Legal regulation of the circulation of medicines. Legal regulation of the circulation of medicines (Mosin V.M.)

20.02.2019

Legal regulation of turnover medicines(Mosin V.M.)

Date the article was posted: 25.02.2015

Maintaining and improving the state of human health is one of the most important problems and tasks of the development of society. In Art. 41 of the Constitution of the Russian Federation, the right of every citizen to health care is enshrined, which is unthinkable without the use of medicines (up to 90% of doctors' appointments fall on drug therapy). The topic of providing the population with medicines is one of the most painful in our country. On January 1, 2010, state regulation of prices for medicines from the list of vital and essential medicines was introduced.
The main law affecting the circulation of medicines is the federal law of April 12, 2010 N 61-FZ (as amended on 03/12/2014) "On the circulation of medicines". In accordance with Art. 1 the scope of this Law is relations arising in connection with the development, production, manufacture, preclinical and clinical trials of medicinal products, control of their quality, efficacy, safety, trade in medicinal products and other actions in the field of medicinal products circulation. In other words, the legislator identifies the following directions of drug circulation: development, production, preclinical and clinical studies, quality control, efficacy and safety, drug trade.
Article 4 of the same Law contains a definition of the circulation of medicines. The circulation of medicines is understood as a generalized concept of activities, including the development, research, production, manufacture, storage, packaging, transportation, state registration, standardization and quality control, sale, labeling, advertising, use of medicines, destruction of medicines that have become unusable, or expired medicinal products and other actions in the field of medicinal products circulation.
The use of drugs, due to their social significance, danger to the life or health of citizens, also determines the need for state regulation of drug consumption (issues of prescribing drugs, prescribing prescriptions, free sale of drugs, etc.).
Destruction of medicines can be singled out as an independent type of activity requiring special legal regulation and state control. The destruction of drugs is preceded by their withdrawal in accordance with the procedure established by law. Medicinal services in modern conditions unthinkable without proper information support for the subjects pharmaceutical market(pharmacists, pharmacists, doctors, citizens, officials) complete and reliable information about new drugs, new indications and contraindications for already known and widely used drugs, unusual side effects, unscrupulous participants in the pharmaceutical market, counterfeit drugs, the results of clinical trials of drugs, etc.
The possibility of causing harm to health by information is recognized at the legislative level, and any actual information related to the medicinal product, primarily instructions for medical use and promotional materials may be harmful. Therefore, the patient has the right to receive reliable information about the medicinal product, containing the rules for its safe use, in accordance with Federal Laws of March 13, 2006 N 38-FZ "On Advertising" (as amended on January 30, 2014), of July 26, 2006 N 135-FZ "On Protection of Competition".
The Civil Code of the Russian Federation contains provisions on obligations, general provisions on the contract, and also governs individual obligations. Regarding the circulation of medicines: purchase and sale (Art. Art. 454 - 491 of the Civil Code of the Russian Federation); retail purchase and sale (Art. Art. 492 - 505 of the Civil Code of the Russian Federation); delivery of goods (Art. Art. 506 - 524 of the Civil Code of the Russian Federation); supply of goods for state and municipal needs (Art. Art. 525 - 534 of the Civil Code of the Russian Federation); performance of research, development and technological work (Art. Art. 769 - 778 of the Civil Code of the Russian Federation); obligations as a result of harm (Art. Art. 1064 - 1101 of the Civil Code of the Russian Federation).
Federal Law of February 7, 1992 N 2300-1 "On Protection of Consumer Rights" contains the basic concepts (consumer, manufacturer, seller, product safety) that are directly related to the sphere of drug circulation. Articles 5 and 6 of the Law establish the obligations of the manufacturer, contractor, seller, and Art. 7 secures the right to the safety of goods (work, services). The law regulates in detail the issues related to bringing information to the consumer about the manufacturer (performer, seller) and about goods (work, services). Article 12 of the Law introduces the presumption that the consumer does not have special knowledge, which requires the relevant persons to provide complete and reliable information.
Articles of the Federal Law of November 21, 2011 N 323-FZ (as amended on December 28, 2013) "On the basics of protecting the health of citizens in Russian Federation"state, municipal and private system health care, which also includes pharmaceutical organizations. The law regulates the application of new methods of prevention, diagnosis and treatment, medicines, immunobiological preparations and disinfectants, as well as the conduct of biomedical research.
Federal Law of January 8, 1998 N 3-FZ "On narcotic drugs and psychotropic substances "defines the directions and principles of state policy in the field of trafficking in narcotic drugs, psychotropic drugs and in the field of countering their illicit trafficking.
It should be noted that all types of legal liability are applied to the subjects of medicines circulation: civil, administrative, disciplinary, and criminal. For example, the Criminal Code of the Russian Federation provides for such compositions as: illegal issuance or counterfeiting of recipes or other documents giving the right to receive drugs or psychotropic substances; illegal traffic potent substances for sales purposes; illegal practice in private medical practice or pharmaceutical; release or sale of goods, performance of work or provision of services that do not meet safety requirements. Also, the Code of Administrative Offenses provides for some types of liability, for example, for violations related to licensing, legislation on advertising of medicines, collection rules medicinal plants, violation of the pricing procedure.
The Law "On Circulation of Medicines" defines that pharmaceutical activity is an activity carried out by wholesale trade organizations and pharmacies in the field of circulation of medicinal products, including wholesale and retail trade in medicinal products, manufacturing of medicinal products. Pharmaceutical activities are carried out by legal entities of various organizational and legal forms, as well as individual entrepreneurs... Currently, the main consumer and payer for medicines is a citizen who enters into a retail sale and purchase agreement with a pharmacy. The second place in the structure of procurement of medicines is taken by medical institutions and private medical clinics, which are independent in choosing a supplier of medicines necessary for carrying out their main activities. The restrictions apply to the lists or names of drugs that are paid for under the compulsory medical insurance system, and some other drugs. The state, represented by the executive authorities in the field of health care, acts as a customer of medicines in order to implement certain federal programs... Also, the state influences the circulation process. medicinal substances regulated and free market. State regulation is one of the functions of public administration aimed at ensuring general rules behavior (activity) of the subjects of certain legal relations. Management tools include the actual management activities government agencies and local government, as well as regulations and court decisions... "State regulation of relations in the field of circulation of medicines is carried out by the federal executive body in the field of health care, whose competence includes the functions of developing state policy and legal regulation in the field of circulation of medicines, by the federal executive body, whose competence includes the implementation of state control and supervision in the sphere of drug circulation (Roszdravnadzor), by the executive authorities of the constituent entity of the Russian Federation ". The system of state regulation of relations in the sphere of drug circulation includes state registration of drugs; licensing of activities in the field of drug circulation; attestation and certification of specialists; state control of quality, efficiency, safety of drugs; regulation of prices for drugs.
Medicines on the territory of the Russian Federation must be registered by the federal quality control body for medicinal products for the purposes of production, sale and use. State registration of narcotic drugs and psychotropic substances used in medicine as medicines and subject to state control in accordance with the Law "On Narcotic Drugs and Psychotropic Substances" is accompanied by the inclusion of these drugs and substances in the appropriate lists in accordance with the above Law. Medicines intended for the treatment of animals are also subject to state registration federal agency for quality control of medicines.
"State registration is subject to: new medicinal products; new combinations of previously registered medicinal products; medicinal products registered earlier, but produced in other dosage forms ah with a new dosage or other composition of excipients; reproduced medicinal products ". Medicines manufactured in pharmacies according to doctors' prescriptions are not subject to state registration. It is allowed to use unregistered medicinal products or to test medicinal products intended for the treatment of animals. State registration of various medicinal products under the same name, as well as multiple state registration registration A registered medicinal product is entered into the state register of medicinal products.
"Licensing is subject to those activities, the implementation of which may entail damage to the rights, legitimate interests, health of citizens, defense and security of the state, cultural heritage of the peoples of the Russian Federation and whose regulation cannot be carried out by other methods other than licensing. "The main regulatory documents in the field of licensing activities related to wholesale trade and pharmacy institutions are: Federal Laws of May 4, 2011 N 99-FZ (ed. 01.09.2013) "On licensing of certain types of activities"; Resolutions of the Government of the Russian Federation of November 21, 2011 N 957 "On the organization of licensing of certain types of activities", dated December 22, 2011 N 1081 "On licensing pharmaceutical activities", dated December 22, 2011 N 1085" On licensing activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants. " and psychotropic substances of lists 1, 2 and 3, in accordance with the Law "On narcotic drugs and psychotropic substances" in terms of wholesale trade and the activities of pharmacies of federal health organizations. Licensing of the production of drugs intended for animals is entrusted to Roszdravnadzor and Rosselkhoznadzor. carry out: provision, suspension, maintenance of registers of licenses; reissuance of documents confirming the availability of licenses, etc.
The system of state regulation of drug circulation provides for the need for attestation and certification of specialists as a way of state control over drug circulation.
The state exercises state control over the quality, efficacy, and safety of medicinal substances and regulates the circulation of medicinal products (produced and imported into the territory of the Russian Federation). This control is carried out by the Law "On the Circulation of Medicines", regulatory legal acts of the Russian Federation, including the federal executive body in the field of health care. Along with the system of state control of quality, efficacy and safety of medicines, there is a system of certification of products and services (mandatory and voluntary) and declaration of conformity.
Fundamentals of price regulation: relations in the sphere of circulation of medicines are carried out, among other things, through state regulation of prices for medicines. In the Decree of the Government of the Russian Federation of October 29, 2010 N 865 "On state regulation of prices for medications, included in the list of vital and essential drugs "it is said that prices for drugs are not subject to state regulation, but only for vital and essential drugs included in a special list approved by the order of the Government of the Russian Federation. Prices for drugs are also subject to state regulation, intended for drug provision of citizens who have the right to state social assistance carried out with the help of regular control and monitoring of prices for medicines. The order of the Ministry of Health of the Russian Federation approves the list of medicines dispensed by prescriptions of a doctor (paramedic) in the provision of additional free medical care to certain categories of such citizens. The state also approves a list of trade names of medicines from the number of international non-proprietary names, drug names, dosage forms, dosages, manufacturers with indication of reimbursement prices.
"Federal fund obligatory health insurance made a proposal to implement in Russia new project in the field of drug provision for Russians - a drug insurance program. " Russian citizens... "It is possible to use both a drug insurance model and an analogue of the reimbursement system." "It is expected that this system will operate on the basis of a list of essential and essential medicines." The drug insurance program is expected to be introduced in 2015.
Legal regulation of the circulation of medicines in the Russian Federation is currently complex and is carried out mainly by the norms of civil and administrative legislation.

