Pricing for medicines. What is the threat to the pharmacy of the overpricing of the drug from the list of vital drugs? application

Vital and essential medications (VED) - a list of drugs approved by the Government Russian Federation for the purpose of state regulation of prices for medicines.

The VED list contains a list of medicines under international non-proprietary names and covers almost all types of medical care provided to citizens of the Russian Federation under state guarantees.

Since 2012, the List of Vital and Essential Drugs approved by the Order of the Government of the Russian Federation dated December 7, 2011 No. 2199-r has been in effect.

In 2013, according to Order No. 1378-r dated 30.07.2012, the list remained unchanged.

List of vital and essential drugs for 2015

The Russian Ministry of Health has compiled a list of vital and essential medicines (VED) for 2015. In the near future, the Russian government will have to approve it.

"The principled position of the Ministry of Health: the list of vital and essential drugs is not reduced. On the contrary, it has been supplemented with a number of drugs," said Andrei Gaiderov, head of the profile department of the Ministry of Health of Russia. efficiency, based on a two-tier expertise and involving a wide range of experts. "

At the same time, all the debates of the experts, and this was also the first time, were held absolutely openly: to the extent that the meetings of the Ministry of Health commission were broadcast over the Internet online. The commission included not only the most respected medical practitioners, but also representatives of the patient communities.

As a result, the government will have to approve four drug list... The VED List is a basic document. It includes medicines, the prices of which are regulated by the state. It is clear that in the context of economic instability and the jumping exchange rate of the ruble against the euro and the dollar, it is the registration of maximum selling prices by drug manufacturers that can protect us from a sharp rise in prices. This list has been seriously updated, and in the direction of expansion.

"We removed only two positions from it, - activated carbon, as well as one of the hormonal contraceptives, which can hardly be attributed to life-saving drugs, - explained Andrei Gaiderov. “At the same time, for the first time, a number of expensive drugs for the treatment of orphan and life-threatening diseases have been included in the VED list”.

"This is a very important step, since, on the one hand, prices for all essential medicines are registered and controlled by the state. On the other hand, the inclusion of a specific drug in this list indicates that the state guarantees its purchase. That is, some expensive drugs will become patients are more accessible ", - said the co-chairman of the All-Russian Union of Public Associations of Patients Yuri Zhulev.

The list of drugs purchased under the "7 nosologies" program for the treatment of rare but very expensive diseases has also been expanded. Several new drugs have also been added to it, in particular one more modern medicine for the treatment of Gaucher disease.

At the same time, the experts faced a difficult choice: no budget would be enough to purchase the entire arsenal offered by pharmaceutical companies today. IN last years many "new generation" drugs have appeared that give patients a chance to recover from diseases that were incurable yesterday. But all innovative drugs are very expensive. Therefore, it was decided to further discuss the issue of additional inclusion in the list of some expensive drugs, in particular those intended for HIV-infected, patients with hepatitis B and C, and some hematological diseases, closer to spring, when the financial situation becomes clearer and it becomes clear whether the state will be able to guarantee purchases such drugs in the required amount. Applications from pharmaceutical companies have been accepted, the Ministry of Health emphasizes, but the costs must be carefully calculated.

As for medicines for beneficiaries, in this list, as before, more than three hundred names of all major drug groups... The exceptions are minimal. “Only some drugs with unproven efficacy were removed from it, for example, valocordin. By the way, we were constantly criticized that an outdated and unsafe drug remained on the list,” explained Andrei Gaiderov.

Finally, a minimum assortment list has been prepared - this is the list of drugs that must be available in any pharmacy. This list protects us from being "washed out" of the sale of cheap drugs. It is clear that it is more profitable to sell an expensive package, which costs several hundred rubles, to a pharmacy than to "fiddle" with cheap drugs. Not always inexpensive medicines lie on the shelves in plain sight, and the pharmacist, if asked, would rather advise something expensive. Therefore, when forming minimum assortment for pharmacies, experts paid attention to the fact that it must contain affordable, familiar drugs. “The absolute majority of pharmacies comply with the rule of preserving the assortment,” said Elena Nevolina, head of the Pharmacy Guild. “Therefore, you just need to ask the pharmacist or pharmacist about the medicine you need. ".

