Much-Needed Or More Delays? UK Industry Responds to Upcoming ACMD Review of Cannabis-Based Medicines
Seven years since the first unlicensed cannabis-based medicinal products (CBPMs) were prescribed in the UK, the move has been welcomed as ‘timely’ and ‘much-needed’ by some, but others say it is action that is needed, not more analysis.
In 2018, the former Home Secretary Sajid Javid announced the rescheduling of cannabis-based products for medicinal use, following the high profile campaigns led by parents of children with treatment-resistant epilepsy.
The change in legislation made it possible for doctors on the GMC specialist register to prescribe unlicensed CBPMs to patients where they felt there was a genuine need, with Javid stating his intention to ‘ensure that patients have access to the most appropriate course of medical treatment’.
However, in the seven years that have passed since the first full licence to prescribe CBPMs was issued in June 2018, only a handful of patients have been able to access these medications through the NHS.
This has paved the way for a prospering private market, with around 40 specialist clinics now prescribing unlicensed CBPMs. The latest data from the NHS Business Services Authority, shows over 300,000 items were prescribed between April 2023-24, more than double that of the previous 12 months.
But repeated calls to make it easier to access CBPMs through the NHS, have been shut down by ministers from both Conservative and Labour governments, citing the need for more ‘high quality’ evidence.
In a letter published on 2 June, Minister of State for Policing, Fire and Crime Prevention, Dame Diana Johnson, set out the next three-year priorities for the ACMD including carrying out a review of the current evidence and publishing new recommendations for CBPMs.
As well as reviewing whether the law change in 2018 has had the ‘desired impact’, the ACMD has been tasked with identifying any ‘unintended consequences which were not anticipated at the time of implementation’ and making ‘recommendations on how to mitigate these’.
This includes, according to Dame Johnson, ‘any inhibiting effect’ that the availability of private prescriptions has had on the ‘incentive to conduct clinical trials to develop safe, effective and cost-effective products for use via the NHS’.
The upcoming review has been welcomed as ‘timely’ and ‘much-needed’ by bosses at the industry trade body the Cannabis Trades Association, which urged the ACMD to consider ‘patient access, real-world data, prescriber confidence, and regulatory clarity’ as key priorities.
However, others pointed out that the ACMD has already provided comprehensive, evidence-based solutions in reports from 2018, 2020, and most recently in 2024.
Writing to Dame Johnson in response to the commission, Professor Trevor Jones CBE FMedSci and chair of the Cannabis Research and Development Group (CRDG) highlighted how in February 2024, the ACMD published recommendations following a review of the ‘barriers to research’ on controlled drugs following a request from Home Office Minister Chris Philp MP in late 2022.
This included a recommendation to exempt universities and hospitals from Schedule 1 licensing requirements (as already exists for Schedule 2-5 drugs), allowing MHRA/HRA-approved clinical studies to proceed without additional Home Office licensing and streamlining the supply arrangements between research institutions.
“While we appreciate the government’s commitment to examining the impact of the 2018 legislative changes, we cannot ignore that practical solutions have been sitting on ministers’ desks for eight years,” said Professor Jones.
“Every month of delay means more UK patients seeking treatment abroad, more researchers relocating to countries with sensible regulations, and more suffering for families desperate for new treatment options.”
According to the CRDG, Schedule 1 licence applications take up to 14 months to process in the UK, compared to two to three months in Canada and the Netherlands, while initial licensing fees exceed £3,000 per site, making multi-centre trials prohibitively expensive. As a result major pharmaceutical companies are relocating cannabinoid research programmes to jurisdictions with streamlined processes.
“The irony is that UK researchers often have the ideas and the funding, but not the regulatory permission,” explained Professor Jones. “We’re watching our competitive advantage evaporate one delayed licence at a time.”
The CRDG says that the government should ‘demonstrate genuine commitment to reform by’ immediately implementing the existing recommendations to address issues facing current research programmes, while proceeding with the new review to address ‘longer-term systemic issues’.
“These aren’t radical proposals,” added Professor Jones.
“They’re common-sense alignments with how we already handle other controlled drugs in research settings. The solutions exist – what’s missing is the political will to implement them.”
Despite the growth of the private sector, the UK is also lagging behind other jurisdictions such as Australia, where over 1 million patients are reported to have received medicinal cannabis prescriptions for more than 200 health conditions.
The UK Cannabis Industry Council says this is largely down to differences in regulations, such as allowing GPs to prescribe CBPMs without the support of a specialist consultant. The Australian Therapeutic Goods Association (TGA) also collects and publishes data on prescriptions via the authorisation process. Welcoming the review, Mike Morgan-Giles, chair of the CIC, told Cannabis Health: “Medical cannabis prescriptions in the UK lag far behind comparable jurisdictions such as Australia, largely due to policy and regulatory issues. The CIC would like to see the introduction of reforms such as GPs initiating prescriptions, pathways for NHS reimbursement of private prescriptions, and electronic prescribing.” However, Morgan-Giles added that it was “fundamentally inaccurate” to imply that the private prescription market has impacted the incentive to conduct research. “There are much wider issues causing this, including an unwillingness to consider real-world evidence where the data is compelling, and a lack of understanding around why the clinical trials framework is completely unsuitable for multi-compound botanical medicines such as prescription cannabis,” he said. “The CIC will be consulting with members and engaging with key stakeholders to develop a detailed response to these matters.”
For children with treatment-resistant epilepsy, whose stories were fundamental in the campaign to change the law, it is safe to say it has not had the desired impact.
Many parents are still paying around £1,500 a month for private prescriptions, while hundreds are forced to access cannabis illegally.
Matt Hughes, co-founder and CEO of Medcan Family Foundation has urged the government to ‘prioritise’ input from the families of these children in the review, saying it would be ‘completely unacceptable’ not to.
“Seven years ago, the government made the intention with cannabis-based medicines clear: the goal was to make NHS access for children with severe drug-resistant epilepsy possible, while in the meantime allowing the industry to move forward with the clinical trials needed before broader access could become a reality,” Hughes told Cannabis Health.
“Sadly, it has been evident for many years that the law change didn’t have the intended impact. In that time, it has only become harder for children suffering from devastating seizures – children with no other options – to access a treatment that is readily available in other advanced healthcare systems.”
Hughes added that despite the challenges of conducting clinical trials on full-spectrum cannabis medicines in children with epilepsy, the industry must take steps to build the evidence base which regulators and clinicians have called for.
“The UK’s cannabis industry has made significant strides over many years to reach its current position. However, it can no longer afford to overlook the critical need for robust data. While establishing and funding clinical trials for multi-compound medications is undeniably complex, the reality is that the industry must undertake this challenge,” he said.
“As a matter of urgency, we need the industry to ensure that the children the law change was intended to help can access the products they need. They also need to take decisive steps towards conducting Randomised Controlled Trials (RCTs) for full-spectrum cannabis medicines. We will not get acceptance within the clinical community until this happens.
“We would also urge the government to prioritise the input of families of severely ill children in this review. It was these children the law change was supposed to help, and to leave them out of the conversation now is completely unacceptable.”