Ukraine Cabinet Backs Bill To Legalize Medical Cannabis (7 June 2022)

At first glance this may look like an odd priority in the middle of a war. But when one thinks of the physical and mental injuries to both those in the armed forces and civilians it makes perfect sense.

Forbes write

Ukraine’s Health Minister Viktor Liashko announced on June 7 that the government had backed the bill that would legalize medical cannabis amid the war with Russia.

“We understand the negative effects of war on mental health. We understand the number of people who will need medical treatment due to this exposure. And we understand that there is no time to wait,” he wrote on a Facebook post.

He also stressed those who campaign against the legalization of medical cannabis in Ukraine deliberately compare cannabis-based medicines with illegal cannabis to negate its medical value as a medicine and to discredit the idea of its use for medical purposes.

The bill aims to improve the quality of medical services for the population that undergoes palliative medicine and encourage medical research on cannabis.

The bill would expand patients’ access to the necessary treatment for more than 50 conditions, including cancer and post-traumatic stress disorder (PTSD), neurological diseases, and chronic pain of neuropathic origin.

At the same time, it would provide strict control over the cultivation, production, and sale of medical cannabis products, including authorizations and licenses for the economic activities for the cultivation of cannabis strains for medical purposes and scientific research, as well as a medical cannabis tracking system in order to provide information for all the stages of products’ circulation.

https://www.forbes.com/sites/dariosabaghi/2022/06/08/ukraine-may-legalize-medical-cannabis/?sh=43d1bb0c7c96

 

Draft Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of the Circulation of Cannabis Plants for Medical, Industrial Purposes, Scientific and Scientific-Technical Activities”

February 17, 2022
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LAW OF UKRAINE

 

On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of the Circulation of Cannabis Plants for Medical, Industrial Purposes, Scientific and Scientific-Technical Activity

 

The Verkhovna Rada of Ukraine resolves :

I. Amend the following laws of Ukraine:

1. Paragraph “e” of the first part of Article 6 of the Fundamentals of Legislation of Ukraine on Health Care (Vidomosti Verkhovnoi Rady Ukrainy, 1993, № 4, Art. 19) shall be worded as follows:

“(E) qualified medical and rehabilitation care, including the free choice of doctor and rehabilitation specialist, the choice of treatment and rehabilitation methods in accordance with the recommendations of the doctor and rehabilitation specialist, the choice of health care facility and access to necessary medicines;”

 

2. In the Law of Ukraine “On Narcotic Drugs, Psychotropic Substances and Precursors” (Vidomosti Verkhovnoi Rady Ukrainy, 1995, № 10, Art. 60):

1) in Article 1:

to supplement, taking into account the alphabetical order, the terms of the following content:

“Cannabis – whole or varying degrees of grinding of a part of a plant of the genus Hemp or a mixture thereof (except for the actual ripe seeds), which contain tetrahydrocannabinol.

Cannabis plant – any plant of the genus Cannabis.

Cannabis resin is a separated resin, unrefined or purified, derived from a cannabis plant.

2) in Article 2:

the third paragraph of the first part shall be worded as follows:

“Table II contains narcotic drugs, psychotropic substances and plants included in lists № 1 and № 2, the circulation of which in Ukraine is limited and for which control measures are established.”;

the third part shall be supplemented with the following paragraphs:

“The percentage of tetrahydrocannabinol in the dry mass in varieties of cannabis (Cannabis) for medical purposes is determined by the central executive body, which ensures the formation of state policy in the field of drugs, psychotropic substances, their analogues and precursors, combating their illicit trafficking;

For the purposes of this article, the content of tetrahydrocannabinol in cannabis plants (Cannabis) is determined by conducting laboratory tests conducted by enterprises, institutions and organizations belonging to the management of the central executive body implementing state policy in the field of drugs, psychotropic substances , their analogues and precursors, counteraction to their illegal circulation, or state specialized expert institutions in the order established by the Cabinet of Ministers of Ukraine. “;

3) the seventh part of Article 8 shall be supplemented with the following paragraph:

“Licenses for the cultivation of varieties of cannabis (Cannabis) for medical purposes shall specify the list of varieties of cannabis that can be cultivated, characteristics, areas and addresses (geographical coordinates) of facilities and premises at ) who are allowed to carry out such activities in accordance with the requirements of this Law. “;

4) Article 11 shall be worded as follows:

” Article 11. Permission for the use of facilities and premises intended for the circulation of narcotic drugs, psychotropic substances and precursors

Permission to use facilities and premises intended for the circulation of narcotic drugs, psychotropic substances and precursors (hereinafter – the permit) is issued to the business entity by the National Police on a free basis for the duration of the license.

