Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that unlicensed cannabis-based products for medicinal use prescribed in the UK, either privately or on the NHS, are subject to robust standards of (a) safety, (b) quality and (c) efficacy.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medicines in the United Kingdom and continues to provide scientific and regulatory advice to any company at any stage of product development to support companies intending to apply for clinical trials authorisations or marketing authorisations. However, the MHRA cannot solicit applications.

The Department has called on industry to invest in clinical trials and subject their products to full scrutiny by the regulators. To stimulate research proposals, the National Institute of Health Research (NIHR) has issued two calls for research into cannabis-based products for medicinal use and has taken steps to advertise the call to all manufacturers interested in supplying the UK market. The NIHR also remain open to the submission of proposals outside of these specific calls.

The vast majority of cannabis-based products for medicinal use are unlicensed medicines and have not had their safety, quality or efficacy assured by the MHRA, nor their cost-effectiveness determined by the National Institute for Health and Care Excellence. However, any unlicensed medicines manufactured in or imported into the UK must be manufactured to Good Manufacturing Practice standards. This is assured through licensing processes and import controls.