Literature

1. Bakhtina V.I. Civilistic studies in modern society... Russia and the world in the XXI century. 8th Interuniversity Scientific Conference of Students and Postgraduates. M., 2010.
2. The main directions and results of the drug policy of the Ministry of Health and Social Development of Russia // Chief physician... 2012. N 6.
3. Soloninina A.V. Legal Aspects regulation of pharmaceutical activities. Perm, 2009.
4. Soloninina A.V. Legislative and regulatory substantiation of the activities of pharmaceutical organizations. Perm, 2004.
5. Pryadko A. Medicines in a club. The Federal Compulsory Medical Insurance Fund proposes to introduce a drug insurance program in Russia // Pharmaceutical Bulletin. 2008. N 17.

Lecture 3

Topic: Legislative and normative legal regulation of activities in the field of drug circulation

Section: State regulation of relations in the field of drug circulation.

Plan:

Legislation of the Russian Federation on the protection of the health of citizens

Introduction

From day to day, people have a need to purchase medicines, however, indifference and mediocrity in terms of choosing a product poses a great threat to a person. Nowadays, pharmaceutical companies often do not pass the proper certification and licensing established by the legislation of the Russian Federation. The result of such offenses is damage to the health of citizens. Based on this, the problem of the circulation of medicines, namely the regulation of this process by the state, seems to be quite urgent.

So, in the message of the President of the Russian Federation in 2004 "On the most important national concerns»One of the main goals of the modernization of Russian healthcare was to increase the availability and quality of medical care for all segments of the population. In addition, domestic pharmaceutical companies must comply with international WHO requirements.

The works of G.T. Glembotskaya, N.B. Dremova, C.B. Kononova, I.V. Kosovoy, P.V., E.E. Loskutova, A.P. Meshkovsky, L.V. Moshkova, E.A. Maksimkina, A.B. Soloinina and others.

The main research in the field of pharmaceutical service management at the level of a constituent entity of the Russian Federation is reflected in scientific works G.N. Andrianova, A.B. Grishina, V.A. Egorova, Yu.A. Muzyry, G.A. Oleinik and others.

