Pricing for essential oils in a pharmacy. Pricing for vital drugs

The current legislation defining the procedure for regulating drug prices is quite confusing and contradictory, despite the efforts of federal and regional legislators. In difficult vicissitudes regulatory documents on regulation of prices for medicines operating at the federal and regional levels, even an experienced lawyer cannot always understand. This clearly 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 Commissions for Licensing of Pharmaceutical Activities at the local level, which will baffle more than one arbitration court.

Today, drug pricing at the federal level is regulated by:

1. Decree of the Government of the Russian Federation dated March 29, 1999 N 347 “On measures state control for prices of medicines" (together with the "Procedure state registration selling prices manufacturers and establishing wholesale and retail markups to manufacturers' selling prices for medicines included in the List of vital and essential medicines and medical products");

2. Decree of the Government of the Russian Federation dated 03/07/95 N 239 “On measures to streamline government regulation prices (tariffs)" (as amended on June 30, 1997);

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

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

5. By 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 by drug manufacturers for drugs included in the list of vital and essential drugs (as amended as of October 8, 2012)”

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

7. By decision of the Department Altai Territory on state regulation of prices and tariffs dated October 17, 2012 No. 132 “On the establishment size limits wholesale markups and maximum retail markups to the actual selling prices established by the manufacturer of medicines for medicines included in the list of vital and essential drugs.

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

Price control for medicines is carried out in accordance with Decree of the Government of the Russian Federation of November 9, 2001 No. 782 “On state regulation of prices for medicines”.

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

State regulation of prices for medicines is carried out through state registration of maximum selling prices of Russian and foreign manufacturing organizations for medicines and the establishment of maximum wholesale and maximum retail markups on the prices of these medicines.

On January 1, 2010, changes to acts of the Government of the Russian Federation on issues related to improving state regulation of prices for vital and essential medicines (hereinafter referred to as VED) came into force. In particular, changes were made to the Decree of the Government of the Russian Federation dated November 9, 2001 No. 782 “On state regulation of drug prices”; Decree of the Government of the Russian Federation dated 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 dated 30.12.2009 No. 1116); in the Regulations on licensing of pharmaceutical activities, approved by Decree of the Government of the Russian Federation dated July 6, 2006 No. 416, - regarding the establishment of new licensing requirements and conditions for the implementation of pharmaceutical activities to comply with the established maximum wholesale and maximum retail markups on prices for vital and essential drugs (violation of these requirements is classified as a gross violation, as a result of which the licensee’s activities may be suspended).

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

Amendments have also been made to the Regulations on licensing the production of medicines, approved by Decree of the Government of the Russian Federation dated July 6, 2006 No. 415, - 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; in the Rules for the import and export of medicines, approved by Decree of the Government of the Russian Federation dated July 16, 2005 No. 438, - regarding 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 the actual prices of imported vital and essential drugs; in the Regulations on the Federal Service for Surveillance in the Sphere of Healthcare 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 drugs; to the Regulations on the Federal Tariff Service, approved by Decree of the Government of the Russian Federation dated 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 involves applying markups to the selling prices of manufacturers, not suppliers. This measure will help avoid the formation of long schemes for promoting drugs from manufacturers to consumers and a multiple increase in prices.

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

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

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

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 "The procedure for state registration of manufacturers' selling prices and the establishment of wholesale and retail markups to selling prices manufacturers' prices for medicines included in the List of vital and essential medicines and medical products" and approved on May 10, 1999 by the First Deputy Minister of Economy of the Russian Federation "Procedure for coordinating manufacturer's selling prices for medicines included in the List of vital and essential medicines and medical products."

Wholesale organizations - importers purchasing goods directly from a foreign manufacturer register prices for drugs from the List of Vital and Essential Drugs 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 will adjust prices in rubles at their next publication, taking into account changes in the foreign currency exchange rate. The registered price for an imported drug consists of the price of a foreign manufacturer on the terms of “delivery without payment of duty” and customs expenses.

