Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Government's response to the Health and Social Care Select Committee’s report on Drugs Policy: Medicinal Cannabis, published in September 2019, what steps his Department has taken with the National Institute for Health Research to develop alternative research approaches to support children who are currently receiving cannabis-based products for medicinal use rather than randomised control trials, as set out in that response.

Research funding can be accessed through applications to the National Institute for Health Research (NIHR). The NIHR relies on researchers submitting high-quality applications and welcomes research proposals to evaluate the safety and clinical efficacy of cannabis-based products for medicinal use. The NIHR and the Medicines and Healthcare products Regulatory Agency (MHRA) will consider novel trial designs and it is not a specific requirement to conduct double blind trials. The MHRA has recently published guidance on the use of real-world data in clinical studies to support regulatory decisions.

The NIHR and the National Health Service will be supporting two randomised controlled trials into epilepsy. Alternative research approaches, such as an observational study, were considered in the trial design but discounted as it would not produce robust results nor add to the current evidence base.

In 2018, NHS England asked the British Paediatric Neurology Association (BPNA) to develop interim guidance for clinicians in the use and prescription of cannabis‐based products for medicinal use in children and young people with epilepsy. The National Institute for Health and Care Excellence (NICE) then published guidelines covering prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy. The BPNA has subsequently updated their guidance. As with all decisions to prescribe medicines, the General Medical Council expects doctors to use their professional judgement when deciding to what extent any clinical guidance is relevant.