Medicines and Medical Devices Bill

Baroness Watkins of Tavistock Excerpts

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

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

We now come to the group consisting of Amendment 94A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Amendment 94A

Moved by

--- Later in debate ---

[Baroness Walmsley (LD) [V]]

My Lords, I heartily support the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I thank the noble Lord for his important evidence, and congratulate the noble Baroness on her many years of energetic campaigning on this matter. Noble Lords may know that I too have campaigned long and hard for medicinal cannabis projects, that have been proved to be safe and effective, to be prescribed on the NHS for UK patients. When the Home Office changed the status of medicinal cannabis two years ago, many of us thought that, given the mass of evidence that there are many such safe and effective products in widespread use abroad, such medicines would become available free to UK patients. That has turned out not to be so. Although some expert clinicians are prescribing them for appropriate patients—including the noble Lord, Lord Field—in a private capacity at high cost, very few patients have received their medicine free on the NHS. Why is this? It seems that it is because NICE has not approved them because there have not been any random controlled double-blind trials. Therefore, several health trusts are forbidding consultants who want to prescribe these medicines to do so, on pain of losing their jobs.

There are children with intractable epilepsy in this country whose lives have been saved by the medicines, for which their parents have had to fundraise. The lives of some of those children have been put at risk because the coronavirus has prevented that fundraising, and they suffered serious preventable fits. Many of these children have been treated with approved pharmaceutical medicines that have never been approved for use with children and have serious side effects. That is why we need a proper regulatory framework based on the full cadre of available evidence, which this amendment proposes. It will not be difficult to establish the safety of these medicines, as required by subsection 3(a). If those making the regulations are allowed to take into account the health records of people who have already been taking these medicines, and also the vast amount of evidence from other developed countries which the noble Baroness, Lady Meacher, has listed, that will subsection 3(c). Subsection 3(b) requires that availability be considered when making the regulations. These medicines are readily available. Indeed, a lot of them are being made in this country and exported because they cannot be sold here. How mad is that? Nor are they expensive as medicines go, and the NHS can bulk buy at a discount anyway.

In order to satisfy those who do not trust evidence from other countries—although why is beyond me—we also need to collect data from UK patients who are managing to get cannabis medicines in order to provide the information required by NICE, but there is no system in place to do that. Will the Minister say why the NHS Commissioning through Evaluation system is not being used? It is a well-established and approved system that collects patient data and clinician observation on the use of novel medicines and treatments. It strikes me that, given that cannabis medicine’s illegal status made it impossible to collect much UK data before 2018, it would be an ideal candidate for this trusted method of evaluation. Finally, I would welcome the Minister’s response to this suggestion.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I call the noble Lord, Lord Norton of Louth. Lord Norton? We will move to call the noble Lord, Lord Patel, and come back to the noble Lord, Lord Norton if we have time. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I will need to speak only very briefly because the noble Lord, Lord Field of Birkenhead, and the noble Baronesses, Lady Meacher and Lady Walmsley, have covered the ground extensively, fully and informatively. It is a privilege to be involved in an amendment moved by my noble friend Lord Field of Birkenhead. We have been friends, discussing such issues for very many years, although he was in a different House, so it is a pleasure to see him and support his amendment.

My noble friend Lord Field spoke from personal experience, and my noble friend Lady Meacher spoke extensively about the information available. In 1998, the Science and Technology Committee of the House of Lords recommended that there should be a programme to assess the medicinal use of cannabis and that ways should be found to use it. NICE has recommended one or two areas where it can be used, as has already been said. Very few NHS prescriptions have been given out, but more than 1 million people use cannabis preparations bought privately at huge cost. They use them because they find benefit from them. The report suggests that the people who benefit from it mostly suffer from chronic pain. Despite that, reports have been published where people with Alzheimer’s, cancer, chronic pain, Crohn’s disease and multiple sclerosis, to name but a few, found benefits from it. More than 20,000 publications on PubMed, not of clinical trials, but of people’s experience and data collected from patients, show that they have found it to be beneficial.

When recommending and assessing medicinal products using cannabis, NICE suggested that research should be carried out in six or seven areas. I do not know what research has been carried out. The problem with such a recommendation is that it does not recommend who should do the research. So I ask the question: who should be doing this research to explore the benefits that patients find in medicinal cannabis?

Private clinics prescribe more and more cannabis on a daily basis, and more and more clinics are opening in cities in England where cannabis is available. My noble friend Lady Meacher and the noble Baroness, Lady Walmsley, alluded to two important issues. One is that a way needs to be found to collect information on patients’ experiences and data to show why so many patients go to private clinics to get cannabis products and what benefits they derive from them.

I look forward to the Minister’s response, but I hope she may agree, as it would not require legislation or an amendment to the Bill, that the NIHR or the Department of Health and Social Care through the NIHR should establish a forum of specialists, including patients, to find a way forward to collect information on a more formal basis. I hope the Minister will respond positively to that. It has been a pleasure to take part in this debate.

