European Journal of Internal Medicine xxx (xxxx) xxx–xxx

Contents lists available at ScienceDirect

European Journal of Internal Medicine

journal homepage: www.elsevier.com/locate/ejim

Narrative Review

Medical use of cannabis and cannabinoids containing products – Regulations

in Europe and North America
⁎
Ran Abuhasiraa, , Liat Shbiroa, Yuval Landschaftb
a
Cannabis Clinical Research Institute, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva, Israel
b
Israel Medical Cannabis Agency, Ministry of Health, Jerusalem, Israel

A R T I C L E I N F O A B S T R A C T

Keywords: In 1937, the United States of America criminalized the use of cannabis and as a result its use decreased rapidly.
Medical cannabis In recent decades, there is a growing interest in the wide range of medical uses of cannabis and its constituents;
Medical marijuana however, the laws and regulations are substantially different between countries. Laws differentiate between raw
Marihuana herbal cannabis, cannabis extracts, and cannabinoid-based medicines. Both the European Medicines Agency
Cannabinoids
(EMA) and the United States Food and Drug Administration (FDA) do not approve the use of herbal cannabis or
Medical legislation
its extracts. The FDA approved several cannabinoid-based medicines, so did 23 European countries and Canada.
Regulation
Law However, only four of the reviewed countries have fully authorized the medical use of herbal cannabis – Canada,
Rules Germany, Israel and the Netherlands, together with more than 50% of the states in the United States. Most of the
European Union regulators allow the physicians to decide what specific indications they will prescribe cannabis for, but some
United States of America regulators dictate only specific indications. The aim of this article is to review the current (as of November 2017)
regulations of medical cannabis use in Europe and North America.

1. Introduction
Evidence of cannabis use for medical purposes can be dated back to
2737 BCE in ancient China [1]. Since then there have been wide var-
iations in the use and acceptance of cannabis as a drug therapy in
Western medicine. In 1937, the United States of America criminalized
the use of cannabis and as a result its use decreased rapidly [2]. In
recent decades, there is a growing interest in the wide range of phar-
macological and medical uses of cannabis and its constituents; however,
the laws and regulations are substantially different between countries.
Following the Single Convention of the United Nations in 1961 (as
amended by 1972), cannabis, cannabis resins and extracts were listed as
Schedule I and Schedule IV. Schedule I — those substances which are,
inter alia, having, or convertible into substances having a liability to
abuse comparable to that of cannabis, cannabis resin or cocaine.
Schedule IV - substances that are particularly liable to abuse and to
produce ill effects, and such liability is not offset by substantial ther-
apeutic advantages not possessed by substances other than drugs in
Schedule IV [3,4]. The 1971 Convention of psychotropic substances
listed Δ9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance in
cannabis, in Schedule II [5]. Schedule II — having addiction-producing
or addiction-sustaining properties not greater than those of codeine but
at least as great as those of dextropropoxyphene [4]. For schedule I
substances, the treaties prohibited all use except for scientific and very
limited medical purposes by duly authorized persons, in medical or
scientific establishments which are directly under the control of their
Governments or specifically approved by them [5].
The aim of this article is to review the current regulations of medical
cannabis use in Europe and North America. This article will not discuss
the recreational use of cannabis nor the evidence for the medical uses of
cannabis. The review is based on information gathered from officials in
the relevant regulatory agencies, previous reports and governmental
websites.
2. Terminology and products
The term “medical cannabis” might refer to different substances and
the distinction has both legal and medical implications [6,7]. These
include:
1. Raw herbal (botanical) cannabis – any part of any plant of the
genus Cannabis.
The genus Cannabis belongs to the Cannabaceae family. Some
people espouse cannabis as a single species with C. indica, C. sativa
and C. ruderalis as three different subspecies and some espouse them
as three different species of cannabis [8,9]. The difference between

⁎
Corresponding author at: Cannabis Clinical Research Institute, Soroka University Medical Center, POB 151, Beer-Sheva, Israel.
E-mail address: ranabu@post.bgu.ac.il (R. Abuhasira).

