1.Last year, the distressing cases of Alfie Dingley and Billy Caldwell caused a public outcry following the experience of their families in trying to obtain supplies of medicinal cannabis products. This prompted the Government to review the regulation of medicinal cannabis. Alfie and Billy both suffer from severe forms of epilepsy that are resistant to conventional treatments and their experiences with medicinal cannabis suggested that these products could help with reducing their seizures. Following expert medical advice, the Government rescheduled medicinal cannabis to relax some of the restrictions to its use. Where previously medicinal cannabis was kept under the strictest of regulations, which made research and obtaining these products difficult, medicinal cannabis products can now legally be prescribed by some specialist doctors.
2.These changes and the failure to be clear about who might then be able to access medicinal cannabis on prescription, raised public expectations and led to many groups feeling let down. Parents of other children suffering severe and intractable epilepsy have continued to face barriers in obtaining medicinal cannabis.
3.It was against that background—and with those children, and others hoping for new treatments for a variety of severe and debilitating illnesses, in mind—that we announced our inquiry into the use of medicinal cannabis.
4.In November 2018 medicinal cannabis was rescheduled from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulation 2001. The rescheduling recognised that medicinal cannabis has some therapeutic benefit. The rescheduling followed a two-part review conducted by the Chief Medical Officer (CMO) and the Advisory Council on the Misuse of Drugs (ACMD). The rescheduling of a drug under the Misuse of Drugs Regulation 2001 relates to the legality of certain activities with the drug such as manufacturing, supplying and possessing the drug. The rescheduling of medicinal cannabis allowed the products to be more available for research and prescribing.
5.The CMO conducted a review of the evidence base for medicinal cannabis and in June 2018 concluded that there is “conclusive evidence of the therapeutic benefit of cannabis based medicinal products for certain medical conditions, and reasonable evidence of therapeutic benefit in several other medical conditions”. Those conclusions allowed her to recommend that medicinal cannabis be considered for rescheduling.
6.In July 2018 the ACMD recommended that a definition of “cannabis-derived medicinal product” be developed, and products meeting this definition be rescheduled. It was after this part of the review that the Government rescheduled medicinal cannabis on 1 November 2018 and provided a definition for cannabis-based product for medicinal use in humans (CBPM).
7.Medicinal cannabis is derived from the cannabis plant and contains more than a hundred chemical compounds called cannabinoids. The two most widely-used cannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC). Each medicinal product will have a different ratio of CBD to THC, as well as other cannabinoids. Different compositions may be more effective for some individuals than single compounds. Each product will have its own benefits and risks, and these are best established through further research.
8.Medicinal cannabis has been used to try to treat a range of medical conditions and symptoms including chronic pain in adults; chemotherapy induced nausea and vomiting; multiple sclerosis spasticity syndromes; and intractable epilepsy.
9.Few CBPMs are currently available. Sativex, for the treatment of Multiple Sclerosis symptoms, is the only licensed CBPM in the UK, but it is not considered to be cost-effective by the National Institute for Health and Care Excellence (NICE). Consequently, Sativex is not a regularly prescribed product on the NHS in England but is available on prescription in Wales. Epidiolex is close to being granted a licence by the European Medicines Agency, which would also grant it a licence in the UK.
10.Most CBPMs are unlicensed products. They have not been assessed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) for their safety or efficacy. However, doctors can still prescribe these products if they believe it is medically appropriate. Under the current regulations, an unlicensed medicinal cannabis product can only be prescribed by a specialist doctor on the Specialist Register of the General Medical Council.
11.In December 2018 we set out to look at the issues around medicinal cannabis. Our terms of reference asked for evidence on:
We heard of a number of issues from different groups. Campaign and patient groups told us about the issues around obtaining products, conducting trials and the various forms of evidence for medicinal cannabis. We also heard that the key issue for clinicians was the lack of a research base into medicinal cannabis products and the issues around off licence prescribing. The research and evidence gap needs to be addressed to determine whether and if so which patients could benefit from CBPMs, and their place in treatment options.
2 House of Commons Library:
5 GW Pharmaceuticals ()
6 MS Society ()
Published: 3 July 2019