To ask the Secretary of State for the Home Department, what the evidential basis is for cannabis-based products for medical use to be placed alongside fentanyl and diamorphine in Schedule 2 of the Misuse of Drugs Regulations 2001; and if she will make an assessment of the potential merits of placing such products in lower schedule such as Schedule 4.1 alongside Sativex.
7 July 2021
In February 2019, the then Home Secretary commissioned the ACMD to conduct a longer-term review of Cannabis-Based Products for Medicinal use (CBPM). The ACMD published their report on 27 November 2020 on gov.uk. In it they recommended:
“that the scheduling of CBPMs under Schedule 2 of the MDR remains appropriate and that no further legislative amendments to the MDR regarding CBPMs are required at this point in time.”
Unlike Sativex, most CBPM do not have a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). As such, in the absence of the reassurance that a CBPM has gone through the safety, quality and efficacy process established by the MHRA, it is right that it is in Schedule 2 of the Misuse of Drugs Regulations 2001. However, should a cannabis-based medicine receive a marketing authorisation from the MHRA, the Government will commission the Advisory Council on the Misuse of Drugs (ACMD) to reconsider the scheduling of the product under the Misuse of Drugs Regulations 2001. This was the case for Sativex following its marketing authorisation.