HEMP flower for sale in Malta
HEMP flower for sale in Malta
Whilst cannabis for recreational use remains an arrestable offence in Malta, the country has
followed in the footsteps of Canada, Australia, and the Czech Republic by approving the use
and possession of medical cannabis with a prescription.
In March 2018, the President of Malta signed into law, legislation that governed the use of
medical marijuana, and it is now taking aggressive steps towards making the cultivation of such
products a new, local industry. In addition to this, it appears that suitably qualified entities will be
authorised to conduct research into the use and benefits of cannabis as a medical product.
The “Production of Cannabis for Medicinal Use Act, 2018’ provides all of the legal guidelines for
those that wish to produce cannabis for medicinal use and it describes the process that needs
to be followed in order to apply.
Can anyone grow cannabis in Malta?
The answer to this is a most definitely no, and the Act makes it clear that “no production of any
products intended for medicinal use deriving from or resulting from the use of cannabis as
defined in this Act and no trade in cannabis and, or any preparations intended for medicinal use
as deriving from cannabis shall be carried out in Malta prior to obtaining all necessary
approvals, authorisations, licences and, or permits as required by or under all applicable laws
including this Act and any regulations made thereunder.”
Anyone that wants to grow, harvest, sell, or do anything else with marijuana for medical
purposes, must apply for the applicable legal authorisation to do so, as per the terms of the Act.
Any form of cannabis that is grown or used for recreational purposes remains completely illegal
under any circumstances.
What steps need to be taken to apply for authorisation?
In order to apply for the necessary permissions and licenses to cultivate medical marijuana, the
entity must follow a number of steps. Firstly, they must obtain a letter of intent from Malta
Enterprise after making an application with them directly. Then they must ensure that they are in
full compliance with both the provisions of the Act, as well as international obligations resulting
from any treaty that Malta may from time to time be party to. They must also show compliance
will all regulations relating to the production of medical products, as laid out in the Medicines
Act. At this point, they are able to apply for a license with the regulatory authority and must then
wait to see if their application is approved or declined.
How can this new industry benefit Malta?
There are several ways in which the cultivation of medical cannabis can potentially benefit the
Maltese economy. Firstly, those entities that apply for permission to grow and/or process the
product will need to employ significant numbers of staff to help them do so. Secondly, the export
and taxes on such products are expected to bring a substantial amount of revenue to the local
market. If the industry’s regulations are enforced correctly and standards are maintained, Malta
could seek to benefit from this potentially lucrative industry.
In the next article we will take a more in-depth look at the licensing process as well as the
requirements and standards that entities wishing to engage in the industry are expected to
In March 2018, Malta officially legalised medical cannabis, in a move which Parliamentary
Secretary Dr Deo Debattista tweeted ‘once again places our citizens’ health and dignity top of
the agenda’. The Production of Cannabis for Medicinal and Research Purposes Act followed a
month later, allowing entities to cultivate, import, process and produce cannabis intended for
medical and research purposes under a controlled and supervised environment – provided they
comply with all necessary regulations.
It was appropriate, then, that Malta should play host in November to the Medical Cannabis
World Forum, which brought together the policymakers, business leaders and healthcare
practitioners who are shaping the global cannabis industry today.
The two-day conference proved an invaluable opportunity for Malta to set out its ambition to
become the medical cannabis capital of Europe. Prime Minister Joseph Muscat explained why
its medical cannabis legislation is a good example of Maltese innovation, while Malta Enterprise
CEO Mario Galea promoted the island as an attractive business location for operators involved
in cannabis research and production.
Debattista, who, as Parliamentary Secretary for Consumer Protection and Valletta 2018, is
responsible for the Malta Medicines Authority, was also present at the event, where he delivered
an interesting presentation on the medical cannabis landscape in Malta today.
Malta’s journey with medical cannabis
He began by praising the steps Malta has taken to set itself apart in the medical cannabis
space: “One would think that a small country like Malta would follow suit; instead, Malta is a
dynamic … leader. The legislative measures enacted with respect to medicinal cannabis are not
some transposition of provisions implemented everywhere else. Many in the field are cognisant
that Malta has floodlit an area which may still be quite hazy elsewhere.”
