Ukraine has officially voted to legalise medical cannabis in what its Health Minister described as a ‘great victory for humanity and the beginning of a long journey’.
After sifting through nearly 1000 amendments, the Verkhovna Rada (Ukraine’s unicameral parliament) voted to regulate cannabis for medical, industrial and scientific purposes.
The new law is now set to be put ‘into effect’ six months after it is entered into force by President Volodymyr Zelenskyy in January, which means Ukrainian citizens will be able to access medical cannabis ‘some time in the second half of 2024’.
Hanna Hlushchenko, Business Development Director at the EU-based medical cannabis licensed producer Cannexpor Pharma, who is now working with the Ukrainian Government to help draft the regulatory framework, told Business of Cannabis that the ‘market is now open’.
“In my opinion, Ukraine will develop quickly due to the fact that we’ve seen the Ministry of Health discuss plans to make product registrations shorter, somewhere around two months, because of the need for the people to get the product.
“I might be optimistic due to the fact that I’m Ukrainian, but I believe the market in Ukraine will develop faster, not only because of the product registration process, but mainly because of the war and the actual needs of soldiers.
“Speaking to hospitals and different people from the military, they are telling me that cannabis is now very widely used. That’s why I believe there will be a huge push in the market.”
What happened?
After the bill passed its first reading in July, on October 10 the proposed legislation was finalised and approved by the National Health, Medical Care and Health Insurance Committee, enabling the bill to progress to a second and final reading in the Verkhovna Rada.
A second reading was scheduled to take place on Wednesday November 22, and the bill was widely expected to sail through.
However, Business of Cannabis reported last month that despite having widespread support throughout the country, including from President Zelenskyy, the reading was delayed due to the actions of a single opposition party, the All-Ukrainian Union ‘Fatherland’ party, referred to as Batkivshchyna, led by former Ukrainian Prime Minister Yulia Tymoshenko who opposes the bill.
After submitting hundreds of ‘spam’ amendments designed to bog down the Verkhovna Rada, the vote was delayed until yesterday (December 21, 2023).
Ukraine’s medical cannabis framework
After considering around 900 proposed amendments, and adopting 100 of those, 248 ‘People’s Deputies’ voted for draft law #7457.
This ‘substantially revised’ bill will enable businesses which obtain the correct licensing to cultivate, import, export, produce and store medical cannabis.
Ms Hlushchenko explained that the passage of the law only provides ‘the possibility to do this’, and the details of the framework beyond that basic model have not yet been defined.
“Basically, there is no clarity on which doctors will be able to prescribe, or for which conditions.”
The Ministry of Health will approve the list of conditions for which medical cannabis can be prescribed in the coming months.
Furthermore, there is also a lack of clarity over the distribution, as currently medical cannabis is ‘supposed to be distributed as an active pharmaceutical ingredient’ (API), which in countries like Germany and Poland can only be sold by pharmacies which produce the product on premises.
“There are only 200 Ukrainian pharmacies that are allowed to produce medicines within, so there is a question mark over how this issue will be solved,” Ms Hlushchenko continued.
As a potential solution, she suggested that either changes could be made to enable API’s to be sold in regular pharmacies, or there could be a ‘boom’ in pharmacies which are able to produce pharmaceuticals.
Imports allowed
Crucially, in a major change to the previous draft, businesses will now be allowed to import raw materials for the production of medical cannabis products, with the Ministry of Health recognising that the establishment of domestic cultivation will ‘require some time’.
Ms Hlushchenko said: “My main concern was that in the first draft before the second hearing, import was prohibited. It was completely wrong.”
Executive director of campaign group ‘Patients of Ukraine’ Inna Ivanenko added: “Thanks to the possibility of import, patients will be able to get medicines in pharmacies that have the appropriate licence in six months. In addition, after the development of all the necessary by-laws, Ukraine will be able to independently manufacture such medicines.”
Some of the provisions that are clear include tight restrictions on cultivation. Areas where cannabis is cultivated must be under 24-hour video surveillance, to which the police must be allowed 24-hour access.
Furthermore the cannabis will be marked with a unique electronic identifier at each stage of its production process, and entered into a specially created unified information hub.
Medical cannabis patients will also need to obtain an ‘electronic prescription’ granted by the doctor based on their condition, ‘as is currently the case with morphine’. Patients will be able to carry and store such drugs in the amount determined by a single prescription.
Michael Sassano- Founder, Chairman & CEO of Somai Pharmaceuticals, told Business of Cannabis: “Ukraine is headed towards cannabis legalisation which will align themselves next to German cannabis reform. As pivotal as Ukraine is right now, incremental gains like cannabis regulations should bring some relief to the people that need and can benefit from medicinal cannabis.”
