MEDICAL CANNABIS AND CBD - Challenges and opportunities
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
MEDICAL CANNABIS AND CBD 1 MEDICAL CANNABIS AND CBD Challenges and opportunities
Healthadviser DAC Beachcroft’s Health Adviser publications seek to provide insight, foresight and thought-provoking features and articles that provide practical solutions for the issues of the day, for health and social care professionals.
MEDICAL CANNABIS AND CBD 3
FOREWORD
Global interest in medical cannabis is disasters such as the Thalidomide MCCS and Campaigner), Professor
booming as legal restraints on scandal, and the current US opioid crisis, Andrew Goddard (President of the
production and use are eased and, urge caution. They want tangible Royal College of Physicians), Eoin
despite the COVID-19 crisis, this evidence of safety and efficacy in the Keenan (Content & Communications
acceleration has continued. form of large-scale clinical trials. Director, Prohibition Partners), Dr Inbar
Maymon-Pomeranchik (founder of
In the UK, following high profile coverage This report sets out some of the thorny BioDiligence Partners), Dr Barry Miller
of cases involving children with ethical, regulatory and legal hurdles the (Chair of the Medicines Advisory Group
intractable epilepsy, medical cannabis UK faces in terms of medical cannabis. the Royal College of Anaesthetists
has been available lawfully in limited It also touches on recent developments Faculty of Pain Management), George
circumstances since 1 November 2018. in the UK relating to cannabidiol (CBD) McBride (Chief Executive Officer,
Opinion is divided as to whether this and includes thoughts from experts Hanway Associates), Marcus Stuttard
change in the law represents an and campaigners, both in the UK and (Head of the AIM and UK Primary
important step forward or a missed abroad, on how one might approach Markets at the London Stock
opportunity; there is a body of highly this new and rapidly-expanding field of Exchange), Melissa Sturgess (Chief
respected medical opinion on each side. medicine. The medical cannabis market Executive Officer of Ananda
is expected to keep developing quickly Developments), Nick Tulloch (Director
Some UK clinicians want to prescribe in 2021 and beyond, despite the of Fetlar Capital), and Marion Zammit
more freely. A growing body of public inevitable hurdles raised by the (Head of Medical Cannabis Activity at
opinion says there are some areas Covid-19 pandemic and resulting Malta Enterprise).
where time-consuming and lengthy global recession.
trials are unnecessary, most notably for Jonathan Deverill
conditions where the drug has been We would like to take this opportunity Partner, DAC Beachcroft LLP
shown to alleviate symptoms. For these, to thank our experts: Dr Leon Barron
some experts argue a new set of (Executive Committee Member – The
prescribing rules need to be formulated. Medical Cannabis Clinicians Society,
The medical cannabis industry and a Founder – The Primary Care Cannabis
range of campaign groups also want Network), Karine Cousineau (Director,
speedier and cheaper access. But Government Relations and Sustainability,
regulators and the medical The Green Organic Dutchman), Hannah
establishment, with an eye to drug Deacon (a founding member of the
dacbeachcroft.com4 MEDICAL CANNABIS AND CBD
CHAPTER 1.
MEDICAL CANNABIS AND CBD IN THE UK
There are growing calls for wider access to medical cannabis, but a lack of hard
evidence surrounding its safety means many doctors are unwilling to prescribe
without randomised controlled trials.
In November 2018 new UK legislation1 (MS), psychiatric conditions and even Global growth industry
came into force making cannabis- chronic musculoskeletal or cancer pain. While the UK medical cannabis market
derived medicinal products available on Furthermore, this new route enables is embryonic, production and research
prescription by a limited number of the doctors concerned to prescribe is a global growth industry, with
specialist doctors. medicines which have not yet been entrepreneurs expecting significant
authorised by the UK Medicines and returns. By 2025 the worldwide
The move meant cannabis changed Healthcare products Regulatory Agency medicinal cannabis market is
from a Schedule 1 classification under (MHRA) – as noted below, only two projected to be worth anything from
the Misuse of Drugs Act 1971 (MDA) products, Sativex and Epidiolex, both £33.64bn2, (according to research firm
– which includes drugs not used produced by GW Pharmaceuticals, Research and Markets), to £62.6bn3
medicinally such as LSD and ecstasy – to have received MHRA marketing (according to Prohibition Partners
Schedule 2, which includes opiates like authorisations so far, following a lengthy, which provides intelligence on the
morphine and methadone that can be and expensive, authorisation process. cannabis market).
prescribed under strict regulations.
The change in law came after ministers While the UK CBMP industry is small, it
The change was welcomed by patients, were made aware of the plight of is significant. In 2010 the MHRA
campaign groups and industry who say children such as Alfie Dingley, whose authorised Cambridge-based GW
cannabis-based medicinal products families had long campaigned to allow Pharmaceuticals’ Sativex oral spray as
(CBMPs) offer new ways to treat NHS doctors to prescribe medical an add-on treatment for symptom
anything from genetic disorders to cannabis to treat their severe types improvement in patients with muscle
childhood epilepsies, multiple sclerosis of epilepsy. spasms and stiffness due to MS.