Permission to use facilities and premises intended for the circulation of narcotic drugs, psychotropic substances and precursors is issued on the basis of the results of verification of compliance of these facilities and premises with the requirements established by the Ministry of Internal Affairs of Ukraine.

The permit is issued based on the results of verification of compliance with the requirements for facilities and premises established by the Ministry of Internal Affairs of Ukraine intended for the circulation of narcotic drugs, psychotropic substances, precursors, cultivation of cannabis varieties for medical purposes. the business entity of the application and duly certified copies of the following documents:

documents confirming the ownership or use of the business entity for facilities and premises intended for the cultivation of varieties of plants of the genus Cannabis for medical purposes and the implementation of activities on the circulation of narcotic drugs, psychotropic substances, precursors and derived from varieties of plants of the genus cannabis for medical purposes;

plan-scheme of objects, premises or their complex, on the territory of which it is planned to carry out activities on cultivation of varieties of hemp plants (Cannabis) for medical purposes, containing information on relevant land plots and premises, indicating their types, boundaries, geographical coordinates , places of passage to the territory of the complex or individual objects and premises.

The decision to refuse to issue a permit for the use of facilities and premises intended for the circulation of narcotic drugs, psychotropic substances and precursors may be appealed in the manner prescribed by law.

The decision to issue or refuse to issue a permit shall be made by the National Police within ten working days from the date of submission by the business entity of the documents specified in part two of this article.

Permission for the use of facilities and premises owned by the National Police, the central executive body implementing state customs policy, the Security Service of Ukraine for the storage of drugs, psychotropic substances and precursors seized by these bodies from illicit trafficking is not required.

5) Article 12 shall be supplemented with parts of the following content:

The circulation of varieties of plants of the genus Cannabis for medicinal purposes, products of their processing and medicines produced (manufactured) from them is allowed in scientific and scientific-technical activities, as well as in medical practice in accordance with Articles 15, 17, 19, 20, 21, 22, 24, 25-27 of this Law, provided that control and traceability is ensured at all stages of such circulation.

The traceability of the circulation of varieties of plants of the genus Cannabis for medicinal purposes, products of their processing or medicines produced from them is ensured by:

marking of each batch and unit of packaged products with a unique bar code;

maintaining an electronic register of movement of cannabis plant varieties (Cannabis) for medical purposes or medicines produced (manufactured) from them at all stages of circulation in the manner prescribed by the central executive body, which ensures the formation of state policy in the field of drugs, psychotropic substances , their analogues and precursors, counteracting their illicit trafficking.

ensuring the release of medicinal products from hemp (Cannabis) for medical purposes, exclusively on the prescription of a doctor in accordance with medical indications according to an electronic prescription issued by the central executive body established by the state policy on drug trafficking, psychotropic substances, their analogues and precursors, counteracting their illicit trafficking. “;

6) Article 15 shall be worded as follows:

“Article 15. Cultivation activities of plants included in Table I of the List shall be prohibited on the territory of Ukraine, except for activities on cultivation and (or) use of plants included in the list № 3 of Table I of the List containing small quantities of narcotic substances, subject to conditions specified in parts two, three and four of this article, and activities for the cultivation of varieties of plants of the genus Cannabis for medical, industrial purposes, in scientific and scientific-technical activities, namely activities for cultivation and (or) use of plant varieties genus of hemp (Cannabis).

