Ukraine is harmonising its national legislation with EU requirements on the compulsory licensing of pharmaceutical patents by allowing Ukrainian companies to produce such patented products.

The compulsory licensing procedure is set forth in the 1994 Agreement on the Trade-Related Aspects of Intellectual Property Rights. With the aim of supporting public health, the procedure authorises the least developed countries to issue compulsory licences for national manufacturers to produce pharmaceuticals for the domestic market (but not for export) without the patent owner's consent.

According to the president's decree, the Ministry of Healthcare and the Ministry of Justice have been instructed to adapt Ukrainian legislation to the requirements of the EU Directive on the Community Code Relating to Medicinal Products for Human Use (2001/83/??). The Ministry of Healthcare has adopted the relevant legal document, which is expected to enter into force in the second quarter of 2013.

It is a well-known fact that the market share of generic drugs exceeds 90% in Ukraine. At the same time, generics manufacturing does not resolve the problem of Ukrainians' limited access to recently developed pharmaceuticals, since Ukrainian manufacturers are legally entitled to produce generics only after the pharmaceutical patent expires. Therefore, it is expected that the implementation of the compulsory licensing procedure will help to resolve the issue of legal manufacturing of recently developed pharmaceuticals in Ukraine.

For further information on this topic please contact Oleksandr Padalka or Yulia Yanyuk at Asters by telephone (+380 44 230 6000), fax (+380 44 230 6001) or email (oleksandr.padalka@asterslaw.com or yulia.yanyuk@asterslaw.com).

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