@healthlawukMEDICAL CANNABIS AND CBD 5
“Looking at data from overseas, cannabis-based a significant proportion of prescribers
in the 50+ countries where cannabis
medicines seem to be a really useful tool to help for medical use has been made legal
some patients improve overall quality of life and and are prescribing for a wide range
of conditions.
symptom control.”
Dr Leon Barron, Executive Committee Member – The Medical Cannabis Clinicians Society, “Looking at data from overseas,
Founder – The Primary Care Cannabis Network cannabis-based medicines seem to be
a really useful tool to help some
patients improve overall quality of life
Sativex contains two active ingredients ingredient is CBD, may only be used to and symptom control,” he says.
derived from the cannabis plant – CBD treat two types of severe epilepsy,
and tetrahydrocannabinol (THC). THC Lennox Gastaut syndrome and Dravet But Dr Barron says many NHS trusts
raises concerns as it is the main syndrome, which cause multiple reject requests to prescribe on cost
psychoactive component of marijuana seizures. Campaigners were grounds. “Patients who can afford it
which gives the ‘high’ and has been linked disappointed, however, that NICE have been forced to pay hundreds of
to agitation, hallucinations and paranoia. ruled out either drug for chronic pounds or more a month for private
musculoskeletal or cancer pain due prescriptions. Costs have been
Potential complications to lack of evidence of efficacy. disproportionately high because up
The Royal College of Psychiatrists said in until very recently, cannabis-based
a statement4 issued in November 2019: While doctors on a specialist register medicines have needed to be
“The propsychotic and anxiogenic have been allowed to prescribe imported on a named patient basis.
properties of THC mean that CBMPs unlicensed CBMPs as a ‘specials It is known as a ‘specials medicine’
containing THC are unlikely to be medicine’, which can be prescribed to which requires Home Office licences
helpful for any psychiatric condition. If just one specific named patient, since and approval by the MHRA, and
such products are prescribed in other November 2018, figures5 provided in doctors are only allowed to prescribe
health settings, clinicians must be aware response to a Parliamentary Question in 28 days’ worth under controlled
of potential psychiatric complications.” June 2019 reveal that they account for drugs regulations.”
fewer than 250 prescriptions a month.
The National Institute for Health and Hannah Deacon became a passionate
Care Excellence (NICE), which produces Unmet patient needs advocate of CBMPs following her
drug and treatment guidelines for the NHS GP Dr Leon Barron believes that successful fight to get NHS treatment
NHS, had ruled out Sativex on cost- GPs are uniquely positioned to for her eight-year-old son, Alfie. She
effectiveness grounds. But in November prescribe medical cannabis for patients says medical cannabis suffers as a
2019, after negotiating a hefty discount, with an unmet clinical need and that result of the ‘demonisation’ of cannabis
it approved Sativex, and another GW cannabis-based medicines should be in general.
Pharmaceuticals drug, Epidiolex. treated in a similar fashion to any other
prescribed unlicensed medications. He She says: “We must accept medical
With concerns about psychiatric believes these treatments should be cannabis as exceptional as it does not fit
complications and other factors in available through the NHS and that an into a pharmaceutical model. Until this is
mind, NICE ruled that Sativex may only evidence base made up of accepted, and a new framework is
be used to treat spasticity – in which observational data can be built in real developed and research is carried out
muscles are continually contracted – in time whilst serving the most in-need based on a real world data approach,
MS. Epidiolex, whose main active patients. General Practitioners make up we will struggle to move forward.
dacbeachcroft.com6 MEDICAL CANNABIS AND CBD
If patients are currently on private “If patients are currently on private prescriptions
prescriptions of medical cannabis and
they show huge improvement, NHS of medical cannabis and they show huge
doctors should be supported through improvement, NHS doctors should be supported
more balanced guidance from NICE
and feel able to prescribe; currently through more balanced guidance from NICE and
that is not happening.” feel able to prescribe.”
