Pharmacoeconomics and clinical-economic analysis, standardization and evaluation of medical technologies in the development of the drug provision system for the population of Russia

Introduction

In 2025, the pharmacoeconomic association ISPOR celebrated its 30th anniversary. It was founded in 1995 by a small group of dedicated and visionary individuals with the goal of becoming a catalyst for the development of the science and practice of health economics and outcomes research worldwide. Originally an American society called the Association for Pharmacoeconomics and Outcomes Research (APOR), led by its founder and executive director Marilyn Dix Smith, it became an international organization, ISPOR, in 1997 [1]. The ideas underlying the creation of ISPOR resonated with the ideas behind the transformations in our country: fairness, quality, outcomes assessment, and an economic foundation.

This article is a personal memoir of the author — a witness and active participant in the events described — and therefore not without bias. Please understand it as such.

While preparing this article, the book Svoya igra: istoriya farmrynka v Rossii (“Own Game: The History of the Pharmaceutical Market in Russia”) by S. N. Zatravkin, E. A. Vyshlenkova, and F. V. Genin (Shiko, 2025) was published [2], which I will need to reference. This is not the first book on this topic, but it appears to be the first attempt at a scientific analysis of the events that took place. It made the article more relevant, because layers of history suddenly and surprisingly turned out to be non‑overlapping: as if we lived in different countries. The book contains no narrative of “the sick person in need of medicines.”

Main theme

The end of the 20th century and the first quarter of the 21st century represented a historical rupture, when the country was shaken and radically changed its development trajectory. The preceding many decades were years of revolution, war, repression, and oppressive ideology. Then suddenly this pressure disappeared. New people came to power. But in reality, these were merely the second echelon, substitute players who often had “special training” from Western curators and acted quite systematically, although outwardly it seemed spontaneous. Experts always reject conspiracy theories, but the author is convinced that a certain design, a plan, did exist. In any case, the emergence of certain documents decades later indicates that a plan for destruction existed. Silent documentary witnesses of this plan: Report No. 6563 Financing Health Services in Developing Countries: An Agenda for Reform December 31, 1986 (Document of the World Bank) [3]: it is necessary to reduce government responsibility for paying for medical services — payment for medical services is made by the patient‑consumer; decentralization of the healthcare system instead of its managerial and economic centralization; freeing up government resources to pay for those services whose benefit to society as a whole is high, primarily preventive technologies — vaccination, lipid‑lowering therapy, etc. This was further refined in the document “Financing Health Services in Developing Countries: An Agenda for Reform” (World Bank, 1987) [4] and the “World Development Report 1993: Investing in Health” (World Bank) [5]. In the 1990s, new approaches to organizing medical care developed rapidly in our country. In June 1991, while still in the USSR, the Supreme Soviet of the RSFSR adopted the law “On Medical Insurance of Citizens in the Russian Federation” [6]. This law contradicted the previously established rules and customs of medical care in the country, and from the moment the country disappeared, it became the only law for Russia. For many decades, a paradoxical situation existed in the country: documents of a state that no longer existed continued to operate and significantly influence the current state of affairs.

The coup d’état in August 1991 and the dissolution of the USSR triggered a series of radical transformations. In particular, it became obvious that changing approaches to providing medical care without standardization was impossible. In the late 1980s, medical care standards were prepared at the N. A. Semashko Research Institute of Healthcare Organization and in the Kemerovo region. These standards were descriptive, not based on a common language, and their use became impossible. For example, the term “complete blood count” was used, but it could cover a huge number of different tests, from the “big three” (hemoglobin, leukocytes, erythrocyte sedimentation rate) to a full count with cell morphology.

The law on medical insurance guaranteed that all citizens of the Russian Federation would have equal opportunities to receive medical and pharmaceutical care provided from compulsory health insurance (CHI) funds in the volume and on the conditions corresponding to CHI programs. But enforcement of the law was a priori impossible under the conditions of the USSR. In other words, the law was written for the conditions of the country’s collapse, but before the collapse. In addition, attention should be paid to the law’s separation of medical and pharmaceutical care into two different types, as well as the limitation of state guarantees to “CHI programs.” The law introduced restrictions on care that would be established by by‑laws, without regulating how these acts (“CHI programs”) are formed and what they include. And that medical care cannot be provided without medicines — the legislators did not think of that. Later, pharmaceutical care somehow evaporated from the text of the law, as if it were part of medical care. But the law is the law: it must be read as written.

The law was put into effect in the new country by Decree of the Government of the Russian Federation No. 41 of January 23, 1992 “On measures to implement the Law of the RSFSR ‘On medical insurance of citizens in the RSFSR’” [7]. Soon the structures directly prescribed in the law began to emerge: medical insurance funds, insurance companies. At the same time, the federal centralized structure disintegrated. Today, the state leader’s call to the regions to take as much sovereignty as they could handle is half‑forgotten. For example, a little later, in the office of the Executive Director of the Moscow CHI Fund I. V. Lomakin‑Rumyantsev, there were two wastepaper baskets: one for unnecessary papers, the second for documents from the Federal CHI Fund.

