Canada versus the United Kingdom – an overview of the cannabis market
On 14 September 2020, the NHS announced its decision to fund the treatment of Billy Caldwell who is severely epileptic. This decision comes nearly two years after the law changed on 1 November 2018, allowing for CBMP’s to be prescribed by specialists for patients who cannot be helped by other available licensed drugs.
The battle for an NHS prescription
Before travelling to Canada for a course of CBMP’s, Billy Caldwell suffered numerous life-threatening seizures each day. The treatment was found to significantly reduce Billy’s seizures but on returning to the UK in 2018, the cannabis oil was seized by the UK Border Force.
Billy was subsequently hospitalised after suffering his first seizure in three hundred days and his mother, Charlotte Caldwell, labelled the decision to confiscate the medication as “[signing] Billy’s death warrant”. This decision attracted widespread criticism and public outcry resulting in the return of Billy’s medication and a policy review which acted as a catalyst for the law change later that year.
However, despite Billy’s medication becoming legal in November 2018, Charlotte Caldwell was left footing the bill. In opposition to this, Charlotte Caldwell took the Health & Care Social Board of Northern Ireland to Court to get them to pay for the prescription. The case was dropped in September 2020 when the Board agreed to fund Billy’s care for four weeks. However, in light of the advice from the Refractory Epilepsy Specialist Clinical Advisory Service (RESCAS) who recommended that Billy’s medication not be discontinued, it is anticipated this agreement will be extended indefinitely.
It is estimated that this year alone, the UK has seen a monthly increase of private prescriptions for CBMP’s of between 20 – 30 per cent, and yet Billy’s is one of only a handful of NHS prescriptions. Whilst the NHS has legally been able to prescribe CBMP’s since 2018, the reality is that families like that of Billy Caldwell have still been paying thousands of pounds a month for private prescriptions.
The reluctance to prescribe cannabis medicine
Part of the reluctance in the NHS to prescribe CBMP’s comes as a result of the guidance within the National Institute for Health & Care Excellence (NICE) Guidelines. NICE is responsible for evaluating the benefits derived from treatment, balancing that benefit against the public expense and advising practitioners on use of the treatment.
In their 2019 Guidelines, NICE stated that there is not enough evidence to recommend CBMP’s for severe and treatment-resistant epilepsy. So, although the Guidelines do not prohibit the prescription of CMP’s, many practitioners interpret the guidance rigidly and use it as justification for not prescribing until further clinical trials are conducted.
The call for greater investment in clinical trials has been met with opposition from the pharmaceutical industry which appears reluctant to fund these trials for two reasons:
1. The cannabis plant cannot be patented meaning the profit for an individual company is limited; and
2. The substance cannot be tested in randomised control trials due to its chemical composition, which means meaning greater flexibility and pragmatism would be required to ascertain its efficacy.
Although many patients and families are hopeful that the decision in Billy Caldwell’s case will allow other patients to obtain NHS prescriptions for similar treatments, the upcoming Judicial Review brought by the family of three-year-old Charlie Hughes would suggest that Billy’s case is an outlier and not indicative of a rapidly growing trend.
The Judicial Review of the NICE Cannabis Guidelines
Charlie Hughes suffers from West Syndrome, a rare form of epilepsy which causes him to suffer up to 120 seizures a day. After Charlie was prescribed six different anti-epileptic drugs by the NHS and none improved his condition, Charlie’s father felt they ‘out of options’ and turned to medical cannabis.
Two NHS clinicians refused to prescribe, and now Charlie’s family pay £1,200 a month for a private prescription of cannabis oil. The family have reported that, since taking the medication, Charlie’s seizures have reduced by 85 per cent with none of the side effects associated with pharmaceutical anti-epileptic drugs and his social and physical development has improved significantly.
The family have found themselves unable to get this medication prescribed by the NHS, so have lodged an application for Judicial Review of the NICE Guidelines. They argue that the Guidelines are so restrictive that they effectively prevent hundreds of children from accessing the treatment they require through the NHS.
On 30 July 2020, Mr Justice Holman granted permission to apply on two grounds:
1. Alleged inadequate consultation; and
2. Alleged failure to take into account relevant considerations.
The family will argue that, although much of the current evidence is anecdotal and of low quality, it should at least be sufficient to support a modest recommendation in the Guidelines for NHS clinicians to consider CBMP’s for severe cases of treatment-resistant epilepsy. NICE is expected to argue to the contrary, that “the guidance is clear and that there is nothing stopping the NHS from currently prescribing cannabis-based products”.
If the review succeeds, the family will seek redress by way of amendment to the NICE Guidelines, but what would that mean for those seeking an NHS prescription for CBMP’s in the future?
The future of NHS prescriptions for medical cannabis
The case brought by the Hughes family is expected to be heard in early 2021, so until then we can only speculate as to the outcome and, further if the family is successful, what the re-drafted NICE Guidelines might look like.
Although NHS Trust’s and clinicians are not required to strictly adhere follow the Guidelines, should they be re-drafted in support of prescription of CBMP’s, we might expect to see:
1. NHS Trust’s and clinicians feeling more comfortable recommending alternative treatments;
2. An increase in data relating to the use of CBMP’s;
3. A greater understanding of the efficacy and benefits of the treatments;
4. A reduction in people obtaining cannabis illegally for medical purposes and less societal stigma around the use of medical cannabis; and
5. A less prescriptive and more flexible approach to its use.
Shannett Thompson is a Partner in the Regulatory team. Shannett has a keen interest in healthcare with her experience extending to the regulation of cannabis based medicinal products and the CBD market.
Ellen Crow is a Legal Assistant in the Regulatory team. She largely works in the healthcare sector conducting investigations on behalf of regulators, but also has a keen interest in developing areas of clinical practice.
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