Decalogue: Increasing access and clinical understanding of medicinal cannabis

Estimated reading time: 9 minutes

Earlier this month, the Decalogue event set out several new ideas for increasing access and understanding of medicinal cannabis in the UK. Alex Fraser, patient access lead for Grow Pharma, reviews it here.

On 3 February I was given the opportunity of attending Decalogue: Increasing access and clinical understanding of medicinal cannabis.

Curated and hosted by the Centre for Medical Cannabis at Imperial College’s famous Great Hall auditorium, this live event featured a collection of talks based on the essays written for the Decalogue pamphlet delivered by the authors themselves, each a noteworthy individual at the top of their respective field in UK medical cannabis.

The Decalogue pamphlet itself, subtitled ‘Ideas to accelerate patient access & therapeutic understanding of medicinal cannabis’ can be accessed here.

I will do my best to summarise the talks and isolate key takeaways. Those who are passionate about the subject matter should download and read it in full, it is well worth your time.

Kicking off proceedings is the CMC’s founder Steve Moore to welcome us. Moore’s background in cannabis goes back to before the 2018 rescheduling. Moore previously founded drug law reform group Volteface and managed the campaigning activities of Charlotte Caldwell who, fighting for access for epileptic son Billy, put enough pressure on Theresa May’s govt that they rescheduled cannabis medicines in 2018 and enabled the current system of access via private prescription.

Blair Gibbs, editor of the Decalogue essays, CMC policy lead and former advisor to Boris Johnson describes the UK medical cannabis industry as “treading water,” saying that the industry is not engaging in a meaningful way with regulators and, whilst there is visible growth, it is slow.

Gibbs believes that more ideas are needed to spur momentum in the coming months and years to improve access for patients. Consider the stage set, we are all here today to hear some fresh innovative ideas on how to move things forward for patients.

Dr Parveen Bhatarah has an extensive background in pharmaceuticals and is regulatory and compliance lead at the CMC. Bhatarah presents a brief overview: a handful of licensed medicines from GW Pharma (recently acquired by Jazz Pharma), with most prescriptions written for the many unlicensed CBMPs made available since 2018.

Dr Bhatarah does not make mention of the RWE registries set up in the UK, but her message is clear; “there is a need for well-designed, properly conducted clinical studies.” She highlights ILAP as an avenue for consideration. ILAP aims to accelerate the time to market and facilitate patient access to medicines. It provides applicants support with trial design and offers “enhanced input” from regulatory bodies such as NICE and the MHRA.

Dr Bhatarah points to the TIGRR report, which details several proposals for regulatory reform in the wake of Brexit. One proposal suggests licensing of certain activities around cannabis medicines, particularly those involved in research, be moved from the Home Office to the MHRA or DHSC. Whilst currently only a proposal, licensing by the MHRA may well be more favourable to cannabis medicines than the current system.

Next, we hear from Professor Trevor Jones. With a wealth of pharma experience, including 10 years as director general of the ABPI (‘94 – ’04), Prof Jones makes the case that CBMP’s may seek to copy the RECOVERY trials undertaken for Covid treatments.

The RECOVERY initiative has shown that UK regulatory bodies are happy to expedite research of potential treatments when urgent and could be the first example of a new way to expedite licensing of crucial medicines. He also suggests we might look to orphan disease areas to seek grants for accelerated product license approval as large scale RCT’s are not feasible. He finishes by echoing Dr Bhatarah, that the industry must involve regulators such as NIHR and MHRA in trial design.

These are all interesting ideas, however, as CMC pharmacy lead Andy Yates rightly points out, clinical trials are complex, lengthy, and costly, particularly for schedule one and two drugs. This poses a significant barrier to the relatively small companies producing and distributing unlicensed CBMP’s in the UK. He too suggests the MHRA may be better placed to manage licenses for cannabis medicines, framing this potential move as a change for the MHRA from “controller to enabler” of access to medicines.

Next up is Jonathan Hodgson, CEO of UK specials importer and distributor Rokshaw. Interestingly this essay is a collaboration between Hodgson and Pierre Van Weperen, CEO of competing distributer Grow Pharma. Hodgson and Pierre highlight the need for collaboration between leading companies in this niche area to improve patient access.

The key takeaway from Hodgson’s piece is the urgency to allow UK companies to export unlicensed CBMP’s. Whilst it may seem a move that would primarily serve those aiming to grow medical cannabis in the UK, it is a crucial step towards increasing access for patients. Interestingly, licensed CBMP’s and all other (non-cannabis) unlicensed medicines can be exported and sold around the world.

