Malta medical cannabis rules will allow clinical trials for products

Malta is set to pass legislation allowing for the production of medicinal cannabis, but in addition to allowing the manufacture of finished products, the legal changes lined up will also be allowing licensed companies to carry out research, including clinical trials.

After easing drug laws in 2015, the Government this year made it easier for patients to access medicinal 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 making moves to attract medicinal cannabis companies, the legislative framework envisioned will put Malta at an advantage when compared to other jurisdictions, according to Antonio Costanzo, the head of international development at Nuuvera, a medicinal cannabis producer which recently acquired ASG Pharma, a local pharmaceutical 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,” Costanzo told MaltaToday.

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

Globally, Israel is the world leader in cannabis research, having identified the main active compound back in the 60s. The country has over a 100 active ongoing clinical trials and is also one of just three countries worldwide that have a government-supported research 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 clinical trials, a fact that complicates research, and the development of new products.

“The difference here, as I understand 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 acquired ASG Pharma, Nuuvera was now waiting to apply for a licence once parliament approved the law.

“We would like to be able to import, extract, produce and export,” he said, adding that it would eventually be looking to scale up the facility. “The only thing we don’t plan on doing in Malta is cultivation.”

The range of products the company was looking to produce, Costanzo said, was dependent on legislation passed in different potential European markets. He said the company was in the process of applying for an importation licence in Germany and has also purchased an Italian company owning an importation licence.

“There are countries like Holland, Poland, Greece, Portugal, Spain that are revising their regulations, so we expect a significant opportunity in Europe in the coming 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 community.

“Absolutely. We want to guarantee access to the highest possible quality GMP standard products to patients in Malta,” he said. “We don’t yet have details on the Maltese regulations, but we understand 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, Costanzo 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.”