Chamber and committees

Chief Pharmaceutical Officer submission of 19 August 2021

PE1884/A - Make whole plant cannabis oil available on the NHS or alternative funding put in place

Thank you for your email of 23 July seeking the Scottish Government’s views on the actions called for in Petition PE1884 on behalf of Steve Gillan: Make whole plant cannabis oil available on the NHS or alternative funding put in place. I was deeply sorry to learn from previous correspondence about the difficulties which Mr Gillan and his family face and I have enormous sympathy for the family’s circumstances.

As the Committee may be aware, the decision on whether to prescribe any medicine for a patient, and which medicine to prescribe, is entirely one for clinicians to make – it would be inappropriate for Scottish Ministers to make or influence individual prescribing decisions. It is also solely a decision for the patient or the patient’s carer whether or not to seek private treatment. Where they do so then they are responsible for paying the costs incurred.

The regulation, licensing and supply of medicines remain reserved to the UK Government under the Misuse of Drugs Act 1971, and this includes the scheduling of Cannabis Based Products for Medicinal Use (CBPMs). Accordingly, the Scottish Government has no power to alter this while responsibility remains reserved to the UK Government.

Under the current rules, only specialist doctors on the General Medical Council (GMC) specialist register can prescribe cannabis-based products where there is clear, published evidence of benefit. While CBPMs can be prescribed on the NHS, the majority of specialist doctors have concerns around the safety and efficacy of CBPMs, and the lack of robust evidence on their use, particularly the long-term side effects. The only evidence for efficacy and safety of products containing cannabis extracts in childhood epilepsies relates to Epidyolex®, an isolated cannabidiol which received a licence in September 2019, from the European Medicines Agency. The Scottish Medicines Consortium (SMC) accepted Epidyolex for routine use in conjunction with clobazam for both Lennox-Gastaut Syndrome and Dravet Syndrome in September 2020. This is because CBPMs are unlicensed products, which means that they have not been tested for safety, efficacy and quality through the marketing authorisation (licensing) process in the way that a licensed medicine would have. A doctor is professionally and clinically responsible for any medicine they prescribe and the responsibility that falls on them when prescribing an unlicensed product is greater than when prescribing a licensed medicine. This means that whilst the evidence base remains limited and there is not better clarity of the risks and benefits, specialist doctors will be cautious about prescribing unlicensed CBPMs. It is only by building this evidence base that doctors will gain the confidence to prescribe them.

With regards to increasing prescribing of CBPMs on the NHS, the Scottish Government is fully aware of the importance of a robust evidence base in reaching a long-term solution. On 8 April 2020, the former Chief Pharmaceutical Officer for Scotland chaired a teleconference with key paediatric neurologists from the specialist centres across Scotland. The specialist doctors had a clear and united view (which I understand to be a UK-wide view) that following GMC and British Paediatric Neurology Association (BPNA) guidelines, they would be unwilling to prescribe any CBPMs containing tetrahydrocannabinol (THC) until there is clear, published, evidence available following a clinical trial.

Some of the main concerns that they highlighted were that there were no published data on dosage ranges, toxicity, interactions, monitoring or long-term side effects (in particular in the developing brain). They were also concerned that they could not guarantee the quality or efficacy of the products due to the variable quantities of THC in dosages. They advised that while they use many medicines ‘off-label’, they knew of no other medicine where it was prescribed without a licence at all, unless part of a clinical trial. They did, however, indicate that they were willing to participate in clinical trials to build the evidence base.

Therefore, the only way to give clinicians the confidence to support NHS prescribing of CBPMs is by building the evidence base relating to their use. To this end, I have been engaging with the development of cannabis clinical trials in refractory epilepsy, which are led by the National Institute for Health Research (NIHR), where the effectiveness of CBPMs can be assessed. Mr Gillan may wish to discuss the possibility of his family member participating in a clinical trial with her clinical team.

While these clinical trials will not offer a short-term solution to the families currently seeking private prescriptions for CBPMs, they are nevertheless critical to developing the evidence base for a long-term solution and the Scottish Government is determined to support their development. To this end, the Cabinet Secretary for Health and Social Care will be writing to the UK Secretary of State for Health and Social Care to see what additional leverage can be brought to bear on potential solutions, including an update on the clinical trials progress and seeking to encourage manufacturers of CBPMs to participate in these trials. I expect this letter to be issued in the next couple of weeks.

In the meantime, I would encourage the petitioner to continue to engage with the specialist doctor and clinical team about any treatment options.