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European Medical: Cannabis Ecosystem
European Medical: Cannabis Ecosystem
Medical
Cannabis
Ecosystem
Published by the First Wednesdays network, with insights
provided in partnership with Hanway Associates and Invest In
Denmark (part of the Danish Ministry of Foreign Affairs).
Introduction 3 Production
Georgia Glick
Contributors
Michael Prytz
Laurence Busch Hansen Derek Light
Inclusion Criteria 5 Pierre-Yves Gallety Dr Marco Ternelli
Elisabetta Calabritto Marion Zammit
Disclaimer
Invest in Denmark contributed to the production of this report. Hanway Associates takes
responsibility for any errors or omissions to the analysis and content of this report.
→ This list has been compiled primarily from → Vertically integrated companies active
the First Wednesdays member database in multiple segments have been listed in
and publicly available information the segment they are best known for.
alongside targeted interviews with non- → In addition to these general
members. requirements, companies must also
→ The ecosystem features the top 150 adhere to the relevant value-chain
companies which are currently active in the specific requirements set out on page 6.
legal, European medical cannabis market → Dispensing has not been included on the
based on the following criteria. ecosystem map as this role is typically
→ We have only featured companies who undertaken by non-cannabis specific
have headquarters or an important hub community pharmacies. Prescribing and
in Europe, or otherwise have a key role in dispensing in Europe is discussed on
supplying the market. page 18.
European
Medical
Cannabis
09
08
Ecosystem
07. Branded Medicines
06 05
01. Genetics & Seeds Banks
07 08. Technology
02. Cultivation
03 04
04. Research 09. Distribution
02 01
First Wednesdays European Medical Cannabis Ecosystem 7
01. Genetics &Seed Banks H A N W AY I N S I G H T S
01
03
04
06
Hanway Associates is a strategic consultancy specialising in cannabis research, new market entry, commercial diligence and
M&A strategy. Hanway Associates provide services to help open and enter markets, build brands and grow clients’ networks,
as well as producing ready-to-buy reports to help companies navigate a complex and rapidly changing industry.
1. Prescribing and Dispensing —
Extemporaneous Preparations
The prescribing and COMPOUNDING PHARMACIES
dispensing landscape
In European countries such as Germany Under the new interpretation, pharmacies will In Germany, cannabis supplied to
varies between countries
and Italy, pharmacists play a large role no longer be permitted to ship prescriptions pharmacies must be as a ‘bulk intermediate
in Europe. We have
in preparing formulations. This allows for to patients or produce oil in bulk, and will be product’ rather than a finished product, and
outlined some of the key
the provision of personalised medicines to limited in the product formats they are able compounding is a compulsory step. The
differences including
patients. The focus is therefore less on off- to process. Dr Ternelli explains, DAC/NRF (New German Formulary) states
uptake of magistral
the-shelf cannabis products, and more on the types of cannabis medicines pharmacists
preparations and the
targeting a patient’s specific need. The Italian Although there is no new law can formulate, including oils and capsules
compounding route, as pharmacist Dr Marco Ternelli reports that in prepared using dried flower or dronabinol.
or decree, the Ministry of
well as the importance Italy, Flower may also be prescribed, and weighing
of private and in driving Health has issued an absurd
and re-packaging by pharmacists constitutes
patient demand and interpretation, denying
The most prescribed and the required processing step.
access to medical pharmacies the ability to
preferred forms are oral oils produce cannabis extracts for
cannabis in several
and capsules, followed by non oral use (eg. eye drops,
European countries.
sachets for vaporising. creams, suppositories) and
A recent interpretation issued by the Ministry
shipping directly to patients
of Health in Italy is believed to have a (home delivery) though
negative effect on patients accessing medical courier. An appeal to court
cannabis preparations. is currently being issued by
some pharmacists.
KEY INFORMATION
Synthetic Isolate Full-Spectrum
DEFINITION Synthetic cannabinoids are the result of Individual cannabinoids can be purified to Full-spectrum refers to a form of plant-
chemical or biochemical synthesis methods to reach beyond 99.5% purity and can be either derived cannabis containing all naturally
reproduce compounds found in the cannabis crystalline or oil form at room temperature. occurring cannabinoids, terpenes and
plant, or artificial derivatives. This laboratory other compounds. The cannabinoid profile
process produces a pure isolated compound, may vary due to difficulties standardising
once the byproducts of synthesis have been composition.
removed.
