UK Government call for more research into medicinal cannabis
pharmafile | July 4, 2019 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | CBMP, Marijuana, UK, medicinal cannabis, pharma, politics
The British government has called for more research into cannabis-based medicinal products (CBMPs).
In a paper published on 3 July, the government said: “The research and evidence gap needs to be addressed to determine whether and if so which patients could benefit from CBPMs, and their place in treatment options.”
The call comes after England’s Chief Medical Officer Dame Sally Davies said the legalisation of medicinal cannabis had opened a ‘Pandora’s box’ leaving patients confused about the laws on CBPMs.
“The reality of the change in law was that medicinal cannabis products were rescheduled, which allowed them to be prescribed. However, most medicinal cannabis products are unlicensed, and therefore remain governed by a restrictive prescribing process. The Government failed to communicate this point, and unduly raised the hopes and expectations of patients and their families,” the paper, titled Drugs policy: medicinal cannabis, says.
The government have thus asked for more clinical trials into the safety and efficacy of CBPMs to address the evidence gap. “Robust randomised controlled trials must be carried out as soon as possible,” the paper says.
“We do not agree that randomised controlled trials should be set aside for cannabis. There are well rehearsed dangers in using anecdotal evidence. The Government and relevant organisations should focus on expediting and encouraging clinical trials. Carrying out clinical trials is the safest and most effective way of ensuring that patients gain access to the most appropriate medication.”
The paper continues in stating that the Government will look at the ways in which medicinal cannabis has been made available to patients in the EU, as it assured the public that the future of CBMPs would not be put at risk by Brexit.
“The Department of Health and Social Care should look at how medicinal cannabis is made available to patients in other EU member states such as the Netherlands and see whether lessons might be learnt which could be helpful,” the paper says.
“Government should also set out how it will ensure that the future of European multi-centre clinical trials and the post marketing surveillance that protects patient safety are not put at risk by Brexit.”
Paul Steckler, Chief Operating Officer at UK medicinal cannabis company Spectrum Biomedical commented: “Not much has happened in the UK since the regulation change in November, which has been frustrating for both the industry and patients. We recognise that it’s quite a complicated issue that the government are trying to navigate… You haven’t got your traditional randomised controlled trials and traditional evidence for governments and payers to make decisions on – hence why medicinal cannabis has its unlicensed status.”
“It’s good that the government is looking to partner with credible industry partners to try and find a solution to having a supply that is continuous…The implication is that medicinal cannabis is being taken more seriously. If you’re a patient with epilepsy, chronic pain or multiple sclerosis – these are conditions that you cannot really be without therapy.”
“One of the gaps we have in the UK is that there is no clinical experience of medicinal cannabis. Patients want access to cannabis but clinicians have no experience.”
Louis Goss
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