Medical Cannabis (Access) Bill
Debate between James Daly and Jeff Smith
Jeff Smith
That is an important point. No one is claiming that every product is absolutely safe, and products often have side-effects, as Alfie’s case demonstrated. He had been pumped full of steroids which affected him badly and would eventually have killed him. That was a medication that was recommended until he started taking medical cannabis.
There is lots of evidence from around the world. Cannabis-based medicines have been legal in Canada and some US states for some time, and there are tens of thousands of individual patient reports on the therapeutic value of cannabis-based medicines in the Canadian and, in particular, Minnesotan databases. They do not equate to the so-called gold standard double-blind randomised control trial level of proof, but they are highly suggestive of a pattern of evidence that should be taken seriously. Another issue is that many people would argue that it is not ethical to insist on RCTs for the cohort of children with epilepsy, as they would have to be taken off the medicine that is keeping them well, and keeping them alive in some cases, to put them on a placebo. Some people would question that process.
In 2019 the Health and Social Care Committee looked at the barriers to access for cannabis-based products, and the Government produced a response to its report in which they made reference to the need for observational trials to help the patient cohort of children with severe epilepsy. Even the Government argued that we should be considering other forms of evidence, and I know from my interaction with the MHRA that it is considering other forms of rigorous, well-researched evidence. Unfortunately, the Government’s view seems to have changed. I have spoken to Ministers and officials again, and they seem to be wedded to the idea that RCTs are the only way forward.
My Bill would set up a commission to propose a framework for the assessment of cannabis-based medicines and their suitability for prescription in England, to sit alongside the existing MHRA processes for conventional pharmaceutical drugs. The commission would help rigorously to assess all the existing evidence base and to consolidate all the available evidence, which could give those who are eligible to prescribe more confidence in the evidence for prescribing this particular unlicensed medicine.
I hope that the commission’s work will result in a more suitable framework for the assessment of the efficacy and safety of cannabis-based medicines, which I hope would result in more cannabis-based medicines, including whole-plant medicines, becoming licensed. That would go a long way towards addressing the problem. It would improve the likelihood of prescription on the NHS for both severe and common conditions. The commission would also be tasked with identifying any other barriers that could be overcome to improve access. That might result in the adoption of short-term solutions that I will touch on shortly.
James Daly (Bury North) (Con)
The hon. Gentleman is making an excellent speech on this important issue. From my research it seems that the manufacturers and producers of cannabis-based products are not investing in the clinical trials and evidence that would be necessary, or at least proportionate in comparison with what happens for other medicines. Will he say why that is not the case, or will he point to evidence of such trials being undertaken by the producers of these medicines?
Jeff Smith
The hon. Gentleman makes an important point. Trials are happening, but there are two problems. The first is the cost, because RCTs are extremely expensive. As I mentioned earlier, the problem with RCTs is that they are not really suitable for some of these medicines, such as whole-plant cannabis extract medicines, which is the essential problem. We can isolate compounds and put them through the RCT process, but it is much more difficult with whole-plant cannabis extract medicines. Those are the two difficulties, and I will go on to suggest that the Government could commission trials as a possible way forward.