Cultivation and (or) use of plants included in list № 3 of Table I of the List containing small quantities of narcotic substances for industrial purposes specified in the license may be carried out by legal entities of all forms of ownership if they have a license within the limits set by the Cabinet of Ministers Of Ukraine quotas. The maximum permissible content of narcotic substances in plants included in list № 3 of Table I of the List is established by the Cabinet of Ministers of Ukraine at the request of the central executive body, which ensures the formation of state policy in the field of drugs, psychotropic substances, their analogues and precursors. circulation.

Activities for cultivation of cannabis varieties for medical purposes, scientific and scientific-technical activities with low tetrahydrocannabinol content are carried out in open or closed soil exclusively with the use of conditioned seeds or planting material that meet the requirements of the Law of Ukraine “On Seeds and planting material “.

Activities for cultivation of cannabis varieties for medical purposes, scientific and scientific-technical activities with high tetrahydrocannabinol content are carried out exclusively in closed soil, using conditioned seeds or planting material that meet the requirements of the Law of Ukraine “On Seeds and Planting material”.

For cannabis cultivation activities (Cannabis) for use in scientific and scientific-technical activities it is allowed to use additional, basic and certified seeds and source, basic and certified planting material that meet the requirements of the Law of Ukraine “On Seeds and Planting Material”.

Cultivation of plants included in the list № 3 of Table I of the List containing small quantities of narcotic substances for industrial purposes specified in the license is carried out by using conditioned and reproductive seeds purchased in the manner prescribed by the Cabinet of Ministers of Ukraine, at the request of the central executive body, which ensures the formation of state policy in the field of trafficking in narcotic drugs, psychotropic substances, their analogues and precursors, combating their illicit trafficking.

Legal entities – which have received a license to cultivate and (or) use plants included in the list № 3 of Table I of the List containing small quantities of narcotic substances for industrial purposes specified in the license, are obliged to take measures to ensure the statutory regime protection of crops, places of storage and processing of these plants.

Legal entities that have received a license to cultivate and (or) use varieties of plants of the genus Cannabis for medical, industrial purposes, scientific and technical activities are required to:

enter into an agreement with a testing laboratory for quality control of medicinal products to carry out activities in accordance with the legislation on technical regulations and conformity assessment, or ensure the continued operation of such laboratory in the production complex where cultivation is carried out, in order to control quality and control its content of tetrahydrocannabinol;

ensure access to the National Police to the areas and facilities where (c) the cultivation, storage, use or destruction of such plants, products of their processing, for the selection and testing of samples of such products in the manner and according to the methodology approved by the Ministry of Internal Affairs of Ukraine . »;

7) Article 16 shall be worded as follows:

” Article 16. Activities for the development of new narcotic drugs or psychotropic substances

Activities for the development of new narcotic drugs or psychotropic substances are allowed only for the purpose of their use for medical purposes or for scientific and scientific-technical activities in any form.

Activities for the development of new narcotic drugs or psychotropic substances are carried out by scientific institutions of state, municipal and private forms of ownership if they have a license for this type of activity.

The development of new narcotic drugs or psychotropic substances is carried out in accordance with the legislation on medicinal products. New narcotic drugs or psychotropic substances in medical practice are used subject to their state registration and the implementation of clinical trials conducted in accordance with the legislation on medicinal products. “.

8) Article 17 shall be worded as follows:

Article 17. Activity on production, manufacture, storage, transportation, acquisition, sale (release), import into the territory of Ukraine, export from the territory of Ukraine, use, destruction of narcotic drugs, psychotropic substances, plants included in Tables II and III of the List, and precursors included in Table IV of the List “;

Activities for the production, manufacture, storage, transportation, purchase, sale (sale), import into Ukraine, export from Ukraine, use, destruction of narcotic drugs, psychotropic substances, plants included in Tables II and III of the List, carried out by legal entities of all forms of ownership, if they have a license to carry out relevant activities and ensure the traceability of the circulation of varieties of hemp (Cannabis), processed products and medicines produced from them at all stages of such circulation in the manner prescribed by the central executive body, which ensures the formation of state policy in the field of trafficking in narcotic drugs, psychotropic substances, their analogues and precursors, combating their illicit trafficking.

