Pricing for zhnvlp. Expert opinion on the new pricing methodology for pharmaceuticals

The current legislation that determines the procedure for regulating drug prices is quite confusing and contradictory, despite the efforts of federal and regional legislators. In complex ups and downs normative documents on the regulation of prices for medicines operating at the federal and regional levels, it is not always possible for even an experienced lawyer to figure it out. This unequivocally gives rise and will give rise to numerous disputes with the Departments of the Ministry of Taxes and Duties of the Russian Federation and the Local Commissions for Licensing Pharmaceutical Activities, which will confuse more than one arbitration court.

To date, pricing for medicines at the federal level is regulated by:

1. Decree of the Government of the Russian Federation of March 29, 1999 N 347 "On measures state control for the prices of medicines" (together with the "Procedure state registration selling prices manufacturers and establishing wholesale and retail mark-ups to manufacturers' selling prices for medicines included in the List of Vital and Essential Medicines and Medical Devices");

2. Decree of the Government of the Russian Federation of March 7, 1995 N 239 "On measures to streamline state regulation of prices (tariffs)" (as amended on June 30, 1997);

3. Government Decree Russian Federation dated August 8, 2009 N 654 Moscow "On the improvement of state regulation of prices for vital and essential medicines

4. Decree of the Government of the Russian Federation of October 29, 2010 N 865 Moscow "On state regulation of prices for medications included in the list of vital and essential medicines"

5. Order of the Ministry of Health and social development RF dated November 3, 2010 No. 961 n/527-a “On Approval of the Methodology for Establishing Maximum Selling Prices for Medicinal Products Included in the List of Vital and Essential Medicines by Drug Manufacturers (as amended as of October 8, 2012)”

6. Federal Law "On the circulation of medicines" No. 192 dated July 27, 2010

7. Decision of the Altai Territory Administration for State Regulation of Prices and Tariffs dated October 17, 2012 No. 132 “On establishing the maximum wholesale mark-ups and the maximum retail mark-ups to the actual selling prices set by the manufacturer of medicines for medicines included in the Vital and Essential Drugs List.

8. Decision of the Office of the Altai Territory for State Regulation of Prices and Tariffs dated July 5, 2010 No. 15 “On the establishment of trade markups on food prices baby food(including food concentrates)

Control of prices for medicines is carried out in accordance with the Decree of the Government of the Russian Federation dated November 9, 2001 No. 782 “On State Regulation of Prices for Medicines”.

According to this document the state regulates prices for medicines included in the list of essential and vital medicines. Prices for medicines, both domestic and imported, are subject to state registration.

State regulation of prices for medicines is carried out by state registration of the maximum selling prices of Russian and foreign manufacturing organizations for medicines and the establishment of maximum wholesale and maximum retail mark-ups to the prices of these medicines.

On January 1, 2010, amendments to the acts of the Government of the Russian Federation on issues related to the improvement of state regulation of prices for vital and essential medicines (hereinafter referred to as VED) came into force. In particular, amendments were made to Decree of the Government of the Russian Federation No. 782 dated 09.11.2001 “On state regulation of drug prices”; Decree of the Government of the Russian Federation of 08.08.09 No. 654 “On improving state regulation of prices for vital and essential medicines” (as amended by Decree of the Government of the Russian Federation of 30.12.2009 No. 1116); to the Regulation on Licensing Pharmaceutical Activities, approved by Decree of the Government of the Russian Federation No. 416 dated 06.07.2006, in terms of establishing new licensing requirements and conditions for the implementation of pharmaceutical activities to comply with the established maximum wholesale and maximum retail mark-ups to the prices of Vital and Essential Drugs (violation of these requirements is classified as categories of gross violations, as a result of which the activities of the licensee may be suspended).

Decree of the Government of the Russian Federation of December 30, 2014 N 2782-r<Об утверждении перечня жизненно необходимых и важнейших лекарственных препаратов на 2015 год, а также перечней лекарственных препаратов для медицинского применения и минимального ассортимента лекарственных препаратов, необходимых для оказания медицинской помощи.

In addition, the list of medicinal products for medical use, including medicinal products for medical use prescribed by decision of medical commissions of medical organizations, was approved; a list of medicines intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher's disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after organ and (or) tissue transplantation; the minimum range of drugs needed to provide medical care. It was established that until March 1, 2015, the list of vital and essential drugs for 2012, approved by the Decree of the Government of the Russian Federation of December 7, 2011 N 2199-r, is applied.

Changes were also made to the Regulations on Licensing the Production of Medicines, approved by Decree of the Government of the Russian Federation No. 415 dated 06.07.2006, - a new licensing requirement is established: in the production of medicines included in the list of Vital and Essential Drugs, the maximum selling price of the manufacturer is registered; the Rules for the Import and Export of Medicinal Products, approved by Decree of the Government of the Russian Federation of July 16, 2005 No. 438, in terms of the provision by foreign manufacturers, when importing vital and essential drugs, of documents on state registration of their maximum selling price, as well as information on actual prices for imported vital and essential drugs; to the Regulations on the Federal Service for Supervision of Health and Social Development, approved by Decree of the Government of the Russian Federation of June 30, 2004 No. 323, - in terms of granting the Service the authority to monitor the range and prices of vital and essential drugs; to the Regulations on the Federal Tariff Service, approved by Decree of the Government of the Russian Federation of June 30, 2004 No. 332, in terms of granting the Service the authority to develop a unified methodology for determining the maximum wholesale and maximum retail markups for vital drugs by the executive authorities of the constituent entities of the Russian Federation.

The new price regulation scheme provides for the application of mark-ups to the selling prices of manufacturers, not suppliers. This measure will avoid the formation of long schemes for promoting medicines from manufacturers to consumers and a multiple increase in prices.

Since January 2010, in accordance with Government Decree No. 654 dated 08.08.09, mandatory state registration of maximum selling prices for medicines included in the Vital and Essential Drugs List is introduced. The list was approved by Decree of the Government of the Russian Federation dated December 30, 2009 No. 2135-r. The List includes 500 names, of which 222 are from the main List of medicines recommended by WHO, and 278 are included directly by Russian specialists. Of the total number - 76 drugs are only of domestic production, 261 are produced by both Russian and foreign factories, 163 are only of foreign production.

The previous List was valid since 2007 and included 658 items. It was still valid until December 31, 2009. The lists differ not only in the reduction in the number of declared drugs. “The share of drugs of domestic production and drugs that are produced both in Russia and abroad is 67.8% in the new List,” head of the department Tatyana Golikova noted earlier. - In the current (expiring) List, this share is 55%. She explained that in compiling the List, preference was given to drugs with a higher level of clinical efficacy.

The Vital and Essential Drugs List is designed to ensure that the maximum selling prices of manufacturers for drugs included in this List are fixed by the state in a special price register. For the drugs in the List, prices are monitored in the regions of Russia and the purchase of medicines for healthcare facilities and the provision of privileged categories of the population at the expense of budgetary funds are organized.

