Issue link: https://maltatoday.uberflip.com/i/949290
maltatoday SUNDAY 4 MARCH 2018 News 7 YANNICK PACE MALTA is set to pass legislation allowing for the production of me- dicinal cannabis, but in addition to allowing the manufacture of fin- ished products, the legal changes lined up will also be allowing li- censed companies to carry out re- search, including clinical trials. After easing drug laws in 2015, the Government this year made it easier for patients to access medic- inal cannabis, and has now moved to attract a growing medicinal cannabis industry to Malta – an industry estimated to be worth over $50 billion by 2025. While Malta is not alone in mak- ing moves to attract medicinal cannabis companies, the legisla- tive framework envisioned will put Malta at an advantage when com- pared to other jurisdictions, ac- cording to Antonio Costanzo, the head of international development at Nuuvera, a medicinal cannabis producer which recently acquired ASG Pharma, a local pharmaceuti- cal company. "Not all countries have done this, and we think that is a mistake because this is a product that we need to learn more about," Cos- tanzo told MaltaToday. Globally, Israel is the world lead- er in cannabis research, having identified the main active com- pound back in the 60s. The coun- try has over a 100 active ongoing clinical trials and is also one of just three countries worldwide that have a government-supported re- search programme, the other two countries being Canada and the Netherlands. "It has positive effects on people with specific conditions but there is more to learn. It has more than 100 active compounds and we are only familiar with two to four, and know practically nothing about the rest," explained Costanzo. He said that very few countries allowed for operators to run clini- cal trials, a fact that complicates research, and the development of new products. "The difference here, as I under- stand it, is that it will be part of the legislation," he continued. Costanzo explained that while it was often a challenge to "convince" governments to allow a certain type of research, in the absence of specific legislation, in Malta's case, it appeared the Government was willing to support such studies. Everything but cultivation Costanzo said that having ac- quired ASG Pharma, Nuuvera was now waiting to apply for a licence once parliament approved the law. "We would like to be able to im- port, extract, produce and export," he said, adding that it would even- tually be looking to scale up the facility. "The only thing we don't plan on doing in Malta is cultiva- tion." The range of products the com- pany was looking to produce, Costanzo said, was dependent on legislation passed in differ- ent potential European markets. He said the company was in the process of applying for an im- portation licence in Germany and has also purchased an Italian company owning an importation licence. "There are countries like Hol- land, Poland, Greece, Portugal, Spain that are revising their regu- lations, so we expect a significant opportunity in Europe in the com- ing months and years," Costanzo said. Asked whether the company intended to have its products on the local market, Costanzo said Nuuvera had decided that once it was going to set up in Malta, it also needed to serve the local com- munity. "Absolutely. We want to guaran- tee access to the highest possible quality GMP standard products to patients in Malta," he said. "We don't yet have details on the Mal- tese regulations, but we under- stand that the product will not be available for smoking for medical purposes, so oils will most likely be the main product." Up and running within a few months The company, he said, had been in contact with Malta Enterprise, and had explained the company's plans. At this stage, however, he said he couldn't say how long it would take for operations to start, given that the legislation had not yet passed through parliament, and so the licence applications had yet to be available. "At this stage it depends more on the authorities than us. We would be happy and ready to start very quickly," he said. "If they are fast introducing the licence it will be a matter of a few months." Once operations began, Cos- tanzo said Nuuvera would be able to trace its products from seed to patient. "From the moment it is planted till the moment it is at the patient, the company will know exactly where the product has been." Medical cannabis rules to allow clinical trials for products Antonio Costanzo is head of international development at Nuuvera "We would like to be able to import, extract, produce and export ... The only thing we don't plan on doing in Malta is cultivation"