Convergence of legal regulation of circulation of healthcare technologies in international law

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 117218, Russia, g. Moscow, ul. Bol'shaya Cheremushkinskaya Ul, 34 vlad.malichenko@gmail.com Other publications by this author

Introduction

Under the influence of scientific achievements of the last decades, health technologies have transformed into one of the most important elements of ensuring the human right to the highest attainable level and achieving the Sustainable Development Goals. The importance of access to health technologies on the international agenda was formulated within the framework of the Millennium Development Goals approved by the UN General Assembly in 2000 and further within the framework of the Sustainable Development Goals, also approved by the UN General Assembly in 2015, as one of the objectives of SDG No. 3 "Ensuring a healthy lifestyle and promoting well-being for all in any age" ^{[1, pp. 256-285]}.

The circulation of healthcare technologies is a complex process, each of the stages of which involves the need to regulate certain spheres of public relations and can potentially limit the provision of equal and fair access to healthcare technologies, as well as form other threats to human security. The complexity of ensuring proper regulation of the processes of circulation of health technologies is associated with their global nature, involving different countries at the stages of development, production, transportation.

Such trends determine the desire of the international community, as well as individual regions of associations, to ensure maximum convergence of the normative content of legal acts regulating the circulation of healthcare technologies in order to form uniform standards of safety, quality, efficiency, and also promote timely access to necessary treatment.

The role of healthcare technologies in the formation of threats and challenges to human security

          Infectious pandemics, the frequency of registration of which has been rapidly increasing since the beginning of the new millennium, as well as demographic changes expressed in the increasing prevalence of non-communicable diseases (NCDs), lead to an increase in the strategic importance of health technologies. The specifics of regulating the circulation of healthcare technologies form a number of systemic threats and challenges to human security.

It is necessary to dwell separately on some stages of the circulation of healthcare technologies that are of the greatest importance for the sustainability of this system. One of the first harmonization processes concerned the standards for conducting clinical trials of medicines, and subsequently other healthcare technologies, in order to ensure proper quality control and effectiveness at the registration stage. Unified standards for conducting clinical trials can prevent cases of falsification of the results obtained. The facts of registration of such activities have been repeatedly considered in the scientific literature ^{[9, p.1-13; 11, p.161-173]}.

No less important is the stage of production of healthcare technologies. First of all, it is necessary to ensure uniform standards for quality control of production, especially in developing countries of the pharmaceutical industry. An increase in the demand for medicines and medical devices leads to an expansion of the scale of production of more affordable analogues, which is often accompanied by a decrease in product quality standards ^{[12, pp.218-243]}. It should also be noted that the peculiarities of the production of a number of medicines and medical devices imply potentially high levels of emissions into the environment, which, as a consequence, creates additional risks to human health ^{[13, pp.1-7]}.

An increase in the need for healthcare technologies leads to the formation of a shortage and, as a consequence, an increase in the detection of counterfeit and low-quality products, which exacerbates the problems of monitoring the safety and quality of healthcare technologies ^{[18, pp.93-98]}. States are not able to independently ensure the necessary quality of control and supervisory measures and the development of the regulatory environment, which is the basis for the harmonization of regulatory regulation at the regional level ^{[7, pp.256-285]}.

The most discussed issues today are pricing and the inclusion of healthcare technologies in state health insurance programs. Historically, this aspect of the circulation of healthcare technologies has been exclusively regulated by domestic law. However, more and more attention is being paid to the formation of legal mechanisms for the exchange of information on pricing between states ^[17], as well as the introduction of unified approaches to the assessment of healthcare technologies.

Legal convergence in the international legal regulation of the circulation of healthcare technologies.

The need to form unified approaches to the regulatory regulation of the circulation of healthcare technologies served as an incentive to strengthen the processes of "legal convergence". "Legal convergence" should be understood as the activities of entities with a rule-making function to bring international and national law closer, aimed at achieving uniformity and unity of legal regulation ^[2]. Legal convergence is carried out on the basis of the following methods: harmonization, unification and integration ^{[3, p. 26-30]}.