The issues of formation and registration of prices for medicines included in the List of Vital and Essential Medicines (VED) are regulated by the approved Decree of the Government of the Russian Federation of March 29, 1999 N 347 "Procedure for state registration of manufacturer's selling prices and the establishment of wholesale and retail allowances for selling manufacturer prices for medicines included in the List of Vital and Essential Medicines and Medical Devices" and approved on May 10, 1999 by the First Deputy Minister of Economy of the Russian Federation medicines and medical devices".

Wholesale organizations - importers that purchase goods directly from a foreign manufacturer, register prices for medicines from the Vital and Essential Drugs List in foreign currency and in rubles at the exchange rate of the Central Bank of the Russian Federation on the date of registration. In the future, the Ministry of Health of the Russian Federation adjusts prices in rubles at their next publication, taking into account changes in the foreign exchange rate. The registered price for an imported medicinal product consists of the price of a foreign manufacturer on the terms of "delivery without payment of duties" and customs expenses.

There are several important groups that are part of the Vital and Essential Drugs List:

I. Anesthetics, muscle relaxants

II. Analgesics, non-steroidal anti-inflammatory drugs, drugs for the treatment of rheumatic diseases and gout

III. Means for the treatment of allergic reactions

IV. Means affecting the central nervous system

V. Means for the prevention and treatment of infections

VI. Antineoplastic, immunosuppressive and concomitant drugs

VII. Means for the treatment of osteoporosis

VIII. Drugs affecting the blood

IX. Drugs affecting the cardiovascular system

X. Diagnostic tools

XI. Antiseptics and disinfectants

XII. Means for the treatment of diseases of the gastrointestinal tract

XIII. Hormones and drugs that affect the endocrine system

XIV. Remedies for the treatment of diseases of the kidneys and urinary tract

XV. Medicines for the treatment of ophthalmic diseases, not elsewhere specified

XVI. Medications affecting the uterus

XVII. Means affecting the respiratory system

XVIII. Solutions, electrolytes, means of correcting acid balance, nutritional products

XIX. Vitamins and minerals

Formally, from a legal point of view, when setting prices for medicines, the prices of which are subject to state registration, it is the Governmental Vital and Essential Drugs List that should be used. However, many local regional acts that establish the pricing procedure refer to the local list of essential drugs or to the List of the Ministry of Health of the Russian Federation.

In accordance with Decree of the Government of the Russian Federation No. 654, the sale of medicines by wholesalers and pharmacies is carried out with the obligatory execution of a protocol for agreeing on prices for the supply of vital and essential drugs, with the obligatory indication of the manufacturer's selling price.

Such a mechanism for regulating prices for vital and essential drugs will ensure "transparency" of pricing at all stages of its formation during the passage of goods from the manufacturer to the end consumer.

After the release of Government Decree No. 2135-r dated December 30, 2009 and the Methodology for determining the maximum selling prices of manufacturers for essential drugs, all prices registered without using the methods for determining the manufacturer's selling price, in pursuance of the previous Decree of the Government of the Russian Federation dated March 29, 2007 No. 376-r, became inactive.

Until 04/01/2010, it was allowed to sell vital and essential drugs that had not passed the state price registration without price approval protocols (Decree of the Government of the Russian Federation No. 782 dated 09.11.2001). At the same time, from January 1, 2010, in accordance with the Regulations on the state regulation of prices for vital and essential drugs, Decree of the Government of the Russian Federation No. 782, pricing by wholesalers and pharmacies is carried out using wholesale and retail markups on the actual selling prices of manufacturers, not exceeding the registered price, and indicating data on the actual selling price of the manufacturer.

After 01.04.2010, a wholesaler and (or) a pharmacy institution was not entitled to sell the balances of previously purchased Vital and Essential Drugs, if the manufacturers of these medicines did not register the maximum selling price for these medicines for various reasons.

Normative acts establishing marginal wholesale and retail markups to the actual ex-factory prices of manufacturers for vital and essential drugs, in accordance with Decree of the Government of the Russian Federation of December 30, 2009 No. 1116, must be adopted by the executive authorities of the constituent entities of the Russian Federation by March 1, 2010. Decisions adopted in the constituent entities of the Russian Federation come into force from the date indicated in the act itself. Until a new regulatory act is adopted by a constituent entity of the Russian Federation, wholesale and retail trade organizations must apply the wholesale and retail mark-ups previously established in a constituent entity of the Russian Federation to the actual selling prices of VED manufacturers.

So in the Altai Territory, the regulation of pricing and drugs included in the list of essential drugs is regulated by the decision of the Office of the Altai Territory for State Regulation of Prices and Tariffs dated October 17, 2012 No. 132 “On the establishment of maximum wholesale markups and maximum retail markups on actual selling prices, established by the manufacturer of medicinal products, for medicinal products included in the Vital and Essential Drugs List.

The decision on state regulation of the maximum wholesale and retail mark-ups for drugs not included in the list of vital and essential drugs, as well as for medical products, is taken by the executive authority of the constituent entity of the Russian Federation independently.

If the supply of vital and essential drugs is carried out outside the territory of the constituent entity of the Russian Federation in which the wholesale organization is located, the amount of the wholesale markup should not exceed the level established in the constituent entity of the Russian Federation to which the supply is made.

It is allowed to sell Vital and Essential Drugs by wholesale organizations at a price lower than the actual selling price of the manufacturer. A pharmacy institution, having purchased medicines from a wholesale organization at a price below the level of the manufacturer's actual selling price specified in the price agreement protocol, forms a retail price by summing up the price of purchasing medicines from a wholesaler and the retail markup established in the constituent entity of the Russian Federation, calculated from the actual manufacturer's price.

Thus, the formation of the selling price for medicines by wholesalers and pharmacies is carried out on the basis of the actual selling price of the manufacturer, not exceeding the registered price, and wholesale and (or) retail markups, not exceeding, respectively, the maximum wholesale and retail markups established in the constituent entity of the Russian Federation .

The medicinal product, the price of which is registered, is entered in the state register of registered maximum ex-works prices. In this case, the manufacturer is issued a registration certificate.

The selling price at which the manufacturer sells the medicinal product may be less than or equal to the state registration price. It is prohibited by law to sell medicinal products at a price higher than the registered one.

In addition, marginal wholesale and retail surcharges are set for medicines. Their sizes are approved by acts of the executive authorities of the constituent entities of the Russian Federation.

Thus, the pricing system in pharmacy, which must be provided by law, remains a paramount issue today. An analysis of the current legislation and regulations in this area showed their inconsistency and fragmentation. It can be argued that there is still no systematic and complete state regulation of the sphere of pricing and provision of medicines, and the role of state bodies in this regard is weakened.

