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Why Cabinet is delaying medical cannabis legalization in Ukraine

Author : Iryna Shostak

Source : 112 Ukraine

"When an epileptic seizure begins, it is often heard that stomach is even contracting. A person is in pain, and conventional drugs are powerless in this situation. The only thing that can improve the quality of life is medical cannabis." Since the topic of legalizing medical cannabis has long remained taboo in Ukraine, two-year-old Eva, as well as about 2 million Ukrainians, are forced to either live in pain or break the law
21:00, 20 April 2021

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In early April, the government passed a decree offering alternatives to both, partially legalizing medical marijuana. In particular, officials say so. However, for Eva, as for other Ukrainian patients, nothing has actually changed with the adoption of the decree.

Eve's disease is special: the girl has a broken gene. Today, technologies are only being developed that could solve its problem in the future. However, parents now have no choice but to relieve their toddler's agonizing attacks with CBD oil.

“For 2 months, while Eva was on cannabis, she became much more concentrated, we manage to learn something new. After all, before that, the child almost did not hold his head, it was difficult to teach him such familiar and even intuitive things for another kid as returning, And so on. Now Eve goes to a neurologist, learns to pronounce sounds, she has her own system of identification marks (when "yes" - shows her tongue, when "no" - raises her hand). That is, CBD really improves the quality of life of the child,” the girl's mother explains.

And while the government will deal with such formal decisions, another 2 million patients will be in this status.

Related: Marijuana for medical sse: Ukraine approves two cannabis-based medicines

Legalized or not legalized?

Medical cannabis helps to fight cancer, irritable bowel syndrome, to resist Crohn's disease, Parkinson's and Alzheimer's disease, to escape from drug-resistant forms of epilepsy and post-traumatic stress disorder (PTSD), and a number of other ailments, namely, its main active substances - cannabinoids, the medical effectiveness of which is recognized even the World Health Organization (WHO), and with it the governments of nearly 40 countries.

While other countries were opening doors for patients to a life of improved quality, in the face of Ukrainian patients, legislation clinks the keys from the bars. Having no alternative, patients either grew several plants on their own for their own medical consumption, or turned to dealers, or endured.

Patients have been trapped in a vicious circle for many years. After all, each of these options can harm health (growing and using cannabis in self-medication mode, as well as buying an uncertified product of unknown origin on the black market are dangerous), and the first two will have to be held accountable before the law.

But this is in the past. Now patients do not have to risk themselves and violate the law - they will get a chance to get the therapy they need legally, thanks to a recent government decree. At least that's what the officials say.

In particular, the chairman of the Verkhovna Rada Committee on Finance and Taxes Danylo Getmantsev said that by this resolution "the issue of legalizing cannabis for medical purposes has been resolved."

"There are no more grounds for (distribution - ed.) photos of children suffering from pain and needing immediate drug legalization. True, the issue has not been resolved the way dealers wanted, dreaming of marijuana plantations with free circulation in the poorest country in Europe," wrote official in his Telegram channel.

The resolution "On Amendments to the List of Narcotic Drugs, Psychotropic Substances and Precursors" is a logical step after the idea of ​​legalizing medical cannabis in Ukraine, voiced at the "National Poll" by the President, was supported by 64% of respondents.

The document allows for the medical use of three drugs containing synthetic cannabinoids and cannabis extract, namely dronabinol, nabilone, and nabiximols. The document also lifts state control over cannabidiol isolates.

In simple words: the list of restricted substances has been supplemented with the following drugs:

  • nabilone is a synthetic cannabinoid that mimics the effects of THC;
  • nabiximols is a cannabis extract with the same THC and cannabidiol content.

So, has the government actually legalized medical cannabis? Not. We are talking only about 2 drugs and isolates of cannabidiol. Cannabis itself, as well as all resins, extracts, tinctures from it, and THC itself, continues to be on the table of prohibited substances. They cannot be used for treatment or research.

Moreover, according to activists, the government legal act not only does not make life easier for patients but on the contrary, creates new problems, postponing the real legalization of medical cannabis.

