July 5, 2019
UK government ‘failing patients’ with medicinal cannabis policy
MPs have said that the UK government is failing patients who are at risk and suffering without access to medicinal cannabis. They are calling for a full inquiry into the weak policy that has stymied research and limited prescriptions for medical cannabis in the UK.
In a report published on Wednesday, members of the Health Select Committee outlined how Britain’s medicinal cannabis legislation has not met promises, with only a handful of patients able to obtain prescriptions since the change in legislation last November.
‘Expectations were unfairly raised that these products would become widely and readily available, and there needs to be far clearer communication that this is not the case,’ said Dr Sarah Wollaston MP, chair of the Health and Social Care Committee (HSCC).
The cross-party committee warned patients with ‘distressing and life-threatening conditions’ would suffer the most if the government did not revamp product licensing.
‘There needs to be a sense of urgency to explore the potential of medicinal cannabis in these conditions so that there is a robust research base on which to base future clinical decisions,’ the report said.
The Home Office tweaked laws in November 2018 following a media campaign from patients demanding the freedom to explore medicinal cannabis to treat symptoms of serious illnesses.
Despite the intervention from Home Secretary Sajid Javid to relax the rules around prescriptions, the HSCC said promises had failed to materialise, and that patients were left frustrated by opaque and confusing medicinal cannabis laws.
‘This rescheduling was widely welcomed but there was a failure to communicate what this would mean in practice for the availability of medicinal cannabis,’ the report said. ‘Most of these products are not licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) and neither have they been approved by the National Institute for Health and Care Excellence (NICE).’
The report goes on to say that the high costs of conducting research, acquiring patents, and limits on accessing products due to stringent legislation has made conducting robust trials all but impossible, which means many products remain unlicensed.
The report also calls on the government to stop border authorities from confiscating prescribed medicinal cannabis brought into the UK from overseas under specialist supervision.Products may only be prescribed if the individual prescribing doctor is satisfied that there is sufficient evidence of the product’s safety and efficacy for an individual patient, and that the patient has exhausted all other options.
Stronger evidence base
The committee called on NICE to engage more deeply with patient groups in the development of its medicinal cannabis guidelines, and for a stronger evidence base, particularly for conditions where the Chief Medical Officer indicated greatest therapeutic benefit. While medical cannabis can be used to treat over 50 conditions, the committee recommends that intractable childhood epilepsy should be a priority.
It wants the government to secure long-term international deals ensuring a consistent supply of medical cannabis for testing to avoid any delay in patient access.
More data is vital
Companies who don’t provide products for researchers should be ‘named and shamed’, the report said but, in reality, suppliers and producers have been forthcoming to offer products for testing and clinical data. While the UK government has insisted on the need to perform clinical trials, there is a clear lack of understanding around the limitations of the data available from these programmes, which has caused a blockage for medical cannabis access.
‘It is important to appreciate that many users of cannabis in the UK use it to derive medical benefit and risk their health and life-changing judicial involvement by sourcing their treatment illicitly,’ said Dr Robert Pawinski, chief medical officer at Althea UK.
‘Given the large number of patients that are currently receiving medical cannabis globally, and the growing evidence base to support their efficacy and their safety, new novel strategies to accelerate access through prospective real-world data registries may be in the best interest of public health,’ he continued.
A government spokesperson said it will consider the report and its recommendations alongside the outcome of the NICE review into the use of cannabis-based products for medicinal use, which is expected in October 2019 according to the most recent letter from NHS England.
‘In doing so, the government will consider any further action we might take to strengthen the evidence base and improve access to cannabis-based products for medicinal use where specialist doctors determine it is clinically appropriate,’ a spokesman said.
The HSCC report reinforces the view that the UK medical cannabis programme is inaccessible to the vast majority of patients, with only a handful of cannabis-based medicines being prescribed domestically. It also further highlights the need to perform robust clinical trials and product testing in order to gather sufficient evidence and data to develop clearer clinical guidelines. While further guidance is expected to come later this year from the government, patients, advocacy groups and industry analysts all contest that not enough is being done to develop a clear long-term strategy for the UK medical cannabis market.