There are several important groups included in the List of Vital and Essential Drugs:

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. Drugs affecting the central nervous system

V. Means for the prevention and treatment of infections

VI. Antineoplastic, immunosuppressive and related drugs

VII. Drugs for the treatment of osteoporosis

VIII. Drugs affecting blood

IX. Drugs affecting the cardiovascular system

X. Diagnostic tools

XI. Antiseptics and disinfectants

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

XIII. Hormones and agents affecting the endocrine system

XIV. Drugs for the treatment of kidney and urinary tract diseases

XV. Means for the treatment of ophthalmological diseases, not indicated in other headings

XVI. Drugs affecting the uterus

XVII. Drugs affecting the respiratory system

XVIII. Solutions, electrolytes, acid balance correction agents, nutritional products

XIX. Vitamins and minerals

Formally, from a legal point of view, when setting prices for medicines, the prices for which are subject to state registration, it is the Government List of Vital and Essential Drugs that should be used. However, many local regional acts establishing pricing procedures refer to the local list of vital drugs or 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 wholesale trade organizations 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 final consumer.

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

Until 04/01/2010, the sale of vital and essential drugs that had not passed state price registration was allowed without price approval protocols (RF Government Decree No. 782 of 11/09/2001). At the same time, from January 1, 2010, according to the Regulations on state regulation of prices for vital and essential drugs, Decree of the Government of the Russian Federation No. 782, prices are formed by wholesale trade organizations and pharmacies using wholesale and retail markups to the actual selling prices of manufacturers, not exceeding the registered price, and indicating data on the actual selling price of the manufacturer.

After 04/01/2010, a wholesale organization and (or) a pharmacy did not have the right to sell the remains 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.

Regulatory acts establishing maximum wholesale and retail markups to the actual selling 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 before 03/01/2010. Decisions adopted in the constituent entities of the Russian Federation come into force on the date indicated in the act itself. Until a constituent entity of the Russian Federation adopts a new regulatory act, wholesale and retail trade organizations must apply the wholesale and retail markups previously established in the constituent entity of the Russian Federation to the actual selling prices of vital and essential drugs manufacturers.

Thus, in the Altai Territory, the regulation of pricing of drugs included in the list of vital and essential drugs is regulated by the decision of the Altai Territory Office for State Regulation of Prices and Tariffs dated October 17, 2012 No. 132 “On establishing the maximum amounts of wholesale markups and the maximum sizes of retail markups to actual selling prices, established by the drug manufacturer for drugs included in the list of vital and essential drugs.

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

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 delivery 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 approval protocol, forms a retail price by summing the purchase price of medicines from the wholesaler and the retail markup established in the constituent entity of the Russian Federation, calculated from the actual price of the manufacturer.

Thus, the formation of the selling price for medicines by wholesale trade organizations 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 medicine, the price for which is registered, is entered into the state register of registered maximum selling prices. In this case, the manufacturer is issued a registration certificate.

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

In addition, maximum wholesale and retail markups are established for medicines. Their sizes are approved by acts of executive authorities of the constituent entities of the Russian Federation.

Thus, the pricing system in pharmacy, which must be ensured by law, remains a paramount issue today. An analysis of current legislation and regulations in this area has shown 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 has been weakened.

UDC 338.517

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

M.O. Olkhovskaya

I.I. Maruschak

Pricing systems for medicines in Russia and abroad

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

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

Email: [email protected]

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

Key words: pricing, medicines, generics, maximum prices, reference prices, profit control, List of vital and essential medicines.

Currently, almost every developed country has a national drug pricing system or a pricing procedure for an entire 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 have a positive effect on the volume of production of new medicines. In Russia, achieving a balance of interests between the state and businesses in the pharmaceutical industry is complicated by the different goals pursued by the parties.

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

In addition, the following factor must be taken into account: there is a group of countries with fierce competition in the market of generics2 (India), innovative drugs and analogue drugs (USA, EU member countries), which determines the development of the 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 too high, it will be quite difficult to regain consumer loyalty. However, in order to reduce the risk of inflated prices for innovative medicines, governments of various countries may refuse to register them. These countries include Portugal, Austria, Switzerland, Greece, Finland, Argentina and Turkey3.

Currently, four main approaches to pricing and determining the reimbursable cost of medicines have been formed:

Limit prices;

Reference prices;

Profit control;

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

Generic is a medicine sold under an international nonproprietary name or under a proprietary name that differs from the brand name of the drug developer.

3 Melik-Guseinov D.V. Information from government 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 (access date: 07.17.2011)

Approach based on the benefits of drugs (pricing based on the advantages of a particular drug relative to others)1.

