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Drugs Licensing

Volume 791: debated on Tuesday 19 June 2018


My Lords, with the leave of the House I will now repeat a Statement made by my right honourable friend the Home Secretary in another place today. The Statement is as follows:

“With permission, Mr Speaker, I would like to make a Statement on the medical use of cannabis.

Over the weekend I issued an emergency licence to allow Billy Caldwell’s medical team to access cannabis-based medicine to treat life-threatening seizures caused by a severe form of epilepsy. This was an emergency procedure that was led by a senior clinician with the support of the medical director at Chelsea and Westminster Hospital. I am pleased to say that Billy has now been discharged from hospital. It is now for his senior clinicians to develop a long-term care plan.

I am sure that the whole House will join me in expressing my sympathy for Billy and his family, who have been going through a very difficult time. The course of action in this case was unprecedented. There is strong scientific evidence that cannabis is a drug which can harm people’s mental and physical health and damage communities. There are currently no legally recognised medicinal or therapeutic benefits. To date, under successive Governments, Home Office policy has been to permit the production, supply and possession of raw cannabis solely for research purposes under a Home Office licence. The cannabis-based medicine Sativex can, however, be prescribed in the UK because there is a proven case for its safety and efficacy.

However, cases like Billy’s, Alfie Dingley’s and others like them have shown that we need to look more closely at the use of cannabis-based medicine in healthcare in the UK, because it has become clear to me since becoming Home Secretary that the position we find ourselves in currently is not satisfactory. It is not satisfactory for the parents, it is not satisfactory for the doctors and it is not satisfactory for me.

I have now come to the conclusion that this is the right time to review the scheduling of cannabis. Before I go into the detail of the review, let me be absolutely clear that this step is in no way the first step in the legalisation of cannabis for recreational use. The Government have absolutely no plans to legalise cannabis, and the penalties for unauthorised supply and possession will remain unchanged. We will not set a dangerous precedent or weaken our ability to keep dangerous drugs off the streets.

The approach that we will be asking the review to consider would be no different from that being used for other controlled drugs where there is evidence of medicinal benefits. The government review will take place in two parts. Part 1 of the commission will consider the evidence available for the medicinal and therapeutic benefits of cannabis-based medicines. Professor Sally Davies, who also serves as the Chief Medical Officer, will take this part forward. This will then inform exactly which forms of cannabis or cannabis-based medicines should be taken forward to Part 2.

Part 2 will be led by the Advisory Council on the Misuse of Drugs. The ACMD will not reassess the evidence issued by Professor Sally Davies but will provide an assessment, based on the balance of harms and public health needs, of what, if anything, should be rescheduled. If the review identifies that there are significant medical benefits, we will reschedule. We have seen in recent months that there is a pressing need to allow those who might benefit from cannabis-based products to access them. It will take time for Professor Sally Davies and the ACMD to complete their work and for the Government to consider their recommendations.

In the short term, the Policing Minister announced yesterday that the Government will be establishing an expert panel of clinicians to advise Ministers on any applications to prescribe cannabis-based medicines. This is intended to ensure that advice to Ministers on licensing in these cases is clinically led, is based firmly on medical evidence and is as swift as possible. The Chief Medical Officers across the UK have been actively working together, and the expert panel will be able to start considering applications within a week.

Earlier today, the Policing Minister also spoke to Alfie Dingley’s mum, Hannah Deacon, and informed her that we will issue a licence for Alfie today. All the work I have outlined today is about making sure that we keep in step with the latest scientific evidence and that patients and their families have access to the most appropriate course of medical treatment. I pay tribute to the Policing Minister for all his excellent and sustained work on this important issue.

As a father, I know that there is nothing worse than seeing your child suffer. You would do anything to take away their pain. That is why I have the utmost sympathy for Billy Caldwell, Alfie Dingley and others like them, and for their parents, who have been under unimaginable stress and strain. I know that they are following a gut parental instinct to do whatever is in their power to try to alleviate their child’s suffering. Today I would like to say to this House that I will do everything in my power to make sure that we have a system that works so that these children and these parents get access to the best medical treatment. I commend this Statement to the House”.

My Lords, that concludes the Statement.

I thank the Minister for repeating the Statement made earlier in the House of Commons, and endorse the views expressed in it of sympathy for Billy Caldwell, Alfie Dingley and others like them, and for their parents, who, as the Statement says, have been under unimaginable stress and strain.

