Medicinal Cannabis Inquiry

Written evidence to the Health and Social Care Committee – Drugs Policy: Medicinal Cannabis Inquiry

In response to the inquiry launched on Thursday 7 December 2018, Amanda Feilding submitted written evidence to the UK government about the failings of the current scheduling system, the continuing obstacles to scientific research, and the pressing need for clearer guidance for medical practitioners.

The Beckley Foundation is an Oxford-based UN-accredited NGO. In collaboration with leading universities in the UK and globally, our Scientific Programme focuses on basic science and clinical research with psychoactive drugs including cannabis and the psychedelics. With the Institute of Psychiatry at King’s College London and UCL, we have mapped the effects of cannabinoids on human brain function and psychopathology, and the Beckley/Exeter Research Programme is currently investigating the potential of the cannabinoid CBD to treat nicotine addiction.

Our Policy Programme has for 20 years developed the scientific evidence base to support policy reform in order to minimise the harms, and maximise the benefits, associated with national and international drugs laws. During this time, I have personally served as a Special Advisor to the governments of Jamaica and the Republic of Guatemala as they sought to develop more effective policy. I have also repeatedly presented reports and papers at the UN, and on numerous occasions at meetings with members of the UK government and other countries.

The Foundation will later this year release a report outlining the weaknesses of the current UK cannabis policy, with regards to both medicinal and recreational uses, and propose alternative measures which can improve outcomes for all sectors of the public. The evidence submitted here to the committee focuses on the current medicinal cannabis regime in the UK:

• The roles of the endocannabinoid system (ECS) in health and disease are many, and as such many potential medical conditions may be ameliorated by a cannabis-based medicine.
• Moving cannabis, in its entirety, to Schedule 2, will facilitate research in order to better understand the benefits and potential harms of consuming the plant in the myriad forms in which it is already prepared and taken illicitly.
• The current prescription guidance was written in great haste and is lacking in the scope of conditions it considered.
• Likewise, Home Office advice guiding cannabis researchers is significantly lacking, and must be updated and clarified so as not to further obstruct research.
• One of the key benefits of medicinal cannabis according to its users is that its side-effect profile is more manageable than other prescription medicines. This benefit is lost by the current instruction that cannabis medicines can only be issued as a last resort, after all other options have been exhausted. Patients must be allowed to try a medicine with a smaller side-effect profile first.
• Cannabinoid pharmacology is a relatively new area of medicine, and as such, the specialists who are permitted to prescribe cannabis medicines are likely to be unfamiliar with them, and therefore disinclined to prescribe. The Department of Health and Social Care must take steps to ensure that present and future doctors are knowledgeable about the subject by supporting the development of CPD courses, as well as the appropriate amendments to medical school curricula.
• The requirement for unlicensed ‘specials’ prescriptions (such as currently available medicinal cannabis products) to be cleared by local governance bodies underlines the importance of widespread dissemination of cannabinoid pharmacology education: all doctors must understand how these medicines can be best used to improve patient outcomes.
• Restricting prescription ability to specialists was driven by a fear of diversion that was misplaced. Where diversion of medical cannabis has been a problem, much more lax regimes have been in place than are found in the UK Health Care System. Additionally, the current effective prohibition of the prescription of herbal cannabis makes diversion of cannabis medicines unlikely.
• General Practitioners are already permitted to prescribe drugs with far higher potentials for abuse than cannabis (e.g., opioids). Preventing GPs from prescribing medicinal cannabis means preventing those clinicians that best know the patient, and their medical history, from providing care according to their professional judgment.

• What plans are there for research into the medicinal use of cannabis, and what challenges are faced by that research?

1. The body’s endocannabinoid system– so named because of its affinity for the chemical components of cannabis – is involved in regulating a diverse array of physiological and cognitive functions, and as such, there is a significant range of medical indications for which cannabis medicines are potential treatments. Somatic, neurological, and psychological conditions for which cannabis medicines are currently being investigated include osteoarthritis, Tourette’s syndrome, generalized anxiety disorder, post-traumatic stress disorder, pain management and epilepsy, among other disorders.

2. Of the UK patients who self-medicate with illicit cannabis, pain is the most common condition, and there is much research planned exploring the use of medicinal cannabis to treat pain that is secondary to various conditions. For example, our partners, Beckley Canopy Therapeutics, are soon to launch a trial of a cannabis medicine in the treatment of cancer pain. In the context of a mounting crisis in North America stemming from the prescription of opioid analgesics, it is crucial that alternative sources of pain relief are identified. Notably, opioid analgesic overdoses have dropped significantly in US states in which medical cannabis is available because of reformed cannabis laws¹.

