Medicines and Medical Devices Bill

Baroness Meacher Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Lord Field of Birkenhead (CB)]

My Lords, I wish, with a straight bat, to move this amendment standing in my name and in the names of my noble friends. Looking at the names of those who will be contributing to this debate, I willingly admit that I probably know least about this subject—although, in declaring an interest, I probably bring a knowledge which most of your Lordships do not have. I use cannabis. My spine is breaking up. I have tried all the traditional painkillers, but they were worse than what they were actually trying to deal with. So I am not somebody who embraced cannabis as a first option; I was driven to it because no other traditional painkillers helped.

It is important to say what I am not asking for. I am not asking for a free-for-all for people who wish to use cannabis for recreational purposes. I understand their case, although I do not share it. Others may wish to use other opportunities to move that interest. I do not. Nor am I—or the other noble Lords who have signed this amendment—asking for a random control trial. We are asking for something much subtler. This medicine helps people and relieves pain, and it is the relief of pain that I wish this debate to concentrate on.

I am no snake oil salesman. I am not here to claim—on behalf of my fellow citizens who suffer, for example, from Parkinson’s or cancer—that this is a miracle cure. I am not arguing that. I know a number of people with Parkinson’s or cancer who have been helped by this, and their lives possibly extended. But in this amendment I am concentrating merely on how to relieve pain. In proposing the new clause, I am really making a plea to the Government to renew past conversations about how we might equalise access to cannabis in this country where people are totally concerned with controlling pain. Clearly—and rather appropriately, given the previous set of amendments—the new clause concerns itself with the devices by which cannabis can be delivered to a patient. Above all, it is a plea to change the schedule within which the drug sits, so that—if they so wish—GPs can prescribe this painkilling drug.

I do not know how many times others have been able to speak in a cannabis debate with your Lordships knowing that the person speaking is actually using that drug. My plea is, very simply, that there are pains that traditional painkillers cannot reach and there is considerable evidence that in those circumstances, when all the traditional painkillers have been tried, cannabis can sometimes work.

What is so unfair is that under the present arrangements, I can pay for my cannabis. There are huge numbers of other people, probably in greater pain than I, who cannot buy cannabis, as I do, within the law as a painkiller. I am therefore moving the amendment with its proposed new clause as a plea to the Government, on behalf of all of us who suffer pain in varying degrees and have tried the traditional methods of pain relief. Where that has failed—it often makes one even more ill than when one started to take those painkillers— we have found some redress in cannabis.

As a user and beneficiary, I hope that I therefore speak on behalf of many of my fellow citizens who get relief for their pain from cannabis. I wish to equalise access to cannabis in the way that I have benefited, so that others might too. I beg to move.

[Baroness Meacher (CB)]

My Lords, it is a great pleasure to follow the noble Lord, Lord Field, who has knowledge that I do not have. I have never used cannabis, but he has made a powerful statement as a user.

The regulations affecting the production of prescription and medical cannabis are incredibly unhelpful. They result in about 1 million people—very sick, disabled people—accessing medical cannabis illegally, usually from the criminal market, although some go to Europe to access medicine for either themselves or their children. Although cannabis medicines have been legalised, most such people simply cannot get access to them. It just is not there for them at all.

Under the regulations in place at present, cannabis medicines are unlicensed—they are known as specials. This means that only consultants can prescribe them, on the basis that if there is a problem—it is extremely unlikely that there would be any problem with medical cannabis—the consultant has to take personal responsibility for having prescribed that medicine. The trouble is that doctors have not been trained in this complex group of medicines. The cannabis plant contains about 540 phytochemicals: 144 known as cannabinoids, 200 terpenes and 20 flavonoids have been identified so far. Maybe there will be more; I do not know.

Different mixes of these phytochemicals alleviate the symptoms for patients with a wide range of conditions. The noble Lord, Lord Field, concentrated on pain, and fibromyalgia is a particular type of pain, which apparently responds well to this. But there is also Crohn’s disease, treatment-resistant epilepsies, PTSD, Parkinson’s and an incredible number of others. I think that Germany approves medical cannabis for something like 40 conditions, which is extraordinary.

