Ensuring the right to use the results of scientific progress in the context of the formation of new threats to human security and the problem of the circulation of dual-use technologies

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

Introduction

Medicines, vaccines, medical devices and other achievements of scientific progress, united by the concept of health technology, are a key means of countering global challenges and threats in the field of health protection and ensuring the human right to the highest attainable standard of health for all in order to achieve the UN Sustainable Development Goals (SDGs). One of the most important elements of ensuring human security is ensuring access to healthcare technologies. Under the influence of the rapid increase in the importance of health issues on the global agenda, the concept of a comprehensive international security system has gradually been rethought, where the concept of "human security" occupies a fundamental place. The increasing need for modern medical and social care determines the leadership of the healthcare technology industry in terms of annual investments in research activities. Technological advances are a fundamental condition for ensuring health protection, social assistance, as well as countering natural and intentional emergencies. The universal accessibility of scientific research results, both in the form of scientific knowledge and directly of health technologies, is guaranteed by the human right to use the results of scientific progress. However, uncontrolled access to scientific data in some cases poses threats to human and State security that significantly exceed the potential benefits.

The right to use the results of scientific progress and protection of intellectual property

The right to access to scientific progress is fundamental in ensuring access to health technologies, which has been clearly demonstrated in the framework of countering pandemics in recent decades. The coronavirus pandemic has forced a new look at the place of health protection regulation in ensuring human and state security. The lack of vaccines and other health technologies at the time of the outbreak of the pandemic has become an indicator of systemic problems in the implementation of global strategies to counter non-military threats and universal health coverage. European and Asian countries have introduced export controls on personal protective equipment and ventilators ^[12]. There have also been publications in the media about attempts by the US administration to acquire exclusive rights to the COVID-19 coronavirus vaccine ^[9]. The fight against the pandemic requires States to commit to international scientific cooperation involving the exchange of the best scientific knowledge and their practical application, especially in the medical field, which becomes a decisive factor in mitigating the effects of the disease and accelerating the discovery of effective methods of treatment and vaccination ^[2].

For the first time, the right to use the results of scientific progress was formulated by the Committee on the Theoretical Foundations of Human Rights, established by UNESCO in 1947 to develop the basic concepts of the Universal Declaration of Human Rights. The statement prepared by the Committee, entitled "The foundations of the international declaration of Human Rights", recognized the "right to a share in progress", characterized by "the right to full access to the use of technical and cultural achievements of civilization". Article 27 of the Universal Declaration of Human Rights enshrines the right of everyone to participate in scientific progress and enjoy its benefits, which is subsequently confirmed in paragraph 1 (b) of article 15 of the International Covenant on Economic, Social and Cultural Rights of 1966 (hereinafter — ICESCR). In particular, Article 15, paragraph 1 (b) of the ICESCR enshrines the right of everyone to use the results of scientific progress and their practical application, as well as the right to protect the moral and material interests arising in connection with any scientific work in the context of Article 15, paragraph 1 (c), without explicitly defining the content and scope of this rights. In CESCR general Comment No. 25, the results of scientific progress are understood to be the use of scientific achievements in order to solve specific problems and meet the specific needs of the population.

The right to access the achievements of scientific progress is confirmed in international treaties at the regional level, in particular: in paragraph 2 of Article 13 of the American Declaration of Human Rights and Duties of 1948; paragraph 1 (c) of Article 14 of the Additional Protocol to the American Convention on Human Rights in the Field of Economic, Social and Cultural Rights of 1988. (San Salvador Protocol); Article 1 of Protocol No. 1 to the European Convention for the Protection of Human Rights and Fundamental Freedoms; Article 42 of the Arab Charter of Human Rights.

International organizations have repeatedly addressed the issue of specifying the normative content of the right to use the results of scientific progress, as well as determining the specifics of the implementation of this right. The 1974 Charter of Economic Rights and Obligations of States establishes the right of States, not individuals, to benefit from scientific progress and developments in the field of science. The 1975 Declaration on the Use of Scientific and Technological Progress emphasizes the importance of applying scientific and technological developments in order to ensure human rights and freedoms in accordance with the UN Charter.

The report "The right to use the results of scientific progress and its applications" (the Venice Statement) emphasizes the importance of the right to use the results of scientific progress to influence TNCs in order 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. The Universal Declaration on Bioethics and Human Rights defines one of the goals to ensure equitable access to medical, scientific and technological achievements, as well as the exchange of information on these achievements.