Hannah Deacon, founding member of the MCCS and Campaigner
In July 2019 the House of Commons
Health Select Committee issued a
report6 on medical cannabis which
called for the Government to act swiftly engage with parents and clinicians who In October 2018, the College produced
to support more trials, including large have argued for observational trials, not guidelines on the limited use of medical
scale Randomised Controlled Trials just RCTs, to “explore all ways to improve cannabis with the Royal College of
(RCTs). These are seen as the gold the evidence base”. Radiologists and the Faculty of Pain
standard in terms of assuring safety and Medicine of the Royal College of
efficacy, but the Select Committee also Dearth of hard evidence Anaesthetists.
welcomed smaller, faster and more But in the meantime, most doctors are
nuanced trials with patients who are reluctant to prescribe unlicensed “If medicinal cannabis was entirely safe
already seeing benefits. products for which there is a dearth of and cost 10p per pop,” Professor Goddard
hard evidence. says, “it would be used fairly freely in the
NHS England has listened to patients NHS. But when you have drugs costing
and clinicians, and in August 2019 Professor Andrew Goddard, the President £10,000 a year per patient, the benefits
produced a report7 looking at barriers to of the Royal College of Physicians, says would have to be pretty compelling in
accessing CBMPs which made a series of a meta-analysis8 of the limited number order to make it cost-effective.”
recommendations around guidelines on of RCTs of medicinal cannabis around
usage. It also called for further research, the world showed a measurable The MHRA’s authorisation made Sativex
led by the National Institute for Health benefit “of around 3mm on a 100mm the first natural cannabis-based derivative
Research (NIHR), with the aim being to pain scale.” to gain market approval in any country.
@healthlawukMEDICAL CANNABIS AND CBD 7
Worldwide sales of Sativex have Unlike other countries that have reformed
promoted GW Pharmaceuticals to their laws, McBride says the UK is trying to
number two in the top ten cannabis shoehorn medical cannabis into its
firms in the world by market “existing model of healthcare through
capitalisation. The business is currently existing pharmaceutical standards and
valued at around $3.6bn, according to healthcare channels – that is not what other
the Prohibition Partners report. countries have done.” And he reiterates
calls for reassurances that the UK Proceeds
Public health imperative of Crime Act 2002 (POCA) would not apply
George McBride, chief executive at to legitimate UK firms doing business with
Hanway Associates, a strategic legitimate cannabis companies abroad.
consultancy working with the cannabis
industry, says there is a “public health McBride says that while the licensing
imperative” to ensure access to safer system treats CBMPs like unlicensed new
and cheaper domestically grown pharmaceuticals which are “for good reason”
products, and calls for Government tightly restricted, “in this case we have a
backing in terms of financial and other product where the lions’ share of patients are
support for industry and research. already obtaining it from the black market”.
“If medicinal cannabis was entirely safe and cost 10p
per pop, it would be used fairly freely in the NHS.
But when you have drugs costing £10,000 a year per
patient, the benefits would have to be pretty
compelling .”
Professor Andrew Goddard, President of the Royal College of Physicians
dacbeachcroft.com8 MEDICAL CANNABIS AND CBD
CHAPTER 2.
A VIEW FROM THE
PROFESSIONAL BODIES
With cost and safety issues looming large, moving forward will require a range of
different approaches – from alternatives to traditional trials, to the involvement of
the pharmaceutical industry.
When clinicians talk about evidence and Dr Miller is the former Dean of the back saying it would have no grounds to
safety, the shadow of Thalidomide looms Faculty of Pain Medicine at the Royal institute any action. What we must see is
large. Thalidomide was widely prescribed College of Anaesthetists and now is chair NICE and the GMC translating that support
in the 1950s and ‘60s to treat nausea in of the Medicines Advisory Group at the directly to doctors and trusts so doctors
pregnancy. But in the ‘60s it became Faculty. He feels that regulators and understand that they are supported if they
apparent that it caused severe birth defects Royal Colleges are right to be cautious in make the clinical decision to prescribe.”
in thousands of children around the world. their prescribing guidelines.
Prescribing guidelines
Dr Barry Miller, a full-time NHS consultant Hannah Deacon says doctors who want With that in mind Dr Barron, who along with
in pain medicine, says there are legitimate to prescribe responsibly have been Professor Barnes is a co-founder of the
concerns. “We don’t know if in twenty given some reassurance by their MCCS, has drawn up prescribing guidelines
years down the line people will develop professional regulator, the General to counterbalance what he sees as relatively
some unusual disease or cancer,” he says. Medical Council (GMC). restrictive official guidelines from NICE
“These things are not uncommon – look at which limit use to a small number of patient
Thalidomide and Vioxx [which caused “Professor Mike Barnes [from the Medical groups with specific conditions or for
heart attacks and strokes]. Maybe medical Cannabis Clinicians Society, or MCCS] prescription as a special medicine.
cannabis will turn out to be a valuable wrote to the GMC to ask what would
addition to pain medicine therapeutics, happen to a doctor who had done their Dr Miller isn’t convinced: “The idea of
but until we have solid evidence of safety, research and prescribed within their asking doctors to prescribe unlicensed
there are real concerns.” competencies. The chief executive wrote substances on a large scale for chronic
@healthlawukMEDICAL CANNABIS AND CBD 9
“If pharmaceutical companies can come in, help to Given that projected global profits from
CBMPs run into billions, Dr Miller was
fund more studies and standardise processes, then concerned at the urgency to extend
it’s beneficial for patients and the industry as a whole.” prescribing and use. “I am a little
concerned that this is a push to try to get
Eion Keenan, Prohibition Partners
something into a market without proper
regulation or scrutiny. Clearly there is
also the issue that a lot of people argue
pain is unique. We need to know if we are Eoin Keenan agrees there is a need to that medical cannabis is a lot better than
going to be doing harm to the developing have a medical consensus on the opioids – again, it might be, but the
brain in young people, or a developing effectiveness of CBMPs “and increased evidence is very weak – we need to be
foetus unexpectedly exposed, particularly trials and data is the best way to get to careful about it.”
if they are using it for pain,” he says. that point”.
