On June 2, 2021, a large bipartisan group of MPs tabled Bill No. 5596 on Medicinal Cannabis (the “design“To the Ukrainian Parliament. The legislature has consolidated into the draft several legislative proposals that were presented to parliament at the end of 2020. If adopted, it will make significant changes to the current legislative landscape; in detail it will be:
- legalize the cultivation of medicinal cannabis and its use by patients on a prescription basis;
- allow the restricted use of medical cannabis for scientific purposes;
- Clearly define CBD and industrial hemp as uncontrolled substances;
- Introduction of a loose regulatory system 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 for the control of cannabis traffic.
Here is a summary of the key changes proposed in the draft.
New classification of cannabis plants and move decision
The draft identifies three groups of cannabis plants depending on the THC content in the dried straw:
- Industrial hemp (THC –
- medical cannabis with low levels of THC (THC – 0.2-1%);
- medical cannabis with a high THC content (THC -> 1%).
The THC content in dried straw is based on:
- a description of the plant variety from the state variety register of Ukraine;
- Testing by authorized laboratories.
The draft provides for different conditions and requirements for cultivation depending on the type of cannabis plant. For example, growing low-THC cannabis will be possible in both open and closed ground, while growing high-THC cannabis plants will only be allowed in closed ground.
In addition, the draft stipulates that cannabis extracts, tinctures, resins along with THC and its isomers are not considered to be completely banned narcotics and psychoactive substances according to the Ukrainian timetable system. The draft contains an instruction to the Ukrainian government to move these categories to the list of narcotics and psychoactive substances approved for controlled traffic and to change its scheduling regulations accordingly after the draft is approved.
The draft generally allows the use of cannabis for medicinal purposes, but only on the basis of the following restrictions:
- the use of cannabis in medical practice is only allowed in the form of cannabis-based medicines approved for use in Ukraine;
- these medicines are made available to patients only on the basis of an electronic prescription;
- Additional traceability requirements apply to these medicinal products, including specific identification of each batch and unit of packaged products with a unique code;
- Patients may only store cannabis-based medicinal products in the amount specified on the prescription.
The draft legalizes the use of medical cannabis for scientific purposes, including its use in clinical trials of cannabis-based medicines.
The draft proposes a relaxation of the current research restriction, which restricts the scientific use of industrial hemp with a THC content of up to 0.08% exclusively by state scientific institutions on state order. In particular, the draft legalizes the scientific use of medical cannabis by all types of scientific institutions, including private institutions, provided that they comply with the legal provisions on the cannabis trade.
The draft only sets out the basic principles of the use of medical cannabis for scientific purposes. The detailed requirements for this use are set out in statutes.
CBD status clearly defined
Due to the lack of clear regulations on CBD, the import, export, local production and marketing of CBD-based products (such as food, veterinary drugs, cosmetics, etc.) are currently associated with significant risks, as law enforcement often regards these products as prohibited controlled substances.
The draft clearly defines CBD as an uncontrolled substance, which makes its circulation in Ukraine legal and free from the restrictions that apply to controlled substances.
Defining CBD as a legally uncontrolled substance is undoubtedly a positive development. So far, the draft lacks a clear definition of CBD, but keeps broad-spectrum and full-spectrum CBD products, which may contain other cannabinoids, including traces of THC, in a gray area.
Loose industrial hemp regulation
The draft expressly removes industrial hemp, the products made from it and its processing results from the category of narcotics and psychoactive substances.
In addition, the cultivation of industrial hemp does not require a permit or a permit from the National Police for the use of premises for cultivation. If the relaxed regulation is adopted, it will be a big step forward for the industrial hemp sector. It will deregulate the market and allow the harvesting and processing of all parts of industrial hemp, not just its seeds and stems, as the current regulation allows.
In addition, the draft contains a direct obligation to constantly adapt the permissible THC content in industrial hemp to European legislation.
New rules for the circulation of medicinal cannabis
The draft relaxes the circulation of medicinal cannabis and lays down more transparent control measures for cannabis, namely:
I. Partially Abolition of cultivation and import quotas. The draft removes quotas for the trade of industrial hemp and temporarily the quotas for the cultivation and import of medicinal cannabis. From 2025, the quotas will only be reintroduced for the import of medical cannabis and cannabis-based medicinal products.
ii. New requirements for holders of medicinal cannabis cultivation permits, namely:
- to ensure compliance with safety regulations;
- either use a certified contract laboratory or set up an in-house laboratory to control the quality of the products and the THC content;
- Ensure national police access to areas and facilities used for the cultivation, storage, use or destruction of medicinal cannabis plants and processed products.
iii. New traceability requirements. The draft provides:
- the establishment of an electronic register to keep track of all transactions in these products;
- Identification of each batch and unit of packaged products with a unique code.
iv. Clear approval system. The draft clearly defines the procedure for obtaining free permits for the use of premises for the cultivation of medicinal cannabis from the National Police of Ukraine.
The draft is sponsored by a large bipartisan group of MPs, including leaders of the majority party and heads of key parliamentary committees. We therefore expect Parliament to adopt the draft at the first hearing in July and then finally by the end of 2021.
The legislature can still change the draft, and its implementation requires further work on the content of certain statutes. But even if some of the many proposed revolutionary changes make it through, we can expect an explosion of activity in these new sectors in Ukraine.