Back in February, President Zelensky signed off on law 3528 - IX, also known as The Medical Cannabis Law, kickstarting the process of legalising medical cannabis in Ukraine.
Initially proposed in late spring last year, this bill seeks to allow access to cannabis-based treatments for those suffering from conditions like cancer, chronic pain and PTSD, to offer therapeutic and medicinal comfort and compassion, while the Russia War rages on.
When President Zelensky signed this legislation, the Ukrainian government was given six months to implement, and adjust, any necessary regulations, rules, and requirements that may be needed to provide the residents of Ukraine safe and standardised access to medical cannabis.
Ukraine is now only a few months away from its goal enforcement or enactment date of 16 August, and over the last few weeks, a number of by-laws have been created, discussed, and approved, helping Ukraine get closer and closer towards its goal of facilitating access to medical cannabis.
Ukraine's Medical Cannabis Law: Law 5328 - IX
Although the Medical Cannabis Law was officially proposed less than a year ago, activists in the country have been campaigning for access to cannabis-based options for years. However, since the Russian invasion in February 2022, the amount of people in Ukraine who could potentially benefit from these treatments is said to have tripled.
According to the Ukraine Ministry of Health, up to six million people now live with mental health conditions like PTSD, or are suffering from chronic pain related to their injuries, or have been diagnosed with cancer - showing the growing need for additional, adjunctive, and alternative treatment options like medical cannabis in Ukraine.
And although many Ukrainians were, and are, supportive of the legalisation of medical cannabis, and this bill was heavily backed by wartime volunteers and veterans, it did face considerable opposition from some of the more traditional and conservative groupings during its discussion period.
Ultimately, it was decided by President Volodymyr Zelensky, that those who are deemed eligible or may be able to benefit from these options should have the right to access them.
It's believed that imported cannabis-based treatments will be available to eligible patients in Ukraine by the end of this summer, and a domestic supply of medical cannabis is not expected until around 2028.
A brief overview of the approval of medical cannabis legalisation
During the law's first reading in July last year, both the President and The Health Minister of Ukraine expressed their support for its enactment due to the country's growing mental health crisis as a result of the war.
And although this legislation did face some opposition during its second reading, on 21 December, 2023, Ukraine’s parliament adopted The Medical Cannabis Law (law 3528-IX), with a plan to make these options accessible to those that need them, by the end of summer 2024. 248 lawmakers voted in its favour.
On 13 February, President Zelensky signed the official legislation, giving the Ukrainian government six months to update the existing legislation's that may be impacted and develop new ones where appropriate, to accommodate for the legalisation of medical cannabis.
Necessary amendments to accommodate the legalisation of medical cannabis
Before its implementation in August 2024, the Ukrainian government is expected to update the scheduling or classification of cannabis, and its derivatives, in Ukraine's Narcotics, Psychoactive Substances and Precursors list.
Similarly, amendments to the current regulations in place surrounding the circulation of psychoactive or narcotic substances are required to reflect this change in law.
Guidelines for pharmacies and cultivators must also be produced, explaining how procurement, compounding, and quality control measures will be governed or regulated, and which forms of cannabis-based medicines will be permitted for prescriptions.
A list of conditions and diseases that are deemed eligible for medical cannabis applications in Ukraine, and set regulations surrounding the prescription, must also be established before August, to ensure those who need these treatments can access them.
But, we’re happy to report, these expectations are being met.
Legal recognition of the cannabis' therapeutic and medicinal applications
Exactly one month after President Zelensky signed on the dotted line, the Ukrainian Scientific Pharmacopoeia Centre for Quality Medicines pre-published the cannabis flower monograph that will appear in volume 2 of the State Pharmacopoeia of Ukraine 2.7.
Pharmacopoeia’s serves as a single reference for official standards and requirements that have been created to ensure the safety, efficacy, and standard of a specific medicinal product or substance. They are essentially published as a set of guidelines, and the monographs they contain have detailed information about each medicinal product.
The pre-publishment of this monograph is identical to the one that appears in the European Pharmacopoeia, and it contains information regarding how medical cannabis flower should be handled to ensure it is safe, suitable, and of a high, consistent quality.
Amendments to the list of Narcotic Drugs, Psychotropic Substances and Precursors
Later, on the 1st of April, a draft resolution to amend the list of Narcotic Drugs, Psychotropic Substances and Precursors was also published by Ukraine’s Ministry of Health.
In this resolution, it was proposed that to reflect the acceptance of Law 3528-IX (on medical cannabis), cannabis, cannabis resin, cannabis extracts and tinctures, as well as THC and a number of its isomers, should be moved from their current scheduling of List 1, to List 2.
It was also suggested that certain licensed cannabis-based medicines, like Nabilone, Nabiximols and Dronabinol are excluded from List 2, and the THC limit that is currently imposed on industrial hemp in Ukraine, is raised from 0.08% to 0.3%.
This proposal has since been accepted, by the Cabinet of Ministers in Ukraine, on 29 April.
Amendments and updates that allow for the prescription of cannabis-based treatments in Ukraine
On the same day, it was reported that the Ministry of Health also released a draft order that provides prescribing guidelines. This draft proposes that when cannabis-based prescriptions are written, they should be available, and issuable, in both physical paper, and electronic form to ensure accessibility and traceability.
This draft is open for public discussion on the Ukrainian Ministry of Health website, and will stay open for discussion for up to 30 days after publishing, so, is still currently open.
After this, official deliberations will take place.
Developments in the regulation of cannabis-derived treatments in Ukraine
In May, The State Service of Ukraine for Medicinal Products and Drug Control added to the efforts made by other governmental departments, and released a draft resolution that outlines regulations and licensing requirements for medical cannabis.
A draft for the processes involved in selecting cannabis plants for scientific or laboratory testing was also released by The Ministry of Health at the end of April, again with suggestions welcomed until the end of May.
Closing considerations
It’s clear to see that the Ukrainian government is taking proactive steps to ensure this law will take effect in a timely manner for those who need it, and it appears they are on track to reach their target enactment date of the 16th of August.
So far, the Narcotics, Psychoactive Substances and Precursors list has been updated to reflect this change, and regulations to ensure the safe use, and prescription of, medical cannabis have been drafted.
As summer draws closer, frameworks to ensure medical cannabis can be accessed by those deemed eligible, are expected, as well as a complete list of conditions deemed suitable for cannabis-based treatments.
While challenges remain and there is more work to be done, we’re pleased to report that progress is being made, and the Ukrainian government seem committed to enabling access to medical cannabis for those who may be able to benefit from these options.