https://doi.org/10.1016/j.ejim.2018.01.001
Received 4 December 2017; Accepted 1 January 2018
0953-6205/ © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Please cite this article as: Abuhasira, R., European Journal of Internal Medicine (2018), https://doi.org/10.1016/j.ejim.2018.01.001
R. Abuhasira et al.
these species will not be elaborated here. The term ‘herbal cannabis’
may refer to anyone of these species.
2. Cannabis extract – any extract, usually by organic solvents to
produce oil, which is extracted from the plant, and any preparation
consisting mainly of it. Magistral preparation – any medicinal
product prepared in a pharmacy in accordance with a specified
medical prescription for an individual patient.
3. Cannabinoids – a class of chemical compounds that have the ty-
pical cannabinoid skeleton in common and affect the cannabinoid
receptors. The cannabis plant is known to contain over 100 different
cannabinoids (Phyto-cannabinoids) [10], with cannabidiol (CBD)
and Δ9-THC being the most studied so far. A few synthetic canna-
binoids are manufactured today as approved drugs – cannabinoid-
based medicines.
In recent years, there has been a substantial change in policies and
more countries are allowing the use of cannabis as a medicine.
Nonetheless, the lack evidence for cannabis efficacy and safety as well
as the concerns regarding addiction and other adverse events, cause
many countries to be cautious before changing cannabis regulations.
Most countries in Europe forbid the use of herbal cannabis, while
cannabinoid-based medicines are legal in many of them. Currently,
there are only three cannabinoid-based medicines available for mar-
keting in different countries [11]:
1. Nabiximols (Sativex®) – oromucosal spray formulated from ex-
tracts of the C. sativa plant that contains the cannabinoids THC and
CBD. Manufactured by GW Pharmaceuticals Plc. The most common
indication for its use is multiple sclerosis associated spasticity,
mostly after the failure of previous treatments. A number of coun-
tries also authorized its use for multiple sclerosis associated neuro-
pathic pain.
2. Nabilone (Cesamet® or Canemes®) – oral capsules containing a
synthetic cannabinoid similar to THC. Cesamet is manufactured by
Meda Pharmaceuticals Inc. and Canemes is manufactured by AOP
Orphan Pharmaceuticals AG. The main indication for their use is
nausea and vomiting due to chemotherapy treatments, mostly after
the failure of previous treatments.
3. Dronabinol (Marinol® or Syndros®) – oral capsules or an oral
solution containing synthetic Δ9-THC. Marinol is manufactured by
AbbVie Inc. Syndros is manufactured by Insys Therapeutics Inc. The
main indications for their use are 1) anorexia associated with weight
loss in patients with AIDS (Acquired Immunodeficiency Syndrome);
and 2) nausea and vomiting associated with cancer chemotherapy,
mostly after the failure of previous treatments.
Additional cannabinoid-based medicines are in different stages of
development, but have not been authorized for marketing yet [11].
3. Regulatory authorities
The main agencies responsible for evaluating and approving drugs
are the European Medicines Agency (EMA) and the United States Food
and Drug Administration (FDA).
3.1. EMA
There are two ways of obtaining a marketing authorization for a
medicine in the European Union (EU): the centralized procedure, via
the EMA, which results in a single marketing authorization valid
throughout the EU, and the non-centralized route where medicines may
be authorized in individual EU countries through the national compe-
tent authorities [12]. To date, no marketing authorization has been
granted for medicines derived from cannabis following evaluation by
EMA, nor did the EMA authorized cannabinoid-based medicines. The
only decisions the EMA authorized regarding cannabis and its products
2
European Journal of Internal Medicine xxx (xxxx) xxx–xxx
include rare diseases (orphan) designations and pediatric investigation
plans. Rare disease designation allows pharmaceutical companies to
benefit from incentives from the EU to develop a medicine for a rare
disease. These include reduced fees and protection from competition
once the medicine is placed on the market. An orphan designation does
not allow the medicine to be marketed. A pediatric investigation plan is
a development plan aimed at ensuring that the necessary data are ob-
tained through studies in children, to support the authorization of a
medicine for children [13]. Nevertheless, many European countries
authorized the use of some cannabinoid-based medicines, by the non-
centralized route, as will be elaborated further on.
3.2. FDA
Similar to the EMA, to date, the FDA has not approved a marketing
application for a drug product containing or derived directly from
herbal cannabis. In contrast to the FDA's position, a number of states
have already approved the use of medical cannabis, as will be elabo-
rated further on [14,15]. The FDA did approve Cesamet® [16], Mar-
inol® [17] and Syndros® [18] for therapeutic uses in the United States.
While the main agencies defer to accept herbal cannabis or its ex-
tracts as approved drugs, an increasing number of countries and states
are changing their regulation, allowing patients access to these sub-
stances.
3.3. Europe
Table 1 and Fig. 1 show that cannabinoid-based medicines, and
especially Nabiximols, have gained wide acceptance and are authorized
for use in most European Union countries. However, it should be noted
that Nabiximols is still indicated only for a small number of indications
and in practice it might be difficult to acquire even in authorized
countries. Furthermore, authorization of a new drug by a specific
European country requires the pharmaceutical company to send a
specific request to the country's regulatory agency. Thus, several of the
countries that do not authorize part of the cannabinoid-based medicines
state that they would agree to authorize the drugs upon receiving a
request from the manufacturers.
4. United States of America
At the federal level, by the way of the Comprehensive Drug Abuse
Prevention and Control Act of 1970, a United States federal law lists
cannabis as a schedule I drug and its use is prohibited for any purpose
[19]. Nevertheless, different states have issued laws of their own, and
most states currently enable the use of medical cannabis to some extent.
California was the first state to pass a law that permits the use of
medical cannabis in 1996. At the time of manuscript preparation, 29
states and the District of Columbia have authorized the use of medical
cannabis, with wide variations between them [20,21].
A current list of states that have broadly authorized medical can-
nabis use in some form includes Alaska, Arizona, Arkansas, California,
Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine,
Maryland, Massachusetts, Michigan, Minnesota, Montana, Nevada,
New Hampshire, New Jersey, New Mexico, New York, North Dakota,
Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, West
Virginia and the District of Columbia [21].
All states, except for the District of Columbia, limit the conditions
for which cannabis can be prescribed [20], but some of them (e.g.
Florida), also allow a broader use for “other debilitating medical con-
ditions of the same kind or class as or comparable to those enumerated,
and for which a physician believes that the medical use of marijuana
would likely outweigh the potential health risks for a patient” [22].
Physicians do not need to have a specific specialty to prescribe
cannabis, but most states require the physicians to obtain a state re-
gistration prior to prescribing cannabis to patients. Physicians must also
R. Abuhasira et al. European Journal of Internal Medicine xxx (xxxx) xxx–xxx

