Lord Field of Birkenhead:
Moved by Lord Field of Birkenhead
15: After Clause 6, insert the following new Clause—“Entitlement of a doctor to prescribe medicinal cannabis productsThe appropriate authority must by regulations make provision to—(a) grant authorisation to place on the market of the United Kingdom high quality, standardised medicinal cannabis products for prescription by a doctor (including, for the avoidance of doubt, by a general medical practitioner),(b) permit doctors to prescribe medicinal cannabis products, and any device or article that is required in the administration of such products, and(c) require the relevant regulatory and advisory bodies to obtain and evaluate relevant scientific and medical literature and data, including on long-term patients’ experience in connection with cannabis for medicinal use (as well as the potential for such use) with particular reference to—(i) the efficacy and therapeutic value of medicinal cannabis products,(ii) matters pertaining to the safety of medicinal cannabis products, and(iii) the medical conditions (indications) in respect of which medicinal cannabis products may be administered and used.”
I beg to move this amendment in my name and those of other noble Lords whom I count as friends. It is quite clear what the amendment is about; we list it at the very top:
“Entitlement of a doctor to prescribe medicinal cannabis products”.
It is an enabling clause to allow that to happen. The debate today is not really about whether we have been clever enough to draft an amendment which will satisfy the Government, but about whether there is the will in Government to make a change that will affect a large number of people in this country, myself included, who use cannabis as a product to counter pain.
We have heard the urgency in today’s discussions, and Oral Questions, to look at the plight of those little children whose brains are shaken to bits and beyond repair if they do not have access to this product. I would not want to be in the ministerial positions which have to decide how many more days those children must wait before their parents can obtain supplies which will abate the terrible effects of these endless fits, which come like the second hand on a clock, devouring their intelligence and ability to lead a proper life.
The debate is about whether the Government will make this change so that those doctors who wish to prescribe medical cannabis products are free to do so. We are not doing so in a form which, I hope, anybody could consider as irresponsible. We know that there need to be checks and that there are dangers with all medical products. But we have seen recently a wonderful example of the political will which decided that as soon as a vaccine was ready to distribute, providing that safety was ensured, that drug would be rolled out. I hope one of the things we will get from this evening’s short but important debate will be a commitment from the Government that the speed shown to protect the whole population from Covid will similarly be displayed when we come—I hope at some stage soon—to agree the distribution of medical cannabis via the NHS rather than privately.
It is rather appropriate that I discovered the world of campaigning on this product when I was involved in a minor role in trying to advance the interests of those children. I must say, to hear parents who are remortgaging their homes to buy the products for those children is pretty grim for somebody like me, who can acquire these products, quite legally, because they have the money in the bank to do so. It is not a principle which I think many in this noble House would agree with. We are anxious not only about the issue with Alfie, who was one of those very people when I first was engaged in this issue. Maybe we will have news from the Minister tonight about an agreement that has been made so that there will not be another day where those children are vulnerably exposed to the will of their bodies, which causes such destruction of their long-term futures.
I quite understand the need for political courage on this issue. Is it not amazing that I have to say that, when we are talking about maybe a million or more people who depend on this drug to counter the pain which they suffer, and that we should be talking in such terms? I do believe that there will be a change soon in these regulations and that we will move to a more civilised position, where people who have tried—as I did—all other traditional methods of controlling pain and then find a way of doing so will be able to secure this product on the NHS rather than because they possess enough private resources to do so.
It is an immensely important topic which, I think, Members of the House will be pleased to know we are not going to extend by reciting the same speeches that we have already given. We will want the key debate to take place—though it cannot—once the Minister has spoken and told us where the Government’s thinking on this issue is. I move the amendment in this brief way not because it is a topic lacking in importance; I hope the brevity will be taken as a sign of concentrating on the issue itself.
I very much hope that there will be a demonstration of the will of this House which strengthens the Government’s position in making a change in policy, particularly from the Home Office, which has the main leave now, to the Department of Health where, of course, this issue belongs and should be settled. I hope very much that we will get a very clear steer from the Minister on what the Government’s plans are in looking at this reform before the Bill goes into the Commons. Therefore, I beg to move the amendment which stands in my name and the names of my noble friends.
