Medical Cannabis: Alleviation of Health Conditions

Basically, doctors are not trained in cannabis medicine, although several teaching programmes are now available. However, the main barrier is the rather unhelpful guidance produced by the National Institute for Health and Care Excellence, which has looked at cannabis as if it were a pharmaceutical product, but it is not. We need better guidance written by people who understand the plant, not by those who understand only pharmaceutical medicine.

We also need acceptance of the validity of real-world evidence. The British Paediatric Neurology Association recently reviewed its guidance on prescribing medical cannabis in cases of intractable epilepsy, about which I have a number of serious concerns. If a family go ahead with a private prescription for medical cannabis, the guidance appears to say that the NHS paediatric consultant should insist that the private paediatric consultant takes on 24/7 care.

I am extremely concerned that this is a further attempt to make private prescribing so burdensome as to deter private prescribers. No private prescriber will have the infrastructure to provide this level of wraparound care. My concerns are further increased as this appears to have happened to one family already, and I have a letter supporting my concerns. I am pretty sure that washing their hands of patients in this way is not legal. Will the Minister immediately examine this issue and seek clarification from the BPNA that this is not the interpretation, and will she insist that the guidance is removed or changed?

Many barriers would be broken if general practitioners were allowed to prescribe, and a recent survey shows that a quarter of GPs would be happy to do so. That would require a simple change of the necessary statutory instrument under the Misuse of Drugs Regulations 2001 and would not require parliamentary time. I notice that, as of today, a leading UK insurer is now offering insurance cover at rates not dissimilar to normal cover for doctors prescribing medical cannabis.

To make this easier, there should be a focus on where the evidence lies for prescribing indication-specific, medicalised, pharmaceutical-grade cannabis. We must build on the legitimacy and efficacy of these medicines through the implementation of structured approaches to prescribing, which would help the UK healthcare system to be more inclined to prescribe cannabis sensibly.

In our debates in this place on refusing access to immigrants, health and safety in the workplace, poverty and welfare, I have heard the question many times: “Does somebody have to die before we take action?” Well, people are dying and people are living in unnecessary pain and discomfort.

I have four questions for the Minister. Will the Government recognise the value of real-world evidence, such as the research of Drug Science—including Project Twenty21—as proof of the efficacy of medical cannabis and stop insisting on randomised controlled trials, which are particularly unsuitable for rare forms of epilepsy in children? Do the Government have any plans to conduct a health economics analysis to investigate the cost-effectiveness of medical cannabis? Will the Government meet the costs of prescriptions for children requiring Bedrocan’s Bedrolite or similar products? And if a child was suffering from an epileptic seizure and the Minister had the medicine in her hands, would she administer it? I am sure the answer to the last question is yes, so will she please help to put that medicine into the hands of those who care for these children?

Finally, access to medical cannabis will someday be the norm. We need to confront the obstacles that exist today and clear the path for better access tomorrow.

I became co-chair of the all-party group in September 2017 and I took the advice I was given by people who had been in this field rather longer than I had, and we got behind the family of Alfie Dingley. A national newspaper had got involved and a petition was signed by 300,000 people. The family had gone to a holiday camp in Holland in order to access medicine from cannabis, because they could not get it in the UK. The Bedrocan oil that Alfie was getting then stopped his epileptic fits, but the family had run out of money, so they had to come back to the UK and they could not access the medicine here. On the day of the presentation of the petition to Downing Street, I was able to ask an urgent question in the House on the matter. The issue was raised with Ministers and we were given assurances that the Dingley family were going to be helped to find their way through the complicated licensing process in order to enable Alfie to be able to access the medicine. Three months later, of course, they still had not got it. The cost of the licence application process—simply buying the licences to access this oil—was £20,000; we are talking about £5,000 a licence, so enormous barriers were put in the way.

