providing Health Education England with the opportunity to bring forward training to share the best quality experience, and by putting through the process review so we can bring down any inappropriate barriers in the system. I hope that encourages the noble Baroness.