Issue link: https://maltatoday.uberflip.com/i/1215405
27.02.2020 12 OPINION Jurgen Dalli Malta's trajectory to medicinal cannabis Jurgen Dalli is a legal analyst at PKF O ne cannot separate cannabis from its long history as an ille- gal substance which is heavily abused. Stigmatisation is a strong deter- rent for many healthcare providers and uncertainty will only hinder the flourish- ing of the use of cannabis. e perception of the public needs to be updated - with the introduction of more information and following frank discussions about cannabis, many would benefit. It is advis- able for the state to provide continuous educational programmes for doctors and pharmacists in order to popularize its use. Given the ever expanding medicinal capabilities present today, Malta has followed pioneering countries such as Canada, and in March of 2018 has offi- cially legalized medicinal cannabis. e 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 pro- cess through which interested parties have to go through to be able to distrib- ute cannabis and the manner in which medical practitioners are to prescribe cannabis to their patients. is legislation does not authorise the production of cannabis unless and until an acknowledged license has been ob- tained. To obtain the aforementioned license, entities are required to obtain a letter of intent from Malta Enterprise. In order to apply for the letter of intent, the applicant must submit all required documents, due diligence documenta- tion and relevant authorisations from other entities. What are the requisites for a license? e 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. ere must be conformity with any rel- evant international obligations result- ing from any treaty that Malta may be a party to and that production of medici- nal products corresponds to the criteria in the Medicines Act. 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 ful- fillment of research and education to be undertaken by the Medicines Authority. Refused applicants can appeal with the Licensing Appeals Board given; factual errors, material procedural errors, and errors of law and material illegality; in- cluding 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 Re- view. e prescription of medicinal can- nabis is possible through any Maltese doctor registered with Malta's Medical Council, however, medicinal cannabis may not be used as a first-line treat- ment, and doctors ought to approve it only if other alternatives were tried and failed prior to prescribing cannabis. Upon adherence, the patient may then request for a Drug Control Card; issued by Malta's Superintendent of Public Health. is card coupled with an au- thentic prescription will enable patients to purchase non-smokable forms of medical cannabis directly from phar- macies. is nascent concept does not only provide new found relief to people af- flicted by certain illnesses, but also introduces a vast array of economic opportunities. Cultivation of cannabis opens job opportunities necessary to ensure a smooth process and there are obvious economic advantages for our export sector, which, given time, will generate revenue. ere is a problem with the intro- duction of this substance for local con- sumption due to the serious lack of information on medicinal cannabis; pa- tients have commented that some med- ical practitioners are reluctant to allo- cate marijuana as a form of treatment. Moreover, a simple consultation may cost a patient a charge of €50. In addi- tion to this, are the hefty prices of the medication, patients have shown their dismay after discovering that some products cost as much as €17 a gram, giving rise to a number of financial con- cerns as people suffering from these in- firmities have limited working capabil- ities and hence a restricted budget. In addition, so far, medicinal cannabis is not offered by the state at a subsidized price. Similar to the medicine continuum, the beauty industry has jumped on the bandwagon. At the moment; CBD oil, is one of the most buzzed words one will find in the beauty spectrum. CBD oil is cropping up in an increasing num- ber of high-end creams, oils and even mascaras. ere is a difference between hemp-derived and cannabis-derived ingredients (as the latter may contain traces of THC oils). Hemp oils are pressed from the seed of the plant, whilst cannabis derived ingredients come from the plant itself. Whilst can- nabis infused products may suffer some form of scrutiny owing to the presence of addictive THC substance, hemp in- fused products are completely legal giv- en that their THC level is negligible. Last year, the medical cannabis busi- ness in Malta enjoyed a strong start and hit the mark right off the bat. Since the inauguration of this new sector, more than 46 international entities have ap- plied to start investing in the sector, exporting to their subsidiaries and oth- er subsidiaries all over Europe and the world, such as, Canada. Under the new cannabis law, the 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 authorisations, approval, permits, and licenses by the Medicines Authority. By November 2019, more than 26 projects had been approved in the field of medical cannabis, accumu- lating a capital investment of €153 mil- lion. anks to aggressive promotion by way of government sponsored confer- ences the country has progressed in the area within a short period of one year after the law was introduced. Whilst government is satisfied about the in- creased investment flowing into Malta, it emphasizes the vigorous verification process which was being adopted across the evaluation of the incoming propo- sitions for licensing. All the applica- tions which were submitted, have gone through a minute evaluation process and a very thorough due diligence exer- cise, in order to ensure that only those applications which met our criteria and shared our vision were eventually ap- proved. In the process, one notes that Malta Enterprise is said to have refused 19 proposals at the least. Some of the most notable entities in this industry are MGC Pharma, Co- lumbia Care, Alvit Les Pharma, Aurora, Wayland, Affinity, Aphria, MPXI Malta, Bortex Group, Panaxia, Supreme and Nuuvera or ASG Pharma. All these en- tities 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 se- cure profiles. e approval test is rigorous and starts with a demanding selection pro- cess which filters the best of the best entities and allows Malta to enjoy and boast an elite group of licensed med- ical cannabis providers. Malta opens its doors only to those providers who qualify under the rigorous test to pro- duce a genuine product and which will not tarnish Malta's reputation. e ap- plications so far approved would create 700 new full-time jobs and supplement Malta's exports by over €900 million by 2023. Matthew Lawson, founder of the Canna Consultants explained that the pharmacy industry in Malta is a signif- icant player which employs more than 3,000 people making up almost 15% of all people in the manufacturing sector in Malta.