Civil Society Advocates for Intellectual Property Law Reform in Ukraine


The All-Ukrainian Network of People Living with HIV (Network) advocate for change of law to improve access to medicines, in negotiations with EU.

A meeting, “EU-Ukraine Intellectual Property Rights Dialogue” was held between officials of the EU and Ukraine, on Wednesday, 6 July at the Ministry of Economy of Ukraine. The All-Ukrainian Network of People Living with HIV/AIDS (Network) was invited by the Ministry of Economic Development and Trade and Intellectual Property Research Institute of the National Academy of Law Science to take part in the meeting. The Network contributed to the part of the meeting devoted to the pharmaceutical market.

European Union Emphasizes Need to Limit Use of Compulsory Licences

EU representatives emphasized that the rules for issuing compulsory licenses should be very clear, and that compulsory licensing should be exclusively used for public health needs, and it should not be used as a competition tool (to reduce the price of drugs). The Ministry of Economy representative noted that compulsory licensing mechanism had never been used in Ukraine, and that there are legal barriers making it impossible to use this mechanism within the current legal framework. However, government officials made it clear that they are keen to introduce ‘government use’ provisions in Ukraine. ‘Government use’ provisions enable the government to use or authorize a third party, to manufacture a patented drug to address public health needs, for example to supply medicines in public funded hospitals and through programs.

EU Represents Interests of the Major Drug Companies

In relation to ‘patent linkage’ the EU representatives noted that although it does not exist in EU, it is a very good tool for preserving evidence in the courts. Patent linkage delays the availability of medicines by linking the registration of a generic medicines to the approval of a patent on an originator drug. The EU made it clear they see this as a positive mechanism for promoting protection of intellectual property rights on medicines.

On data exclusivity, the EU raised concerns regarding a situation where a generic medicine was registered by the Ukrainian Drug Regulation Authority a month after registration of the originator product, although Ukrainian law provides a data exclusivity period of five years. The company is now seeking intellectual property protection through the courts. This case in question is of the market authorization for the drug GRATEZIANO by Pharco, that was issued after authorization for Gilead’s Sovaldi in Ukraine.

On each of these points the EU officials were clearly representing the interests of the major drug companies.

Right to Health More Important than Intellectual Property Rights

“Trade Related Aspects of Intellectual Property Rights, in place in Ukraine are harming access to essential medicines in our country,” explained Sergey Kondratyuk, from the Network. “There is a contradiction between the right to health and the protection of trade regimes. The recent resolution of the UN Human Rights Council (UNHCR) confirmed the supremacy of right to health over intellectual property rights.The position of the UNHCR emphasizes the need to use the TRIPS “flexibilities” in Ukrainian intellectual property legislation, designed specifically to ensure national sovereignty on issues such as public health. This agreement allows countries to take advantage of “flexibilities” to tailor the intellectual property protection to local circumstances and needs.The EU doesn’t seem to recognize this.”

At the end of the meeting the EU representatives expressed concern that the Ministry of Health did not attend the meeting. The EU officials were keen to point out that while they are not against the participation of civil society, the dialogue should be government to government. It is clear why they would prefer to talk without civil society in the room.