27th March 2019
From Transform Drug Policy Foundation and Release.
This submission outlines how the unique nature of cannabis as a medicine and the unique history of cannabis based medicinal products in the UK has created a series of urgent challenges to meaningful research and patient access, despite recent reforms. It then makes a series of pragmatic recommendations for how these challenges can be addressed
Clarity needed over what ‘medical cannabis’ means
- Cannabis is a plant containing a complex array of active components with known or potential medical indications. This most prominently includes the cannabinoids THC and CBD, but there are, in fact, over 100 cannabinoids that have been isolated, as well as numerous other components that may also have medical uses, individually or in combination. There are also several species within the cannabis genus - and 1000’s of strains within these species, often containing very different amounts and ratios of the active components.
- From this array of different plant varieties and active components, many different medical preparations have been created, including herbal products, whole plant extracts and tinctures, isolates and isolate combinations, various edibles, sublingual sprays, creams, balms, and much more besides.
- If the topic of cannabis based medicinal products (CBMPs, a more useful catchall than ‘medical cannabis’) is to be sensibly engaged with, a clear taxonomy of these products is needed. They will be associated with a diverse range of uses (raising the secondary question of how ‘medicine’, and ‘medical use’ is defined), and have widely varying efficacy and risks - engaging in different ways with a broad range of different domestic and international legislation (including, but not limited to the Misuse of Drugs Act 1971, the Human Medicines Regulations 2012, the Food Supplements (England) Regulations 2003, and the UN Drug Conventions 1961,1971,) and domestic and international regulatory agencies (MHRA, NICE, GMC, EFSA, INCB etc.)
Historical challenges to the development of research into cannabis derived medicines
- Research and development of cannabis based medicines, and legal access to them has been critically undermined for many decades by the wider politics of cannabis for non-medical (or recreational) use. The wider debate has been characterised by ‘tough on drugs’ political posturing, media hysteria, exaggeration and bad science around cannabis and its potential risks. This political climate has seen cannabis historically mis-scheduled in domestic and international legislation as having no medical utility; creating significant regulatory obstacles to medical research and making legal access to CBMPs all but impossible in most of the world, including the UK, until relatively recently.
- This situation is now changing, with recent announcements for the rescheduling of some CBMPs in the UK from schedule 1 to 2, and the recommendation from the WHO Expert Committee on Drug Dependence for cannabis to be deleted from the most restrictive schedule IV under the 1961 UN Single Convention on Drugs (in effect acknowledging its medical potential and - if the recommendation is passed by a vote the Commission on Narcotic Drugs - ending the default prohibition of medical uses under the UN drugs treaty framework). Around 45 countries now have some form of legal access to CBMPs.
Moving forward: The UK situation
- Despite recent positive developments, the highly politicised history of cannabis over the past century has created a challenging legacy for today’s policy makers, medicines regulators and prescribers. In the UK there is now strong public support for access to CBMP’s, and since 2018, cross party political support as well. However, there now exists a bottle-neck in the form of the UK medical regulatory agencies and regulatory architecture. There are several challenges they now face.
- The UK medicines regulatory systems - that have evolved to deal with single or dual component refined pharmaceuticals - are ill equipped to deal with multi-component herbal/plant based products, particularly when they as complex as many cannabis based medicines.
- Additionally, for medicines to be licensed for prescription on the NHS they have to establish safety and efficacy through rigorous, time consuming and expensive clinical trials - and prove they are value for money under NICE guidelines. But due to the historic political obstacles to research very few CBMPs have been able to achieve this standard of clinical data - Sativex (a whole plant cannabis extract in tincture form as a sublingual spray) being the only current UK example available on the NHS. While it is possible for unlicensed medicines to be prescribed as ‘specials’ in the UK, such prescribing faces substantial regulatory hurdles (specifically General Medical Council guidance, and relevant NHS Trust governance procedures) making it impractical in most cases.
- The UK now faces a situation where political will exists, public demand is growing, and demand by doctors to prescribe standardised CBMPs licensed in other countries is growing. Yet it remains almost impossible for patients to have access to most CBMPs (with the exception of Sativex and some CBD products) even when a doctor wants to prescribe them.
- If no solution can be found then increasing numbers of UK citizens will seek out and self medicate with cannabis products from the illegal market. Estimates are difficult for what is by its nature a hidden activity - but there are certainly many tens of thousands of individuals - potentially as many as million people (according to estimates from the United Patients Alliance) in this situation. This is obviously highly problematic for multiple reasons.
- People who self-medicating with illegally obtained cannabis face the risk of non-trivial prosecution and receiving a criminal record. Such prosecutions are not uncommon and have, on occasion resulted in imprisonment. Medical cannabis users calling the Release legal helpline have sought advice in relation to a variety of drug offences including:
- Personal possession
- Possession with intent to supply, where they (often by necessity) buy a larger amount of cannabis, that the police/prosecution might consider too much for personal use
- Cultivation (or production), where they are growing their own cannabis (frequently this is in order to avoid contact with the criminal market and for more control over the specific strain of cannabis they are using for their particular medical condition)
- Production, where they are making their own tinctures or other preparations. from cannabis which they have either grown or purchased
- Confiscation proceedings, where charged with a production or supply offence which are specified offences for the purposes of the Proceeds of Crime Act 2002
- The cannabis products they receive are unregulated, of unknown quality and therefore potentially unsafe; in terms of variable and unreliable potency of active contents, adulterants and contaminants. Individuals will frequently be making potentially important medical decisions about whether and how to use CBMP’s in conjunction with or instead of other treatments, in the absence of advice and guidance from the appropriate medical professionals. Given the serious, sometimes life threatening conditions some people are self medicating with CBMPs, this is a profound concern
- The UK’s medicine regulators may quite understandably be uncomfortable with making certain CBMPs more widely available if this is seen to bypass or shortcut regulatory systems put in place to protect patient’s interests. However, the pragmatic reality is that if no formal way can be found to bridge the gap between growing demand, from both patients and doctors, and the existing restrictions on legal supply channels, then the far more risky scenario of ill-informed self-medication with CBMPs from informal/ unregulated/ criminal channels will only continue to grow.