Synthesis avoids supply The movement towards synthetic Single compounds are better-suited Unlike whole plant products,
disruptions arising from compounds has already been for use in trials to identify the effects isolated cannabinoids make
failed harvests and difficulties experienced with the likes of aspirin, of specific cannabinoids. Synthetic it possible to utilise minor
transporting the controlled plant caffeine and multivitamins due to cannabinoids are typically easier cannabinoids with high
matter. It enables manufacturers their lower production costs and the to obtain for research purposes therapeutic potential to target
to scale production depending capacity for large-scale production. and are sometimes viewed more specific medical conditions, and
on market demand and While the cost of synthetic favourably from a regulatory to avoid unwanted side effects
changing national requirements cannabinoids is currently high standpoint, driving progress towards caused by the presence of THC
and regulations. relative to plant-based production, the body of evidence needed for patients that express sensitivity.
prices are falling with new market for wider adoption of medical
entrants and increasing R&D. cannabinoids.
The Netherlands was the first European nation to collaboration will continue to improve
introduce access to medical cannabis, yet patient the lives of patients.
adoption rates and market growth have been hindered PAUL NORTH, DIRECTOR OF VOLTEFACE
UK LITHUANIA FRANCE
October 11, 2018 October 11, 2018 October 25, 2019
Regulatory Parliament approves a law National Assembly
amendment enables allowing for medical use of of France authorises
the prescription of cannabis, with an effective plans for a two-year
medicinal cannabis date of 1 May 2019 medical cannabis trial,
due to commence in
2021
imports. INSIGHTS → An estimated 6,500kg was imported for dispensing → Domestic production remains insufficient → Elkoplast Slušovice was the only bidder in the
to domestic patients in 2019. Imports will still be compared to patient demand. Just 11% of cannabis most recent tender in 2017, and previous tenders
required to supplement domestic supply. sold in 2019 was produced by SCFM. were reportedly cancelled due to no applications
being made.
→ The government may purchase a larger → Production is supplemented by imports from
quantity depending on the size of the harvests, Bedrocan and a state-issued tender of which → In 2019, imports from Bedrocan and Canadian
at a potentially lower cost than the previous Aurora was the sole winner. producers still occurred despite production
government estimate of an average €2.3 per volumes being greater than demand. This is
→ SCFM has signed a three-year joint venture with
gram. thought to be the result of both quality and
the Italian region of Tuscany, in part exploring
logistical challenges.
→ The first tender was issued for just 6,600kg over a production of flower and standardisation of oil
four-year period, but was cancelled due to legal extracts.
challenges.
INSIGHTS → The Office of Medicinal Cannabis (OMC) purchases all cannabis → The domestic production pilot runs in parallel with the four-year
produced by Bedrocan at a mandated price and facilitates medical cannabis pilot programme.
distribution and exports. → No cap on production volumes or limit to the number of licensed
→ The OMC has an ongoing tender application process for a producers.
maximum of two new suppliers. → Producers must follow strict requirements including additional
→ The Netherlands now exports significantly more cannabis than is restrictions on pesticide use and required levels of product
sold domestically. 2,150kg was exported to Germany alone in 2019, consistency.
compared with 580kg supplied to domestic patients. → A number of international cannabis companies have established
facilities in Denmark with a view to develop an export hub to the
wider EU.
27
There is a clear growing interest SPONSORS OF ONGOING NUMBER OF CLINICAL TRIALS
in research into cannabis and CANNABIS & CANNABINOID RESEARCHING MEDICAL CONDITIONS
psychiatric disorders such as CLINICAL TRIALS IN EUROPE 1 2 3 4
Psychiatric
schizophrenia, PTSD, fear and 7.4% 70.4% Disorder
Government Academic Alzheimer’s
ongoing clinical trials phobias. Research Diseases
across Europe for a
70%
Cancer
wide range of medical Over
Neuropathic Pain
conditions such as:
→ Multiple sclerosis (MS) Cancer Pain
Epilepsy
Cardiometabolic
Disease
Brain
Functioning
Source: www.clinicaltrialsregister.eu
Invest in Denmark provided background information on the industry and identified some of the key stakeholders, and
Hanway Associates carried out independent research including interviews with stakeholders to structure the analysis,
and take responsibility for any errors or omissions.
