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New rules on the cultivation of medicinal cannabis in Poland

On 29 March 2022, the Polish President signed the Act of 24 March 2022 amending the Act on Counteracting Drug Addiction (the "Act"). The Act sets out rules for the cultivation and harvesting of medicinal cannabis in Poland for the first time, and raises the maximum THC level in hemp from 0.2% to 0.3%.

In November 2021, we wrote about a bill aimed at specifically regulating the cultivation of hemp. It was submitted to the Sejm (the lower house of the Polish Parliament) in April 2021, along with another bill providing rules for the cultivation of non-fibrous hemp intended for the manufacture of pharmaceutical raw material and liberalising the use of cannabis and the cultivation of medicinal cannabis for patients. Both bills were rejected by the Sejm earlier this year.

However, as the need to regulate the cultivation and harvesting of non-fibrous hemp for medical purposes remained a hot topic, in the meantime another bill was submitted – and eventually the Act was passed. Its main goal is to enable the cultivation and harvesting of non-fibrous hemp intended for the manufacture of pharmaceutical raw material, essentially making the manufacture of medicinal cannabis in Poland legal. The Act will come into force 30 days after its publication.

In Poland, the use of medicinal cannabis was legalised in 2017. Ever since, the herb of non-fibrous hemp and extracts, pharmaceutical tinctures and all other extracts of non-fibrous hemp and the resin of non-fibrous hemp may constitute pharmaceutical raw material intended for the preparation of compounded medication in pharmacies on the basis of a medical prescription. However, the cultivation of non-fibrous hemp itself is not permitted – the pharmaceutical raw material for medicinal cannabis can currently only be imported.

The Act will make it possible to cultivate non-fibrous hemp and harvest the herb or resin of non-fibrous hemp intended for the manufacture of pharmaceutical raw material – however, only for research institutes supervised by the Minister of Agriculture. The research institutes will have to obtain a permit from the Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny, "GIF") for cultivation and harvesting.

Before issuing the permit, the GIF will consult the provincial police headquarters competent for the area of cultivation covered by the application on how the crop is secured against unauthorised access.

The Act also introduces a long expected change in the authorised delta-9-tetrahydrocannabinol (THC) level in hemp. It raises the allowed THC level from 0.2% to 0.3% in fibre hemp, meaning that the cultivation of fibre hemp in which the sum of THC and tetrahydrocannabinoleic acid (delta-9-THC-carboxylic acid) content in the flowering or fruiting tops of plants from which the resin has not been removed does not exceed 0.3% on a dry matter basis will be authorised.

In addition, the Act provides a definition of radio-frequency identification technology (RFID) as a technology for the remote (radio) surveillance of objects, in this case plants, which uses radio waves to read and transmit the data contained on a label applied to each plant that is being grown. The system makes it possible to identify and supervise each of many labels in the reading field, therefore protecting the entire plant population from theft or falsification. Having the RFID technology in place will be one of the conditions for a research institute’s obtaining a GIF permit for the cultivation of non-fibrous hemp and hemp herb other than fibrous hemp.

To sum up, the Act is a step in the direction of making medicinal cannabis cheaper and more accessible for patients, as a result of the possibility to manufacture the pharmaceutical raw material in Poland, thus not having to rely on imports. In practice, the actual manufacturing may be quite limited since the group of entities allowed to apply for a permit includes only research institutes supervised by the Minister of Agriculture, which also have to satisfy the infrastructural conditions of the premises where the hemp will be grown. Nonetheless, raising the THC level to 0.3% is good news for the hemp industry, and, in fact, in line with the European Parliament's vote on 23 October 2020[1], as well as the new common agricultural policy (CAP) for the period of 2023-2027[2], adopted by the Council of the European Union on 2 December 2021.

References:

[1] https://www.europarl.europa.eu/doceo/document/TA-9-2020-0287_EN.html

[2] https://www.consilium.europa.eu/en/policies/cap-introduction/cap-future-2020-common-agricultural-policy-2023-2027/

Tags

cannabis, pharmaceuticals, poland
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