Pharmaceutical market reform will accelerate patient access to generic medicines

The implementation of the so-called “Bolar exemption” in Ukraine will help avoid delays in access to generic medicines after patent protection expires.

This opinion was expressed by Oksana Kashyntseva, Head of the Department of Research on Intellectual Property Rights and Human Rights in Health Care at the Institute of Intellectual Property of the National Academy of Law Sciences of Ukraine, during a press conference at the Media Center Ukraine.

“We are currently actively working with legislators who have a pro-public, pro-patient stance on the so-called Bolar exemption. Let’s say we have a patent that expires on January 31, so what should we have by February 1? By February 1, Ukraine should already have a generic medicine available alongside the original, but at a lower cost,” Kashyntseva explained.

Currently, she noted, Ukrainian legislation does not allow generic manufacturers to start the registration process until after the patent expires. This creates a gap in which patients lack access to more affordable alternatives – even if those generic medicines are technically ready for production.

“The patent expires on January 31, but on February 1 we still don’t see the generic version. Because only on February 1 can we even ask the State Expert Center of the Ministry of Health whether these medicines are safe and effective,” she added.

According to the expert, a draft law now being considered by the Verkhovna Rada would allow pharmaceutical manufacturers to begin preparation and registration procedures in advance – ensuring that generic medicines are ready for sale the moment the patent expires.

“Today, we have a draft law in the Verkhovna Rada that allows us to prepare and be ready to launch a generic medicine alongside the original by January 31. Then, on February 1 – when the patent expires, which is an absolute rule – we would already have the generic medicine available here in Ukraine,” Kashyntseva explained.

Read more: https://mediacenter.org.ua/news