In November 2018, the significant medicinal properties of cannabis were finally recognised after 50 years of misinformation—I can only call it that—about the plant. At that time, around 1 million patients thought, “Oh my goodness, we’re going to be able to obtain our medicines free of charge through the NHS.” How wrong we all were. I think I am right in saying that only three prescriptions have been written under the NHS since that date; in my view, that is some indication of the degree of misinformation over so many years.
The epilepsy crisis illustrates powerfully that the right medical cannabis is essential for the treatment of severe epilepsies that are resistant to standard medications. I understand that Ministers know this well and are doing what they can behind the scenes. I know that the noble Baroness, Lady Walmsley, will focus strongly on this particular issue.
I want to mention an economic point, if you like. Until his parents so brilliantly found medical cannabis, dear Alfie Dingley’s terrible emergency ICU admissions —nearly every week—were costing the NHS around £100,000 a year. That included his consultant cost, GP costs and medications. The reality is that this amendment could save the NHS hundreds of millions of pounds. It is absolutely crazy to make this so difficult.
The aim of our amendment is to ensure that medications such as Bedrolite, which saved Alfie’s life—I do not think that that is an exaggeration—could receive marketing authorisation, thus immediately resolving the problem for Alfie and other children like him. The fact is that Bedrocan products have been used very successfully for decades, showing that they are both safe and effective.
As my noble friend Lord Field of Birkenhead said, the amendment would solve the problem not only for epileptic children, terribly important though that is, but for the very many people who suffer severe chronic pain, particularly neuropathic pain. It would open the way for cannabis products with a track record of efficacy and safety to be given marketing authorisation and prescribed by GPs as licensed products. That is what we want to achieve here.
I want to make a few further comments. I hope that I am reflecting correctly the comment of June Raine, the chief executive officer of the MHRA, in a Zoom meeting in which we were both involved. She seemed to suggest that, finally, she understood that the MHRA needs to take real-world experience much more seriously. If this is what she meant, I applaud her most strongly; I have been waiting for a senior person in the MHRA to take that view for some time.
If a patient has many years of experience of medical cannabis and has found that it really helps them when other products had not done so, surely this experience should be taken very seriously, not only by the MHRA but by doctors too. Cannabis should be prescribed for the patient in question and other patients with similar conditions. I therefore plead with the Minister, the noble Lord, Lord Bethell—for whom I have the greatest respect on a whole range of issues—to encourage the MHRA to revisit its rules for assessing the efficacy of medical cannabis, to take account of the real-world experience I have mentioned.
I am not talking about a few patients or a few weeks of trying something out—not at all. The fact is that 78 medications prescribed within the NHS have never been through random control trials. It is simply not true to say that medical cannabis products must go through such trials. The complexity of the cannabinoids in cannabis is such that RCTs tend to lead to suboptimal products being approved as single cannabinoids when in fact several cannabinoids and some terpenes might be a great deal better.
Another aspect of real-world experience is the research undertaken in other countries. The National Academies of Sciences, Engineering and Medicine published the report The Health Effects of Cannabis and Cannabinoids in 2017, more than three years ago. It was a review of global research into the efficacy of cannabis medicines. Already, three years ago, it was able to conclude:
“There is substantial evidence that cannabis is an effective treatment for chronic pain in adults”.
Since then, the WHO has finally recognised the medicinal value of cannabis. More and more countries are also recognising the facts about this important medicine. The UK is now lagging behind the English-speaking world. It is really time to catch up, and I hope that our Minister can help us.
My last point concerns our own police forces. Many have now moved ahead of the Government in deciding not to arrest patients who have a few plants in their kitchen to supply themselves with their medicines, or even those who get such medicines from illegal dealers—let me tell you, that is the last thing patients want to do. The police know perfectly well that it is cruel to add a criminal offence to all the pain that these patients already go through.