He does not think that other countries
The Royal College of Psychiatrists’ position “The head of Public Health England have a better handle on cannabis
paper called for more high-quality RCTs. It [Duncan Selbie] has suggested that medicines. While doctors are freer to
backs calls by the research community for private companies take the lead on prescribe in Holland, Germany, Denmark
the MDA to be amended so that clinical establishing the research on cannabis. and Canada, he says this doesn’t equate
trials of all types of cannabis can be carried If pharmaceutical companies can to evidence that it works and is safe.
out without a Home Office licence, of come in, help to fund more studies “I have seen papers from across the
which the College says “that is costly and and standardise processes, then it’s world but very little of it is good quality
time-intensive to obtain”. beneficial for patients and the industry evidence that would get licences.”
as a whole,” he says.
Given what it calls the “global precedent” Need for caution
of CBMPs being sanctioned without Long lead time Prof Goddard says that for very challenging
trials, the College wants Government Given the long lead time for RCTs and conditions, such as childhood epilepsies,
and patients’ groups to pressure the fact that patients are using illegal alternatives to RCTs are “not unreasonable.”
pharmaceutical companies to invest in cannabis, TWENTY219 was launched But he adds: “When it comes to common
research “or the evidence for the efficacy in November 2019 by independent conditions such as chronic pain, where
of CBMPs won’t allow for a change in scientific body Drug Science. The there are a large number of patients who
current practice around prescribing”. organisation is led by the controversial can be tested on a large scale, RCTs should
former Government drugs policy be done – particularly where the benefits
It also wants the potential adverse adviser Professor David Nutt, who was are small and you need a clear answer.”
consequences of the mass-prescription sacked after publicly stating that
of products containing THC to be ecstasy and LSD were less dangerous In time Prof Goddard feels CBMPs will
explored, and says countries that have than alcohol. form part of the GP formulary. But he
already allowed mass prescribing reiterates the need for caution. “Just
should share their clinical findings. By 2021 the project hopes to enrol because it is exciting and so many
20,000 patients with a range of companies want to do it doesn’t mean
Taking the lead on research conditions to create the largest body we should run before we can walk.
If CBMPs are to become widespread, the of evidence for the effectiveness People seem to think that as cannabis is
College says clinicians need guidance on and tolerability of medical cannabis. a plant, it must be safe. But taxol, which
how to prescribe them effectively and “We hope that the findings will make we use to treat some cancers, is from
safely, and any change in prescribing must a powerful case for NHS funding, by the Pacific yew tree, and aspirin, which
be accompanied by a public education proving the favourable risk/benefit comes from willow bark, is perfectly
campaign where people are “informed of ratio of medical cannabis in seven key capable of killing. We have to learn the
the potential health risks of cannabis use identified conditions,” Drug Science lessons from previous drugs we thought
and discouraged from self-medication”. said in a launch statement. were safe – like Thalidomide.”
dacbeachcroft.com10 MEDICAL CANNABIS AND CBD
CHAPTER 3.
OPPORTUNITIES FOR INVESTORS
Companies are putting the pieces in place to benefit once the industry does take
off, although legislation and regulation means UK investors remain cautious.
Marcus Stuttard, Head of AIM and UK To be admitted onto AIM, companies Nomads work with the company, its
Primary Markets at London Stock must undergo a vetting process lawyers and accountants and any
Exchange, does not give definitive managed by a nominated adviser, other relevant sector specialists.
figures on how many cannabis-related known as a Nomad. AIM keeps a “They do all the due diligence to
companies are listed, but says it register of about 20 licensed Nomads, prepare the company for admission
remains a growing sector. usually smaller investment banks or to AIM, and produce admission
corporate finance houses. documents which set out the core
Stuttard says existing pipeline companies
on AIM, London Stock Exchange’s market
for dynamic high-growth and medium “With the expertise we will gain growing and stabilising
size companies, include businesses that
are active in the CBD and wellness space, 65 strains of cannabis at scale, when the time comes
and companies investing in businesses for cannabis to be grown meaningfully in the UK, we
that are producing pharmaceuticals or
providing infrastructure such as will be one of the turnkey companies.”
