Medicines and Medical Devices Bill

Lord Field of Birkenhead Excerpts

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

Moved by

[Lord Field of Birkenhead]

94A: After Clause 15, insert the following new Clause—
“Requirement to make regulations concerning medicinal cannabis and associated devices
(1) The appropriate authority must by regulations amend the law relating to medicinal cannabis and devices used to administer medicinal cannabis.(2) Regulations under subsection (1) must establish criteria for the licensing of cannabis medicines and medical devices.(3) In making regulations under subsection (1), the appropriate authority must have regard to—(a) the safety of medicinal cannabis;(b) the availability of medicinal cannabis;(c) international evidence of the efficacy of cannabis medicines.”

[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.

--- Later in debate ---

[Baroness Penn (Con)]

My Lords, the only thing that I will add is that the noble Lord, Lord Field of Birkenhead, said that this was about equality. My point is that MHRA’s approach to medicinal cannabis is the approach it takes to licensing all other medicines. So whatever approach we take to evidence, or how we look at the appropriate gathering of that evidence, will be based on the approach we take to all medicines. The way in which cannabis is treated is not as a different or exceptional case, and we will want to ensure that that is the case going forwards.

[Lord Field of Birkenhead (CB)]

My Lords, it may be because I am a new Member that I do not quite understand the nuances of language in the House of Lords. I thank most sincerely my fellow Peers who have participated in the debate, and I agree with the Minister’s wish that at this stage I should withdraw the amendment, but in doing so, I would like to say that we will return to this issue. I would particularly like to return to the issue that my noble friend Lady Thornton raised, about equal access.

Only 10 NHS prescriptions have been offered under the new provisions that Parliament made. When I got what had to be a private prescription and took it to Boots, the pharmacist came back with it as though I had left some terrible mess, dropped the prescription back on the counter and said, “We do not dispense that drug.” So all the talk that somehow, if only we could get a prescription, we would get a supply, is also a myth.

I am disappointed with the Minister’s reply. I thought it was pretty thin gruel to offer us. Although I beg leave to withdraw the amendment, I hope that those of us who are interested in this topic will return to it at the most suitable date.

Amendment 94A withdrawn.

Medicines and Medical Devices Bill

Lord Field of Birkenhead Excerpts

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

Moved by

[Lord Field of Birkenhead]

15: After Clause 6, insert the following new Clause—
“Entitlement of a doctor to prescribe medicinal cannabis products
The 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.”

[Lord Field of Birkenhead (CB)]

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.

--- Later in debate ---

[Baroness Penn (Con)]

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 1 November 2018, to reschedule cannabis-based products for medicinal use in humans. This moved these products from Schedule 1 to the Misuse of Drugs Regulations 2001—no legitimate use—to Schedule 2, to permit the lawful prescribing and supply of cannabis-based medicines when certain criteria are met. In particular, cannabis-based medicinal products can be prescribed by one of three routes: as a “special medicinal product”, subject to the “specials regime” contained in the Human Medicines Regulations 2012, prescribed by a specialist medical practitioner; as an investigational medicinal product for use in a clinical trial; or as a medicinal product with a marketing authorisation.

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.

[Lord Field of Birkenhead (CB)]

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.