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

Table 1

Countries that use registration of maximum (maximum) prices for drugs that are (In-patent) and not (Off-patent) under patent protection2

Taking into account 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 disadvantage 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 receiving the necessary medicine on the market of countries with an existing mechanism. And, indeed, predominantly the latest medical developments come from the USA, Great Britain and Germany.

Let's consider the second approach to drug pricing - reference pricing.

Most 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 feasible level of reimbursement for each group of medicines included in the list of reimbursable drugs (from reimbursement - reimbursement of the cost of medicines). And, secondly, to increase the number of citizens, primarily low-income and socially vulnerable, 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 retail trade in Germany, the income of firms producing patented drugs in the UK) or drug 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 does regulate prices.

The essence of the method is that pricing set by producers is considered free as long as producers do not exceed the maximum profit ratio. Thus, prices are regulated indirectly - through an agreement on the amount of profits received. In this case, the company's profit level 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 sales revenue5.

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

Polyakova D. Reference pricing: side effects [Electronic resource] // Pharmacies online 03.24.2008. Access mode: http://www.apteka.ua/article/6385 (date of access: 04/27/2011)

3 About reference pricing on the Ukrainian pharmaceutical market first-hand: Interview with A. Solovyov and V. Bortnitsky [Electronic resource] // Apteka.online.ua. 04/09/2012. No. 835 (14). Access mode: http://www.apteka.ua/article/136717 (date of access: 07/20/2011).

4 Telnova E.A. Pricing: foreign experience // Pharmacoeconomics. 2009. T. 2. No. 4. P. 24.

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

Looking 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 product portfolio, and the margin that can be set for one company will not be sufficient for another.

table 2

Application of reference prices in various countries1

Country Availability of SR Scope of application Basis for calculating the reference price Method of calculating the reference price and reference countries

Austria + Reimbursable2 medicines Manufacturer prices (for individual countries - wholesale prices) The reference price is calculated as the average price in all EU member countries, with the exception of Romania and Bulgaria

Belgium + All medicines Manufacturer prices Comparison is carried out with all EU member countries

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

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

Italy + Reimbursable medicines Manufacturer prices The reference price is calculated as the average price in reference countries (not defined), the HR is used as additional information during negotiations on the cost of the drug with the manufacturer

Latvia + Reimbursable medicines Manufacturer prices Reference price is calculated as the third lowest price in the EU countries

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

Portugal + Prescription and reimbursable over-the-counter (excluding generics) medicines Manufacturer prices, end-use prices Reference price is calculated as the average of prices in the following countries: Greece, Spain, France, Italy

France + Innovative medicines Manufacturer prices Comparison is carried out with the prices of the manufacturing company in the following countries: Germany, Spain, Italy and the UK

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

The Indian Government has proposed introducing a new approach to regulating the cost of medicines, in particular limiting the cost of drugs under patent protection to the level determined using an external reference pricing system adjusted for GDP from

How does the reference pricing system work? [Electronic resource] // Pharmacy.opNpe.ia 2012. February 27, No. 8 (829). Access mode: http://www.apteka.ua/article/126957 (date of access: 04/30/2012).

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

per capita calculation. In this case, the UK, Canada, France, Australia and New Zealand were chosen as reference countries. It is proposed to calculate the maximum 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 approximately 2170 dollars. Moreover, the per capita GDP in these countries is more than 10 times higher than in India. Thus, the maximum cost of this drug in India, according to the government’s proposal, should be the same number of times lower than in Australia and France, and be approximately 1011 thousand rupees ($185-209), which is almost 3 times less compared to its current value.

Brazil has a strict system of regulating drug prices: when a drug is registered with the Ministry of Health, its price is officially recorded. The process of assessing medical technologies is becoming increasingly stringent (at the end of 2008, of the proposed prices for drugs, only 15% were approved, the rest were proposed to be reduced). Moreover, internal committees for assessing medical technologies, using federal legislation on NTA as a model, are also being created in private insurance systems. The national list of expensive drugs in Brazil includes 106 drugs for the treatment of 87 nosologies1.

Strict price controls in China apply only to drugs reimbursed by government funds. The list of such drugs includes from 1500 to 2000 items. On average, 500-1000 of them are traditional Chinese medicine, and 1000 are pharmaceutical products of two categories: A (cheap generics) and B (innovative drugs). 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, China's economic achievements are not helping to improve the healthcare 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 sets a goal to increase this figure to 100% by 2010, which is highly unlikely. At the same time, there has been a gigantic increase in healthcare costs (for 15 years they have increased annually by 10-15%). Payments are charged not only for services, but also for visiting a doctor; the share of expenses out of the patient’s pocket reaches 60%. A characteristic shortcoming of Chinese healthcare is the inequality between urban and rural populations.

