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.
6 pm