Supply of medicines and social policy of the state

The issues of providing the population of the Russian Federation with safe and effective medicines represent an important area of the policy of the state, which is called social in the Constitution.

The right to the protection of life, as an inalienable value, belongs to everyone from birth, is fundamental, and the right to health care and the right to medical care accompanying it, which form the basis for the realization of the above inalienable right. It is noteworthy that the right to health protection and the

right to medical care are fixed in the dispositions of one constitutional norm, which speaks not only of their constitutional value, but also their inextricable interrelation with each other, as well as with personal human rights.

Traditionally, human rights are classified into three generations: the first one includes civil and political rights, the second one covers economic, social and cultural rights, and the third one - collective rights. At the same time, personal rights are included in the civil rights of a person, and the core of personal rights is the right to life and dignity of the individual, the right to freedom and personal security.^[225]

The Russian state, sharing and following this legal tradition, in Art. 17 of the Constitution has enshrined the presumption that basic rights and freedoms are inalienable and belong to everyone since their birth, regardless of whether they are established in the law. At the same time, the social rights of a person related to the second generation of rights depend on the level of development of society and require their legislative filling. The very same social rights is a kind of guarantee for the protection of personal rights. For this reason, there is currently a scientific discussion on the attribution of social rights to the category of inalienable personal rights. Thus, in the article "On human rights and social rights" K.V. Aranovskiy, S.D. Knyazev and Ye.B. Khokhlov, while noting the close connection of personal and social rights, indicate that, judging by their name, social rights mean a lot to the whole society. But personal rights are also of great social importance. Personal and social rights sometimes deal with one subject, for example, with dwelling or life, health and dignity.

Developing similar judgments, Yu.D. Sergeev and M.I. Litovkina note that health is a multidimensional phenomenon and constitutes a category of purely biomedical (human health, mental health, etc.), biosocial (public health, health of a nation or a country, etc.), and legal (human right to health, the right to protection of health, etc.).^[227] Thus, the state calls life and health of citizens one of the priority values, in turn, guaranteeing the exercise of protection of this right, on the one hand, being personal, and on the other hand, being an indispensable condition of a developed state. Individual health is most often identified with a particular condition or property of the human organism (which fully agrees with the biomedical approach to the notion of health), and public health reflects the aggregate state of individuals.

Taking this argument into account, it is obvious that social rights are valuable both in terms of their functional focus on ensuring personal, nonproperty rights of each person, and also because of their high significance for social life of society as a whole. It can be said that it is in social rights, where the interconnection and interpenetration of private interests of individuals and the public interest of the state and society are traced. That is, public interest in the context of social rights is manifested as a target for achieving a common social good, carried out by coordinating, harmonizing and satisfying the significant and legitimate private interests of members of society, which in turn serves as a guarantee of the existence of a public system.^[228]

The fundamental law that established the social rights of Russian citizens in the field of public health is Federal Law of November 21, 2011 N 323-FZ "On the fundamentals of protecting the health of individuals in the Russian Federation" (hereinafter - FZ No.

use of medicines registered on the territory of the Russian Federation.^[230]

The foregoing allows us to assert that providing the population with medicines is the most important function of the state aimed at protecting public health both in the context of rendering medical assistance to the population and providing them to the population for independent consumption. In this regard, the sphere of treatment of medicines is socially significant, and violationbi of the principles of quality, safety and accessibility in this area do not only threaten the harm to the health of individuals, but also damage the society as a whole, as well as the state as a guarantor of such rights .

It should be noted that the legislator does not always follow the broad interpretation of the concept of the supply of medicines proposed in Art. 18 of FZ No. 323-FZ. Thus, the term "supply of medicines" in regulatory acts is for the most part used in the narrow sense either as part of medical assistance or as a set of state measures aimed at providing socially unprotected citizens with medicines for free or on preferential terms (that is, as one of the Directions of social security). The first of these approaches corresponds, in particular, Art. 80 FZ No. 323-FZ, where the term "supply of the population with medicines" is defined as providing citizens with medicines according to the list of essential medicines, implemented within the framework of the program of state guarantees for free provision of primary health care to citizens, assistance in conditions of a day hospital and in urgent form, specialized medical care, including high-tech, emergency medical care, specialized ambulance and palliative care in hospital settings.