A separate block is an analysis of pricing for innovative medicines, which shows that prices for fundamentally new drugs subject to reimbursement in most countries studied are determined in accordance with international trade prices. At the same time, in France their effectiveness is also taken into account, in Sweden - social prospects, in Belgium - the prices of drugs in the EEC countries, in Japan - the level of production costs and the origin of drugs, in China - whether a drug is a patented drug or not. In countries such as Germany and the USA, innovative drugs are subject to free pricing. In the UK, free pricing also applies, but within the limits of the firm’s established income2.

The above approaches to pricing 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 analogues will not exist for a certain period of time. Of course, this gives rise to speculation on drugs on the part of manufacturers, who initially set inflated prices that are difficult to verify, but, on the other hand, the number of dangerous pathologies is growing every year and the lives of citizens may depend on the timing of the drug’s introduction to the market.

Currently, our country uses the List of vital and essential medicines, approved by Order of the Government of the Russian Federation of December 30, 2009 No. 2135-r (hereinafter referred to as List No. 2135-r), the pricing for which can be openly viewed.

For all drugs that are listed in List No. 2135-r, the price is regulated by the state, while prices for medicines of both domestic and imported origin are subject to state registration. The medicine, the price for which is registered, is entered into 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 establish maximum wholesale and retail markups for medicines:

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 invoices, etc.), and of a 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 registration of the cargo customs declaration;

1 Here: classification and nomenclature of diseases (in modern medical literature the concept of “nosological approach” is usually used, i.e. the desire of clinicians and representatives of theoretical medicine to identify 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 December 11. 09 “On approval of the methodology for determining by the executive authorities of the constituent entities of the Russian Federation 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).

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 presenting data on the size of the maximum wholesale and retail markups established in the constituent entities of the Russian Federation on prices for 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 rub. inclusive;

Over 500 rub.

Table 3

Maximum wholesale and maximum retail markups to the actual selling price (excluding VAT)1

Surcharges Actual selling price of the manufacturer Maximum markup, %

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

Over 50 rub. up to 500 rub. inclusive 15

Over 500 rub. 10

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

Over 50 rub. up to 500 rub. inclusive 28

Over 500 rub. 15

The actual selling price of the manufacturer means the price (excluding value added tax) indicated by the Russian manufacturer of the medicinal product in the accompanying documentation for the goods (in invoices and the like), and by the foreign manufacturer of the medicinal product in the accompanying documentation for the goods (in the invoice and the like). etc.), on the basis of which a cargo customs declaration is drawn up, taking into account the costs associated with customs clearance of cargo (customs duties and fees for customs clearance), 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 applies2.

A wholesale organization received Corvalol drops from another organization at a price of 10.5 rubles. for packaging, taking into account a trade markup of 5%. The price from the manufacturer is 10.2 rubles.

We will calculate the maximum wholesale price.

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

The LLC Zdorovye pharmacy, located in Moscow, received three percent hydrogen peroxide from a wholesale organization at a price of 5 rubles. Let's calculate the maximum retail price for a pharmacy for this medicine.

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 drugs are included in List No. 2135.

Together with the invoices, the pharmacy was given protocols for agreeing prices for medicines. According to these protocols, the price for state registration of one package of Corvalol drops is 15 rubles, one package of the drug Retinol is 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 of December 11, 2009 “On approval of the methodology for determining by executive authorities of the constituent entities of the Russian Federation maximum wholesale and maximum retail markups to the actual selling prices of manufacturers for vital and essential medicines” provides clear instructions on pricing for each of pharmaceutical market participants. However, in practice, the consumer still did not experience an effective reduction in drug prices.

A number of experts believe that the list of vital drugs is not initially perfect, since specialists cannot afford to add expensive drugs to it - the state is simply not able to afford this. Therefore, the list primarily includes domestic and cheap imported drugs3.

It is for this reason that doctors often prescribe not the most effective medicine, but the cheapest one 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, medicines and healthcare (based on the Panos Institute (London) report “Patents, medicines and healthcare”, December 2002) [Electronic resource] // RMS-Expo: medical exhibitions and conferences. Access mode: http://expo.rusmedserv.com/articli.html (access date: 11/10/2012)..