By July 1, 2015, Russia should have adopted a new pricing methodology for those on the VED list. Its draft, developed by the Russian Ministry of Health and the Federal Tariff Service, was presented for public discussion. RG invited market experts to take part in a round table to discuss the pros and cons of the proposed methodology.

Roza Yagudina, Head of the Department of Drug Supply Organization and Pharmacoeconomics, I.M. THEM. Sechenov:

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

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

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

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

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

As for originator drugs, R&D and clinical researches... The question that worries the whole world - are these costs real? There is evidence that they are overstated. Therefore, setting a price for an original drug is always a bargaining chip. Here, normal mechanisms can be applied that significantly reduce prices. For example, sharing risks or limiting profits, marketing expenses, etc. As the main buyer here, the state can dictate its terms. Among other things, this encourages companies to look for cost-effective methods.

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

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

The industry proposal to switch to using the arithmetic average price of the lower segment of the basket as a base did not find support.

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

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

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

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

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

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

At the same time, the new provisions of the document erase the differences in approaches to registration of prices for imported drugs and drugs in the process of localization - the upper price limit is determined by the minimum price from the reference basket. As a result, the benefits of localization in stages will not be as noticeable in terms of pricing.

David Melik-Huseynov, Director of the Center for Social Economy:

- New provisions of the methodology can be interpreted ambiguously. For the regulator itself, whose goal is to curb the rise in drug prices, perhaps some of the innovations will be positive - prices will be under greater control. However, the interests of both business and, most importantly, patients must be considered. Business may experience discomfort due to the government's decision to interfere with the profitability of drug production.

Such interference could provoke large-scale inspections of pharmaceutical companies by regulatory and law enforcement agencies. But the obligatory declaration of profitability is a figure that can be made the way it will be beneficial to the manufacturer, having included in it all the conceivable and inconceivable costs of the business (for example, marketing costs, etc.).

This norm, in my opinion, is more of a brake than an incentive. And the new method does not solve the most important question. The patient has paid for the medicines and will continue to pay. So far, we were not ready for a radical change in the pricing system. For this, it is necessary to register the price not of the package, but of the unit (mg or daily dose) of the medicinal substance. In addition, it is necessary to abandon the system of markups for distributors and pharmacies and move to a tariff system.

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

UDC 338.517

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

M.O. Olkhovskaya

I.I. Maruschak

Pricing systems for medicines in Russia and abroad

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

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

E-mail: [email protected]

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

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

Currently, practically in every developed country there is a national pricing system for medicines, or there is 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 social support 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 production of new drugs. In Russia, achieving a balance of interests between the state and businesses in the pharmaceutical industry is complicated by various goals pursued by the parties.

There is a relationship between the price of medicines and the volume of products offered on the market. In countries with a low level of restriction on the volume of supply on the market, the price of a drug tends to be higher (USA, Japan) than in countries where there is a stricter regulation of the volume of supply (India, China, a number of 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 for generics2 (India), innovative drugs and analog drugs (USA, EU member states), which determines the development of pricing policy for a particular category of drugs. The price of a drug that has patent protection is a priori higher than the price category of generic drugs, in the market of which, if the price of one drug is overpriced, it will be quite difficult to regain consumer loyalty. However, in order to reduce the risk of overpricing for innovative medicines, governments of different countries may refuse to register them. These countries include Portugal, Austria, Switzerland, Greece, Finland, Argentina and Turkey3.

At the moment, four main approaches to the pricing and determination of the recoverable cost of medicines have been formed:

Limit prices;

Reference prices;

Profit control;

1 Bennett N. Pharmaceutical Pricing Strategies 2000: Entering the New Millenium. Washington: Reuters Business Insight. 2000.221 p.

Generic is a drug sold under the international non-proprietary name or under a proprietary name that differs from the brand name of the drug developer.

3 Melik-Guseinov D.V. Information from public authorities. Federal Antimonopoly Service of the Russian Federation: Analytical note on the development of options for reference pricing approaches for drugs that are in the group of vital and essential [Electronic resource]. 21.10.2011. Access mode: http://farm.lobbying.ru/gosinfo.php?id\u003d110 (date of access: 17.07.2011)

Drug benefit approach (pricing based on the benefits of a drug over others) 1.