At the same time, it should be noted that many provisions of the regulatory, organizational and economic framework are controversial, and the specifics of managing this area are insufficiently studied both at the federal and regional levels. In my opinion, assessments of the quality of pharmaceutical services in pharmacy organizations have not been fully developed. The problem of managing the development of the sphere of pharmaceutical services as one of the directions of its improvement requires additional study.

The existing mechanisms of state regulation of the pharmaceutical market are designed to influence not only prices, but also the very structure of consumed drugs. For this, the state must have a stable, clear regulatory and legal framework.

V Lately The problem of drug supply in Russia is increasingly viewed from two positions: increasing the availability of modern, innovative drugs (hereinafter referred to as drugs) and import substitution of foreign drugs with domestic analogues. There is no doubt that society will benefit from the emergence of new highly effective drugs. This is evidenced by both the indicators of improving the health of citizens and the savings in treatment costs. As for import-substituting drugs, their appearance allows saving on costs, and also stimulates the development of the domestic pharmaceutical industry. In this regard, already in 2008-2009, the Strategy for the development of the domestic pharmaceutical industry until 2020 was approved, the program for additional drug supply (hereinafter referred to as DLO) underwent some changes, and the Concept for the development of healthcare until 2020 was adopted. These measures should contribute to improving the situation with drug supply in Russia.

Theoretical foundations of state regulation in the field of drug circulation

The role of the state in managing the development of the pharmaceutical industry

The state in the field of social policy has set the main objective- to make medical, including medicinal assistance, accessible and of high quality for all segments of the population. Achievement of these goals should be facilitated by various measures, such as: the creation of competent regulatory and legal framework in the field of drug circulation, its regulation, the development of various concepts and strategies, and, of course, their implementation.

Thus, the National Security Strategy of the Russian Federation until 2020, approved by the Decree of the President of the Russian Federation in May 2009, identified the strategic goals of national security in the healthcare sector as:

Improving the standards of medical care;

Quality control, efficacy and safety of medicines.

In addition, there is a Concept for the development of the healthcare system in the Russian Federation until 2020, which also involves the development of the following factors:

Improving the organizational system to ensure the formation healthy way life and the provision of high-quality free medical care to all citizens of the Russian Federation (within the framework of state guarantees);

Development of infrastructure and resource support for health care, including financial, material, technical and technological equipment of medical institutions based on innovative approaches and the principle of standardization;

Availability of a sufficient number of trained medical personnel capable of solving the tasks set for the health care of the Russian Federation.

Undoubtedly, these factors are interrelated, moreover, interdependent, which means that drug provision will play an important role in the implementation of this concept. It should be borne in mind that medical care accounts for 95% of all medical appointments, in connection with which it should be considered as a component of the treatment process. So, in this concept, special attention is paid to drug provision of citizens on an outpatient basis.

Currently, there are three main models of drug provision for citizens in the Russian Federation: additional drug supply(hereinafter referred to as DLO) within the framework of a set of social services provided for by the Federal Law of July 17, 1999 No. 178-FZ "On State Social Assistance" and drug provision of certain groups of the population free of charge or with a discount on doctor's prescriptions in accordance with the Decree of the Government of the Russian Federation dated July 30, 1994, No. 890, as well as providing patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, myeloid leukemia, multiple sclerosis, as well as after organ and tissue transplantation with expensive drugs.

Obviously, when developing this concept of drug provision, the categories of citizens who cannot be obliged to pay extra for the necessary drugs according to various reasons... Thus, disabled people of the Second World War for certain political reasons, rural residents due to a low level of material support, patients with high-cost drug provision, cancer patients should be protected by the state. The proportion of the population receiving drug subsidies is shown in table. 1 in Appendix 1, compiled by expert group 11 "Human health and environment".

There is a clear tendency of a decrease in the share of the population receiving reimbursement of drugs from budgets of various levels from 11% to 9.4%. In addition, if in 2008 the expenses of citizens on outpatient treatment for medicines were approximately twice the amount provided by the state, then by 2010 this figure had become a difference of almost 4 times.

So, on the way to achieving the goal of ensuring the availability of medicines, as well as their quality and rational use the main role undoubtedly assigned to the state. It should be noted here that by accessibility we mean equal opportunities for all citizens to purchase medicines at a reasonable cost, and by quality - the safety and effectiveness of these funds. With regard to rational use, the state needs to create conditions under which doctors will prescribe and patients, accordingly, take drugs. However, both should be guided by two basic principles: therapeutic feasibility and cost-effectiveness.

At the same time, the state must ensure that the goals of both health care and industry are equally achieved, not forgetting the need to contain drug costs. Thus, the government is faced with a choice between regulatory methods that can allow pharmaceutical companies to develop costly new drugs, and methods that ensure the affordability of high-quality drugs to the public.

In general, the current system is still subject to some changes for a number of reasons. First, the system does not allow for effective planning and control of the level of costs - the per capita DLO standard is not based on an analysis of needs, but is formed on the basis of the established monthly cash payment. Secondly, the DLO model using procurement procedures for state needs does not guarantee uninterrupted service of preferential recipes of the appropriate range. Thirdly, the main limiting mechanism is a restrictive list, but its formation is not based on an analysis of clinical and economic efficiency. And, finally, there are no participants who are economically motivated to efficiently spend budget funds.

Thus, according to a study conducted by Expert Group 11 "Human Health and Environment", certain problems were identified during the functioning of the current system. First of all, it is alarming that a citizen is ready to refuse necessary treatment only due to the high cost of the drug. Thus, according to the FOM survey, in 2009, 54% of citizens are forced to periodically, and 29% - often refuse to buy drugs because of their high cost. Moreover, 78% of respondents with chronic diseases noted problems with the availability of drugs due to their high cost.

Further, dissatisfaction is also caused by the regulation of prices for drugs only related to the list of vital and essential drugs (hereinafter - VED). However, as the analysis shows, 27.1% of packages of drugs required to treat a patient from a preferential basis? categories of the population and almost two thirds of the volume of medicines needed by the rest of the population (66.6% in value terms) are not included in the VED list.

In addition, reimbursement of the cost of purchasing prescription drugs at the current? the structure of consumption of drugs for outpatient treatment is only 213 billion rubles, or 1,345 rubles. per inhabitant per year (17.5% of the per capita standard of the state guarantee program?).

The undeniable fact remains that the state is the steering one in the field of public health protection, which means that it must correct the shortcomings associated with drug supply. In this aspect, most of both developed and developing countries use different methods regulation of the pharmaceutical market, which will be discussed below.