They are subject to state control over pricing in the Russian Federation.

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

According to the authors, it is necessary for all market entities to transition to pricing based on reference prices. This may make it possible to reduce prices for a number of goods that have analogues abroad, and to control prices at all levels from the manufacturing company to the retailer. However, in order to most accurately establish the price of a drug according to reference pricing, it is advisable to follow the Indian experience: compare prices for drugs abroad and set an adjustment taking into account 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 analogue drugs and innovative drugs).

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

LITERATURE

1. Order No. 442-a dated December 11, 2009 “On approval of the methodology for determining the subjects of

Russian Federation of 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).

2. How does the reference pricing system work? [Electronic resource] // Pharmacy.opNpe.ia 2012. February 27. No. 8

(829). Access mode: http://www.apteka.ua/article/126957 (date of access: 04/30/2012).

3. Medical goods and services. Pricing for medicines, taking into account recent changes // Law-

vaya 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 government authorities. Federal Antimonopoly Service of the Russian Federation:

Analytical note on the development of options for reference pricing approaches for drugs included in the group of vital and essential drugs [Electronic resource]. 10/21/2011. Access mode: http://farm.lobbying.ru/gosinfo.php?id=110 (access date: 07.17.2011)

5. About reference pricing on the Ukrainian pharmaceutical market first-hand: Interview with A. Solovyov and V. Bortnits-

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

http://www.apteka.ua/article/136717 (date of access: 07/20/2011).

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

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

7. Polyakova D. Reference pricing: side effects [Electronic resource] // Apteka.online.ua 03/24/2008.

Access mode: http://www.apteka.ua/article/6385 (date of access: 04/27/2011)

8. Telnova E.A. Pricing: foreign experience // Pharmacoeconomics. 2009. T. 2. No. 4. P. 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.

16. Ruggeri K., Nolte E. “Pharmaceutical Pricing. The Use of External Reference Pricing.” Rand Research Reports RR-240. RAND

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

Quoting according to GOST R 7.0.11-2011:

Marushchak, I. I., Olkhovskaya, M. O. Pricing systems for medicines in Russia and abroad // Space and Time. - 2013. - No. 4(14). - pp. 44-49.

Prices used in the pharmaceutical market.

Depending on the nature of the serviced turnover, the following are distinguished:

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

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

Retail prices are the final prices for goods at which the population purchases them.

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

• 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 constituent entities of the Russian Federation, local government bodies). With regard to regulated prices, the listed government authorities establish conditions limiting their level (VED, etc.).

State expenditures on providing care for inpatients and maternity leave groups of the population increase every year.

• with an increase in morbidity among the population;
• with the introduction of new technologies;
• increasing the number of doctors;
• an increase in the proportion of elderly people;
• increasing patient demands on the healthcare system.

Therefore, the task of our government in the field of pricing of medicines is to control government spending on medicines, 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 in the pharmaceutical market.

The free price system also includes selling, wholesale and retail prices.

When pricing drugs, the following are used:

• free selling price of the manufacturer;
• free wholesale (selling) price for medicines and medical products purchased at the expense of own foreign currency funds;
• free wholesale price of an intermediary;
• contract price (stipulated in the contract);
• estimated price for medicines and medical products purchased at the expense of own foreign currency funds;
• free retail price.

The free selling price of the manufacturing enterprise is set by the manufacturing enterprise based on cost, market conditions, product quality, etc. Selling prices, in accordance with current legislation, include some taxes and fees.

Free wholesale (selling) prices for medicines purchased abroad at the expense of their own foreign currency are established by organizations purchasing imported medicines for subsequent sale to all wholesale consumers. This price is formed based on the calculated price, which takes into account the contract price of the goods, various customs duties, storage costs and others, as well as market conditions, quality products and current prices for similar goods on 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 (demand and supply), the current level of prices for similar domestic and imported goods. The intermediary's markup is determined by agreement and documented in a price agreement protocol.

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

In accordance with clause 3 of Rules 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:

• by the Russian manufacturer - in the accompanying documentation for the product;
• 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 drawn up, taking into account the costs associated with customs clearance of the cargo (payment of customs duties and fees for customs clearance).

