LA promotes medicines affordability. Session of Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance
At the invitation of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance (hereinafter referred to as the Committee), LA Law Firm's Managing Partner Dmytro Aleshko and Head of Intellectual Property Practice Vitalii Savchuk participated in a meeting on medicinal products affordability with representatives of the Association of Manufacturers of Medications of Ukraine (AMMU).
The meeting's attendees included Chairman of the Committee Mykhailo Radutsky, Health Minister Viktor Liashko and the top officials of Ukraine's major pharmaceutical companies.
Vitalii Savchuk noted the necessity of intellectual property reforms related to medicinal products, particularly discussing the core concepts of implementation of Bolar exemption. He presented draft regulatory texts aimed at resolving several key issues.
The Bolar exemption allows generic medicine manufacturers to start marketing authorization of generic drugs while the patent rights to the original medicinal product are still valid. These changes will not violate the original manufacturers' intellectual property rights and will expedite the availability of generics in pharmacy chains at a reduced price.
The participants also discussed critical bills proposing the suspension of the patent extensions during martial law, which will also facilitate the introduction of generic medicinal products to the Ukrainian market.
"The need for this reform has been discussed in the market for years," Vitalii Savchuk said. "The challenge lies in reducing medicinal products cost by speeding up the entry of competitors, but without violating the intellectual property rights of the original manufacturers. I believe now is an opportunity time to develop a fair and sustainable mechanism for this."
LA Law Firm team of Vitalii Savchuk and Oleksandr Tsurkan, an intellectual property lawyer, have submitted their proposals to the Committee and pharmaceutical companies regarding bills on the aforementioned issues on intellectual property. Our team, as part of communication with the Committee, constantly conduct research and analysis of international and European legislation, development of relevant bills in order to align legislation with the European Union and ensure robust intellectual property rights.
The Committee meetings are ongoing, and the LA Law Firm team received an invitation to the next meeting to discuss the results of the documents developed.
These initiatives demonstrate a commitment to reforming and fostering more competitive and affordable pharmaceutical market in Ukraine. The Bolar exemption and the abolition of the indefinite patent extensions during martial law are important steps towards balancing rights of patent holders with the needs of society.
If you have any further questions or suggestions, please do not hesitate to contact Vitalii Savchuk, partner and head of intellectual property practice at LA Law Firm, at: savchuk@l-a.com.ua.
