🇵🇹 Portugal Overview
Portugal has become one of the most important medical cannabis producers for European and international markets, as the country has developed a business-friendly regulatory framework for commercial production and export.
Although the country’s domestic medical cannabis production for export has been skyrocketing over the past five years, access to medical cannabis treatment is significantly restricted. The restrictive product approval process, the lack of cannabis education and infrastructure in the medical community, high product prices, no public reimbursement schemes and the strict requirements towards its prescription have all contributed to bottlenecks in patient access and domestic market growth.
Portugal is the largest European exporter of medical cannabis, with the country establishing more production facilities yearly and exporting over 18 tonnes of medical cannabis in 2024 to countries including: Germany, Poland, Spain, Australia and Malta.
🇵🇹 Regulations
Portugal first established a medical cannabis framework in 2018, through Law No. 33/2018, of 18 July, which legislated the regulations on the use of medicinal products, preparations and substances from cannabis plants for medical purposes. This was followed up in 2019 through Decree-Law No. 8/2019 of 15 January, which established the legal framework for medical cannabis and its market authorisation procedure, specifically in terms of its prescription and dispensation.
Medical cannabis products, which are not pharmaceutical-based i.e., Sativex and Epidyolex, have to receive a market placing authorisation (ACM) before they can be prescribed to patients in Portugal. Receiving an ACM for a medical cannabis product is a bureaucratic, costly, and long process which has hindered many companies actually undergoing the procedure. Companies undergoing an ACM for their product need to provide evidence of good agricultural and collection practices (GACP) & good manufacturing practice (GMP) compliance, proof of compliance towards local laws on cultivation and/or manufacturing, copy of a manufacturing licence, and provide dossiers ensuring the quality of the product according to European Medicine Agency standards.
The pricing framework for medical cannabis products was set out in Ministerial Order No. 44-A/2019, of 31 January, in which authorised product suppliers have to provide a price for their product to Portugal’s National Authority of Medicines and Health Products (INFARMED) regarding international market prices of the same or a similar product. INFARMED has the authority to approve or disapprove.
Along with authorising product approvals, INFARMED inspects and issues licences to companies involved in the country’s medical cannabis supply chain. The establishment of Portugal’s commercial supply chain is regulated under the Ministerial Order 83/2021. This defines the requirements and procedures related to the cultivation, manufacture, wholesale trade, transport, circulation, import, and export of medical cannabis.
🇵🇹 Patient Access
Who Can Prescribe?
In Portugal, any doctor can prescribe medical cannabis, but only for specific conditions and as a last resort, in cases where conventional therapies have been proven to be ineffective or have resulted in unwanted side effects.
However, it must be noted that due to the lack of sufficient education/training regarding medical cannabis and the endocannabinoid system, only a few doctors are willing to prescribe medical cannabis in the country.
What are the treatable pathologies?
The pathologies in which medical cannabis has been approved as an appropriate treatment in Portugal are:
- Spasticity associated with multiple sclerosis or spinal cord injuries
- Nausea from chemotherapy, radiotherapy, HIV treatment, and hepatitis C treatment
- Appetite stimulation for palliative care patients undergoing cancer or AIDS treatment
- Chronic pain
- Tourette's syndrome
- Epilepsy disorders
- Therapy-resistant glaucoma
Reimbursement
Currently, there is no reimbursement for medical cannabis in Portugal; patients have to pay for their treatment out-of-pocket.
Prescriptions
From 2021 to 2023 the number of annual medical cannabis prescriptions in Portugal rose from 460 to 1,157. However, the latest figures published by INFARMED show that up to Q3 2024, only 757 medical cannabis prescriptions were issued in Portugal; this represents a quarterly average of 252 prescriptions. Although Q4 numbers still remain to be published, if this quarterly rate continues, 2024 prescription numbers would fall short when compared to 2023. The lack of prescriptions in Portugal compared to other established medical cannabis markets is due to: the lack of doctors educated on and willing to prescribe medical cannabis, the bureaucracy involved with a special medical cannabis prescription, the smaller population size of Portugal and the small list of approved conditions in which medical cannabis can be prescribed.
🇵🇹 Products & Prices
The lack of available products on the Portuguese market is driven by the bureaucratic ACM process as well as the fact that there is low demand due to the low levels of medical cannabis prescriptions. Companies in Portugal are more invested in producing products for export.
There are currently only six medical cannabis extract products available in Portugal. Prices for medical cannabis extracts range from €64.50 to €193.4 per packaged product. FAI Therapeutics produces three extract products, while Tilray and Portocanna each produce one.
There are only two available flower products on the market, one produced by Tilray and the other produced by Portocanna. Portocanna’s Hexacan flower is available in 10-gram packages, while Tilray’s THC 18 flower is available in 15-gram packages. Although the Hexacan flower product holds a higher THC ratio of 22% compared to Tilray’s 18% THC flower, Tilray’s product is more expensive on a price-per-gram basis.
🇵🇹 Imports & Exports
Portugal has become a significant exporter of medical cannabis for Europe and international markets as the country has seen exports increase year-over-year, with over 50 companies authorised to export medical cannabis substances and preparations. In the first three quarters of 2024, Portugal exported over 18 tonnes of medical cannabis, witnessing an increase of 54% compared to 2023, with 11,973 kilograms exported.
Germany is by far the largest importer of Portuguese medical cannabis, contributing roughly 46% of total exports, followed by Spain (20%), Poland (16%), the UK (10%), and Australia (5%). Some companies in the country also package and re-export medical cannabis imports, and since Portuguese authorities do not provide import figures, it is not clear what proportion of total exports this activity represents.
🇵🇹 Domestic Production
The significant number of cannabis producers in Portugal is driven by:low production costs, a relatively open commercial framework, an educated agricultural workforce, and ideal climate conditions for cannabis cultivation.