Invest in Denmark is part of the Danish Ministry of Foreign Affairs. They provide tailor-
made solutions for foreign companies looking to set up or expand business or research
activities in Denmark. www.investindk.com 38
Introduction to Medical Cannabis
in Denmark
The Danish medical cannabis program is actually scope to explore business models, breeding
two parallel four-year trials – one for domestic approaches, and improving cultivation
medical use and another for domestic cultivation. techniques.
The trial program was launched in 2018 and
A clear framework has been set but many
backed by a unanimous vote of the country’s
opportunities remain to be explored. This
parliamentarians. 2020 marks the halfway point of
means that cultivators need to engage with the
the programs, and an evaluation is pending. The
local ecosystem of plant scientists, breeders, Michael Prytz
country’s parliamentarians will decide on further INVESTMENT MANAGER,
AgTech, and pharma engineering firms to
courses of action on whether to extend or adjust MINISTRY OF FOREIGN
bring the standards up to higher levels of AFFAIRS OF DENMARK
the program after 2022. The Danish framework was
medical grade cultivation. It is not a quick copy-
developed on a hybrid model, bringing together
paste process. Some of the know-how from
the “patient-driven model” based on the needs
North America and elsewhere in Europe has
Derek Light
of patients and their doctors, and the “cultivation SPECIAL ADVISOR,
been really valuable to the development of a LIFE SCIENCES,
for export model”. This is where the Danish hybrid
Danish model, but it has required a process MINISTRY OF FOREIGN
model is especially interesting. In Denmark,
of incorporating and also developing Danish AFFAIRS OF DENMARK
cultivation is structured in an open-ended system
expertise to help the industry.
with no cap on production volumes and no limit to
the number of licenced producers. Berit Chavez Azeri
INVESTMENT MANAGER,
It is based on a pharma paradigm that requires MINISTRY OF FOREIGN
serious planning to achieve minimum standards, AFFAIRS OF DENMARK,
but the transparent requirements offer significant LONDON
STRUCTURAL ADVANTAGES
Denmark’s strong business ecosystem offers investors Producers also benefit from sustainable access
a plug-and-play model for establishing and rapidly to low-cost renewable energy, which is highly
scaling operations in the pharma-oriented European advantageous for indoor production to ensure the
market. Denmark has been quick to attract investment required consistency levels for EU-GMP certification.
as a result, with Canadian producers driving a large
Denmark’s proximity to major markets, particularly
proportion of direct expenditure. Initially announced
the UK, Germany and France, alongside excellent
foreign direct investment into the sector totalled
infrastructure for transport and shipping is
over CAD$407 million, according to estimates by
advantageous from an export-focused perspective.
Denmark’s Horticultural Association and Invest in
Cannabis producers can leverage Denmark’s optimal
Denmark.
location as has historically benefitted pharmaceutical
Investors can draw on expertise from both manufacturers, combatting Europe’s historical
pharmaceutical and horticultural industries, with reliance on Canadian and Dutch imports.
strong Danish heritage in agriculture and greenhouse
production and 2.6% of national GDP originating from
pharmaceutical manufacturing. Denmark benefits
from a highly-trained talent pool, readily-available
land and deep expertise in product development and
Quality Assurance.
Hanway Associates is the leading European strategic consultancy, specialising in cannabis research,
new market entry, commercial diligence and M&A strategy.
Whether you are looking to understand the market, pivot your existing business, expand to new
markets, apply for licences, protect your reputation, find the right partners, or start a business from
scratch, our multidisciplinary teams can help. Our clients include listed-pharmaceutical companies,
global FMCG consumer brands, top tier cannabis companies, investors, and innovative biotech /
R&D startups.
hanwayassociates.com