International legal means of protecting human rights in health emergencies

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

Global threats in the field of health protection.

Over the decades, under the influence of globalization processes, socio-economic upheavals, a number of systemic problems have emerged in the field of human health protection at the international level, which have determined the rethinking of the role of health care in implementing the concept of a comprehensive system of international security and ensuring fundamental human rights. Threats and challenges that acquire the character of emergencies arising under the influence of globalization processes are not limited to State borders and require coordinated intersectoral interaction, which leads to a rapid increase in the number of different participants in international relations.

Among the variety of different forms of emergency situations, the threat of the spread of infectious diseases deserves special attention. The International Health Regulations (IHR), revised by WHO in 2005, introduce the concepts of "a public health emergency of international importance" (an emergency of international importance), meaning an extraordinary event that poses a risk to public health in other States as a result of the international spread of the disease and presupposes a coordinated international response.

Infectious diseases have historically been the basis for the consistent development of international legal regulation of the field of health protection. Since the middle of the 19th century, European countries have been looking for a way to develop unified mechanisms to counter the spread of infectious diseases due to the development of trade relations with Asian and Middle Eastern countries, which led to the holding of the first International Conferences on Sanitation and the development of relevant international conventions. It is noteworthy that initially the main challenge in agreeing on the provisions of International Conventions on Sanitation was to reduce the possible impact of quarantine measures on trade relations between countries.

Paradoxically, after 150 years, infectious diseases have once again become an indicator of systematic problems of international legal regulation of health protection and the international human rights protection system. In recent years, more than 30 cases of the occurrence and spread of infectious diseases have been registered, 7 of which have received the status of an "international emergency" ^{[11, 147-152]}. The COVID-19 coronavirus pandemic has had a catastrophic impact on the socio-economic indicators of each state, due to the burden on the health system and the need to introduce quarantine measures, surpassing the economic losses from the global financial crisis of 2008. In 2020 alone, the total economic losses of states according to the International Monetary Fund amounted to more than 11 trillion US dollars, and The global GDP index decreased by 4.9%. The COVID-19 pandemic has become an indicator that has revealed systematic problems in the global health management system, as well as problems in the organization of medical care and ensuring human rights, which, in particular, was noted in the recent Statement of the Committee on Economic, Social and Cultural Rights (hereinafter — CESCR) on the coronavirus pandemic (COVID-19) and economic, social and cultural rights ^[1].

Among the main problems of the international legal response to emergencies of international importance, it is necessary to highlight: the lack of global leadership in coordinating initiatives in the field of health protection; outdated mechanisms for informing and imposing restrictive measures in the event of pandemics; the lack of a system for sustainable financing of vaccine development; the need to introduce mechanisms to hold States accountable for intentionally concealing data on the spread of infectious diseases or the spread of infectious agents of artificial origin, the impossibility of fulfilling guarantees to ensure fundamental human rights ^{[4, 174-197]}.

The responsibility of TNCs for human rights violations.

The role of TNCs in providing access to vaccines, medicines and other health technologies is undeniable. As the main source of investment in the development of new health technologies, the activities of TNCs can lead not only to the introduction of new technological solutions in the field of human health protection, but also to systematic restrictions on the provision of fundamental human rights.

The fundamental normative legal acts of a universal and regional nature on the protection of human rights contain formulated provisions that indirectly establish the obligations of TNCs in relation to ensuring the protection of human rights. In particular, the preamble to the Universal Declaration of Human Rights (UDHR) states that "every organ of society", by which TNCs should be understood, should strive to promote respect for the rights and freedoms established by the Declaration ^{[2, 178-181.]}. Also, General Comment No. 24 of 2017 emphasizes that the participating States have based on Article 2 of the ICESCR, extraterritorial obligations to take measures to prevent and combat human rights violations occurring outside their territories as a result of the activities of economic entities over which they can exercise control. The problem of TNCs' responsibility for ensuring the human right to health has repeatedly been systematically considered within the framework of the special procedures of the Human Rights Council and human rights treaty bodies ^[13,14].

