Theory and practice of intellectual property
№ 3 / 2018

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

PDF (Ukrainian)

DOI: https://doi.org/10.33731/32018.156009

Published      2018-06-26

Ключові положення української патентної реформи у сфері охорони здоров’я

Oksana Kashyntseva
Ukraine

Abstract
Medicines are essential element of effective health care system. Innovative medicines are the result of complex research and development work conducted by research institutes, universities and pharmaceutical companies. Governments have equally important responsibility to protect intellectual property rights of the patent-holders as well as ensure access to life-saving treatments for patients. 95 % of Ukrainians are buying their medications out of pocket, including such expensive new treatments for cancer, HCV, and TB. It is the new, innovative drugs that are mostly out of the reach of an average Ukrainian patient: 15 % of them are forced to borrow money or never even initiate a treatment due to lack of financial recourses. Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 (the «Doha Declaration») by the Ministerial Conference of the WTO is calling to recognize the superiority of the right to protect public health and, in particular, to promote access to medicines for all, over the intellectual property rights. EU-Ukraine Association Agreement respects this priority as reflected in the Article 219 of the Agreement by reinstating the priority of human rights in accordance with fundamental European values and principles. This Article provides solid foundation for the patent law reform to enable balance between the access to medicines and IPR protection. Countries around the world are successfully using TRIPS flexibilities such as compulsory licensing, strict patentability criteria, patent oppositions, parallel importation to improve access to new treatments. Ukrainian government started to implement patent reform aimed at striking the balance between public health interests and patent protection by introducing the following progressive provisions in Law of Ukraine “On Protection of Rights on Inventions and Utility Models”: excluding from the patentability objects the methods of diagnostic, treatment and surgery and new forms of known pharmaceutical products to counter low-quality patents that artificially extend patent monopoly on medicines so called ‘ever greening’ practice; implementing of pre-granting and post-granting patent opposition procedures in the Ukrainian Patent Office, when third parties can contest the quality of patent to be granted; deleting overly burdensome provisions from compulsory licensing procedure; implementing the supplementary protection for the inventions on pharmaceutical products basing on the same principles like in EU Legislation; allowing preparatory actions to be made with drug regulatory authority to ensure early entry of generic products right after patent expiry (Bolar exception).

Keywords: patent reform, human rights, access to medicines, healthcare