Last week, Ukraine’s law officially legalising medical cannabis came into effect, eight months after initially being passed.
Despite the positive progress, the list of diseases for which it will be prescribed, currently being decided upon by the Ministry of Health, does not yet include Post-Traumatic Stress Disorder (PTSD).
Despite this, plans are underway to ensure potential patients with conditions not included on the official list can still access medical cannabis treatment, though access is expected to be more restricted.
According to the Ministry of Health’s own figures, an estimated 6m patients in the country could benefit from medical cannabis, triple the 2m potential patients prior to Russia’s invasion, almost entirely due to the increase in those suffering from combat-related PTSD.
What happened?
Despite the Cabinet of Ministers allowing the use of two medical cannabis drugs in 2021, access and availability of these treatments have remained out of reach for Ukrainians.
On August 16, Ukraine enacted a new legal framework for medical cannabis, allowing for the cultivation, processing, and distribution of medical cannabis under strict licensing and quota regulations, focusing on medical, research, and educational purposes.
A number of by-laws, or details surrounding the bill, are still working their way through parliament at the time of writing.
Hanna Hlushchenko, Founder of Ukrainian Cannabis Consulting Group, told Business of Cannabis: “Long story short, the practical aspect is that the law has come into force, which is the most important part concerning the readiness of the documents. Most of the documents are prepared.”
On domestic cultivation, the Ukrainian Cabinet of Ministers still needs to adopt the licensing requirements, which are reportedly similar to what is seen elsewhere: ‘the government issues licenses for cultivation, and the facility must comply with Good Manufacturing Practice (GMP) and Good Storage and Distribution Practice (GSDP) standards’, Ms Hlushchenko explained.
“The necessary document for this process has already been prepared and is awaiting approval by the Cabinet of Ministers.”
However, as domestic supply is not expected to enter the market until around 2028, Ukraine is now accepting registrations from international companies hoping to supply the newly established market.
A streamlined production registration process has now been established, which could take as little as 30 days ‘if all documents are properly prepared according to Module Three of the Common Technical Document (CTD) format’, the standard method of registering active pharmaceutical ingredients (APIs).
“Based on this, I anticipate that the product could appear on the market as early as October or November,” Ms Hlushchenko added.
Companies wishing to register cannabis products must submit documentation to the State Expert Center of the Ministry of Health (DEC).
Distribution
Despite this rapid approval process, distribution remains an issue. There currently isn’t a specific license for cannabis, meaning local pharmaceutical distributors who are already licensed to handle narcotics will likely have a head start in the market.
She continued: “The situation with pharmacies is more challenging. Since the product would be prescribed based on magistral preparations, pharmacies must be able to produce these preparations.
“Unfortunately, this market is underdeveloped in Ukraine, with most pharmacies lacking the capacity to produce magistral preparations. Additionally, not all pharmacies are licensed to handle narcotics, limiting the number of pharmacies that can supply cannabis to around 200.”
The Cabinet of Ministers has now moved cannabis and related products like resins and extracts from the strictest category (Table I) of controlled substances to a less restrictive one (Table II), but the cannabis plant itself remains in Table I.
Furthermore, the law stipulates that all activities, including prescribing, related to medical cannabis must be entered into an electronic tracking system, which is not expected to be operational until October, 2024.
According to Ms Hlushchenko, there are currently two separate tracking systems being developed.
The first system is an electronic platform designed to track the activities of cannabis cultivators. This system will require cultivators to input details about their production processes, including the seeds used and other relevant production data.
“The second system is focused on ensuring that prescriptions for cannabis products are issued electronically. The law clearly states that it is impossible to issue non-electronic prescriptions. However, the system responsible for issuing these electronic prescriptions is not yet complete. The Ministry of Health, which is responsible for this system, has indicated that it should be ready by October.”
Regulations on industrial hemp have similarly been eased, reducing the need for quotas and expanding its potential for commercial use.
