Portugal decriminalized cannabis use two decades ago, aiming to provide treatment options in place of punishment. Authorization for cannabis cultivation arrived in 2018 and thrived, as the country's climate and low costs lend themselves well to inexpensive production as well as trade in the region, but this did not create a supply source for domestic patients. Instead, it attracted investment from foreign entities such as Canadian Licensed Producers (LPs) aiming to cultivate cannabis for export throughout Europe.

In 2018, a domestic medicinal cannabis market was finally formally legalized, and in 2019, the National Authority of Medicines and Health Products (INFARMED) declared it would be licensing the cultivation, production and trade of medicinal cannabis (including hemp-derived CBD, if sold within Portugal's borders).

Though legalization occurred roughly two years ago, Sativex is the only medical cannabis product available for purchase by Portuguese patients (and the market for the product is negligible). This is largely because the various companies that have applied for and received cultivation licenses have done so with the aim of exporting product to large European medical cannabis markets like Germany’s rather than supplying the smaller and less developed domestic market.

As the Portuguese population is declining, disposable income is relatively low, and insurance reimbursement for medicinal cannabis is limited, only modest patient growth and spending is expected over the forecast period, especially with various limiting factors being exacerbated by the pandemic. Despite this, the market is expected to continue growing (albeit slowly), with prospects improving as the economy recovers from COVID-19 and a greater variety of less expensive products are made available to consumers.

Portugal decriminalized the consumption and possession of all drugs, cannabis included, for personal use in July 2001, intending to focus on treatment of addiction rather than punishment. However, this change did not establish a legal framework for the sale of cannabis, which was still considered trafficking.

Many years later, in 2018, Portugal’s Parliament passed a law to open the country's domestic market by legalizing doctor-prescribed medicinal cannabis. It tasked INFARMED, the National Authority of Medicines and Health Products, with developing medical cannabis regulations and product licensing standards. A decree formally defined these regulations and standards in early 2019, with INFARMED in charge of licensing the cultivation, production, wholesale trade, import, and export of medicines and substances containing cannabis.

Unfortunately, this decree created chaos among hemp growers due to the conflicts between formal hemp and medical-grade cannabis licensing policies. As the law did not differentiate clearly between the two, jurisdictional conflict between agencies over licensing created confusion among growers and caused hemp cultivation to come nearly to a halt during the 2019 cultivation season. Since that time, it has been clarified that the Government Food and Veterinary General Directorate (DGAV) - which originally licensed hemp farmers and processors - continues to have jurisdiction in that realm, though companies wishing to sell product into the Portuguese medical market, including hemp-derived CBD, must seek authorization from INFARMED. CBD products may not legally be purchased over-the-counter in the country, still requiring a doctor's prescription as is the case for all cannabis products sold domestically.

While cannabis cultivation has positioned Portugal to become a cultivation hub for cannabis in Europe, largely due to the country’s favorable climate and lower labor costs, domestically-grown product has yet to be made legally available to consumers in Portugal with product instead being largely destined for export.

The Portuguese approval system for cannabis medicines requires that any cannabis preparation to be sold obtain an Authorization for Placement on the Market (ACM). This is a simplified version of the ‘typical’ Portuguese registration process for pharmaceutical medicines (the Authorization for the Introduction on the Market (AIM)) – with reduced registration requirements including no need to demonstrate clinical efficacy – though the process is nonetheless complex and slow-moving. Further medical market regulations have been defined since the initial decree. Among them:

• Patients are not allowed to cultivate cannabis for personal use.
• Only medicinal cannabis products purchased through pharmacies are considered legal.
• Pharmacies may only distribute said products after discussing their correct use with each patient.

Currently, this legislation applies to newly-legalized cannabis products. That said, Sativex is the only medicinal product that is available through pharmacies today. It is primarily prescribed to patients with spasms associated with multiple sclerosis, but can be authorized for patients with: spinal cord injuries, nausea or vomiting resulting from chemotherapy or radiotherapy, HIV and hepatitis C, Tourette’s syndrome, glaucoma, chronic pain, severe childhood epilepsy, and loss of appetite in palliative care patients.

