Chamber and committees

Petitioner submission of 12 September 2021

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

The paragraph below it taken out of the submission received from the Chief Pharmaceutical Officer:

"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. " 

My response is who actually is responsible for the licensing supply of medicines including scheduling of CBPM for medicinal use? As both Governments are saying each other has the right .

I have previously contacted the MP for my constituency David Mundell. Who in turn asked the UK Health Secretary at that time, Matt Hancock, to look into the case for CBPMs being prescribed to children on the NHS and I was told this was a matter for the devolved Government. Which in my case is the Scottish Government.

The Chief Pharmaceutical Officer goes on to say: 

"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.  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"

This is not the case that specialist doctor have concerns and so we are unable to get CBPMs with THC, it is the case that these are not available to them to prescribe on the NHS. We personally have learned this first hand. Again, it’s not the concern it’s the fact they are not there to give out.

The paragraphs that follows on from the submission in which I have a response to are:

“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”

The GMC and BPNA said they would be unwilling to prescribe CBPMs containing THC until there is clear published evidence. There are currently 3 NHS prescriptions handed out.

Why can 3 children have CBPMs containing THC on the NHS when there are a lot more looking to have this luxury? I can only describe it as a luxury as most other patients are having to pay out vast amounts of money each month for private prescription.

In terms of evidence why can’t the patients on private and NHS prescription provide their details of current studies?

The first NHS prescription was handed out 2018 that alone is 3 years worth of reliable evidence.

To finish of my submission I also asked if the Government would be willing to provide funding to help out with private prescription cost, I still await an answer to any help that could be given.