In November 2018, the UK made medical cannabis products legal on prescription, joining the growing number of European countries that have done so. The changes, announced by UK Home Secretary Sajid Javid, followed several high profile cases in which seriously ill children were unable to access the medicines they needed.
“Having been moved by heartbreaking cases involving sick children, it was important to me that we took swift action to help those who can benefit from medicinal cannabis,” said Javid.
The new law moved medical cannabis from schedule one under the Misuse of Drugs Regulations 2001, to schedule two. Schedule one means a drug has ‘no therapeutic value’, whereas schedule two means a drug is controlled but does have a recognised medical use.
Problems with patient access
While the change was welcomed by advocacy groups – the United Patients Alliance called it a “long overdue and historical day” – it has not been quite the revolution that many had hoped for.
For one thing, it doesn’t give GPs free rein to prescribe medical cannabis. Rather, the law applies only to specialist doctors, such as neurologists or paediatricians, and requires that the patient’s needs cannot be met by existing, licensed medicines.
“The new legal framework can only benefit a very small number of patients, including children and adults with rare, severe forms of epilepsy and adults with vomiting or nausea caused by chemotherapy,” explains Ramya Sriram, manager of the freelance scientist platform Kolabtree, which has helped several clients with medical cannabis research products.
Moreover, few doctors feel they have the information necessary to prescribe medical cannabis. They are currently relying on the guidelines issued by the Royal College of Physicians (RCP) and the British Paediatric Neurology Association (BPNA), which some have dubbed ‘unnecessarily restrictive’.
Take Epidiolex, GW Pharma’s cannabinoid drug for treatment-resistant epilepsy conditions. Under the BPNA guidelines, this can only be considered once all other options, including surgery, have been exhausted.
“Doctors are not familiar with medical cannabis so lack the confidence needed to prescribe it,” says Sriram. “To help combat this, in October 2019, the National Institute for Health and Care Excellence (NICE) will publish new guidelines, which may provide doctors with the information they need to confidently prescribe the drug.”
Time and money
Then there’s the fact that, as a Class B controlled substance, cannabis based medical products (CBMPs) are subject to costly, time-consuming restrictions. Every step along the supply chain (pharmacies, shipping companies, importers, etc requires a special license, which takes time and money to obtain.
According to reports, the first private prescription of cannabis, for chronic pain sufferer Carly Barton, will cost her £10,000 a year.
“Cost is an issue as NHS trusts do not currently routinely fund CBPMs,” says Dr Samantha Drake, senior lecturer in forensic chemistry at the University of Derby.
“On top of that, proving a patient’s needs cannot be met by existing, licensed products can be difficult and take time – a licensed medicine which works well for some patients might elicit an adverse reaction or have no therapeutic effect in other individuals. Before CBPMs can be prescribed, NHS England requires clear, published evidence that the benefit could not otherwise be achieved by a licensed product.”
Five months after the law change, only a handful of patients have actually benefited. The few who have gained access to these products have done so privately, leaving a huge base of patients still in need.
The market potential
According to Australian medical cannabis company Althea, 2.9 million UK patients could benefit from CBMPs. Whether or not that figure stands up to scrutiny, we know there are thousands of patients with conditions like MS and fibromyalgia who currently self-medicate with cannabis illegally. There is therefore a sizeable market for CBMPs, assuming the present challenges can be overcome.
“Following the introduction of legislation for access to medical cannabis in Germany in 2017, prescriptions grew from 1,000 to nearly 80,000 in the first half of 2018,” says Marc Wayne, managing director of Beckley Canopy Therapeutics and Spectrum Biomedical, UK. “In 2016, End Our Pain estimated that one million people across the UK already rely on cannabis for medical reasons. We see the UK as the next hotbed for cannabis innovation in Europe and through our research with Beckley Canopy Therapeutics, we plan to be at the forefront of exploring the potential for cannabis across a range of indications.”
Spectrum Biomedical – a joint venture between cannabis giant Canopy Growth and research company Beckley Canopy Therapeutics – was formed in January. It hopes to simplify the UK’s medical cannabis landscape and improve access to CBMPs, in part through educating healthcare practitioners.
“Without additional physician training and evidence, they will continue to be reluctant to prescribe products to patients,” says Wayne. “Spectrum Biomedical is keen to support patient access by closing this gap. Spectrum has developed accredited training courses in Canada and we are working hard to ensure the same evidence-based, independently-validated information is provided to physicians in the UK.”
Althea has similar goals. Having launched in the UK in February, the company will supply CBMPs through its partnership with Canadian producer Aphria. Like Spectrum, it will place a strong focus on medical education, and has launched a resource for healthcare practitioners called Althea UK Concierge.
Another major player is Jacana, a UK-based startup that has secured €22m to cultivate and distribute medical cannabis solutions. Then there is Grow Biotech, which in February received the UK’s first ever import of ‘bulk’ medical cannabis, and Oxford Cannabinoid Technologies, which raised $10m of private equity last year.
While it’s early days, analysts are speaking of a coming ‘green rush’ of investment. According to market intelligence firm Prohibition Partners, the UK medical cannabis market has strong potential over the medium term. While it will only be worth £10m this year, it could be worth over $1bn by 2022 – and the European medical cannabis market could be worth $55bn by 2028.
The months ahead
Over the short term, patient access will remain an issue, with thousands of patients being forced to break the law to obtain medical cannabis. However, medical cannabis is a dynamic area that’s undergoing rapid change.
In March, the UK’s first specialist medical cannabis clinic opened in Cheadle, Greater Manchester. It is expected to provide a ‘lifeline’ to those suffering chronic pain, with patients reportedly paying around £200 to see a doctor and £600-£700 a month for a private prescription.
There will soon be data available from the NHS monitoring unit, which was established to determine how many MCBPs are being prescribed. While the figure is likely extremely low, it will provide a useful benchmark going forward. On top of that, the NICE guidelines, due October, should give doctors more clarity and confidence about prescribing MCBPs.
In the meantime, advocacy groups and healthcare organisations will have their work cut out for them.
“The challenge ultimately comes down to changing decision makers’ minds about a drug that, unfortunately, still has a negative stigma attached to it,” says Sriram. “Recent high profile media cases, like those involving Billy Caldwell and Alfie Dingley, have helped to kick start conversations to change minds, but further scientific communication – and further research – about the benefits of medical cannabis are needed.”