Access to healthcare technologies in the context of sanctions and unilateral restrictive measures.

Malichenko Vladislav Sergeevich ORCID: 0000-0003-3136-8054 PhD in Law Senior Researcher of the Department of Social Legislation, Institute of Legislation and Comparative Law under the Government of the Russian Federation; Researcher, Institute of National and Comparative Legal Studies, Faculty of Law, National Research University “Higher School of Economics” 117218, Russia, Moscow, Bolshaya Cheremushkinskaya Str., 34 vlad.malichenko@gmail.com Other publications by this author

Gadzhieva Albina Omarovna ORCID: 0000-0002-3971-4903 Director, Institute of National and Comparative Legal Studies, Deputy Dean of the Faculty of Law, Associate Professor of Department of Public Law, National Research University “Higher School of Economics” 117218, Russia, Moscow, lane. Bolshoy Trekhsvyatelsky, 3, room 216 agadzhieva@hse.ru

Introduction

1. The role of health technologies in international and national priorities in the field of health protection.

The first mention of the use of technologies in ensuring human health protection dates back to the VII century BC, but to date no comprehensive definition of the concept of "health technology" has been formulated ^{[1, pp. 256-285]}. The World Health Organization (WHO) defines health technologies as the application of systematized knowledge and skills in the format of various medical devices (medicines, medical devices, etc.) aimed at improving the quality of life and solving global health problems (resolution WHA 60.29). In the modern system of medical and social care, health technologies they undoubtedly occupy a central place, providing an increase in the duration and quality of life of the population, as well as a decrease in the disability rate among the able-bodied population.

Ensuring access to health technologies is central to the global health and sustainable development agenda. Health technologies were an important component of achieving the three Millennium Development Goals (hereinafter — the MDGs) approved by the UN General Assembly (hereinafter — the UNGA) in 2000 (combating HIV/AIDS, malaria and other diseases, improving maternal health and reducing child mortality, ensuring the availability of essential medicines in developing countries). The Sustainable Development Goals (hereinafter referred to as SDGs), which replaced the MDGs in 2015, defined access to health technologies as one of the objectives of SDG No. 3 "Ensuring a healthy lifestyle and promoting well—being for all at any age". The issues of ensuring access to technology in the context of the development of international legal mechanisms for the protection of intellectual property rights have been systematically considered in the documents of the World Trade Organization (WTO). Access to healthcare technologies occupies an important place in the system of international legal guarantees of social protection formed by the conventions of the International Labour Organization (ILO). The problem of the rational use of antibacterial therapy in the provision of medical care and in agriculture is systematically considered in the activities of WHO, FAO, UNEP and OIE.

Access to healthcare technologies is an essential element of national strategies in the field of health protection and State security. Various aspects of regulating access to healthcare technologies have been considered in several editions of the national security strategy in the US healthcare sector ^[12]. The National Security Strategy of the Russian Federation, developed every five years since 2009, formulates goals for ensuring access to healthcare technologies. In the latest version of the Strategy approved by Presidential Decree No. 400 dated 02.07.2021, the development of promising technologies in the field of health protection to counter various threats is identified as one of the state priorities.

Summarizing the considered documents of international organizations, as well as domestic acts, it can be concluded about the strategic importance of health technologies in ensuring the socio-economic well-being of the population and the security of each state. The indicator of the availability of healthcare technologies directly depends on a variety of geopolitical factors and restrictions formed by international treaties, as well as the extraterritorial influence of laws adopted by industrialized countries. One example of such restrictions is sanctions and unilateral measures applied as an element of political pressure against certain States. In the domestic science of international law, a small number of publications are devoted to the study of the impact of the application of sanctions and unilateral restrictive measures on access to healthcare technologies, which determines the relevance of the study.

The structure of the publication assumes a consistent analysis of the position of international organizations and doctrinal sources regarding the legitimacy of the use of sanctions and unilateral restrictive measures, as well as an assessment of the consequences of the use of restrictive measures on ensuring the human right to health in various regions of the world. In conclusion, a list of international legal and domestic mechanisms designed to ensure access to healthcare technologies in the face of sanctions and unilateral restrictive measures is systematized.

2. "Sanctions" and "unilateral restrictive measures" in international law.

Under the influence of the media and foreign doctrinal sources in the science of international law, the normative content of the concepts of "sanctions" and "unilateral restrictive measures" is being identified, which blurs ideological differences in their perception, and also contradicts the principles of international law.