The peculiarities of the legal regime for the protection of intellectual property rights in scientific literature and documents of international organizations are primarily considered in the context of ensuring the realization of the human right to use the results of scientific progress. The patent protection mechanism, which has been repeatedly criticized as a means of granting TNCs exclusive rights to use technology and establish monopolistic high prices, at the same time creates sustainable access to the results of scientific activities. Patent registration provides for full disclosure of the data of their inventions, allowing other entities to use this technology in the future, which in the future significantly expands its availability. CESCR General Comment No. 17 defines intellectual property as a social product that performs a social function, which leads to the obligation of participating States to prevent the influence of legal norms in the field of intellectual property protection, leading to increased costs for health technologies. When considering the problem of access to healthcare technologies in scientific research, primary attention is paid to issues of international legal regulation of intellectual property protection, emphasizing the importance of expanding access to the results of scientific activities. However, increasing the availability of research results, as well as simplifying the production cycle of various technologies, provides not only a wide coverage of the population, but also creates potential risks of their use for military and terrorist purposes ^[10].

Summarizing the considered international treaties and documents of international organizations, it should be noted the consistent formation of international legal guarantees to ensure the human right to access to scientific progress. At the same time, the achievements of scientific progress in recent years, manifested in the development of completely new approaches to the prevention, diagnosis and treatment of diseases, determine the need to expand the formulations enshrined in documents adopted by international organizations.

Dual–use technologies are a new threat to global security.

Advances in biotechnology, which have become the key to solving many challenges in the health system, including the development of measures to counter pandemics, have simultaneously revealed security threats, expressed in the possibility of developing and intentionally using biological agents, which, according to the scale of the potential threat, can be attributed to weapons of mass destruction. Chemical compounds obtained as part of the drug development process, but not allowed to enter the next stages of research due to lack of clinical efficacy or sufficient commercial value, can potentially be used to adapt to military needs or develop harmful agents ^[13].

Technologies using artificial intelligence, data processing algorithms and pattern recognition contribute to the development of personalized medicine and significantly improve the efficiency of medical care. One of the most frequently discussed threats to the use of AI is the violation of the principles of personal data protection. The rapid spread of public-private partnerships involving the transfer of volumes of personal data to private companies specializing in AI development greatly increases the risk of access to this information by third parties. The use of AI technologies carries a potential risk of restricting the rights of certain groups of the population. When creating AI algorithms based on data from a certain patient population, there is a risk of forming biased results ^[3], which will potentially strengthen existing social biases and discrimination against individual groups ^[8].

Genomic editing technologies pose significant threats to human security. Genomic editing technology makes it possible to artificially recreate existing pathogenic viruses by synthesizing bacteria and viruses with higher pathogenicity, whose receptors may have unprecedented biological characteristics ^[12]. In the report of the Director of National Intelligence of the United States, genome editing technology was defined as a weapon of mass destruction, since in countries with low ethical standards of research this threat is increasing due to the economic availability of new genome editing methods ^[15].

The issue of using various technologies to improve the physiological characteristics of a healthy person deserves special attention. Thus, CRISPR technology can be used to modify genes responsible for aging and muscle degeneration ^[6]. The UNESCO International Bioethics Committee noted that intervention aimed at changing the human genome can only be carried out for preventive, diagnostic or therapeutic purposes, and any attempts to achieve this goal should be prohibited ^[11].

As it was emphasized earlier, the right to use the results of scientific progress implies access not only to technology, but also to scientific knowledge, know-how, and unique professional skills of specialists, which can be provided in the form of "technological assistance". The provision of consulting services or training programs by government agencies or private companies from foreign countries may also indirectly contribute to the spread of potentially dangerous technologies ^[7].

The development of technologies, the use of which can not only counteract life-threatening diseases, but also form new threats to human security, influenced the formation of the term "dual-use technologies" in scientific literature and documents of international organizations. To date, a unified approach to the definition of "dual-use technologies" has not been formed, but a number of industrialized countries have tried to outline the boundaries of this concept within the framework of domestic acts ^[4]. Summarizing these definitions, dual-use biotechnologies should be understood as systematized knowledge and skills that are potentially used both for the development and production of medical products (medicines, medical devices, etc.), and for the purpose of creating biological agents and other means that pose a threat to human security ^[1].

The development of international legal regulation of the circulation of dual-use technologies.

The problem of regulating access to scientific knowledge and technologies with the potential for military and terrorist use is increasingly on the agenda of international organizations. The UN General Assembly resolution (A/RES/53/73) on the report "The role of science and technology in the context of international security and disarmament" emphasizes that the use of science and technology can contribute to the improvement of modern weapons systems, and also formulates the task of controlling the international transfer of products, services, and know-how dual-use. Subsequently, the UN General Assembly repeatedly adopted resolutions on "National legislation on the transfer of weapons, military equipment, dual-use goods and technologies" (A/RES/57/66; A/RES/68/44; A/RES/71/68), proposing to adopt or improve national laws, regulations and procedures in the field of in order to effectively control the transfer of dual-use goods and technologies.