hydroponics or greenhouses. Melissa Sturgess, Chief Executive Officer, Ananda Developments plc
@healthlawukMEDICAL CANNABIS AND CBD 11
information about the company, Reading between the lines, broader on identifying which cannabinoids,
its financial position and growth investor protection concerns would also flavonoids and terpenes are working in
prospects,” says Stuttard. seem to be a motivation. In Canada, entourage to treat various indications.
some people made a lot of money
Where companies ‘overlap’ between during the “greenrush” when it seemed “With the expertise we will gain growing
recreational and pharmaceutical that the share prices of listed cannabis and stabilising 65 strains of cannabis at
products, Stuttard says Nomads would companies could only go in one scale, when the time comes for cannabis
look closely at the business model to direction – up. But since Canada’s to be grown meaningfully in the UK, we
make sure there is nothing in it that recreational cannabis legalisation on will be one of the turnkey companies,”
falls foul of POCA or any other 17 October 2018, share prices of Sturgess says.
legislative requirements, whilst also Canadian cannabis companies have
taking into account the overriding typically fallen by a significant amount, Given that most of the medicinal cannabis
requirement that any applicant must with many investors losing money, an available in the UK is grown and processed
be appropriate for AIM. experience UK regulators do not wish elsewhere, Sturgess adds that patients,
to see repeated on stock markets here. doctors and investors are increasingly
Risk remains interested in a UK supply of medical
POCA was not drafted with the modern Investors are cautious cannabis. “Our partners grew medicinal
cannabis industry in mind, and Melissa Sturgess is the Chief Executive cannabis for GW Pharmaceuticals’
deliberately couched in broad terms. Officer of UK company Ananda Epidiolex trials and so we have a very good
One consequence is that investors Developments plc, listed on London’s opportunity to provide the UK industry
could in theory face prosecution under AQSE Growth Market, Aquis Stock with high quality product for both the API
POCA for receiving dividends or Exchange’s market for earlier stage, and unlicensed CBMP markets.”
interest payments from an overseas entrepreneurial companies seeking
company even though the operations access to growth capital. She also feels there are opportunities in
of that company are entirely lawful in education given the relatively new (1992)
its home country. While the filing of a She agrees that UK investors and discovery of the body’s endocannabinoid
“Suspicious Activity Report”, amongst entrepreneurs are cautious and that POCA system which produces its own
other things, may in certain is one factor. Nevertheless, the company cannabinoids. “Medical education is
circumstances provide some relief, has spent more than a year putting starting in this country and as our
areas of doubt – and therefore risk – together the case for an application to the understanding of cannabis grows this
can remain. Home Office to grow medical cannabis will become increasingly in demand.”
initially for research and development
The FCA recently attempted to address purposes and ultimately for commercial Moving away from opioids
this issue by setting out its approach to supply to the UK medical cannabis sector Eoin Keenan says that across the world
listings of cannabis-related businesses and internationally. most requests for medical cannabis come
(18 September 2020). This clarity has from patients eager to move away from
been broadly welcomed by the sector Ananda is partnering with Dr Dedi opioid-based pain relief. He says that in
and it will be interesting to see what Meiri’s laboratories at The Technion in addition to the conditions such as
impact it has on investment in the Israel. Dr Meiri is working on a wide spasticity in MS and childhood epilepsies,
longer term. range of projects, ultimately focused medical cannabis can be prescribed for
dacbeachcroft.com12 MEDICAL CANNABIS AND CBD
rheumatoid arthritis, fibromyalgia, Novel Foods legislation and may create opportunities, as well
dementia (including Alzheimer’s) and It remains to be seen what the ultimate as some challenges, for those in the
Crohn’s disease. impact of the guidance will be; but the UK CBD industry.
February 2020 UK Food Standards
“In the long term, research and data will Agency guidance on the application of While the UK is a long way from
influence how we prescribe cannabis- the “novel foods” legislation to CBD following US states such as California
based medicines,” he says. “If you look at products has been broadly welcomed and Alaska, where recreational
the clinical trial registers, a lot of the by many companies at the forefront of cannabis is legal, Tulloch points out
studies focus on chronic pain and the UK CBD industry. Companies may the benefits. “Legalisation has closed
Parkinson’s disease, but mental health continue to sell existing products in the down large swathes of organised
issues such as anxiety, insomnia and UK after 31 March 2021 only if, prior to crime and taken recreational cannabis
PTSD feature frequently.” that date, they have submitted a proper into a regulated field where people
“novel foods” authorisation application. know that what they buy is tested and
Nick Tulloch, Director at Fetlar Capital, Anecdotally, it is clear that “quality” high quality. It has also generated a
says the rapid expansion of the CBD operators believe this should have large amount of revenue as it is taxed
market has thrown up some high-quality quite an effect in terms of improving like tobacco and alcohol.”
