Pricing for zhnvlp. Pricing on the drug market On clarification of the methodology for calculating the procedure for the formation of the selling price of vital and essential drugs

Freedom of economic activity guaranteed by art. 8 of the Constitution of the Russian Federation, implies and. Restriction of freedom of the manufacturer (seller) in this issue should not only pursue very specific economic and social goals, but should be clothed in an appropriate legal form.

The legal basis is laid down in paragraph 1 of Art. 424 of the Civil Code of the Russian Federation (CC RF), which states that in cases provided for by law, prices are applied that are set or regulated by authorized state bodies. In other cases, the price should be set by agreement of the parties, which is a reflection the principle of freedom of pricing.

Currently, Decree of the Government of the Russian Federation dated November 9, 2001 No. 782 “On state regulation of prices for medicines» state regulation of prices has been established according to the List of Vital and Essential Medicines (VED), periodically approved by the Government of the Russian Federation.

To the greatest extent, state control affects Russian pharmaceutical companies. For them, in addition to registering the price of vital and essential drugs, the state regulates the methodology for attributing costs to prime cost. So, for example, only 5% of marketing costs can be attributed to the cost of production, and the remaining 95% are covered from profits.

Thus, at present price of medicines is formed from the price of the manufacturer, the supply and marketing allowance of wholesale structures and the trade allowance of the pharmacy.

Executive authorities of subjects Russian Federation based local features in order to ensure the normal functioning of the pharmacy network enterprises, the maximum amounts of trade mark-ups to the prices of medicines and medical products of domestic and foreign production are established. The established limits of trade markups apply to all retail and wholesale pharmaceutical enterprises, regardless of their form of ownership. The marginal size of the trade margin is most often set to the free selling prices of manufacturers or the first suppliers of imported drugs, as a rule, regardless of the number of intermediaries. The marginal allowances of the wholesale market are lower than the retail ones. They make up 10-25%.

The results of price monitoring conducted by Roszdravnadzor showed that their increase during the crisis was largely influenced by the imperfection of the existing pricing system, which needs to be corrected long ago. Since 2009, intensive work has been carried out to introduce changes to the existing pricing procedure. The main differences of the new pricing system are presented in the table.

Table 1. Changes in the pricing system

Changes in drug pricing should also affect the price registration system. If earlier the price was registered at the request of the manufacturer, then with the release of the new resolution, price registration will be mandatory.

The changes will also affect the system of formation of trade allowances. When they are formed and registered, the new system will make it possible to get away from subjectivism and a personal approach. It is planned to use methodological guidelines with a unified approach to the formation of trade allowances in the regions and guidelines by definition selling prices manufacturer for vital drugs. New system will change the procedure for applying marginal wholesale and marginal retail markups to the prices of medicines included in the Vital and Essential Drugs.

The executive authorities of the constituent entities of the Russian Federation set the maximum wholesale and maximum retail mark-ups on the actual selling prices of manufacturers in accordance with the methodology approved by the FTS of Russia. Currently, work is underway to implement Decree of the Government of the Russian Federation dated 08.08.2009 No. 654 “On improving state regulation of prices for medicines included in the list of vital and essential medicines”.

In the meantime, medicines are supplied to the territory of the Russian Federation in some cases at higher prices than to other countries. This is due to the lack of transparency in the procedures for determining the list of essential drugs, which, due to their high cost, are financed from the state budget, as well as the lack of logistical and financial plans and reliable legal regulation of the drug supply process. Therefore, drug manufacturers cannot draw up long-term plans and optimize the drug production process, which leads to an increase in their cost for the Russian market.

The increase in the selling price is also due to the lack of guaranteed payments for deliveries on credit and the long credit period associated with the established regulation of payment for government contracts from the budget of the Russian Federation. Therefore, selling prices take into account the risks and the cost of working capital pledged by companies to refinance the supply of medicines.

