Parliament has passed a bill on the introduction of the “Bolar Rule” into Ukrainian legislation

The Verkhovna Rada adopted as a basis draft law №13087 on the introduction of the “Bolar rule” in Ukrainian legislation, which will reduce prices for medicines. This is reported by UNN with reference to the press service of the “Servant of the People” party.

DetailsAccording to Mykhailo Radutskyi, Head of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance, the “Bolar rule”, which is in effect in EU countries, allows manufacturers to start registering and manufacturing generic drugs (analogues of original drugs) before the expiration of the patent of the original drug.

In particular, the draft law stipulates that medicines can be registered on the day after the expiration of the patent for the original drug. At the same time, it is forbidden to sell, advertise or commercialize medicines until the patent expires.

“The adoption of draft law № 13087 will increase competition among manufacturers of generic drugs and reduce prices for medicines for patients. Also, the state’s priority is to support domestic producers. We are preparing the draft law for the second reading,” said Radutskyi.

Let us remind youNew regulations of the pharmaceutical market came into force in Ukraine on March 1. Resolution of the Cabinet of Ministers of Ukraine №168 of February 14, 2025 provides new rules for regulating the pharmaceutical market.

In particular, restrictions were introduced on markups on supply and marketing and retail markups for all medicines, not only for certain categories. In addition, the resolution prohibits retailers from entering into marketing agreements with pharmaceutical manufacturers, which allowed pharmacies to make discounts for patients, implement social projects and train pharmacists.

The purpose of the resolution was to reduce the prices of medicines and increase their availability to the population.

At the same time, patient organizations warned that excessive regulation could lead to a shortage of medicines, the closure of pharmacies in small towns and villages, and the termination of social programs to support patients.

As UNN was informed in the State Regulatory Service, despite the fact that this CMU resolution is regulatory, it did not undergo their expertise. They stressed that this is a violation of the Law on Regulatory Policy. The Ministry of Justice and the Commissioner of the Verkhovna Rada for Human Rights also did not provide their conclusions to the draft resolution. In particular, Ombudsman Dmytro Lubinets appealed to the Ministry of Health and the Regulatory Service due to the risk of closing pharmacies in villages and small towns.

CMU resolution on reducing drug prices was adopted with violations – regulatory service27.03.25, 10:19 • 143817 views