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

Table 1

Countries that apply the registration of maximum (maximum) prices of medicines being (In-patent) and not (Off-patent) under patent protection2

Including prices abroad Countries Price limits

In-patent Off -patent

v Brazil V v

v Canada V -

v China V v

v France V -

Germany - -

v Italy V -

v Hollandia 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 medication on the market of countries with a functioning mechanism. Indeed, most of the newest medical developments come from the USA, Great Britain and Germany.

Consider the second approach to drug pricing - reference pricing.

Most of the EU countries have switched to reference pricing.

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

Comparative data on the mechanism of reference pricing 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 pricing mechanism. Since the pharmaceutical industry is predominantly socially oriented, state control should also take place for certain categories of drugs. For example, countries with predominantly free pricing necessarily have areas (for example, wholesale retail trade in Germany, revenues of firms that manufacture patented drugs in the UK), or drug supply programs (federal programs in the US) where prices are regulated. In turn, in countries with tight control, free pricing applies to drugs, the cost of which cannot be reimbursed 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 regulates prices.

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

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

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

3 On the reference pricing in the Ukrainian pharmaceutical market firsthand: Interview with A. Soloviev and V. Bortnitsky [Electronic resource] // Apteka.online.ua. 09.04.2012. No. 835 (14). Access mode: http://www.apteka.ua/article/136717 (date of access: 20.07.2011).

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

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

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

table 2

Application of reference prices in different countries1

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

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

Belgium + All medicines Manufacturer prices Comparison with all EU member states

Bulgaria + Prescription medicines Manufacturer's 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 + Reimbursed medicines Manufacturer prices The reference price calculation takes into account the lowest price in the reference countries (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, Netherlands, Ireland, Italy, Luxembourg, United Kingdom, Sweden

Italy + Reimbursed Medicines Manufacturer's Prices The Reference Price is calculated as average price in reference countries (not defined), SR is used as additional information during negotiations on the cost of the drug with the manufacturer

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

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

Portugal + Prescription and reimbursed over-the-counter (excluding generics) medicines Manufacturer prices, final consumption prices The reference price is calculated as the average price in the following countries: Greece, Spain, France, Italy

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

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

The Indian Government has proposed a new approach to regulating the cost of medicines, in particular to limit the cost of patented medicines to the level determined by the external reference pricing system, adjusted for GDP from

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

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

calculation per capita. At the same time, Great Britain, Canada, France, Australia and New Zealand were selected as the reference countries. It is proposed to calculate the marginal retail cost of a drug as follows: for example, in India, the cost of a drug under patent protection is 35.5 thousand rupees (US $ 636), and the same drug in Australia and France is approximately US $ 2,170. Moreover, per capita GDP in these countries is more than 10 times higher than in India. Thus, the marginal cost of this drug in India, according to the government's proposal, should be as many times lower than in Australia and France, and amount to approximately 1,011 thousand rupees ($ 185-209), which is almost 3 times less compared to its current cost.

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

China strictly controls prices only for drugs reimbursed from public funds. The list of such drugs includes from 1500 to 2000 names. On average, 500-1000 of them are traditional Chinese medicine, and 1000 are pharmaceutical products of two categories: A (cheap generics) and B (innovative medicines). 15% of category B drugs (75 names) are covered by regional budgets. Medicines not on this list are free pricing. Paradoxically, the achievements in the field of China's economy are not helping to improve the health situation, it is even worsening. The share of insured patients has been declining from year to year (from 90% in 1981 to 60% in 2008). At the same time, the government sets a goal to bring this figure to 100% by 2010, which is very unlikely. At the same time, there is a gigantic increase in health care costs (for 15 years they have been increasing annually by 10-15%). The fee is charged not only for services, but also for visiting a doctor, the share of expenses from the patient's pocket reaches 60%. A characteristic flaw in Chinese health care is the inequality of urban and rural populations.