Decree No. 41 instructed the Ministry of Health of the Russian Federation to develop, by September 1, 1992, a system of medical‑economic standards of medical care and criteria for its quality for the implementation of CHI programs. Note the word “system,” which changes everything in this clause: it was not just standards that had to be developed, and moreover medical‑economic ones. It seems that no one understood what stood behind these fancy words. But economics was knocking on the door.

These provisions were literally transferred into Order No. 93 of the Ministry of Health of the Russian Federation of March 20, 1992 “On measures to implement the Law of the Russian Federation ‘On medical insurance of citizens in the RSFSR’” [8]: clause 6.1 instructed Deputy Ministers N. N. Vaganov, A. M. Moskvichev, and V. I. Starodubov to develop a territorial system of medical‑economic standards of medical care. Again, nothing was mentioned about medicines.

The order introduced provisions on licensing of medical organizations, their accreditation, and accreditation of medical personnel. In the process of drafting these provisions, and the author was directly involved in writing the texts, it turned out that none of the experts who boasted of their participation in creating the law on medical insurance had any idea what was meant by licensing and accreditation. It seemed that the text of the law was written by some outsider, a person (or group) who never appeared again in the expert field of the country. Who could it have been? A consulting company? What kind – there were none in the country at that time?

You will not find significant differences between licensing and accreditation in the order either, although it mentions physicians and nurses who also must be accredited. However, having appeared once in a regulatory document, they subsequently disappeared from the legislative and regulatory field, and never reappeared: according to our legislation, a medical organization provides medical care, and the law does not see the doctor or the nursing staff. Because no one understood the differences between licensing and accreditation, these procedures were later merged, and the commissions became known as licensing‑accreditation commissions (LAKs). Nevertheless, the regulation on accreditation of medical organizations stated that “accreditation of institutions and individuals – determination of compliance of their activities with established standards for the provision of medical care and services.” The document included the first Basic Program: a guaranteed list of types of medical care financed from budgets (not CHI!) allocated for healthcare. And for outpatient care, it was directly written as a separate line: “pharmaceutical care in accordance with the list of diseases and conditions for which benefits for drug provision are determined by decision of government bodies.” In other words, medical care – separately, pharmaceutical care – again separately. It was “care”, not “provision”, which would be logical. What this emergence of “dark matter” was, this release of some wild ideas about medicine and its pharmaceutical component – is unclear.

Decree of the President of the Russian Federation No. 1137 of September 26, 1992 “On measures for the development of healthcare in the Russian Federation” [9] introduced a new term – “quality standards”: “…in the shortest possible time, proposals for uniform state quality standards for medical care…, pricing methods for medical services to the population.” Quality standards, as you might guess, are not medical‑economic standards. However, the provisions of the Decree were not implemented, just like the provisions of the Government Decree and the Law.

In the autumn of 1992, under the leadership of S. N. Gorbunov, we created a standardization department in the Ministry of Health of the Russian Federation, but in 1993 it was liquidated amid a public scandal covered by the media. As a result, the work on creating standards that had been started in the Ministry of Health shifted to the work of a team from various organizations, including State Standard structures, and financed by four territorial CHI funds: Moscow City and Regional, Leningrad Regional, and St. Petersburg City. The specialized commissions created earlier in the Ministry of Health began to work in a commercial version under the leadership of P. A. Vorobyov and O. S. Yakimov, with V. V. Balchevsky playing an important role.

It should be noted the rapid turnover of heads of the Ministry of Health of the country during these years; each managed only to change the top leadership. The government of the country and the top officials of the state had no time for healthcare. Confusion with CHI and drug provision grew. A detailed description of what happened during these years is given in the already mentioned book Svoya igra. Istoriya farmrynka v Rossii [2]. The musical chairs with the heads of the Ministry of Health, corruption and bribery, the arrest of the deputy minister and the flight of his patron from the country, a fight between a drunken minister and one of the pharmaceutical distributors at night in front of the Ministry of Health further characterize what happened.

This continued for 5 years. The key year was 1997, associated with the arrival of T. B. Dmitrieva as Minister of Health. Within a year, a joint meeting (a unique occurrence) of the Collegia of the Ministry of Health of the Russian Federation, the State Committee of the Russian Federation for Standardization, Metrology and Certification, and the Council of Executive Directors of Territorial Compulsory Medical Insurance Funds was prepared and held, and on December 3, 1997, Document No. 14/43/6‑11 “On the basic provisions of standardization in healthcare” was approved [10]. On its basis, a joint order “On the organization of work on standardization in healthcare” was issued by the Ministry of Health of the Russian Federation (No. 12) and the Federal CHI Fund (No. 2) on January 19, 1998. V. I. Starodubov and A. I. Vyalkov took an active part in organizing and holding the Collegium. T. B. Dmitrieva and the head of the CHI Fund V. V. Grishin signed the joint order.

The document established objects of standardization and the structure of the system of regulatory documents on standardization in the form of various groups of documents, including Group 5 (“Requirements for drug provision”) and Group 14 (“Requirements for economic indicators in healthcare”). It was assumed that pharmaceutical care for citizens would be provided on the basis of requirements for the performance of medical services. The formation of the “List of Vital and Essential Medicines” would be based on the minimum requirements of diagnostic and treatment protocols for diseases, later – patient management protocols.

