Legalization of medical cannabis
On December 21, 2023, the Verkhovna Rada of Ukraine adopted bill No. 7457 “ On regulating the circulation of plants of the hemp genus ( Cannabis ) for medical, industrial purposes, scientific and scientific-technical activities to create conditions for expanding patient access to the necessary treatment for cancer and post-traumatic stress disorders resulting from war” (hereinafter referred to as the Law).
According to the authors, the Law was developed with the aim of implementing the best experience in the field of regulating the limited circulation of cannabis, cannabis resin, extracts and tinctures of cannabis, as well as tetrahydrocanabinol by amending the laws of Ukraine that regulate the handling of narcotic drugs, in order to create conditions for expanding patient access to necessary treatment and conducting scientific research into the effectiveness of cannabis.
Not only doctors and medical workers, but also volunteers and charitable organizations advocated for the adoption of the Law.
The law introduces into the current legislation such concepts as: “sample of a plant of the hemp genus ( Cannabis ) for laboratory testing (research)”, “cannabis ” , “hemp for medical purposes”, “hemp for industrial purposes”, “hemp processing products for industrial purposes (parts thereof)”, “recreational use”, “cannabis plant”, “cannabis plant substance”, “hemp raw materials for industrial purposes”, “cannabis resin” and others.
The legislator provides that cannabis, cannabis resin, extracts and tinctures of cannabis from especially dangerous drugs, the circulation of which is prohibited on the territory of Ukraine, turn into narcotic drugs and plants, the circulation of which is limited.
The dispensing to persons of medicinal products produced (manufactured) from hemp for medical purposes or the plant substance of cannabis will occur exclusively as prescribed by a doctor in accordance with medical indications according to an electronic prescription issued in the manner established by the Ministry of Health of Ukraine. Patients can carry, transport, and store cannabis-derived medications in the quantities specified in one prescription.
At the same time, the Law does not provide for the recreational use of narcotic drugs, psychotropic substances, cannabis plants (their parts) without a doctor’s prescription and for reasons not related to medical use. Consequently, criminal liability for illegal possession of narcotic drugs remains.
As for economic activities, in connection with the adoption of the Law, the cultivation of plants of the hemp genus for industrial purposes, with the exception of the production and (or) manufacture of narcotic drugs and psychotropic substances, is permitted when using seeds collected from plant varieties whose dried straw contains tetrahydrocannabinol does not exceed 0.3 percent (previously it was 0.15 percent).
The circulation of hemp for medical purposes, products of their processing, and plant substance of cannabis is permitted for educational purposes, educational, scientific and scientific-technical activities, production (manufacturing) of narcotic drugs, psychotropic substances and medicines for further use in medical practice, subject to ensuring control and traceability at all stages of such treatment.
Traceability of the circulation of hemp for medical purposes, their processed products, the plant substance of cannabis, and medicines produced from them is ensured by: using conditioned and certified seeds for cultivating hemp for medical purposes, purchased in the manner established by the Cabinet of Ministers of Ukraine; labeling with a unique electronic identifier of each hemp plant for medical purposes, each batch of their processed products and each unit of packaged products, including the plant substance of cannabis, as well as medicines made from them in a pharmacy with a doctor’s prescription or by order of medical institutions in compliance with the requirements of legislation on medicines.
Business entities engaged in the cultivation of hemp for medical purposes, the production or import of cannabis plant substances, the production of narcotic drugs, psychotropic substances or medicines from them, including production in a pharmacy according to a doctor’s prescription or on the order of medical institutions, and also activities related to the circulation of medicines produced (manufactured) from them, who are obliged to timely enter reliable information into the electronic information accounting system in the manner, terms and volumes determined by the Regulations on the electronic information accounting system. The regulations on the electronic information accounting system and the procedure for its functioning are approved by the Cabinet of Ministers of Ukraine.
A license to carry out activities involving the use of plants of the hemp genus, which are subject to this Law, except for the production (manufacturing) of narcotic drugs, psychotropic substances, is issued to legal entities, provided that they provide the conditions determined by the Cabinet of Ministers of Ukraine to prevent the theft of such plants and the products obtained from them products or waste.
In accordance with the Law, legal entities - holders of a license to carry out activities for the cultivation and (or) use of plants of the hemp genus, are obliged to take measures to fulfill the conditions established by the Cabinet of Ministers of Ukraine to prevent the theft of plants, ensure the regime established by law for the protection of crops, places of storage and processing of such plants and providing free round-the-clock access to video surveillance data of the National Police of Ukraine at the place of licensed activities and the central executive body implementing state policy in the field of circulation of narcotic drugs, psychotropic substances and precursors, and combating their illegal circulation.
The Cabinet of Ministers of Ukraine, within 3 months from the date of entry into force of the Law, was instructed to work out the issue of regulating the legal and organizational foundations for the functioning of the licensing system in the field of economic activity in the circulation of narcotic drugs, psychotropic substances and precursors in order to eliminate duplication in the activities of licensing authorities authorized to issue documents permissive nature. and ensure the development of regulations necessary for the implementation of this Law.
It should be noted that after the bill was introduced, heated discussions took place in parliament regarding its provisions. Thus, more than 800 amendments were submitted to the bill , more than 100 of which were taken into account by the relevant committee. The law comes into force on the day following the day of its publication and is put into effect six months from the date of its entry into force.
Taking into account the above, the Law will not only strengthen guarantees of access to necessary medical services and medicines that are made on the basis of plants of the hemp genus ( Cannabis ), but will also allow business entities to carry out legal activities for the cultivation of such plants containing permitted quantities of narcotic substances, and use such plants for scientific, educational and medical purposes without violating Ukraine’s international obligations to prevent the circulation of narcotic drugs and substances. In addition, with the adoption of the Law, Ukraine opens up the opportunity to receive international investment in the development of science and industry, which will allow the development of national medical science and the pharmaceutical industry.
Senior Lawyer
Oleh Lyhin
