The plight of children affected by intractable epilepsy and the efforts of the families of Alfie Dingley and Billy Caldwell to access to medicinal cannabis led to a change in Government policy. In November 2018 medicinal cannabis was changed from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulation 2001, allowing specialist doctors to prescribe it and for products to be available for further research to be conducted.
This rescheduling was widely welcomed but there was a failure to communicate what this would mean in practice for the availability of medicinal cannabis. Expectations were raised that these products would become widely available and there needs to be far clearer communication that this is not the case.
Very few prescriptions have been issued for medicinal cannabis since the rescheduling in November 2018. This is because most of these products are not licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) and neither have they been approved by the National Institute for health and Care Excellence (NICE).
There are major gaps in the research base for medicinal cannabis in part because research was very difficult under the previous scheduling. There were restrictions on accessing products to conduct the robust clinical trials necessary to test efficacy and safety. Without a thorough research base products remain unlicensed and may only be prescribed if the individual prescribing doctor is satisfied that there is sufficient evidence for the product’s safety and efficacy for an individual patient.
We are deeply sympathetic to families who want to be able to use medicinal cannabis to treat their children and who have seen individual benefit but are unable to obtain the product here in the UK. There needs to be a sense of urgency to explore the potential of medicinal cannabis in these conditions so that there is a robust research base on which to base future clinical decisions. We also call on the Government to desist from confiscating prescribed medicinal cannabis obtained overseas under specialist supervision.
Randomised double blind controlled trials (RCTs) are the gold standard for research and we are fully supportive of the need for patients to have the opportunity to take part in robust research trials. These trials are also important in order to provide evidence for licensing purposes and for NICE assessment. We also call on the NIHR to engage with patients and their representatives on additional suggestions for improving the evidence base.
Medical products are usually developed by industry as they stand to profit from investing in the research. However, in the case of medicinal cannabis, this is not happening in part because of the difficulty in obtaining patents for medicinal cannabis products. The call for research proposals by the National Institute for Health Research demonstrates that the public sector is taking the lead in this area but it is also important for industry to be more involved in developing medicinal cannabis products and supplying products for research.
There is potential medicinal benefit to cannabis-based products but the gaps in the research base mean that we do not know where this sits alongside other therapies. The Government should focus efforts in facilitating research especially in those areas where there is greatest patient need, as in the case of children with intractable epilepsy. We heard arguments that the small numbers of patients makes it difficult to conduct double blind RCTs but the Chief Medical Officer argued that if treatments are highly effective then this can be demonstrated with smaller numbers and that trials can be discontinued early in order that all participants can benefit.
The UK needs to do more to learn from international best practice. We reiterate the importance of the UK being able to take part in multi-centre international research and post marketing surveillance. Some have argued that double blind RCTs are inappropriate for cannabis research but we do not support making an exemption for this class of medicines.
Current and future patients could benefit greatly from a swift move to carry out robust research into medicinal cannabis products. We call on the Government to support the research community and industry to take this forward.
Published: 3 July 2019