Theory and practice of intellectual property
№ 5 / 2021

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/52021.244533

Published      2021-11-17

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

Oksana Kashyntseva
Ukraine
https://orcid.org/0000-0002-2598-5614

Yaroslav Iolkin
Ukraine
https://orcid.org/0000-0002-9030-6809

Abstract
The article concerns the analysis of global trends in the paradigm of intellectual property rights on the objects used in the diagnosis, prevention and treatment of COVID-19. The experience of the implementation of pharmaceutical nationalism 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 coponsor of the IP waivers proposals, which are submitted to the TRIPS Council by some members of the WTO. The authors stress the need for Ukraine to use the historic opportunity for the development of the national pharmaceutical industry, which would contribute to the interests of the domestic patient, and make proposals for the necessary changes to national 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 during a Pandemic. The law provides, inter alia, for amendments to the Patent Law, according to which the Federal Ministry of Health has the right to authorize the use of relevant patents to ensure the production and supply of pharmaceuticals or medical devices. In 2020, France adopted the Emergency Law No 2020-290 to combat the COVID-19 epidemic, which introduced Article 3131 15 of the French Public Health Code. This rule authorizes the Prime Minister to issue orders to recover or seize all goods and services necessary to combat the disaster, to temporarily control the price of products and, if necessary, to take any measures to ensure that patients are provided with appropriate drugs to deal with the disaster, related to health. It is useful for Ukraine to use the experience of Canada in terms of facilitating negotiations with major vaccine manufacturers to establish national drug production and in terms of developing legislation in the field of compulsory licensing.

It is obviously, voluntary licences from patent owners, which provide for the full transfer of technology, and not just patent disclosure, are the most effective tool for the national production of biosimilars. However, international experience shows that pharmaceutical companies are holding back the issuance of compulsory licences. Therefore, our government’s biosecurity portfolio should include an effective tool for compulsory licensing or emergency use of biosimilars and generic drugs by the Government.

Keywords: intellectual property, human rights, patients’ rights, pharmaceutical nationalism, protectionism, vaccines, generics, COVID-19

References

Vaccine nationalism means that poor countries will be left behind.
https://www.economist.com/graphic-detail/2021/01/28/vaccine-nationalism-means-that-poor-countries-will-be-left-behind

Biden backs COVID-19 vaccine patent waivers.
https://thehill.com/policy/healthcare/551992-biden-backs-covid-19-vaccine-patent-waivers

Угода про асоціацію між Україною, з однієї сторони, та Європейським Союзом, Європейським співтовариством з атомної енергії і їхніми державами-членами, з іншої сторони.
https://zakon.rada.gov.ua/laws/show/984_011

Governmental Use of Patented Inventions during a Pandemic: A Global Survey. 
https://www.nortonrosefulbright.com/-/media/files/nrf/nrfweb/knowledge-pdfs/governmental-use-of-patented-inventions-during-a-pandemic-guide.pdf?revision=9d9d116f-20b6-4016-928d-64395c088681&fbclid=IwAR3okqq_WC8wh2bc1E-UyiAaingFprxuazvWH6ZA3xgfAjW4Dp6hppx2x9w

Backgrounder – Government of Canada investments in COVID-19 vaccines, therapeutics and biomanufacturing capacity.
https://www.canada.ca/en/innovation-science-economic-development/news/2021/02/backgrounder–government-of-canada-investments-in-covid-19-vaccines-and-biomanufacturing-capacity.html

Паризька конвенція про охорону промислової власності.
http://zakon2.rada.gov.ua/laws/show/995_123