Production, manufacture of narcotic drugs, psychotropic substances included in Tables II and III of the List are carried out within the quotas set by the Cabinet of Ministers of Ukraine;

The following restrictions apply to the activities specified in part one of this article in respect of narcotic drugs and (or) psychotropic substances made (produced) from the circulation of varieties of plants of the genus Cannabis:

production, manufacture, sale and export of such narcotic drugs and (or) psychotropic substances from the territory of Ukraine may be carried out only at the request of business entities that have a license to use such narcotic drugs and (or) psychotropic substances or health care facilities other countries whose legislation allows the import of such narcotic drugs, psychotropic substances into their customs territory;

transportation of such narcotic drugs and (or) psychotropic substances is allowed only on order or directly to persons licensed to manufacture, manufacture and (or) use such narcotic drugs and (or) psychotropic substances, unless otherwise provided by this Law;

the use of such narcotic drugs and (or) psychotropic substances may be carried out in medical practice only in the form of drugs permitted for use by the central executive body that ensures the formation and implementation of state health policy in the prescribed manner.

Activities for production, manufacture, storage, transportation, purchase, sale (sale), import into Ukraine, export from Ukraine, use, destruction of precursors included in Table IV of the List, as well as cultivation of cannabis plant varieties (Cannabis) for medical the purposes are carried out by legal entities of all forms of ownership, if they have a license to carry out the relevant activities, unless otherwise provided by this Law. “.

9) Article 20 shall be worded as follows:

“Article 20. Activities on the use of narcotic drugs, psychotropic substances and precursors in scientific, scientific-technical and educational activities

Activities on the use of narcotic drugs, psychotropic substances and precursors in scientific, scientific, technical and educational activities are allowed to legal entities of all forms of ownership if they have a license for this activity in the manner prescribed by the Cabinet of Ministers of Ukraine.

Preclinical studies and clinical trials of medicinal products made from varieties of plants of the genus Cannabis are carried out in the manner prescribed by the legislation on medicinal products.

The procedure for accounting and control of the use of cannabis, narcotic drugs, psychotropic substances and precursors in scientific and scientific-technical activities is determined by the central executive body, which ensures the formation of state policy in the field of narcotic drugs, psychotropic substances, their analogues and precursors , counteracting their illicit trafficking.

If non-compliance with the requirements of this Law on the use of plants, narcotic drugs, psychotropic substances and precursors has led to misuse or illicit trafficking in narcotic drugs, psychotropic substances and precursors, the perpetrators shall be administratively and criminally liable in accordance with law. “;

10) parts one to three of Article 21 shall be worded as follows:

“Narcotic drugs, psychotropic substances included in Tables II and III of the List, precursors included in Table IV of the List may be used in medical practice. Medicines made (cannabis) from plants of the genus Cannabis are approved for use in accordance with current legislation. The central executive body that ensures the formation of state policy in the field of trafficking in narcotic drugs, psychotropic substances, their analogues and precursors, combating their illicit trafficking determines the percentage of tetrahydrocannabinol in the dry mass in cannabis varieties for medical purposes with small and high content of THC; “.

Legal relations related to the circulation of narcotic drugs, psychotropic substances included in Tables II and III of the List, and precursors included in Table IV of the List, which are permitted for use in medical practice, are subject to the legislation on medicinal products in part not contradicts this Law.

Health care institutions of all forms of ownership and natural persons – entrepreneurs who have a license to conduct medical practice, carry out activities for the purchase, transportation, storage, release, use and destruction of drugs, psychotropic substances included in Tables II and III of the List, and precursors included in Table IV of the List, admitted for use in the manner prescribed by law, if they have a license to carry out relevant activities in the manner prescribed by the Cabinet of Ministers of Ukraine. “;

11) Article 22 shall be worded as follows:

” Article 22 Use of narcotic drugs and psychotropic substances to provide medical care to patients entering Ukraine, leaving the territory of Ukraine or transiting through the territory of Ukraine.

