Ukraine might depend on cannabis imports for years before local production is ready

January 18, 2024 · MJ Biz Daily

Local industry watchers say it could be years before domestic cannabis cultivation in Ukraine is up and running after Parliament gave the green light to a draft law that will lay the legal foundation for a medical marijuana industry.

That might open the door to import-export opportunities for local and international businesses looking to match supply with demand, at least in the early years of the Ukraine market.

Even though the bill was approved in the Verkhovna Rada, Ukraine’s Parliament, a substantial amount of work would need to be done before any medical cannabis could be sold legally in the country.

That’s because the law defines the general scope of activities that will be possible – including for businesses – but it does not spell out the exact rules.

“The law provides citizens with access to the necessary treatment for serious illnesses, including cancer and post-traumatic stress disorders caused by war,” Ruslan Stefanchuk, the speaker of Ukraine’s Parliament, said in a statement.

“The list of conditions and methods of using cannabis medicines will be determined by the Ministry of Health.”

The product types and qualifications to prescribe cannabis also are among the details that must be defined.

What is known is that medical cannabis will be distributed in pharmacies to patients with certain conditions and a prescription from a physician, meaning Ukraine’s medical marijuana market will more closely resemble pharma-focused European regulatory models than North American ones, which generally prioritize access and private enterprise.

Ukraine’s law sets an aggressive timeline for implementation.

The law will take effect six months after it receives approval from Ukraine President Volodymyr Zelenskyy, who is expected to sign the legislation soon, pending any legal challenges.

The law requires authorities to develop a draft of the regulations within three months of Zelenskyy’s approval.

While other specifics of the law remain unknown, Ukraine’s move to establish a functional medical cannabis industry is a meaningful milestone.

Next steps

Hanna Hlushchenko, an independent European medical cannabis adviser, said the first step that government needs to tackle is defining the licensing requirements.

Hlushchenko is working with the Ukrainian Association of Medical Cannabis to assist the government in creating the regulations.

In Europe, regulated medical cannabis products generally fall into two categories: flower and extracts, usually oils.

“I hope it will be the same format, but that is still subject of discussion, and it’s not defined in the law itself,” Hlushchenko told MJBizDaily.

“Ukraine will likely have similar requirements as Europe, so Ukraine will make it as a pharmaceutical industry.

“To be able to produce and sell, the facility should comply with Good Manufacturing Practice (GMP) rules and all of the rules that are within the scope of pharmaceutical supply chains.”

GMP is a stringent quality-control certification that applies in the production stage and is typically used by pharmaceutical companies.

Medical cannabis producers interested in exporting – no matter where they’re located – typically require GMP certification, which is usually administered by a European health authority.

That requirement alone could add years to the runway for prospective Ukrainian cultivators.

Hlushchenko believes licensed producers could begin cultivating cannabis in Ukraine by late 2026 or early 2027 – but only if everything goes according to plan.

It’s still unknown whether Ukraine will cap the number of cultivation licenses.

The two primary regulatory bodies from a business standpoint are expected to be the Ministry of Health and the State Service of Ukraine on Medicines and Drugs Control.

Imports to start?

Imports could play a big role in the early years of Ukraine’s medical cannabis industry, Hlushchenko said, but specific rules still must be determined.

The law defines cannabis as an active pharmaceutical ingredient (API), meaning that established local rules for importing such substances will likely be applied, Hlushchenko said.

APIs must be registered with Ukraine’s State Expert Center, a division of the Ministry of Health.

Medical cannabis is unlikely to be covered by the country’s universal health care scheme, although that has yet to be decided.

Once in the country, cannabis products will be distributed to patients through pharmacies, but the incoming law does not specify which of Ukraine’s 18,000 pharmacies will be able to sell marijuana.

Hlushchenko said pharmacies would need a license to produce medicine on-site and about 200 pharmacies have such a permit.

She is optimistic that imports could start as early as 2025, though much work still needs to be done and Zelenskyy has not approved the law yet. (Full Story)

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