With yesterday’s Urgent Question in the other place on the medical use of a cannabis-based medicine uprated to today’s Statement on drugs licensing, this appears to be another example of the Government making decisions on the hoof, in a flap and in response to embarrassing media stories, rather than being a proactive Government who make measured, fully thought-through proposals to address developing issues before they hit the national headlines. Despite this, we still welcome the Home Secretary’s statement that the Government will look more closely at the use of cannabis-based medication in healthcare in the UK, and that they will review the scheduling of cannabis. As the Minister said, what started this off was the case of a 12 year-old boy suffering from severe epilepsy, whose cannabis-based medication was confiscated on arrival at Heathrow from Canada—a decision now modified by the Home Secretary. It contains THC, the primary psychoactive constituent of cannabis, which is illegal in this country but not in a number of other countries, including Germany, the Netherlands, Italy and much of America.

Yesterday, the Government said that the Chief Medical Officer for England had been asked to establish a panel to advise on an individual-case basis on when medicinal cannabis-based products should be prescribed. How many such cases per month do the Government anticipate the panel having to adjudicate on and advise, and against what criteria will that advice be given? What fresh instructions have been issued to officials over allowing through or confiscating cannabis oil and other medicinal cannabis products as from now at our borders and entry points in the light of the Billy Caldwell case? Through what procedure and process will an individual case reach the expert panel? How many instances have there been during the past 12 months of cannabis oil needed for medical use being confiscated at our borders and entry points, and how many of those cases were reviewed by the then Home Secretary, and with what result, under the powers which have apparently just been used by the current Home Secretary? What is the Government’s estimate of the time it will take for the two-stage review just announced by them to conclude its work?

The Statement says:

“If the review identifies that there are significant medical benefits, we will reschedule”.

In other words, the Government do not yet know whether there are such significant benefits. In which case, against what criteria or evidence will the expert panel of clinicians being set up to advise Ministers on any individual applications to prescribe cannabis-based medicines—based firmly on the medical evidence, as the Statement says—make its judgments? I ask that because the Government believe that a two-stage commission is needed to decide whether there is even a case for any change on scheduling in the light of the available evidence.

I come back to the Statement and the words:

“If the review identifies that there are significant medical benefits, we will reschedule”.

Would that apply if the Advisory Council on the Misuse of Drugs came to the conclusion that there were also significant harms from rescheduling, which is what the ACMD is apparently being asked to consider under stage 2?

Finally, a recent report in Private Eye, under the heading “Pot and Kettle” and referring to the Alfie Dingley case as does the Statement, stated:

“A UN report this month found that the UK is in fact the largest producer of legal cannabis in the world—responsible for almost half the global total … As … the drug reform think tank Transform, said: ‘The government is denying that cannabis has medical uses but at the same time licensing production of the world’s biggest medical cannabis production and export market”.

Is that report correct?

My Lords, I, too, welcome the Statement and thank the Minister for making it. I thank her also for her efforts in this cause and those of her noble friend Lord O’Shaughnessy, who is in his place. I welcome the fact that Professor Sally Davies will now review the mountain of evidence for the medicinal and therapeutic benefit of cannabis-based medicines. She will undoubtedly find that the fact that there are no legally recognised benefits is quite wrong and must change. By what means will Professor Davies hear evidence from the many patients who already know about the benefits? Their doctors know the benefits, too. If she does not already, I am quite sure that Professor Davies will soon know them as well.

I also welcome the fact that the Government will reschedule cannabis when Professor Davies demonstrates those benefits. It should never have been scheduled as a drug without any medical benefits in the first place. Can the Minister estimate how long this process will take, as thousands of patients await the outcome in pain and discomfort?

While we wait for this to be done, it is very welcome that the Government have set up an expert panel to advise Ministers on any applications to prescribe cannabis medicines. It is outrageous that the Dingley family’s heroic doctors should have been put through the wringer by the inappropriate processes which the Home Office has imposed on them during the past four months.

I cannot say how delighted I am that Alfie Dingley and Billy Caldwell will get their medicines at last. However, it should not have taken four months since the Prime Minister promised Alfie’s mother, Hannah Deacon, when she visited No. 10 with me and a group of Peers and MPs, that her son would get a licence for his cannabis medicines on compassionate grounds and speedily. During that four-month period Home Office officials were trying, mistakenly, to operate a system for licensing which was not intended for such cases but was intended for normal clinical trials. It became clear very quickly that the system they were trying to use was not fit for purpose, yet they persisted. I would like to be assured that a system that is fit for purpose will be put in place. Will the Minister give me that assurance? It should not have taken a child, Billy Caldwell, being put in a life-threatening situation for the Government to take this action but I am delighted that they now have.