products. But he adds: “There’s also a overall standards, specifically because
dark side of people literally creating CBD it is believed that many smaller market Market analysts agree that medicinal
products in their kitchens where not only participants simply won’t have the cannabis could be an investor goldrush,
the composition of each product may be funding or the capability to comply. but Tulloch advises investors to be
different, but some of the ingredients are careful. “Back those companies that
undesirable. For example, tests in 2019 The position for European Union have a high social media profile, good
showed a handful of CBD products on countries currently seems less clear branding, a clear strategy, good
UK shelves contained illegal solvents.” because it has been reported that the financial controls and most importantly
European Union is considering have products that are differentiated. A
Tulloch calls for the equivalent of a classifying hemp-derived CBD as a copycat company is going to struggle in
kitemark on CBD products so that controlled narcotic; if this occurs, it the long term.”
consumers know they can be trusted. would probably result in significant
“Often products have nothing on the restrictions on EU market participants
label that says how much CBD is in it.
For an industry that wants to be as big
as CBD does, that’s unacceptable,”
Tulloch says. “More regulation will do
everyone good and take out the people
“If you look at the clinical trial registers, a lot of the
that are doing things they shouldn’t. It studies focus on chronic pain and Parkinson’s disease,
would also make consumers more
confident and probably push prices up a
but mental health issues such as anxiety, insomnia and
bit, but at least everyone would know PTSD feature frequently.”
products are what they claim to be.” Eoin Keenan, Prohibition Partners
@healthlawukMEDICAL CANNABIS AND CBD 13
CHAPTER 4.
INTERNATIONAL MODELS
Several countries have loosened restrictions on medical cannabis, offering the UK
lessons in terms of its approach to research, manufacturing and access.
At the end of 2019, Thai Prime Minister The Canadian, Israeli and Maltese Canada
Prayut Chan-o-cha launched the governments face similar critiques In 2001 Canada became the first G7
government’s medical cannabis to the UK that access to medical country to create an exemption in
education website at an event alongside cannabis is limited by cost and criminal law to allow approved patients
its official mascot Dr Ganja – in white lab bureaucracy which helps the black to possess and grow their own cannabis
coat and a green marijuana leaf head. market flourish. following the lengthy legal battle of
Terry Parker, a man with epilepsy who
Thailand already has a string of government All three nations have individual was arrested for cannabis possession,
medical cannabis clinics and is one of many approaches, and are at different stages cultivation and trafficking.
countries making medical cannabis in their relationships with medical
products available. It is also creating cannabis, but experts say all three In 2013, the Canadian Federal
significant production and manufacturing offer the UK lessons in terms of its Government implemented regulations
bases. But the rate of change and the level approach to research, manufacturing which created a commercially licensed
of ambition varies from place to place. and access. industry for the production and
dacbeachcroft.com14 MEDICAL CANNABIS AND CBD
She feels the UK, with its reputable
“Waiting for clinical trials would delay everything institutions, could take the lead in an
by about 10 years, while patients resort to industry that is still in its infancy.
“Considering some of the public
potentially more harmful substances and drugs – health challenges like opioid usage,
such as opioids.” the health costs of an ageing
population, and the fact that general
Karine Cousineau, Director, Government Relations and Sustainability at The Green
Organic Dutchman stigma associated with cannabis is
diminishing, it would be less of a
political risk for a government to invest
distribution of medicinal cannabis. Some grows, manufactures and sells a range in cannabis research.”
37,800 people are authorised to possess of cannabis products including
marijuana under the programme, up prescription items. She says this is a Malta
from fewer than 100 in 2001. problem the Canadian Government is Medical cannabis has a growing role in
trying to address. the Maltese economy – it has already
Patients with the authorisation of their created more than 900 jobs and it is
doctor can access cannabis by either Given public demand, Cousineau says that expected to increase trade in exported
registering with a licensed producer, while it could be tempting for policy makers goods by 30%.
registering with Health Canada to in Canada and across the world to demand
produce a limited amount for their own RCTs before providing access to patients, it In April 2018 Malta introduced medical
medical purposes, or designate would be a mistake. “There is enough data, cannabis legislation covering
someone else to produce it for them. anecdotal evidence and advocacy out there production, manufacture, distribution
to do a reasonable assessment of the and, significantly, research – one of the
However, Canada’s black market is still minimal risk associated with cannabis use as freedoms UK doctors are hoping for.
flourishing as medical grade cannabis is medicine. The development of the industry
expensive to produce and there are a and research needs to be done in tandem Marion Zammit is the head of medical
limited number of suppliers. in order to be successful. Waiting for clinical cannabis activity at Malta Enterprise,
trials would delay everything by about 10 Malta’s economic development
Karine Cousineau is the Director, years, while patients resort to potentially corporation, and the first point of entry
Government Relations and Sustainability more harmful substances and drugs – such for anyone wanting to invest in the
at The Green Organic Dutchman which as opioids,” she says. medical cannabis industry.