Then we had the case of Charlotte Caldwell and her epileptic son Billy, who had been in the United States getting treatment. When they returned to the UK, wisely doing so via Dublin, because she lived in Northern Ireland, her GP gave her a prescription for the medicine she had brought back from the US. When the manufacturer of that medicine changed and it became a Canadian company, she needed a new prescription, at which point it all fell apart. The doctor was told, “You are not allowed to prescribe that medicine for this epileptic child to stop him having his fits.” With the support of Richard Branson and others, Charlotte went to Canada, collected the medicine, came back and presented it to customs at Heathrow on the Monday, when it was confiscated. By the Thursday the boy was in hospital fitting, and his consultants were on the steps of the hospital saying, “It really doesn’t matter. What is unacceptably cruel is to take a medicine that is working off a child.” The current Health Secretary, to his huge credit, then issued a special licence for Billy Caldwell to be able to get his medicine back from customs. That led to the then chief medical officer being invited to offer an opinion as to whether there was anything in this cannabis stuff as far as medicine is concerned. It only took her two weeks to come back with a strongly affirmative answer, based on the evidence available around the world. That then led to the regulations that the Government passed in November 2018, which have not solved the issue. As the hon. Member for Inverclyde said, only three prescriptions have been made on the NHS.

You will be familiar, Madam Deputy Speaker, as we all are in our constituencies, with the position of multiple sclerosis sufferers. There are about 50,000 people in this country growing their own medicine. They are committing quite a serious criminal offence in the process, but they are trying to treat their health condition. What we have failed to do on the back of the regulations passed in November 2018 is get an evidence-based approach to medicine from cannabis, and educate the health service, prescribing doctors and the rest about the potential benefits and how we should have developed a position from the first go at the regulatory change in 2018.

This is not just about children with epilepsy, although they are of course the point of the spear, and everyone has huge empathy for them. Huge credit goes to End Our Pain, which got behind the Dingley family and put together the initial petition that got the issue into the public consciousness. That, combined with the Caldwell family, then got us formally over the line. I thought, as my right hon. Friend the Member for New Forest East (Dr Lewis) did, that this was done; but it was not. That is the tragedy: we have built up expectations. Out there in our constituencies, people have legitimate expectations that they can now get this medicine legally—that they do not have to criminally grow it or go to a drug dealer and get God knows what, because trading standards do not exactly apply to the supply of medicine that is criminally delivered.

Behind those children with epilepsy—our hearts go out to the families, and I give them huge credit for the effort they put into the campaign, along with the people from End Our Pain and the associated parliamentary group—there are tens of thousands of people with multiple sclerosis and chronic pain who could, by now, be benefiting from this medicine. The Government have gone to great lengths to try to address the issue of the epileptic children. I pay tribute to the Minister’s predecessor, my hon. Friend the Member for Bury St Edmunds (Jo Churchill), for all the time and passion that she put into engaging with this issue, meeting colleagues who represent epileptic children and getting into the detail of the prescribing barriers and the difficulty of moving cannabis-based medicines across international frontiers.

The Department of Health and Social Care also has to work through the Home Office regulations, which is not easy. If a Minister finds it difficult to enable medicines to be got to children who desperately need them, imagine how difficult it is for everybody else. I have huge confidence in the Minister, my hon. Friend the Member for Lewes (Maria Caulfield), who has empathy and understanding from her service as a nurse. She faces the challenge of having to grasp this complex issue.

The basis of the problem arose more than half a century ago. When cannabis was banned in the United States and then globally under the 1961 convention on drugs, it was put in the most restricted category of all for a reason that should shock and shame us: because 1950s American law enforcement thought that the principal users of cannabis were black Americans, so “It must be absolutely frightful. There can’t be any benefit in this.” Subsequently, cannabis found itself in schedule 1 of the Misuse of Drugs Regulations 2001, which made research almost impossibly expensive. That was utter madness, because the harms associated with cannabis-based medicines are fleeting and it is difficult to find evidence of them. That should be set alongside the potential benefits of treatments that ought to be available to people.

This research vacuum has meant that the Government are caught in a complex situation, and regulators are understandably highly risk-averse. We do not have the necessary skills, understanding or expertise among the medicine and health regulators who currently advise the Government. The medical and research community and the regulatory community are having to play catch-up because of the barriers that we politicians put in place in respect of a policy that has been around for more than 60 years.

Let me suggest to the Minister how we can move this issue forward, do our duty and serve UK citizens who find themselves in the wretched position of having to self-treat their conditions criminally because they cannot access the medicine otherwise. The public expect us to support them, and do not want sick individuals to be prosecuted for trying to obtain a medicine; that is where all registered public opinion sits.

My first suggestion is, of course, on funding for the epileptic children with the most serious conditions. There are so few of them, but the British Paediatric Neurology Association suggested that neurologists assess the parents’ finances before issuing a private prescription, lest they be unable to pay for treatment in future. Is that really the place where we want to be? It is inappropriate and impractical for doctors to make assessments of their patients’ financial circumstances because those patients have been driven into the private sector.

