In Ukraine will appear another effective mechanism for reducing the cost of medicines. In the second reading, the Verkhovna Rada adopted draft law No. 13087, which introduces the so-called “Bolar rule” into Ukrainian legislation. This is a significant step in the direction of the availability of medicines and the development of competition in the market.
The “Bolar Rule” allows manufacturers of generic drugs (similar to original drugs) to start preparing for their launch even before the patent for the original drug expires.
It is about the fact that companies will be able to conduct research in advance, submit documents for registration and set up production so that drugs appear in pharmacies the very next day after the end of patent protection. This will allow patients to receive the necessary medicines faster at a more affordable price.
A similar practice has long been used in EU countries, but in Ukraine its implementation was impossible due to gaps in the legislation. The new law eliminates these obstacles. For patients, this means that generic drugs will appear on the market earlier, competition among manufacturers will increase, and the cost of drugs will decrease. In addition, it will speed up access to free medicines within the Medical Guarantee Program.
At the same time, the law provides for clear protection of the rights of patent owners. “It is forbidden to sell, advertise or offer the medicine until the patent is completed. Violations are subject to significant fines.”
The implementation of the “Bolar rule” was identified as one of the priorities in the decision of the National Security and Defense Council of February 12, 2025 “On additional measures to ensure the availability of medicinal products for Ukrainians”. This step not only contributes to lower drug prices, but also brings national regulation closer to European standards.