A separate block is the analysis of pricing for innovative drugs, which indicates that prices for fundamentally new drugs subject to reimbursement in most of the studied countries 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 - a patented drug or not. In countries such as Germany and the United States, innovative drugs are subject to free pricing. In the UK, there is also free pricing, but within the established income of the firm2.

The above approaches to the pricing of innovative drugs are determined by the fact that the costs of their development, as well as the level of risks of various kinds, are quite high. In addition, often a fundamentally new drug cannot be compared in price with another drug, since there will be no analogues for a certain period of time. Of course, this gives rise to speculation on drugs from 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 life of citizens may depend on the time the drug is brought to market.

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

For all drugs that are listed in List No. 2135-r, the price is regulated by the state, while prices for drugs, both domestic and imported, are subject to state registration. The medicinal product, the price of which is registered, is entered in the State register of registered maximum selling prices.

The price is calculated as follows 3.

Acts of the executive authorities of the constituent entities of the Russian Federation set the 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 dispenses the drug and which is indicated in the sales contract and accompanying documentation for the goods (in invoices, etc.), and the foreign manufacturer is the contract price for the drug, not exceeding the registered maximum selling price, in rubles at the exchange rate of the Central Bank of the Russian Federation as of the date of registration of the cargo customs declaration;

1 Here: the classification and nomenclature of diseases (in modern medical literature, the concept of "nosological approach" is usually used, that is, the desire of clinicians and representatives of theoretical medicine to isolate a nosological form, which is characterized by a certain 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 of 11.12. 09 "On approval of the methodology for determining the maximum wholesale and maximum retail mark-ups to the actual selling prices of manufacturers for vital and essential medicines by the executive authorities of the constituent entities of the Russian Federation" [Electronic resource] // GARANT. Information and legal portal. 2009.22 December. Access mode: http://www.garant.ru/products/ipo/prime/doc/12071699/ (date of access: 05/09/2013).

To the selling price of a wholesaler that purchases medicines from their own funds directly from manufacturers.

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

Up to 50 rubles. inclusive;

From 50 to 500 rubles. inclusive;

Over 500 rubles

Table 3

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

Markups Actual selling price of the manufacturer Maximum markup,%

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

Over 50 rubles. up to RUB 500 inclusive 15

Over 500 rubles ten

Maximum retail mark-up to the manufacturer's actual selling price Up to 50 rubles. inclusive 32

Over 50 rubles. up to RUB 500 inclusive 28

Over 500 rubles fifteen

The actual selling price of the manufacturer is understood as the price (excluding value added tax) indicated by the Russian manufacturer of the medicinal product in the accompanying documentation for the product (in invoices, etc.), and by the foreign manufacturer of the medicinal product in the accompanying documentation for the product (in the invoice and the like), on the basis of which the cargo customs declaration is drawn up, taking into account the costs associated with customs clearance of the cargo (customs duties and customs clearance fees) that do not exceed the registered maximum selling price of the manufacturer.

Let us give examples of calculating wholesale and retail markups on the example of Moscow; in many constituent entities of the Russian Federation, a similar procedure applies2.

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

Let's calculate the maximum wholesale price.

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

Pharmacy LLC "Zdorovye", located in Moscow, received 3% hydrogen peroxide from a wholesale organization at a price of 5 rubles. Let's calculate the maximum retail price for a pharmacy for this drug.

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

Together with the invoices, the pharmacy received the protocols for the coordination of prices for medicines. According to these protocols, the price of state registration of one package of Corvalol drops is 15 rubles, one package of the Retinol drug 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 Subjects of the Russian Federation of Limit Wholesale and Maximum Retail Markups to Actual Selling Prices of Manufacturers for Essential and Essential Medicines" provides clear instructions on pricing for each of the participants in the pharmaceutical market. However, in practice, the consumer still did not feel an effective reduction in drug prices.

A number of experts believe that the list of essential drugs is not initially perfect, since specialists cannot afford to add expensive drugs to it - the state simply cannot afford it. Therefore, the list includes primarily 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 medicines (VED), since only on

2 Medical goods and services. Pricing for medicines, taking into account the latest changes, 22.07.2010 [Electronic resource]. Access mode: http://www.referent.ru/50/179984 (date of access: 09/01/2013).

