Legal Measures to Expend the Access to Treatment during the Pandemic in Ukraine and in the World

  • O. Y. Kashyntseva
  • M. M. Trofymenko
Keywords: managed entry agreements, compulsory licenses, government use, intellectual property, human rights, access to medicines.

Abstract

The problem of ensuring access to treatment has become global at the beginning of the XXI century, when the patent monopoly began to run counter to fundamental human rights. It is clear that with the proclamation of the WHO pandemic COVID-19, the issue of access to medicines has become particularly acute. The world faced the problem of "pharmaceutical nationalism", when the governments of many countries (even within the EU) provided priority access to the then strategic hydroxychloroquine at the national borders of their states, and kept parallel imports of drugs within the EU at the national borders.

Intellectual property and the monopoly it creates have the greatest impact on the pharmaceutical market. Awareness of the need to strike a balance between intellectual property rights and the human right to life and health has prompted both the search for compromises and the development of appropriate legal mechanisms, as well as a rethinking of the paradigm of intellectual property rights in health care. Let us turn to the retrospective of rethinking the role of intellectual property in ensuring such a balance by international organizations.

Thus, the United Nations Millennium Development Goals (MDGs) [1] identify the need to encourage the development of the generic pharmaceutical industry in order to ensure the distribution of essential medicines and their availability in developing countries. In the field of public health, innovation and trade of the WHO (The Global Strategy and Action Plan on Public Health, Innovation and Intellectual Property), the organization has a key role in balancing the tasks of public health, innovation and intellectual property [2].

Please note that the EMA (European Medicines Agency, the organization responsible for the centralized registration of medicines in the EU) emphasizes that the use of unregistered medicines in the treatment of COVID-19 (use for humanitarian reasons) is not part of the experiment or clinical study required. for the registration of a medicinal product, and thus gives grounds for the conclusion that such data cannot be closed in the mode of commercial secrecy as an object of intellectual property rights. This regime of joint research and the position of WHO and EMA give grounds to conclude that all data obtained in the course of such research cannot be monopolized by intellectual property instruments, neither as objects of patenting for a new scope / new purpose, nor in the mode of exclusivity. drug dossier data [3].

IFLA (International Federation of Library Associations and Institutions) also called on WIPO to introduce wide access to information on COVID-19 treatment, in which it called on WIPO to use all available flexible intellectual property mechanisms to maximize access to the world of access. to information (research data) on the treatment of COVID-19 [4], and the International Organization Médecins Sans Frontiers (Doctors Without Borders), which calls on governments not to patent drugs for COVID-19 and to cede property interests to the interests of human survival [5].

The purpose of this article is to analyze the existing legal mechanisms in international law and national legislation to ensure access to innovative medicines and generic versions of branded medicines that are outside the clinical trials of COVID-19 therapy. The need for such an analysis arose due to a number of circumstances:

- the fight against the pandemic "delays" the planned financial resources for drugs from other nosology’s;

- Infection and the threat of COVID-19 infection exacerbates comorbidities, as the priority of hospitalization, treatment and prevention is shifted over time and requires additional resources;

- pharmaceutical companies, manufacturers of original medicines, are not able to meet all market needs (example of remdesivir);

- The governments of many countries have taken a protectionist position on the national pharmaceutical industry, seeing this as a guarantee of national biosafety.

Today, the world practice knows several effective legal mechanisms to ensure access to innovative and generic drugs that can mitigate the patent monopoly on the latter. Thus, in Ukrainian legislation there are three of them, the legal analysis of which we propose:

- controlled access agreements (DCAs), which provide access to branded innovative medicines, and which are currently regulated by Article 79-1 of the Fundamentals of Health Legislation [6],

- compulsory licensing of inventions related to medicinal products and providing access to their generic forms in order to ensure the health of the population (Article 30 of the Law of Ukraine "On protection of rights to inventions and utility models") and

- use of a patented medicinal product in the form of its generic version in the interests of the state in emergency circumstances (Article 31 of the Law of Ukraine "On protection of rights to inventions and utility models").

These mechanisms are most widely used in the EU, USA, Canada and others. countries. In their legal essence, these legal instruments are radically different. We offer a comparative table and define in which we define the common and distinctive features of DKD, compulsory licensing and use of a patented drug in the public interest.

In conclusion, it should be noted that the STA does not solve the problem of wide access to medicines and this further highlights the need to improve the legislation governing the use of patents in emergency circumstances, as well as compulsory licensing in Ukraine. The flexible provisions of the TRIPS Agreement provide ample opportunities for WTO members to improve the provision of medicines to the population by detailing the grounds, conditions and mechanism for issuing compulsory licenses at the level of national legislation. International experience in implementing some of the flexible provisions of the TRIPS Agreement shows that the effective enforcement mechanism enshrined in WTO law and clear legislation on freedom of competition make it possible to achieve the main goal of providing medicines, sometimes without coercion, through voluntary licensing.

References

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Published
2020-09-29
How to Cite
Kashyntseva, O. Y., & Trofymenko, M. M. (2020). Legal Measures to Expend the Access to Treatment during the Pandemic in Ukraine and in the World. Medicne Pravo, (2(26), 34-48. https://doi.org/10.25040/medicallaw2020.02.034
Section
Articles