The obligations presented presuppose not only ensuring the human right to health, but also ensuring the right to enjoy the achievements of scientific progress, formulated in Article 15 of the ICESCR. According to the position of CESCR, the results of scientific progress should be understood as the use of scientific achievements in the interests of solving specific problems and meeting specific needs of the population ^{[3, 7-11]}. Taking into account the role of TNCs in the development of vaccines and other health technologies, special attention should be paid to the report "The right to use the results of scientific progress and its application" (Venice Statement). The document formulates the need to find a balance between the individual's right to use the results of scientific progress and the rights of society to share such achievements, despite the main role of private companies in ensuring scientific progress. The document also emphasizes that the right to enjoy the results of scientific progress is an important tool for influencing TNCs to ensure access to research and development in order to maintain the necessary balance in access to medicines that meet the needs of the health system.

I am investigating the specifics of ensuring a balance between public and private legal guarantees in countering emergency situations, the issue of applying the legal regime for the protection of intellectual property deserves special attention. Patent protection mechanisms, as well as other legal mechanisms for protecting exclusive rights to the developed technology, have a beneficial effect on attracting investments necessary for research and production preparation, but at the same time allow manufacturers to determine the price of products, which often forms a significant economic burden on the health budget of each state. In addition, exclusive rights to technology are a deterrent when it is necessary to produce large volumes of medicines, vaccines and other health technologies in emergency situations. Recognizing this barrier, international organizations have repeatedly emphasized in their documents that intellectual property rights protection standards should not prevail over obligations to ensure universal and fair access to the COVID-19 vaccine, and intellectual property as a whole is a social product aimed at fulfilling a social function.

Summarizing the position presented in the documents of international organizations, it should be concluded that the obligations to ensure the human right to the highest attainable standard of health and the right to enjoy the results of scientific progress, formulated in the IPEXP, as well as other international treaties, apply to TNCs.

International legal means of ensuring the human right to health.

Access to healthcare technologies is one of the main elements determining the effectiveness of countering threats and challenges in the field of health protection and, as a result, ensuring the human right to the highest attainable standard of health. The indicator of accessibility of healthcare technologies is directly dependent on the existence of a balance between public-law guarantees of ensuring the human right to health, formulated in international treaties of a universal nature and acts of domestic law, and private-law guarantees for the protection of the exclusive rights of TNCs of the medical and pharmaceutical industries.

In an emergency situation, an important factor in increasing access to healthcare technologies is the timeliness of development, which is usually not possible in advance, due to the willingness of manufacturers to invest in development only if there is a guaranteed profit in the future. It is impossible to predict the required amount of investment in development at the initial stages, since in practice only a few initially selected molecules of medicines or prototypes of medical devices reach the moment of registration.  The scientific community is often aware in advance of the existence of a virus or bacterium of the causative agent of the disease, but due to the lack of appropriate mechanisms for the prospective assessment of pathogenicity, but, more likely, a potential market, research for the development of vaccines or other health technologies has not been initiated. Thus, the first human coronavirus was described in the 1960s ^{[8, 1-31]}, but it was only in 2003 that a coronavirus causing severe SARS respiratory syndrome was registered ^{[6, 1967-1976]}, and in 2012 — a coronavirus causing Middle East respiratory syndrome ^{[12, 121-136]}.

Based on public law guarantees formulated in international human rights treaties, access to each vaccine should be ensured for all countries without any need to negotiate with manufacturers, States, and international organizations. However, in practice, in a pandemic, countries with a developed pharmaceutical industry and a high level of economic well-being form stocks of vaccines and other vital health technologies, which only prolongs the duration of the fight against the pandemic, preventing the formation of collective immunity due to lack of access to vaccines in developing countries ^[15].