3. Despite being one of the oldest continuously used medicines, cannabis retains its utility into the 21^st Century. However, there are significant bureaucratic and financial burdens placed on research institutions who seek to undertake any research with a controlled drug within Schedule 1 of the Misuse of Drugs Regulations (2001). While ‘cannabis based medicinal products’ such as oils, softgels and sprays have been moved to Schedule 2; chemically indistinguishable whole plant cannabis remains in Schedule 1, subject to the strictest controls, and generating research costs up to ten times greater than a comparable study investigating an uncontrolled drug.

4. As a consequence of the laudable pace at which November’s legislative reforms were introduced to resolve recognised shortcomings in the nation’s medicinal cannabis regime, there remains significant ambiguity about what factors determine whether a cannabis product is in Schedule 1 or Schedule 2 for the purposes of research. It is, for example, unclear whether a cannabis product intended only for a preclinical trial involving nonhuman animals is “produced for medicinal use in humans.” Moreover, it is illogical for researchers seeking to explore potential risks associated with recreational cannabis to face significantly more stringent requirements than colleagues who may be using a plant from the same crop to perform medicinal research – an apparent consequence of the ambiguous wording. Scientists wishing to engage in cannabis research already face a significantly demanding bureaucratic workload to ensure that their work meets the regulatory and licensing requirements imposed by the Home Office. Failing a wholesale rescheduling of all cannabis to Schedule 2, the Home office must release fuller guidelines about the implications of the new legislation for researchers.

5. In early February, the World Health Organisation’s Expert Committee on Drug Dependence (ECDD) submitted its findings with regards cannabis, and recommendations, to the UN’s Commission on Narcotic Drugs (CND), the body which decides the scheduling of controlled drugs internationally. The ECDD recommended that cannabis be scheduled “at a level of control that will prevent harm from cannabis use and at the same time will not act as a barrier to research.” The CND are anticipated to follow this advice and reschedule cannabis next month. It is our view that the United Kingdom’s status as signatory to the UN’s Single Convention on Narcotic Drugs adds further reason to act on the ECDD’s recommendations on a national level, and reschedule cannabis in toto into Schedule 2 of the Misuse of Drugs Regulations.

6. Whole plant, i.e., herbal cannabis, can be cultivated and produced to standardized, GMP-quality requirements (such as Bedrocan). Herbal cannabis, smoked or vaporized, is preferred by many patients, including those with chronic pain and multiple sclerosis, as inhalation allows immediate relief that other modes of consumption do not. The health consequences resulting from smoking notwithstanding, it is indefensible to claim that whole plant cannabis should remain in Schedule 1. Moving forward, fuller engagement with patients currently illicitly consuming cannabis for its therapeutic properties is needed. Their choices about cannabis product and mode of consumption were made as rational adults, settling on their preferred balance of treatment efficacy and side-effect profile.

7. Whole plant, i.e., herbal cannabis contains a diverse range of cannabinoids beyond THC, and there is increasing scientific evidence to show that these may yield therapeutic and medicinal effects themselves and contribute to an ‘entourage effect’ greater than the effect of THC and/or CBD alone. There is also increasing evidence to suggest there is a positive synergy between THC and CBD, with CBD buffering against some of THC’s fewer desirable effects such as intoxication, sedation and tachycardia and augmenting some of its more valued effects, such as its pain relieving, anti-nausea and anti-carcinogenic effects. CBD rich full spectrum extracts may also be superior in the treatment of refractory epilepsy compared to pure CBD. Research conducted by the Beckley Foundation in collaboration with UCL has also shown that CBD buffers against THC-elicited paranoid symptoms and hippocampal-dependent memory impairment. Thus, there is an expanding evidence base to show that in some cases, use of whole plant cannabis or full spectrum extracts may have medicinal advantages over the use of isolated THC or CBD.

• Is the current guidance around prescribing CDMPs fit for purpose? 

8. The current interim guidance for the prescription of CDMPs were written, at NHS England’s request, by the Royal College of Physicians and the British Paediatric Neurology Association. Swift legislative change meant that these bodies had to develop clinical advice within a very limited time frame, and as such were restricted to writing prescription guidelines only for certain forms of severe epilepsy in children, chemotherapy-induced nausea and vomiting, and chronic pain.

9. As such, the current guidance is necessarily and understandably lacking. In comparison, US states with medical cannabis programmes typically record a dozen or more qualifying conditions for which cannabis is recognized to bring relief.

10. Within this restricted remit, there are two notable shortcomings within the current guidance that should be addressed before the publication of the full guidelines in 2019. The first is the failure to recognize the weight of evidence in support of cannabis medicines for the relief of chronic pain. Although the mechanisms of action and interaction among cannabinoids in pain relief are not yet clear, the clinical evidence, and systematic reviews thereof, confirm that cannabis and its derivatives do have demonstrably analgesic effects. We are confident that the due diligence undertaken when writing the new guidelines will confirm this.