Issues of drug provision for the population in Russia have a fairly long history. Thus, in 1921, the “Decree of the Council of People’s Commissars. On the abolition of fees for medical products dispensed from pharmacies by doctors’ prescriptions” was issued under the signature of V. I. Ulyanov (Lenin) [11], under which prescription drugs became free for the population. Today such a system would be called reimbursement, although there was no reimbursement of costs to the patient, but rather payment to pharmacies. However, as early as 1935, a resolution “On the sale of medicines” was issued [12], which terminated the previously existing free dispensing of drugs by prescription: “Clause 6. While maintaining completely free services and medical care for patients in hospitals, outpatient clinics, polyclinics, etc., discontinue, in connection with the significant price reduction, the free dispensing of medicines to homes.” At the same time, the cost of products was reduced by 2–3 times, the average price of a prescription (medication) was set at 90 kopecks instead of the previous 3 rubles, and the retail price was determined by a single price list. From that time to the present, citizens of the country have purchased outpatient medications with their own money, and the state has tried to regulate prices.

Pharmacies were state property until February 1992, when by Order No. 42 of the Ministry of Health of the Russian Federation of February 7, 1992 [13], authored by the author of this article, pharmacy institutions were allowed to become legal entities and escape state supervision. This order was aimed at the privatization of the pharmacy network and the development of market relations in the healthcare system. The text of the order, handed to Minister A. I. Vorobyov, also included medical organizations and blood transfusion stations, but they were excised from the order by Deputy Minister A. M. Moskvichev. That is how we have lived since then, but it could have been different.

Pharmacy directors ceased to be employees of regional “Pharmacies”; they gained the opportunity to independently purchase drugs from manufacturers, and later from distributors. We see this as the most important real reform of drug provision.

In the new Russia, the World Bank for Reconstruction and Development became very active. Its representatives initially had one room in the Russian Ministry of Health on Rakhmanovsky Lane, later moved to a spacious room in the Biochemical Building of the 1st MMI named after I. M. Sechenov on Sadovo‑Kudrinskaya Street, and then the bank moved closer to Novy Arbat. The Bank began to gather around itself active healthcare organizers and clinical pharmacologists who tried to change the situation around the provision of medical care in Russia. The WHO was also “brought in.” Projects of various international organizations in the mid‑1990s were implemented not at the federal level, but in the regions of the country. One such project was the drug management project, in which Yu. B. Belousov and A. V. Bykov actively participated. In particular, within the framework of the WHO rational management project, in 1996 and 1997, Manual for the development and maintenance of hospital drug formularies (Savelli A, Schwarz H, Zagorski A, Bykov A, 1996) [14], which presents project participants from Ryazan, Moscow, Novgorod, Pskov, and Guidelines for implementing drug utilization review programs in hospitals (Moore T, Bykov A, Savelli T, Zagorski A, 1997) [15] were published.

As early as 1985, the WHO defined rational use of medicines as follows: “Rational use of medicines requires that patients receive medications appropriate to their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and their community.” Of course, it is impossible to determine clinical needs without having “needs standards.” The end of this “classical” definition also draws attention: it seems to contain economics, but it looks somehow outdated; patient communities never paid for medicines anywhere. The presented guidelines did not discuss any clinical‑economic analysis at that time, and health technology assessment was in its infancy in the documents: only ABC and VEN analyses. Not to mention that both guidelines prescribed work at the level of the medical organization, which is clearly impossible if there are no decisions at the state level. However, processes were rapidly gaining momentum.

During the tenure of Minister of Health T. B. Dmitrieva, another event important for the development of drug provision in Russia took place: an expert council for the formation of the list of essential medicines appeared, headed by the former first minister of health of the new country, Academician A. I. Vorobyov. This council initially worked behind closed doors in the depths of the Ministry of Health of the Russian Federation, but soon, after one list was submitted for approval, each page signed by A. I. Vorobyov, but a completely different list was approved, a decision was made to make the decisions public. There was always intrigue around the List, most likely related to certain sums meant for officials for including drugs in it. Everyone showed interest in the List, including third parties of the state. Various means were used to combat leaks, up to submitting draft documents with different errors in the text to different officials. Deputy Minister A. V. Katlinsky turned out to be a master at this. In this simple way, the sources and channels of information leakage were quickly identified and stopped.

In forming the council, it was possible to formulate clear requirements for the dossier on the drug, which was prepared in advance and discussed at the meeting. Along with evidence of efficacy, submission of clinical‑economic analysis data soon became a mandatory requirement. Note: it was not required to reduce costs compared to analogues, but to understand how much funds are needed to introduce the new drug. The development of a health technology assessment (HTA) system began, and this work began before the HTA system was created by Great Britain – NICE. A little later, a new pharmacotherapeutic classification (PTC) for the country was introduced, giving the doctor an understanding not of the chemical or biological properties of the drug, but of its purpose. Of course, it was not perfect – the same drug could be used for different indications – but it was much closer to physicians than the Anatomical Therapeutic Chemical (ATC) classification adopted by pharmacists.

