To: UK Home OFFICE
RE: Urgent Review Requested for Scheduling Issues Hindering Progress in the UK Medical Cannabis Sector
I am reaching out on behalf of the recently established Medical Cannabis Alliance (MCA), the successor to the Centre for Medical Cannabis (CMC). Our organisation represents key stakeholders within the UK medical cannabis sector, including licensed producers, clinics prescribing cannabis-based products for medicinal use in humans (CBPMs), biotechs researching and developing CBPMs and various industry leaders.
Following extensive discussions with our members, our expert panel (see undersigned) and former Minister of State for Science and Innovation Technology George Freeman MP, we have identified three critical scheduling issues that are impeding the growth of the medical cannabis industry and hampering innovation.
1. Schedule Classification Transition for CBPMs:
There remains confusion and inconsistencies in the approach taken by the Home Office and the MHRA when confirming to companies the scheduling of their products and raw materials related to CBPMs. This confusion negatively impacts the supply chain of CBPMs reaching patients, as there is no clear definition or agreement for when a product containing cannabis is not a CBPM (i.e., a Schedule 1 Controlled Drug) versus when it is deemed to be a CBPM (i.e., a Schedule 2 Controlled Drug prescribed by a Specialist Prescriber).
2. Schedule Classification During Development for Products Leading to Clinical Trials:
During the development stage leading to a clinical trial, cannabis and controlled drugs such as THC remain classified under Schedule 1, leading to increased complications related to compliance in handling Schedule 1 products by companies involved in pre-clinical development (i.e., toxicology assessments), Drug Substance and Drug Product development before clinical trials. This makes Research and Development activities a more protracted, difficult, and expensive endeavour for UK companies and academics, hindering much-needed research and innovation in the medical cannabis field.
3. Assumed THC Presence in Cannabidiol (CBD):
All CBD products and raw materials are currently assumed by the Home Office to contain or can convert to tetrahydrocannabinol (THC), resulting in their classification under Schedule 1 (unless meeting the criteria of an Exempt Product). This incorrect generic assumption adversely affects companies dealing with high purity CBD isolates and synthetic CBD when there is no scientific evidence of conversion to THC under normal processing and storage conditions. This makes it extremely difficult for companies to import, export and work with third-party companies involved in the development of CBD as a medicine.
We request that the Home Office undertake an urgent review of these scheduling issues to facilitate a more conducive environment for research, innovation, and growth within the UK medical cannabis sector. Your attention to these matters is crucial to the advancement of medical science and patient care, especially when the UK is ‘falling behind’ other countries which have already established solutions to these issues.
We believe that Points 2 and 3 above can largely be addressed by adopting the recommendations made in the ACMD Barriers to Research II report published in December 2023. However, we believe the ACMD report fails to address the complexities associated with defining a CBPM which in turn determines whether the product containing cannabis is a Schedule 1 or Schedule 2 controlled drug. This is particularly pertinent when engaged in the research and development of Drug Substance and Drug Product before progression into clinical trials, as outlined in Point 1. We would like to highlight and address this matter separately with you.
We will draw examples of real-life challenges businesses are facing when this letter is released.
Thank you for your consideration, and we look forward to the possibility of working collaboratively to address these challenges.
Professor Trevor Jones
Chief Scientific Adviser, Medical Cannabis Alliance
George Freeman MP, Dr Andy Yates, Dr Elisabeth Philipps, Greer Deal and Dr Parveen Bhatarah