Basic theoretical concepts of state regulation in the field of drug circulation

A large number of researchers turned to the topic of state regulation of the field of medicines. Among them are a huge number of employees of the Russian Academy of Medical Sciences (Russian Academy of Sciences); candidates of sciences such as Zasimova L.S., Chubrova T.V., Milushin M.I. It is on their works that this work is partly based. And, of course, the main role in this issue is assigned to the executive authorities, whose powers include the circulation of medicines.

There are a number of principles in the development of the pharmaceutical industry. First, the industry must be viewed as a holistic, open and evolving system. Second, the industry can be regulated by administrative, regulatory and market mechanisms. Further, as in many other areas, the active participation of all interested parties is required to solve the existing problems. And, finally, reforming this industry is possible only on the basis of a comprehensive analysis and a comprehensive assessment of all aspects of activities.

In international practice, there is such a concept as a quality system for pharmaceutical products. This concept is defined as a set of measures to ensure the effectiveness and safety of pharmaceutical products, as well as their compliance with official requirements for quality indicators.

As a rule, this system includes the following indicators:

Legislation in the field of pharmaceutical products circulation;

Standardization in the field of drug quality and methods of their control;

The procedure for laboratory and clinical trials in the creation of medicinal products;

The procedure for registration of pharmaceutical products;

The system of research centers and institutes;

Supervision and control over the conditions of production of medicines;

Supervision and control over import, wholesale and retail trade and the licensing stage, as a measure of admission to the type of activity;

A system of control laboratories independent of production;

Inspectorate (inspection);

Specific quality assurance measures in the drug distribution network.

In other words, the priority task of the state in the sphere of drug circulation is the transition from the so-called socially irresponsible market to the effective provision of the treatment process with drugs.

Nevertheless, the system of state control in the Russian Federation presents a slightly different model than in most developed countries, which we will consider a little later. So, this system includes the following elements:

1) implementation in the Russian Federation of a unified state policy in the field of providing citizens with medicines on the territory of the Russian Federation;

2) approval of general pharmacopoeial monographs, monographs, publication of the state pharmacopoeia;

3) implementation of state control and supervision;

4) licensing the production of medicines and pharmaceutical activities in accordance with the legislation of the Russian Federation;

5) organization of expert examination of medicinal products, ethical examination of the possibility of conducting a clinical trial of a medicinal product for medical use;

6) issuance of permits for conducting clinical trials of medicinal products, maintaining a register of issued permits for conducting clinical trials of medicinal products;

7) state registration of medicinal products, maintenance of the state register of medicinal products;

8) inspection of the production of medicines for compliance with the rules for organizing production and quality control of medicines, issuing opinions on the compliance of the manufacturer of medicines with the requirements of the rules for organizing production and quality control of medicines;

9) state registration of maximum selling prices established by manufacturers of medicinal products for vital and essential medicinal products and maintaining the state register of maximum ex-factory prices of manufacturers for medicinal products included in the list of essential and essential medicinal products;

10) establishment of the procedure for the import of medicinal products into the territory of the Russian Federation and the export of medicinal products from the territory of the Russian Federation;

11) creation of councils on issues related to the circulation of medicines;

12) attestation and certification of specialists;

13) approval of educational programs for training specialists;

14) monitoring the safety of medicinal products;

15) participation in international cooperation;

16) receiving, at the request of the authorized federal executive body, from the executive bodies of the constituent entities of the Russian Federation, as well as from the subjects of circulation of medicines for medical use, information on the establishment and application of prices for medicines and markups to them;

17) application of measures of responsibility for violation of the legislation of the Russian Federation.

It is obvious that the system of state control in the Russian Federation is shifted to control finished product, and not at the stages of its creation and production. It is on the control over the circulation of medicines that we focus on in this work.

Here it is worth paying attention to the fact that the system of state control of the Russian Federation does not include such an important element as the standardization of the quality of medicines provided by the Institute of the State Pharmacopoeia and control of the conditions of its production at the registration stage. The creation of these elements, by all means, should be included in the further development strategy. In addition, in my opinion, the lack of a clause on legislation is also an omission, since the harmonization of the regulatory and legal framework in the field of pharmaceutical products circulation is also an integral element of state regulation.

International experience in the application of regulatory and organizational and economic methods of state regulation in the field of circulation of prescription drugs

V modern world The circulation of medicines takes place against the background of the integration of the development, research, production and sale of pharmaceutical products. Thanks to this, we can confidently assert that there is an international harmonization of standards for safety measures for drugs, their effectiveness and quality.

Next, let's move on directly to the consideration of the methods of state regulation of drug circulation used in international practice. There are both global public mechanisms, such as the World Health Organization - WHO, the International Pharmaceutical Federation - FIP, the World Medical Association, the International Council of Scientific Medical Organizations - CIOMS, and regional forms of cooperation, carried out within the framework of the European Union and the Council of Europe only, Pharmaceutical Inspection Cooperation Scheme - PIC / S; International Society for Pharmaceutical Engineering - ISPE; International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use - ICH; "Convention on the Establishment of a European Pharmacopoeia".

It should be noted that in Russian reality such mechanisms of international cooperation are rarely used.

So, the system of regulation of relations in the field of admission and control of medicines in most developed countries (Europe, USA, Japan) is a model based on four main elements:

1. Standardization in the field of quality control of medicines (development of the Institute of Pharmacopoeia)

2. Systems of good practice for development, research, production and sale (GLP, GCP, GMP, GDP, GPP, GEP). The development of the GXP standards system is a major global trend

3. Pharmaceutical inspection

4. Control over the circulation of products on the market

As you can see, the main focus of government regulation and control in these countries is directed at the stages of drug development supervision, clinical efficacy and safety studies, control over production and marketing authorization in the form of a trade license. Supervision over the quality of the product in circulation is carried out within the framework of pharmacovigilance, which is the collection of information on the effectiveness of the drug and its side effects, as well as control at the stage of circulation (in the retail network).

It is important to note that the quality control system in these countries goes to a fundamentally new level, which includes quality requirements not only for active pharmaceutical ingredients, but also requirements for excipients. For example, the European Pharmacopoeia contains 1800 monographs on excipients and reagents used in the manufacture of medicines.