The amount of wholesale markups to the manufacturer's actual selling price for a medicinal product, applied by all wholesale trade organizations involved in the sale of this medicinal product on the territory of a constituent entity of the Russian Federation, should not exceed the corresponding maximum amount of the wholesale markup established by the executive authority of the given constituent entity of the Russian Federation (clause 4 Rule No. 865).

The amount of the retail markup to the actual selling price of the manufacturer for a medicinal product established by a pharmacy organization, individual entrepreneur and medical organization that sells medicinal products on the territory of a constituent entity of the Russian Federation must not exceed the corresponding maximum retail markup established by the executive authority of that constituent entity of the Russian Federation (clause 5 of Regulation No. 865).

In order not to exceed the size of wholesale markups established by trading participants, a protocol is used to agree on prices for the supply of vital and essential drugs in the form approved by Decree of the Government of the Russian Federation of 08.08.2009 No. 654 “On improving state regulation of prices for vital and essential medicines.”

The sale of medicines 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 sales price for pharmacies for a drug was previously explained in the joint Letter of Roszdravnadzor dated January 28, 2010 No. 01I-52/10, FST of the Russian Federation dated January 29, 2010 No. SN-466/7. In accordance with paragraphs 28, 35 of the said letter, when calculating the sales price of a medicinal product, it should be taken into account that the amount of the retail markup to the actual selling price of the manufacturer for the medicinal product should not exceed the maximum amount of the retail markup established by the executive authority of the relevant constituent entity of the Russian Federation. As noted above, this norm is enshrined in clause 5 of Rules No. 865.

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

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

If wholesale or retail trade organizations use the simplified tax system 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 and essential drugs by summing the actual purchase price of the goods including VAT and the wholesale or retail markup, which are calculated from the actual selling price of the manufacturer including VAT.

Traditional tax system: pharmacy is a VAT payer

USNO, special regime in the form of UTII: pharmacy is not a VAT payer

Manufacturer price without VAT: 100 rub. (with VAT – 110 rub.) Wholesale markup (20% of the manufacturer's price excluding VAT): 100 rubles. x 20% = 20 rub. Selling price for a wholesale organization without VAT: (100 + 20) rub. = 120 rub. Retail markup (40% of the manufacturer's price excluding VAT): 100 rubles. x 40% = 40 rub. Retail price of the pharmacy without VAT: (120 + 40) rub. = 160 rub. Pharmacy retail price with VAT: 160 rub. x 1.1 = 176 rub.

Manufacturer price including VAT: (100 + 10) rub. = 110 rub. Selling price for a wholesale organization including VAT (surcharge - 20%): 110 rubles. x 1.2 = 132 rub. Pharmacy retail markup (40% of the manufacturer's price including VAT): 110 rubles. x 40% = 44 rub. Pharmacy retail price excluding VAT: (132 + 44) rub. = 176 rub.

However, as stated by the Supreme Court in Resolution No. 304-AD15-2723 dated 06/09/2015, The current legislation does not make the procedure for setting the selling price for vital and essential drugs dependent on the taxation system applied by wholesale trade organizations and (or) pharmacy organizations that have a license for pharmaceutical activities. Clause 3 of Rules No.865 establishes that the manufacturer’s actual selling price for a medicinal product means the price (excluding 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 dated 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. SN-466/7 is not normative legal act, therefore has no legal force, therefore, is not objective evidence for the court. A similar opinion was expressed in the Resolution of the Arbitration Court of the ZSO dated December 3, 2014 No. F04-11609/2014 in case No. A81-756/2014.

Thus, the pharmacy establishment was charged with a classification violation - as failure to comply with the procedure for setting the price for a drug from the Vital and Essential Drugs List. As for bringing to administrative responsibility for the alleged violation, the pharmacy organization was held accountable 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, based on the provisions of the Federal Law of May 4, 2011 No. 99-FZ “On licensing of 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 referred to as Regulation No. 1081).

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

Based on the above paragraph, as well as other regulations, in particular Rules No. 865, the Supreme Court, in Resolution No. 304-AD15-2723 dated 06/09/2015, ruled that the court of first instance justifiably brought the pharmacy organization to administrative liability under Part 4 of Art. . 14.1 of the Code of Administrative Offenses of the Russian Federation, imposing punishment in the form of a fine in the amount of 50 thousand rubles. The pharmacy did not agree with this punishment and asked to assign her a punishment under Part 1 of Art. 14.6 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, inflating 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 double the amount of excess revenue received from the sale of goods (work, services) due to unlawful inflation 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 liability for carrying out business activities without state registration or without a special permit (license), the concept of a gross violation is established by the Government of the Russian Federation in relation to a specific licensed type of activity. Since the control body has established and confirmed by the evidence presented a violation by the pharmacy of the requirements of paragraphs. “g” 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 Code of Administrative Offenses of the Russian Federation.

