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Medicines licensing

DHSC to clarify to MPs that medical cannabis licensing will include clinical trials

The Department of Health and Social Care (DHSC) is to write to the House of Commons Health and Social Care Committee to clarify that the licensing process for medical cannabis will include clinical trials.

The clarification comes after health secretary Matt Hancock told the committee on 9 July 2019 that medical cannabis will not need to be tested through randomised controlled trials (RCTs) in the UK in order to be licensed.

However, in a statement to The Pharmaceutical Journal, the DHSC said health ministers have been clear that good evidence of safety, quality, efficacy and cost efficacy is needed to support the NHS in making funding decisions, as well as giving clinical guidance, about medical cannabis.

The statement confirmed that the evidence will include clinical trials.

It added that a larger evidence base is needed to support routine publically funded treatment, but noted that if a patient has a particular clinical need for medical cannabis, and there is enough evidence that it will benefit their case, then unlicensed cannabis-based products can be considered by specialist NHS doctors.

A spokesperson for the DHSC said: “The decision to prescribe unlicensed cannabis-based products for medicinal use is a clinical decision for specialist hospital doctors, made with patients and their families, taking into account clinical guidance.”

The government has asked the National Institute of Health and Care Excellence to develop clinical guidelines, which are expected to be published in October 2019, to look at the effectiveness and safety of cannabis-based medicinal products.

The DHSC also said it is working with Health Education England to provide additional training to support doctors prescribing these products.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206821

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