Moreover, a new component is the emergence of requirements in relation to controlled organizations with their quality systems. Thus, a broader set of rules is already being formulated. The so-called good regulatory practice for control and authorization systems - GRP, with the inclusion of such elements as transparency in work, controllability and accountability to parliament and the public, measures against conflicts of interest among system employees, confidentiality of official documents containing know-how and others. Already in many countries, external quality control of laboratories is becoming a necessary requirement due to the fact that the practice of professional testing of independent laboratories for the analysis of drugs, including at the international level, is growing more and more.

In addition, in most of the developed countries of Europe, the USA, Japan and other functions for the formation and implementation of policies in the field of drug circulation (including such aspects as quality control, control of preclinical and clinical trials, registration and issuance of approvals for the release of drugs into circulation , monitoring of side effects) are entrusted to special supervisory organizations (the so-called Drug Regulation Agencies), such as the FDA in the USA, Lakemedelsverket in Sweden, DRA in the UK, which are, in fact, a pharmaceutical inspectorate and operate independently of other government organizations. At the same time, in their work, the main emphasis is placed, as already shown earlier, on the assessment of the conditions for the production of medicines and the supervision of production conditions in the subsequent period, when the drug is registered and supplied to the market. This assessment is provided by a government inspectorate that is appropriately trained and empowered to carry out inspection activities.

So, let us summarize some conclusions regarding the development of events in the international arena. It is clear that regulators in the United States, Japan, and the European Union are taking various steps to develop the world's largest pharmaceutical markets. First, this is achieved by eliminating technical barriers in the international circulation of medicines through the mutual recognition of legislation and standards in relation to the development, research, registration process, form and structure of registration documents, production and sale of medicines.

Second, a consensus has finally been reached on pharmacopoeial requirements in a common regulatory approval system. The Institute of Pharmacopoeia has not been considered for a long time as the main instrument for ensuring the quality of medicines, but it remains the most important scientific and methodological guide for manufacturers in the development of internal quality specifications and for registration authorities. In addition, only they contain publicly available quality standards for the sale of finished preparations, pharmaceutical substances, excipients and packaging materials, since the relevant manufacturers' specifications are usually confidential.

As for the shortcomings of pharmacopoeial programs, it is worth noting that in world practice, pharmacopoeial authorities do not participate in the registration process, and therefore do not have access to registration materials. The development of a private monograph for a specific drug in all countries begins only after its registration.

Here, taking into account the Russian reality, it should be noted that abroad, private articles on specific drugs without the presence of the pharmacopoeia itself or as additions to it are not approved and are not considered as regulatory documents.

In international trade, for confirmation of compliance, a certain certification is required, confirming the quality, efficacy and safety of a medicinal product. Consequently, the compliance procedure is complex, and its rules must be established within a specific system.

The certification system was developed by WHO and GMP-based certification is an integral part of it. Here are the basic requirements for this system:

1. Quality Assurance / Quality Management

2. Personnel / Personnel

3. Premises and Equipment

4. Documentation

5. Production / Production

6. Quality Control

7. Contract Manufacture and Analysis

9. Self Inspection

In addition, in each state, it is necessary to have an inspection that regularly arranges verification. Thus, the introduction of the GMP system is realistic only with the involvement of both parties: manufacturers and government agencies.

However, this system also has its drawbacks. These include the lack of external inspection, as well as the lack of an assessment of the national authorized body and production conditions. Such a procedure may confuse the importing country with regard to the quality of the supplied medicines, as well as the reliability of the system as a whole.

Legal, organizational and economic foundations of state regulation in the field of drug circulation in the Russian Federation at the present stage

Legal aspects of state regulation in the field of drug circulation

The problem of creating, improving and further development the legislative framework in the field of public health protection in the Russian Federation remains one of the most pressing.

Unfortunately, domestic health care does not provide one of the main constitutional rights of a citizen to receive free medical care, not to mention its qualified composition. Consequently, the executive and legislative authorities should pay attention to this area for a long time.

So, the population's need for medicines is satisfied only by half, if not less. Adequate provision of the population with drugs on an outpatient basis makes it possible to reduce the exacerbation of diseases and the number of hospitalizations in hospitals. Thus, in Russia, only $ 45 per capita is spent from state public sources per year. At the same time, almost the majority of drugs that are purchased at the state expense are imported drugs, and, accordingly, their price is equal to foreign ones. And in the EU countries, these costs amount to $ 250 per capita per year, that is, almost 5.5 times higher than in the Russian Federation, and this serious problem you need to work on.

The prices for medicines remain too high for more than half of the citizens, vital drugs (hereinafter - vital drugs) continue to be inaccessible for the majority, as evidenced by Table 2 in Appendix 1.

It describes the managers' assessments of changes in the affordability of medicines belonging to the VED category for buyers. As can be seen from the table, they turned out to be not so unambiguous: more than half of respondents (53%) believe that their availability has remained the same, a quarter of respondents (27%) believe that accessibility has increased, but every fifth (20%) believes that availability has decreased.

In addition, there is the most vivid picture of the growth of the population's costs both for medicines and for paid medical services... The calculations were made by experts from the Higher School of Economics according to Rosstat and the Federal Compulsory Medical Insurance Fund.

The conclusion suggests itself: in order to prevent a real threat to national security, it is high time to include the problem of human health protection among the priorities of state policy.

However, it seems impossible to reform the national health care system without developing an effective legal framework.

At present, when characterizing the current situation in the field of drug circulation, there is an interaction between the state represented by the Ministry of Health of the Russian Federation and health authorities of the constituent entities of the Russian Federation, state and municipal institutions, private domestic and foreign capital of the society. And the protection of public health is one of the most important social functions of the state, where its role is of great importance.

So, it is worth noting that the formation of the legislative base began in 1997 - 1999, when one of the fundamental laws, "On Medicines" (Federal Law No. 86), was adopted. Years later, a number of amendments and additions were made there in accordance with the requirements of the present time. So, already in 2010, this law was replaced by the Federal Law “On the Circulation of Medicines”. Compared to Law No. 86-FZ, Law No. 61-FZ pays more attention to the relations associated with the circulation of medicines. In particular, Law No. 61-FZ establishes provisions on examinations preceding the registration of medicinal products, incl. on the ethical examination of the possibility of conducting their clinical research. He also considers the procedure for state registration of drugs, including the grounds for making appropriate decisions at various stages of the registration procedure by the authorized federal executive body.

Considering the adopted laws and the draft laws being developed, it should be noted that they are distinguished by two features: coordination with the current federal legislation and taking into account the peculiarities of their region, its demographic, climatic and socio-economic characteristics. It is this approach that can ensure the conduct of purposeful and effective activities of health authorities.