During the campaign I have been convinced of the Minister’s good faith in this matter but, frankly, although she is always welcome in her place, it should be a Health Minister standing there at the Dispatch Box. I am delighted to see the noble Lord, Lord O’Shaughnessy, in his place listening to this debate. Drug licensing is a health matter, not a Home Office matter and clearly the Secretary of State for Health and Social Care agrees with that, so how will the Department of Health and Social Care be involved in the new arrangements outlined in the Statement and those that will inevitably follow?

Yesterday the Prime Minister said a system is already in place for the medicinal use of cannabis and that government policy would be driven by “what clinicians are saying”. The system has failed thousands of patients, but it is good news that the Government are now trying to put that right, and I thank the Minister for that. Can she say whether expert evidence from countries such as the Netherlands, where cannabis medicines have been safely used for some time, will be heard during the review?

My Lords, I did not do it yesterday, but I welcome the noble Lord, Lord Rosser, back to his place. It is such a pleasure to be debating with him. The first question he asked me was about whether we are doing this on the hoof given the Alfie Dingley case. We are not. One of the noble Lord’s further questions was about why it took so long between Alfie Dingley’s family coming forward and him being issued with a licence today. That is because the correct process was followed. Noble Lords would expect the correct process to be followed. The reverse of this is that a child gets given the wrong drug and becomes very ill. The correct process was followed here. The Home Office and the Department of Health and Social Care have worked extensively together over the past three months to ensure that Alfie has been well cared for, and the licence for his drugs was issued today.

The noble Lord asked how many people would be on the panel. I cannot say. It was announced today, and numbers and people will be announced in the coming week. He asked about the criteria the panel will use for who will be issued with drugs. I assume that there will be clinical experts on the panel and that they will base their criteria on their clinical judgment of the benefits.

On stuff being confiscated, I hope that people do not present at the border with drugs that are not yet licensed, and will come forward to the panel for consideration and for drugs to be issued if that is appropriate. The noble Lord asked how long the review will take. Cannabis is a very complex substance, as noble Lords probably know. It will be a complex review, but the Home Secretary expects an interim report to him within three months.

The noble Lord asked about the expert panel and the advice that it will give. Again, the proper process will be followed. It will be a scientific process with clinical judgment at its heart. He also made the Private Eye point about the UK being the largest producer of cannabis. I do not think that the Government are saying that there are no benefits to be had from cannabis; they are saying that cannabis as a whole plant is currently classified as a Schedule 1 drug, as we have discussed previously. However, as we have seen, constituent parts of it have huge benefits, particularly in the areas of MS and, now, epilepsy.

The noble Baroness, Lady Walmsley, asked for details of the review. We are working through those. I certainly know, because my noble friend has just told me, that Sally Davies will be carrying out a literature review. There are findings from across the world. Much work has been done on this and that will be very informative.

The noble Baroness also made the point about the Dingley family being put through the wringer. Again, it was important that the proper process was followed, and it was. A licence application needed to be made. It was made and I am very pleased to say that Alfie Dingley’s licence was issued today. She asked for an assurance that a system fit for purpose will be put in place. The answer to that is firmly yes: the system has to have longevity. This has been a very big and important step for the Government today.

My Lords, the noble Baroness has listened sympathetically to representations in this area in the past, and that has been much appreciated. Does she accept that the issue of cannabis-based medication for children with severe epilepsy, which has aroused intense sympathy and concern on the part of the public, should be part of a wider review? Does she agree that that review should look at the substantial body of existing evidence that cannabis-based medication might have significant and, in some cases, unique benefits for people suffering from cancer, multiple sclerosis, Tourette’s syndrome, chronic severe pain and other distressing conditions?

Will the noble Baroness recognise that the Government’s position on rescheduling that she has described creates something of a Catch-22 situation? The categorisation of cannabis as a Schedule 1 drug of no medicinal value has, in the past, proved to be a considerable impediment to the advancement of research. Therefore, will the Government straightaway reschedule cannabis to Schedule 4 in order to unblock the barrier to research? May we take it that the involvement of Professor Dame Sally Davies that she described is indeed the prelude to the transfer of lead responsibility from the Home Office to the Department of Health?

Of course, Sally Davies will be advising on the review. The scheduling of cannabis will be looked at with a fresh pair of eyes, being mindful of the international research on this subject. In talking about the benefits of cannabis-based medication for epilepsy and multiple sclerosis and as pain relief in some forms of terminal illness, the noble Lord has precisely laid out the point of the review. It will look at all the benefits to be gained in all areas of medical consideration, but it will be clinically and scientifically led. As I said, I think that today the Home Secretary has prompted a first in the consideration of cannabis and its medical benefits.

