Medicinal Cannabis

Jeff Smith Excerpts

Monday 6th September 2021 Commons Chamber

[Jeff Smith (Manchester, Withington) (Lab)]

Will the Minister give way?

[Jo Churchill]

One second. On the expansion of Epidiolex, NICE will work with the manufacturer to assess the clinical and cost-effectiveness of the medicine in the indicated patient group before making recommendations for routine prescribing and funding on the NHS. That is the proof. Where there is the will and investment in clinical trials, cannabis-based medicines can achieve the medicinal licence that is the gateway to routine funding. They have become a useful tool for clinicians in treating diseases where other licensed treatments have failed, but the licensing process also provides for the development of the evidence and information that doctors rely on to support their treatment decisions, as was laid out by my hon. Friend the Member for Reigate (Crispin Blunt). The MHRA is well equipped to provide advice to any prospective applicants wishing to conduct clinical trials or marketing authorisations. Indeed, there have been 13 trials ongoing in the UK in the past 12 months, and six other trials of this type of medicine have been completed.

On refractory epilepsy and the children we are specifically interested in tonight—that is not to exclude any other patient group—NHS England, NHS Improvement and the National Institute for Health Research have confirmed in principle support for two randomised control trials on early onset and genetic generalised epilepsy. These will compare medicines that contain cannabis oil, CBD only and medicines that contain CBD plus THC with placebos. While, like many other projects during the pandemic, there have been delays on commercial discussions, these are nearing completion. Once supply contracts have been finalised, the study team will be able to initiate the formal trial set-up process and confirm a date for patient recruitment. This is a pioneering area of research, and we are keen to support patients by progressing these trials as soon as possible. I feel keenly the frustration that they have taken so long, and I hope to be in a position to make a further announcement on these clinical trials in the next few weeks.

[Jeff Smith]

The Minister is being very generous in giving way, and I know she wants to find a solution to this problem. I tried to get in earlier when she referred to some parents who had used medical cannabis and found that some of it worked and some of it did not work. It sounds like an evidence base was being created there. I understand that she does not want to create a system for all our medical regulation based on observational trials, but there are many experts who say that randomised control trials will not work for cannabis and we need another way of getting the evidence. Given that we clearly have a system that is not working, is there not a case for this particular condition and this particular type of medicine being a special case? We need to find a different way of creating such an evidence base to give the clinicians comfort.

[Jo Churchill]

I will focus on the end bit. We do need to give clinicians comfort if they are going to prescribe medicines that help alleviate children’s pain. The challenge with the observational trial, as anyone who has been involved with medical trials will tell you, is that the smaller the cohort, very often the greater the problem is with the confidence intervals, and so on and so forth. There is a need to look at things by perhaps turning the telescope the other way up to see whether we can focus ourselves on approaching this in a different way to find solutions. However, the bottom line is that we need good evidence, because we have also been in this Chamber talking about drugs where the challenge to the patient has then transpired, and we later we have been here talking about the damage.