Unification presupposes the formation of a single normative legal act regulating a certain sphere of public relations at the regional and international level. The integration process is aimed at achieving the unity of legal regulation and strengthening the interdependence of states, being a higher degree of consistency of the wills of states ^{[1, pp.63-67]}. Harmonization in the scientific literature refers to the process of convergence of national legal systems, reduction and elimination of differences between them ^{[4, p.164; 5, p.122]}.

The processes of convergence of regulatory and legal regulation of the circulation of healthcare technologies should address the following issues: organization, conduct and financing of scientific research; introduction of healthcare technologies into the system of medical and social care; protection of exclusive rights of developers; ensuring the safety and quality of production and application of healthcare technologies; introduction of sustainable mechanisms for the transfer of healthcare technologies; limiting emissions during production; ensuring rational application; implementation of a fair pricing system.

One of the first initiatives to ensure legal convergence was the establishment in 1990 of the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceutical Products Used by Humans (ICH), aimed at harmonizing the regulatory regulation of individual stages of the circulation of healthcare technologies. The International Conference ensures the development of guidelines on the safety, quality and effectiveness of medicines, which subsequently become mandatory after their approval by acts of domestic law ^{[14, pp. 926-931]}. In particular, it is worth mentioning the guidelines on "Good Clinical Practice" (GCP), aimed at the introduction of uniform standards for quality assurance of clinical trials of medicines, or the guidelines on "Good Manufacturing Practice" (GMP), providing uniform standards for the production of medicines in various regions of the world. Thus, in the EU, the ICH guidelines are implemented by the Committee on Medicinal Products for Humans (CHMP) and are included in the list of scientific guidelines that the subjects of circulation of medicines in the EU must comply with. In accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code of Medicinal products for medical use, each application for a permit for the circulation of a medicinal product in the EU must take into account the ICH guidelines.

Another example of harmonization is the development of the Council of Europe Convention "On Combating the Falsification of Medical Products and Similar Crimes that Threaten Public Health" (CCE No. 211 Convention "Medicrim"). The provisions of the Convention are aimed at forming a unified understanding of the concept of "falsified medical products", which has been the subject of discussions by the World Health Organization for many years. In addition, the document provides a standardized list of liability measures for falsification of medical products and similar crimes for subsequent implementation into the national legislation of countries that have ratified the Convention ^{[8, p.87-100]}.

It is impossible not to note the role of regional trade agreements in ensuring the harmonization of certain aspects that determine access to health technologies. In particular, most regional trade agreements contain provisions establishing additional measures to protect intellectual property rights on the territory of the participating countries. In scientific works, such measures have been called "TRIPS Plus" and "TRIPS Extra", since they introduce additional mechanisms for protecting intellectual property rights that are not contained in the TRIPS Agreement ^[10]. Such a manifestation of harmonization may have negative consequences for ensuring the human right to the highest attainable standard of health due to the potential restriction of access to health technologies in certain regions of the world ^{[16, pp.1-40]}.

It should be noted that today the convergence of international legal regulation of the circulation of healthcare technologies affects only certain stages of this process, not allowing a systematic approach to be formed. One of the practical solutions to this problem may be the development of a normative legal act of a universal nature, which makes it possible to form the basic principles and approaches to regulating this sphere, by analogy with codifying conventions existing in other branches of international law.

The practice of harmonization of regulation of the circulation of healthcare technologies in the activities of regional integration associations.

          The strengthening of processes aimed at the formation of a single economic space and the development of trade processes on the territory of a particular region contributed to the development of the application of methods of harmonization and integration of regulatory regulation of the circulation of health technologies.      