UDC 338.517

Marushchak I.I.*, Olkhovskaya M.O.

M.O. Olkhovskaya

I.I. Maruschak

Pricing systems for medicines in Russia and abroad

*Marushchak Ilya Ivanovich, Candidate of Economic Sciences, Associate Professor, Head of the Department of Economics, Moscow State Industrial University

**Marina Olegovna Olkhovskaya, Lecturer at the Department of International Economic and Financial Relations of the Russian State Academy of Intellectual Property, applicant for the Department of Economics, Moscow State Industrial University

E-mail: maria.rg [email protected]

The authors consider the issue of pricing for medicines in Russia and abroad. Currently, there are several pricing systems, each of which is supported by certain groups of countries. Different pricing models are compared, including the mechanisms of pricing for a medicinal product, operating in the Russian economy.

Key words: pricing, medicines, generics, marginal prices, reference prices, profit control, Essential and Essential Medicines List.

Currently, almost every developed country has a national drug pricing system, or there is a pricing procedure for the whole region, taking into account local characteristics. On the one hand, the procedure for determining the price of medicines is the task of the state, which acts as a guarantor of social support for the population, on the other hand, it is also necessary to take into account the interests of manufacturers whose profits positively affect the production of new drugs. In Russia, achieving a balance of interests between the state and businesses in the pharmaceutical industry is complicated by the various goals pursued by the parties.

There is a relationship between the price of medicines and the volume of supply of products on the market. In countries with a low level of supply restriction on the market, the price of a drug tends to be higher (USA, Japan) than in countries where there is more stringent regulation of the supply volume (India, China, a number of countries in Central and Eastern Europe) .

In addition, the following factor should be taken into account: there is a group of countries with fierce competition in the market of generics2 (India), innovative drugs and analogues (USA, EU member states), which determines the development of pricing policy for a particular category of drugs. The price of a drug that has patent protection is a priori higher than the price category of generic drugs, in the market of which, if the price of one drug is overstated, it will be quite difficult to restore consumer loyalty. However, in order to reduce the risk of overpricing of innovative medicines, governments of various countries may refuse to register them. These countries include Portugal, Austria, Switzerland, Greece, Finland, Argentina and Turkey3.

To date, four main approaches to pricing and determining the recoverable amount of medicines have been formed:

Marginal prices;

Reference prices;

Profit control;

1 Bennett N. Pharmaceutical Pricing Strategies 2000: Entering the New Millennium. Washington: Reuters Business Insight. 2000. 221 p.

Generic (eng. Generic) - a drug sold under an international non-proprietary name or under a proprietary name that differs from the brand name of the drug developer.

3 Melik-Guseinov D.V. Information from public authorities. Federal Antimonopoly Service of the Russian Federation: Analytical note on the development of options for reference pricing approaches for medicines included in the group of vital and essential [Electronic resource]. 10/21/2011. Access mode: http://farm.lobbying.ru/gosinfo.php?id=110 (date of access: 07/17/2011)

Benefit-based approach (pricing based on the benefits of a particular drug relative to others)1.

Limit (maximum) prices for drugs are set by many countries, with the exception of Germany, Great Britain, and the USA (Table 1).

Table 1

Countries that apply the registration of marginal (maximum) prices of drugs that are (In-patent) and are not (Off-patent) under patent protection2

Including prices abroad Countries Limit prices

In-patent Off-patent

v Brazil V v

v Canada V -

v China V v

v France V -

Germany - -

v Italy V -

v Holland V v

v Spain V -

Great Britain - -

A significant drawback of this method is that the manufacturer in this case may not be sufficiently motivated to create new molecules for the production of drugs). Consequently, society will be exposed to the threat of not getting the necessary medicine in the market of countries with an operating mechanism. And, indeed, mostly the latest medical developments come from the USA, Great Britain and Germany.

Consider the second approach to drug pricing - reference pricing.

Most of the EU countries have switched to reference pricing.

Reference pricing is an element of the state reimbursement system for medicines, designed, firstly, to optimize these costs by determining an economically justified level of reimbursement for each group of medicines included in the list of reimbursed medicines (from reimbursement - reimbursement of the cost of medicines). And, secondly, to increase the number of citizens, primarily low-income and socially unprotected, receiving adequate medical care.3

Comparative data on the reference pricing mechanism in the EU countries are presented in Table 2.

Germany, Denmark, Great Britain, Sweden do not use this mechanism. In these countries, there is free pricing, which involves finding a balance between supply and demand. However, it cannot be argued that for these countries free pricing is the main mechanism for setting prices. Since the pharmaceutical industry is predominantly socially oriented, state control should also take place for certain categories of drugs. Thus, in countries with predominantly free pricing, there are necessarily areas (for example, wholesale trade in Germany, the income of firms that produce patent drugs in the UK), or drug provision programs (federal programs in the USA) where price regulation is carried out. In turn, in countries with strict control, free pricing applies to drugs whose cost is not subject to reimbursement from public funds (for example, France, Sweden, Japan, Spain, etc.)4.

Thus, the state does not interfere in the procedure for setting prices by the company itself, but it regulates prices.

The essence of the method is that the pricing set by the producers is considered free as long as the producers do not exceed the maximum profit ratio. Thus, prices are regulated indirectly - through an agreement on the amount of profits received. At the same time, the level of profit of the company is measured based on the return on invested capital. For companies that do not have any significant capital investment in the UK, the valuation is based on the proceeds from the sale5.

On the one hand, companies are better than other entities in determining the level of cost recovery for research in the field of new drugs, including costs in the price, but if

Polyakova D. Reference pricing: side effects [Electronic resource] // Aptekam online 24.03.2008. Access mode: http://www.apteka.ua/article/6385 (date of access: 27.04.2011)

3 On reference pricing in the Ukrainian pharmaceutical market from the first mouth: Interviews with Soloviev A. and Bortnitsky V. [Electronic resource] // Apteka.online.ua. 04/09/2012. No. 835 (14). Access mode: http://www.apteka.ua/article/136717 (date of access: 20.07.2011).