The second approach is enshrined in the Federal Law of July 17, 1999 N 178-FZ^[231] "On State Social Assistance," where in Art. 6.2 supply of medicines is defined as the right of certain categories of citizens to recieive medicines upon prescription. This legal position of the legislator is also reflected in a number of regulations defining the provision of medicines in ambulatory facilities at the expense of the federal budget for citizens who have certain nosologies^[232], free provision of medicines for ambulatory treatment for military personnel and citizens signed up for military training.^[233] Therefore, the analyzed approach reflects the direction of state policy, providing, on preferential terms or on a free basis, with medicinal products certain categories of citizens, referred either to the most socially vulnerable groups of the population or to those having a special status due to the social significance of the disease or the professional activity of a citizen.

It is possible to single out one more (not indisputable) approach as to the notion of " supply of medicines" proposed in science. Thus, M.V. Podvyaznikova in her thesis "Legal regulation of medicinial assiance in the social security system"^[234] on the basis of the lexical analysis of the terms "medicinal assistance" and "supply of medicines" concluded that supply of medicines is one of the stages of medicinal assistance, within which the patient is provided with necessary medicines. It seems that the controversy of this approach is indicated by the fact that analyzing the current state of the level of medicinal assistance, as well as pointing out the inadequacy of the legislative framework governing this issue, M.V. Podvyaznikova, in fact, is constantly investigating the medicinal supply of the population, and not the medicinal assistance. Seven out of the ten conclusions formulated by the author hereof describe the revealed defects in the legislative regulation of supply of medicines, and also point out the shortcomings in the mechanisms of medicinal supply of citizens in the system of state social assistance. The "present uncertainty of the scope and content of the relevant state guarantees for medicines is called as the reason for these defects and shortcomings, which causes the possibility of arbitrary application of the relevant norms and simultaneously creates difficulties for citizens in determining the scope of their rights in the field of medicinal supply, as well as difficulties in the process of their implementation and protection."^[235]

Thus, it seems that M.V. Podvjaznikova assigns a much more significant and independent role to such a category as "supply of medicines" rather than the role of an integral part within the broader concept of "medicinal assistance".

It seems that the analyzed legal constructions, first of all, do not reflect the essence of medicinal supply as a broad socially significant obligation of the state. After all, given the premise that medicines are an integral element in the provision of any medical assistance, and also taking into account the possibility of using them as an independent element of the general right to health protection, it can be assumed that the term "supply of medicines" should be interpreted not only as a direction of social security mesuares related to the supply of medicines to certain categories of individuals, and not only as a stage of medicinal assistance, but in a broader sense as social state's obligation to protect the health of each individual. Therefore, it is not enough that the term "supply of medicines" is amounted to the state's activity at the stage of distribution (redistribution) of available medicines from the point of view of social justice. It is necessary to distinguish the function of state management of all processes, such as creation of a medicinal product, its registration, production, market launching, etc., which allows considering supply of medicines as a social function of the state. Such a wide application of the term "supply of medicines" is supported by a high degree of social importance of medicines, first, due to the universality of their provision to an indefinite number of persons, in other words, all people needing medicines, and, secondly, the quality, safety and accessibility for each stage of treatment of medicines. So, in support of this point of view, we may refer to the provisions of the Medicinal Supply Strategy for the Population of the Russian Federation for the period until 2025 and the plan for its implementation approved by Order No. 66 of the Ministry of Health of Russia dated February 13, 2013^[236] (hereinafter - the Strategy). This document calls generality (indicating the protection of the health of every citizen of the Russian Federation), as well as the rationality, balance and safety, effectiveness and quality of medicinal products for medical use, as the main priorities of the state policy of supply of medicines.

The Strategy specifies that the special feature of the forthcoming period of socio-economic development is the emergence of external and internal challenges that create prerequisites for improving the state policy in the field of health and medicinal supply, along with changing the requirements for the organization of the health care system and medicinal supply, the emergence of increased demands as to the resource support for the systems of social insurance and social assistance, the increasing role of human capital as a basic factor of economic development. The strategy links the need to implement the above actions, including the need to strengthen the role of social programs that ensure the preservation of the high quality of human potential, primarily contributing to the improvement of the quality of medical care provided to the population, including those of the working age, by increasing the availability of modern highly effective medicinal therapy. Along with general economic measures, it is also planned to equalize the quality of life of the population through free or simplified supply of medicines to the categories of the population most in need (persons with disabilities, people suffering from orphan or socially significant diseases, children under 3 years of age).^[237] Thus, among the measures to improve the supply of medicines, both the measures aimed at its implementation among an unlimited circle of citizens and those intended to support the so-called special subjects most in need of medicinal supply are described. In addition, to ensure the safety, efficacy and quality of medicinal products for medical use, the following measures are envisaged: improvement of the state control and permissive system through quality control, efficacy and safety of medicines at all stages of their circulation, including side effects monitoring and investigation of complications and unusual reactions that occur after the drug is applied; harmonization of requirements for preclinical and clinical research, organization of production, storage, transportation, dispensing, destruction of medicinal products, as well as rules and forms of assessment, taking into account international standards.