I hope that the Minister will be willing to meet the noble Lord, Lord Field, and I, ideally with June Raine, to discuss the best way forward. I believe that to improve access to medical cannabis for patients, Ministers will need to adjust the regulations that currently restrict that access and prevent GPs prescribing medicines that patients so desperately need.
Before I specifically address the amendment of the noble Lord, Lord Field, I would like to acknowledge the Minister’s reply to my Oral Question earlier today about the negative effect of Brexit on the legal supply of Bedrocan, and probably other cannabis medicines, to patients in the UK. He knows that this is a life-changing and life-saving medicine, so he will understand that patients and their families are very anxious. Can he assure me that they will be kept informed about progress on sorting this out? They and their clinicians were very worried by his suggestion that there needs to be compromise on both sides. There can be no question of compromise; it would be dangerous to try to substitute this medicine for a different formulation, extracted from a different strain of cannabis.
In response to the DHSC’s suggestion to pharmacists that one cannabis medicine can easily be replaced by another, I will quote from evidence that I have received from Evan Lewis, director of the Neurology Centre of Toronto. He is a clinician with extensive experience of medicinal cannabis for adults and children, and has said:
“It is imperative that children who are benefiting from a particular medical cannabis product are not changed to another product. There is significant variation from one product to the next, and many unknowns as to how all the cannabinoids interact with each other to treat seizures”.
He goes on to say that swapping backwards and forwards between products can be extremely dangerous and is often ineffective. This misunderstanding nicely illustrates some of the problems we face in our campaign to make the benefits of cannabis medicines more widely available to UK patients on the NHS.
On the wider issues in Amendment 15, the key issue is how evidence is obtained about the safety and efficacy of these medicines. I see the Government’s fixation with random-controlled clinical trials as a real barrier to progress in the field of cannabis medicine. When scientists are trying to investigate any issue, they always use procedures that are appropriate to the material being investigated and to answering the question asked. When you have a very small patient cohort, such as the cohort of children with drug-resistant epilepsy, it is impossible to have a meaningful clinical trial. Besides, when giving a placebo to half the sample could be life-threatening, it could be unethical.
As the noble Baroness, Lady Meacher, said, many drugs and medical devices are already used on an anecdotal basis. For example, as she said, 78 drugs are available and in use in the NHS that have no random control trial. The vagal nerve stimulator, which is successfully used to prevent seizures in some epileptic patients, also has no RCT in relation to it. There are many drugs used on children that have not been tested in clinical trials for use in children. Indeed, some of them were used on Alfie Dingley and the other children who now receive cannabis medicines before they fortunately discovered the benefits of the latter.
These drugs are used off-label. This is a well-used way of prescribing in the NHS. Unfortunately, clinicians are being deterred from prescribing cannabis medicines in this way by very negative government messaging, and are even threatened with sacking by their health trust. They also need more information on these matters.
It would be appropriate to set up a formal system of observation, recording and clinical evaluation of these products in use in the UK, alongside accepting the mass of evidence from other developed countries. Such observational studies are not the same as anecdote and would most certainly result in the acceptance of the safety and efficacy of these products for certain indications. Such evidence should then be included in medical education, particularly for neurologists and general practitioners, so that they can have the confidence to write free NHS prescriptions for patients who could benefit from cannabis medicines that have been used safely for years elsewhere.
I hope the Minister is able to tell us in response what appropriate system the Government are prepared to put in place as an alternative to clinical trials, so that UK patients can have the benefits that patients in the Netherlands, Canada, the United States and many other countries have had for years.
It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE approved it? If it is waiting for more research, there will have to be more people using medical cannabis so that the information can be collected. If it is helping, doctors who understand the problems need to be the people who prescribe it. It should be carefully monitored. If it gives better quality of life, why should it not be prescribed? I hope the Minister will do his best to see that it is.
Last week, I heard Hannah Deacon talk on the “Today” programme about her son Alfie and the devastating consequences of Brexit and the impact of the inability to import Bedrocan from Holland. I know the Government have been active, and I very much hope the Minister will be able to report progress tonight.