4 Telnova E.A. Pricing: foreign experience // Pharmacoeconomics. 2009. V. 2. No. 4. S. 24.

5 Melik-Guseinov D.V. Decree. op.

look at it from the other side, the state, acting as a regulator, is faced with the problem of determining the rate of return for individual enterprises. In addition, all enterprises have their own assortment portfolio, and the margin that can be set for one company will be insufficient for another.

table 2

Application of reference prices in various countries1

Country Presence of SR Scope of application Basis for calculation of the reference price Method of calculation of the reference price and reference countries

Austria + Reimbursable2 medicines Producer prices (wholesale selling prices for individual countries) The reference price is calculated as the average price in all EU member states, except for Romania and Bulgaria

Belgium + All medicines Manufacturer's prices Comparison is made with all EU member states

Bulgaria + Prescription medicines Producer prices Since 2010, the reference price is calculated as the average of the 3 lowest prices in the following countries: Romania, Russia, Czech Republic, Slovakia, Hungary, Poland, Portugal, Spain, Austria

Hungary + Reimbursable medicines Manufacturer's prices When calculating the reference price, the lowest price in the reference countries (France, Ireland, Germany, Portugal, Italy, Greece, Poland, Czech Republic, Slovenia, Slovakia, Belgium, Austria and one additional country) is taken into account

Spain + Innovative medicines Producer prices The reference price is calculated as the lowest price among the following countries: Germany, Austria, Belgium, Denmark, France, Netherlands, Ireland, Italy, Luxembourg, United Kingdom, Sweden

Italy + Reimbursable medicines Manufacturer's prices Reference price is calculated as the average price in reference countries (not defined), SR is used as additional information when negotiating the cost of the drug with the manufacturer

Latvia + Reimbursable medicinal products Manufacturer's prices Reference price is calculated as the third lowest price in the EU countries

Poland + Reimbursable drugs Producer prices Reference price is calculated as the lowest in the reference countries (Belgium, UK, Ireland, France, Germany, Netherlands, Sweden, Denmark, Spain, Portugal, Italy, Greece, Czech Republic, Hungary, Luxembourg, Lithuania)

Portugal + Prescription and reimbursement OTC (excluding generics) medicines Producer prices, end-use prices The reference price is calculated as an average of prices in the following countries: Greece, Spain, France, Italy

France + Innovative medicines Manufacturer's prices Comparison is made with the manufacturer's prices in the following countries: Germany, Spain, Italy and the United Kingdom

Let us consider the main mechanisms for determining the price of medicines in other regions. In our opinion, it is advisable to refer to the experience of such developed countries in terms of pharmaceutical products as India, China, Brazil (partner countries of the Russian Federation in BRIC).

The Indian Government has proposed to introduce a new approach to the regulation of the cost of medicines, in particular to limit the cost of medicines under patent protection to the level determined using the system of external reference pricing, adjusted for GDP from

How does the reference pricing system work? [Electronic resource] // Apteka.opNpe.ia 2012. February 27, No. 8 (829). Access mode: http://www.apteka.ua/article/126957 (accessed 30.04.2012).

Reimbursement is a system of reimbursement of funds spent by the population on outpatient consumption of medicines.

calculation per capita. The UK, Canada, France, Australia and New Zealand were selected as reference countries. It is proposed to calculate the marginal retail cost of a drug as follows: for example, in India, the cost of a drug under patent protection is 35.5 thousand rupees (636 US dollars), and the same drug in Australia and France is about 2170 dollars. At the same time, GDP per capita in these countries is more than 10 times higher than in India. Thus, the marginal cost of this drug in India, according to the proposal of the government, should be as many times lower than in Australia and France, and amount to approximately 1011 thousand rupees (185-209 dollars), which is almost 3 times less compared to its current value.

In Brazil, there is a strict price regulation system for drugs: when a drug is registered with the Ministry of Health, its price is officially registered. The process of evaluating medical technologies is becoming more stringent (in 2008, only 15% of the proposed prices for medicines were approved, the rest were proposed to be reduced). Moreover, internal committees for the evaluation of medical technologies, using federal legislation on NTA as a model, are also created in private insurance systems. Brazil's National List of Expensive Drugs includes 106 drugs for the treatment of 87 nosologies1.

Strict price controls in China are limited to medicines reimbursed by public funds. The list of such drugs includes from 1500 to 2000 items. On average, 500-1000 of them are traditional Chinese medicine products, and 1000 are pharmaceutical products of two categories: A (cheap generics) and B (innovative medicines). 15% of category B drugs (75 items) are paid for by regional budgets. Medicines not included in this list are subject to free pricing. Paradoxically, the advances in China's economy are not conducive to improving the health situation, it is even getting worse. The proportion of insured patients is decreasing year by year (from 90% in 1981 to 60% in 2008). At the same time, the government aims to bring this figure to 100% by 2010, which is very unlikely. At the same time, there is a huge increase in health care costs (for 15 years they have been increasing annually by 10-15%). The fee is charged not only for services, but also for visiting a doctor, the proportion of out-of-pocket expenses reaches 60%. A characteristic shortcoming of Chinese health care is the disparity between urban and rural populations.

A separate block is the analysis of pricing for innovative medicines, which indicates that the prices for fundamentally new drugs subject to reimbursement in most of the countries under study are determined in accordance with international trade prices. At the same time, in France, their effectiveness is also taken into account, in Sweden - social perspective, in Belgium - the prices of drugs in the EEC countries, in Japan - the level of production costs and the origin of drugs, in China - a patented drug or not. In countries such as Germany and the United States, innovative drugs are subject to free pricing. The UK also has free pricing, but within the established income of the firm2.

The above approaches to pricing for innovative drugs are determined by the fact that the costs of their development, as well as the level of risks of various kinds, are quite high. In addition, often a fundamentally new drug cannot be compared in price with another drug, since there will be no analogues for a certain period of time. Of course, this gives rise to speculation on medicines by manufacturers who set initially inflated prices, which are difficult to verify, but, on the other hand, the number of dangerous pathologies is growing every year and the life of citizens may depend on the timing of bringing the drug to the market.

At the moment, our country uses the List of Vital and Essential Medicines, approved by Decree of the Government of the Russian Federation of December 30, 2009 No. 2135-r (hereinafter - the List No. 2135-r), the pricing of which can be openly viewed.

For all drugs that are listed in the List No. 2135-r, the price is regulated by the state, while the prices for drugs, both domestic and imported, are subject to state registration. The drug, the price of which is registered, is entered in the State Register of Registered Maximum Selling Prices.

The price is calculated as follows3.

Acts of the executive authorities of the constituent entities of the Russian Federation for medicinal products establish the maximum wholesale and retail markups:

To the actual selling price of the drug manufacturer. At the same time, the actual selling price of a Russian manufacturer is understood as the price at which the manufacturer actually sells the medicinal product and which is indicated in the sales contract and accompanying documentation for the goods (in waybills, etc.), and the foreign manufacturer - the contract price for the medicinal product, not exceeding the registered maximum selling price, in rubles at the exchange rate of the Central Bank of the Russian Federation on the date of execution of the cargo customs declaration;

1 Here: classification and nomenclature of diseases (modern medical literature usually uses the concept of "nosological approach", i.e. the desire of clinicians and representatives of theoretical medicine to isolate a nosological form, which is characterized by a specific cause, unambiguous pathogenesis, typical external manifestations and specific structural disorders in organs and tissues).

