From today, medicinal cannabis products can legally be prescribed in the UK for the first time, although campaigners say many patients who could benefit will still be denied access.
The change in policy comes on the back of months of campaigning by patient advocacy groups and means that specialist doctors can prescribe products containing cannabis, cannabis resin or cannabinol in cases of “exceptional clinical need”. Funding of the treatment will be at the discretion of individual NHS trusts.
GPs won’t be able to prescribe these products, and new NHS guidance for England says that they should only be made available to children with rare, severe forms of epilepsy, adults with vomiting or nausea caused by chemotherapy, and adults with muscle symptoms caused by multiple sclerosis.
The list doesn’t include chronic pain, however, which is thought to be one of the main drivers for medicinal use of cannabis. The End Our Pain campaign – which has estimated that up to 1m people in the UK rely on cannabis for medicinal reasons – described it as “yet another obstacle on the road to patient access”.
Home Secretary Sajid Javid announced the initiative in the summer, in the wake of a high-profile case in which the mother of a boy with severe epilepsy had cannabis oil bought in Canada seized on her return to the UK. in the meantime, the government has been working to define what constitutes a cannabis-derived medicinal product so that they can be rescheduled. An expert panel of clinicians has also been set up to assess applications for licences to prescribe cannabis-based medicines.
Before today, almost all cannabis products were classed as Schedule 1 drugs, which meant access was only possible with a special, vanishingly rare license from the Home Office. It’s now Schedule 2, which acknowledges some medical benefits, and any prescribed product must stick to pharmaceutical-grade production standards.
Canada has allowed medicinal cannabis use since 2001 and legalised it almost entirely earlier this month, while some states in the US have also allowed medicinal use. In Europe, Germany legalised medicinal use last year and saw around 80,000 prescriptions in the first half of this year, although it is reportedly hard to get insurance coverage. Denmark started trialling limited use from January.
One company planning to help supply the UK’s demand is Spectrum Cannabis, a subsidiary of Canada’s Canopy Growth Corp, which says the new framework is “a bold first step” but doesn’t go far enough to ensure “reasonable access” to these products.
The company’s chief medical officer, Mark Ware, thinks that the UK should follow Canada’s lead in allowing GPs to prescribe when they deem it necessary as this builds “knowledge and capacity in the medical community and…an increased understanding among both patients and healthcare practitioners surrounding the place of cannabis in medical care”.
Meanwhile, GW Pharma – which has been cultivating medicinal cannabis in the UK for more than 20 years – just recently got approval and favourable scheduling for its cannabis-based epilepsy therapy Epidiolex in the US, setting up an imminent launch, and is waiting for a verdict from the European regulatory authorities early next year.
It already has approval for an oral spray product called Sativex in the UK and other European markets as a treatment for spasticity associated with MS, but this product isn’t authorised as being a cost-effective use of NHS resources by the National Institute for Health and Care Excellence (NICE).
NICE has been asked to produce a clinical guideline on the prescribing of cannabis-based products for medicinal use in humans, and this is expected by October 2019 at the latest.
“The UK’s rescheduling of cannabis-based medicine has come about from a groundswell of patient need, but is rooted in scientific evidence and experience,” comments Professor Marie Fallon of The University of Edinburgh.
“There is a significant real-world experience and clinical evidence pointing to the fact that cannabis-based medicines can be safe and effective treatments for some patients with unmet clinical needs, for instance in the areas of cancer pain and chemotherapy induced nausea and vomiting,” she adds.
What is clear is that the market for these products is immense, and likely to grow if – as seems likely – other countries follow the lead of Canada, German, the UK et al in loosening regulations on the products.
Cowen & Co estimated recently that cannabis could be a $75bn market in the US alone by 2030, although Europe will be a trickier proposition with its patchwork of national regulatory systems, particularly as the European Medicines Agency (EMA) has said it will defer to member states on the issue.