Guided by the scientific works of domestic legal scientists, sanctions are understood to be generally binding decisions of the UN Security Council (UNSC) taken in accordance with Article 41 of the UN Charter to maintain peace and security. Unilateral restrictive measures are applied by the decision of one State or a group of States by agreement, and the object is States, individual individuals and legal entities that commit undesirable or illegal actions from the point of view of the implementing State. The object of unilateral restrictive measures may also be third countries that have refused to join these measures against another State ^[13].

In foreign scientific research, the content of the concepts of "sanctions" and "unilateral restrictive measures" are equated. Sanctions are understood as any measures applied by subjects of international law in response to undesirable or possibly illegal actions of another State ^[7].

If the procedure for the application of UN Security Council sanctions is determined by the Charter of the Organization, then the legality of the use of unilateral restrictive measures is very controversial, which has been repeatedly noted not only in doctrinal sources, but also in documents of international organizations. Criticism of the use of unilateral restrictive measures has been repeatedly formulated in UNGA resolutions (Declaration on the Inadmissibility of Interference in the Internal Affairs of States, on the Protection of Their Independence and Sovereignty; Declaration on the Principles of International Law concerning Friendly Relations and Cooperation between States in Accordance with the UN Charter).

The role of unilateral restrictive measures in the formation of barriers to ensuring human rights has been repeatedly considered in the work of the Office of the United Nations High Commissioner for Human Rights (OHCHR) ^[18]. A systematic analysis of the legitimacy of the application of sanctions and unilateral restrictive measures in accordance with international law was presented in the report of the Sub-commission on the Promotion and Protection of Human Rights ^[17]. Within the framework of the mandate of the Special Rapporteur on the negative impact of unilateral restrictive measures on the enjoyment of human rights, the thesis of the inconsistency of unilateral restrictive measures with the principles of international law, as well as the systemic humanitarian consequences of their application, has been repeatedly argued.

Among domestic legal scholars, a critical assessment of the legality of the use of unilateral restrictive measures also prevails, due to the contradiction to the principles of international law ^[2-4].

Summarizing numerous documents of international organizations, as well as doctrinal sources, it is necessary to conclude that to date, various approaches have been formed to determine the normative content of the concepts of "sanctions" and "unilateral restrictive measures", equating these definitions or, conversely, defining a clear distinction between them. However, most opinions agree in the perception of such measures as triggers for the formation of socio-economic shocks among the population and the occurrence of humanitarian disasters.

3. The problem of access to healthcare technologies.

Since the application of the first UN Security Council sanctions and unilateral restrictive measures, numerous scientific studies, as well as documents of international organizations, have noted their negative impact on the socio-economic sector. According to the World Medical Association (WMA), modern science is vulnerable to political sanctions that form discriminatory restrictions on the freedom of scientific activity, affecting the exchange of information and knowledge ^[11].

The use of sanctions and unilateral restrictive measures directly or indirectly affecting the social sphere leads to restrictions on the human right to health, enshrined in the WHO Charter of 1946, Article 25 of the Universal Declaration of Human Rights of 1948 (UDHR) and Article 12 of the International Covenant on Economic, Social and Cultural Rights of 1966 (ICESCR).

The introduction of unilateral restrictive measures and sanctions leads not only to widespread restriction of the human right to health, but also to discrimination against vulnerable categories of the population in terms of access to medical and social care, contrary to the provisions of Article 7 of the UDHR, Article 26 of the International Covenant on Civil and Political Rights (ICCPR) and article 2, paragraph 2 of the ICESCR.

The Committee on Economic, Social and Cultural Rights (CESCR) has repeatedly raised issues of human rights protection in the context of the proliferation of sanctions and unilateral restrictive measures. CESCR General Comment No. 8 of 1997 formulates a generalizing thesis about the impact of "sanctions" on ensuring human rights and the need to form a list of goods that should be removed from sanctions measures in order to reduce possible consequences with respect to ensuring the rights defined by the ICESCR. General Comment No. 14 of the CESCR specifies the issues of the negative impact of restrictive measures on access to various health technologies. It is important to note that the CESCR also considered the problem of ensuring human rights by States against which unilateral restrictive measures and sanctions were imposed. In particular, in General Comment No. 3 of 1990, it is formulated that even in a situation of obvious scarcity of resources, the State must ensure that at least the minimum necessary level of each of the rights enshrined in the ICESCR, including access to health technologies, is fulfilled.