Leading foreign manufacturers are becoming more and more specialized. The list of potential suppliers is determined at the stage of compiling the list of essential medicines and adopting medical standards. Competition between manufacturers plays an insignificant role in regulating the final prices at which medicines are purchased by the Russian budget.

And if in relation to distributors and retailers the state has the opportunity to carry out price regulation, to introduce profitability norms for the supply and sale of medicines within the framework of state programs, then there is no such possibility with respect to producer prices. The main regulatory mechanism should be market competition, but this mechanism does not work for a number of reasons. One of these reasons is the lack of activities to calculate the profitability of medicines. Another is the lack of high-tech industries in the country. Therefore, Russia is increasingly becoming a springboard for the competition of unique foreign-made medicines.

On October 27, 2015, a letter was posted on the website of the department for state regulation of tariffs to clarify the methodology for calculating the procedure for forming a vacation pay Vital and Essential Drugs prices, which states that the manufacturer's price without VAT must be used to calculate the retail price for essential medicines. The full text of the letter with examples of calculations is given below.

The Farm-Auditor 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 a new LH markup formula, just select the desired markup scheme from the list. To do this, in the incoming invoice, click on the button prices. A window with pricing settings will appear.

Using the manufacturer's price without VAT instead of the manufacturer's price with VAT when calculating the prices of vital medicines will reduce the final retail price by about 4 - 5%.

Application. The text of the letter from the department for state regulation of tariffs on clarifying the methodology for calculating the formation procedure

Heads of wholesale and retail trade organizations that sell medicines in the Voronezh Region

On the refinement of the methodology for calculating the procedure for the formation of the selling price of vital and essential drugs

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

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

In this regard, the FAS Russia considers that wholesale trade organizations and retail trade organizations that are on the general taxation system (that is, they are VAT payers) need to form 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, it is not a VAT payer, the actual purchase price of VED from such a supplier), a surcharge (the amount of which does not exceed the maximum wholesale or retail surcharge established in the constituent entity of the Russian Federation for this price group), calculated from the actual selling price manufacturer's prices without 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 form the selling price for vital and essential drugs by summing up the purchase price of vital and essential drugs from the supplier (the organization's actual expenses for the purchase of vital and essential drugs, regardless of the taxation regime applied by the supplier) and the surcharge (the amount of which does not exceed the limit of the wholesale or retail mark-up established in the subject of the Russian Federation for this price group), calculated from the actual selling price of the manufacturer without VAT.

Examples of the formation by wholesale and retail trade organizations of selling prices for vital and essential drugs, depending on the applicable taxation system, are given in the annex 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 applicable taxation system

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

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 the maximum wholesale markup of 13%.

Example 3. A retail 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 the maximum wholesale markup of 13%.

Example 4. A retail trade organization that is on the simplified tax 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 the maximum wholesale markup of 13%.

Example 5 about a wholesale organization that is on the simplified tax system or is a UTII payer and has applied the maximum wholesale markup of 13%.

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 products medical purpose acquired 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 established 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).

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

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 by Manufacturers of Medicinal Products the Maximum Selling Prices for Medicinal Products Included in the List of Vital and Essential Medicines (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 the establishment of maximum wholesale markups and maximum retail markups 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 markups 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 following was approved: a list of medicinal products for medical use, including medicinal products for medical use, prescribed by decision of medical commissions of medical organizations; 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 medicines needed to provide medical care. It has been established that until March 1, 2015, the list of vital and essential drugs for 2012, approved by Decree of the Government of the Russian Federation of December 7, 2011 N 2199-r, is applied.

Amendments 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 assortment 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 items, 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 on 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 (ZHNVLS) 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 make up 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. Agents 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 vital and 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 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 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 vital and 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, the sale of vital and essential drugs that did not pass the state price registration was allowed 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 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 establishment 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-works 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 vital and essential drugs is regulated by the decision of the Altai Territory Administration 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 subject 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 subject 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 drug provision of funds, and the role of state bodies in this regard is weakened.

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