1998 can be considered a turning year in the development of pharmacoeconomics. Following the results of the aforementioned Collegium of the Ministry of Health, the Federal CHI Fund, and State Standard, a meeting was held in Yaroslavl where the Basic Provisions of Standardization were reported. After the report, S. A. Kobina approached the author with a question: would there be a topic on economics in drug provision in the standardization system? And a few months later, a delegation from Russia flew to Cologne for the first European meeting of ISPOR. This trip resulted in the first national chapter of ISPOR (Russia). Within a few months, a legal entity was formed – the Interregional Public Organization “Society for Pharmacoeconomic Research” (RSPOR), which exists to this day.

During the Cologne Congress, two consecutive sessions were held, at which the author of this article had to twice present the same text in English to an absolutely empty audience: the founder and executive director of ISPOR Marilyn Dix Smith, Yu. B. Belousov, and S. A. Kobina were present. The topic was standardization and the place of economics within it. Other representatives of European countries showed no interest, and people from the former USSR and Warsaw Pact countries simply did not exist yet.

In September 1999 (September 28, 1999), the Collegium of the Ministry of Health of the Russian Federation was held on the topic “On the Concept of the program for the development of the drug provision system for healthcare and the population of the Russian Federation.” It was prepared by B. I. Shpigel, who was not yet a Senator. It is now difficult to recall what was wrong with the proposed concept, but the text of the decision was given to me by A. V. Katlinsky for one night to make changes. Overnight, the text was radically changed, and as a result, almost a year later, Order No. 304 of the Ministry of Health of the Russian Federation dated August 2, 2000 “On the Formulary Committee of the Ministry of Health of the Russian Federation” appeared [16]. This order abolished two Ministry councils with similar functions.

RSPOR was headed, not without some difficulties, by P. A. Vorobyov. It was not immediately possible to gain control over financial flows and the seal, but within a year M. V. Sura became the executive director of the organization.

The first period was devoted to writing articles on pharmacoeconomics, deciphering the concepts included in this science – cost minimization, cost‑effectiveness using various effectiveness estimates – from surrogate endpoints to quality of life assessment and incremental costs. There were endless presentations at all conceivable venues: everyone was interested. M. V. Avksentyeva, S. G. Gorokhova, E. V. Derkach, I. V. Tyurina, V. P. Komarova, and D. V. Lukyantseva joined the work. All of them were employees of the laboratory of standardization in healthcare under my leadership at the 1st MMA named after I. M. Sechenov. It became clear that economic assessments are characteristic not only of medicines but also of any healthcare technologies: therapeutic, diagnostic, organizational. In this regard, we replaced the original term “pharmacoeconomics” with “clinical‑economic analysis.” Soon it began to be used in international discussions as well.

Cost assessment was a big problem, as it was in other countries. Structuring costs and their economic assessment is an important independent section of clinical‑economic analysis. While the effectiveness of a technology can be evaluated from the results of randomized or other studies, costs, especially in Russian practice, were a big problem. Of course, real cost data were available to compulsory medical insurance institutions, but they had never been analyzed by anyone and access to them was closed.

Here, the development by our team of the Nomenclature of Works and Services in Healthcare came to the rescue. Of course, it was not always possible to find prices for services, but through certain combinations, prices were nevertheless determined. Price lists of the CHI Funds, most fully represented in Moscow, were often used. But CHI prices corresponded to approximately one‑third of the costs, as they covered (and still cover) only a few cost items: wages and payroll taxes, costs for small instruments, and in hospitals – medicines and patient meals. Costs associated with repairs, construction, utilities, procurement of equipment, including devices, beds, tables, chairs, etc., were not covered by CHI payments and remained unaccounted for state expenses. Not to mention the personal funds of citizens. However, it was possible to estimate the ratios of costs under CHI, budgets, and personal funds of citizens, and here the estimates of the Higher School of Economics, conducted by S. V. Shishkin based on citizen surveys, helped. These costs were roughly compared, and as a result of consensus estimates, it was decided that the prices in the CHI price lists for services in cost calculations should be multiplied by a factor of 3. It was not possible to calculate this ratio more precisely for each service, taking into account its outpatient or inpatient use, nor was it required for comparing different technologies.

It should be noted that cost analysis was not part of the traditional international “palette” of pharmacoeconomic studies. In Russia, we had to independently develop ABC analysis (A – group accounting for 80% of costs, B – 15% of costs, C – 5% of costs), VEN analysis (V – vital, E – essential, N – non‑essential), frequency analysis, DDD analysis – costs taking into account recommended daily doses of drugs. During ABC analysis, it was found that group A accounted for 5% of the nomenclature of used drugs, group B – about 10‑15%, and group C consisted of 80% of items. In VEN analysis, group V was distinguished – drugs formally included in the national List of Vital and Essential Drugs, E – not included in the list but important for the provision of medical care (primarily symptomatic drugs), and N – drugs unimportant for the provision of medical care. It quickly became clear that such a formal approach requires constant expert evaluation, so in practice, expert analysis began to be used for assigning drugs to one group or another. Especially since in different situations, drugs in the essential (A) and auxiliary (E) groups could be redistributed if the issue was not decided formally. Frequency analysis helped to identify huge costs in the medical insurance system for the purchase of cheap solutions of NaCl and glucose: these drugs always ended up in group A. DDD analysis and its modifications became an important element in the formation of medical care standards, which indicated equivalent daily doses of drugs for further economic justification of treatment costs, and later – for justifying costs when purchasing drugs at public expense.

