Ukraine is taking the next step towards implementing medical cannabis as a therapeutic tool, bringing this initiative closer to realization. A
law published on 15 February 2024, will come into effect on 16 February 2024, with its enforcement starting six months later, on 16 August 2024, aims to expand patient access to treatment using medical cannabis for specific conditions.
As mentioned in
a previous article, while the law will regulate the circulation of cannabis for medical, industrial, and scientific purposes, recreational cannabis will remain illegal.
Under this law, the government is obliged to make essential amendments to the regulatory framework within three months and move cannabis from the list of banned narcotics to controlled substances suitable for medicinal use.
The Ministry of Health will approve a list of illnesses and conditions eligible for medical cannabis-based treatments. Dispensing these medicines will require a doctor's prescription, following medical guidelines similar to those for narcotic and psychotropic medicines. Patients can transport and store these medications as specified in their prescription.
FrameworkTo ensure the safety and quality control of medical cannabis-based products, licensing will be required for cultivation, import, export, storage, sales, and transportation. Importation of raw materials for medical preparations will be authorized to promptly meet patient needs.
The government
emphasizes, "To expedite the delivery of medications derived from medical cannabis to patients, initial production will use imported raw materials. Entities will need to obtain licenses for raw material importation, transportation, storage, sales, etc., and register the imported cannabis plant substance in the State Register of Medicinal Products."
NB! Until January 1, 2028, importing cannabis plants, narcotics, and psychotropic substances is prohibited except for scientific and technical purposes, importing cannabis plant substance for medication production, and finished medicinal products listed in the State Register, and importing hemp seeds and planting material.
Quotas will be established to control cannabis cultivation, and farms must be enclosed (greenhouses), hold special licenses, and ensure cultivation safety, including 24/7 police access, the use of specialized equipment, and continuous video surveillance.
The government plans to implement supervision for each plant, greenhouse, preparation, and prescription. To monitor medical cannabis turnover, a separate electronic registry will be created, containing all information about each plant, preparation, and prescription. Thus, all plants in the greenhouse must be registered and assigned a corresponding number. Pharmacies licensed by the Ministry of Health will be able to sell cannabis-based medicines, which can be purchased only with a prescription, following medical tests and examinations. This will allow the state to accurately track all information about cultivation, production, and sale of cannabis-based medicines.
The law also ensures quality control of products and sets the THC content in medical cannabis to ensure treatment effectiveness and safety. The law sets the THC content norm in Ukraine at no higher than 0.3% (0.2% for the first 3 years from the effective date of the law) for industrial purposes and above 0.3% for medical purposes.
Is there potential for investment?In Germany, where medical cannabis has been legalized for six years, the market is estimated at over €300 million,
says Ivan Garev, founder of Drapalin Pharmaceuticals GmbH. "The Ukrainian market is quite large and interesting for companies in Europe, as well as in Canada and the USA," he adds. Mr Garev believes that the Ukrainian market could grow to €250 million by 2028.
Mr Garev decided not to wait until competition becomes high and is already planning to enter the Ukrainian market. "We have opened a branch in Ukraine and this year we are launching an online store where CBD extract will be sold," Mr Garev explains. After the law comes into force, Drapalin Pharmaceuticals GmbH plans to start importing raw materials into Ukraine and is also considering the possibility of building its own farm. "At first, an imported product will appear on the market because it takes about one and a half years and substantial investment to build a farm," says Mr Garev. Farms will require €10-50 million, while laboratories will need €2-3 million.
ConclusionIn conclusion, this legislation represents a significant step towards medical cannabis legalization in Ukraine. It presents a chance to lay the groundwork for health and wellness as Ukraine rebuilds, while also providing a substantial economic opportunity for businesses to enter this growing market.