Ukraine implements the “Bolar rule” into its legislation
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.
Ukrainian mineral water producer fined 73 thousand USD for spreading misleading information about medicinal properties
On May 29, 2025, the Antimonopoly Committee of Ukraine recognized that Aqua-Polyana LLC committed a violation stipulated by the Law “On Protection against Unfair Competition” in the form of spreading misleading information.
The Committee established that Aqua-Polyana LLC distributed misleading information by informing an unspecified circle of consumers on the labels of mineral natural therapeutic and table bottled water “Shayanska” of false information regarding some of the medical indications for its use (“Uncomplicated gastric and duodenal ulcers”, “Diseases of the operated stomach in connection with gastric and duodenal ulcers”, “Hepatitis”, “Cholecystitis”, “Angiocholitis of various etiologies without a tendency to frequent exacerbations”, “Chronic pancreatitis”, “Metabolic diseases: obesity, gout, oxaluria, phosphaturia”).
At the same time, the manufacturer provided appropriate evidence to confirm that such products have the proper medical indications for use, which were distributed on their labels.
According to the results of the survey conducted by the Committee, in particular, it was established that the information reported on the labels of water about medical indications for its use may affect consumers' intentions to purchase such products.
In this regard, the company could strengthen its competitive position and gain unfair competitive advantages over business entities that produce and/or sell natural mineral therapeutic and table waters not due to its own achievements, but by spreading false information.
The actions of Aqua-Polyana LLC were recognized as a violation of the legislation on protection against unfair competition, and the manufacturer was fined 3,3 mln UAH (73 thousand USD).
It is worth noting that Aqua-Polyana LLC stopped spreading misleading information about the medical indications for the use of water "Shayanska", as confirmation of which it provided its updated label, which was taken into account by the Committee when calculating the amount of the fine.