3 Patents, Drugs and Health Care (based on the Panos Institute (London) report "Patents, Drugs and Health Care", December 2002) [Electronic resource] // RMS-Expo: medical exhibitions and conferences. Access mode: http://expo.rusmedserv.com/articli.html (date of access: 10.11.2012) ..

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

Summing up 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 drugs, local prices are not compared with prices abroad, which can lead to overpricing of drugs, state control over prices relative to the categories of drugs other than vital drugs is weak due to the lack of a pricing mechanism for them.

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

Among the countries whose market prices are to be compared, it is advisable to consider India (as the largest manufacturer of generics), the USA, Great Britain, France, Germany (as the main manufacturers of analog drugs and innovative drugs).

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

LITERATURE

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

Of the 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. 2009.22 December. 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.opNpeia 2012. February 27. No. 8

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

3. Medical goods and services. Pricing for medicines, taking into account the latest changes // Legal

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

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

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

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

The amount of the amount of wholesale mark-ups to the actual selling price of the manufacturer for a medicinal product used by all wholesale organizations involved in the sale of this medicinal product in the territory of a constituent entity of the Russian Federation should not exceed the corresponding maximum amount of the wholesale mark-up established by the executive authority of this constituent entity of the Russian Federation (clause 4 Of Regulation No. 865).

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

In order not to exceed the amount of wholesale mark-ups set by traders, the VED supply price agreement protocol is applied in the form approved by the RF Government Decree of 08.08.2009 No. 654 "On improving state regulation of prices for vital and essential medicines."

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

Further, we would like to note that the procedure for calculating the selling price for a drug for pharmacies was previously explained in a joint Letter of Roszdravnadzor dated 28.01.2010 No. 01I-52/10, the Federal Tariff Service of the Russian Federation dated 29.01.2010 No. CH-466/7. In accordance with clauses 28, 35 of the above letter, when calculating the selling price for a medicinal product, it should be taken into account that the size of the retail mark-up to the manufacturer's actual selling price for the medicinal product should not exceed the maximum retail mark-up established by the executive authority of the corresponding constituent entity of the Russian Federation. As already noted above, this rule is enshrined in paragraph 5 of Regulation No. 865.

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

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

If wholesale or retail trade organizations use the simplified taxation 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 drugs by summing up the actual purchase price of goods with VAT and a wholesale or retail markup, which are calculated from the actual manufacturer's selling price with VAT.

Traditional taxation system: pharmacy is a VAT payer

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

Manufacturer's price excluding VAT: 100 rubles. (including VAT - 110 rubles) Wholesale markup (20% to the manufacturer's price excluding VAT): 100 rubles. x 20% \u003d 20 rubles. Selling price of the wholesale organization without VAT: (100 + 20) rubles. \u003d 120 rubles. Retail surcharge (40% to the manufacturer's price excluding VAT): 100 rubles. x 40% \u003d 40 rubles. Pharmacy retail price excluding VAT: (120 + 40) rubles. \u003d 160 rubles. Pharmacy retail price VAT included: 160 rubles. x 1.1 \u003d 176 rubles.

Manufacturer's price with VAT: (100 + 10) rubles. \u003d 110 rubles. Selling price of the wholesale organization with VAT (surcharge - 20%): 110 rubles. x 1.2 \u003d 132 rubles. Pharmacy retail markup (40% to the manufacturer's price with VAT): 110 rubles. x 40% \u003d 44 rubles. Pharmacy retail price without VAT: (132 + 44) rub. \u003d RUB 176

However, as the Supreme Court asserts in the Resolution dated 09.06.2015 No. 304-AD15-2723, the current legislation does not make the procedure for forming the selling price for vital and essential drugs dependent on the taxation system used by wholesale trade organizations and (or) pharmacy organizations licensed to conduct pharmaceutical activities. Clause 3 of Regulation No.865 found that the actual selling price of a manufacturer for a medicinal product is understood as 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 Okrug dated 04/17/2014 in case No. A81-756 / 2014, it is noted that the Letter of Roszdravnadzor No. 01I-52/10 and the FST RF No. SN-466/7 is not a regulatory 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 03.12.2014 No. Ф04-11609 / 2014 in case No. А81-756 / 2014.

