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Ukraine: Recent Legal Developments on Medical Cannabis

Ukraine: Recent Legal Developments on Medical Cannabis

Issue 9.11
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Ukraine’s approach towards the circulation of cannabis has traditionally been strict: the cannabis market in Ukraine is not legalized, and the circulation of both cannabis itself and cannabinoids is generally prohibited. Both the Criminal Code of Ukraine and the Code of Administrative Offences of Ukraine provide for liability for illegal sowing or cultivation, manufacture, acquisition, storage, transportation, or shipment of cannabis.

However, as the legal status of cannabis and its derivatives is undergoing significant changes worldwide, and the approach of foreign regulatory bodies is shifting towards liberalization of the cannabis market both in terms of medical and recreational use, Ukraine’s legislators have gradually started a discussion on the liberalization of their approach as well.

The first step towards liberalization has been made in April 2021, when the Cabinet of Ministers of Ukraine adopted a resolution that specifically permits the limited circulation of three cannabinoids (dronabinol, nabilone, nabiximols) on the Ukrainian market. Yet, circulation of these substances is only permitted as ready-to-use medicinal products or substances for the preparation of medicinal products. The resolution also clarified that isolated CBD is not subject to restrictions and is not considered to be a narcotic substance subject to state control.

The ongoing Russian war against Ukraine – resulting in multiple patients requiring medical cannabis to relieve them from suffering caused by PTSD and injuries – has led to the development of a draft law aimed at regulating cannabis circulation in Ukraine. In June 2022, the Cabinet of Ministers submitted for consideration by the Parliament of Ukraine the draft law On Regulation of the Circulation of Cannabis Plants for Medical, Industrial, Scientific and Technical Purposes to Create Conditions for Expanding the Access of Patients to the Necessary Treatment of Cancer Diseases and Post-Traumatic Stress Disorders Obtained as a Result of the War.

As it follows from the explanatory note, the gist of the draft is to create the conditions for expanding the access of patients to the necessary treatment with cannabis-based medicines, to induce scientific research and development in the pharmaceutical industry – including by conducting clinical trials of cannabis-based medications – to ensure the legalized commercial activity of cannabis cultivation, as well as to attract foreign investments. The draft law is aimed at regulating the process of receiving the necessary licenses and permits and sets rules for laboratory testing, traceability, labeling, transportation, medical use, prescribing, and selling of cannabis-based medicinal products to patients.

At the same time, the wording of the draft law allows for the medical use of only cannabis-based medicines that have undergone state registration and clinical trials. This means that, on the Ukrainian market, medical cannabis can only be in the form of registered medicinal products. And there are not that many ready-made medicinal products based on cannabis in the world, as many countries apply a more liberal approach allowing the sale to patients of pharmacy-made cannabis medications that do not require formal registration.

Among other important changes proposed by the draft law is the right of the Cabinet of Ministers to establish the percentage of tetrahydrocannabinol (THC) in the dry mass in varieties of cannabis for medical purposes. The determination of THC content in plants shall be carried out by laboratories managed by the State Service of Ukraine on Medicines and Drugs Control. An active discussion is ongoing to ensure that the limits of THC content in cannabis for industrial purposes shall be harmonized with the European approach (currently Ukraine only allows industrial cultivation of those sorts of cannabis that contain less than 0.08% THC, while the EU regulations allow for up to 0.2% THC content).

While the adoption of the draft law will become an important step to further liberalize Ukraine’s approach towards cannabis circulation, considering the high demand of Ukrainian patients for cannabis-based medications, there is still significant room for improvement in the regulation to ensure that the interests of the state, businesses, and patients are well-balanced.

The amendments to Ukrainian legislation introduced in 2021 have made Ukraine open to the registration of medicinal products containing dronabinol, nabilone, nabiximols, and isolated CBD. Yet, at the time of writing, no medicines with such active ingredients have been registered in Ukraine. Which only means that the market comprising at least 2 million potential patients (based on various estimations) remains open for those suppliers that are brave enough to enter a new market.

By Yevgeniya Ocheretko, Co-Head of Life Sciences and Healthcare, Arzinger

This article was originally published in Issue 9.11 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here

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