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Medicines licensing 

UK trials not needed for medical cannabis licensing process, says Hancock

Medical cannabis will not need to be tested through randomised controlled trials (RCTs) in the UK in order to be licensed, health secretary Matt Hancock has told MPs.

Speaking to the Health and Social Care Select Committee on 9 July 2019, Hancock said the Medicines and Healthcare products Regulatory Agency had already started the licensing process for medical cannabis, with a decision expected in autumn 2019.

Dame Sally Davies, outgoing chief medical officer for England, told MPs in March 2019 that medical cannabis could only be licensed through RCTs, adding that the process needed to start as soon as possible with funding from the pharmaceutical industry.

The government-funded National Institute for Health Research has already put out two calls for trial funding, which are set to close on 31 July 2019.

However, when asked by MPs whether the licensing process will need RCTs, Hancock said: “Well, no, because the licensing process takes into account global evidence. You don’t have to have trials in this country.

“I’ve put in place a processes review to make sure the process of getting the drug to the people who need it goes as well as possible.”

On 8 April 2019, Hancock announced that he had asked NHS England to launch a process evaluation of medical cannabis prescribing to “address barriers” to its prescription in order to ensure that medical cannabis reaches patients in need.

In June 2019, former health secretary Sir Norman Lamb warned that if medical cannabis was available “only after the route of clinical trials; we will be waiting years”.

The Pharmaceutical Journal has approached the Department of Health and Social Care for further comment.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206808

Readers' comments (1)

  • Peter, the Misuse of Drugs Act as it pertains to cannabis these days is a joke, as Trev Coleman says, the foundational evidence for cannabis being in schedule 1 (a dangerous drug with no accepted medical use) does not exist, is outdated and never was evidence based anyway, foundations and reasons for classification are important, Matt Hancock states in this article that cannabis doesn't have to go through clinical trials due to 'global evidence' and that evidence directly refutes schedule one status for cannabis, so despite what it might say in the missuse of drugs act, it is very much a grey area, we now know that our bodies make their own version of thc 'anandamide' so how can thc be addictive if our body makes a chemical that does the same job? I have to ask once again which side are you on Peter?

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