@healthlawukMEDICAL CANNABIS AND CBD 15
Zammit says local producers can export, in medical cannabis. “Nonetheless, psychoactive molecule in marijuana
as well as sell, locally to licensed products manufactured in Malta that causes a high, was first isolated in
pharma distributors who then sell onto needs to be produced adhering to the 1964 by Professor Raphael Mechoulam,
pharmacists. Any doctor can prescribe highest pharmaceutical standards. a scientist at Hebrew University.
medical cannabis; however patients Drugs produced in Malta are renowned
need to apply for a permit from the for their quality all around the world, Marijuana for medical use has been
country’s Superintendent of Health. and the same standards will be applied permitted since the early 1990s
to medical cannabis products.” for cancer patients and those with
The country aims to become an pain-related illnesses such as
influential producer and exporter of Some Maltese doctors are reluctant Parkinson’s, MS and Crohn’s disease,
CBMPs. More than 50 companies to prescribe, given the lack of RCTs. but recreational use remains illegal.
including businesses based in the UK, “When it comes to the medical
Israel, Canada and Australia have profession, cannabis represents a In April 2017 it was made possible for
applied to work in Malta. To date, paradigm shift,” Zammit concedes. medical cannabis companies to export
Zammit says 27 have been approved “Patients come to doctors saying their products, with analysts estimating
with more to come. would you prescribe. Not all doctors that the measure could generate Israel
are taking it up, as for many it some $267m per year.
She says that greater competition will represents a challenge in their
help drive CBMP prices down. “When prescribing habits, especially since According to iCan, an Israeli company
evaluating projects for approval, three there is a lack of medical information. which invests in the local cannabis
main criteria are used, namely, due But some are seeing patient benefits market, more than 50 US companies
diligence on the shareholders of the from the drug, and the more happy- have relocated or invested in cannabis
company, financial viability of the ending stories and empirical research in Israel to evade onerous
project, as well as sectorial/relevant evidence they see, the more likely research regulations in the UK and US.
experience of the shareholders.” they will prescribe.”
There are eight government-sanctioned
As the science is in a fledging state, Israel cannabis growing operations in
the legislation does not put any Israel has been at the centre of Israel, which distribute to patients who
restrictions on the amounts or cannabis research for decades, with the have a licence from the Ministry of
combinations of THC and CBD used Ministry of Health playing an active role Health and a prescription from an
in finance and support. THC, the authorised doctor.
dacbeachcroft.com16 MEDICAL CANNABIS AND CBD
“There is a lot of bureaucracy around the process Around 100 Israeli physicians can
prescribe medical cannabis but
and patients are complaining because they knew Maymon-Pomeranchik says doctors are
their strain and they knew the farms they got it from. required to present extensive evidence
that other treatments have failed.
The intention, which was to ensure labs safety, was
very good, but the bureaucracy is very tough.” That said, she feels more doctors are
willing to prescribe cannabis simply
Dr Inbar Maymon-Pomeranchik, founder of BioDiligence Partners because of the empirical evidence that it
seems to be effective. To help doctors
understand how medical cannabis can be
Dr Inbar Maymon-Pomeranchik is the manufacturing practice] registered used she says there has been a big growth
founder of BioDiligence Partners, pharmaceutical company, then it goes in physician education programmes, but
which advises investors and biotech to a pharmacy where the patient can there will always be those who want to see
companies on medical cannabis. While buy their supply on prescription. hard evidence in the form of RCTs.
some 50-60,000 Israelis use prescribed
medical cannabis, Maymon-Pomeranchik “There is a lot of bureaucracy around the In terms of lessons for the UK, she feels
says the regulatory system is still too process and patients are complaining that more emphasis must be placed on
bureaucratic, which means people turn because they knew their strain and they physician and patient education
to the black market. knew the farms they got it from. The programmes, as well as ways of
intention, which was to ensure labs safety, reducing the bureaucracy and cost in
“Until a year ago patients could choose was very good, but the bureaucracy is terms of access, particularly around
the farm that supplied their products. very tough and complying with GMP adds import licences.
Now the farm must sell to a GMP [good to the expense,” she says.
@healthlawukMEDICAL CANNABIS AND CBD 17
IN SUMMARY
There is worldwide demand for medical cannabis, and growing calls to make it
more widely available in the UK. But some doctors urge caution and more
medical trials.
• There would appear to be significant • High costs associated with the trialling • More trials are in the pipeline in the
potential worldwide demand for and development of medical products, form of NHS RCTs, privately
medical cannabis, with market sales the principle that products already sanctioned RCTs and qualitative
estimated at anything between licensed should be used first and observational trials. But advocates of
£33.64bn and £62bn by 2025. doctors’ reluctance to prescribe medical cannabis, as well as NHS
without RCT evidence, means very England and the Health Select
• Public opinion, several high-profile few UK patients currently benefit. Committee, say big pharmaceutical
cases such as that of eight-year-old companies also need to take part.
