British Government should move the licensing regime for cannabinoid pharmaceutical research and CBD over-the-counter medicines from the Home Office to the Department of Health and Social Care (DHSC) and Medicines and Healthcare products Regulatory Agency (MHRA) and create a regulatory pathway for approving these products using an evidence-based assessment of their medicinal effects, state the recommendations reported by the Taskforce on Innovation, IGrowth and Regulatory Reform (TIGRR).
Today, the TIGRR reported its recommendations to the Prime Minister on how the UK can reshape its approach to regulation and seize new opportunities from Brexit with its newfound regulatory freedom.
In the TIGRR recommendations, the experts suggested that the regulation of medical cannabinoids and medicinal CBD should be moved from the Home Office to the DHSC/MHRA to create a regulatory pathway for assessment and approval based on patient benefit.
Proposal 1.15 acknowledges two problems with the existing licensing rules.
The first is the current regime makes it very difficult for scientists in the UK to conduct pharmaceutical research on the potential medical benefits of cannabinoids and medicinal CBD. International examples and leading scientists working in this area have shown that sensible, but limited, reforms to the current licensing process could unlock significant investment into UK medical research into cannabinoids for pain relief.
The second is the dichotomy that whilst there is in the UK a fast-growing, legal, and well-established consumer market for medicinal CBD for a range of pain and neurological conditions, current Home Office rules make it impossible for them to be produced in the UK. This means that domestic consumers are relying on imported products and the UK is losing out on a c£1 billion medicines industry.
To resolve these problems, the Taskforce recommends that Government should move the licensing regime for cannabinoid pharmaceutical research and CBD over-the-counter medicines from the
Home Office to DHSC/MHRA and create a regulatory pathway for approving these products using an evidence-based assessment of their medicinal effects. At present this is prevented because the rules governing CBD medicines are not properly separated from the criminal law on banned substances derived from cannabis.
The recommendations cover legal-to-use CBD medicinal products only, and the report has focused on potential medical usage, not recommending decriminalization for recreational use.
A new industry body, the Cannabis industry Council (CIC), has recently been launched in the UK, with more than 90 members joining. They aim to set standards and drive meaningful change within the UK’s medical cannabis and CBD sector.
In March, Novel Food Consortium’s applications successfully passed the Food Standards Agency (FSA) administrative check and are now in a review phase. The list of validated products for the British market is expected.