COMPULSORY LICENSING OF VACCINES AS A BALANCE BETWEEN PATENT LAW AND THE RIGHT TO HEALTH

Abstract

The article examines the legal institution of compulsory licensing of pharmaceutical inventions, in particular COVID-19 vaccines, as a mechanism for ensuring a balance between patent rights of manufacturers and the right to health of the population during a pandemic. The provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of April 15, 1994, in particular Article 31 regarding the use of the patent object without the authorization of the right holder, and the Doha Declaration on the TRIPS Agreement and Public Health of November 14, 2001, which confirmed the right of WTO member states to use the compulsory licensing mechanism to protect public health, are analyzed. The provisions of the Law of Ukraine "On the Protection of Rights to Inventions and Utility Models" of December 15, 1993, in particular Article 30, which provides for the possibility of granting authorization to use a patented invention without the consent of the patent owner in conditions of extraordinary public need, are examined. The initiative of India and South Africa regarding the temporary waiver of patent obligations for COVID-19 vaccines (TRIPS waiver) within the World Trade Organization, supported by over one hundred member states, is considered and the legal arguments of proponents and opponents of this approach are identified, in particular regarding the impact of limiting patent rights on the innovation potential of the pharmaceutical industry and regarding global equity in vaccine distribution. The necessity of improving the compulsory licensing mechanism in domestic legislation and its adaptation to the conditions of global public health threats is substantiated, including the specification of the procedure for issuing compulsory licenses and the criteria for determining the amount of compensation to the right holder.