Alfie Dingley, the UK medical cannabis • Supporters say medical cannabis is
industry and a small but vocal body of so different from ‘normal’ new • In light of some recent experiences, it
medical opinion are driving calls to pharmaceuticals that it needs its own was clear that the CBD market needed
make medical cannabis more widely trials and prescribing criteria. Others more regulation and a ‘kitemark’
available in the UK. advocate continued trust in established approval system to stamp out rogue
research procedures, to minimise risk producers – the February 2020
• However, a separate body of respected to patients and protect the public. guidance from the UK Food Standards
medical opinion, driven by public safety Agency has therefore been broadly
concerns, urges caution in the absence welcomed by many companies at the
of further medical research data. forefront of the UK CBD industry.
dacbeachcroft.com18 MEDICAL CANNABIS AND CBD
• The recent statement by the FCA of its • Campaigners say the UK Government • Clinician and patient education also
approach to listings of cannabis- needs to help kick-start the industry present business opportunities.
related businesses has been broadly via grants for growing companies
welcomed and it will be interesting to producing pure strains and bringing • Overseas observers say the UK needs
see whether this has an impact on UK products to market, since in their to make it easier for clinicians to
investor confidence. view this would bring prices down prescribe on the NHS and to free up
and competition would keep prices legislation and bureaucracy to make
• To protect those investors and lower. However, it should be noted investment, import and research
entrepreneurs keen on medical cannabis that the National Institute for Health easier, although some commentators
businesses, all companies wishing to list Research is already making some would argue that the 2018 change in
on UK stock markets need to go through grants for this purpose. the law already represents a
rigorous checks, in the same way as significant step forward.
for businesses in any other industry. • There may be opportunities for
Furthermore, in light of the Canadian investors in end-to-end supply chain
“greenrush” experience, broader companies which grow, manufacture,
investor protection concerns would also and package products, subject to
seem to be a motivation for UK financial compliance with applicable legal
regulators when looking at the medical restrictions.
cannabis sector.
ENDNOTES
1 https://www.gov.uk/government/news/government-announces-that-medicinal-cannabis-is-legal
2 https://www.researchandmarkets.com/reports/4763121/medical-cannabis-market-global-industry-trends
3 https://prohibitionpartners.com/reports/#the-global-cannabis-report
4 https://www.rcpsych.ac.uk/docs/default-source/improving-care/better-mh-policy/position-statements/ps05_19.
pdf?sfvrsn=e91154ba_2
5 https://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/
Commons/2019-06-27/270334/
6 https://publications.parliament.uk/pa/cm201719/cmselect/cmhealth/1821/182102.htm
7 https://www.england.nhs.uk/wp-content/uploads/2019/08/barriers-accessing-cannabis-based-products-nhs-pre-
scription.pdf
8 https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(19)30401-8/fulltext
9 https://drugscience.org.uk/project-twenty21/
@healthlawukCONTRIBUTORS
Dr Leon Barron Eoin Keenan Marcus Stuttard
Executive Committee Content & Head of the AIM and UK
Member – The Medical Communications Primary Markets at the
Cannabis Clinicians Society, Director, Prohibition London Stock Exchange
Founder – The Primary Partners
Care Cannabis Network
Karine Cousineau Dr Inbar Maymon- Melissa Sturgess
Director, Government Pomeranchik Chief Executive Officer
Relations and Founder of of Ananda
Sustainability, The BioDiligence Partners Developments
Green Organic
Dutchman
Hannah Deacon Dr Barry Miller Nick Tulloch
founding member Chair of the Medicines Director of Fetlar
of the MCCS and Advisory Group the Capital
Campaigner Royal College of
Anaesthetists Faculty of
Pain Management
Professor Andrew George McBride Marion Zammit
Goddard Chief Executive Officer, Head of Medical
President of the Royal Hanway Associates Cannabis Activity at
College of Physicians Malta Enterprise20 MEDICAL CANNABIS AND CBD
dacbeachcroft.com
Follow us: @healthlawuk
Connect with us: DAC Beachcroft LLP
DAC Beachcroft publications are created on a general basis for information
only and do not constitute legal or other professional advice. No liability is
accepted to users or third parties for the use of the contents or any errors or
inaccuracies therein. Professional advice should always be obtained before
applying the information to particular circumstances. For further details please
go to www.dacbeachcroft.com/en/gb/about/legal-notice. Please also read
our DAC Beachcroft Group privacy policy at www.dacbeachcroft.com/en/gb/
about/privacy-policy. By reading this publication you accept that you have
read, understood and agree to the terms of this disclaimer. The copyright in
this communication is retained by DAC Beachcroft. © DAC Beachcroft 2019.
@healthlawukYou can also read
