Issue link: https://maltatoday.uberflip.com/i/1214775
10 maltatoday | WEDNESDAY • 26 FEBRUARY 2020 OPINION ONE cannot separate canna- bis from its long history as an illegal substance which is heav- ily abused. Stigmatization is a strong deterrent for many healthcare providers and un- certainty will only hinder the flourishing of the use of canna- bis. The perception of the pub- lic needs to be updated, with the introduction of more infor- mation and following frank dis- cussions about cannabis, many would benefit. It is advisable for the state to provide contin- uous educational programmes for doctors and pharmacists in order to popularize its use. Given the ever expanding medicinal capabilities present today, Malta has followed pio- neering countries such as Can- ada, and in March of 2018 has officially legalized medicinal cannabis. The Maltese govern- ment has adopted the 'Produc- tion of Cannabis for Medicinal Use Act 2018'; an all-encom- passing Act regulating which entities are eligible to distribute and grow the plant, the process through which interested par- ties 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 un- less and until an acknowledged license has been obtained. To obtain the aforementioned li- cense, 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 dil- igence documentation and relevant authorizations from other entities. What are the requisites for a license. The ap- plicant must be in possession of the relevant qualifications in line with the Mutual Rec- ognition Qualification Act and any other additional request from the Authority or Malta Enterprise. There must be con- formity with any relevant in- ternational obligations result- ing from any treaty that Malta may be a party to and that pro- duction of medicinal products corresponds to the criteria in the Medicines Act. A fee of €35,000 has been attached to the application and an equiva- lent annual fee has to be paid. Furthermore, entities are re- quired to pay €1/unit product transacted, in fulfillment 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 mate- rial illegality; including both unreasonableness and lack of proportionality. Grounds of appeal are similar to those per- tinent to Article 469A of the Code of Organisation and Civil Procedure, leading to Judicial Review. The prescription of medicinal cannabis is possible through any Maltese doctor registered with Malta's Medical Council, however, medicinal cannabis may not be used as a first-line treatment, and doctors ought to approve it only if other al- ternatives were tried and failed prior to prescribing cannabis. Upon adherence, the patient may then request for a Drug Control Card; issued by Mal- ta's Superintendent of Public Health. This card coupled with an authentic prescription will enable patients to purchase non-smokable forms of med- ical cannabis directly from pharmacies. This nascent concept does not only provide new found relief to people afflicted by cer- tain illnesses, but also intro- duces a vast array of economic opportunities. Cultivation of cannabis opens job opportu- nities necessary to ensure a smooth process and there are obvious economic advantag- es for our export sector which given time, will generate rev- enue. There is a problem with the introduction of this sub- stance for local consumption due to the serious lack of infor- mation on medicinal cannabis; patients have commented that some medical practitioners are reluctant to allocate marijuana as a form of treatment. More- over, a simple consultation may cost a patient a charge of €50. In addition to this, are the hefty prices of the medica- tion, patients have shown their dismay after discovering that some products cost as much as €17 a gram, giving rise to a number of financial concerns as people suffering from these infirmities have limited work- ing capabilities and hence a re- stricted budget. In addition, so far, medicinal cannabis is not offered by the state at a subsi- dized price. Similar to the medicine con- tinuum, 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 spec- trum. CBD oil is cropping up in an increasing number of high- end creams, oils and even mas- caras. There is a difference be- tween hemp-derived and can- nabis-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 cannabis infused products may suffer some form of scrutiny owing to the presence of addictive THC substance, yet hemp infused products are completely legal given that their THC level is negligible. Last year, the medical canna- bis business in Malta has en- joyed a strong start and hit the mark right off the bat. Since the inauguration of this new sector, more than 46 interna- tional 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 Canna- bis law, entities in Malta are al- lowed to produce, process, im- port, and cultivate cannabis for purposes of research and med- icine. However, they can only do so after being granted all the necessary authorizations, ap- proval, 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 invest- ment of €153 million. Thanks to aggressive promotion by way of government sponsored conferences 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 increased investment flow- ing into Malta, it emphasizes the vigorous verification pro- cess which was being adopted across the evaluation of the in- coming propositions for licens- ing. 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 ap- plications which met our crite- ria and shared our vision were eventually approved. In the process, one notes that Malta Enterprise is said to have re- fused 19 proposals at the least. Some of the most notable en- tities in this industry are MGC Pharma, Columbia Care, Alvit Les Pharma, Aurora, Way- land, Affinity, Aphria, MPXI Malta, Bortex Group, Panax- ia, 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 secure profiles. The approv- al test is rigorous and starts with a demanding selection process which filters the best of the best entities and allows Malta to enjoy and boast an elite group of licensed medi- cal cannabis providers. Malta opens its doors only to those providers who qualify under the rigorous test to produce a genuine product and which will not tarnish Malta's rep- utation. The applications so far approved would create 700 new full-time jobs and supple- ment 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 significant player which em- ploys more than 3,000 people making up almost 15% of all people in the manufacturing sector in Malta. Given the ever expanding medicinal capabilities present today, Malta has followed pioneering countries such as Canada, and in March of 2018 has off icially legalized medicinal cannabis Jurgen Dalli Malta's trajectory to Medicinal Cannabis Jurgen Dalli is a legal analyst at PKF