My Lords, I thank the noble Baroness, Lady Meacher, for her Question. There is no legal impediment to prescribing medicinal cannabis where clinically appropriate, and the Government are keen to make progress in this area. However, these are largely untested, unlicensed products. To support further NHS funding decisions, we have committed public funds to develop the evidence base. I thank NHS England, NHS Improvement and the National Institute for Health Research for their work to establish much-needed clinical trials and call on the industry to support clinical trials in refractory epilepsy and other treatment areas.
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There is a difference between the issue of controlled drugs and that of access to regulatory approved drugs. The noble Baroness is right that medicinal cannabis offers huge hope to those in pain and with severe symptoms. However, it is only through the process of regulation, clinical trials and scientific proof that we can guarantee that the benefits of this important medical opportunity are truly exploited.
My Lords, is the Minister aware of the predicament of the person who suffers chronic and unbearable pain from degeneration of the spine, the only effective relief for which is medicinal cannabis in the form of Bedrocan? Is he aware that her medication is not allowed to be prescribed by a GP on the NHS, that it costs her an unaffordable £750 a month to obtain it on private prescription, that she can obtain it at an affordable price in Holland, that due to the circumstance of the pandemic she cannot make that journey, but that she is none the less expected to pay the Dutch pharmacist for the medication being held for her? What is she to do, and how will the Minister help?
My Lords, I cannot comment in detail on the specific situation the noble Lord refers to. I recognise the high costs of medicinal cannabis, and we have done an enormous amount to bring those costs down and to regularise the transport and regulation of those drugs, but this is the way our medical arrangements are made in this country. Private prescriptions are an option for those who can seek them, and we are working hard to get more of these medical cannabis treatments on the NICE schedule, but they require clinical trials.
My Lords, will the Minister accept that the existing protocols and regulatory mechanisms suitable for most pharmaceutical medicines are not capable of handling medical cannabis, which has multiple active ingredients and is therefore not suitable for the usual randomised control trials? Does he therefore agree that a new regulatory system is required for medical cannabis, as there is in many other countries?
I do not think the noble Baroness is right. There are always groups advocating that their medicines are different from every other type of medicine, but the processes of clinical trials have served medical science extremely well. I share her frustration that the process of medical trials around cannabis has not moved quickly enough. That is why NIHR is looking again at the way these trials are funded; I have spoken to it about how this can be accelerated.
Given the importance my noble friend attaches to tests, may I ask whether any have started, the dates on which they started and when we might expect results?
The noble Baroness is very specific in her questions, and I am afraid I am not able to answer them specifically because they are subject to restrictions and confidentiality. Where I agree with the thrust of her question is that we have been in a bit of a cul-de-sac in this area, but the department is working hard to unblock the problems that have existed. Despite Covid, we appear to be making some progress on this.
My Lords, two cannabis medicines have MHRA approval. One of them, Sativex—prescribed within the NHS for multiple sclerosis—has a high level of the active cannabinoid THC, so we know cannabis has medical value. There is no doubt that many more cannabis medicines will be licensed in the coming years. Does the Minister therefore agree that while we are reviewing our current trials, we should evaluate whether it is justified to regard cannabis, in a medical way, as a controlled drug in the long term?
The noble Baroness will not be surprised to learn that I have just spent three and a half months looking at drugs that might make a difference to Covid, only to find that many of them are not helpful and often quite dangerous, so I do not share the optimism bias that many have towards unlicensed drugs. We remain conservative in our approach to clinical trials. I agree with the noble Baroness and others who have suggested that progress on this should be quicker, and I am leaning into the subject to try to bring that about as soon as we can.
My Lords, it is deeply concerning that no new NHS prescriptions for full extract cannabis oil have been issued since the medicinal use of the drug was legalised more than 18 months ago. This leads to a health inequality: 313 private prescriptions for unlicensed cannabis medicine items, including full extract oil, have been issued. Does the Minister share my concern that only wealthy families and those who can successfully raise funds in the region of £2,000 a month have access to cannabis medicines, while children from poorer families who are unable to afford the prescription are going without? What does he think needs to happen next?
The noble Baroness shines a spotlight on an uncomfortable but realistic fact of life in our medical service: those with money are able to pay for treatments beyond the reach of those who rely on the NHS for absolutely everything. Another area that concerns me is that those who have relied on fundraising have found that Covid has restricted the amount of money coming from donors. That is why we have put money into medical research charities and support charities that can help support those fundraising for their medicine.
Since the law changed in 2018, only two children with severe epilepsy have accessed whole-plant cannabis medicine via the NHS. Recently, a child ended up in intensive care in the middle of the Covid pandemic and almost died because her parents could not fundraise the money to buy her medicine privately. Does the Minister accept that this is a complete failure of the policy and that a new regime for the regulation and control of access to medical cannabis is now required?
The noble Baroness’s point on fundraising is well made, and I think I answered it in my previous answer. We are looking at it closely. On policy-making in this area, it is extremely tough to regulate innovative drugs that simply do not have clinical trials and evidence bases behind them. We have put a huge amount of effort into this area. We are working closely with industry; I call on industry to do everything it can to help this process. We are trying our hardest to provide the right regulatory environment. As the noble Baroness pointed out, we have already made important changes to the law.
My Lords, the report of NHS England and NHS Improvement, commissioned by the Secretary of State, was published last year. Very little appears to have been done to implement its recommendations. Can my noble friend say which recommendations have been implemented and what plans he has to ensure that they are all met?
The noble Lord is right to point out the importance of that report, which we have taken very seriously. We have worked closely with industry to find a suitable product to take into the trial process, and it is a great shame that we have not found the right combination. We are looking at how to address that cul-de-sac and I hope to unblock it shortly.