Thus, the pharmacy was charged with a violation of classification - as non-compliance with the procedure for setting the price of a drug from the VED List. As for bringing to administrative responsibility for the imputed 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 of 50 thousand rubles.

The Supreme Court noted in the above ruling that on the basis of the provisions of Federal Law No. 99-FZ dated 04.05.2011 "On licensing certain types of activities" pharmaceutical activity is licensed. The procedure for licensing pharmaceutical activities is established by the corresponding regulation approved by the Decree of the Government of the Russian Federation of December 22, 2011 No. 1081 (hereinafter - Regulation No. 1081).

By virtue of this provision, the licensee must comply with the licensing requirements and conditions when carrying out the licensed type of activity. So, in particular, in paragraphs. “D” of clause 5 of Regulation No. 1081, it is established that pharmacy organizations engaged in retail trade in medicinal products must comply with the maximum retail markups to the actual manufacturer's selling prices for medicinal products included in the VED List. At the same time, clause 6 of Regulation No. 1081 establishes that non-compliance with this requirement refers to gross violations of license requirements and conditions.

Based on the aforementioned paragraph, as well as other normative acts, in particular, Rules No. 865, the Supreme Court in its Resolution No. 304-AD15-2723 dated 09.06.2015 No. 304-AD15-2723 ruled that the court of first instance reasonably brought the pharmacy organization to administrative responsibility under Part 4 of Art. ... 14.1 of the Administrative Code of the Russian Federation, imposing a penalty in the form of a fine in the amount of 50 thousand rubles. The pharmacy did not agree with this punishment and asked to appoint her punishment under Part 1 of Art. 14.6 of the Administrative Code 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, an overstatement of state-regulated prices (tariffs, prices, 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 proceeds received from the sale of goods (work, services) due to illegal overstatement of state-regulated prices (tariffs, prices, 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 arguments of the organization about the need to qualify the established offense under Part 1 of Art. 14.6 of the Administrative Code of the Russian Federation, the court of first instance indicated the following. In accordance with the notes to Art. 14.1 of the Code of Administrative Offenses of the Russian Federation, which establishes administrative responsibility for carrying out entrepreneurial activities without state registration or without special permission (license), the concept of gross violation is established by the Government of the Russian Federation in relation to a specific licensed type of activity. Since the control body established and confirmed by the evidence presented, the pharmacy's violation of the requirements of paragraphs. "G" of clause 5 of Regulation No. 1081, which by virtue of clause 6 of this regulation is recognized as a gross violation of license requirements, an offense committed by the company entails liability established precisely by part 4 of Art. 14.1 of the Administrative Code of the Russian Federation.

The grounds for recognizing the offense committed by the pharmacy as insignificant and releasing it from administrative responsibility in accordance with Art. 2.9 of the Code of Administrative Offenses of the Russian Federation, the courts of all instances did not establish. These conclusions were recognized by the Supreme Court as reasonable, therefore the complaint of the pharmacy organization was dismissed.

Taking into account the foregoing, pharmacies should think about the fact that violation of the pricing rules in terms of establishing trade markups can lead to negative consequences and be accompanied by administrative penalties from the regulatory authorities. Taking into account the opinion of the Supreme Court, expressed in June 2015, the sanction established by Part 4 of Art. 14.1 of the Administrative Code of the Russian Federation. Since the Letter of Roszdravnadzor No. 01I-52/10 and the Federal Tariff Service of the Russian Federation No. SN-466/7 is not a normative act, the calculation of retail trade markups should be based on the manufacturer's actual selling price for the drug (excluding VAT), excluding the taxation system applied by the pharmacy.

The list of vital and essential medicines, approved. By the order of the Government of the Russian Federation of December 30, 2014 No. 2782r.

Federal Law of 12.04.2010 No. 61-FZ "On the Circulation of Medicines".

Decree of the Government of the Russian Federation of October 29, 2010 No. 865 "On state regulation of prices for drugs included in the List of vital and essential drugs."

