Ukraine is harmonizing its national legislation with EU requirements on compulsory licensing of patents for pharmaceuticals by allowing Ukrainian companies to produce such patented products (the "Compulsory Licensing").

The Compulsory Licensing procedure is set forth in Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) of 1994. With aim to support public health this Compulsory Licensing authorizes the least-developed countries to issue compulsory licenses for national manufactures to produce pharmaceuticals without consent of patent owners for domestic market, but not for export.

According to the President's Decree No.526/2012 dated 30 August 2012, the Ministry of Health and the Ministry of Justice were instructed to adapt Ukrainian legislation to the requirements of the EU Directive No. 2001/83/ЕС on the Community Code relating to Medicinal Products for Human Use. The Ministry of Health adopted the relevant legal document which is expected to come into effect in the second quarter of 2013.

It is a well-known fact that market share of generic drugs exceeds 90% in Ukraine. At the same time, generics manufacturing does not solve a problem of access of Ukrainian citizens to recently developed pharmaceuticals, since Ukrainian manufacturers are entitled to legally produce generics only after pharmaceutical patent expires. Therefore, it is expected that the implementation of Compulsory Licensing would help to solve the problem of legal manufacturing of recently developed pharmaceuticals in Ukraine.

For further information please contact partner Oleksandr Padalka
and associate Borys Snizhko