Related: Ukraine not ready to legalize prostitution, marijuana, - parliamentary speaker Razumkov

Why the decree actually slows down "legalization"

"The decree of the Cabinet of Ministers legalizes the import into Ukraine of only two drugs containing a chemical copy of cannabis, and completely leaves patients with hope for drugs from cannabis," said Dmytro Sherembey, Chairman of the 100% Life.

According to expert on drug policy, co-founder of the Freedom March for the Legalization of Medical Cannabis Taras Ratushny, the Cabinet of Ministers approved a resolution in order to neutralize an alternative draft resolution developed by the Ministry of Veterans Affairs.

it was the Ministry of Internal Affairs that twice blocked the decision to transfer cannabis from the category of drugs, the circulation of which is prohibited, to the category of substances, the circulation of which is limited.

One way or another, but the decision of the Cabinet of Ministers postpones the legalization of medical cannabis for another six months or even a year. After all, the main thing that activists and patients advocated was the beginning of the Ukrainian history of the scientific study of cannabinoids as analgesics and other drugs, which is still legally impossible. As a result, the scientific base is completely absent in Ukraine.

"We are glad that the Cabinet of Ministers at least admitted: medical cannabis has a therapeutic effect, it has benefits. They confirmed this by adopting this resolution. But we want our scientists to have the opportunity and the right to study the medicinal properties of cannabis, and now this is very limited. current legislative acts," Alina Prymak, chairman of the Veterans for Medical Cannabis NGO, says.

In the context of future legalization, the decree becomes a significant stumbling block. But what about the drugs they are allowed to do? Indeed, according to chief sanitary doctor Viktor Lyashko, they will be able to help in the treatment of epilepsy, Alzheimer's, Parkinson's, psoriasis, depression, post-traumatic syndrome in the military and many other diseases.

Does this mean that the Cabinet of Ministers has really solved several requests of Ukrainian patients? At first glance, it seems that yes, the first step has been successfully taken.

But if you study the price, the procedure for obtaining and the history of each of the drugs, you can come to the conclusion that we are not walking, but actually marking time. Why?

Related: March for marijuana legalization held in Kyiv

Reason # 1. Inaccessible availability

“Why do we need a chemical copy of a plant, if this plant grows on its own, and medicines from it will cost $ 20, instead of 600 and 2,000, as is the case with nabilon and nabiximols specified in the decree? It reminds me of creating artificial gasoline and sale at $ 600 per liter, when petrol can be made from oil for a dollar,” Sherembey says.

A number of other public organizations that are fighting for the legalization of medical cannabis agree with this opinion. In particular, Alina Prymak explains that with such prices of drugs, there is really no need to talk about availability.

That is, the alternative proposed by the government under the auspices of the Ministry of Health absolutely does not solve the problem at its root - it is "easier" for patient wallets to purchase and bring a product to the "black" market. For example, as noted by the mother of the girl Eva with a rare genetic disease due to epilepsy Nia Nikel.

"We are now buying CBD at $ 100, so is there any point in buying the government's CBD for $ 1,000? Plus, synthetic," adds Niya Nikel.

Synthetic? Yes, the preparations permitted by the regulation are not natural substances.

Reason # 2. Patients will not see natural drugs

According to chief sanitary doctor Viktor Lyashko, with the adoption of the decision by the government, more than ten trade names of drugs made on the basis of approved drugs should become available in Ukraine. All of these drugs will also be synthetic. Why?

Let's get back to the fact that the decree specifies only three drugs (dronabinol, nabilon, and nabiximols), on the basis of the form of which others will appear. It is about the subject of patents. In the case of dronabinol, the patent is a method of reproducing a chemical formula (synthetic tetrahydrocannabinol), and to repeat this formula would violate patent conditions.

In the case of the second drug, everything is much more interesting. Nabiximols patented is proportion (50% cannabidiol isolate and 50% THC). But the bottom line is that this is a herbal preparation, it is a certified cannabis extract, and since cannabis and THC are banned, a legal case arises. Therefore, the issue of its legality can be left to the discretion of law enforcement officers.

"Therefore, the drug Nabiksimols will have obvious problems with state registration, it has every chance of not even getting on the Ukrainian market as a drug approved for use," explains Taras Ratushny.