The foregoing suggests that the scope of the concept of "supply of medicines" has a wider general social and, therefore, a wider legal meaning. The legislator (directly in the Strategy and, indirectly, in other legal acts governing suppyly of medicines provision as the direction of state policy), represents this activity not only as the supply of certain social groups with medicines in the framework of state programs, but as all activities to provide the population with medicines, from the stage of their production to distribution. On this basis, it appears that for the improvement of governmental activities and the development of appropriate measures aimed at implementing the set objectives of the Strategy, it is appropriate to the introduction of legislation the concept of "supply of medicines" that will highlight specific activities at each stage of the execution of this public function, as well as to consolidate the powers of their implementation and monitoring at various stages for certain government agencies and other entities handling pharmaceuticals classified as such by the legislation of the Russian Federation. Such an approach will allow, both from the theoretical and practical points of view, to give substance (including legal substance) to the corresponding social obligations owed to the people of Russia.

The following main characteristics of the notion of "supply of medicines" can be distinguished: 1) a comprehensive nature, that is, its focus on preserving the life and health of the entire population of the country, as well as certain categories of citizens who receive state social assistance; 2) safety, efficacy and quality of medicines; 3) the social obligation of the state (within the framework of state social policy), expressed in the control of the state at all stages of the circulation of medicines, including control over pricing, which should ensure the availability of socially significant medicines.

Thus, "supply of medicines" should be considered as part of the state social policy aimed at preserving the life and health of citizens, manifested in securing the state's obligations to take a set of economic, organizational, legal measures that ensure both the provision of medicines to all citizens and control over the circulation of safe, effective, affordable medicines, including, as part of their distribution under state guarantees programs.

Supply of medicines to the population is one of the most important factors of the social development of society and serves as an indicator of the security of the population as a whole, which is the bearer of different interests. Consequently, as Yu.A. Tikhomirov stated, there is need for the efforts to harmonize such interests with the use of rules of law, which "imposes new demands on the law called upon to gently and rigidly govern various aspects of life of individuals, create conditions for the active operation of civil institutions and stimulate the harmonization of social relations."^[238]

In this context, it should be noted that in the field of providing the population with medicines, the state, althougn remaining burdened by this important social obligation, should create conditions for active involvement of civil society institutions in this process that can and should contribute to the solution of this task, directly related to the protection of public health. So, in the Russian Federation there are self-regulated public organizations and associations, as well as professional communities, whose sphere of activity includes the issues of medicinal supply for the population. In particular, we can highlight the important role of the First National Congress of Doctors of the Russian Federation, held on October 5, 2012, in whose resolution it was noted that the consolidation of the medical community on the principles of professionalism, responsibility, honesty, equality will be an important step in improving the quality, accessibility, security of medical care to our fellow citizens.

At the same time, among the problems requiring urgent decisions, the delegates to the congress stressed the inadequacy of the existing mechanisms of medicinal supply of the population, and therefore the Congress approached the Ministry of Health of the Russian Federation with concrete suggestions aimed at overcoming this situatiom. ^[239] Such an initiative is an expression of the civic position of the professional community of Russian doctors, prompting the competent state bodies to more effectively fulfill their obligations.

In addition, as an example of the active participation of public institutions in the provision of medicines, it is possible to bring organizations that unite representatives of the pharmaceutical community. In particular, the Association of Russian Pharmaceutical Producers, has determined as its mission the development of the leading socially responsible pharmaceutical manufacturers capable of providing patients with quality, modern and affordable medicines. The Association of International Pharmaceutical Manufacturers has prepared and signed the Memorandum of Understanding with the All-Russian Union of Patient's Public Associations, which establishes basic ethical principles that increase transparency in the interaction of the pharmaceutical, medical and patient communities.^[240]

In turn, the citizens themselves, being subjects of the right to medicinal supply, in accordance with part 2 of Article 45 of the Constitution of the Russian Federation can protect this right by all means not prohibited by law, including, and using the institutions of civil society. In the field of realization of citizens' rights to medicines, an important role belongs to such patient organizations as the All-Russian Patients' Union^[241], the League of Patients' Defenders ^[242] (the “Right to medication” website is created and maintained, which aims not only to help patients, but also to change the medicinal supply system generally).