As part of the 2018 Strategy for New Technologies presented by the UN Secretary General, the importance of developing legal regulation of the development and application of technologies based on artificial intelligence, biotechnology, and robotics in order to prevent the development of inequality and limit the provision of human rights is emphasized ^[14]. In 2021, the UN General Assembly adopted a resolution "Promoting international cooperation in the field of peaceful uses in the context of international security" in order to identify unjustified restrictions on exports to developing countries of materials, equipment and technologies for peaceful purposes, as well as to identify possible measures to achieve a balance between non-proliferation and peaceful use.

The UN Security Council (UNSC) has repeatedly raised the issue of the need to strengthen control over the use of technological advances for terrorist and military purposes. UN Security Council Resolution 1373 calls for the expansion of information exchange on illegal transfers of biological and other potentially deadly materials that can be used by terrorist groups. UN Security Council Resolution 1540 of 2004 focuses on the need for States to refrain from providing any form of support to non-State actors developing, acquiring, producing biological weapons and their means of delivery. In resolution 1540 (2004), the UN Security Council decided to establish a committee that, involving other experts as necessary, would submit reports on the implementation of the resolution to the Council for its consideration.

At the same time, the resolutions of the UN General Assembly and the UN Security Council considered did not trigger the formation of international legal means of controlling the circulation of such technological achievements and scientific knowledge. To date, there are still no international legal mechanisms regulating the circulation of dual-use technologies.

Separate international treaties contain provisions defining the procedure for regulating the circulation of health technologies, which can also be used for military and other purposes. In particular, the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (BTWC) for the first time addressed the issue of control over the deliberate use of technological achievements of life sciences as weapons. Article I of the BTWC itself emphasizes the obligation of States not to acquire or use microbiological or other biological agents, regardless of origin, in a situation where they are not intended for peaceful purposes. The BTWC Review Conferences have repeatedly raised the issue of potential safety risks due to increased access to scientific data and the development of the biotechnology industry, as well as the impossibility of restricting research activities with microbiological and other biological agents and toxins, as well as the development, production, acquisition, conservation, transfer and use for peaceful purposes ^[5].

Within the framework of the International Health Regulations (IHR) 2005 also provides for provisions regulating access to scientific data, the use of which poses potential threats to human security. In particular, Article 7 establishes that, regardless of the origin or source that may create a health emergency, WHO Member States shall transmit to the Organization all relevant health information. The obligation to share health information involves providing samples of possible pathogens, as well as other laboratory data that can be used to develop various health technologies aimed at combating a potential threat. However, it should be noted that there are no provisions in the IHR that directly provide for the transfer of virus and bacterial samples for the development of appropriate technologies.

One of the first steps towards the formation of special control mechanisms for the use of "dual-use technologies" was the development by WHO of the "Global System of Recommendations for the Responsible Use of Life Sciences: Reducing Biorisks and Regulating dual-use Research" in 2022, which sets out recommendations for various stakeholders on the management of biological risks and dual-use technologies.

Summarizing the considered international initiatives to control access to scientific data and health technologies of dual importance, it should be noted that the international community recognizes commitments to the sustainable exchange of information on these technologies. However, the declared obligations are mostly voluntary in nature, which limits the possibility of ensuring systemic control at the global level.

Conclusion

Technological progress in the field of health protection has made it possible to achieve significant results in improving the efficiency and quality of medical and social care and countering threats and challenges to human security on a global scale. However, the activities of subjects of international relations in ensuring equal access to scientific knowledge and technology within the framework of ensuring the right to use the achievements of scientific progress pose potential risks of their uncontrolled use, both by States for the purpose of creating new types of weapons, and by non-State actors for carrying out illegal activities and acts of terrorism.

The documents of international organizations have repeatedly noted the potential threats of biotechnologies in rethinking the modern concept of human and state security, but so far no international legal mechanisms have been prepared to regulate their circulation. It is advisable to formulate definitions of the concept of dual-use technologies in the context of the field of health protection in order to form the basis for normative activities in this area in the future.

Taking into account that the content of General Comment No. 14 to Article 12 of the ICESCR does not meet modern problems in the field of circulation of health technologies, it is advisable to consider the possibility of developing a general comment on the obligations of States under the ICESCR in the context of access to health technologies, taking into account the normative content of the human right to health and access to scientific progress.

In order to systematically monitor the conduct and publication of scientific research results in the field of medical and related sciences, it is advisable to provide for the possibility of establishing a special working group based on WHO, as well as the normative consolidation of the obligation of States to voluntarily provide scientific data, as well as other information of importance for understanding the assessment of potential risks of the technology under study.