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Being at the centre of many debates worldwide throughout the
years, Cannabis refers to a group of three plants known as
Cannabis sativa, Cannabis indica and Cannabis
, which commonly possess psychoactive elements. Also
referred to as marijuana, weed or pot, harvested and dried flowers
of the aforementioned plants produces one of the most commonly used
drugs in the world. Whilst many countries have legalised or are
moving towards the legalisation of medical cannabis, only a limited
number of countries worldwide have introduced laws permitting the
use of recreational cannabis.

Medical Cannabis Developments through the years

Attracting attention once again in recent years, the use of
cannabis for medicinal purposes has a long history, dating back to
ancient times. Despite its initial success, medical cannabis was
largely rejected in the 20th century with the United
Nations classifying cannabis as a drug having no medical uses in
the UN Single Convention on Narcotic Drugs. However, this did not
bar its development over the recent years due to the re-emergence
of patients’ interest in the use of medical cannabis to treat a
plurality of medical conditions.

The medical use of cannabis saw a revival in the United states
in the late 20th century following the discovery that
the human body and brain possess an Endocannabinoid system which
enables the control of key biological functions including pain and
sleep, which in turn maintains human health. Cannabis works in such
a way that its chemicals attach to the cannabinoid receptors in the
brain, consequently activating them to disrupt various mental and
physical functions, producing a multitude of effects. Amongst
others, the effects known to be beneficial to suffering patients
include the relief of chronic pain, the alleviation of anxiety,
reducing symptoms of epilepsy, asthma and Alzheimer’s disease,
and the improvement of lung capacity. Such benefits emerge due to
the anti-inflammatory effects it produces on the nervous system of
the body.

Responding to patients’ demands, a number of states in the
US paved the way on a global level towards the legalisation of
medical cannabis following a referendum which positively affirmed
the desire for such possibility. By 1999, many other US states
adopted a similar approach through which the medical use of
cannabis was recognised as legal. It was not until the
21st century that European countries followed suit, such
as the Netherlands, Czech Republic and Germany in 2003, 2013 and
2017 respectively. Indeed, today, most EU member states have
legalised or are actively considering the legalisation of medical
cannabis. In fact, a resolution was passed in the EU Parliament
following the production of evidence highlighting the power of
medical cannabis. As a result, Resolution 2018/2775 passed in
February 2019 effectively urged the EU Commission and Member States
to carry out research and form a legal framework on medical
cannabis. Nonetheless, the approaches taken, both from a regulatory
and product point of view, vary considerably. This is due to the
fact that no EU-wide policy has been adopted to date.

Being at the forefront of the medical cannabis industry, Malta
was one of the first EU countries which legalised the prescription
of medicinal preparations of cannabis and cannabinoids by medical
practitioners by virtue of the Drug Dependence (Treatment not
Imprisonment) Act (Chapter 537 of the Laws of Malta) (the
Drug Dependence Act“). This was
followed by legislative enactments in 2018 which provided the
possibility for the local production and distribution of cannabis
for medical and research purposes. The principal comprehensive law
regulating its production is the Production of Cannabis for
Medicinal and Research Purposes Act (Chapter 578 of the Laws of
Malta) (the “PCMRP Act“), together with
subsidiary legislation and official guidelines. Collectively, they
describe the process required for the application for the necessary
approvals, authorisations, licences and/or permits.

Moreover, the Medicines Act (Chapter 458 of the Laws of Malta)
is another piece of relevant legislation which regulates medicinal
products as a whole as it transposes Directive 2001/83/EC as

In order to be permitted at law to carry out the activities or
any preparation thereof set out in the PCMRP Act, the applicant
shall first apply to obtain a letter of intent from Malta
Enterprise who is responsible with ensuring that the intended use
of the proposed activity is solely for medicinal and research
purposes. Moreover, prior to carrying out activities or preparation
thereof, the applicant shall acquire a licence from the Medicines
Authority. This is done by filing an application with the Medicines
Authority together with any other documentation it requires as set
out by the PCMRP Act. Mainly relating to the production and quality
control, applicants seeking to manufacture cannabis shall also
satisfy the Good Manufacturing Practices requirements.
Consequently, successful applicants who abide by the PCMRP Act
shall be exempt from the provisions of the drug laws in relation to

Recreational Cannabis

Despite the fully-fledged developments in Malta with regard to
medical cannabis, the recreational use of cannabis is to date
illegal as per the Dangerous Drug Ordinance (Chapter 101 of the
Laws of Malta) (the “Ordinance“). Being
illegal in many countries around the world, the legalisation of
recreational cannabis has become a topic of broad interest.
However, given its current classification as a drug, it is a
controversial point of discussion as strong views exist, both
against and in favour of its legalisation.

In Malta, there are ongoing debates on the issue. Indeed,
several interested parties have contributed by highlighting the
positive and negative aspects tied with the legalisation of such.
The legalisation of recreational cannabis can create a legal
framework which ensures legal certainty and minimisation of abuses,
doing away with the perilous black market providing the substance.
This is because, the law can specifically set the parameters within
which the use of recreational cannabis is permitted, provide for
educational campaigns to ensure individuals make informed
decisions, and a strong enforcement procedure be imposed where the
law is breached. On the other hand, opponents of the legalisation
of recreational cannabis highlight the regulatory challenges which
may emerge.

Whilst not affecting the illegality of recreational cannabis,
the possession of small amounts of cannabis, being less than 3.5g,
for personal use was decriminalised in 2015 under the Drug
Dependence Act. Any person in possession of such an amount is tried
by the Commissioner of Justice, rather than the Criminal Court and
may only be subject to an administrative penalty of €50 to

Given that the use of cannabis for recreational purposes is
still illegal in Malta, any authorisation to produce cannabis
awarded by the Medicines Authority is strictly limited to the
cultivation and manufacturing of cannabis for medicinal and
research purposes. The Ordinance specifically prohibits the
cultivation, production and supply of cannabis for any other
purpose. Notwithstanding, the law provides for a lighter punishment
with respect to the cultivation of plants for personal use.

Maltese Market Projections

Having attracted investments from around the globe, the cannabis
market in Europe has made big leaps. With the increased demand for
the supply of cannabis, more and more companies are seeking to
establish a European base for the production and distribution of
cannabis. In turn, Malta poses to be a favourable opportunity due
to the comprehensive laws introduced in the recent years.

Being home to well-established and reputable pharmaceutical
activities, Malta offers resources and proficiency which can be
easily utilised for the production of cannabis for both medicinal
and research purposes. This goes hand in hand with Malta’s
willingness and determination to place itself at the heart of the
growing industry.

Originally published by DF Advocates, August 2020

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.


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