Following a long-lasting legislative process, on 28 July 2022 new and long-awaited Ukrainian law on Medicines has been adopted by Verkhovna Rada.
For several years a consortium initiated by the EBRD and lead by Tomasik Jaworski Sp. p. advised Ukrainian authorities on this reform and prepared legislative solutions. The aim of the consortium's work was to prepare a new statute on medicines consistent with European law in several key areas including: procedures of marketing authorisation, advertising, quality control, pharmacovigilance, clinical trials, compassionate use and solutions aimed at counteracting drug falsification. Many of the provisions then drafted by the consortium have now been included in the adopted bill.
Our team consisting of Tomasz Jaworski, Marcin Tomasik, Bartłomiej Sasin, Filip Gołba and our pharmaceutical consultant Prof. Leszek Borkowski worked on the draft alongside our colleagues from Kiev: Borys Danevych, Artem Grudinin, Anastasiia Filipiuk, @Anastasiia M. and Yuliya Cherniavska, LL.M. Our joint efforts benefited from considerable assistance of members of EBRD team, especially Florence Bachelard-Bakal, Svitlana Khandazhevska, Natalka Nazarovets, Radomska Evgenia, Olyana Gordiyenko and Olha Pankiv as well as help of business representatives.
We want to thank them for our fruitful collaboration and express the hope that new law will benefit Ukrainian medicine market and facilitate the process of integration of Ukraine to European Union.