Debattista acknowledged that the Malta Medicines Authority has attracted an impressive
international reputation for its “patient-centric work in the regulation of medicines – be it
assessments, inspections, pharmacovigilance, or other advanced scientific contributions”, and
set out to reassure his audience that the regulation of cannabis for medicinal and research
purposes would do nothing to risk this.
“Communication and co-operation are key,” he said. That’s why Malta “embarked on this
initiative in strong liaison with the Superintendence of Public Health, Malta Enterprise and
University of Malta, while reaching out to our counterparts far and beyond. I have accompanied
a number of delegations from the Medicines Authority myself in visiting medicinal cannabis
procedures, analytical laboratories, dispensing pharmacies, and regulatory agencies to develop
competence and explore potential areas of collaboration.”
Quality, front and centre
Debattista was also keen to assure his audience that the quality and safety of the medical
cannabis being produced in Malta is front and centre of the work the Medicines Authority is
He said: “The Medicines Authority has invested in capacity building, engaging pertinent experts
and establishing the means to review submissions for the introduction of medicinal cannabis
preparations in Malta.
“The former deputy director at the US Office of National Drug Control Policy under George W
Bush, Dr Andrea Barthwell, in a 2005 statement referring to cannabis remarked [that] it is not a
medicine – you don’t know what’s in it.
“Quality of medicinal cannabis preparations is in effect the preliminary concern we wanted to
The Medicines Authority is therefore concentrating not on putting tight restrictions on the
percentages of, for example, CBD or THC included in medical cannabis products – “because
the applicable concentrations for specific patient populations are not for us to define,” Debattista
explained – but on ensuring that the labelling is “true to the contents and backed by analytical
results, specifications and standards”.
Leaving nothing to chance, Debattista added: “We are also well aware of the potential for
contamination, which is not an imaginary scenario. Growers within the EU itself have been
halted because of contaminated produce, an issue which may be detrimental to particularly
vulnerable individuals, as is the case for immunocompromised patients.”
Like most endeavours, Debattista went on, comparing the regulation of cannabis for medicinal
and research purposes to that implemented for the pharmaceutical industry and controlled
medicine, the process is expected to encounter setbacks and failures, which will prove valuable
opportunities from which to learn.
In fact, this learning opportunity has already begun: “The first GMP-certified medicinal cannabis
products were launched in Malta a few months following the legislative amendments. The
measures of traceability and reporting structures with respect to local patients being prescribed
medicinal cannabis present a unique opportunity for data collection as a preliminary cohort to
the anticipated scientific and clinical studies in the field.”
Indeed, the Medicines Authority has put medical cannabis at the top of its research agenda,
collaborating with the University of Malta to support advanced research and innovative projects
in the field.
“This prospect of extending such collaborations to involve the sharing of knowledge and
resources that shall complement established organisations intending to make Malta the
European hub is highly regarded,” Debattista said.
On top of its research activities, he added, the Medicines Authority also “offers scientific
consultations, technical guidance, EU GMP inspections for local and international facilities,
timely review of applications and whatnot”.
Putting patients first
Above all else, Debattista continued, patients will be vital to securing the future of Malta as a
centre of excellence for medical cannabis. This motivation is especially close to his heart and
guides his actions as both a doctor and politician, he said.
“As a medical doctor, I follow with compassion and concern the emerging evidence and also
some conflicting debates on the clinical applications of cannabis for medicinal use. As a
politician, I work to ensure that whatever the pros and cons, the certainties and the doubts, the
facts and the myths, it shall not be deferred decisions, bureaucracy, or lack of robust regulatory
infrastructure [that] delays research, development and practice in the field.
“I believe that the framework we have set and is enrolling in real time regulates activities,
facilitates investigations, and enables progress to deliver authentic outcomes to our patients.”
The future for medical cannabis in Malta
Debattista rounded out his presentation by emphasising the importance of an event like the
Medical Cannabis World Forum as an opportunity to exchange views, share experiences and
drive progress on medical cannabis – an area in which Malta will no doubt continue to lead the