Ukrainian experience in implementation of the flexible provisions of the TRIPS Agreement in the context of European integration and the pandemic

Keywords: intellectual property, human rights, patients' rights, pharmaceutical nationalism,protectionism, vaccines, generics, COVID-19 The article concerns the analysis of global trends in theparadigm of intellectual property rights on the objects used in the diagnosis, preventionand treatment of COVID-19. The experience of the implementation of pharmaceuticalnationalism policies provided by the EU, Canada and Israel are presented in the article.The authors provide the legal backgrounds of the need for Ukraine to be a co-sponsor ofthe IP waivers proposals, which are submitted to the TRIPS Council by some membersof the WTO. The authors stress the need for Ukraine to use the historic opportunity forthe development of the national pharmaceutical industry, which would contribute tothe interests of the domestic patient, and make proposals for the necessary changes tonational legislation.The authors also stressed the position of the governments of Germany and France.Thus, in Germany there is the Law on Governmental Use of Patented Inventions duringa Pandemic. The law provides, inter alia, for amendments to the Patent Law, accordingto which the Federal Ministry of Health has the right to authorize the use of relevantpatents to ensure the production and supply of pharmaceuticals or medical devices.In 2020, France adopted the Emergency Law № 2020-290 to combat theCOVID-19 epidemic, which introduced Article 3131 15 of the French Public HealthCode. This rule authorizes the Prime Minister to issue orders to recover or seize allgoods and services necessary to combat the disaster, to temporarily control the price ofproducts and, if necessary, to take any measures to ensure that patients are providedwith appropriate drugs to deal with the disaster, related to health. It is useful forUkraine to use the experience of Canada in terms of facilitating negotiations with majorvaccine manufacturers to establish national drug production and in terms of developinglegislation in the field of compulsory licensing.It is obviously, voluntary licences from patent owners, which provide for the fulltransfer of technology, and not just patent disclosure, are the most effective tool for thenational production of biosimilars. However, international experience shows that pharmaceuticalcompanies are holding back the issuance of compulsory licences. Therefore,our government's biosecurity portfolio should include an effective tool for compulsory licensingor emergency use of biosimilars and generic drugs by the Government.