In order to receive medical care, a patient who enters the territory of Ukraine, leaves the territory of Ukraine or transits through the territory of Ukraine, may import into the territory of Ukraine, export from the territory of Ukraine or transport through the territory of Ukraine drugs and (or) psychotropic substances , included in Tables II and III of the List, as well as medicines manufactured from them in the amount not exceeding the amount prescribed by a doctor’s prescription issued to such a patient, and without the need to obtain a permit under Article 24 of this Law.

If the patient mentioned in part one of this article, who enters the territory of Ukraine or passes through the territory of Ukraine, and is a citizen of another state or stateless person, is detained in Ukraine and requires additional purchase of narcotic drugs, their release is carried out according to a prescription issued in Ukraine in accordance with the procedure for providing medical care to foreigners and stateless persons temporarily staying in Ukraine, approved by the central executive body, which ensures the formation of state policy in the field of drugs, psychotropic substances, their analogues and precursors , counteracting their illicit trafficking. “;

12) Article 25 after Part Two shall be supplemented with a new Part Three as follows:

In this connection, part three shall be considered part four;

“Storage of narcotic drugs, psychotropic substances, precursors and manufactured (manufactured) medicinal products from plants of the genus Cannabis for medical purposes without the use of special facilities and (or) equipment may be carried out by an individual subject to Article 27 of this Law. does not exceed the amount of such drugs, substances, precursors in medicines, allowed for such a person on a prescription issued by a doctor in the manner prescribed by the central executive body, the central executive body that ensures the formation of state policy in the field of drugs, psychotropic substances, their analogues and precursors, counteracting their illicit trafficking. “;

13) part one of Article 26 shall be worded as follows:

In this connection, part three shall be considered part four;

“Activities for the transportation of narcotic drugs, psychotropic substances and precursors on the territory of Ukraine are carried out by economic entities of all forms of ownership if they have a license for this type of activity. Transportation of varieties of the genus Cannabis for use in medical practice or in scientific and scientific-technical activities may be carried out by health care institutions, scientific institutions, other economic entities if they have a license for this type of activity. “;

14) in Article 27:

the first part shall be worded as follows:

“Acquisition by an individual for medical indications of medicinal products containing narcotic drugs, psychotropic substances included in Tables II and III of the List, precursors included in Table IV of the List, medicinal products made (manufactured) from varieties of cannabis (Cannabis) for medical purposes, is carried out on a doctor’s prescription, issued in electronic form in the manner prescribed by law by the central executive body, which ensures the formation of state policy in the field of drugs, psychotropic substances, their analogues and precursors, combating their illicit trafficking. “;

part three shall be worded as follows:

“Retail sale to individuals of drugs containing narcotic drugs, psychotropic substances included in Tables II and III of the List, precursors included in Table IV of the List, drugs made (produced) from varieties of hemp (Cannabis) for medical purposes , allowed for use in medical practice, is carried out in pharmacies of all forms of ownership if they have a license for this activity .

Prescriptions for narcotic drugs, psychotropic substances included in Tables II and III of the list, and registration of the
release of such drugs are carried out exclusively in electronic form
through the electronic health care system in accordance with the legislation
of Ukraine. The procedure for registration, accounting and storage, as well as the
rules for issuing electronic prescriptions are determined by the central executive body, which ensures the formation of state policy in the field of drugs, psychotropic substances, their analogues and precursors, combating their illicit trafficking.

 

3. To supplement the Annex to the Law of Ukraine “On the List of Permitting Documents in the Sphere of Economic Activity” (Vidomosti Verkhovnoi Rady Ukrainy, 2011, № 47, p. 532) with the following paragraph 156:

 

«

156 Permission for the use of facilities and premises intended for the circulation of narcotic drugs, psychotropic substances and precursors. “ Law of Ukraine “On Narcotic Drugs, Psychotropic Substances and Precursors”

                                                                                                             ».

 

II. Final and transitional provisions

1. This Law shall enter into force three months after its publication.

2. The Cabinet of Ministers of Ukraine shall, within three months from the date of entry into force of this Law, ensure that the central executive bodies bring regulations into line with this Law.

 

 

Chairman of the Verkhovna Rada of Ukraine     

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