2 Telnova E.A. Decree. op.

3 Order No. 442-a dated 11.12. 09 “On Approval of the Methodology for Determining by the Executive Authorities of the Subjects of the Russian Federation the Limit Wholesale and Limit Retail Markups to the Manufacturers’ Actual Selling Prices for Vital and Essential Medicines” [Electronic resource] // GARANT. Information and legal portal. 2009. December 22. Access mode: http://www.garant.ru/products/ipo/prime/doc/12071699/ (date of access: 05/09/2013).

To the selling price of a wholesale trade organization that purchases medicines at its own expense directly from manufacturers.

The Federal Tariff Service of the Russian Federation, in Order No. 73-a dated March 11, 2010, approved a form for submitting data on the size of the maximum wholesale and retail markups established in the constituent entities of the Russian Federation to the prices of vital and essential medicines, which presents the size of the maximum surcharges in expanded form for the following price groups:

Up to 50 rub. inclusive;

From 50 to 500 rubles. inclusive;

Over 500 rubles.

Table 3

Limit wholesale and limit retail mark-ups to the actual selling price (excluding VAT)1

Mark-ups Manufacturer's actual selling price Marginal mark-up, %

Maximum wholesale markup to the actual selling price of the manufacturer Up to 50 rubles. inclusive 20

Over 50 rubles. up to 500 rubles inclusive 15

Over 500 rubles. ten

Maximum retail markup to the actual selling price of the manufacturer Up to 50 rubles. inclusive 32

Over 50 rubles. up to 500 rubles inclusive 28

Over 500 rubles. fifteen

The actual selling price of the manufacturer is understood as the price (without value added tax) indicated by the Russian manufacturer of the medicinal product in the accompanying documentation for the goods (in waybills, etc.), and by the foreign manufacturer of the medicinal product - in the accompanying documentation for the goods (in the invoice and etc.), on the basis of which a customs cargo declaration is issued, taking into account the costs associated with the customs clearance of the cargo (customs duties and customs clearance fees), not exceeding the registered maximum selling price of the manufacturer.

Let us give examples of the calculation of wholesale and retail markups using the example of Moscow; in many constituent entities of the Russian Federation, a similar procedure is in place2.

The wholesale organization received Corvalol drops from another organization at a price of 10.5 rubles. per package subject to a 5% trade markup. The price from the manufacturer is 10.2 rubles.

We will calculate the maximum wholesale price.

Since Corvalol is included in the List No. 2135-r, the maximum trade markup in this case will be: 15% (20% - 5%), where 20% is the maximum amount; 5% - already applied trading margin. The marginal wholesale price will be equal to: 12.03 rubles. (10.5 rubles + 10.2 rubles x 15%).

Pharmacy OOO Zdorovye, located in Moscow, received 3% hydrogen peroxide from a wholesaler at a price of 5 rubles. Calculate the maximum retail price for a pharmacy for this drug.

The maximum retail price for a pharmacy will be: 6.6 rubles. (5 rubles + 5 rubles x 0.32), where 0.32 is the coefficient for calculating the amount of the maximum retail price at a rate of 32%. These medicines are included in the List No. 2135.

Along with the invoices, the pharmacy received protocols for agreeing prices for medicines. According to these protocols, the price of state registration of one package of drops "Corvalol" is 15 rubles, one package of the drug "Retinol" - 9 rubles.

As a result of the calculation, the retail price of medicines will be:

- "Corvalol" - 23.75 rubles. (20 rubles + 15 rubles x 25%);

- "Retinol" - 15.15 rubles. (12 rubles + 9 rubles x 35%).

Order No. 442-a dated December 11, 2009 “On approval of the methodology for determining the maximum wholesale and maximum retail mark-ups by the executive authorities of the constituent entities of the Russian Federation to the actual selling prices of manufacturers for vital and essential medicines” provides clear pricing instructions for each of participants in the pharmaceutical market. However, in practice, the consumer still did not feel an effective reduction in drug prices.

A number of experts believe that the list of essential medicines is not perfect from the outset, since specialists cannot afford to add expensive drugs to it - the state is simply not able to afford it. Therefore, the list includes, first of all, domestic and cheap imported drugs3.

It is for this reason that doctors often prescribe not the most effective drug, but the cheapest, from the list of vital and essential drugs (VED), since only

2 Medical goods and services. Pricing for medicines, taking into account the latest changes, 07/22/2010 [Electronic resource]. Access mode: http://www.referent.ru/50/179984 (date of access: 01/09/2013).

3 Patents, drugs and healthcare (based on the report of the Panos Institute (London) "Patents, drugs and healthcare", December 2002) [Electronic resource] // RMS-Expo: medical exhibitions and conferences. Access mode: http://expo.rusmedserv.com/articli.html (date of access: 11/10/2012)..

them in the Russian Federation is subject to state control in relation to pricing.

Summing up the comparative analysis of the Russian pricing system for medicines, the following can be noted: the pricing procedure is strictly fixed for only one category of drugs - vital and essential drugs, local prices are not compared with prices abroad, which can lead to overpricing of medicines, state control over prices regarding categories of non-vital drugs, it is weak due to the lack of a pricing mechanism for them.

According to the authors, it is necessary to transfer all market entities to pricing based on reference prices. This can make it possible to reduce prices for a number of goods, analogues of which are available abroad, to control prices at all levels from the manufacturer to the retailer. However, for the most accurate setting of the price of a drug according to reference pricing, it is advisable to follow the experience of India: compare drug prices abroad and set an adjustment based on GDP per capita.

Among the countries on the basis of whose market prices a comparison should be made, it is advisable to consider India (as the largest producer of generics), the USA, Great Britain, France, Germany (as the main producers of analogues and innovative drugs).

In Russia, there is currently no clear pricing strategy for developed drugs (except for vital and essential drugs), which leads to the independent setting of prices for drugs by manufacturers and distributors;

LITERATURE

1. Order No. 442-a dated December 11, 2009 “On Approval of the Methodology for Determining the Subjects by the Executive Power of

Russian Federation of the maximum wholesale and maximum retail markups to the actual selling prices of manufacturers for vital and essential medicines” [Electronic resource] // GARANT. Information and legal portal. 2009. December 22. Access mode: http://www.garant.ru/products/ipo/prime/doc/12071699/ (date of access: 05/09/2013).

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(829). Access mode: http://www.apteka.ua/article/126957 (accessed 30.04.2012).

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Wai system "Referent". 07/22/2010 [Electronic resource]. Access mode: http://www.referent.ru/48/215984 (date of access: 01/09/2013).

4. Melik-Guseinov D.V. Information from public authorities. Federal Antimonopoly Service of the Russian Federation:

Analytical note on the development of options for approaches to reference pricing for drugs that are in the group of vital and essential [Electronic resource]. 10/21/2011. Access mode: http://farm.lobbying.ru/gosinfo.php?id=110 (date of access: 07/17/2011)

5. About reference pricing in the Ukrainian pharmaceutical market from the first mouth: Interview with A. Solovyov and V. Bortnits-

kim [Electronic resource] // Apteka.online.ua. 04/09/2012. No. 835 (14). Access mode:

http://www.apteka.ua/article/136717 (date of access: 20.07.2011).

