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A historic decision. The Parliament adopted the draft law No. 7457 on the use of cannabis-based drugs in medicine

21 December 2023
25

The Verkhovna Rada of Ukraine has adopted in the second reading the draft law No. 7457 “On Regulation of the Turnover of Cannabis Plants for Medical, Industrial, Scientific and Technical Purposes”. 248 people’s deputies voted in favor.

Draft law No. 7457 was significantly revised for the second reading. After the first reading, almost 900 amendments were submitted, of which more than 100 were taken into account.

This is another step towards improving the quality of healthcare services in Ukraine for millions of people: cancer patients, people with multiple sclerosis, and epilepsy, patients receiving palliative care, etc.

“The adoption of draft law No. 7457 is both a great victory for humanism and the beginning of a long journey to implement all the voted norms. There is a lot of work ahead, but the first step has been taken. Millions of people have been waiting for it. Today, all of them finally got a chance for a better quality of life. I would like to emphasize an important point: the state will strictly control the circulation of cannabis-based medicines, and its use for recreational purposes will remain prohibited,” said Viktor Liashko, Minister of Health of Ukraine.

To carry out activities related to the cultivation, import/export, production, storage, etc. of medical cannabis, a business entity must obtain a license.

For example, the law allows the cultivation (growing) of medical cannabis in Ukraine only with strict compliance with the requirements. It should only take place in an enclosed environment (e.g., a greenhouse), with round-the-clock video surveillance and free round-the-clock access to the National Police.

The adopted document also stipulates that each plant, batch of processed products, unit of packaged products, and packaging of a cannabis-based drug will be marked with a unique electronic identifier. The data will be entered into a specially created unified information database.

Since the launch of the domestic production mechanism will require some time to get medical cannabis medicines to patients faster, the first stage will be based on imported raw materials. To do this, a business entity needs to obtain a license to import raw materials, as well as related licenses (transportation, storage, sale, etc.) and register such imported cannabis plant substance (active pharmaceutical ingredient) in the State Register of Medicines. After that, it will be possible to produce medicines from it.

The Ministry of Health will approve a list of diseases and conditions for which patients can be prescribed medicines based on medical cannabis. The dispensing of medicines based on medical cannabis will be possible only upon a doctor’s prescription following medical indications and on a prescription (as is the case with narcotic and psychotropic drugs). Patients will be able to transport and store such medicines in the amount specified in one prescription.

The use of plants of the genus Cannabis for other than medical, industrial, scientific and technical purposes is prohibited.

The law comes into force on the day following the day of its publication, and is put into effect six months after the date of entry into force. Within three months, the Cabinet of Ministers must bring all regulatory acts in line with the adopted law: create 5 new ones and amend 12 existing ones.

Cannabis-based medicines are authorized in 56 countries, including the EU, Canada, the United Kingdom, and the United States.

 

For reference: the therapeutic effect of cannabidiol (CBD) contained in cannabis and the effectiveness of its use for medical purposes have been confirmed by numerous scientific studies and conclusions of specialized international institutions. In particular, the World Health Organization (WHO) Expert Committee on Drug Dependence published reports in June 2018 and January 2019 in which, based on the analyzed data from preclinical and clinical research studies, it came to the unequivocal conclusion that CBD is not a psychoactive substance, belongs to natural cannabinoids, does not lead to drug intoxication, does not cause addiction, has no serious side effects, and has significant therapeutic potential.

The International Narcotics Control Board, an independent body established by the United Nations responsible for monitoring compliance with international conventions in this area, in its 2019 report once again emphasized the need to ensure the availability of medicines containing narcotic substances in accordance with international law, which, in particular, includes the authorization of the use of cannabis for medical and research purposes.