[Baroness Jolly (LD) [V]]

My Lords, the amendment signed by my noble friend Lady Walmsley and others would require the Secretary of State to make regulations concerning medicinal cannabis and associated devices. The noble Lord, Lord Field of Birkenhead, made his case clearly and strongly. I have a family member who used cannabis as a painkiller towards the end of their life when pharmaceuticals failed. Given the huge relief it can bring to patients with conditions such as epilepsy, it is vital that barriers to access are removed. We have heard that since the law was changed in November 2018, only a very small number of prescriptions have been written for medical cannabis.

The noble Baroness, Lady Meacher, my noble friend Lady Walmsley and the noble Lord, Lord Patel, have for many years supported the use of medical cannabis for a small number of conditions. Very few patients have received their medicine on the NHS because NICE has yet to approve the use of cannabis in any context. Evidence is available, so why are the Government fighting shy of using cannabis or its derivatives, thus forcing individuals to become criminals by having to go abroad to countries where cannabis is legally available, but at a huge cost, and then smuggle it home? It does not make sense. We support the amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

We do not seem to be able to contact the noble Lord, Lord Norton of Louth, so I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

I thank my noble friend Lord Field—he may not technically be my noble friend, but he is really—for bringing this issue to the Committee at this stage. He probably knows that he is not the only parliamentarian who has been driven to cannabis products for similar reasons, but my lips are sealed about who the others might be.

The noble Baroness, Lady Meacher, is absolutely correct. She and I have form. I have been supporting her from the Front Bench on this issue for quite a long time. While the debate was going on, I looked to see what Hansard had to say about this. The last time, I think, that we discussed this was in March 2019. At that time, the framework and law had been changed the previous November, so that is two years ago. At that point four people had managed to get cannabis products prescribed. When the noble Baroness put the question to the House, it was answered by the Minister’s predecessor. Will the Minister say how many more people there are now? I think it is probably not that many more, and I see this amendment as a scream of frustration about this issue. There is justifiable frustration that we have not managed to regulate this product in a way that makes it accessible to people who need it most. It also exacerbates the inequalities in our health system because, as the noble Lord, Lord Field, said, he can afford to buy it, but there are thousands of people who need it and cannot afford to buy it. I support this amendment, but I am really much more interested to see what on earth the Government are going to do to make progress with this.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I am now able to call the noble Lord, Lord Norton of Louth.

[Lord Norton of Louth (Con) [V]]

My Lords, I am delighted to have the opportunity to contribute to the debate and I apologise for not being able to contribute in my allocated slot.

I was very keen to add my name to the amendment to support the noble Lord, Lord Field of Birkenhead. I do not want to repeat the points that have already been made, but I draw attention to the fact that a few years ago I initiated a debate in the House on drugs policy. My point was to argue the case not for a change in policy but that policy must be—or should be—evidence-based. At the time, the Minister who replied said that opinion on this is divided. Someone afterwards pointed out that only the Minister disagreed with me because everyone else who spoke in the debate supported the case I was making that the Government were resisting going on the basis of evidence. For whatever reason, they were sticking their heels in.

As we have heard, the evidence really supports the case for change. The APPG for Drug Policy Reform showed the case and that there is evidence for the value of medicinal cannabis in relieving pain. There is a very strong argument on the basis of evidence and a moral case as well, given the sheer number of people who are forced, at great expense and possibly some danger, to find alternative ways of getting hold of cannabis for medicinal purposes, so I very much support what has been said by preceding speakers, including the noble Lord, Lord Field. I think the amendment is a step in the right direction in what it seeks to achieve. It is targeted and proportionate. It is designed to help to expand access to safe and regulated medicinal cannabis products in the United Kingdom. There were other points I was going to make in support, but I do not want to repeat points that we have already heard. I just wanted my name to be on the record as supporting the very powerful cases that have been made for the amendment.

[Baroness Penn (Con)]

My Lords, Amendment 94A in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic of great difficulty. As the noble Lord has personally testified, patients and families deal courageously with challenging conditions, and I know that the issue of medicinal cannabis is one that has had much debate.

As other noble Lords have pointed out, it is almost two years to the day that the Government changed the law to allow the supply of medicinal cannabis under misuse of drugs legislation. These regulations provide that medicinal products containing cannabis can be prescribed or supplied when certain conditions are met. These conditions are that the relevant cannabis product is a special medicinal product, an investigational medicinal product for use in a clinical trial or a medicinal product with a marketing authorisation.

I do not have specific figures for the noble Baroness, Lady Thornton, on the number of people who may have accessed cannabis drugs since then. I understand that the collection of data on certain private prescriptions was suspended because of Covid-19, but we can go away and look for the latest data and, when it becomes available, update the House. I believe I heard the noble Lord, Lord Field, say that there may have been 204 prescriptions. While I cannot endorse that figure, and noble Lords may feel it is low, it is considerably higher than the figure that the noble Baroness quoted for one year after the approval of medicinal cannabis. Therefore, if it is correct, progress is being made in the right direction.

