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Counsel, Head of Pharmaceuticals & Healthcare, Asters
Evolution and Perspectives of Cannabis Regulation in Ukraine
The global cannabis market is estimated to be valued at USD 20.5 billion in 2020 and is projected to reach USD 90.4 billion by 2026, recording an annual growth rate of 28%, in terms of value. This makes the cannabis industry one of the fastest growing in the world.
But there also are actual human lives behind these figures. Medical significance of cannabis is no longer in debate. It is only the scope of it that is still being researched. Studies have shown that cannabinoids can help patients with nausea and vomiting in cancer and AIDS, facilitate treatment of asthma and glaucoma and be used as an antidepressant, appetite stimulant, anticonvulsant and anti-spasmodic.
In December 2020 the United Nation’s drug policy-making body removed cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs. Cannabis had been on that list for 59 years alongside most dangerous opioids (including heroin), which generally discouraged its use for medical purposes. This decision officially opened the door to recognizing the medicinal and therapeutic potential of the drug, though many countries had already done so long before that.
Let’s have a look at where Ukraine stands in terms of cannabis regulation, as compared to global trends.
For many years Ukrainian regulation of cannabis has been extremely restrictive:
- Cannabis (including its resin, extracts and tinctures): classified as schedule I substance is banned in Ukraine;
- Tetrahydrocannabinol (THC), main psychoactive component of cannabis: classified as schedule I substance banned in Ukraine;
- Cannabidiol (CBD), another cannabinoid with no psychoactive effect and huge potential for health and food industries: not separately classified as a controlled substance. However, due to a mix of restrictions and lack of clarity in regulations, CBD products may not be produced domestically and are in the grey legal zone in terms of import.
Permitted local operations only include license-based cultivation of industrial hemp for fiber and seeds, subject to a very low THC limit of 0.08%. Even this narrow segment of the hemp cultivation business is excessively controlled by the Government.
Until recently, medical use of cannabis was fully prohibited. Patients had no legal access to cannabinoid-based treatments available abroad and had to come up with ways to go around the system to get them.
Against this background, Ukrainian patient organizations have been advocating for access to medical use of cannabis, hitting against the wall of rejection from the State. In 2021 it appeared that the wall was finally starting to crack. But is it really?
In April 2021, the Government changed regulations for cannabis as follows:
- the Ukrainian market is now potentially open for a limited scope of cannabinoid-based pharmaceuticals and active pharmaceutical ingredients for their production. In particular, nabilone and nabiximols (in addition to dronabinol that already had similar status) were classified as controlled substances that may be used in medical practice on prescription basis. They will however be subject to control measures, similar to the ones currently applicable to morphine, that are complex and burdensome in Ukraine;
- it was clarified that CBD isolate is exempted from drug control. This should clear the way for pharmaceuticals and other products based on CBD isolate.
Other than that, the regulation of cannabis remains unchanged.
While this liberalization is a first move forward, it alone will not be sufficient to do the job. The Ukrainian patient community is raising concerns that the effect of new regulation will be limited (if any), as it only covers a narrow scope of high-cost pharmaceuticals and does not adequately address the need for affordable cannabinoid-based treatments. Local cultivation of medical cannabis remains unavailable.
Moreover, drug control exemption for CBD isolate only is highly conservative and not in line with current international practice. In many EU jurisdictions, not only CBD isolate, but also other cannabis products with minimum THC content (up to 1%, depending on the country) are exempt from the majority of drug control measures.
It remains to be seen whether the new regulation will be able to make at least some cannabinoid-based medicines actually available in Ukraine. To reach Ukrainian patients pharmaceuticals will need to go through a lengthy process. This would only be possible if their manufacturers and distributors see the potential of the local market and would be prepared to go through local bureaucratic hurdles surrounding the circulation of controlled substances.
At this stage Ukraine is still far from becoming a player in the growing global cannabis industry and granting sufficient access to cannabinoid-based treatments for patients who need them. Changing that would require a significantly more comprehensive regulatory shift on the legislative level.
Close, but No Cigar
In late 2020 — early 2021, members of parliament introduced several proposals for legislation on cannabis. Further in June, those were consolidated in a single bill put before the Ukrainian Parliament. The bill was supported by a large group of representatives from different political parties, as well as the Ministry of Health of Ukraine.
The bill provided, among other things, for the following:
- the regulatory treatment of cannabis would depend on its THC content. In particular, it was proposed to introduce 2 major categories falling under limited legalization: (a) medical cannabis with THC content starting from 0.2%, and (ii) industrial hemp with THC content of up to 0.2%;
- products derived from medical cannabis would be permitted for medical use in Ukraine based on e-prescriptions, but only to the extent they qualify as pharmaceuticals authorized by the Ministry of Health;
- controlled local cultivation of medical cannabis would be allowed both for the internal market and export. This had the potential to increase the affordability of cannabinoid treatments for Ukrainian patients and create business opportunities for Ukraine;
- various types of safeguards were suggested to prevent the risk of illicit distribution (including licensing, laboratory testing, labelling and traceability system, physical security requirements, prescription only access for patients etc.);
- in line with existing international practice, it was proposed to establish a relaxed regulatory regime for the cultivation of industrial hemp and operations with low-THC products (subject to the THC limit of 0.2%);
- CBD would be clearly exempted from drug controls in Ukraine;
- it would finally create a legal basis for research and development in the cannabis field that has been blocked for many years due to gaps in legislation.
The bill was quite conservative in its regulatory approach, but the first attempt to pass it through the Parliament still failed. In July 2021, it was put to the floor of the Parliament for the first reading but did not get enough votes from MPs.
Nevertheless, given that the bill has strong advocates among different political forces and its public support is growing, we believe there is a fair chance of it being resubmitted to, and eventually pushed through, Parliament, though perhaps in a modified form.
If we Wait until Everything is Ready, we will Never Begin
Liberalization of Ukrainian regulations on cannabis is long overdue. Ukrainian patients are striving for it. Medical cannabis, industrial hemp and CBD wellness industries are quickly developing globally in a completely legitimate way. The tide for cannabis is changing. It is now for our policymakers to decide if we will surf the wave.