On 2 June 2021, a large cross-party group of MPs submitted a draft law No. 5596 on medical cannabis (the “Draft”) to the Ukrainian parliament. Lawmakers consolidated several proposed pieces of legislation, initially submitted to parliament at the end of 2020, into the Draft. If adopted, it will introduce substantive changes to the current legislative landscape; specifically, it will:
- legalise the cultivation of medical cannabis and its use by patients on a prescription basis;
- allow the limited use of medical cannabis for scientific purposes;
- clearly define CBD and industrial hemp as non-controlled substances;
- establish a relaxed regulatory regime for the cultivation of industrial hemp and more transparent rules for the cultivation of other types of cannabis plants;
- establish more detailed and transparent rules on control over cannabis circulation.
Here is a summary of the key changes proposed in the Draft.
New classification of cannabis plants and rescheduling decision
The Draft identifies three groups of cannabis plants depending on the THC content in the dried straw:
- industrial hemp (THC - <0.2%);
- low-THC medical cannabis (THC – 0.2-1%);
- high-THC medical cannabis (THC - >1%).
The THC content in dried straw will be determined based on:
- a description of the plant variety from the State Registry of Plant Varieties of Ukraine;
- testing by authorised laboratories.
The Draft provides different conditions and requirements for cultivation depending on the type of cannabis plant. For example, cultivation of low-THC cannabis will be possible both on open and closed ground, while the cultivation of high-THC cannabis plants will be permitted only on closed ground.
In addition, the Draft stipulates that cannabis extracts, tinctures, resins, along with THC and its isomers are not considered fully prohibited narcotic and psychoactive substances under the Ukrainian scheduling system. The Draft contains an instruction to the Ukrainian government to move these categories to the list of narcotic and psychoactive substances that are allowed for controlled circulation and amend its scheduling regulations accordingly after the Draft is adopted.
The Draft generally permits the use of cannabis for medical purposes, but only based on the following restrictions:
- the use of cannabis in medical practice will only be allowed in the form of cannabis-based medicinal products, authorised for use in Ukraine;
- these medicinal products will be available to patients only based on an electronic prescription;
- additional traceability requirements will apply to these medicinal products, including specific marking of each batch and unit of packaged products with a unique code;
- patients will only be allowed to store cannabis-based medicinal products in the amount specified in the prescription.
The Draft legalises the use of medical cannabis for scientific purposes, including its use in clinical trials of cannabis-based medicinal products.
The Draft proposes relaxing the current restriction on research, which limits scientific use to industrial hemp containing up to 0.08% of THC solely by state-owned scientific institutions based on government orders. Specifically, the Draft legalises the scientific use of medical cannabis by any type of scientific institutions, including private ones, provided they comply with the legislation on cannabis circulation.
The Draft establishes only basic principles of using medical cannabis for scientific purposes. The detailed requirements for this use will be specified in bylaws.
CBD status clearly defined
As of today, due to a lack of clear regulation on CBD, the import, export, local manufacturing and commercialising of CBD-based products (such as foods, veterinary products, cosmetics, etc.) are associated with significant risks, as law enforcement often views these products as controlled substances that are prohibited.
The Draft clearly defines CBD as a non-controlled substance, making its circulation in Ukraine legal and free of any restrictions that apply to controlled substances.
Defining CBD as a non-controlled substance under law is undoubtedly a positive development. So far, the Draft does not include a clear definition of CBD, keeping broad- and full-spectrum CBD products, which may contain other cannabinoids, including traces of THC, in a grey area.
Relaxed industrial hemp regulation
The Draft explicitly removes industrial hemp, products manufactured from it and its processing results from the category of narcotic and psychoactive substances.
Additionally, the cultivation of industrial hemp will require neither licensing nor the National Police’s permit for using premises for cultivation. If adopted, the relaxed regulation will be a huge step forward for the industrial hemp sector. It will deregulate the market and enable harvesting and processing of all parts of industrial hemp, not only its seeds and stem, as the current regulation permits.
In addition, the Draft contains a direct obligation to keep constantly aligned the level of permitted THC content in industrial hemp with European legislation.
New rules of medical cannabis circulation
The Draft relaxes medical cannabis circulation and sets more transparent control measures over cannabis, namely:
i. Partial abolition of cultivation and import quotas. The Draft removes quotas for the circulation of industrial hemp and temporarily removes quotas for the cultivation and import for medical cannabis. From 2025, quotas will come back only for imports of medical cannabis and cannabis-based medicinal products.
ii. New requirements on cultivation licence holders for medical cannabis, namely:
- to ensure compliance with safety rules;
- either engage a contracted certified lab or set up an in-house lab to control the quality of products and the level of THC;
- ensure access by the National Police to areas and facilities used for cultivation, storage, use or destruction of medical cannabis plants and processing products.
iii. New traceability requirements. The Draft provides for:
- the creation of an electronic registry for tracking all transactions with these products;
- marking each batch and unit of packaged products with a unique code.
iv. Clear permit system. The Draft clearly defines the procedure for obtaining free-of-charge permits to use premises to cultivate medical cannabis from the National Police of Ukraine.
The Draft is sponsored by a large cross-party group of MPs, including leaders of the majority party and heads of key parliamentary committees. Therefore, we expect that parliament will adopt the Draft at the first hearing in July and then finally by the end of 2021.
Lawmakers may still amend the Draft and its implementation will require further substantive work on specific bylaws. However, even if only a few of the many proposed revolutionary changes get through, we can expect an explosion of activity in these new sectors in Ukraine.