Ukraine MoH proposes loosening regulations on cannabinoids circulation

In July 2021, the Ministry of Health of Ukraine (MoH) published for public discussion a draft governmental resolution (Draft) amending Resolution No. 770 dated 6 May 2000 that lists the schedules of controlled psychoactive and narcotic substances under Ukrainian laws.

Earlier this year, the Ukrainian government permitted limited use of certain cannabinoid-based psychoactive substances and clarified the legal status of cannabidiol (CBD) isolate and CBD isolate-based products in Ukraine. These developments were followed by an unsuccessful attempt by the Ukrainian parliament to adopt a revolutionary law on Medical Cannabis, which would legalise cultivation of medical cannabis and its use by patients, allow use of medical cannabis by patients, permits the limited use of cannabis for scientific purposes, and establish more detailed rules of control over cannabis circulation.

The Draft currently under public discussion proposes permitting limited circulation of cannabis, cannabis resin, extracts, tinctures, and tetrahydrocannabinol (THC), and relaxes the rules of circulation of already permitted cannabinoid-based psychoactive substances.

The key points contained in the Draft include the following:

Rescheduling cannabis, cannabis resin, extracts, tinctures, and THC

The Draft suggests recognising cannabis, including its extracts, tinctures and resins (Cannabis), and THC as controlled substances and permitting their limited circulation in Ukraine.

The proposed rescheduling of Cannabis and THC may fix the current legal uncertainty over circulation of cannabinoid-based psychoactive substances Nabilone, Nabiximols and Dronabinol. These substances are currently formally permitted for limited medical use in Ukraine. However, in practice their circulation is associated with significant risks due to the current classification of Cannabis and THC as fully prohibited substances. None of these substances are authorised for marketing in Ukraine.

Relaxing R&D rules for rescheduled substances

The Draft proposes use of Cannabis and THC:

• in the form of finished medicines – for medical use only under prescription issued through the electronic healthcare system;
• in the form of active pharmaceutical ingredients, API – for manufacturing of finished medicines;
• in any form – for the scientific purposes.

Permission to use Cannabis and THC for scientific purposes may intensify R&D in this area, since currently this use is not possible. Still, use of these substances for scientific purposes will require development of additional regulations.

THC level for cannabinoid-based substances and CBD isolate

The Draft proposes setting the allowed THC level of up to 0.1% for:

• cannabis;
• cannabinoid-based psychoactive substances – Nabilone, Nabiximols, Dronabinol;
• CBD isolate.

Establishing a maximum THC level for CBD isolate would fill the gap in the current legislation, which defines CBD isolate as an uncontrolled substance, but does not set the allowed level of THC.

In the meantime, the wording of the amendments proposed by the MoH links the maximum permitted THC level (including the level for the CBD isolate) solely to the process of quality control of medicines, implying that circulation of the CBD isolate as an uncontrolled substance is permitted only in the form of API or finished medicines. Such a narrow interpretation leaves many products containing CBD (e.g. cosmetics, oils, foodstuffs, etc.) in a regulatory grey zone. However, any uncertainty surrounding CBD products could be addressed by removing any reference to them from the Draft.

For more information on these amendments and regulations on cannabis in Ukraine, contact your regular CMS client partner or local CMS experts: Borys Danevych, Maria Orlyk.