The methodology for determining the maximum wholesale and maximum retail markups to the actual selling prices of manufacturers for vital and essential medicines by the executive authorities of the constituent entities of the Russian Federation, approved by By order of the Federal Tariff Service of the Russian Federation of December 11, 2009 No. 442-a.

The rules for setting the maximum wholesale and maximum retail markups to the actual selling prices of manufacturers for drugs included in the list of vital and essential drugs in the constituent entities of the Russian Federation, approved by Decree of the Government of the Russian Federation of October 29, 2010 No. 865.

The current legislation defining the procedure for regulating drug prices is rather confusing and contradictory, despite the efforts of federal and regional legislators. Even an experienced lawyer is not always able to understand the complex vicissitudes of regulatory documents on the regulation of prices for medicines, operating at the federal and regional levels. This unambiguously generates and will continue to generate numerous disputes with the Departments of the Ministry of Taxes and Duties of the Russian Federation and the Commissions for licensing pharmaceutical activities in the field, which will baffle more than one arbitration court.

Today the pricing of 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 of state control over the prices of medicines" (together with the "Procedure for state registration of manufacturer's selling prices and establishing wholesale and retail markups to manufacturer's selling prices for medicines included in the List of vital necessary and essential medicines and medical products ");

2. Decree of the Government of the Russian Federation of 03/07/95 N 239 "On measures to streamline state regulation of prices (tariffs)" (as amended on 06/30/97);

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 medicines included in the list of vital and essential medicines"

5. Order of the Ministry of Health and Social Development of the Russian Federation of November 3, 2010 No. 961 n / 527-a "On approval of the methodology for setting maximum selling prices by manufacturers of medicines for medicines included in the list of vital and essential medicines (with changes by 8 October 2012) "

6. Federal Law "On the Circulation of Medicines No. 192 dated July 27, 2010.

7. 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 wholesale mark-ups and maximum retail mark-ups to the actual selling prices established by the manufacturer of medicinal products for medicines included in the VED list.

8. By the decision of the Altai Territory Office for State Regulation of Prices and Tariffs dated July 5, 2010 No. 15 "On the establishment of trade markups to prices for 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 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. The prices for medicines, both domestic and imported, are subject to state registration.

State regulation of prices for medicines is carried out through state registration of the maximum selling prices of Russian and foreign manufacturing organizations for medicines and setting maximum wholesale and maximum retail markups to prices for 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 - VED) came into force. In particular, changes were made to the RF Government Decree of 09.11.2001 No. 782 "On state regulation of prices for drugs"; Decree of the Government of the Russian Federation of 08.08.09 No. 654 "On the improvement of state regulation of prices for vital and essential medicines" (as amended by the Decree of the Government of the Russian Federation of 30.12.2009 No. 1116); in the Regulation on Licensing of Pharmaceutical Activities, approved by Decree of the Government of the Russian Federation of 06.07.2006 No. 416, regarding the establishment of new licensing requirements and conditions for the implementation of pharmaceutical activities in compliance with the established maximum wholesale and maximum retail markups to the prices for essential drugs (violation of these requirements is attributed to categories of gross violations, as a result of which the activity of the licensee may be suspended).

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

Amendments have also been made to the Regulation on Licensing the Production of Medicines, approved by Decree of the Government of the Russian Federation of 06.07.2006 No. 415, - a new licensing requirement is established: for the production of medicines included in the VED list, 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 of July 16, 2005 No. 438, regarding the provision by foreign manufacturers when importing vital drugs of documents on state registration of their maximum selling price, as well as information on actual prices for imported vital drugs; to the Regulations on the Federal Service for Supervision in the Sphere of Healthcare and Social Development, approved by Decree of the Government of the Russian Federation No. 323 dated June 30, 2004, in terms of granting the Service the authority to monitor the assortment and prices for essential drugs; in the Regulation on the Federal Tariff Service, approved by the RF Government Decree 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 margins to the selling prices of producers rather than suppliers. This measure will allow to avoid the formation of long drug promotion schemes from manufacturers to consumers and a multiple increase in prices.