A patent for the chemical formula of nabilone, a synthetic simulator of the action of tetrahydrocannabinol, expired in 1999. Therefore, its import is possible not only in finished dosage forms but also raw materials for the production of drugs at pharmaceutical plants in Ukraine. However, experts doubt that this drug will satisfy even a small percentage of the needs of Ukrainian patients.

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Reason number 3. New is well forgotten old

"These are antiquity drugs. Nabilon was developed in 1979 by an American company that was then trying to circumvent the legal ban on the use of cannabinoids for scientific research and synthesized an analogue of tetrahydrocannabinol so that it could be used in research," the expert explains.

Further, this drug, and with it others that overcame the ban on the use of plant cannabinoids, entered the market in the 2000s. The study of these drugs has revolutionized and laid the foundation for evidence-based medicine that has changed the vectors of cannabis policy in several countries.

"Today in civilized countries dozens of drugs of higher quality and more comfortable for patients with a wide variety of pharmaceutical forms (sprays, tablets, extracts, inflorescences) are used. Officials suggest that Ukrainian patients and scientists be 20 years behind the civilized world," adds Ratushny.

In addition, it should be noted that dronabinol (the third drug of the decree) has long been legal in Ukraine, that is, "The Cabinet of Ministers has allowed to be treated with dronabinol for the second time." This is noted by a neurophysiologist, candidate of biological sciences Dmytro Isaev.

"I'll tell you the truth: cannabinoids have long been legalized in Ukraine in the form of dronabinol, 98% of synthetic THC (psychoactive cannabinoid). And the Cabinet of Ministers allowed us to be treated with dronabinol for the second time," the expert notes on his Facebook page.

Reason # 4. Drugs for drug-resistant epilepsy were not included in the list at all

We are talking about epidiolex, the only drug made only from cannabidiol isolate. They are treated for certain types of epilepsy (for example, Dravet and Lennox-Gastaut syndromes). This drug is needed by 18,000 children in Ukraine.

However, Deputy Minister of Health Ihor Ivashchenko claims that manufacturers of those medicines that contain isolated cannabidiol can apply for registration at the State Expert Center.

According to Ivashchenko, Epidiolex is the trade name of a drug that contains isolated cannabidiol.

That is, Epidiolex manufacturers can really already apply to the State Expert Center for registration? The question is debatable, because, according to an expert on public policy on drugs, there is also cannabis extract in the structure of the drug. Moreover, in "Epidiolex" the manufacturer even allows minor admixtures of other active substances. Therefore, whether this drug, like nabiximols, will have problems with registration, we will only find out later.

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Bonus. The level of trust in customs is poor

Suppose that the state registration of drugs was successful and there are patients who can afford to purchase these drugs, even despite their cost. The next bastion, which, according to the patients themselves, has repeatedly stood in the way of access to independently purchased medicines, is the State Customs Service.

In particular, Niya Nikel speaks about her experience with Ukrainian customs. The woman ordered a special hormone for babies to enhance the effect of the main drug. That is if a child takes this drug, but there is no effect, a hormone is prescribed.

These medicines should be stored in a special box at a temperature of 15 degrees (neither lower temperature nor higher temperature is allowed). At stake is the suitability of the drug and its effectiveness.

The woman says that a few months later she took the child to Israel for treatment, and then she received a call from customs. It turned out that the package was not in the refrigerator, although such a storage condition was mentioned in an additional letter. This experiment cost Nya about a thousand euros.

Such a case is not an exception, but rather a confirmation of the rule. There is always a risk that there will be problems with ordering expensive foreign medicines.

According to her, taking into account all the problems of drug delivery to the patient, it is necessary that these drugs be sold in pharmacies.

And what is the result? Ukrainian patients will have one hundred percent access to an expensive synthetic drug, and even questionable - to the other two, no less expensive.

It should be noted that the affordability of such drugs in different countries is regulated in different ways: somewhere they use compensatory practices, reimbursing the price to patients, and somewhere they impose this on insurance medicine. The government does not explain how it will be in Ukraine. It is also unknown when officials will realize that relaxing cannabis legalization could save numerous lives and create a market worth tens of billions of dollars.

In the meantime, little Eva, like the other 2 million patients, continues to be in the status of "gangsta baby" and "gangsta fights," risking their health.

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