Author: Jurgen Dalli
Published on: 13/04/2020 on PKF Malta website
Cannabis has undergone a normalizing process given its wide adoption, social tolerance and generally speaking a broader cultural acceptance; going from being branded as a gateway drug to being used as a therapeutic alternative to conventional medicine. However, one ought not to forget that recreational use of cannabis is illegal, giving rise to several sanctions.
Therefore, normification is more appropriate than normalization, given the barriers cannabis still faces. Drug stores are now providing medicinal cannabis to aid ailments and infirmities, and although not curative, cannabis eases and alleviates the sufferings patients go through.
Given the ever-expanding medicinal capabilities present today, Malta has followed suit pioneering countries such as Canada, and in March of 2018 has officially legalized medicinal cannabis. The Maltese government has adopted the ‘Production of Cannabis for Medicinal Use Act 2018’; an all-encompassing Act regulating which entities are eligible to distribute and grow the plant, the process through which interested parties have to go through to be able to distribute cannabis and the manner in which medical practitioners are to prescribe cannabis to their patients.
This legislation does not authorize the production of cannabis unless and until an acknowledged licence has been obtained. This obviously does not permit the harvesting or selling of cannabis for recreational purposes, leaving such activities illicit and illegal. To obtain the aforementioned licence, entities are required to obtain a letter of intent from the Malta Enterprise. In order to apply for the letter of intent, the applicant must submit all required documents, due diligence documentation and relevant authorizations from other entities.
The applicant must be in possession of the relevant qualifications in line with the Mutual Recognition Qualification Act and any other additional request from the Authority or Malta Enterprise. There must be conformity with any relevant international obligations resulting from any treaty that Malta may be a party to and that production of medicinal products corresponds to the criteria in the Medicines Act.
Refused applicants can appeal with the Licensing Appeals Board given; factual errors, material procedural errors, and errors of law and material illegality; including both unreasonableness and lack of proportionality. Grounds of appeal are similar to those pertinent to Article 469A of the Code of Organisation and Civil Procedure, leading to Judicial Review.
A fee of €35,000 has been attached to the application and an equivalent annual fee has to be paid. Furthermore, entities are required to pay €1/unit product transacted, in fulfillment of research and education to be undertaken by the Medicines Authority.
The attainment of medicinal cannabis is possible through any Maltese doctor registered with Malta’s Medical Council and the acquisition of a prescription, however, medicinal cannabis may not be used as a first-line treatment, and doctors ought to prove that other alternatives were tried prior to prescribing cannabis. Upon adherence, the patient may then request a Drug Control Card; issued by Malta’s Superintendent of Public Health. This card coupled with an authentic prescription will enable patients to purchase non-smoke-able forms of medical cannabis directly from drug stores.
This nascent concept does not only provide new-found relief to people afflicted by illnesses but also introduces a vast array of economic opportunities. Cultivation of cannabis requires a sizeable quantity of staff to allow a smooth and pacey process and the local market would flourish with the creation of revenue from the exportation of cannabis.
The problem is the serious lack of information on medicinal cannabis; patients have commented on the lack of knowledge which is expected from medical practitioners, as some medical professions are reluctant to allocate marijuana as a form of treatment. Moreover, a simple consultation tantamount to an outstanding charge of €50. In relation to this are the hefty prices of the medication, patients have shown their dismay after discovering that some medication costs as much as €17 a gram, giving rise to a number of financial concerns as people suffering from these infirmities have limited working capabilities and hence a restricted budget. In addition, medicinal cannabis is not offered at a subsidized price.
One cannot separate cannabis from its long history as an illegal substance that is heavily abused. Stigmatization is a strong deterrent for many healthcare providers and uncertainty will only hinder the flourishing of the use of cannabis. The perception of the public needs to be updated, with the introduction of more information and frank discussions about cannabis, many would benefit. Continuous educational programmes for doctors and pharmacists are a must.
Similar to the medicine continuum, the beauty industry has jumped on the bandwagon. At the moment; CBD is one of the most buzzed words one will find in the beauty spectrum. CBD oil is cropping up in an increasing number of high-end creams, oils, and even mascaras. There is a difference between hemp-derived and cannabis-derived ingredients. Hemp oils are pressed from the seed of the plant, whilst cannabis-derived ingredients come from the plant itself. Whilst cannabis-infused products may suffer some form of scrutiny, hemp-infused products are completely legal given that their THC level is negligible.
The medical cannabis business in Malta has enjoyed a strong start and hit the mark right off the bat. Since the inauguration of this new sector in our economy, more than 46 international entities have applied to start investing in the sector, exporting to their subsidiaries and other subsidiaries all over Europe and the world such as Canada. Under the new Cannabis law, entities in Malta are allowed to produce, process, import, and cultivate cannabis for purposes of research and medicine.
However, they can only do so after being granted all the necessary authorizations, approval, permits, and licenses by the Medicines Authority. By November 2019, more than 26 projects had been approved in the field of medical cannabis, accumulating a capital investment of €153 million. This is a clear indication of just how the country has progressed in the area within a short period of one year after the law was introduced.
Some of the most notable entities in this industry are MGC Pharma, Columbia Care, Alvit Les Pharma, Aurora, Wayland, Affinity, Aphria, MPXI Malta, Bortex Group, Panaxia, Supreme and Nuuvera or ASG Pharma. All these entities undertook the tests imposed upon them by MSE and were issued with a letter of intent by the same regulatory body for their impressive effort and scores.
This rigorous and demanding selection process filters the best of the best entities and allows Malta to enjoy and boast an elite group of licensed medical cannabis providers whom share the vision set up by the Government. Malta opens its doors only to those providers who are not only serious but also to those who produce a genuine product and which will not tarnish Malta’s reputation. The applications were approved on the basis that they would create 700 new full-time jobs and supplement Malta’s exports by over €900,000,000 by 2022. Matthew Lawson, founder of the Canna Consultants explained that the pharmacy industry employs more than 3,000 people making up almost 15% of all people in the manufacturing sector in Malta.
Whilst Muscat boasted of the increased investment flowing into Malta, the PM emphasizes the vigorous verification process which was being adopted across the evaluation of the incoming propositions for collaboration. Muscat emphasized: “All the applications which were submitted, have gone through a minute evaluation process and a very thorough due diligence exercise, in order to ensure that only those applications which met our criteria and shared our vision were eventually approved.” This comes as a result of Muscat’s determination to attract the ‘right kind of business’. For this reason, the Malta Enterprise is said to have refused 19 proposals at the least.
Author: Jurgen Dalli
Published on: 13/04/2020 on PKF Malta website