Another innovation, possibly done for the first time in the world, was the assessment of real costs in patient treatment. Several methods for such assessment were proposed: analysis of data from medical records and analysis of expert opinion data. Gradually, costs in typical practice for major diseases began to be formed. These costs were compiled into a large table and published in the journal Problems of Standardization in Healthcare. The new direction was called “analysis of typical practice.”

The number of scientific studies on clinical‑economic analysis grew rapidly. The number of articles reached dozens, and the journal Problems of Standardization in Healthcare even had to start a special section on clinical‑economic analysis. Books were published, chapters were written in manuals and reference books:

• Economic evaluation of drug therapy effectiveness (pharmacoeconomic analysis) (2000, ed. Vorobyov PA) [17];

• Planning and conducting clinical trials of medicines (2000, ed. Belousov YuB) [18];

• Fundamentals of clinical pharmacology and rational pharmacotherapy (2002, ed. Belousov YuB) [19];

• Clinical‑economic analysis (2004, ed. Vorobyov PA) [20];

• Pharmacoeconomics as a basis for managerial decision‑making on the example of acute myocardial infarction (2007, ed. Vorobyov PA) [21];

• Clinical‑economic analysis (assessment, selection of medical technologies and quality management of medical care) (2008, ed. Vorobyov PA) [22].

Research quickly turned into dissertations. Among the candidates were both employees of the Department of Hematology and Geriatrics and the Department of Standardization in Healthcare of the Moscow Medical Academy, as well as external applicants. The problem of defenses was complicated by the fact that the topic was new, some applicants were healthcare organizers, and others were clinicians. The topics might not correspond to the specialty passport, clinical pharmacologists disowned these defenses, and the applicant often did not have the appropriate certificate. But all formal problems were overcome. So, let me list the dissertations defended under my supervision: S. G. Gorokhova “Chronic heart failure in the elderly and senile age (clinical‑economic aspects)” (Dr. Sci. (Med.), 2001); V. B. Gerasimov “Methodology of clinical‑economic analysis in hematology (socio‑hygienic study)” (Dr. Sci. (Med.), 2001); M. V. Avksentyeva “Methodological foundations of the organization, conduct and application of clinical‑economic research in the management of medical care quality” (Dr. Sci. (Med.), 2003); L. A. Lisenkova “Pharmacoepidemiological and pharmacoeconomic aspects of outpatient treatment of arterial hypertension in Yaroslavl” (Cand. Sci. (Med.), 2003); S. S. Leontyev “Pharmacoeconomic analysis of drugs used for the treatment of cochleovestibular syndrome” (Cand. Sci. (Med.), 2004); M. V. Sura “Optimization of the choice of medical technologies in the medical care quality management system” (Cand. Sci. (Med.), 2004); E. V. Derkach “Clinical‑economic justification for the use of alprostadil in conservative therapy of patients with lower limb ischemia” (Cand. Sci. (Med.), 2006); V. V. Baev “Clinical‑economic analysis in acute myocardial infarction” (Dr. Sci. (Med.), 2007); K. A. Lytkina “Methodological approaches to clinical‑economic comparative analysis of non‑steroidal anti‑inflammatory drugs in osteoarthritis in elderly and senile patients” (Cand. Sci. (Med.), 2007); A. N. Shilova “Optimization of antithrombotic prophylaxis and clinical‑economic analysis of the use of low‑molecular‑weight and unfractionated heparins in cancer patients” (Dr. Sci. (Med.), 2008); A. V. Fedoruk “Features of diagnosis and treatment of iron deficiency anemia in elderly and senile patients” (Cand. Sci. (Med.), 2009); O. V. Borisenko “Optimization of the choice of medical technologies to ensure the quality of medical care in a multidisciplinary hospital” (Cand. Sci. (Med.), 2010).

From the late 1990s, RSPOR became the official national chapter of ISPOR, organizing the first and largest ISPOR chapter in the world. At its peak, RSPOR had more than 1,300 members from 76 cities of Russia, 26 branches in the constituent entities of the Russian Federation, 2 student branches, a Far Eastern branch, and national chapters in Kazakhstan, Ukraine, Moldova, and Belarus. RSPOR carried out extensive educational and research work in the field of clinical‑economic analysis, drug provision, standardization of medical care, quality management in healthcare, and health technology assessment. RSPOR conducted more than 50 clinical‑economic studies in various fields of medicine, including hematology, oncology, pulmonology, cardiology, endocrinology, neurology, and others. The society’s branches were widely involved in the research, and multicenter prospective randomized clinical‑economic studies were conducted in particular. For the first time in our country, RSPOR began to use the methodology of clinical‑economic modeling (decision trees, Markov analysis, etc.), cost‑per‑quality‑adjusted life year (QALY) analysis, and budget impact analysis.

