The medical cannabis market in Poland is characterized by doctors reluctant to prescribe, unaffordable pricing, and limited product authorization. These factors contribute to a currently limited and constrained medical cannabis market. However, an estimated number of 300,000 to one million eligible patients alongside industry calls for regulatory improvements indicate the potential for a significant Polish medical cannabis market in the future.  

Poland legalized medical cannabis ‘under certain circumstances’ in June 2017, but the Polish Ministry of Health did not grant any foreign producer of medical cannabis permission to export to Poland until October 2018 (Spectrum Therapeutics, a subsidiary of Canada’s Canopy Growth Corporation), and with no domestic production authorized, the country’s first prescription was not issued until January 2019.  

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is responsible for regulating the medical cannabis program, and all cannabis-based medicines must be registered with this Office (authorizations last for 5 years). The Ministry of Health is responsible for granting approval to import medical cannabis into Poland, and the Chief Pharmaceutical Inspectorate (GIS) is responsible for issuing cultivation licenses for scientific purposes. There is now an official ‘Cannabis Office’ that sits under the Chief Pharmaceutical Inspectorate, which is expected to oversee a long-awaited domestic cultivation tender (still in a ‘discussion phase’).

The medical cannabis program is intentionally open-ended to enable doctors to issue prescriptions for conditions, if supporting evidence is provided - there is no list of conditions for which cannabis can be prescribed. Prescriptions can be issued by any doctor and are typically valid for 30 days unless extended. Theoretically, all products are covered under statutory health insurance however reimbursements are considered on an individual basis, with actual cases of reimbursements very rare. In 2018, the Agency for Health Technology Assessment and Tariffs recommended cannabinoid medicines not be reimbursed.

Only six flower products have been approved for sale on the Polish medical market:

• Red No 2 produced by Spectrum Therapeutics (subsidiary of Canadian licensed producer, Canopy Growth Corporation. Supply imported)
  • 17-21% THC: <1% CBD
  • An additional Spectrum flower product
• Four cultivars produced by Aurora Polska (subsidiary of Canadian licensed producer, Aurora Cannabis. Supply imported)
  • 1% THC: 12% CBD
  • 20% THC: 1% CBD
  • 22% THC: 1% CBD
  • 8% THC: 8% CBD

There is also limited access to two varieties of Bedrocan flower (Bediol and Bedrocan) for the treatment of drug-resistant epilepsy in children. These products have not been fully approved and must be imported on a named-patient basis under the “designated import” scheme.

In addition, PharmaCann Polska has recently been authorized to manufacture and process medical cannabis-based products, including extracts. Their North Macedonian facility was awarded EU-GMP certification, with its GMP certificates issued in March 2020 by the Chief Pharmaceutical Inspectorate of Poland, making it the first company to obtain a cannabis license from this entity. PharmaCann intends to produce lower cost extracts for European markets, planning to commence sales of what would be the first oils in the Polish market by the end of 2020.

Competitors in the country are also wrestling with challenging tax infrastructure which has helped contribute to prohibitively high pricing in Poland. This is largely related to the VAT rate (23%) applied to medical flos, classified by the Central Statistical Office as a pharmaceutical substance rather than a medical product (covered by a preferential 8% VAT rate). Spectrum Therapeutics went to the Voivodship Administrative Court in 2019 to try to reduce VAT to 8%, but was ultimately unsuccessful. However, reports suggest recent progress has been made with VAT being reduced to 8% for three Aurora cannabis products in August 2020.

While medical cannabis is still unaffordable for a large proportion of the population, this decision has opened the door for future reductions of VAT on cannabis products, which may shift pricing downward substantially in the coming years.

Domestic cultivation is only permitted for research purposes and as a result, all medical cannabis products must be imported. Imported products are distributed through wholesalers to pharmacies, though patients may apply for a permit allowing them to import medical cannabis individually. Foreign producers must be approved by the government and obtaining licenses is challenging; importers must obtain a license for each product line they want to import, valid for five years. The forms required are complex and vague, and the process is very time consuming – the Polish Office for Medicinal Products (UPRL) has 270 days to process applications.