A Protocol amending TRIPS Agreement executed on 6 December 2005 in Geneva (the Protocol) is under ratification in Ukraine (TRIPS Agreement is the Agreement on Trade-Related Aspects of Intellectual Property). Relevant draft law to ratify the Protocol was adopted by Verkhovna Rada of Ukraine (the Parliament) in early February 2016, in order for the draft law come into effect it has to be signed by the President of Ukraine.
The Protocol supplements the valid TRIPS Agreement with Article 31 bis; its provisions enable pharmaceuticals to be exported on the terms of compulsory licensing into the countries which either do not have their own capacities to manufacture such products or their existing capacities are not sufficient to satisfy their own health care needs. It should be noted that currently TRIPS Agreement permits compulsory licensing provisions to be applied, presumably to meet the demand existing in the national market.
We remind that the compulsory licensing is the right granted to the governments in WTO countries in emergency situations, such as a crisis of the health care system, including in connection with HIV/AIDS, tuberculosis, malaria and other epidemics, to issue licenses to use the intellectual property protected by a patent, i.e. to permit manufacture of generic drugs without any consent of the patent holders. The compulsory licensing procedure for pharmaceuticals in Ukraine is prescribed in the Procedure approved by Decree no. 877 of the Cabinet of Ministers dated 4 December 2013.
It is necessary to note that the provisions of the Protocol introduce a number of mechanisms designed to limit possible abuse and protect the rights of holders, in particular, mandatory prior notice to the Council for TRIPS about any intention to apply the procedure, the requirement to identify products with special packaging or color/form of products and restrictions on the amount of such products, etc.
The amendments set forth in the Protocol will come into effect for Ukraine only after such amendments are approved by two-thirds of the WTO members, i.e. 108 out of 162 WTO member states. According to WTO data, as of 11 February 2016, 93 WTO member states have carried out the procedure to adopt the Protocol.
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