Grounds for recognizing the offense committed by the pharmacy as insignificant and releasing it from administrative liability in accordance with Art. 2.9 of the Code of Administrative Offenses of the Russian Federation was not established by the courts of all instances. These conclusions were recognized by the Supreme Court as justified, therefore the complaint of the pharmacy organization was left unsatisfied.

Taking into account the above, pharmacies should think about the fact that violation of pricing rules in terms of establishing 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 Code of Administrative Offenses of the Russian Federation. Since Roszdravnadzor Letter No. 01I-52/10 and the Federal Tariff Service of the Russian Federation No. SN-466/7 is not a regulatory act, the calculation of retail trade markups should be based on the manufacturer’s actual selling price for the drug (excluding VAT) without taking into account the taxation system used by the pharmacy.

List of vital and essential medications, approved. By Order of the Government of the Russian Federation dated 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 markups to the actual selling prices of manufacturers for vital and essential medicines by executive authorities of the constituent entities of the Russian Federation, approved. By Order of the Federal Tariff Service of the Russian Federation dated December 11, 2009 No. 442-a.

Rules for establishing the maximum amounts of wholesale and maximum amounts of retail markups to the actual selling prices of manufacturers for medicinal products included in the list of vital and essential medicinal products in the constituent entities of the Russian Federation, approved. Decree of the Government of the Russian Federation dated October 29, 2010 No. 865.

On October 27, 2015, a letter was posted on the website of the Department for State Tariff Regulation to clarify the methodology for calculating the procedure for forming the selling price of vital and essential drugs, which states that to calculate the retail price for vital medicines, it is necessary to use the manufacturer’s price excluding VAT. The full text of the letter with examples of calculations is given below.

The Pharm-Inspector program supports the calculation of the retail price for vital and essential drugs both from the manufacturer’s price without VAT and from the manufacturer’s price with VAT. To switch to the new markup formula for live goods, just select the desired markup scheme from the list. To do this, click on the button in the invoice prices. A window with settings for calculating prices will appear.

Using the manufacturer's price excluding VAT instead of the manufacturer's price with VAT when calculating prices for essential medicines will result in a reduction in the final retail price of approximately 4 - 5%.

Application. Text of the letter from the Department for State Regulation of Tariffs on clarifying the methodology for calculating the formation procedure

To the heads of wholesale and retail trade organizations selling medicines in the Voronezh region

On clarifying the methodology for calculating the procedure for forming the selling price of vital and essential drugs

In connection with the clarification by the Federal Antimonopoly Service of Russia of the methodology for calculating the procedure for forming the selling price of vital and essential drugs, the department for state regulation of tariffs of the Voronezh region brings to the attention of the heads of wholesale and retail trade organizations selling medicines in the Voronezh region the following information.

Currently, the current legislation does not provide for differentiation in the procedure for setting selling prices for medicines included in the list of vital and essential drugs, depending on the tax regimes used by organizations of wholesale and retail trade in medicines. The current Rules for establishing the maximum amounts of wholesale and maximum amounts of retail markups to the actual selling prices of manufacturers for medicines included in the list of vital and essential drugs in the approved constituent entities of the Russian Federation (hereinafter referred to as the Rules) provide for the calculation of wholesale and (or) retail markups to the actual selling price of the manufacturer for vital and essential drugs without value added tax (hereinafter - VAT).

In this regard, the Federal Antimonopoly Service of Russia believes that wholesale trade organizations and retail trade organizations that are on the general taxation system (that is, VAT payers) need to formulate the selling price for vital and essential drugs by summing up the purchase price of vital and essential drugs without VAT (if the supplier of vital and essential drugs is a payer UTII or is on the simplified tax system, that is, is not a VAT payer, the actual purchase price of vital and essential drugs from such a supplier), a premium (the amount of which does not exceed the maximum amount of the wholesale or retail premium established in the constituent entity of the Russian Federation for a given price group), calculated from the actual selling price manufacturer's prices excluding VAT, and value added tax calculated from the amount obtained by adding the above purchase price and surcharge.

