As societies have tackled the ongoing chaos and tragedy of COVID, the past year has seen rapid changes in regulatory flexibility to fight back against the pandemic. This has been particularly pronounced in the accelerated review and approval of new, innovative medicines.
Of course, the clearest example of the impact of this new flexibility can be seen in the UK’s recent approval of several vaccines. As we hope to move beyond the pandemic over 2021, new approaches to regulation and patient outcomes could present a rare opportunity in medical cannabis.
In spite of regulatory changes in November 2018, levels of access to unlicensed Cannabis-based products for medicinal use (CBPMs) on the NHS have remained low. Part of the problem stems from the lack of randomised-control trial (RCT) data for several CBPMs.
While the two best-known components of cannabis, THC (the main psychoactive compound responsible for the intoxicating effect of cannabis) and CBD (the non-intoxicating compound found in certain medical cannabis products) are relatively well-understood in science, cannabis contains hundreds of chemical compounds.
There is some evidence to support the efficacy of CBD and THC in treating severe epilepsy, spasticity in MS, as well as in the management of nausea and chronic pain, but trial data for individual CBPMs is harder to establish. As a result, many CBPMs in the UK are available only without licence.
Without a licence, products such as these are often met with strong reluctance to prescribe and reimburse from NHS physicians and commissioners. As a result, patients are pushed to either high-cost private prescriptions or, for an estimated 1.3 million people, the black market.
This is in rather stark contrast with countries such as Germany, which allows every doctor to prescribe CBPMs and to have these prescriptions reimbursed under the state insurance system. In 2019, Germany saw 267,000 prescriptions for medicinal cannabis. In England, there were only 320 NHS prescriptions.
But change does seem to be on the way; recently, NHSE has ramped-up monitoring efforts through an upcoming national patient registry for those receiving CBPMs, strongly implying an eagerness to find the data needed to fully embrace the potential benefits of medicinal cannabis, and potentially a tentative openness to the use of real-world data. The role of CBPM manufacturers now is to welcome this approach by showing how quality data can exist outside of the RCT.
With the lessons of the innovative development of COVID vaccines still fresh in mind, this is a rare opportunity for the CBPM industry to work with authorities to pave new routes to data, licensing and ultimately patient access.