On May 15, 2025, the Ukrainian Parliament passed Bill No. 13087 in full, with 265 votes in favor. This decision aligns Ukraine’s pharmaceutical regulations with European Union norms and supports domestic generic drug manufacturers.
What Is the Bolar Rule?
The “Bolar provision” is a legal mechanism that allows drug manufacturers to prepare for the production and registration of generic medicines before the expiration of a patent on the original (brand-name) drug. While it still prohibits commercial sale and advertising of these generics during the patent period, it ensures that generics can enter the market immediately after patent expiration.
This principle is widely used across the European Union, and Ukraine’s adoption marks a major step in harmonizing its pharmaceutical laws with EU standards.
How the Law Works
Under the new law:
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Generic drug developers can begin research, development, and registration procedures before the patent on the original drug expires.
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Commercialization, sales, and advertising of the generics remain prohibited until the expiration of the patent.
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This allows faster market entry of affordable drugs once patent protection ends.
“This will stimulate competition in the pharmaceutical market and reduce the cost of treatment for Ukrainian patients,” said Mykhailo Radutsky, Chairman of the Verkhovna Rada Committee on National Health.
Why This Is Important
Ukraine’s pharmaceutical market has long been dominated by monopoly conditions granted through patent protection, which can keep prices high and limit access. The Bolar rule reduces the regulatory time lag between patent expiration and generic availability — a key issue in patient access to affordable medications.
Key Benefits:
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Lower prices on essential medicines
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Boost for domestic pharmaceutical manufacturers
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Stronger alignment with EU legal and market standards
Additional Context
Earlier this year, the Ukrainian Cabinet of Ministers also adopted Resolution No. 168, aimed at stabilizing drug prices by limiting wholesale and retail mark-ups. However, this resolution faced procedural challenges, including lack of legal review by the Ministry of Justice and non-approval from the State Regulatory Service.
Despite these hurdles, the adoption of the Bolar rule demonstrates Ukraine’s continued progress in reforming its healthcare system, supporting local production, and meeting EU integration benchmarks.