6. Patents, drugs and healthcare (based on the report of the Panos Institute (London) “Patents, drugs and healthcare

protection”, December 2002) [Electronic resource] // RMS-Expo: medical exhibitions and conferences. Access mode: http://expo.rusmedserv.com/articl1.html (date of access: 11/10/2012).

7. Polyakova D. Reference pricing: side effects [Electronic resource] // Apteka.online.ua 24.03.2008.

Access mode: http://www.apteka.ua/article/6385 (date of access: 27.04.2011)

8. Telnova E.A. Pricing: foreign experience // Pharmacoeconomics. 2009. V. 2. No. 4. S. 14-24.

9. Balotsky E.R. “Where Strategy and Ethics Converge: Pharmaceutical Industry Pricing Policy for Medicare Part D

beneficiaries.” Journal of Business Ethics 84 (2009):75-88.

10. Bennett N. Pharmaceutical Pricing Strategies 2000: Entering the New Millennium. Washington: Reuters Business Insight. 2000.

11. Daems R., Maes E., Glaetzer Ch. “Equity in Pharmaceutical Pricing and Reimbursement: Crossing the Income Divide in Asia

12. D "Mello B. “Transnational Pharmaceutical Corporations and Neo-Liberal Business Ethics in India.” Journal of Business Ethics

36.1-2 (2002):165-185.

13. Kanavos P, Costa-Font J, Seeley E: "Competition in Off-patent Drug Markets: Issues, Regulation and Evidence." economic

Policy 23.55 (2008): 499-544.

14. Pammolli F., Riccaboni M. “Market Structure and Drug Innovation.” Health Affairs, January/February 23.1 (2004): 48-50.

15. Ridley D. “Price Differentiation and Transparency in the Global Pharmaceutical Marketplace,” Pharmacoeconomics 23.7

(2005): 651-658.

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Corporation, 5 June 2013. Web. 11 Oct. 2013. .

Citation according to GOST R 7.0.11-2011:

Marushchak, I. I., Olkhovskaya, M. O. Drug pricing systems in Russia and abroad // Space and Time. - 2013. - No. 4(14). - S. 44-49.

Prices used in the pharmaceutical market.

Depending on the nature of the serviced turnover, there are:

• selling prices;
• Wholesale prices;
• retail prices.

Selling and wholesale prices ensure the turnover of products in large quantities between enterprises and organizations.

Retail prices are the final prices for goods at which they are purchased by the population.

The difference between selling and wholesale prices iswholesale trade allowance, and between the wholesale and retail price -retail trade allowance.

• regulated prices;
• free prices.

Regulated prices are established by the relevant governing bodies (the President of the Russian Federation, the Government of the Russian Federation, federal executive authorities, executive authorities of the constituent entities of the Russian Federation, local governments). In relation to regulated prices, the listed state authorities establish conditions that limit their level (VED, etc.).

The government's spending on providing inpatients and decreed groups of the population is increasing every year.

• with an increase in the incidence among the population;
• with the introduction of new technologies;
• an increase in the number of doctors;
• an increase in the proportion of older people;
• increasing demands of patients on the healthcare system.

Therefore, the task of our government in the field of drug pricing is to control public spending on drugs, on the one hand, to provide guarantees for the purchase of necessary medicines at affordable prices, on the other.

Free (market) prices - these are prices set for products and services based on supply and demand in a given market, in our case, the pharmaceutical market.

The system of free prices also includes sale, wholesale and retail prices.

When pricing medicines, the following are used:

• free selling price of the enterprise - manufacturer;
• free wholesale (selling) price for medicines and medical devices purchased at the expense of own foreign currency;
• free wholesale price of the intermediary;
• contract price (specified in the contract);
• estimated price for medicines and medical devices purchased at the expense of own foreign currency;
• free retail price.

The free selling price of the enterprise - manufacturer is set by the enterprise - manufacturer based on the cost price, market conditions, product quality, etc. Selling prices include certain taxes and fees in accordance with applicable law.

Free wholesale (selling) prices for medicines purchased abroad at the expense of their own foreign exchange funds are set by organizations that purchase imported medicines for subsequent sale to all wholesale consumers. This price is formed on the basis of the estimated price, which takes into account the contract price of the goods, various customs payments, storage costs and others, as well as market conditions, quality products and prevailing prices for similar products in the Russian market. The settlement price determines the minimum level of the wholesale (selling) price.

The free wholesale price of the intermediary is determined based on the free selling prices and the wholesale trade markup. When forming wholesale prices, the intermediary takes into account market conditions (supply and demand), the prevailing level of prices for similar domestic and imported goods. The intermediary's markup is determined by agreement and is documented in a price agreement protocol.

Free retail prices for medicines are determined independently by retail trade enterprises in accordance with the prevailing supply and demand, the quality of the goods and are formed from free selling prices and the retail markup or the total markup of the retail and wholesale link (when products are supplied through intermediaries).

By July 1, 2015, Russia should adopt a new pricing methodology for Vital and Essential Drugs. Its draft, developed by the Russian Ministry of Health and the Federal Tariff Service, was submitted for public discussion. RG invited market experts to take part in the round table to discuss the pros and cons of the proposed methodology.

Roza Yagudina, Head of the Department of Drug Supply Organization and Pharmacoeconomics, First Moscow State Medical University named after I.I. THEM. Sechenov:

— The proposed method leaves an ambiguous impression. On the one hand, it has many advantages. For example, a requirement was finally introduced that the price of a reproduced drug (generic) cannot be higher than 80% of the price of a reference drug, and for a biosimilar - no higher than 90%. After all, we have cases where the price of a generic is higher than that of the original drug. Many countries have such a legal requirement, and some even require that each subsequent generic is cheaper than the previous one. This allows you to optimize the system, reduce the number of unnecessary generics. A rule has been introduced that when making minor changes to the registration dossier, there is no need to go through the entire price registration procedure - the last registered price is saved. Another advantage is that local producers can in some cases register a price above the inflation rate, if there is a serious justification. And in principle, it’s good that they didn’t radically change the methodology before the introduction of universal drug insurance - it would, of course, be difficult to adopt a new system twice.

On the other hand, the disadvantages include the fact that we have such a large "basket" of reference countries - 23 countries. Usually there are 5-7 of them, and no more than 10. It is bad that it includes countries where prices are very low, and this is due either to the threat of default, as in Greece, or with a completely different procurement system, as in Turkey. The process of re-registration of prices for foreign producers remained too complicated - they are allowed to increase the average import price by the level of official inflation, only if it is not higher than the minimum price in the “basket” of reference countries. But in such a large "basket" you can always find a suitable country.