Who can access medical cannabis?
The Ministry of Health had until August 16 to finalise the list of conditions eligible for medical cannabis treatment and the forms of cannabis products allowed. However, key documents for patients are still being decided upon.
The list of conditions, still making its way through the final stages of approval in the Verkhovna Rada (Ukraine’s Parliament) will focus on chronic and neuropathic pain, but include other conditions such as Parkinson’s and refractory epilepsy.
Notably, however, the Ministry of Health refused calls to include PTSD or PTRS on the list. Its ‘conservative position’ on this condition is due to research cited by the ministry suggesting cannabis is not especially helpful in treating the condition.
“We worked hard to include more conditions, but the Ministry of Health has taken a conservative approach. For example, we pushed for the inclusion of conditions like insomnia and PTSD, but these were not added.”
However, Ms Hlushchenko believes a compromise may have been reached ‘that allows some flexibility’.
As seen in the list of conditions below, unspecified ‘other diseases’ are included. “This means that if a patient needs cannabis for a condition not explicitly listed, they can go to a healthcare institution where a commission of doctors can review the case. If the commission decides the patient needs cannabis, they can prescribe it even if the condition isn’t on the original list.
“There is a very small chance that this specific list will change, but it’s unlikely… This decision does limit the possibilities, but those who are advocating for the inclusion of PTSD are now trying to initiate a study at the ministry level. The plan is to gather patients with PTSD, provide them with cannabis, and monitor its effects to gather more evidence.”
Speaking to local news publication Espreso, Olha Stefanyshyn, a member of the Committee of the Verkhovna Rada of Ukraine on National Health, Medical Assistance and Medical Insurance, said: “We are negotiating so that this position will change in the near future, but most of the diseases are already included in the list, and patients will be able to get these drugs by prescription.”
In a separate interview with Unian, she added: “We call on the Ministry of Health, after this act is adopted, to still listen to the international community and add these states as well. Because, I think, it is extremely relevant in Ukraine today.”
“Before the war, before such active military operations, we had two million people only with oncology, epilepsy, and various such conditions. And now it is another plus four, probably millions. In general, the information is estimated, but I think that it corresponds to reality.”
The current list of conditions for which medical cannabis can be prescribed is as follows:
- Chronic or neuropathic pain (R52.2)* and/or spasticity (R25.2) which are caused by such diseases as:
– malignant neoplasms (C00 – C97);
– diabetic neuropathy (E10.4, E11.4, E12.4, E13.4, E14.4);
– multiple sclerosis (G35);
– damage to the trigeminal nerve (G50);
– damage to the facial nerve (G51);
– neuralgia due to shingles (G53.0);
– damage to nerve roots and plexuses (G54);
– compression of nerve roots and plexuses in diseases (G55);
– mononeuropathy of the upper limb (G56);
– mononeuropathy of the lower limb (G57);
– polyneuropathies and other lesions of the peripheral nervous system (G60-G64);
– cerebral palsy and other paralytic syndromes (G80 – G83);
– spinal cord injuries (S14.0, S14.1, S14.7, S24.0, S24.1, S24.7, S34.0, S34.1, S34.3, S34.7, T09.3, T91.3);
– intracranial injuries (S06). - Nausea and vomiting (R11) caused by chemotherapy (Z51.1) during treatment of neoplasms (C00 – C97)
- Parkinson’s disease (G20)
- Combined vocal tic with multiple motor tics (de la syndrome Tourette’s) (F95.2).
- Refractory (pharmacoresistant) epilepsy (G40 – G41).
- Diseases that cause seizures in childhood, such as the syndrome Lennox-Gastaut (G40.4), Dravet syndrome (G40.4), tuberous sclerosis (Q85.1).
- Weight loss associated with anorexia (R63.0) in patients with diseases caused by human immunodeficiency virus (B20-B24).
- Other diseases (A00 – T98)**.
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Author: Business of Cannabis