Noble Lords are right that cannabis remains a controlled drug. I appreciate that the noble Baroness, Lady Meacher, already expressed views on this in our discussions with the MHRA on whether it ought to be a controlled drug at all. The noble Lord, Lord Field, also made that point. However, the changes to its restrictions are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, for England, Scotland and Wales, and the Misuse of Drugs Regulations (Northern Ireland) 2002. Those regulations are not within the scope of the Bill.

What is within scope is when those medicinal products are regulated as a human medicine. The noble Lord is asking for regulations to provide for a specific licensing regime for medicinal cannabis. However, I stress that medicinal cannabis products already have a route to market. They fall within the scope of the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. It is entirely appropriate that they are subject to the same standards and requirements of evidence as any other medicine. The MHRA’s licensing process takes into account evidence of clinical efficacy. This includes consideration of all evidence supplied by the manufacturer. The regulators also inspect the factory where the medicine is to be made to make sure that supplies will be of a uniformly and consistently high standard. Companies can and do submit evidence of use from other countries, so there is no need to set an explicit requirement to consider efficacy internationally. If a company wishes to make a product available, it can within this regime.

Medicinal devices that administer medicinal products, including medicinal products containing cannabis, would also need to comply with the relevant provisions of the Medical Devices Regulations 2002. But a medicinal product in the UK must be safe. We have talked throughout the Committee about the critical importance of safety and the need to uphold standards. There is a paucity of evidence to support the quality, safety and efficacy of these products, meaning that very few hold marketing authorisations. To address this, the industry needs to further the evidence base and support the use of their products. Government is supporting this with a programme of two randomised control trials commissioned by the National Institute for Health Research. I hope that reassures the noble Lord, Lord Patel, as the National Institute for Health Research is engaged in assessing the evidence in this matter. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to plan future NHS commissioning decisions for the many patients who may benefit from these innovative medicines.

Just to pick up on the question of how many drugs may already hold licensing, I can say that there are three such licensed products, including Sativex for MS and Epidyolex for rare epilepsies. These drugs are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK. I say to the noble Baroness, Lady Jolly, that the drugs that have been licensed by the MHRA also have NICE approval for use in the NHS in certain appropriate conditions. As we heard in our meeting with the MHRA on Monday, it is able and willing to provide advice to researchers and companies that wish to conduct clinical trials and go through the licensing process for their products.

Cannabis-based products for medicinal use can also be supplied as unlicensed “special” medicines, as noble Lords have noted. A special medicinal product is a product that is manufactured or assembled according to the specifications of a specialist medical practitioner to meet the needs of a specific patient, in accordance with the stringent “specials” regime provided for in the Human Medicines Regulations 2012. Those unlicensed products have not been assessed by the National Institute for Health and Care Excellence for clinical or cost effectiveness. These are the foundations of NHS decisions about routine funding for medicines.

I appreciate that families with ill children, or patients themselves, would dearly love to have greater products available to them for more purposes, but this is not about creating new licensing routes. It is about companies coming forward and undertaking clinical trials and tests and it is about having the appropriate level of assessment and understanding of the impact. We are taking steps to improve the body of evidence available. When marketing authorisations are sought, they will be dealt with by the regulator, as they would for any other medicine. That may not be as quickly as some would like, but it is necessary to protect patients. On that basis, I hope that the noble Lord, Lord Field, is content to withdraw his amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I have received requests from three noble Lords to speak: the noble Baronesses, Lady Finlay, Lady Walmsley and Lady Thornton. I call the noble Baroness, Lady Finlay.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I am most grateful to be able to come in at the end of this important short debate. I particularly commend the noble Lord, Lord Field of Birkenhead, for his outstanding and long history as a parliamentarian and, yet again, for his clarity and ethical approach to every subject that he addresses.

I am glad that the Minister has referred to the two studies from the NIHR and simply support the idea that we need to wait for those, although I draw attention to the fact that, in 2018, there was a Cochrane database review, which looked at the 16 double-blind randomised control trials that it could find. It found some support, but it was not terribly strong. One of the difficulties here is that pain is a symptom that occurs in an enormous range of disorders, but the fundamental cause of the pain will be very different in different people. To get a matched population where you can compare one with another is extremely difficult. I hope that the change that NICE is looking to in the evidence that it seeks, where it will also look at evidence in practice, will support the evidence coming through from large patient cohorts who can then be put into broader groups.

The other point about pain is that, as people get multiple pathologies, they often take several other medications as well, which can interfere with the ability to assess them. They are also often elderly. The evidence certainly needs to be accrued. I would say as a clinician that one worry was always whether there would be a leak of cannabis on to the streets. However, in practice, I think that the leakage has gone other way so that it comes from the streets into people’s homes. Clinicians have had to look at this with Nelson’s eye because they do not want to support clinical activity. In a study that I did, while we did not ask patients to tell us specifically where they were getting some things from, when we put together all the different types of alternative therapies being used by a group of people who were cancer patients, the numbers were huge. This supports many of the comments that have already been made. I am glad that the Government are looking at it and I expect that it will not be too long before we find that the ability to get the medication that is needed is made easier. I worry that it may be too late for some patients, but we are getting there.