The analysis carried out by the Ministry of Health and Social Development of the Russian Federation in August 2010 showed that in many constituent entities of the Russian Federation, purposeful work is underway to create a legislative framework, taking into account all the components designed to ensure the protection of human health. This is the legislative regulation of socio-economic issues, and the organization of health care, and labor protection, and environmental protection.

The Ministry of Health of the Russian Federation, carrying out constant monitoring of laws and other normative legal acts of the constituent entities of the Federation, has already begun to disseminate the positive experience of legislative work in individual regions.

In legislative activity, one should proceed from the need for regional laws to comply with the current federal legislation, while taking into account the specifics of each territory, its socio-economic characteristics, medico-demographic, environmental and climatic characteristics.

The Ministry of Health of the Russian Federation is the federal body responsible for the implementation of state policy in the field of health protection of Russian citizens. In this regard, the policy of the Ministry of Health of the Russian Federation can be considered justified, which assumes the main burden of work on the formation of the legislative framework and the improvement of specific legislative acts. At the same time, the legislative initiative of the constituent entities of the Russian Federation should be more widely involved in this process. The State Duma and the Federation Council, as subjects of legislative initiative, also participate in the formation of the legislative framework in the field of health protection.

The structure of regulatory regulation in the field of drug circulation

Speaking about the pharmaceutical market, it should be borne in mind that this sector of the economy currently remains almost completely privatized. Being in market conditions, the network pharmacies developed without taking into account the existing standards and principles of placement. As a result, the underdevelopment of the regulatory framework led to the inexpediency of the existence of most pharmacies, namely to their excessive number.

First of all, the structure itself has changed pharmacy chain... This is evidenced by the number of pharmacies with production departments, the number of which is not even 10% of the total number of pharmacies. And even less, pharmacies with a full range of services began to occupy the structure. The reason for this, in my opinion, was the opinion of experts that factory production is much safer than directly in a pharmacy. V in this case we are already talking about a threat to the lives of citizens, which means that the issue is quite serious.

Indeed, GMP standards are prescribed only for production, and pharmacies are known to undergo only routine inspections. In the course of such inspections, it is rather difficult to identify any violations.

Under the production, in turn, according to Federal Law No. 61, it should be understood: “activity on the production of medicinal products by organizations - manufacturers of medicinal products at one stage, several or all stages technological process, as well as storage and sale of manufactured medicines ”. Moreover, this law separates the concepts of production and manufacturing.

Further, the profitability of the medical services market attracted a significant number of people with capital for development. own business in the industry. As a rule, such people are not professionals in the field of pharmacy. Consequently, we are talking about a decrease in moral principles in the circulation of drugs.

So, it is obvious that without changing the legislative and regulatory framework, it is practically impossible to establish order and civilized relations in the modern pharmaceutical market. Existing on this stage the legal framework is far from perfect. The role of the state in resolving these issues is rather weakened today, and therefore reforms in this industry are controlled rather superficially.

Now let us turn directly to the consideration of the normative regulation of the sphere of circulation of medicines. So, some norms relating to private issues of providing medicines to certain groups of the population are contained in a number of conventions and declarations that have not been published and ratified in the prescribed manner, therefore they are not binding on the Russian Federation. Nevertheless, it should be borne in mind that in accordance with them, several dozen existing agreements have been signed between the Russian Federation and other states.

So, for example, the UN Declaration of Commitment on HIV / AIDS, adopted on June 27, 2001, recognizes that it is necessary to provide wider access to vaccines, bactericides, drugs, including antiretroviral therapy (paragraph 23). Paragraph 24 states that the cost, availability and availability of medicines are important factors that need to be periodically reviewed and revised in all their aspects. Reducing the cost of these drugs and technologies is possible as a result of close cooperation of government agencies with the private sector and pharmaceutical companies. The lack of affordable pharmaceuticals and supply structures is seen as an obstacle to an effective response to HIV / AIDS in many countries. Paragraph 103 of the Declaration provides for the possibility of creating systems for voluntary monitoring of prices for medicines in the world and submitting reports in this regard.

Further, the United Nations Millennium Declaration, adopted on 8 September 2000, among its goals and principles, points to the need to encourage the pharmaceutical industry to make essential medicines more widely available and more accessible to all who need them in developing countries.

UN Resolution 53/243 of September 13, 1999 approved the Declaration and Program of Action on a Culture of Peace, which emphasizes that drugs should not be used as leverage for political pressure, and also indicates the need for an immunization campaign and drug distribution during periods of war. action.

So, here are a couple of clear examples of how international normative acts can influence the regulation of the pharmaceutical supply in the Russian Federation.

Further, with regard to regulatory regulation directly in the country itself, at present in the Russian Federation there are more than 200 acts of the federal level concerning various aspects of activities related to the circulation of medicines. In total, the norms related to medicines are presented in more than 700 acts.

The overwhelming majority of these acts are of a subordinate nature. 89 federal laws in force contain norms related to relations related to drugs (from individual norms to Federal Law No. 61-FZ "On the Circulation of Medicines"). A similar situation is typical for 122 decrees of the Government of the Russian Federation, only 16 of which are directly aimed at regulating relations in the field of medicines.

As for the Constitution of the Russian Federation, such terms as "drugs" and "drug supply", unfortunately, are not covered in this law. However, practice has shown that the closest in terms of the regulation of relations in the field of drug provision is the content of Art. 7 and 39 of the Constitution of the Russian Federation.

Here, drug provision is considered as the provision of goods (drugs) to an individual that are of particular importance and represent elementary benefits, corresponds to the spirit of social security in general, including provided by age, in case of illness, disability, loss of a breadwinner, for raising children and in other cases. established by law.

These constitutional norms have been embodied in various acts. In particular, Art. 26 of the Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens, defining the rights of elderly citizens, establishes that citizens who have reached the age established by the legislation of the Russian Federation for the appointment of an old-age pension, have, among other things, the right to drug provision, including preferential terms... Article 27 of the Fundamentals establishes for disabled persons the right to be provided with medicines, prostheses, prosthetic and orthopedic products, means of transportation on preferential terms. According to Art. 28 of the Fundamentals, citizens of the Russian Federation living in areas recognized as environmentally unfavorable in the manner prescribed by law are guaranteed the provision of medicines, immunobiological preparations and products medical purpose on preferential terms.