Not surprisingly, consultants have been very reluctant to prescribe medical cannabis. Only 204 prescriptions have been written in the two years since medical cannabis has been legalised, and only 10 within the NHS. It is pretty disastrous in terms of the regulations and it is essential that a way is found to license high-quality medical cannabis for the alleviation of symptoms for a specified list of conditions.

The Medicines and Healthcare products Regulatory Agency generally insists on random controlled double-blind trials, and I very much support that gold standard for the great majority of medicines. However, medical cannabis medicines are different from almost anything else I can think of, in part because in general—certainly until now—they claim only to alleviate symptoms. At this point they do not claim to be a cure, although there is some interesting current research on the curative potential of cannabis. But we will not talk about that now. Also, cannabis has been used as a medicine for thousands of years; I do not think there is any other medicine quite like it. A million patients use it today, and can provide evidence of its efficacy, minimal side effects and safety. Many patients have used it over many years, so I argue strongly that cannabis medicines are in a really different position from other medicines.

There are a considerable number of studies across the world that clearly show the efficacy and safety of medical cannabis. In 2017 the National Academies of Sciences, Engineering, and Medicine published a great volume called The Health Effects of Cannabis and Cannabinoids, a review of global research into the efficacy of cannabis medicines. It concluded:

“There is substantial evidence that cannabis is an effective treatment for chronic pain in adults.”


Why is this not taken seriously?

Until now the MHRA has been unwilling to consider that and much more international research. Bedrocan products have been widely used in Europe for more than 20 years, greatly benefiting patients. If the Government did nothing else but allow Bedrocan products to be approved in this country, that would be of enormous benefit to a huge number of patients. High-quality products are now available in the US, Latin America, Canada and many other countries across the world. Outcome data is available from Columbia Care, for example, but also from many other organisations, universities and so on.

Not only do the regulations place medical cannabis in the “specials” category, they also complicate the import and production processes, adding considerable costs to the medicines. The situation cannot, in my view, be justified. It creates criminals out of completely law-abiding incredibly sick and disabled people. It wastes police, court and prison time, and considerable sums of taxpayers’ money—and, indeed, NHS resources. Most important of all, it is ruining the lives of many of our most vulnerable citizens.

I am in touch with GW, the pharmaceutical company that has produced the only cannabis medicines licensed in this country. I hope to work with GW, and I have a meeting with its representatives—next week, I think. They understand the problem. Epidyolex, trialled by GW, is a single cannabinoid medicine. GW spent many years and hundreds of millions of pounds undertaking the double-blind trials of Epidyolex and, understandably, wants a return on its investment. I have huge sympathy with it.

Since that work started, research in other countries has shown that a single cannabinoid medicine is suboptimal for many treatment-resistant epileptic children. The evidence tells us that it helps 43% of children with two particular variants of epilepsy, and the reduction in symptoms is only 50%. I sincerely want Epidyolex to succeed. It may be the right drug for some children. However, more recent research internationally has shown that some children given whole plant products can achieve up to 100% improvement, with minimal side-effects .The evidence available justifies regulation changes to enable very sick patients to benefit from cannabis medicines, which patients say alleviate their symptoms more effectively and with substantially fewer side-effects, than prescribed medications, as the noble Lord, Lord Field, has told us from personal experience.

We genuinely wish GW well, and we are privileged to be in discussions with it to try to find a way forward that will benefit patients and work for pharmaceutical companies, while upholding the high standards of safety and efficacy for which this country is renowned. At a recent virtual meeting with our highly valued Minister and the CEO of the MHRA, I was encouraged to see that the CEO also recognised the need to discuss a possible way to increase access to cannabis medicines for patients who benefit significantly from them.

The aim of the amendment is to initiate a discussion with Ministers, alongside discussions with officials and experts, about how to remove the umpteen hurdles within the regulations which prevent patient access to cannabis medicines. We hope through these discussions to find a way forward, and I look forward to the Minister’s response.

Medicines and Medical Devices Bill

Baroness Meacher Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Meacher (CB) [V]]

My Lords, I have added my name to the amendment moved by my noble friend Lord Field of Birkenhead. I want to give it my strongest possible support, as Ministers will expect of me.

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.

[Baroness Walmsley (LD) [V]]

My Lords, I am honoured to follow the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I too have put my name to Amendment 15.

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.