Initially, Portugal intended for the Military Laboratory of Chemical and Pharmaceutical products (LMPQ) to be the sole manufacturer of cannabis-based medicines in the country. However, in early 2019 INFARMED began to grant additional licenses to external bodies for cultivation, manufacturing, wholesale trade, import, export, and transit of specific substances. As legislation has developed in Portugal, companies have continued to express interest in the country – primarily export opportunities, though licensing processes have been slow. As of late 2020, only nine companies are officially licensed to grow medical cannabis in Portugal, though INFARMED does not provide public information on license applicants.

Some of the larger firms known to be authorized or operating in Portugal include:

• Tilray Portugal, which has 24 hectares of outdoor growing space, one hectare of greenhouse, and 65,000 square feet of manufacturing, processing, and research space in Alentejo and Cantanhede. The company is aiming to complete construction on an additional 3.4 hectares of greenhouse in 2020 to help support production for export across Europe, though construction delays are anticipated due to COVID. To date, Tilray Portugal has completed the largest intra-European bulk shipment of $3.3 million worth of medical cannabis to Germany and entered into an agreement with Canndoc to export a wholesale shipment of up to 2.5 tons from Portugal to Israel.
• A Portuguese company called RPK Biopharma (owned by Holigen, which was acquired by Flowr, a Canadian licensed cannabis producer in August of 2019), has been approved to cultivate medicinal cannabis on a 650,000 square meter outdoor cultivation site, and has a 30,000 square meter indoor facility working its way through the construction planning procedure with local government. RPK has applied for a second licence in a new R&D and cultivation facility located near Lisbon.
• Canadian licensed producer Aurora Cannabis, which acquired a 51% stake in Gaia Pharm (renamed Aurora Portugal) based in Funchal. The company established a facility to cultivate and process medical grade cannabis and aimed to produce 2,000 kilograms by late 2020, and eventually ramp up to 4,000 kilograms. However, in July 2020 Aurora announced plans to shutter its offices in Portugal due to disappointing international sales.
• Sabores Purpura, authorized to produce cannabis in the country since January 2019, it is hoping to place oil and/or capsule products on the Portuguese market by 2021.
• Terra Verde, a Portuguese genetic and cultivation company owned by European medical cannabis and wellness company EMMAC Life Sciences.
• Clever Leaves Portugal, a New York-based vertically-integrated medical cannabis producer, provisionally licensed to cultivate, import and export GACP quality dried flower from its Portuguese cultivation site in late 2020.

Medical cannabis is theoretically available by prescription from a doctor in pharmacies nationwide., Cannabis may be prescribed as a last resort for seven approved indications:

• Spasticity associated with multiple sclerosis
• Nausea and vomiting caused by chemotherapy or radiotherapy
• Appetite stimulant for cancer or HIV patients in palliative care
• Chronic pain associated with oncologic disease or to the nervous system
• Tourette syndrome
• Refractory epilepsy in children
• Drug-resistant glaucoma

In practice, however, this is only if patients can find a doctor to write them a prescription. Most doctors remain unwilling to do so as there is still important stigma attached to cannabis - even that used for medicinal purposes - among Portuguese medical practitioners. Furthermore, no product beyond finished pharmaceutical Sativex has yet been authorized for sale on the market.

All medical cannabis-derived products must be approved by INFARMED before they can be sold. As such, today, GW Pharmaceuticals’ Sativex is the only cannabis-derived pharmaceutical drug that is formally available to patients. Dry flower and its extracts are also technically legal, though their sales have yet to commence in Portugal as of 2020 despite legalization having taken place in 2018. We will see more products become available - accompanied by a larger market - once medical prescriptions become more commonplace and further INFARMED authorizations are granted. The first round of non-pharmaceutical companies have been applying to have their products formally approved, largely favoring extracted products (oils and capsules) given the ease of assuring consistent dosage relative to flower. These newly authorized products are expected to reach Portuguese patients by 2021, thus the market is expected to diversify and broaden with regard to product type in the near term.