[Ip-health] Ukraine adopts compulsory licensing of pharmaceutical patents

Baker, Brook b.baker at neu.edu
Tue Mar 26 07:30:42 PDT 2013

It is certainly a positive development that Ukraine is adopting a legal
framework for compulsory licensing of pharmaceuticals, but the description
of the policy does not seem to go as far as Ukraine is legally entitled to
go.  The TRIPS Agreement Art. 31 would allow the issuance of compulsory
licenses on any public interest ground whatsoever and would further allow
those licenses to be issued to foreign companies for importation as well
as to domestic producers.  In addition, the Art. 31 allows exportation of
non-predominant quantities to other countries, and in the case of
competition-based licenses would allow exportation of unlimited
quantities.  Similarly, adoption of a Paragraph 6 system would allow
Ukraine to export to non-producing countries under special compulsory
license rules as well.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

On 3/26/13 9:17 AM, "Thirukumaran Balasubramaniam" <thiru at keionline.org>

>Ukraine adopts compulsory licensing of pharmaceutical patents
>March 25 2013
>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/ЕС). 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 at asterslaw.com
>oryulia.yanyuk at asterslaw.com).
>Thiru Balasubramaniam
>Geneva Representative
>Knowledge Ecology International (KEI)
>thiru at keionline.org
>Tel: +41 22 791 6727
>Mobile: +41 76 508 0997
>Ip-health mailing list
>Ip-health at lists.keionline.org

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