Table 1
Medical cannabis programs and regulations by country – European countries and Israel. Detailed report about each country is given in the supplementary data.

Country Cannabinoid-based medicines authorized Raw herbal Magistral preparations authorized Limit indications for herbal cannabis or
cannabis (including special permit) magistral preparations?

Austria Nabiximols, Nabilone and Dronabinol Not authorized Yes No limit

Belgium Nabiximols Not authorizeda No Not applicable
Bulgaria Not authorized Not authorized No Not applicable
Croatia Nabilone and Dronabinol Not authorized Yes (drugs containing THC) No limit
Cyprus Not authorized Not authorized No. Oil approved on a named basisa Not applicable
Czech Republic Nabiximols Not authorized Yes Yesb
Denmark Nabiximols (Nabilone and Dronabinol by Not authorized Yes No limit
compassionate use)
Estonia Not authorized Partially Noa Not applicable
authorizeda
Finland Nabiximols Partially No No limit
authorizeda
France Nabiximols (Nabilone and Dronabinol by Not authorized No Not applicable
temporary use authorization)
Germany Nabiximols and Nabilone Authorized Yes No limit
Greece Not authorized Not authorized No Not applicable
Hungary Not authorized Not authorized No Not applicable
Iceland Nabiximols Not authorized No Not applicable
Ireland Nabiximols (Nabilone and Dronabinol by Partially Noa No limit
import only, not authorized) authorizeda
Israel Nabiximols Authorized No Yesb
Italy Nabiximols Not authorized Yes Yesb
Latvia Not authorized Not authorized No Not applicable
Lithuania Nabiximols (for clinical trials only) Not authorized No Not applicable
Luxembourg Nabiximols Not authorized No Not applicable
Malta Nabiximols Not authorized Yes No limit
Netherlands Nabiximols and Dronabinol Authorized Yes No limit
Norway Nabiximols Not authorized Yes No limit
Poland Nabiximols Not authorized Yes No limit
Portugal Nabiximols Not authorized No Not applicable
Romania Not authorized Not authorized No Not applicable
Slovakia Nabiximols Not authorized No Not applicable
Slovenia Not authorized Not authorized Yes Yes
Spain Nabiximols Not authorized No Not applicable
Sweden Nabiximols Not authorizeda No Not applicable
Switzerland Nabiximols (Dronabinol by special permit) Not authorized Yes No limit
United Kingdom Nabiximols and Nabilone Not authorized No Not applicable

a
See supplementary data for exact limitations.
b
See supplementary data for exact indications.