Analysis of the consequences of unilateral restrictive measures in various regions of the world has demonstrated a significant impact on access to health technologies. The Cuban trade embargo imposed by the United States since 1961 provided for restrictions on the import of medicines and medical devices ^[8]. Thus, the number of medicines in circulation in Cuba has decreased from 1,297 to 889 items. Sanctions against Yugoslavia led to a 50% decrease in the availability of essential medicines, and as a result, an increase in the overall mortality rate by 10% and the spread of infectious diseases ^[15].

A vivid illustration of the negative impact of unilateral restrictive measures and sanctions on access to healthcare technologies is the consequences of their introduction into Iran's relations. Until October 2012, in accordance with the US Trade Sanctions Reform and Export Expansion Act of 2000, it was necessary to apply for a special license to export each category of medicines and medical devices to Iran, which significantly limited the possibility of timely access of the population to the necessary healthcare technologies. Subsequently, the export procedure was simplified by introducing a procedure for obtaining a general license for most medicines united by the EAR99 category. However, a special license was supposed to be obtained for the remaining groups of medicines. In particular, they should include opioids, narcotic drugs, vaccines, toxins, etc. The requirements for certain categories of medicines were determined by their potential dual purpose and the possibility of use for the development of chemical and biological weapons (Subchapter C - Export Administration Regulations. Code of Federal Regulations).

Unilateral restrictive measures and sanctions imposed on Iran have had a significant impact on the purchase of components for the production of medicines, as well as medical equipment and consumables for hospitals and medical institutions. In particular, the restrictions also affected the import of high-tech equipment: X-ray machines, laboratory equipment, etc. According to a 2016 study, unilateral restrictive measures and sanctions caused the formation of a shortage of medicines in 73 positions, 44% of which were included in the WHO list of essential medicines ^[16].

The restriction of access to vital medicines and components for their production, combined with the weakening of Iran's national pharmaceutical industry, has also led to the proliferation of counterfeit and low-quality medicines in Iran's healthcare system ^[10].

Despite the timeliness of the measures implemented by the Government of the Russian Federation to overcome the consequences of unilateral restrictive measures, negative trends can be traced in relation to access to healthcare technologies. In 2022, it was reported that there were risks of stable provision of medicines to children with life-threatening diseases due to the revision of logistics chains and problems with banking operations, and by the beginning of 2023, there was information about the development of defects in more than 80 medicines.^[1]

4. Mechanisms for ensuring access to healthcare technologies

To date, various legal mechanisms have been formed aimed at mitigating the consequences of the application of sanctions. One of such mechanisms is "humanitarian exceptions", which presuppose permission to conduct certain activities by States against which sanctions or unilateral restrictive measures have been applied. In particular, the UN Security Council has consistently adopted resolutions (S/RES/2615; S/RES/2551; S/RES/1916) that place certain types of activities aimed at ensuring the implementation of humanitarian programs in specific countries.

However, in practice, the existence of a mechanism of "humanitarian exceptions" does not allow to fully minimize the effects of restrictive measures on the social sphere. The practice of imposing restrictions in excess of those indicated in the framework of the adopted sanctions has a significant impact on ensuring the implementation of humanitarian exceptions. This trend is particularly evident in the banking sector, as banks seek to minimize the risks of interaction with organizations under sanctions or unilateral restrictive measures. This practice of banks' activities is due to the fear of "Tuesday sanctions" applied against States and organizations interacting with States that are under the effects of sanctions and unilateral restrictive measures.

Studies of international organizations have repeatedly demonstrated that humanitarian exceptions are usually ambiguous and interpreted arbitrarily and inconsistently, leading to delays and, in some cases, to the rejection of requests for the export of humanitarian goods, complicating the work of TNCs and international organizations ^[9]. During her visit to Iran, the Special Rapporteur drew attention to the obstacles in the acquisition and delivery of vital medicines and medical devices for the treatment of rare and severe diseases due to compliance with sanctions by foreign companies in excess of the prescribed restrictions ^[14].

In order to form a systematic approach to the application of humanitarian exceptions, the UN Security Council adopted for the first time in 2022 a resolution that formulated the obligation of states, international organizations and other subjects of international and national law, confirming the possibility of their use for all countries subject to UN Security Council sanctions measures. In particular, the resolution formulated the thesis that "the provision, processing and payment of funds, other financial assets or economic resources and the provision of goods and services necessary to ensure the timely delivery of humanitarian aid or to facilitate the implementation of other activities that contribute to the satisfaction of basic human needs" is not a violation of the obligations imposed on States to freezing of funds and other assets.

