Seeding the medical cannabis sector: on the challenges to a burgeoning industry

Rebecca Anastasi - 4th January 2020 


‘Proposals for local manufacture are evaluated in line with the national laws and international obligations, including comprehensive requirements related to GMP certification, responsible personnel, analytical consistency, security measures and reporting responsibilities.’

Much has been made in recent years of Malta’s buoyant economy, with many praising the island’s legislative environment for enabling the establishment and rise of the iGaming sector; the strengthening of the financial services industry; and the fomenting of a possible future in blockchain.

And, in the urge to keep the momentum moving, the authorities, last year, enacted the Production of Cannabis for Medicinal and Research Purposes Act, regulating – and allowing for – the production of medical cannabis, and opening the doors to further research in the area. The hope was – and remains – that the regulatory framework will attract foreign firms to establish roots on the island, employ local staff and push exports out to pump more revenue into the island.

Moreover, prior to this – also in 2018 and laying the groundwork for what was to come – the Drug Dependence Act (Treatment not Imprisonment) had been amended to allow doctors to prescribe medicinal preparations of cannabis to patients in Malta. Together, these legislative changes seem to be an attempt to further bolster the island’s economy.

Indeed, the Minister for the Economy, Investment and Small Business, Chris Cardona, has recently claimed that exports of medical cannabis “will reach €1 billion by the industry’s third year of local operations,” as reported on local media, while also asserting that it would only take three years for Malta to start shipping the products out of the island, with the Hal Far industrial estate set to serve as a hub for the sector.

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Moreover, within the health sector, Health Minister Chris Fearne has also praised recent developments, while also stating that over 400 patients are already using medical cannabis in Malta, though he did acknowledge that the industry still faces an uphill trajectory to fully realise its potential.

In addition, it seems that international players in the sector are also preparing to rally their forces: just this November, the second Medical Cannabis World Forum was organised, bringing together business leaders in the sector as well as policymakers for a three-day conference in Malta, while the first Malta Medical Cannabiz Summit – earlier in the same month – attracted around 1,500 attendees from all four corners of the globe.

The Malta Medicines Authority (MMA) has a central part to play in this. In conjunction with the Superintendence of Public Health, the entity regulates cannabis for medicinal and research purposes through the established Advanced Scientific Initiatives Directorate. And indeed, the legislation also authorises the MMA to review and monitor “relevant operations within premises” and decrees that it shall “have the right at all reasonable times to enter and inspect any premises.”

In comments to this publication, an MMA spokesperson underlined the prudent and thorough approach to be taken in the manufacture of such products, which will occur under Good Manufacturing Practice (GMP), among other provisions. “The requirements laid down in the guidelines issued by the Authority for this industry reflect the recognised pillars of good practices and quality standards. Proposals for local manufacture are evaluated in line with the national laws and international obligations, including comprehensive requirements related to GMP certification, responsible personnel, analytical consistency, security measures and reporting responsibilities.”

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This careful approach is being extended to the dispensation of medical cannabis products. Indeed, the spokesperson notes that while “four products of the required quality were introduced in local pharmacies and are used by a number of patients, medicinal cannabis should not be considered first-line therapy,” and “it is important to understand the precautions necessary to ensure patient health and safety.”

In this regard, the Authority also stresses that “as is standard good practice, it is wise for patients to consult their family doctor about their perceived needs for the use of cannabis products.” The regulatory function of the MMA within this sector has also pushed the Authority to recruit, the spokesperson goes on to explain, saying that the entity “has expanded human resources, invested in capacity building, and engaged experts to manage this dynamic field, marked by evolving policies and continuous change.”

Moreover, the MMA has increased its outreach to ensure that the correct information is distributed. “Guidance was issued to stakeholders and educational activities unfolded alongside the implementation of the regulatory framework,” the MMA says.

To this end, training initiatives have also been hosted through the MMA’s Academy. By way of example, the spokesperson cites a networking meeting – Implications of Cannabis for Medicinal Purposes: The Role of Cannabidiol in the Treatment of Neuropsychiatric Disorders – held this October; and a seminar – Regulatory Sciences, As Applied To Cannabis for Medicinal and Research Purpose – held earlier on, in May.

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Concurrently, Malta Enterprise – responsible for issuing letters of intent (LOIs) to firms wishing to invest in the sector in Malta – announced that 24 medical cannabis companies, out of 50 applicants, hold the required documentation, with six at an advanced stage. In response to questions asking for more details on the criteria of evaluation, Marion Zammit, the entity’s Head of the Medical Cannabis Cluster, says that “projects are evaluated using three main criteria: financial viability of the project; due diligence on the shareholders; and the provision of sectorial experiences incorporated in the shareholding structure.”

Indeed, she notes that the rejected projects were refused “on the basis of these three criteria.” Those which have been issued with an LOI originate from “all over the globe”, she underlines, specifying Canada, Israel, Europe and Australia as examples.

Some of these firms have been identified by local media and include Australian firm MGC Pharmaceuticals, which, it has been reported, will be investing €11 million to construct a ‘state-of-the-art’ medical cannabis facility in Hal Far; and Supreme Cannabis, a Canadian publicly traded company which aims to extend its portfolio to Malta.

Ms Zammit goes on to explain that Malta Enterprise is confident that the first licenses for such companies will be issued before the end of this year, with the exports kicking off “before end of the first quarter 2020”. Furthermore, the sector is expected to produce more than “950 full-time jobs” over a five-year period, she underlines.

The advantages for these firms seeking to operate from Malta are several, Ms Zammit states. They can benefit from the “existing expertise in pharma and a solid life sciences sector; an enabling and forward-looking regulatory framework; a robust and growing economy; a clear vision for the medical cannabis ecosystem; and a clear and transparent application process.” Yet, such firms still need to contend with hurdles which stand in their way.

This feature was initially carried in the December edition of the Commercial Courier.


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