The issue has to do with the public stigma around the word “cannabis”, but that is utterly unrelated to any assessment of the evidence of risk. We have to take ourselves away from coming to a view having seen that word. That is no way for those of us to proceed who are charged with responsibility for legislating, for regulating, and for serving our citizens. If we put our reputation ahead of the evidence and what we ought to enable for our citizens, shame on us.

In the case of Orkambi for cystic fibrosis, my right hon. Friend the Member for West Suffolk (Matt Hancock) and his predecessor, my right hon. Friend the Member for South West Surrey (Jeremy Hunt), were prepared to go the extra mile to find different routes to enabling the use of that drug through a managed access agreement. That shows that we can find creative solutions in this space if we are prepared to look for them. I urge the Government to return to this issue in a creative frame of mind to find a solution that will work.

Sitting behind this is the claim that we are a bioscience leader. Cannabis-based medicines should be part of that bioscience development. In the United Kingdom, another set of drugs—psychedelic-class drugs—suffer from similar problems. Some $6 billion has been invested in companies in north America to develop what is seen as the next leap forward in mental health treatment for addiction, trauma and depression. That sum is completely explicable if one considers the scale of those mental health conditions. If we are on the verge of enabling psychotherapy to work effectively for the people with the most difficult and challenging conditions, it is no wonder that the financial markets found $6 billion to invest in that—but by and large, they are not investing in it here, and this nation is a bioscience leader.

It is the experience of many prescribers of medical cannabis and their patients that medicines that contain additional cannabinoids—not just tetrahydrocannabinol and cannabidiol—are the most effective. As a result, children with treatment-resistant epilepsy are benefiting from prescription of those cannabis-based medicines, although largely privately. However, the manufacturers have struggled to respond to the calls for research from the National Institute for Health Research. The NIHR must engage with manufacturers more directly and, again, more imaginatively, and provide sufficient support and detail to help them through the regulatory minefield and over the regulatory barriers that are stopping the delivery of these medicines.

The fact that the research is so immature is a direct consequence of the blanket censorship of scientific inquiry around cannabis, because the attitude to it was formed, racistly, on the basis of who used it illegally. There was no regard to the evidence on cannabis. It is the same with the psychedelic class of medicines. There is very little evidence of risk, or of deaths arising from the misuse of these medicines in their pure form, and we have perhaps put mental health treatment back five decades by not investing in, and exploring, these medicines in the way that their risk deserved.

We must learn lessons from the way that the policy developed in the lead-up to the November 2018 regulations, which failed to deliver the reform and change that we seek in order to treat sick, epileptic children, and those with so many other conditions.

I offer my hon. Friend the Minister the solution, and I hope that she will take it up. I am conservative in the proper sense—in terms of machinery of Government changes, and in terms of uprooting public administration and then replanting it to solve a problem. However, we are in desperate need of an office for drug control to enable all the interested Departments to take counsel together in Government. When the business is led by the Home Office, we find that its job is to protect the nation and to stop things happening. It has certainly succeeded in that, as far as research is concerned. It is the former Home Secretary, now the Health and Social Care Secretary, who opened up progress on this. I have great hopes that we will push on with this when it is on the health agenda, as well as the science agenda, and the agendas of the Department for Business, Energy and Industrial Strategy and, given the amounts of money being invested, the Treasury. [Interruption.] I am not sure about the level of demand for this debate, Madam Deputy Speaker. I appreciate that everyone would like to get away as soon as they reasonably can.

I am passionate about this, because we can do some real good here. If we push forward with creating an office for drug control, we will bring together all the interests in making progress in this area—for example, the Department for Environment, Food and Rural Affairs with regard to the growing of hemp in the United Kingdom. One begins to see a picture of how some Departments that Carol Black did not mention in her review as engaging in the treatment of those suffering from drug misuse still ought to be involved in the whole drug policy conversation. Opportunities for treatment and for better healthcare are being missed, quite apart from the economic opportunities that should be available for the nation.

Mr Deputy Speaker, I know that you want me to bring my remarks to a close. NHS England and NHS Improvement were tasked in 2019 with designing clinical trials appropriate for children who, in many cases, have made significant improvements and cannot ethically have their treatment withdrawn as would be required in a standard randomised control trial. We can and we must be flexible. The urgency of enabling timely access to medicines for these children was made clear, but it has not happened. These trials must happen and must present a route to access.

