On November 22, 2013, in Kyiv hosted a round table onpressing matters of intellectual property rights protection, development andimprovement of investment attractiveness of the pharmaceutical market ofUkraine, organized by the US-Ukrainian Business Council (USUBC) and Associationof Pharmaceutical Research and Development (APRaD) in partnership with VasilKisil & Partners law firm.

The event was designed to examine current issues ofintellectual property protection in the context of creating an enablingenvironment for investing in the pharmaceutical sector and improving access ofUkrainian patients to innovative therapies. In addition to organizers thediscussion was attended by representatives of the Ministry of Health, the StateIntellectual Property Service, U.S. Embassy, lawyers, as well as pharmaceuticalmanufacturers of innovative drugs.

Oleksandr Mamunya, partner with VKP’sintellectual property group reported on the issue of compulsory licensing. Inparticular, he compared global application of compulsory licensing andUkrainian realities, presented data on the absence of compulsory licensing inmost EU countries, Russia and Belarus, as well as its applicationonly to a narrow circle of specific drugs in some countries in Asia and Africa.Legislative initiatives that exist today, according to Mr Mamunya aredeliberately vague on the subject, which in turn may have a significantlyadverse affect on the operation of many innovative pharmaceutical manufacturersthus limiting public access to the cutting edge medicines.

"In order for Ukrainian legislation to be compatible with TRIPSrequirements and the international practice, it is necessary to establish clearterms of granting compulsory licenses, in particular, to lock in thefundamental condition of the "existence of health care emergencies"and to avoid ambiguous wordings such as "in the public interest," - said Oleksandr Mamunya. Also, the participants were unanimous on theneed of a clear and transparent procedure for the application of a compulsorylicense and the procedures for its cancellation, securing a clear mechanism forthe calculation of compensation to the owner of the patent.

Based on data from studies of major European andinternational associations and research programs (EFPIA, IMC MIDAS, Eurostat,OECD Health Data) Executive Director of APRaD Yuriy Savko demonstrated a direct relationship between the qualityof life and life expectancy and the availability of innovative medicines forthe population. APRaD believes that the main obstacles for the development ofthe industry are the following:

·        Lack of understandingof the importance of innovation in health care and pharmaceutical industry;

·        Weak mechanisms forprotecting intellectual property rights in Ukraine, which in turn creates abarrier for foreign manufacturers of innovative medicines to enter theUkrainian market;

·        Financial constraintsof the health system.

Participants hope that the government authorities will consider the opponionof the industry and make relevant changes to the discussed draft laws.

{AG}20131122 PharmaVKP-USUBC{/AG}

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For more details please contact YuliyaChervonookaya,