On May 15, 2025, the Law on Amendments to Certain Laws of Ukraine regarding the Implementation of the Bolar Provision was adopted.
The law provides that registration of medicines can be carried out the day after the patent for the original drug expires. This will allow for increased competition between manufacturers of generic drugs and reduce drug prices for patients.
This rule, which is already in force in most EU countries, allows manufacturers to begin production of generic drugs even before the expiration of the patent for the original drug. According to current regulations, registration and production are allowed only after the expiration of the patent term.
A number of safeguards have also been established against the premature entry of generic drugs into the market, namely:
– a ban on placing on the market before the expiration of the patent term;
– a ban on any commercialization (advertising, marketing, offering for sale);
– determination of the date of placing on the market – no earlier than the day after the expiration of the patent;
– increased fines for patent infringement.