That is the immediate issue, but of course there is then the long-standing issue that, when Parliament agreed to the legalisation of medical cannabis under prescription, there was a distinct impression that NHS patients would receive medical cannabis where appropriate. It is very clear that the NHS is not prepared to do that. The small number of prescriptions and the approach of the various bodies that advise the health service on commissioning make it abundantly clear that, unless Ministers intervene, patients will simply not be able to get these products in a legal way.
I say to Ministers that, with the campaigns, it is obvious there will be increasing noise, increasing concern. They really will have to step in and find a way of getting access to these products for patients. It is inevitable that it will happen, and it is better than they do this now rather than wait for another three, four or five years. I remind them that, when the legislation went through, the Home Secretary at the time said:
“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”
That simply has not happened.
I suggest four approaches: first, the All-Party Parliamentary Group on Medical Cannabis under Prescription believes that the only way to help families at the moment, and to make sure the policy does not stall completely, is to set up a small fund called something like the medical cannabis access fund, which can be used to help those families, until the blockage on NHS prescription eases.
Secondly, we have to come to the issue of research. I know the Minister is frustrated—he repeated this today—because he thinks the companies producing these products should come forward and undertake clinical trials and tests. I am not an expert, but I have listened very carefully to noble Lords and to advice that I have received, which suggests that randomised control trials are very difficult in this area. In that case, surely the Government should revisit the NHS England report, Barriers to Accessing Cannabis-based Products for Medicinal Use on NHS Prescriptions. The report looked at the issue of research, and said that there should be randomised controlled trials but, alongside this:
“NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT.”
I gather that this has not happened. The Minister really should inquire into this. It would basically be an observational study; it would allow medical cannabis to be prescribed for large numbers of people and for proper research to be undertaken. I suggest to him that it would be a way forward, so that the current frustration of so many patients is responded to in a sympathetic but also practical way.
My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.
When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.
I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.
My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.
The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.
Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.
The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”
“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.
My Lords, Amendment 15 in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic that has been discussed at length in both Houses. The noble Lord spoke eloquently in Committee, sharing his experience of medicinal cannabis and the benefits he obtains from it.
I will first address a separate but related matter that a number of noble Lords raised concerning the supply of certain cannabis-based medicines from the Netherlands. I know that the noble Baroness, Lady Walmsley, and others in the House have received distressing calls from patients and families who have relied on these imported medicines. The Parliamentary Under-Secretary of State for Prevention, Public Health and Primary Care, Jo Churchill, met Alfie Dingley’s family and the patient group End Our Pain on Saturday to provide reassurance and an update on the action that we are taking.
I reassure noble Lords that we are working urgently with the Dutch Government to find a solution that will enable patients to access the medications they need. I cannot discuss the details of the proposals today, but I commit to provide noble Lords with a further update when I can.
Returning to the matter at hand, I reassure noble Lords that the issues raised by the noble Lord, Lord Field, in his amendment sit firmly with the Department of Health and Social Care, not the Home Office. While I am pleased that the noble Lord finds some relief with this medicine, the fact remains that the vast majority of cannabis-based medicines have not been assessed by the MHRA for safety, quality and efficacy, nor by the National Institute for Health and Care Excellence for clinical and cost effectiveness. I believe that that is the nut that the noble Lord is trying to crack with his amendment. We are also trying to crack it as a Government, but from a slightly different approach.
As the noble Baroness, Lady Meacher, noted, the Government changed the law on
Given that there is insufficient evidence on the safety, quality and efficacy of these unlicensed medicines, it is entirely appropriate that these products are subject to these stringent conditions. It would be inappropriate to establish parallel arrangements or to subject medicinal cannabis to any less stringent assessment than is the case for other medicines used for serious or chronic conditions. To do so would undermine the integrity of our medicines regulation in the UK. Also, it would run counter to the noble Lord’s objective to see the placing on the market of high-quality, standardised cannabis-based medicinal products that are safe and effective.