          As a first example, it is necessary to refer to the experience of forming a unified system of regulation of medicines in the European Union. Harmonization processes began on the territory of the EU with the convening of the European Commission conference of representatives of industry, doctors and consumers to discuss the standardization of the regulatory framework in the pharmaceutical sector and already in 1965 Directive 65/65/EEC of the European Economic Community "On the approximation of legislative provisions, rules and administrative measures in relation to medicines" was approved. In the following years, dozens of directives, decisions and resolutions of the governing bodies of the European Community, and later the EU, were adopted. As part of the development of harmonization processes at the beginning of the new millennium, the previously existing regulations were revised and replaced by the single Directive 2001/83/EC of November 6, 2001.

          The manifestation of the integration method was the establishment of the European Agency for the Examination of Medicines, later renamed the European Medicines Agency (EMA), which establishes union registration and supervision procedures for medicines. The main task of the EMA is to conduct expert activities associated with different stages of the circulation of medicines, including centralized registration and pharmacovigilance, on the basis of which the necessary decisions are made at the level of EU management institutions. The emergence of a centralized procedure for the registration of certain categories of medicines in its meaning is a kind of apotheosis of the integration process, in which the participating countries delegate part of the sovereign rights in relation to the examination and determination of the expediency of allowing the circulation of a medicinal product on the territory of the state ^{[6, p.75-81]}.

          The increase in cases of registration of low-quality and falsified medicines in the countries of the African region has strengthened the use of harmonization and integration methods. In particular, in 2009, an Initiative was established to harmonize the regulation of the circulation of medicines in African countries, which developed a "Model Law on the Regulation of Medical Products", approved by the heads of State and Government at the summit of the African Union in Addis Ababa in 2016. The Model Law forms a framework for harmonization at the regional and subregional levels in order to expand cooperation between countries and ensuring the development, testing and application of promising healthcare technologies to improve the performance of healthcare systems ^{[15, p.1-12]}. In November 2021, an agreement on the establishment of the African Medicines Agency entered into force with the aim of forming standards and rules to improve the effectiveness of regulating the circulation of medical products and coordinating the activities of national regulatory authorities for their implementation

          Special attention should be paid to the practice of using convergence methods in the context of the formation of single markets for medicines and medical products in the space of the Eurasian Economic Union (EAEU). It should be noted that the activities of the single markets do not imply full integration of regulatory regulation, being limited to the harmonization and unification of the legislation of the member states. The Treaty on the Eurasian Economic Union defines the concept of harmonization, which should be understood as the convergence of legislation to establish comparable regulatory regulation in certain areas. According to the Methodology of Harmonization of the legislation of the EAEU member states, the unification of national legislations involves bringing national legislation into relation with supranational acts of the EAEU to ensure their full identity.

Long-term priorities for the development of harmonization of regulatory and legal regulation are determined in accordance with the provisions of the Decision of the Supreme Eurasian Economic Council dated 11.12.2020 No. 12 "On Strategic directions for the development of Eurasian economic integration until 2025". In particular, in paragraph 4.10.1. of the document, tasks are formulated for "the adoption of the concept of further development of common markets for medicines and medical devices within the Union. In paragraph 10.3.7. tasks are defined for "creating effective mechanisms for supporting and financing joint initiatives and cooperative projects in the field of research and the introduction of innovative developments in prevention, diagnosis and treatment infectious diseases".

          Based on the practice of applying methods of harmonization and integration within the framework of convergence of regulatory regulation of the circulation of health technologies in the European and African region, it is advisable to consider the possibility of creating a supranational body of the EAEU authorized to regulate certain stages of the circulation of health technologies. Equally important is the formation of unified approaches to setting the maximum selling price for strategically important medicines and medical products in the EAEU countries, which will prevent situations of unfair pricing, as well as provide a unified approach to the formation of supranational guarantees of human security.

Conclusion

To date, a small number of scientific publications are devoted to the study of the features of convergence of legal regulation of the circulation of healthcare technologies. However, the globalization of the processes of development, production and transportation of medicines and medical devices, involving the simultaneous involvement of states with different levels of regulatory system development, determine the need for systematic application of convergence methods to ensure timely access to safe and high-quality healthcare technologies.