11. More troubling, however, is NHS England’s discussion of prescribing cannabis-based medicines ‘where there is an unmet clinical need… and where established treatment options have been exhausted’, effectively relegating cannabis to a last resort. This represents a failure to recognize the nature and potential utility of cannabis-based medicines.  A recent survey of 1,750 self-medicating cannabis patients² showed that cannabis was preferred because of its more manageable side-effect profile compared to prescribed medicines. It is a mistake to subject patients to each medicine, and its concomitant side-effects, before permitting a trial of a CBMP. Relaxing the requirement to prescribe CBMPs only as a last resort should therefore be a priority of the next iteration of the prescription guidance.

12. With the National Institute for Health and Care Excellence in the process of writing fuller prescription guidelines, we applaud the fact that these are being developed in consultation with stakeholders including the Beckley Foundation, who, after twenty years of working with cannabis, are well-placed to provide expert advice to optimize patient access.

• Do practitioners have the knowledge and products available to them to confidently prescribe medicinal cannabis?

13. The rescheduling of Cannabis Based Medicinal Products (CBMPs) in November 2018 has largely failed to translate to optimal prescription rates for cannabis-based medicines, and the paucity of understanding of cannabinoid pharmacology is a significant factor in this.

14. Nearly half of the GMC-registered specialists clinicians are over the age of 50, meaning that their primary medical training was delivered before the discovery of the ECS, as well as the significant advances that have been made regarding its many roles in health and disease. The teaching of cannabinoid pharmacology remains absent from medical school curricula. Although practicing clinicians are required to undertake CPD training every year, the effective prohibition of cannabis medicines prior to last year has meant that, understandably, no such training in cannabinoid pharmacology has been available.

15. Specialists are rightly hesitant to prescribe a medicine where they lack an understanding of its pharmacology, and the onus is on the Department of Health and Social Care to facilitate the education of current and future clinicians about this relatively new area of medicine. In addition to appropriately amending medical education, the bodies overseeing the medicinal cannabis programmes in Canada³ and the Netherlands⁴ host clear and detailed information concerning medical cannabis for medical practitioners as well as patients. Such support would increase physicians’ confidence in prescribing.

16. Physician-confidence would also be markedly increased by the provision of information regarding the choices of product available for prescription. A tangle of regulatory restrictions concerning importation, GMP-certification, etc, make it unclear quite which products are legal, and which are best suited to a given patient. The Department of Health and Social Care must better signpost specialists to where to determine this information.

• How suitable are the current procedures for enabling the use of medicinal cannabis in appropriate cases?

17. A full review of the current medicinal cannabis regime must address the shortcomings not only in the prescription guidelines, but also the constraints on prescribing from national and local policy. 

18. The government’s decision to restrict the decision to prescribe CBMPs to GMC-registered specialists is worthy of review. We judge this choice to be driven by concerns about the potential for diversion of CBMPs. However, diversion to non-medical markets in North America is attributable to controls on access that are much more lax than in, e.g., Israel or Europe, and for reasons orthogonal to the prescribing base. Moreover, while herbal cannabis – its predominant form in the recreational market – is effectively forbidden within the UK medical system, risk of diversion is particularly low.

19. Widening the authority to prescribe CBMPs to General Practitioners, meanwhile, would allow the clinicians who know a patient best to make an informed decision about the best course of action. Note when considering this recommendation, that GPs are already authorized to prescribe drugs with much higher potentials for abuse than cannabis, including opioid painkillers.

20. In the current system, where specialists do judge it in the best interests of the patient to prescribe a CBMP, local governance structures, including hospital boards, and policies governing the prescription of unlicensed ‘specials’, can nonetheless restrict the patient’s ability to access cannabis medicines. As hospital boards are staffed by, and prescription policies are written by, senior clinicians, the gatekeeper functions performed by these structures requires the fullest possible dissemination of cannabinoid pharmacology education. It is not sufficient for a patient’s specialist to be confident in prescribing a CBMP. Her senior colleagues must also sufficiently understand the reality of the medicine and its evidence base in order to support prescription.

1. Bachhuber, M. A., Saloner, B., Cunningham, C. O., & Barry, C. L. (2014). Medical cannabis laws and opioid analgesic overdose mortality in the United States, 1999-2010. JAMA internal medicine, 174(10), 1668-1673.
2. United Patients Alliance Survey 2018. https://www.upalliance.org/2018-upa-patient-survey-results/
3. Health Canada. https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/information-medical-practitioners.html
4. The Office of Medicinal Cannabis. https://www.cannabisbureau.nl/