Taking into account the fact that the solution of the important national task to provide the citizens of the country with medicines serves all kinds of social needs (public, corporate and personal), the state should use the high potential of civil society consolidated to ensure its interests. Thus, it is necessary to improve the system of measures at the organizational and legislative levels, stimulating the participation of public associations, professional communities and citizens in the supply of medicines to the population in those aspects of it that such social selforganization can encompass.

As already emphasized, the state should ensure the safety, effectiveness, availability of medicines in the framework of the supply of medicines, which is a strategic goal of ensuring national security in the area of public health of the nation and, therefore, can be referred to as "medicinal security", which should be regarded as part of the national security of the country. This point of view is maintained by Presidential Decree No. 537 dated May 12, 2009, "On the National Security Strategy of the Russian Federation until year 2020"^[243], the preamble of which states that the main directions of the national security policy of the Russian Federation are strategic national priorities that determine the tasks of the most important social, political and economic transformations to create safe conditions for the exercise of constitutional rights and freedoms of citizens of the Russian Federation, and to support the country's development, territorial integrity and sovereignty of the state. Among the strategic goals aimed at ensuring national security in the area of public health of the nation in Art. 71 the Decree called the improvement of controls over the quality, efficacy and safety of medicines. Thus, in the Russian Federation, the National Standards have been adopted,^[244] according to which the medicines must be produced, and they contain the requirement for compulsory licensing of both the production and sale of medicinal products.

Federal Law No. 61-FZ dated 12 April 2010 "On the circulation of medicinal products"^[245] (hereinafter referred to as the Law on the circulation of medicinal products) was modified with amendments to enter into force on January 1, 2015, whereby section 52.1 of Article 1 was added with the concept of pharmaceutical supervision as a type of activity for monitoring the effectiveness and safety of medicines aimed at identifying, assessing and preventing undesirable effects of the use of medicines.

The foregoing allows us to determine that violations in the sphere of the circulation of medicines will not only lead to serious damage to the health of citizens, but also could generally threaten national security. Due to the fact that the state has assumed the responsibility to provide Russian citizens with quality, safe and effective medicines, both directly and as part of the medical assistance provided, the state authorities also have the priority to control any activity related to the production, release and circulation of medicines, including monitoring their safety and effectiveness. Such control and supervision activity is a natural consequence of the public nature of the state's public health obligations, which ensure both the health of individuals and the health of the nation as a whole.

In the light of the foregoing the medicinal security in the national scope must be considered as the state-guaranteed protection of the citizen's right to have access to medicines of proven efficacy for the treatment of a particular disease, and the safety of these agents for human organism, implying a risk/benefit ratio for its use, which is in favor of the patient.

For the implementation of medicinal safety policy the Russian legislator has developed the " Strategy for the development of the pharmaceutical industry for the period until year 2020" approved by Order of Industry and Trade of Russia No. 956 dated October 23, 2009,^[246] that provided further detail to the relevant challenges that the state is facing. The main objectives of this strategy are to increase the availability of medicines for both the population directly and through medical organizations, boost the domestic pharmaceutical industry onto the international market and ensure its competitiveness, stimulate the development and production of innovative medicines and support the exports of Russian medicines, improving the conformity assessment system and ensure proper control over their quality. It is worth noting that the current geopolitical realities and the economic situation can be attributed to a number of external challenges, in connection with which the problem of transition to import substitution of drugs, as set by the state, is particularly relevant. In this context, the availability of medicines as part of a pharmaceutical security strategy must be understood in the context of the increase of the share of Russian medicines in the domestic pharmaceutical market, which would allow improvement and maintenance of public health.

The proper supply of medicines to the population (including its medicinal security aspect) must be guaranteed by the state through the steps defined in the Law on the Circulation of Medicines, such as the development, pre-clinical research, clinical trials, expertise, state registration, standardization, quality control, production, manufacture, storage, transport, import to the Russian Federation and export from the Russian Federation, advertising, release, sale, transfer, use and destruction of medicines.

Clinical trials of medicinal products for medical use (hereinafter referred to as CT) are the final stage of development of a medicine, during which the efficacy and safety of the drug for the patients are investigated. It is the results of such studies that are the basis for resolving the issue of whether a new drug may be registered and released to the pharmaceutical market. This functional purpose of CT makes it possible to distinguish them as the most important stage of medicinal supply to the population. At the same time, it should be noted that such a high value of CT in the process of supply of medicines and medicinal security is due to the fact that, according to experts, mortality from adverse drug reactions is among the top five causes thereof (along with cardiovascular, oncological, bronchopulmonary diseases and injuries).^[247] In this regard, it is important to conduct legal analysis of the public relations that arise in the course of the CT, taking into account, among other things, the social orientation of this process.

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