Sitting behind that are children who naturally tug at our heartstrings, given their conditions and the extraordinary cornucopia of steroid treatment and everything else that has been thrown at them. They deserve our sympathy. Behind them sit tens, hundreds and possibly millions of our fellow citizens who can also benefit if we get the bioscience, the research and the regulatory framework right. I look forward to conversations with my hon. Friend the Minister as we go forward. I recognise her need and that of her fellow Ministers in the Health and Social Care Department to make sure that the advice of the regulatory agencies that advise them is properly taken. In the first instance, though, those regulatory agencies require the right expertise, knowledge and understanding, and they need to acquire it in order to give her and her colleagues the right advice.

In June 2018, Dame Sally Davies—who was then chief medical officer and chief medical adviser to the Government—was looking at the issue for the Government. She said that there was “conclusive evidence” in support of the use of medical cannabis for a number of conditions and “reasonable evidence” in others. It is safe and effective to prescribe these medicines and patients are being given prescriptions via the private route. As we heard earlier, 10,000 private prescriptions have been issued in the UK, but we still face a blockage, as a very tiny number of NHS prescriptions have been agreed. It is a great frustration that the public and many Members may feel that this problem has been solved, when it has not.

I appreciate that there are a number of problems. The Minister has already identified one of them to me: the reluctance of clinicians to prescribe. That is a real problem. The question for us is, how do we give them that comfort to prescribe? There are a couple of ways. The first is evidence, to which I will return in a minute. Another is training. We heard from my friend the hon. Member for Reigate about the difficulty of training clinicians on these issues. The endocannabinoid system—I can never pronounce that word—is a very complex system and it is not part of routine medical training. The 147 different cannabinoids that affect that system are difficult to isolate and the interrelation between them is difficult to identify, but there are people who can provide such training. We need to ensure that it is available to the clinicians, GPs and others who would like to be involved.

Even when a specialist consultant—somebody who is on the register of consultants—has agreed to prescribe, there is another barrier. They have to go to the next level for approval by a higher authority, as I think it is called, which means the trust, the clinical commissioning group or sometimes NHS England, although it is usually the trust. A number of prescriptions have been blocked at that stage, and that is a barrier that private prescribers do not have to surmount, which is a real issue. It seems to be a fault that is built into the system, and I am not convinced that it is a necessary barrier.

We have a set of problems to solve. The Minister knows that I have a private Member’s Bill, the Medical Cannabis (Access) Bill, which is due for debate on 10 December. I hope that it might be an opportunity to address the issue. Somewhat unusually, I guess, I have put that at the disposal of the Government and asked if they will work with me to use this legislative opportunity to find a way forward. I have my own thoughts on how a private Member’s Bill might address the problem and I have made some suggestions that have not yet been supported by Ministers, although in fairness they were supported by the Minister’s predecessor, the hon. Member for Bury St Edmunds (Jo Churchill). I welcome any suggestions or ideas about how we might frame the Bill to get around the problems. Even if we can only make baby steps, I am happy to work with the Government to find a way forward. I really want to make progress, so I make that offer to the Minister again today. I am grateful to her for saying that she will meet me to discuss the issue in the near future.

Let me return to the issue of evidence. As I have said, there is a lot of evidence out there, from around the world, about the effectiveness of cannabis-based products. Lots of work is going on. As the hon. Member for Inverclyde mentioned, the charity Drug Science has a fantastic, academically robust evidence gathering research project called Project Twenty21, in which 1,800 people are currently being treated. I pay tribute to Drug Science. I should declare my interest as a trustee of that charity—an unpaid trustee, of course. The study is an excellent piece of work to try to create a better body of evidence on the issue.

The matter comes down to the medical approvals system in this country, which emphasises so strongly double-blind randomised controlled trials—rightly so, as they are seen as the gold standards of trials. However, that system is set up to look at pharmaceutical products, not at something like whole plant extract medicines. As I mentioned earlier, cannabis contains 147 different cannabinoids, plus terpenoids and various other elements. It is quite a complex interaction on the nervous system. Sometimes a treatment will only work for a particular individual, and individuals have to work out their best balance of treatment.

