🇲🇹 Malta Overview
In 2018, Malta set up a regulatory framework allowing for medical cannabis treatment of patients in Malta, as well as for the cultivation and manufacture of medical cannabis for commercial purposes.
The number of medical cannabis patients relative to the overall population in Malta is high in a European context, despite the regulations around patient access being reasonably restrictive.
The domestic production industry for medical cannabis did not take off in the way that regulators had hoped when the sector was created in 2018, and though there is some industrial activity in medical cannabis which happens in the country, it is relatively limited.
The market is supplied by both imports and domestic production, with a significant amount of medical cannabis flower imported from Canada.
🇲🇹 Regulations
Malta legalised the production of medical cannabis in 2018 through the adoption of the Cannabis for Medicinal and Research Purposes Act, and simultaneously legalised the prescription of medical cannabis through Act No. V of 2018 – Drug Dependence (Treatment not Imprisonment) (Amendment).
The Malta Medicines Authority is responsible for the licensing of medical cannabis production and distribution activities. In order to operate commercially, the company must get the following granted or approved – a Letter of Intent (LOI), the Licence for the Production of Cannabis for Medicinal and Research Purposes, an EU-Good Manufacturing Practice (GMP) certificate (as applicable) and a Facility Security Clearance Certificate.
Regulations for the exportation of medical cannabis produced in Malta are focused primarily on finished products. The exportation of intermediate products is also possible, but subject to additional conditions and approvals.
Firms producing medical cannabis in Malta are subject to annual fees of approximately €70,000, with an initial licensing fee of €10,000.
🇲🇹 Patient Access
Who Can Prescribe?
Medical cannabis can be prescribed by any doctor in Malta if it is considered that there is no viable alternative after all other treatment options have been tried.
What are the treatable pathologies?
The pathologies for which medical cannabis has been approved as an appropriate treatment in Malta are:
- Multiple sclerosis
- Chronic pain
- Chemotherapy side effects
- ‘Debilitating conditions’ - generally used for chronic rather than acute conditions
Reimbursement
Medical cannabis treatment is generally non-reimbursable. There is an exception for inpatients in hospitals, and for 3 days after a patient is discharged. Low-income patients and/or those with chronic illnesses may also be entitled to free prescriptions.
🇲🇹 Products & Prices
The majority of products available to Maltese patients are high THC flower, with only one high CBD flower available, and no balanced flower.
Oil products are more varied in their cannabinoid content; however, with only nine such products available, product choice is relatively limited for patients and doctors.