Health Minister Maksym Stepanov (left) and Prime Minister Denys Shmyhal (Photo: UNIAN)
The Cabinet of Ministers has expanded the list of cannabis-based medications that can be used in medicine. Critics are calling this decision an attempt at lobbying and "blindfolding." What the government actually decided to do is discussed below. RBK-Ukraine.
Medical cannabis has been partially legalized in Ukraine. Last week, headlines like these were shared about a Cabinet of Ministers decree that authorized several cannabis-based medications, Nabilone and Nabiximols, for limited use. Another substance, cannabidiol isolate, has been removed from state control. This should also provide patients with greater access to the medication.
Despite the fact that marijuana legalization is still a long way off, many are unhappy with the Cabinet's decision. Those who previously advocated for the free circulation of medical marijuana believe it will do little to help patients. Some critics blame the Ministry of Internal Affairs, which has resisted cannabis legalization in recent years, for these half-measures. Other skeptics believe the Ministry of Health is also involved, allegedly lobbying for specific manufacturers and medications.
The Ministry of Internal Affairs states that it supports the legalization of cannabis, but only in the form of medicinal products needed by patients. They assert that the Ministry of Health is responsible for determining these products. The Ministry, however, defends the Cabinet's decision on cannabis-based medications, calling it a significant step. The ministry is convinced that such steps should be gradual. Otherwise, allowing everything at once could cause more harm than good.
Help, but not for everyone
For several years now, Ukraine has been announcing plans to legalize medical cannabis. However, attempts by the Cabinet of Ministers and the Verkhovna Rada to bring this to fruition have been fruitless. In 2016 and 2019, documents on marijuana circulation were submitted to parliament, but they never reached the floor.
President Volodymyr Zelenskyy brought up this issue in a nationwide poll held alongside local elections last October. The Presidential Administration stated at the time that at least 2 million people needed marijuana.
Cannabis can help patients with severe systemic pain, extreme anxiety and depression, and post-traumatic stress disorder. Marijuana can help ease the diagnosis of cancer patients, epileptics, and those suffering from Alzheimer's disease.
Zelenskyy promised that if the votes were positive, he would submit a bill legalizing medical cannabis. Servant of the People had previously expressed support for this idea. In a survey, nearly 65% of respondents supported legalization.
Access to narcotic drugs and psychotropic substances is regulated by Cabinet of Ministers Resolution No. 770. Substances are classified into several tables: some are completely prohibited, while others have limited circulation.
Last week, the government added two more cannabis-based drugs – Nabilone and Nabiximols – to the list of restricted medications. Dronabinol, another cannabis-based drug, was already listed in Table 2.
"Cannabis remains banned, and cannabis extract remains banned altogether. The government has only added two drugs to Table 2. It's worth paying attention to what these drugs are. This will clarify the rationale behind the Cabinet's decision," Taras Ratushny, co-organizer of the Freedom March for the Legalization of Medical Cannabis, told RBC-Ukraine.
Nabilone is a synthetic substance that mimics the effects of tetrahydrocannabinol. THC and cannabidiol (CBD) are the two main compounds found in cannabis. And, as Ratushny explains, approving this medication won't solve all patients' problems, as it is only prescribed for certain diagnoses, the expert says.
Moreover, Ratushny doubts this drug will ever reach the Ukrainian market. He noted that Dronabinol, another synthetic THC-based drug, has long been legalized but is still not available for sale.
"In fact, it's never been available to Ukrainian patients, and doctors have never prescribed it. It simply wasn't imported into Ukraine; it doesn't even have state registration. I predict the same thing could happen to Nabilone," the expert explained.
Nabilone is used, among other things, to treat certain symptoms in cancer patients after chemotherapy. Nabiximols helps relieve spasms in multiple sclerosis. It is also known as Sativex. This herbal remedy contains 50% THC and CBD. Ratushny believes Nabiximols may face legal conflicts and registration issues in Ukraine.
According to him, this drug is a standardized cannabis extract, which remains completely banned in Ukraine. Moreover, it contains tetrahydrocannabinol, which is also prohibited for circulation.
Another change introduced by the Cabinet of Ministers: "isolated cannabidiol substances (cannabidiol isolate)" will be exempt from state control. This refers to limiting quotas on production, consumption, and sales, Deputy Minister of Health Igor Ivashchenko explained to the publication. There is one drug on the market that contains this substance: Epidiolex. It helps treat epilepsy.
Ratushny believes that by authorizing these funds, the Cabinet of Ministers wants to dampen the debate around the legalization of medical cannabis, which is already approaching the finish line.
The fact is that members of parliament prepared four different bills to address this issue. Furthermore, the Ministry of Veterans Affairs proposed a different draft amendment to the resolution. It was publicly reviewed, and the deadline for suggestions and comments expired on February 25. But then the government adopted an entirely different resolution.
"This is a 'soap bubble' designed to convey the message that we've supposedly legalized medical cannabis and that patients' problems have been solved. In reality, they haven't been solved, nor have the problems of scientific research. Patients have been offered synthetic substitutes that significantly limit the use of cannabis-based medications, even compared to those used in other European countries," Ratushny asserts.