Larisa Popovich, Director of the Institute for Health Economics, Higher School of Economics:

— It is important that the “basket” includes countries comparable to ours in terms of GDP per capita, socio-economic development, and healthcare systems. But there is another risk, which, unfortunately, is little taken into account. The fact is that the prices for, available to us in open sources, often do not correspond to the domestic prices at which this or that state purchases these. There are some separate agreements with manufacturers, contracts on special terms, etc. And they give completely different external prices so that companies do not dump. The use of external reference prices in our country is likely to lead to initial overpricing.

Internal reference pricing is always replacement prices. Its meaning is in comparing the price with a certain standard, which is accepted as a state or departmental guarantee of reimbursement of the cost of medicines to the patient. The second axis of coordinates here is the status of drugs - is it a generic or an original drug. If Russian drugs are generics, then an external reference comparison with imported analogues is quite suitable for them, but ours should be made cheaper. The principle of price reduction for subsequent products, both imported and ours, should also be applied. In many countries, the price of each subsequent generic is reduced by 5-10%. But there should be an optimal number of them - no more than 5, and not 120 or 200, as we have.

As for original drugs, the main share in their price is the cost of R&D and clinical trials. The question that worries the whole world is whether these costs are real? There is evidence that they are overestimated. Therefore, setting the price for the original drug is always a subject of bargaining. Normal mechanisms can be applied here, which significantly reduce prices. For example, sharing risks or limiting profits, marketing expenses, etc. Being the main buyer here, the state can dictate its terms. Among other things, this encourages companies to look for cost-effective methods.

Danil Blinov, CEO of Pfizer in Russia, Deputy Chairman of the Board of Directors of AIPM:

- The proposed project, in fact, does not contain fundamentally new approaches. The only exception was the control of profitability, which worsens the position of domestic producers and those foreign companies that have localized their production. The pricing methodology for drugs from foreign manufacturers remained almost unchanged, with the exception of the transition from comparing the cost of a drug package to the cost of one.

The industry proposal to move to base the arithmetic average price of the lower segment of the basket did not find support.

The new methodology is designed to solve the problem of minimizing the price of medicines from the Vital and Essential Drugs List, which should help increase the availability of medicines and reduce government spending. But it puts manufacturers in a very strict framework, the production of a number of drugs may become unprofitable, the risk of their exit from the market will increase.

In addition, the procedure for confirming reference prices becomes more complicated, and the registration time increases. As a result, the interests of patients may suffer. In the medium term, the proposed methodology may have a negative impact on the implementation of the Pharma-2020 strategy for the development of the domestic pharmaceutical industry and the localization of production.

Dmitry Efimov, Senior Vice President of AG for Russia, the CIS and Southeast Europe:

- The current methodology does not solve the problems of pricing for . Price adjustments for medicines from the Vital and Essential Drugs List prior to the launch of the co-payment system are only a “tuning” of the existing economic model and do not solve the problems of affordability of medicines, and, moreover, carry high risks for all participants in the process - the regulator, business and patients.

Ekaterina Tsekhmistrova, Head of the Pricing and Pharmacoeconomics Group, Rossiya:

— Changes such as the possibility of an annual increase in the price of drugs by the amount of inflation provided for by the updated pricing methodology for imported drugs are, of course, positive. This is a measure that international pharmaceutical manufacturers have been waiting for for several years. At the same time, a restraining mechanism has been thought out, since growth will be limited to the minimum level of prices in the reference countries.

At the same time, the new provisions of the document erase the differences in approaches to registering prices for imported drugs and drugs in the process of localization - the upper limit of the price is determined by the minimum price from the reference basket. In this regard, the advantages of localization, carried out in stages, in terms of pricing will not be so noticeable.

David Melik-Guseinov, director of the Center for Social Economy:

- The new provisions of the methodology can be interpreted ambiguously. For the regulator itself, whose goal is to curb the rise in drug prices, perhaps some of the innovations will be positive - prices will be under greater control. However, the interests of both business and, most importantly, patients must be taken into account. For business, discomfort is possible due to the decision of the state to interfere in the profitability of the production of medicines.

Such interference can provoke large-scale inspections of pharmaceutical companies by supervisory and law enforcement agencies. But a mandatory declaration of profitability is a figure that can be made such that it will be beneficial to the manufacturer, including all conceivable and unimaginable business costs (for example, marketing costs, etc.).

This norm, in my opinion, is more of a brake than an incentive. But the new technique does not solve the most important question. The patient both paid for medicines and will continue to pay. So far, we have not been ready for a radical change in the pricing system. To do this, it is necessary to register the price not of a package, but of a unit (mg or daily dose) of a medicinal substance. In addition, it is necessary to abandon the mark-up system for distributors and pharmacies and switch to a tariff system.

“We hope that the state will continue the dialogue with the industry, and we will be able to find the best solution to fulfill the main common task, including the new pricing methodology, to provide patients with high-quality, modern and affordable medicines,” summed up the discussion Danil Blinov.

In accordance with paragraph 3 of Regulation No. 865, wholesale and retail markups are set to the actual selling price of the manufacturer, which should be understood as the price (excluding VAT) indicated:

• Russian manufacturer - in the accompanying documentation for the goods;
• by a foreign manufacturer of a medicinal product - in the accompanying documentation for the goods, on the basis of which a cargo customs declaration is issued, taking into account the costs associated with customs clearance of the goods (payment of customs duties and customs clearance fees).

The amount of the amount of wholesale markups to the actual manufacturer's selling price for a medicinal product used by all wholesalers participating in the sale of this medicinal product in the territory of a constituent entity of the Russian Federation should not exceed the corresponding maximum wholesale markup established by the executive authority of this constituent entity of the Russian Federation (clause 4 Regulation No. 865).

The amount of the retail markup to the manufacturer's actual selling price for a medicinal product established by a pharmacy organization, an individual entrepreneur and a medical organization selling medicinal products in the territory of a constituent entity of the Russian Federation should not exceed the corresponding maximum retail markup established by the executive authority of this constituent entity of the Russian Federation 5 of Regulation No. 865).

In order not to exceed the amount of wholesale markups set by trade participants, a protocol for agreeing on prices for the supply of vital and essential drugs is applied in the form approved by Decree of the Government of the Russian Federation dated 08.08.2009 No. 654 “On improving state regulation of prices for vital and essential medicines”.

The sale of medicinal products by a pharmacy organization, an individual entrepreneur and a medical organization is carried out in the presence of the specified protocol (clause 6 of Rules No. 865).

Further, we would like to note that the procedure for calculating the selling price for pharmacies for a medicinal product was previously explained in the joint Letter of Roszdravnadzor dated January 28, 2010 No. 01I-52/10, the Federal Tariff Service of the Russian Federation dated January 29, 2010 No. CH-466/7. In accordance with paragraphs 28, 35 of the said letter, when calculating the selling price for a medicinal product, it should be taken into account that the size of the retail markup to the actual manufacturer's selling price for the drug should not exceed the maximum retail markup established by the executive authority of the relevant subject of the Russian Federation. As noted above, this rule is enshrined in clause 5 of Regulation No. 865.