In my opinion, the use of the term "drug supply" suggests that we are talking only about a rather narrow sphere of relations, which does not include all types of activities of subjects in the field of drugs. Pharmaceutical provision in the narrow sense of the word is a kind of social security, which consists in providing a number of socially unprotected subjects with medicines either free of charge or on preferential terms. In this case, part of the drugs is either withdrawn from the market turnover, or the conditions of this turnover undergo significant changes.

However, it is necessary to take into account the presence of entities that are manufacturers, distributors and consumers of medicinal products that do not fall under the social protection from the state. If it was possible to consider drug care separately from medical care, then the circulation of drugs would be regulated by the norms of civil law and the principles of freedom of entrepreneurial activity. However, medical care is inextricably linked with the provision of medication to the patient, which, in turn, requires the use of Art. 41 of the Constitution of the Russian Federation. According to this article, everyone has the right to health care and medical assistance, which is provided free of charge in state and municipal health care institutions. It seems that it is precisely these constitutional norms, as well as the recognition of the priority of activities to protect human health, that lead to the predominance of administrative-legal norms and corresponding regimes in regulating the circulation of medicines.

So, the bulk of the norms in the field of medicines is concentrated in three branches of Russian legislation: legislation on the protection of public health, administrative legislation and legislation on social security.

So, according to clause "g" of Part 1 of Art. 72 of the Constitution of the Russian Federation, the coordination of health issues is under the joint jurisdiction of the Russian Federation and its subjects. Thus, the constituent entities of the Russian Federation received the opportunity for active lawmaking in this area. About a third of all constituent entities of the Russian Federation have adopted laws in the field of drug circulation (for example, the Republic of Adygea, the Republic of Mari El, the Republic of Tyva, the Chuvash Republic, Altai region, Krasnodar Territory, Stavropol Territory, Khabarovsk Territory, Vologda Region, Kostroma Region, Murmansk Region, Nizhny Novgorod Region, Novosibirsk region, Kursk region, etc.).

It is characteristic that only for some subjects the subject of regulation of the law coincides with the subject of a similar federal act. In most cases, laws are adopted concerning the provision of drugs for the population of a particular subject (Chuvash Republic, Krasnodar Territory, Stavropol Territory, Vologda Region, Kostroma Region, Murmansk Region, Novosibirsk Region), or the population and medical institutions (Republic of Adygea, Nizhny Novgorod Region ), or drug provision of the population and pharmaceutical activity (Altai Territory, Omsk Region). In a number of subjects there are very original acts, the subject of which has no analogues in federal legislation. For example, the Law of the Republic of Mari El dated May 31, 1994 "On the procedure for exporting forest food products and medicinal and technical raw materials outside the Republic".

These examples indicate that at the level of by-law regulation there are significant discrepancies concerning the subject of the by-law planned in the law and the subject of the current by-law. This leads not only to problems in legal regulation, but also to a decrease in the authority of the law, since the legislative level of regulation, based on the importance of the law and the norms enshrined in it, does not allow the possibility of its correction by an act that has obviously lower legal force.

So, today we can confidently assert that the negative aspects in the drug supply of the population of the Russian Federation, which today continue to worsen, are partly due to the imperfection of legal regulation, the declarative nature of the norms of a number of previously adopted acts, as well as the fact that the practice of their implementation is far from the desired characteristics. ...

Analysis of the state and problems of public administration in the field of drug circulation in modern Russia

As already mentioned, for the formation of a clear policy in the field of pharmacy, legislative support is necessary. An analysis of the current legislation, as well as regulations, shows their fragmentation and inconsistency. Therefore, it becomes possible to assert that until now in Russia there is no complete systemic regulation of the sphere of drug provision, moreover, the position of the state in this issue remains rather weak.

Today, work is underway with a large number of new federal regulations, decrees, orders, instructions related to this area. However, meeting the requirements of individual laws and regulations can be challenging for several reasons. First, the concepts, terms that are used in documents, contradict each other, and sometimes even common sense. Secondly, most laws are indirect laws, and the requirements of many bylaws distort their meaning. Thirdly, the requirements of various documents do not correspond to each other, since the laws contain many references to other acts (government, departmental, etc.).

It is from here that the active creation of their own legislative and regulatory framework in the regions takes place.

At first glance, the list of regulations adopted in the regions is impressive. However, this is a misleading impression, because mainly the documents mentioned regulate drug provision. preferential categories citizens. At the same time, one of the central places in the state policy in the field of pharmacy should be occupied by normative regulation, i.e. development of industry standards, norms, rules, instructions, orders, which should not contradict each other, but complement.

Moreover, since the opening of the domestic market for imported drugs to this day, not a single by-law harmonized with the WHO or the European Union has been adopted, which indicates that there is no opportunity to enter the world market for drug circulation. As a result, by 2003 the domestic market was filled with imported drugs by 70%, despite the fact that our manufacturers did not manage to enter the world arena.

In addition, the problem of drug pricing is acute. The practice of work on the implementation of the decree revealed a number of significant shortcomings in the current system of state registration of prices for medicines in the constituent entities of the Federation. This is both a cumbersome mechanism for agreeing, registering and re-registering prices, and a different understanding and interpretation of the procedure for enacting registered prices by tax authorities, prosecutors and business entities in the field of production and trade of medicines. All these shortcomings lead to unreasonable loss of time in the course of state registration of prices and to financial losses for manufacturing enterprises, and most importantly - to an increase in prices.

It is worth mentioning the increasingly depleting human potential of domestic science and industry.

So, in view of the existence of such serious problems in the foreseeable future, the Russian drug market may cease to exist as a basic manufacturing sector. Therefore, it is worth taking any measures to restore it now.

According to the innovative development of the scenario, which assumes a guaranteed, high-quality and inexpensive provision of the Russian population with drugs for the treatment of socially significant groups of diseases based on the selected nomenclature of existing high-quality generics, licensed drugs and their patentable modifications, and, in the future, innovative drugs of our own design, proposed in the "Strategy development of the pharmaceutical industry of the Russian Federation until 2020 ”.

Within the framework of of this document the development of personalized medicine based on knowledge of genetic characteristics is also proposed a specific person and the selection of an individual complex of drugs.

In accordance with the existing experience of the Western pharmaceutical industry and Russian realities, it is now necessary to start a strategic scenario for the development of the pharmaceutical industry in the Russian Federation, which includes the passage of four stages:

Stage 1. Manufacture of generic drugs

Stage 2. Production of licensed drugs

Stage 3. Production of new drugs for the domestic market

Stage 4. Production of innovative drugs for the international market.

