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Poland: Legislative Reform is Lacking for One of Europe’s Largest Medical Cannabis Markets

Poland: Legislative Reform is Lacking for One of Europe's Largest Medical Cannabis Markets
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By Maciej Konarowski, President of the Polish Medical Cannabis Patients Association and founder of the Can advocare law firm, and Conor O’Brien, Analyst at Prohibition Partners

28 January 2022

Newly released data show that Poland is home to over 9,261 patients legally accessing medical cannabis, making it one of the largest such populations in Europe. Demand for medical cannabis from patients in Poland is growing fast, but the government is still failing to ensure adequate supply. New legislation that would bolster the national supply has been rejected by the Parliament.

New cannabis legislation in Poland

On 13 January 2022, the Polish Parliament held the first reading of three draft laws intended to overhaul the cannabis laws in Poland. Out of the three drafts under consideration, two were rejected, and the third one was accepted for further proceedings by the Health and Agriculture committees. Currently, legislative work is taking place with respect to six different drafts of amendments to the hemp law, two of which (including one citizen’s draft) relate to the legalisation of recreational use.

The first of the rejected drafts provided for the general admission of cannabis cultivation with high THC concentration for the needs of the pharmaceutical industry in Poland, allowed the reimbursement of cannabis-based medicines for certain indications, and aimed to regulate the legal issue of driving after the use (2-5 ng Δ9 THC/ml) and in an intoxicated state (>5 ng Δ9 THC/ml) of THC. It therefore remains illegal to cultivate medical cannabis commercially in Poland and patients must rely on imports from Europe and North America.

The second bill, also rejected, was a new law comprehensively regulating the cultivation of industrial hemp (with a low THC content), the cultivation of which is now legal in Poland, but regulated (like so-called ‘medical marijuana’) by the Anti-Drug Abuse Act. The proposal assumed raising to 0.3% THC the limit, differentiating between fibrous (industrial) hemp and hemp with high THC content used for medical purposes.

The third draft, which has been sent for further proceedings, provides for enabling state research institutes supervised by the Minister of Agriculture to cultivate hemp with higher than 0.3% THC in Poland for the needs of the pharmaceutical industry.

Maciej Konarowski of Can advocare commented:
“The draft law is clearly underdeveloped and contains many loopholes, which means that even if the discussed regulations find political support and are enacted, their actual use will not occur during the current term of the parliament.”

Currently, there are about twelve research institutes that could carry out such cultivation, and it is likely that the Institute of Natural Fibres and Herb Plants in Poznań would be involved. However, the draft of a Bill does not specify such important issues as the following.

  • Where would the funds for the creation of infrastructure for indoor cultivation come from?
  • Would the Institute, in addition to a permit from the Chief Pharmaceutical Inspector for cultivation, have to obtain the relevant permits under the Pharmaceutical Law (for the production of pharmaceutical raw materials and EU GMP)?
  • Who (whether private entities) and on what principles (commercial) could acquire and process the raw material?

Konarowski concluded that in the light of these numerous doubts, it should not be expected that the production of pharmaceutical raw material will actually take place in Poland within the next few years.

Extracts available for the first time

At the end of 2021, the first pharmaceutical raw material for the preparation of prescription medicines in pharmacies in the form of cannabis 10% THC extract received a marketing authorisation.

‘This is breakthrough news for Polish patients, doctors and pharmacists, as until now they could only use the authorised dried Cannabis flower. It will undoubtedly contribute to increasing the therapeutic options available in Poland,’ explains Konarowski. ‘However, in order for this to actually come true, it is necessary to intensify efforts to educate the medical community, which should be supported by adoption of a cannabis monograph in European Pharmacopoeia.’

Official data from the Ministry of Health

Maciej Konarowski of Can advocare recently obtained data pertaining to the number of medical cannabis patients obtaining prescriptions in Poland, and the quantities of medical cannabis being used. This is the first time ever that comprehensive data has become available indicating the patient population size in Poland, building on 2020 import figures published last year. The data were obtained by means of a parliamentary question posed with the help of Beata Maciejewska MP.

In the first three quarters of 2021, physicians in Poland issued 28,076 prescriptions to 9,261 patients, of which 22,029 prescriptions were filled. This would mean about 7,270 patients collected their prescriptions during the period. In total, 197kg of dried flowers were dispensed to patients. According to official data, the Main Pharmaceutical Inspector issued a permit for importing 1,380,309 g of the dried product into Poland, though it is unclear how much of this was actually imported by the licensed distributors.

In light of this data, Poland is one of the largest cannabis markets in Europe by patient population, behind Germany and Italy, similar to the Netherlands and ahead of other developing markets such as the UK, Denmark, France and Czechia.

The above figures do not take into account Q4 – where a months-long supply drought in Poland was relieved by the delivery of 140kg of dried flower, which was introduced by Aurora and bought up in just two days. The speed with which the imports were bought by pharmacies and patients demonstrates the degree to which demand is outstripping supply in the country. Just 167kg were imported up to August in 2020.

Marketing authorisation procedure

One bottleneck for satisfying the constantly growing demand of Polish patients is the registration procedure. Currently, the Office for Registration of Medicinal Products (URPL) is processing 20 applications for marketing authorisation for raw materials based on Cannabis (in accordance with the law the procedure should not take more than 210 days), of which 6 have been suspended at the request of the applicant (most over a year ago).

Prohibition Partners consider this, and other issues, in more depth in our upcoming report – The European Cannabis Report: 7th Edition. 

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