Medicines and Medical Devices Bill

Debate between Baroness Walmsley and Baroness Meacher

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.