Another international legal mechanism that allows access to healthcare technologies, even under conditions of unilateral restrictive measures, is compulsory licensing. The use of the compulsory licensing mechanism is provided for by the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). A compulsory license may be granted to one or more persons for the use of patented products without the permission of the patent owner, provided that sufficient monetary compensation is paid. The conditions for the application of compulsory licensing in Russian legislation are determined by the provisions of Article 1360 of the Civil Code of the Russian Federation, which have undergone certain changes in recent years. The basis for the use of compulsory licensing is to ensure the interests of defense and security of the state, as well as the protection of life and health of citizens.

The experience of countering sanctions and unilateral restrictive measures in various regions of the world has demonstrated the importance of implementing mechanisms for monitoring and preventing the formation of a shortage of healthcare technologies. Since 2022, as part of measures to minimize the shortage of vital medicines formulated in Federal Law No. 46-FZ of 08.03.2022 "On Amendments to Certain Legislative Acts of the Russian Federation", the Government of the Russian Federation is entitled to determine a separate procedure for their registration, as well as to establish the specifics of licensing pharmaceutical activities, activities for the production of medicines, activities related to the maintenance of medical devices in order to stimulate the creation and development on the territory of the Russian Federation of the production of medicines or medical devices that do not have registered analogues.

In order to prevent the formation of defects in medicines, an Interdepartmental Commission was established by Order of the Ministry of Health of the Russian Federation No. 339n dated 05/19/2022. The document defines 10 grounds for making a decision by an interdepartmental commission on a defect or the risk of a defect, on the basis of which a conclusion is formed on the possibility of issuing a permit for the temporary circulation of a series (batch) of a medicinal product having INN analogues registered in the Russian Federation or the import of a medicinal product in foreign packaging.

Iran has taken a number of consistent measures aimed at curbing the effects of sanctions and unilateral restrictive measures on access to healthcare technologies. The volatility of the exchange rate has led to a sharp increase in prices for imported medicines included in state health insurance programs. A Memorandum of Understanding was signed between the Iranian Ministry of Health and medical insurance organizations for additional financial protection of patients with chronic high-cost diseases. Some initiatives were aimed at facilitating the accelerated registration of medicines manufactured in Iran, as well as the formation of favorable conditions for their sale through various restrictions on the import of equivalent drugs of foreign production. In particular, in accordance with the Emergency Pharmaceutical Centers Act of 2008, unregistered medicines can be imported by special institutions if there is a shortage or lack of alternatives for the patient. The consistent development and implementation of the presented measures allowed not only to cope with the current threats and challenges of ensuring access to healthcare technologies, but also to contribute to the development of the pharmaceutical industry. Iranian pharmaceutical manufacturers produce almost 40 billion annually. units of medicines, providing 96% of domestic demand ^[8]. In recent years, there has been a significant development of the biotechnological industry, the production of biosimilars of immunological and antitumor drugs is expanding.

Conclusion.

The analysis of domestic doctrinal sources and documents of international organizations allows us to draw a scientifically based conclusion about the illegitimacy of the application of unilateral restrictive measures against individual states in order to influence the directions of their political development. The humanitarian disasters that have occurred in countries where restrictive measures have been applied indicate the need to assess the impact of sanctions and unilateral restrictive measures on processes that affect access to health technologies, as well as goods that indirectly affect the human right to health ^{[6, 19]}. Restrictive measures have an impact not only on access to medicines or medical products in a specific period of time, but also paralyze the development of the pharmaceutical and medical industry, not allowing the state to independently meet the needs of the health system.

"Humanitarian exceptions", as a legal mechanism existing in the system of international and domestic law, has demonstrated its inconsistency in ensuring timely access to healthcare technologies, which prompted States to develop and apply other mechanisms to minimize the consequences of unilateral restrictive measures.

The presented analysis of the measures taken by States to overcome the consequences of sanctions and unilateral restrictive measures demonstrates the possibility of minimizing their consequences in the medium term. The regulatory consolidation of initiatives for the development of industry and the prevention of the formation of shortages, allows for the local production of vital technologies. However, the issue of developing international legal mechanisms aimed at preventing the humanitarian consequences of the application of unilateral restrictive measures and sanctions remains open.

^[1] The Circle of Good announced problems with the import of medicines due to sanctions. 11/09/2022 // URL: https://www.rbc.ru/society/11/09/2022/631d4bf39a794715f61b1082 (accessed: 02/22/2023)

The list of potentially defective drugs includes 86 drugs. 23.01.2023 // URL:https://pharmvestnik.ru/content/news/V-spisok-potencialno-defekturnyh-lekarstv-voshli-86-preparatov.html (accessed: 02/22/2023)