RSPOR held more than 15 congresses, conferences, and schools on clinical economics per year, including the Plenum on drug provision at the annual congresses “Man and Medicine” (Moscow), “Rational Pharmacotherapy” (St. Petersburg), the annual off‑site school‑seminar of the Formulary Committee, Russian forums within the framework of the International and European ISPOR Congresses, and the congress “Justice, Quality, Efficiency” (Moscow). More than 1,500 specialists participated in RSPOR events throughout the year: healthcare managers, drug supply specialists, representatives of drug and medical equipment manufacturers, patient societies, and decision‑makers.

A Russian‑English Internet portal was created (www.rspor.ru, more than 1,500 visits per day, an actively working forum) and an e‑mail newsletter to which more than 17,000 healthcare specialists and organizations were subscribed.

Starting in 1998, RSPOR members actively participated in events in the United States and Europe, attending all of them, conducting seminars, and giving presentations. The delegations traveling to events often numbered several dozen people and received ISPOR grants. In addition to scientific activities, O. V. Borisenko’s musical performances were very popular. Good relations developed with colleagues from Poland, Ukraine, Kazakhstan, Serbia, Slovakia, and Hungary. Joint conferences were held in these countries, and representatives often came to Moscow with presentations.

Cooperation with other countries is well illustrated by the interaction of the Polish and Russian chapters of ISPOR in 2010‑2015, as recalled by M. Kholovnya‑Voloskova at our request. It was aimed at exchanging experience in clinical‑economic analysis, health technology assessment (HTA), drug policy, and reimbursement in Central and Eastern Europe. During this time, at least 15 joint events took place: Russian‑Polish‑Ukrainian sessions within the framework of ISPOR congresses (Atlanta, Berlin, Dublin, Montreal, Amsterdam, Philadelphia), and in the format of separate bilateral and regional meetings in Warsaw, Krakow, Moscow, Kharkiv, and Astana. A significant contribution to the coordination of events and international cooperation was made by L. S. Krasnova, Executive Director of the Russian ISPOR chapter, A. V. Bykov, V. P. Komarova, S. Sh. Suleymanov, B. A. Ainabekova (Kazakhstan), L. V. Yakovleva (Ukraine), and on the Polish side, representatives Prof. Karina Janc‑Rużyk, Prof. Marcin Czech, Prof. Maciej Niewada participated in joint initiatives. One of the central events of the cooperation was the V Polish‑Russian Forum on Pharmacoeconomics, held in June 2013 in Moscow on the territory of the Embassy of the Republic of Poland, and in 2014 – the Eurasian Congress in Astana. A Eurasian Alliance of Pharmacoeconomic Societies was organized. It should be noted the negative reaction of Marilyn Dix Smith to the creation of this alliance, the demand to abandon its organization, and the subsequent lack of support from ISPOR.

Within the framework of Polish‑Russian cooperation, professional development of young specialists was also carried out. For example, in 2009, Malwina Albertovna Kholovnya‑Voloskova completed an internship in Russia, organized by the Russian ISPOR Chapter with co‑financing from the Warsaw Medical University, and participated in the work of the ISPOR Student Chapter. In 2010, she defended her master’s thesis on comparing drug reimbursement systems in Russia, the United Kingdom, and Germany. In 2012‑2014, she worked at the Russian ISPOR Chapter in Moscow, and later was associated with the Research Institute of Healthcare Organization and Medical Management of the Moscow Department of Health, where she headed the health technology assessment unit. In 2023, she defended her doctoral dissertation at the Warsaw Medical University on norms of quality of life of the Moscow population measured using the *EQ-5D* questionnaire, under the scientific supervision of Prof. Dominik Golicki. Research on orphan drugs was also carried out.

Another important area of cooperation was the transfer of methodological knowledge in the field of drug pricing policy: translation, editing, and publication of the book Pricing by K. Land from Krakow. In addition, in 2009, under the leadership of P. A. Vorobyov and O. V. Borisenko, Cost, Quality and Outcomes in Healthcare. ISPOR Book of Terms was translated into Russian and published [23]. It should be noted that both Kazakhstan and Ukraine adopted and implemented many of the ideas on drug provision for the population put forward in Russia. ISPOR created the Committee for Pharmacoeconomic Research of the Central and Eastern European Network (CEU), which also included the branch from Israel. Lyubov Krasnova was chosen as the first scientific supervisor in 2013‑2015. This union created its own journal, which published articles from member countries.

The motorcycle trip of P. A. Vorobyov and L. S. Krasnova under the slogan “For Fair Healthcare” across the USA in 2013 was accompanied by a visit to the ISPOR headquarters in Princeton, where, according to the head, none of the members of the organization had ever been. There was a warm meeting with Marilyn Dix Smith and Nadia Maldonado, a tour of the ISPOR office, which was owned by the organization, and an inspection of an exhibition of meeting brochures.