Under the influence of the COVID-19 pandemic, disparities in access to vaccines have reached their peak. In January 2020, the U.S. Department of Health and Human Services, together with the Department of Defense, initiated the Operation Warp Speed program, which provides targeted funding for the development of vaccines against COVID-19 coronavirus infection, setting an ambitious goal of producing 300 million doses of vaccines by January 2021. However, by January 2021, it was possible to produce about 30% of the required demand, which was primarily due to the presence of disruptions in the logistics chains and the lack of necessary production components. In this situation, government agencies resorted to the use of the "Law on the Defense Industry" (U.S. Defense Production Act), which sets the priority of government orders, which led to a shortage of individual components of production worldwide ^[10]. Within the framework of the EU, EU Regulation 2021/111 imposed restrictions on the export of "coronavirus vaccines", as well as "active substances, including working cell banks used for vaccine production" in order to fulfill pre-purchase agreements concluded with vaccine manufacturers." At the beginning of January 2021, while in developed countries, where 14% of the world's population lives, a stock of 53% of the vaccines produced was formed, only 25 doses of vaccines were used throughout sub-Saharan Africa ^[5].

The introduction of mechanisms for the constant exchange of data on pathogens contributes to the accelerated development of vaccines, medicines and necessary measures to prevent the spread of the disease. One example of the implementation of such a concept is the "WHO Pandemic Influenza Preparedness Mechanism", which ensures the transfer of virus samples to developers, as well as forming counter obligations for developers to supply certain volumes of vaccines or other manufactured health technologies to the State that provided the sample. Such a mechanism makes it possible to realize the sovereign rights of States to their biological resources and defines the main purpose of the exchange of influenza viruses with pandemic potential, as well as scientific data and developments.

In order to achieve the goals of universal vaccination, a Mechanism for Global Access to vaccines against COVID-19 (hereinafter — COVAX) has been established, aimed at the equitable distribution of diagnostic drugs, therapeutics and vaccines, as well as financing the development of production and development. However, it was not possible to implement this mechanism, since countries simultaneously signed exclusive agreements with manufacturers to purchase vaccines, as many countries have done industrially, undermining the idea of health as a global common good. Consequently, COVAX could not access the necessary volumes of vaccines produced, which effectively limited the ability to achieve the agreed goals in the field of universal vaccination ^[7].

The COVID-19 coronavirus pandemic has demonstrated the possibility of forming positive synergies between TNCs and States in relation to countering the global challenges of the pandemic. This orientation of state activity has formed the concept of "Vaccine Diplomacy", according to which states expand the scope of their political interests by providing access to vaccines for developing countries ^[9].

In May 2020, the General Secretary of the Central Committee of the Communist Party of China, Xi Jinping, declared his readiness to make Chinese vaccines against COVID-19 a "global public good" to ensure "the availability and affordability of vaccines in developing countries" ^[17]. The scale of production allowed access to vaccines in 119 countries around the world, and the main consumers were Indonesia, Iran, Pakistan, and Brazil. Cooperation with developing countries to expand vaccination coverage involves various formats of technology transfer, such as direct vaccine supply, import of production components, or complete transfer of production technologies, including staff training and equipment transfer. According to a joint study by the WTO and the International Monetary Fund, Russia has produced and exported more than 100 million doses of vaccines to other countries, which accounts for 1.7% of global exports and is the seventh indicator in the world ^[16].

Conclusion

         Based on the presented features of ensuring the human right to health in emergency situations, it is necessary to formulate a number of practical recommendations aimed at expanding access to health technologies.

         In the context of increasing foreign policy pressure from unfriendly states, as well as weakening WHO leadership in countering pandemics and emergencies, it is advisable to ensure the consistent development of the health agenda within the framework of BRICS activities. In order to determine the priorities of interstate cooperation in the field of health and social protection, it is necessary to approve the development of an appropriate roadmap within the framework of the BRICS Ministerial conference. One of the important decisions may be the development of a Declaration of Principles of Interaction between the BRICS member states in the event of public health emergencies, emphasizing the supremacy of public law guarantees to ensure the protection of human rights.

In the context of the spread of the practice of concluding bilateral agreements between states and manufacturers, which leads to limited availability of health technologies in many regions of the world, it is advisable to develop a BRICS mechanism for the sustainable exchange of scientific knowledge, as well as health technologies designed to contain threats to public health of an infectious and other nature, and ensure technological independence in the face of unilateral restrictive measures by unfriendly states.