The Ministry of Health explains that they chose these particular drugs because they are indicated for the treatment of specific diagnoses and are used in countries with strong regulatory policies.
"Why were these medications included, and not more generally, as some activists proposed? The Ministry of Health is following the approach of European countries: we restrict circulation of medications that cannot be synthesized into narcotics. All countries do this because we are talking specifically about medications and the treatment of patients," Deputy Minister of Health Igor Ivashchenko told RBC-Ukraine.
When people want to grow "pots of cannabis," Ivaschenko counters, "that's a different matter, and governments haven't resolved it overnight." He noted that the Ministry of Health is prepared to move toward legalization in the future. However, it's important to avoid triggering another problem—the development of drug addiction.
"That's why the focus was on these medications. I'm sure people who take them will appreciate this step. And it's very significant. By allowing everything, we won't solve the drug addiction situation in Ukraine, but will only worsen it," the official explained.
Marijuana in the law
There are several ways to address the issue of broader patient access to medical marijuana. One is to move cannabis as a plant and its main component from Schedule 1 (complete prohibition) to Schedule 2 (limited access), says Ratushny.
The second option is to amend the law to allow the medical use of cannabis, currently listed in Table 1. This would allow the import of marijuana-based drugs into Ukraine and the study of this substance.
Ratushny noted that in 2019, Acting Minister Ulana Suprun attempted to push through partial legalization through the Cabinet of Ministers. However, Interior Minister Arsen Avakov blocked this decision. He then explained his position by saying that the legalization issue required a "unique constructive approach" and the definition of "red lines."
His deputy, Anton Gerashchenko, claims the Ministry of Internal Affairs supports the idea of legalizing medical cannabis. Specifically, the official clarified that THC-based products could be used for treatment. However, these products must be in the form of ampoules or tablets and used only for medical, not recreational, purposes.
"In our opinion, the Ministry of Health should initiate the use of tetrahydrocannabinol for treatment. It is the Ministry of Health that can determine which specific narcotics patients need. The Ministry of Health needs to demonstrate a willingness to contribute additional funds, and we will provide our position on this matter. This doesn't require a special law—amending Resolution No. 770 is sufficient," Anton Gerashchenko told RBC-Ukraine.
Government bylaws only partially address the legalization issue. The Cabinet of Ministers has the right to permit the use of cannabis substances or even finished medications, but they will still be imported from abroad. Legislative amendments are needed to launch production of these products in Ukraine. On the one hand, this will eliminate complete dependence on imports. On the other, it will reduce the cost of the drugs, as they include the patent price, production costs, and intermediaries' profits, says Ratushny.
"You can see how high the price of the drugs included in the Cabinet of Ministers' resolution is. If they are produced in Ukraine, they will be much cheaper. This will also help Ukraine economically, since this business is profitable for every country in the world," Olha Stefanishyna (Golos faction), a member of the parliamentary committee on public health, told the publication.
Members of parliament also have concerns about the Cabinet's resolution. However, some see it as the work of the Ministry of Health, not the Ministry of Internal Affairs. Stefanishyna calls the government's decision "blindfolding" that "will not help more patients."
"Developed countries are moving toward regulating the use of medical cannabis and its domestic production based on the active ingredient. Then, any drug based on medical cannabis can be consumed, used, or produced," the deputy complained.
According to her, patients should have the opportunity to choose based on price, quality, and effectiveness. After all, different patients need different medications. "My suspicion is that this is simply some kind of agreement with the manufacturers of these specific medications, with the Minister of Health having included these medications in the government decree. This decision bears the hallmarks of corruption," Stefanishyna stated.
Similar suspicions were voiced off the record by members of the Servant of the People party. One influential member of the mono-majority party saw this resolution as an attempt at lobbying and a diversion from an important issue. The Ministry of Health categorically denies all these accusations. Deputy Minister Igor Ivaschenko says that of all the approved drugs, only Nabiximols is patent protected.
"There's no patent protection for Nabilone. There's a decision by the US FDA, and a number of different similar drugs are registered in Canada. That means there are definitely four such drugs on the market, and others are pending approval. Therefore, there's no pharmaceutical lobbying here, since overall, there aren't just two or even three approved drugs. If we look at specific trade names, there are about a dozen," the official explained.
According to him, the Ministry of Health has already contacted and will continue to contact the manufacturers of these drugs to request their registration in Ukraine. Most of them are registered in the US, EU, Canada, and the UK. Therefore, a simplified registration procedure is in place for them in our country, which won't take much time, says Ivaschenko.
Meanwhile, parliament hasn't abandoned plans to pass a separate law on legalization. According to Stefanishina, who authored one of the drafts, the relevant committee has nearly completed work on a general document on legalization. It is based on four previously submitted bills.
The document will regulate the use of medical cannabis-based medications, their oversight, and their production in Ukraine. Both the Ministry of Health and the Ministry of Internal Affairs will be responsible for monitoring the circulation and use of marijuana-based products.
It's unclear when this bill will reach the floor. As one source in the mono-majority explained, the Ministry of Health assured deputies that it would resolve the legalization issue through a resolution, and therefore there was no need to rush the bill.
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