- Another pressing issue related to the provision of CBMPs is that of importation for personal use. The Home Office has a licensing system for people to import medication, which is controlled under the Misuse of Drugs Act 1971, however this is only permissible in relation to substances that fall within Schedules 2 to 5 of the Misuse of Drugs Regulations 2001 and where they have confirmation from their doctor that the medication was prescribed. Release has received a significant number of enquiries from people wishing to visit the UK, and concerningly, British citizens who relocated to other jurisdictions in order to access legal CBMPs, wanting to know if they can travel to the UK with their medications legally. Whilst SI 1055 (2018) provides the regulatory framework on CBMPs, the lack of specificity in what falls within that category makes it impossible to confidently advise people on what they can and cannot import. This issue needs urgent clarification, as in reality people bringing their medication could be at risk of prosecution for importation of cannabis if their medication does not fall within the definition contained in the statutory instrument.
- The unprecedented set of political and legal circumstances with CBMPs, the unique nature of cannabis as a medicine, and its unique history and development within the pharmacopoeia, may now demand a unique policy and regulatory response.
We therefore recommend that;
- In the short term, prescription-based access should be more effectively facilitated for a range of CBMPs that meet established MHRA quality and standardisation criteria, that are already licensed for medical prescribers in the EU and currently available to millions in multiple jurisdictions without significant problems (a notable example being Bedrocan herbal and oil products - licensed for prescription in the Netherlands). This would seem to be the most obvious and immediate way for those in urgent need to access key CBMPs on prescription. Similar standardised products that would appear to meet the MHRA criteria also exist in Canada and several other jurisdictions and should be similarly available for import on prescription.
- A list of products that meet these criteria should be made available by the MHRA - to replace the current confusion over which products qualify and which do not under existing published guidance. In some cases this necessitates the use of ‘specials’ prescribing procedures for unlicensed medicines, and the almost impossibly high regulatory bar that accompanies their use.
- Specialist doctors should be supported with further training and authoritative guidance to make informed prescribing decisions, and the list of which conditions can be prescribed for currently under NHS guidelines expanded in line with operational prescribing guidelines in other EU countries, including greater tolerance for ‘off list’ prescribing of approved CBMPs
- Consideration should be given to granting prescribing access to non-specialist doctors and GPs for specific approved products for use with certain specific less serious indications - with guidelines drawn up the MHRA/NHS/GMC
- Considering the significant limitations created by the current system - for the range of reasons outlined above - it is inevitable that people will continue to engage in illegal activities, such as possession, cultivation and production of cannabis, in order to self-medicate for a range of health problems. It seems unjust and disproportionate for those who are suffering, and who use cannabis to relieve that suffering, are at risk of prosecution and, in some cases, imprisonment. Consideration should be given to developing a statutory defence of medical necessity in these circumstances, alternatively the Committee should recommend that the Crown Prosecution Service develop non-prosecutorial guidelines to deal with such cases.
- In the medium term, the UK should examine and learn from the CBMP access models established in multiple countries around the world - including Israel, Germany, the Netherlands, and Canada - who have faced the exact same dilemmas UK medicine regulators are currently wrestling with. In many cases they have created a bespoke regulatory agency or legislative framework that exists in conjunction with or in parallel to established medicines regulation models, to deal with the unique challenges CBMPs raise
- The UK Government should pro-actively facilitate and support domestic CBMP research, and the development of a domestic CBMP industry
- To avoid confusion created by the scheduling problems and personal import licenses highlighted above, we recommend that any CBMPs be treated as a schedule 2 drug under the Statutory Instrument where it has been prescribed by a medical practitioner in another jurisdiction
- Noting the wider cannabis reform debate developing in the UK and internationally (around decriminalisation of personal possession, home growing, cannabis social clubs, and legally regulated supply for non-medical use) we recommend that the implications of such reforms on CBMP policy also be considered in the policy planning process
Details on the inquiry are available here
And all written submissions (and ongoing oral evidence) available here
From Transform Drug Policy Foundation, and Release.
Transform Drug Policy Foundation is an independent UK-based think tank working the field of UK and international drug policy and law reform. Transform is engaged in policy analysis and advocacy for more effective and humane drug policies, with a particular focus of the legal regulation of drugs to better protect people.
Contact: Steve Rolles firstname.lastname@example.org
Release is the UK centre of expertise on drugs and drugs law and has provided free and confidential specialist advice to the public and professionals for almost 50 years. Release aims to raise awareness of how UK drug policy and legislation impacts on people who use drugs. Based on our clients’ experiences, the organisation advocates for changes to UK drug laws to bring about a fairer and evidence-based legal framework to manage drug use in our society.
Contact: Niamh Eastwood email@example.com
Both Transform and Release are NGO’s in Special Consultative Status with the Economic and Social Council of the United Nations, as well as being part of the Vienna NGO Committee on Narcotic Drugs (VNGOC) and the New York NGO Committee on Drugs (NYNGOC).