So, it is obvious that the primary task in the field of drug circulation is the formation of a clear and precise state policy, which must be ensured by law.

However, the existing legislative and regulatory framework is not complete and perfect enough. It regulates separate, disparate issues. For a number of years, there has been no systematic and complete state regulation in the sphere of circulation and production of medicines. The role of state bodies in these matters is very weakened. There is no clear infrastructure for managing the pharmaceutical industry. As a result, there is weak management of the effect of reforms in the industry on the part of state bodies: their decisions do not anticipate events, but in best case are a reaction to the current situation.

Conclusion

Finally, let's summarize the work done. As mentioned earlier, in Russia for a long time there was an underestimation of the role of pharmaceutical services in the socio-economic development of the country. However, the implementation of state policy aimed at improving the level and quality of life of the population has now led to a noticeable expansion of theoretical research, including in the field of state regulation of the circulation of medicines. Thus, the works of G.T. Glembotskaya, N.B. Dremova, C.B. Kononova, I.V. Kosovoy, P.V. , HER. Loskutova, A.P. Meshkovsky, L.V. Moshkova, E.A. Maksimkina, A.B. Soloinina and others.

The analysis, partly based on these works, as well as on the legislative basis, indicates that the state of the domestic pharmaceutical market and the pharmaceutical industry does not allow satisfying the needs of modern healthcare and solving the increasingly aggravating problems of the growth of morbidity and mortality of the population of the Russian Federation.

Despite the apparent external well-being, the current state of the Russian pharmaceutical sector is unstable.

Undoubtedly, the pharmaceutical industry, which is one of the most important elements of the health care system, is on the verge of fundamental changes. To the greatest extent, these changes are associated with the formation of an innovative component, the development of import substitution and an increase in labor productivity.

An innovative scenario for the development of events involves the development and adoption of the Strategy for the development of the pharmaceutical industry in Russia, as well as the adoption of the Concept for the development of the healthcare system in the Russian Federation until 2020, which were discussed in the first chapter of this work. These documents are intended to solve the problem of drug provision for the population of Russia in the current conditions for the long term.

The ultimate goal of all these initiatives is to create a sustainable national industry capable of providing the population of the Russian Federation with affordable, effective and safe medicines in the required quantities.

Further, the problem of creating, improving and further developing the legislative framework in the field of public health protection in the Russian Federation remains one of the most pressing. The federal body responsible for the implementation of state policy in the field of health protection of Russian citizens is the Ministry of Health and Social Development of the Russian Federation. In this regard, the Ministry of Health and Social Development of the Russian Federation assumes the main burden of work on the formation of the legislative framework and the improvement of specific legislative acts. However, in this process, in my opinion, one should also involve the legislative initiative of the constituent entities of the Russian Federation. The State Duma and the Federation Council, as subjects of legislative initiative, also participate in the formation of the legislative framework in the field of health protection.

Quite illustrative examples considered in the work indicate that at the level of subordinate regulation there are significant discrepancies regarding the subject of the subordinate legislation planned in the law and the subject of the current subordinate legislation. This leads not only to problems in legal regulation, but also to a decrease in the authority of the law.

Further, when studying the international system of drug provision, it was revealed that the Russian system differs significantly from a number of developed and developing countries. In the Russian Federation, the emphasis is shifted to the control of the finished product, and not to the stages of its creation and production.

In addition, the analysis showed that international methods of cooperation such as the organization of WHO, CIOMS, etc. Russia rarely uses it. Meanwhile, while the Russian Federation adheres to its tactics, the United States, Japan, as well as a number of European Union countries are taking various actions to develop the world's largest pharmaceutical markets. This is precisely what is achieved by establishing contacts in the field of international circulation of medicines through mutual recognition of legislation and standards in relation to the development, research, registration process, form and structure of registration documents, production and sale of medicines. In my opinion, the Russian state should share such a policy, and not remain on the sidelines.

In general, there are a number of primary tasks to which the government should pay attention.

First, as the analysis has shown, government regulation of the pharmaceutical market should be based on developed and constantly updated regulatory documents.

Secondly, in order to avoid lowering the moral character of this area, not only activities, but also the functions of state supervision should be carried out by specialists with special training in this industry, as well as a certificate for this type of activity.

Third, at the regional level, it is necessary to coordinate the activities of regulatory organizations in order to reduce subjective administrative barriers. Regional bodies, which are entrusted with the functions of managing pharmaceutical activities, can also act as coordinators.

This issue requires constant government intervention, its regulation, since the sphere related to the health of citizens should not tolerate any delay.

1.Strategy of national security of the Russian Federation until 2020

2. Concept for the development of the healthcare system in the Russian Federation until 2020

3. N.V. YURGEL DLO - ONLS, "7 nosologies", and what next? / Remedium. March 2009

4. Russian Federation. Constitution of the Russian Federation.

5. Russian Federation. The laws. Federal Law of the Russian Federation No. 86 - FZ "On Medicines" dated 22.06.98.

6. Russian Federation. The laws. Federal Law of the Russian Federation No. 61 - FZ "On the Circulation of Medicines"

7. Strategy for the development of the pharmaceutical industry in the Russian Federation until 2020 [ Electronic resource] (date of circulation 12.05.2011)

8. The development of a strategy for the development of the Russian pharmaceutical industry for the period up to 2020 has been started [Electronic resource] (date of circulation 05.12.2011)

9. Antoniu, T. Pharmaceutical industry in a changing world / T. Antonio // Remedium. - 2000. - No. 12. - p.22-23

10. Beregovykh V., Kasyanova O., Analysis of the current situation in the regulation of pricing for lek. funds in Russia / V. Beregovykh, O. Kasyanova // Pharmacy. - 2002. - No. 3. - p. 17-19

11. Ivanov, V. Russian pharmaceutical market yesterday, today and tomorrow / V. Ivanov // Remedium. - 2001. - No. 7/8. - S.26-32

12. Trofimova, E.O., Novikov, A.I. Results and forecasts of the development of the pharmaceutical market / E.O. Trofimova, A.I. Novikov // Remedium North-West. April 2002

13. Pharmaceutical market in figures [Electronic resource] (date of circulation 23.05.2011)

14. G. Ulumbekova Lessons from the reform of Russian healthcare [Electronic resource] (date of treatment 28.05.2011)

15. M. Sakaev Drug prices are falling due to state regulation [Electronic resource]

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17.Federal Law of July 22, 1993 N 5487-1 Fundamentals of the Legislation of the Russian Federation on the Protection of Citizens' Health

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