Patient advocates say that regulators must do more to support patient access in Poland, by increasing the number of approved products, ensuring the consistency of supply of existing products and increasing affordability, e.g. by providing for insurance on medical cannabis prescriptions. Already, some pharmacies in Poland are warning that the 140kg supply is running out and that shortages may soon return.
Patient demand advancing faster than regulations
Poland legalised medical cannabis in 2017 and demand has grown rapidly since then, but the industry has yet to properly find its feet. Conservative regulations lead to pharmacies across Poland intermittently running out of cannabis supplies, meaning patients have to find alternative ways to meet their needs. This can entail obtaining a prescription for another cannabis strain or leaving the legal medical cannabis market altogether, e.g. to obtain from the black market. Poland is completely reliant on imports of cannabis from Canada, Germany and Denmark as no domestic production is currently permitted.
To date, the Office for Registration of Medicinal Products (URPL) has approved just the following six strains of medical cannabis:
More support needed for Polish patients
While extract products are technically permissible, none have been approved to date. Imports of medical cannabis also need specific approval by the Chief Pharmaceutical Inspectorate (GIF) before being distributed to Polish patients and this can also be a lengthy process, with long delays being experienced by importers. Currently no reimbursement for medical cannabis is offered in Poland and the average price of PLN 650–670 (€138–149) for 10-gram packages of cannabis is reported to be prohibitively high for many patients.
Prohibition Partners spoke to Maciej Konarowski, founder of legal firm Can advocare, on the recent developments in Poland and what this means for domestic patients. He said:
“After several months of interruption, patients will finally be relieved to be able to stock up on medical cannabis. From the perspective of continuity of therapy, such interruptions are unacceptable. Doctors (in Poland, any doctor with a licence to practise has the right to issue a prescription for cannabis), who are still quite cautious about recommending cannabis, will be afraid to start therapy, knowing that the drug they are recommending may run out. The transfer of supplies from the Canadian to the Danish Aurora production unit should significantly improve the consistency of supplies, but there is no certainty that this will completely eliminate the availability difficulties.
To improve the situation of patients, the regulatory authorities (URPL, GIF, MZ) should ensure transparency of procedures, unambiguously indicating the requirements for manufacturers, and simplify and accelerate the application procedure. Currently, registrations drag on for years and at least a few manufacturers are stuck in this process. The second issue is the unreasonable, overly rigorous and formalistic approach to the stability marker set at +/- 10%. The third problem is the lack of a sense of duty to meet patients’ drug needs, which should characterise the Ministry of Health. As a patient organisation, we have intervened on this issue, but one gets the unpleasant impression that patients who use cannabis for medicinal purposes are treated as second-class, while they continue to face criminal charges for cultivating the plant.”
Rapid growth checked by strict regulations
Poland is among the fastest growing markets for medical cannabis in Europe and has the potential to grow into one of the largest in Europe. The last time official import statistics became available for 2020, 160kg of cannabis was imported for the entire year up to August, more than double the 2019 figures.
For context, in the Czech Republic, 67kg of cannabis supplied just over 3,750 patients in 2020. Early reports from patient forums in Poland indicate that the 140kg of medical cannabis is almost sold out already, and while official statistics on imports for 2021 are not yet available, it is clear that market demand has continued to progress quickly.
New regulations inbound
Product shortages in Poland mirror those in another of Europe’s growing markets, Italy, where Prohibition Partners reported product scarcity in 17 of Italy’s 20 administrative regions earlier this year. In Italy, new tenders are expected to be announced for the production of extra medical cannabis for the country. Similarly in Poland, patient advocates are highly anticipating new legislative amendments, which have recently been passed to Parliament.
Included in this raft of proposals is the possibility of medical cannabis cultivation by Polish research institutes, with the probable long-term aim of shoring up domestic supply while also providing economic relief for licensed farmers in the country if legislation for commercial cultivation is passed. Advocates are hopeful that these measures, along with the cannabis supplies from Aurora, Canopy Growth and any future approved products will be enough to support the growing legal patient population in the country.
Prohibition Partners continues to monitor the situation in Poland and elsewhere for our readers, and will consider these issues in more detail in our upcoming Global Cannabis Report 2021.