Let us return to the activities of the Formulary Committee. Soon after the start of work, the Expert Council on the List of Vital and Essential Medicines was transformed into the Formulary Committee. It included well‑known clinicians and chief specialists of the Ministry of Health of the Russian Federation. Meetings became not just public – representatives of drug manufacturing companies, journalists, and representatives of patient public organizations were also invited. Soon the meetings turned into something like small scientific sessions. It was decided to start holding off‑site meetings of the Formulary Committee, inviting specialists from different countries. Off‑site meetings of the Formulary Committee took place in Greece, Crete, Italy, Slovenia, Finland, Sweden, Turkey, and Israel. Smaller‑scale conferences were held in Khabarovsk, Abakan, Krasnoyarsk, St. Petersburg, Chelyabinsk, Minsk, Kharkiv, Warsaw, Budapest, Bratislava, Belgrade, Astana, Yaroslavl, and Petrozavodsk. There was an active exchange of experience and approaches to the assessment and standardization of medical technologies. Due to the abundance of scientific work, from 2008 to 2012 a special journal Clinical Pharmacology and Pharmacoeconomics was established and published 4 times a year, edited by O. V. Borisenko.

Order No. 494 of the Ministry of Health of the Russian Federation of October 22, 2003 “On improving the activities of clinical pharmacologists” [24] was conceived by Yu. B. Belousov, V. A. Baturin, A. L. Khokhlov, S. Sh. Suleymanov, and the author of this article during a conference in Kislovodsk. Writing the text itself was not very difficult, but getting it approved by the Ministry took… a year. The officials really did not want to see the activity of clinical pharmacologists as determining the pharmaceutical component, dealing with hospital formularies. Moreover, a letter on hospital formulary commissions, their conduct of HTA, and the formation of formulary lists of medical organizations had already been sent to medical institutions, and in some places they still operate. Although the order itself has long been canceled, and the activity of clinical pharmacologists has been reduced.

In 2003, at the end of Yu. L. Shevchenko’s tenure as Minister, our team, on the instructions of Deputy Head of the Presidential Administration of the Russian Federation I. I. Shuvalov, developed a draft Law on State Guarantees of Free Medical Care based on the standardization system, which was solemnly presented to the Minister of Health M. Yu. Zurabov. The draft law was discussed in the State Duma, presented by R. A. Khalfin, and L. M. Roshal turned out to be a fierce opponent. Although Zurabov expressed support for this draft law, it was not adopted. Nevertheless, on its basis, about 1,000 medical care standards were developed and approved, which formed the basis for drug provision for certain categories of citizens, and later for patients with rare and expensive diseases.

In 2015, Marilyn Dix Smith left the leadership of ISPOR due to illness, and Nancy S. Berg took her place. The organization’s policy changed: it transformed from a socially‑oriented organization into a business structure. Old employees were dismissed, in particular Nadia Maldonado. All negotiations and correspondence were switched to English, although previously everyone communicated, including in Russian. Nadia was a Ukrainian from South America who had moved to the United States, and she also brought peace at the political level: there was great friendship between Poles, Ukrainians, and Russians, not to mention other countries – Hungary, Greece, Serbia. There was a stated agreement not to mention politics. Attempts at political provocations were suppressed.

Shifts and changes in RSPOR occurred in the early 2010s. In 2007, O. V. Borisenko came to Moscow from Stavropol to work; he had previously been involved in epidemiology and had grants in this area. He replaced M. V. Sura, who had left the position of executive director by that time, and headed RSPOR until 2011. After Borisenko’s departure for Stockholm, A. A. Shustov became executive director of RSPOR, and two years later, M. A. Kholovnya‑Voloskova. By the time of her appointment, Malwina had been working in Russia for several years. A hematologist, Candidate of Medical Sciences L. S. Krasnova, came to work at the department and quickly got up to speed. For several years, Kholovnya‑Voloskova and Krasnova became the core of RSPOR.

Negative trends were brewing in Russia. The elite in the industry leadership completely changed. The managers who came on the wave of the 2004 administrative reform almost completely left their positions in 2007‑2008. Slogans were proclaimed for radical changes in healthcare with a reduction in the bed capacity – healthcare optimization. A number of laws concerning healthcare were adopted, with the simultaneous repeal of existing ones. Entire layers of work disappeared, particularly in drug provision. Public discussions of ongoing processes ceased (“The State Duma is not a place for discussion”).

Our team, among others, is responsible for two system‑forming State Standards: GOST R 56034‑2014 “Clinical recommendations (treatment protocols). General provisions” [25] and GOST R 56044‑2014 “Health technology assessment. General provisions” [26], which incorporated all the achievements in this field of the previous 15‑20 years.

The Ministry of Health of the Russian Federation introduced amendments to the legislation on standardization, directly prohibiting all departments except the Ministry of Health from dealing with the standardization of medical technologies. The development of documents on health technology assessment and clinical recommendations ignored the requirements of the relevant GOSTs. The standardization in healthcare department at the I. M. Sechenov MMA, which performed many of the above functions, was liquidated. State Standard Committee 406 “Medical Technologies,” which was chaired by P. A. Vorobyov and had RSPOR as its base organization, practically ceased to exist within a few years. Under these conditions, the demand for clinical‑economic research and the scientific development of the field rapidly fell.