It is difficult to have randomised controlled trials for such medicines. Leaving aside the moral issue of taking young people who are being treated off their medicine to take a placebo, if it is even possible to get a placebo—from what I hear, I am not convinced that people can really have a placebo for this kind of trial—it is still just a really difficult thing to do. I am not an expert on pharmacology or neurology, but I have spoken to people who are, and some are doubtful that it would be possible to get effective, useful evidence from such randomised controlled trials on whole plant cannabis. It is quite a unique plant that has a unique set of interactions with the body, so it is difficult to carry out those trials effectively.

Randomised controlled trials are not the only method of approval. I am told that 72 drugs have made it on to the approved medicines list without that kind of double-blind controlled study, so there are ways of doing it. The problem is that none of those drugs are plant-based medicines. As I understand it, cannabis is pretty much unique, given the interaction of the elements within it. We need a unique way of looking at the problem and at the evidence.

I made a couple of suggestions to the former Minister about how we might gather evidence and I was knocked back because they might bypass our current system of medical approvals, but I am afraid I have become convinced that part of problem is the current system of medical approvals when it comes to cannabis-based medical products. As my friend the hon. Member for Reigate said, we need Ministers to be flexible and creative, maybe a bit radical—maybe brave, if that is not a word that has been outlawed after its use by Sir Humphrey Appleby. We need Ministers to look at this in a new way. I appreciate that it is really difficult and quite an intractable problem, but we have to look at new ways of breaking the logjam, assessing the evidence base and making it easier for specialists—and perhaps others, such as some GPs—to prescribe.

I appreciate that the Government do not want to give widespread approval for GPs to prescribe these medicines. They are worried about the pressure that GPs might come under from people wanting recreational cannabis; I think that is overstated. Perhaps with some specialist training by an approved body, we might have a register of GPs who are able to prescribe. Most conditions that can be treated by cannabis are what we might call GP conditions—things like pain and anxiety. A survey said that a quarter of GPs would be happy, with the right training, to prescribe medical cannabis. We need to look at how to give people other than specialist consultants on the register a way of prescribing. That is perhaps one way of tackling this problem. Looking at trying to expand the evidence is so important, because there is so much evidence out there. It may not be through randomised controlled trials, but there are lots of other ways we can gather evidence. There are also a number of ways we can build safeguarding into the system, which I am happy to discuss with the Minister, as that might alleviate some of the concern.

The evidence is all around us that cannabis-based products can help patients. Hundreds of thousands of people in the UK are currently self-medicating. One of my relatives does that to treat their IBS. There are lots of conditions that people use cannabis to alleviate. The problem is that most are buying it illegally. It is probably high-THC skunk that they are getting on the streets, which is not the product that is best suited to them. We need to find a way to enable them to use a safer product. Again, my private Member’s Bill may be part of the solution.

I hope we can find a way forward because, as we heard earlier, this is a problem that ought to have been solved by now and has not been. If we do not have a concerted attack on this issue with some new thinking from Ministers, officials and others, then we are condemning people to continue in a situation where they are paying a fortune for their private product, going to illegal drug dealers, or condemned to pain or ill health from other conditions. We have to find a way forward, and I am very happy to work with the Government to try to do so.

This is the third debate on this subject that I have taken part in in the past couple of months. Each of them was secured by an MP from a different party. Today’s debate was secured by the hon. Member for Inverclyde, who is a Scottish National party Member. Yesterday’s debate in Westminster Hall was secured by a Conservative Member. I secured the other debate, as a Liberal Democrat Member, and we had support from Labour Members. I am at a loss as to how an issue that is so emotive, and has so much support across this House and across this country, has to keep coming back. We have to keep asking the same questions. We have to keep saying that clinical trials will not work because cannabis oil is not suitable for clinical trials. Even the NHS has said so. In its report of 8 August 2019, it recommended that there should be alternative trials. By that I assume it means observational trials.

I wonder what motivated the Government and the then Home Secretary to change the law: I suspect that he wanted to do it in the best interests of a child, and children, who were suffering and could be helped by that change in the law. I also wonder how frustrated he, and other politicians who took part in that decision, including all of us who worked hard and campaigned for it, must now be that despite that significant—in some terms, massive—change by this Government, we have not made the intended progress. People are still in pain in this country. Families are spending, as we have heard, upwards of £1,000, sometimes £3,000, a month to secure legal medication for their children that they cannot get on the national health service—the national health service of which we are so proud and that is supposed to deliver free-at-point-of-delivery care from cradle to grave.