Currently, due to these restrictions on export, UK based growers and producers are limited to supplying the relatively small number of UK patients (currently estimated at 10K). Allowing export of unlicensed CBMP’s would mean that UK producers could reach a far larger number of patients around the world and therefore scale up their activities. Doing so could create a potential 41k direct jobs and £1.2B taxable revenue for the UK, incentivise more companies to set up UK cultivation facilities and reduce the cost of medicines to patients too.

If there is one simple change in policy that will help speed up growth and improve patient access to cannabis medicines in the UK, it is allowing export of unlicensed CBMP’s.

Pierre Van Weperen, CEO of Grow Pharma takes a different angle. He brings us forward in time to 2028, where over 100,000 patients are now accessing cannabis medicines, and explains how we got there.

Van Weperen highlights the initial stumbling blocks; that uptake of new medicines in the UK is generally slow and that unlicensed medicines slower still, that a focus on activism to move things forward (in this case arguing for NHS access due to high cost to patients) has not worked historically, and that the inability to promote unlicensed medicines to patients or doctors is a significant barrier that has led the industry to focus on “converting” those using illicit cannabis for medical reasons instead of the much larger pool of “cannabis-naïve” patients who stand to benefit.

According to Van Weperen, the next phase starts here in 2022 with the first ever MHRA and REC approved trial of an unlicensed cannabis medicine, soon to launch from LVL Clinic (IRAS 304548). Van Weperen tells us we must ensure GP’s and pharmacists are made aware of CBMP’s and that NHS specialists should be empowered to write private prescriptions – reducing cost and increasing awareness for patients – and that we should focus on reaching cannabis-naïve patients, particularly those on high-dose prescription opiates, and ensure the public are aware of the difference between over-the-counter CBD supplements and cannabis medicines, if we want to reach 100,000 patients.

Head of Columbia Care International Hari Guliani speaks next. He starts by highlighting the many issues with illicit cannabis and that the vast majority of the 1.3M proposed patients are still sourcing potentially harmful illicit products to treat their symptoms. Typical contaminants include synthetic cannabinoids, unapproved fertilisers and in some instances harder drugs. Guliani suggests a “risk-based approach” to cannabis medicines to ensure the safety of these patients.

VP of investment analysis at Seed Innovations Alfredo Pascual highlights how Germany has reached over 150k patients. Key factors being a high rate of insurance coverage for CBMP prescriptions, pharmacy involvement and local cultivation. Whilst insurance is unlikely a route for UK patients, the majority of whom pay National Insurance for NHS medicines rather than having private insurance, the need for allowing export of unlicensed CBMP’s and normalisation in traditional healthcare settings is reinforced.

Lastly, CMC medical lead Dr Daniel Couch makes the case for allowing GPs to prescribe cannabis medicines. UK legislation states that only specialist consultants may prescribe CBMP’s however, Couch argues that they may be best placed to do so. He highlights that cannabis medicines impact multiple bodily systems. Unlike Consultants, GPs do not specialise in a single area but rather take a more holistic approach to caring for their patients and may be better able to assess the impact of a new medicine on multiple of bodily systems

Couch argues GPs are much easier for patients to access and likely know their patients’ medical history more intimately. Whilst it may be possible to change the legislation to allow private GPs to prescribe, it would be another step for NHS GPs, who are truly the gateway to patients finding new medicines, to do so. Couch believes that prescribing in primary care is the clear next step for UK medical cannabis and proposes a pilot scheme to trial this approach.

Like all the talks today it is well worth delving into the detail in the published essays.

UK medical cannabis is not simple and there is no singular answer to making it work for patients. Key will be regulator engagement to develop high-level research and better safety and efficacy data.

Enabling export and drawing a clear line between OTC CBD and medical cannabis will make an enormous difference to the speed at which this will grow and allowing GP’s to prescribe would certainly increase awareness in healthcare professionals.

Ultimately our success will be measured not simply in patient and prescriber numbers, but in how attitudes shift, and cannabis medicines become normalised into everyday healthcare.

Read more from Alex Fraser here 

• ‘Confused’ medical cannabis report ignores lack of patient access
• The importance of peer-to-peer learning in medical cannabis
• Cannabis both ‘helps and hurts’ creativity – study
• Big plans for Little Green Pharma
• On the campaign trail