Asked by: Joani Reid (Labour - East Kilbride and Strathaven)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of the availability of Bedrocan oil.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
Bedrocan oils are a range of unlicensed cannabis-based products for medicinal use. These products have not been assessed by the Medicines and Healthcare products Regulatory Agency (MHRA) for safety, quality, or efficacy, or assessed by National Institute of Health and Care Excellence (NICE) for clinical and cost effectiveness.
Bedrocan, and other unlicensed cannabis-based products for medicinal use, are available from independent providers across the United Kingdom, regulated by the Care Quality Commission. Unlicensed cannabis-based products for medicinal use can only be prescribed by, or under the direction of, a clinician on the General Medical Council Specialist Register. Prescribers of unlicensed medicines have increase medico-legal responsibilities and are responsible for the quality and availability of the medicine prescribed.
These products are not routinely prescribed on the National Health Service, as clinical guidelines from the NICE demonstrate a clear need for further evidence on the safety and effectiveness of unlicensed cannabis-based medicines to support prescribing decisions.
The National Institute for Health and Care Research (NIHR) has issued two calls for research proposals and a highlight notice on medicinal cannabis. Manufacturers, including those for Bedrocan oils, are responsible for generating evidence to support the use of these products and to seek regulatory approval. The Government encourages manufacturers to do so and offers scientific and research advice from the MHRA and the NIHR.