have a bona fide relationship with the patient in order to register them
with the program. Some states (e.g. New-York and Massachusetts) re-
quire the physicians to complete a short medical education program
about cannabis as a prerequisite to their registration [23,24].
Cannabis is supplied to the patients via specified dispensaries in
every state. These dispensaries can provide herbal cannabis, cannabis-
derived products, and cannabis consumption devices. The routes of
administration also vary between the states – widely authorized routes
are oil, vaporizing and capsules. Smoking cannabis for medical pur-
poses is prohibited in many states and edible forms are also prohibited
in some states [25].
As previously stated, the FDA approved Cesamet® [16], Marinol®
[17] and Syndros® [18] for therapeutic uses in the United States.
5. Canada
Since April 2014, physicians can sign a medical document author-
izing a patient's access to, and the dispensing of, a specified quantity of
the dried cannabis plant, which patients purchase through a licensed
producer. Nevertheless, herbal cannabis is not authorized as a drug and
therefore is not available in regular pharmacies. The cannabis can be
given for any condition, without proving a failure of previous treat-
ments. On August 11, 2016, Health Canada announced the new Access
to Cannabis for Medical Purposes Regulations (ACMPR). Under the
ACMPR, patients with a valid cannabis authorization can register with
Health Canada to produce a limited amount of cannabis for their own
medical purposes, or they can designate someone else to produce it for
them. In addition to physicians, nurse practitioners can also authorize
patients to receive medical cannabis. In a hospital setting, the person in
charge of the hospital can allow fresh or dried marijuana or cannabis oil
to be administered to a patient or, to be sold or provided to a patient or
to the individual responsible for the patient [26–28].
Nabiximols is approved for use for multiple sclerosis associated
spasticity [29]. Additional indications include: adjunctive treatment for
symptomatic relief of neuropathic pain in adult patients with multiple
sclerosis; and adjunctive analgesic treatment in adult patients with
advanced cancer who experiences moderate to severe pain while on the
highest tolerated dose of strong opioid therapy for persistent back-
ground pain. Nabilone is approved for severe nausea and vomiting as-
sociated with cancer chemotherapy. Dronabinol was approved for
AIDS-related anorexia associated with weight loss and for severe nausea
and vomiting associated with cancer chemotherapy. Dronabinol was
withdrawn from the Canadian market by the manufacturer in February
2012, however not for safety reasons [30].
6. Summary and conclusions
Authorization of raw herbal cannabis is still generally unaccepted.
Only four of the reviewed countries have fully authorized its medical
use – Canada, Germany, Israel and the Netherlands, together with more
than 50% of the states in the United States. Magistral preparations from
cannabis plants are more acceptable and have been approved by 10
more European countries. Most of the regulators allow the physicians to
decide what specific indications they will prescribe cannabis for, but

3
R. Abuhasira et al. European Journal of Internal Medicine xxx (xxxx) xxx–xxx

Iceland

Finland

Norway
Sweden
Estonia*

Latvia

Denmark Lithuania

Ireland

United
Netherlands Poland
Kingdomm

Belgium Germany

Lux Czech Rep.

ep.
p.
Slovakia

Austria Hungary
France Switzerland
Slovenia
ven
nia
n Romania
Croatia

Bulgaria
Italy

Portugal Spain
Greece

Malta

Cyprus
Israell

Herbal or magistral preparaon of cannabis are authorized.

Cannabinoid-based medicines only are authorized.

Complete prohibion of cannabis and cannabinoid-based medicines.

Fig. 1. Summary map of cannabis regulation in European countries (European Union, European Free Trade Association and Israel). Lux – Luxembourg. Czech rep – Czech Republic.
*See supplementary data for detailed status of authorization.

some regulators dictate only specific indications. As opposed to herbal
cannabis, cannabinoid-based medicines are authorized by the FDA and
by most of the countries in Europe. Many countries have changed their
legislations about medical cannabis in the past several years and it is
likely that the regulations will continue to change in the upcoming
years. It should be noted that in many countries there is considerable
gap between the official authorizations, which may be quite permissive,
to the actual access of patients to medical cannabis.
The main aim of this review was to present the current regulations
in Europe and North America of medical use of cannabis and cannabis-
based products, including cannabinoid-based medicines. The on-going
debate in the medical and scientific community, the lack of approval by
the central agencies (the EMA and the FDA), as well as social and po-
litical influences, cause wide variation between countries. All of these
differences influence the therapeutic and the research options world-
wide. The growing public interest and published data about the ther-
apeutic uses of cannabis creates pressure both on physicians and on the
policy makers. In our opinion, the discussion of the medical use of
cannabis and cannabinoids must be clearly differentiated from the
discussion of the legal status of recreational cannabis. Furthermore, we
believe that the creation of the international research program dedi-
cated to the investigation of the cannabinoid derived medicinal pro-
ducts under the evidence based paradigm is imperative.

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R. Abuhasira et al. European Journal of Internal Medicine xxx (xxxx) xxx–xxx

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