Last month, the UK Government finally responded to a report by the Advisory Council for the Misuse of Drugs, originally published in November 2020.
Proposing two initiatives, the report highlights the progress of the UK’s medical cannabis prescribing regime - and how it needs to be improved.
However, the Governments lack of urgency in responding and making changes have once more left the medical cannabis industry feeling underwhelmed.
There is an ongoing battle to gain support from Members of Parliament and have the UK Government make access to medical cannabis easier for so many families across the country.
BusinessCann approached various health authorities for comments on the UK Government efforts, and received the following response: “Given that any decisions about the extension of the patient registry or sharing of data to date would be undertaken by NHS England and NHS Improvement, rather than ourselves, then this enquiry would need to be directed to their media team”.
Following this, the team at BusinessCann approached NHS England, who told them to pose the question to the Government.
One step forward, another step back.
Take a look at the full article from BusinessCann below.
Trial And Registry
The two key developments involve establishing a Randomised Controlled Trial (RCT) into childhood epilepsy and the widening the Patient Registry to include the private sector.
The latter, the registry, which was launched in April 2021, aims to create a database which would help inform future prescribing practices for medical professionals.
But, the registry currently only covers NHS prescriptions and one of the recommendations says that ‘further work is required to explore how to capture data from private providers’.
At the time of its launch the industry welcomed the principle of the idea, but said it would be of little use unless it was opened up to the private sector.
One of those who criticised this narrow focus was leading UK cannabis clinician Prof Mike Barnes.
‘Next To Useless‘
Following the latest developments Prof Barnes repeated this criticism, telling BusinessCann: “If it only covers NHS prescriptions it will be next to useless as there are no NHS prescriptions of full spectrum products – with three exceptions. It has to involve the private sector or they are wasting their time.”
The three exceptions Prof Barnes refers to are for Alfie Dingley, Billy Caldwell and a third child, with Alfie receiving full-plant-extract cannabis, with a combination of CBD and THC – made by Dutch firm Bedrocan – to treat childhood epilepsy.
And, this approach to treatment of epilepsy – with a combination of THC and CBD – is set to be the focus of the RCT.
The Minister’s letter backs the trial recommendation saying: “The National Institute for Health Research (NIHR) and NHS England are developing a programme of two randomised controlled trials into early-onset and genetic-generalised epilepsy.
“These will compare medicines that contain cannabidiol (CBD) only and that contain CBD plus delta-9-tetrahydrocannabinol (THC) with placebos.
“The results of this trial will answer the critical question of whether adding THC to CBD improves anti-epileptic properties.”
Three Licensed Medicines
As well as the Bedrocan ‘special’ medicines there are three licensed cannabis medicines which are prescribed by UK doctors.
Latest figures show there are around 1,000 NHS patients receiving either Epidiolex for epilepsy, Sativex for spasticity – both made by GW Pharma – or Nabilone a synthetic cannabinoid to treat chemotherapy-induced sickness.
The limited availability of cannabis medicines through the NHS is down to a very conservative medical profession brought up in a ‘quasi-religious’ mindset that only RCTs can provide the evidence base needed to prove efficacy.
However, those working with cannabis say observational trial data is a much more suitable source of reference due to the nature of the cannabis plant – its 100-plus compounds and the benefits of the entourage effect.
As a result of this clinical intransigence the private sector has grown to meet the demand of patients wanting a supply of cannabis medicine.
Private Sector Prescriptions
With over 5,000 such patients now securing medicines Pierre Van-Weperen, Managing Director of the Grow Group UK, which supplies a large chunk of these medicines highlighted the flaws in the new proposals.
He said: “The ACMD are, as we have noticed before, completely missing the point because they have only looked at the licensed products and have no overview at all of the private market.
“So they are making recommendations based on a very low number of prescriptions of licensed products that have very limited evidence behind them.
“The registry will not capture the private market and one would highly question if the registry protocol would be able to capture all different diseases and symptoms outside epilepsy that are being treated with CBMPs (cannabis-based medicinal products).”
He noted how the health service had previously recorded private prescription data but stopped doing so at the start of the pandemic, in April 2020.
He added: “On a very different note, I would struggle allowing my child with epilepsy to go into a study that actually has placebos and we also know that current licensed products have very limited evidence in a very narrow indication. That study is biased from the start to show lack of effect and the statistics will not work.”
The report contained two further recommendations one of which is a review of progress since the change of the law, which will be undertaken later this year, and the other will see cannabis remain in Schedule 2 of the 2001 Misuse of Drugs Regulations.