Lifeblood and Med-Tech World Summit forge partnership to connect MedTech visionaries
Article written by Chiara Xuereb
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 ruderalis, 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.
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 amended.
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 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 €100.
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.
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.