As noble Lords heard in Committee, we have removed some of the barriers to how these products are imported into the UK and we now see a wider range of products available to prescribers. I reassure noble Lords that we are also taking steps to improve the body of evidence available. NHS England and NHS Improvement have made good progress to establish a national patient registry for patients receiving medicinal cannabis. This has been developed with clinicians and aims to cover all clinical indications and all licensed and unlicensed medicinal cannabis products prescribed on the NHS and privately. The registry will be an important step forward in the collection of uniform data to support monitoring and evaluation of prescribing activity, patient safety and clinical outcome data. This data, and that produced from clinical trials, will help inform future NHS commissioning decisions. The registry is currently being piloted, with a view to further rollout next year.
On clinical trials, the National Institute for Health Research and NHS England are working together to set up a programme of two randomised controlled clinical trials. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to inform future NHS commissioning decisions for the many hundreds of patients in the UK with refractory epilepsy. This is a pioneering area of research and we hope the trials will start as soon as possible. However, I must emphasise that industry also needs to step up and invest in robust clinical trials to improve understanding of how patients might benefit from these products.
I must say to noble Lords that it is not the job of the independent regulator to generate evidence. To do so would undermine the independence and objectivity of medicines regulation in this country, including the pharmacovigilance of medicines. The safety of the public will always come first, and the producers of medicinal cannabis must be prepared to subject their products to scrutiny by the MHRA and by NICE.
When marketing authorisations are sought, they will be dealt with by the regulator, as with any other medicine, taking into account their herbal origin. The MHRA offers, and has given, regulatory and scientific advice to companies and researchers to support their research and development of these products. I reassure noble Lords that the MHRA is committed to using the latest techniques and takes a patient-centric approach to medical regulations.
Regarding further discussion of this with the MHRA, I will take that request away. I think we all welcomed June Raine’s approach in the meeting with Peers last year on this Bill. I am also conscious at this exact moment in time of the pressures on the MHRA to support our national effort on vaccination rollout. I am sure we will get a positive response, but there might be a small issue around timing that we will have to take away and address.
As we have seen with the Pfizer and BioNTech Covid vaccine, and, indeed, with the other Covid vaccines that have come online, the MHRA upholds the highest standards and will authorise the use of medicines only following the most rigorous scientific assessment. This is essential to ensure that the public can have trust in the regulator and the medicines they use. Licensed products, such as Sativex for multiple sclerosis and Epidyolex for rare epilepsies, have gone through this process and are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK.
On that basis, and on the basis of the Government’s ongoing efforts to ensure that we have a strong evidence base to provide further access to these medicines, I ask the noble Lord, Lord Field, to withdraw Amendment 15.
My Lords, I can willingly agree to that last request. I think if we put it to a Division we might not win, so what is the point of closing doors when the Minister was busy opening them? I am immensely grateful to her for that.
As the House can see, many people can do two things at once—both speak and keep their masks in place. I fail that test. But I want to thank those who have participated—the noble Baronesses, Lady Meacher, Lady Walmsley, Lady Thornton, Lady Masham, Lady Jolly, Lady Bennett and Lady Penn, and the noble Lord, Lord Hunt—for their contributions in taking this debate further.
If I may, I will end on a cheerful note. Let us suppose that, in the next few days, the Prime Minister finds the time to look at this issue and decides that the Government’s line will be different. We know that the people who have had to defend the line tonight would then put another case to us, and I hope that that case will be put very shortly.
Safety is, of course, crucial. However, we have just experienced the introduction of the Oxford vaccine and other vaccines. Presumably they went through randomised controlled trials, so those can be accomplished very quickly. I hope that, when the Prime Minister changes his mind, we will move to testing the safety of these products as quickly as we have the vaccines. Just as the vaccines offer us hope of life after Covid, I hope that we will see a quick response for those millions of people who are not free to obtain their cannabis on the NHS but who, like me, are lucky enough to be able to buy it. I hope that we will move very quickly and resolutely. One way of levelling up is to make these products—once their safety has been established—free for everybody on the NHS.
Amendment 15 withdrawn.
Consideration on Report adjourned.
House adjourned at 9.10 pm.