Положення Болар відкриває нові можливості для доступності ліків для українців
"This is a significant milestone not only for the pharmaceutical industry but, first and foremost, for patients, who primarily bear the burden of medication treatment. For them, it means faster access to alternative therapies. In the past, it could take years from the expiration of a patent to the availability of a domestic generic due to the lengthy registration process. Now, that delay is eliminated," says Ihor Nykyforchyn, Director of Medical and Regulatory Affairs at the pharmaceutical company Darnytsia.
This mechanism enables Ukrainians to access affordable treatment options earlier, particularly for serious conditions such as cardiovascular, oncological, or autoimmune diseases. It not only improves treatment outcomes but also helps reduce the financial burden on patients.
The Bolar Provision allows the necessary research and registration procedures for generic medicines to begin even before the patent protection for the original drug expires. Considering that generics account for 85%* of the Ukrainian pharmaceutical market, this significantly speeds up the release of affordable medicines.
Darnytsia is consistently developing its portfolio by investing in the creation of new medicines, with a focus on complex generics. In 2024, the company allocated UAH 260 million for this purpose. In the past year alone, 13 new products were launched, and over 60 are currently in development.
"Why is this important? Because health can’t wait — and now, this is affirmed by law," adds Ihor Nykyforchyn.
Generic medicines are more affordable than their original counterparts, making them accessible to a broader population. For pharmaceutical manufacturers, this serves as an additional incentive to reduce prices, improve quality, and promote fair competition.
Darnytsia’s products comply with EU GMP standards and are certified by ISO 9001 and ISO 13485 quality management systems, covering more than 20 therapeutic areas.
*Pharmaceutical Industry of Ukraine, 2023.