With the departure of Marilyn Dix Smith, the trend in ISPOR also changed. Russian delegations sharply decreased in size, and support from the leadership clearly disappeared. The ongoing “re‑division” in the country was taken beyond its borders, and the “new elite” (V. V. Omelyanovsky) publicly discredited domestic authorities. Employees who had started work and were actively developing the topic of clinical‑economic analysis were lured into a new structure of the Ministry of Health. General political processes also played an additional negative role. I will not name names – everyone knows them anyway. Unfortunately, the brief period of development ended; what happened later can be assessed as a parody of management technologies in healthcare, which originally looked completely different.

The Formulary Committee did not resume its work in the new Ministry of Health of the 2004 edition. Not that its activities were recognized as negative, the composition changed – no, its activity became obviously undesirable. Deputy Minister of Health A. V. Katlinsky, who supervised and supported the committee’s activities, was fired in a scandal, and A. I. Vyalkov, who was responsible for standardization issues, left the Ministry. For some time it was possible to work with Deputy Ministers R. A. Khalfin and V. I. Starodubov, but their professional path in the department also came to an end fairly quickly. Of course, in a short time it was possible to develop and approve almost a thousand medical care standards, implement a program of preferential provision for certain categories of citizens (a reduced reimbursement system in which only part of the population has access to medicines – the “DLO program”), and provide access to high‑cost medicines (the “7 nosologies program”). When creating these programs, economic approaches were taken into account, and medical care standards were created in which the pharmaceutical component was scientifically substantiated. The Formulary Committee migrated under the jurisdiction of the Russian Academy of Medical Sciences, which was certainly facilitated by the status of its chairman, Academician A. I. Vorobyov. In fact, RSPOR and the Formulary Committee formed a single team at this stage.

It is worth noting the “Federal Guide for the Use of Medicines (Formulary System)”, which went through 18 annual editions (2000‑2017) edited by A. G. Chuchalin, Yu. B. Belousov, and others, which originally copied an English reference book for doctors, containing very brief information on drugs. The order and regulation on this guide were formed with the active participation of the Formulary Committee. Unfortunately, it was not possible to implement health technology assessment in the creation of this guide: on the one hand, many drugs with unproven efficacy “penetrated” it, on the other hand, for many years, for example, a section on the treatment of pneumonia was absent.

Within the framework of the activities of RSPOR and the Formulary Committee, an optimal model of drug provision was created, including the necessary costs per resident of the country. The costs for the entire list of drugs used in hospitals were taken into account, based on trading data in Moscow. For each drug, DDD and the corresponding costs based on the results of government contracts were estimated. As a result, cost figures per resident were obtained. Based on this, a draft law was created on free provision of medicines and medical devices to residents. A few years later, this draft law was submitted to the State Duma to create an all‑Russian reimbursement system. Hearings were held, but the law never left the working offices. The main point in the calculations: through the rational use of essential drugs, it is possible to optimize, without increasing costs, and provide all citizens with free medicines.

I want to believe that this story is not yet over.

Key findings

1. The formation of pharmacoeconomics and clinical‑economic analysis in Russia took place under conditions of systemic healthcare transformations from the late 1980s, influenced by international initiatives (WHO, World Bank, ISPOR).

2. Key achievements:

   • development of a standardization system in healthcare;

   • creation of the Formulary Committee and introduction of clinical‑economic evaluation of medicines;

   • founding of the Russian chapter of ISPOR (RSPOR) and active integration into the international scientific community;

   • development of clinical‑economic analysis methodology, including cost assessment, modeling, and analysis of typical practice;

   • training of personnel, publications, dissertation defenses, conferences, and educational programs.

3. Problems and obstacles:

   • inconsistency of state policy, frequent changes in the leadership of the Ministry of Health of the Russian Federation;

   • bureaucratic and corruption barriers to implementing reforms;

   • lack of a systematic approach to drug provision, separation of medical and pharmaceutical care;

   • gradual curtailment of initiatives after the 2010s, liquidation of structures (standardization department, State Standard Committee), reduction of the expert community’s influence.

4. Role of international cooperation – active interaction with foreign colleagues (Poland, Ukraine, Kazakhstan, etc.) facilitated exchange of experience, but after the change in ISPOR leadership, cooperation decreased.

5. Incompleteness of reforms – despite significant progress, a system of universal free drug provision has not been implemented, and many initiatives remained at the project level.

Conclusion

The article provides a valuable historical and analytical review of the development of pharmacoeconomics and related disciplines in Russia. The author, as a direct participant in the events, demonstrates how, in the context of healthcare transformation, it was possible to lay the foundations of a scientifically based approach to drug provision, standardization, and health technology assessment. Methodological and organizational structures were created, personnel were trained, and international cooperation was established.

However, these achievements remained largely unfinished. The systematic development of the field encountered institutional and political barriers, the absence of a consistent state strategy, and the gradual curtailment of expert and public initiatives. Despite this, the accumulated experience and scientific developments remain relevant and can serve as a basis for future reforms in drug provision and healthcare management in Russia.