My Lords, perhaps I may take odds with my noble friend Lord Rosser on the Front Bench because there are times occasionally when members of the Opposition should congratulate the Government on what they are doing. This is a good decision which is urgently needed. To be fair to the Government, 20 years ago I chaired the Science and Technology Select Committee when we had an inquiry into the medicinal purposes of cannabis and, before our report was even published, the then Home Secretary in a Labour Government refused to take any notice of what we had said and published his comments in the newspapers. So we are making progress here.

It is good to see that the noble Lord, Lord O’Shaughnessy, is also on the Front Bench with the Minister because this is an important issue which the Department of Health should also consider. I am glad that there is joined-up government in this consideration.

Given my experience from that committee, it might be worth while looking at our original report, which is still relevant. The people that we saw again and again who were suffering from these terrible conditions were absolutely clear that they did not want to get high. They were all suffering from spasms and other problems and wanted relief of their serious symptoms. That can be regulated through the medical profession because, after all, sensible medical practitioners have access to all kinds of drugs which, if used wrongly, are dangerous.

I hope the Government will continue with their plans and that the review will not take an age to complete.

I thank the noble Lord for his words of congratulation. The history that he tells is interesting. Successive Governments have not done this and today is an historic day in the advancement of a substance that may prove to have huge benefits for all kinds of conditions. I worked with sufferers of multiple sclerosis for 10 years and the use of cannabis-derived products—and now Sativex—helped to ameliorate some of their spasms. They did not want to get high; they just wanted to stop the spasms that happened day and night.

I recommend that we look at the original report because I bet there will be a bit of déjà vu when we do. I thank the noble Lord for his comments and his sound advice.

My Lords, it would be appropriate to draw a parallel with opium. The fact is that heroin—a derivative of opium—is a dangerous and addictive illegal drug, whereas morphine has a medical use derived from opium. Here we are talking about the medical derivatives of cannabis—which it would be helpful to move to a different schedule—and not about the legalisation of recreational use.

The Statement says that there are currently no legally recognised medicinal or therapeutic benefits, but it also says that the Home Secretary has issued an emergency licence to allow Billy Caldwell’s medical team to access cannabis based on medicine to treat life-threatening seizures caused by a severe form of epilepsy. As a consequence, Billy has now been discharged from hospital. Can the Minister explain why the clear medicinal and therapeutic benefits of cannabis are not legally recognised?

The noble Lord underlines precisely why we are where we are today. Clearly, for those two little boys it has had obvious benefits and—once the doctors and the clinicians who are treating them are satisfied that those benefits of the cannabis-based medicine are real and that without them they would go back to their previous suffering—that entirely underlines why this review is well worth doing.

The noble Lord is right to make the point about opium, which of course is schedule 2—which states that it has medical benefits—but is class A in terms of control. Cannabis is schedule 1 but class B. He is also right that this review is well overdue and I look forward to some of the work that will be done over the coming months. It will take time because cannabis is a complex drug and it is important that the proper process is followed and sound clinical judgments are arrived at.

My Lords, further to the question of the noble Lord, Lord Howarth, and having taken a little advice from the noble Baroness, Lady Meacher, can I ask the Minister whether the Government will review not only the schedule but also the regulations to ensure quality standards so as to set out the conditions for which prescriptions should be made available? Does she recognise that if cannabis is widely prescribed, it could save the NHS billions of pounds? Will she also look at the report on this subject prepared for the APPG by Professor Michael Barnes which collates a great deal of evidence on this topic?

My noble friend has read out the question of the noble Baroness, Lady Meacher, very well. I knew that there was mischief going on behind me. The answer to those questions is yes.

My Lords, I feel that we should certainly put on the record our appreciation of the steps the Government are taking. I declare an interest in this because for some time my daughter and her partner worked with drug addicts. They would never leave me in peace on the issue of how soon we could move to an understanding in our society that drugs are primarily a health issue, not a crime issue. They used to berate me about the amount of resources used for anti-criminal activity and how they could have been deployed so effectively in positive work, not least education in and around the subject.

I should like also to put on the record our deep appreciation of the courage of the parents and families who are standing by these two boys, but I hope that we are now beginning a process which will have its own self-generating logic within it so that we can reach a more enlightened and effective—that is the important word—policy on drugs and their use in medical treatment.

As my right honourable friend the Home Secretary said today, this is not about the recreational use of cannabis. This is entirely about making medicines available to very sick children as well as adults, should they need them. We are not going into the pros and cons of the recreational use of drugs because this is an entirely separate matter. I take on board what the noble Lord has said, but I think he will appreciate that I will not go there today.