Retail prices for vital and essential drugs for free sale to the population are formed by adding the actual price of receipt and the established retail markup, calculated from the manufacturer's price.

At the same time, Roszdravnadzor and FTS officials gave the following instructions on pricing, taking into account the pharmacy taxation system .

If wholesale or retail trade organizations apply USNO or UTII, i.e.e. are not a VAT payer, then on the basis of Part 2 of Art. 170 of the Tax Code of the Russian Federation, they can form the selling price for vital drugs by summing up the actual purchase price of the goods with VAT and the wholesale or retail mark-up, which are calculated from the actual selling price of the manufacturer with VAT.

However, as the Supreme Court asserts in Resolution No. 304-AD15-2723 dated June 9, 2015, The current legislation does not make the procedure for setting the selling price for Vital and Essential Drugs dependent on the taxation system used by wholesale trade organizations and (or) pharmacy organizations licensed for pharmaceutical activities. Paragraph 3 of the Rules No.865 states that the manufacturer's actual selling price for a medicinal product is the price (without VAT) indicated by the Russian manufacturer of the medicinal product in the accompanying documentation for the product. In addition to the above, we point out: in the Decision of the Arbitration Court of the Yamalo-Nenets Autonomous District of April 17, 2014 in case No. A81-756 / 2014, it is noted that the Letter of Roszdravnadzor No. 01I-52/10 and the Federal Tariff Service of the Russian Federation No. CH-466/7 is not a regulatory act, therefore, has no legal force, therefore, is not objective evidence for the court. A similar opinion was expressed in the Decree of the Arbitration Court of the WSO dated 03.12.2014 No. F04-11609/2014 in case No. A81-756/2014.

Thus, the pharmacy institution was charged with a violation of classification - as a failure to comply with the procedure for pricing a drug from the Vital and Essential Drugs List. With regard to bringing to administrative responsibility for the imputed violation, the pharmacy organization was held liable under Part 4 of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation in the form of imposing a fine on the organization in the amount of 50 thousand rubles.

The Supreme Court in the above decision noted that on the basis of the provisions of the Federal Law of 04.05.2011 No. 99-FZ “On Licensing Certain Types of Activities”, pharmaceutical activities are licensed. The procedure for licensing pharmaceutical activities is established by the relevant regulation approved by Decree of the Government of the Russian Federation of December 22, 2011 No. 1081 (hereinafter - Regulation No. 1081).

By virtue of this provision, the licensee must comply with the licensing requirements and conditions when carrying out the licensed type of activity. So, in particular, in paras. "d" clause 5 of Regulation No. 1081 establishes that pharmacy organizations engaged in retail trade in medicines must comply with the maximum retail mark-ups to the actual selling prices of manufacturers for medicines included in the Vital and Essential Drugs List. At the same time, clause 6 of Regulation No. 1081 establishes that non-compliance with this requirement refers to gross violations of license requirements and conditions.

On the basis of the above paragraph, as well as other regulations, in particular Rules No. 865, the Supreme Court, in Resolution No. 304-AD15-2723 dated 09.06.2015, ruled that the court of first instance reasonably brought the pharmacy organization to administrative responsibility under part 4 of Art. . 14.1 of the Code of Administrative Offenses of the Russian Federation, imposing a penalty in the form of a fine of 50 thousand rubles. The pharmacy did not agree with this punishment and asked to impose a punishment on her under Part 1 of Art. 14.6 of the Code of Administrative Offenses of the Russian Federation.

For reference:

In accordance with Part 1 of Art. 14.6 of the Code of Administrative Offenses of the Russian Federation, overstatement of state-regulated prices (tariffs, rates, rates, etc.) for products, goods or services entails the imposition of an administrative fine:

• for citizens - in the amount of 5 thousand rubles;
• for officials - in the amount of 50 thousand rubles. (or disqualification for up to three years);
• for legal entities - in the double amount of excessively received proceeds from the sale of goods (work, services) due to unlawful overstatement of state-regulated prices (tariffs, rates, rates, etc.) for the entire period during which the offense was committed, but not more than one of the year.

At the same time, rejecting the organization's arguments about the need to qualify the established offense under Part 1 of Art. 14.6 of the Code of Administrative Offenses of the Russian Federation, the court of first instance indicated the following. In accordance with the notes to Art. 14.1 of the Code of Administrative Offenses of the Russian Federation, which establishes administrative responsibility for carrying out entrepreneurial activities without state registration or without a special permit (license), the concept of gross violation is established by the Government of the Russian Federation in relation to a specific licensed type of activity. Since the supervisory authority has established and confirmed the evidence presented, the violation by the pharmacy of the requirements of paragraphs. "d" clause 5 of Regulation No. 1081, which, by virtue of clause 6 of this provision, is recognized as a gross violation of licensing requirements, an offense committed by the company entails liability established precisely by Part 4 of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation.

Grounds for recognizing the offense committed by the pharmacy as insignificant and releasing it from administrative responsibility in accordance with Art. 2.9 of the Code of Administrative Offenses of the Russian Federation, the courts of all instances did not establish. These conclusions were recognized by the Supreme Court as justified, therefore the complaint of the pharmacy organization was left without satisfaction.

In view of the foregoing, pharmacies should think about the fact that a violation of pricing rules in terms of setting trade markups can lead to negative consequences and be accompanied by administrative penalties from regulatory authorities. Taking into account the opinion of the Supreme Court, expressed in June 2015, the sanction established by Part 4 of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation. Since the Letter of Roszdravnadzor No. 01I-52/10 and the Federal Tariff Service of the Russian Federation No. CH-466/7 is not a normative act, the calculation of retail markups should be carried out on the basis of the manufacturer's actual selling price for the medicinal product (excluding VAT) without taking into account the taxation system used by the pharmacy.

List of vital and essential drugs, approved. Decree of the Government of the Russian Federation of December 30, 2014 No. 2782r.

Federal Law of April 12, 2010 No. 61-FZ “On the circulation of medicines”.

Decree of the Government of the Russian Federation dated October 29, 2010 No. 865 “On State Regulation of Prices for Medicines Included in the List of Vital and Essential Medicines”.

Methodology for determining the maximum wholesale and maximum retail mark-ups by the executive authorities of the constituent entities of the Russian Federation to the actual selling prices of manufacturers for vital and essential medicines, approved. Order of the Federal Tariff Service of the Russian Federation dated December 11, 2009 No. 442-a.

Rules for establishing limits on wholesale and retail mark-ups on actual manufacturers' selling prices for medicines included in the list of vital and essential medicines in the constituent entities of the Russian Federation, approved. Decree of the Government of the Russian Federation dated October 29, 2010 No. 865.