Wholesale trade organizations and retail trade organizations that are on the simplified tax system or are UTII payers need to formulate the selling price for vital and essential drugs by summing up the purchase price of vital and essential drugs from the supplier (the actual expenses of the organization for the purchase of vital and essential drugs, regardless of the taxation regime applied by the supplier) and the markup (the amount of which does not exceed the maximum amount of the wholesale or retail markup established in the constituent entity of the Russian Federation for a given price group), calculated from the actual selling price of the manufacturer without VAT.

Examples of how wholesale and retail trade organizations formulate selling prices for vital and essential drugs, depending on the applicable taxation system, are given in the appendix to this letter.

Application. The procedure for the formation by wholesale and retail trade organizations of the selling price for vital and essential drugs, depending on the applied taxation system

Example 1. A wholesale trade organization purchases Vital and Essential Drugs from a Vital and Essential Drugs manufacturer.

	Manufacturer's actual selling price		Taxation regime for wholesale trade organizations	Amount of applied wholesale markup, %	Amount of applied wholesale markup, rub.		Selling price for organizing wholesale trade on the general taxation system without VAT, rub.	VAT accrued by a wholesale trade organization, rub.	Selling price for organizing wholesale trade on the general taxation system including VAT, rub.	Selling price for organizing wholesale trade on the simplified tax system or UTII, rub.
			general taxation system		150*13/100= 19,50		150+19,50= 169,50	169,50*10/100= 16,95	150+19,5+ 16,95=186,45		186,45-165-16,95+15= 19,50
			UTII or simplified tax system		150*13/100= 19,50					165+19,50=184,50	184,50-165=19,50

Example 2. A retail trade organization that is on the general taxation system purchases vital and essential drugs from a wholesale organization that is on the general taxation system and has applied a maximum wholesale markup of 13%.

							Input VAT, rub. (will be accepted for deduction)				Supplement received after payment and deduction of VAT, rub.
			150*25/ 100=37,50				186,45-169,50=16,95	169,50+37,50=207,00	207,00*10/100=20,70	207,00+20,70= 227,70	227,70-186,45-20,70+16,95= 37,50

Example 3. A retail trade organization that is on the general taxation system purchases vital and essential drugs from a wholesale organization that is on the simplified tax system or is a UTII payer and has applied a maximum wholesale markup of 13%.

without VAT		Amount of applied retail markup, %	Amount of applied retail markup, rub.	Purchase price of vital and essential drugs from a supplier subject to the general taxation system, rub. without VAT	Purchase price of vital and essential drugs from a supplier subject to the general taxation system, rub. VAT included	Purchase price from a supplier who pays UTII or is on the simplified tax system, rub.	Input VAT, rub. (will be accepted for deduction)	Without VAT	VAT accrued by a retail trade organization, rub.	Selling price of a retail trade organization including VAT, rub.	Supplement received after payment and deduction of VAT, rub.
			150*25/ 100=37,50					184,50+37,50=222,00	222,00*10/100= 22,20	222,00+22,20=244,20	244,20-184,50-22,20=37,50

Example 4. A retail trade organization that is on the simplified taxation system or is a UTII payer purchases vital and essential drugs from a wholesale organization that is on the general taxation system and has applied a maximum wholesale markup of 13%.

Manufacturer's actual selling price, rub.		Amount of applied retail markup, %	Amount of applied retail markup, rub.	Purchase price of vital and essential drugs from a supplier subject to the general taxation system, rub. VAT included	Purchase price from a supplier who pays UTII or is on the simplified tax system, rub.	Selling price for retail trade organization, rub.
			150*25/100=37,50			186,45+37,50= 223,95	223,95-186,45=37,50

Example 5. A retail trade organization that is on the simplified tax system or is a UTII payer purchases vital and essential drugs from O a wholesale organization that is on the simplified tax system or is a payer of UTII, and has applied a maximum wholesale markup of 13%.

Manufacturer's actual selling price, rub.		Amount of applied retail markup, %	Amount of applied retail markup, rub.	Purchase price of vital and essential drugs from a supplier subject to the general taxation system, rub. VAT included	Purchase price from a supplier who pays UTII or is on the simplified tax system, rub.	Selling price for retail trade organization, rub.	Retail trade organization allowance, rub.
			150*25/100=37,50			184,50+37,50= 222,00	222,00-184,50=37,50