The Government’s Advisory Council on the Misuse of Drugs (ACMD) has been ‘strongly urged’ to support the rescheduling of cannabis for research purposes to help patients access it as a possible treatment.
In an open letter, the UK Cannabis Industry Council (CIC), has called on the ACMD to formally recommend to the Home Office that cannabis be rescheduled for research purposes.
The ACMD is currently conducting a review of the ‘barriers to research’ on Schedule 1 drugs, following a request from Home Office Minister Chris Philp MP in late 2022, in order to ensure that research into controlled drugs ‘continues to expand’.
Schedule 1 includes drugs which are deemed to have no medicinal use, including LSD, ecstasy, opium and cannabis when not prescribed for medical use. A company wishing to carry out research on these substances in the UK must apply for a licence from the Home Office, a process which can be complex and expensive, requiring extensive applications and approvals.
While there is increasing amounts of real-world evidence for the safety and efficacy of medicinal cannabis, regulators have repeatedly called for more randomised control trials (RCTs) before products can be made available through the NHS.
In a letter to the ACMD, co-chairs of the CIC Research Working Group, Melissa Sturgess and Dr Shanna Marrinan highlight the challenges of meeting the ‘stringent criteria’ required to run these clinical trials under the current regulations.
“In effect, cannabis used in a clinical trial still remains a Schedule 1 Drug under the Misuse of Drugs Act, which necessitates extensive Home Office applications and clearances,” they state.
“It is therefore very difficult under the present regulations to run clinical trials which meet the stringent criteria required to obtain the data requested by NICE to expand access to cannabis-based medicines on the NHS.
“The industry has sought to provide substantive amounts of ‘real world evidence’, much of which suggests strong clinical effectiveness across a range of indications. This effectively uses cannabis as a Schedule 2 Drug prescribed by Specialists, but this on its own is not considered enough by regulators.”
During a parliamentary debate on Tuesday 14 March, Mr Philp acknowledged the current situation for drugs research was a ‘Catch-22’ scenario, adding that there was ‘a commercial as well as an academic benefit’ to conducting research on ‘all drugs’.
“I accept that there is an element of chicken and egg or Catch-22 about the situation, because we need to do the research before there is an evidence base to justify the rescheduling that might be merited,” he stated.
“I do strongly support making it as easy as possible for UK institutions—universities, hospitals and private companies—to conduct research using not just psilocybin, but all drugs, and there is clearly a commercial as well as an academic benefit.”
The CIC has urged the ACMD to recommend cannabis be moved to a less controlled category for research purposes in order to encourage companies to invest in the trials.
“Adjustments to the regulations to make legitimate use of cannabis in research more accessible will improve industry’s ability to provide the data requested by regulators, thereby taking over much of the costs burden from regulators,” they add.
“The Cannabis Industry Council therefore supports the adjustment of the scheduling of cannabis for research and strongly urges the ACMD to make such a recommendation in your response to the Home Office.”
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