Since January 2010, in accordance with Government Decree No. 654 of 08.08.09, the state registration of maximum selling prices for medicines included in the List of Essential Drugs is mandatory. The list is approved by the Order of the Government of the Russian Federation dated 30.12.09 №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, 76 drugs are only domestically produced, 261 are produced by both Russian and foreign plants, and 163 are produced only abroad.

The previous List has been in effect since 2007 and included 658 items. It was still valid until December 31, 2009. The lists differ not only in the decrease 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,” said earlier the head of the department, Tatyana Golikova. "In the current (expiring) List, this share is 55%." She explained that in the preparation of the List, preference was given to drugs with a higher level of clinical efficacy.

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 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 procurement of drugs for health care facilities and provision of privileged categories of the population at the expense of budget funds is organized.

The issues of formation and registration of prices for medicines included in the List of Vital and Essential Medicines (VED) are regulated by the approved Resolution of the Government of the Russian Federation of March 29, 1999 N 347 "Procedure for state registration of manufacturer's selling prices and establishment of wholesale and retail markups to selling manufacturer's 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" The procedure for agreeing manufacturer's selling prices for medicines included in the List of Essential and Essential Medicines medicines and medical products ".

Wholesale organizations - importers who purchase goods directly from a foreign manufacturer register prices for medicines from the VED 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 Healthcare of the Russian Federation adjusts prices in rubles at their next publication, taking into account changes in the foreign exchange rate. The registered price of an imported drug is made up of the price of a foreign manufacturer on the terms of "delivery without payment of duty" and customs costs.

There are several important groups that make up the List of 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 concomitant drugs

Vii. Osteoporosis Treatment

VIII. Drugs affecting 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 affecting the endocrine system

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

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

XVI. Drugs affecting the uterus

XVII. Drugs affecting the respiratory system

Xviii. Solutions, electrolytes, acid balance correction, food

XIX. Vitamins and minerals

Formally, from a legal point of view, when forming prices for medicines, the prices of which are subject to state registration, the Government List of Essential Drugs should be used. However, many local regional acts establishing the pricing procedure refer to the local VED list or to the List of the RF Ministry of Health.

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

Such a mechanism for regulating prices for essential drugs will provide "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 the Government Decree No. 2135-r dated 30.12.09 and the Methodology for determining the maximum selling prices of manufacturers for essential drugs, all prices registered without using the methods for determining the manufacturer's selling price, in pursuance of the previous RF Government Decree No. 376-r dated March 29, 2007, became inoperative.

Until 04/01/2010, it was allowed to sell vital drugs that did not pass state registration of prices, without price approval protocols (Resolution of the Government of the Russian Federation No. 782 of 09.11.2001). At the same time, since January 1, 2010, in accordance with the Regulation on State Regulation of Prices for Vital and Essential Drugs, Resolution of the Government of the Russian Federation No. 782, the formation of prices by wholesalers and pharmacies is carried out using wholesale and retail markups to the actual selling prices of manufacturers that do not exceed the registered price. and the indication of data on the actual selling price of the manufacturer.

After April 1, 2010, the wholesale organization and (or) pharmacy institution did not have the right to sell the balances of the VED purchased earlier, if the manufacturers of these medicines did not register the maximum selling price for these medicines for various reasons.

Normative acts establishing maximum wholesale and retail markups to the actual selling prices of manufacturers for essential drugs, in accordance with the RF Government Decree of 30.12.2009 No. 1116, must be adopted by the executive authorities of the constituent entities of the Russian Federation by 01.03.2010. Decisions made in the constituent entities of the Russian Federation come into force from the date indicated in the act itself. Prior to the adoption by a constituent entity of the Russian Federation of a new normative 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 VED manufacturers.

So in the Altai Territory, the regulation of pricing and medicines included in the list of vital 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 size of wholesale mark-ups and maximum size of retail mark-ups to actual selling prices, established by the manufacturer of medicinal products, for medicinal products included in the VED list.

The decision on state regulation of the maximum wholesale and retail markups for drugs not included in the list of 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 delivery of vital 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 mark-up 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 drugs by wholesale organizations at a price lower than the manufacturer's actual selling price. A pharmacy, having purchased medicines from a wholesale organization at a price lower than the manufacturer's actual selling price specified in the price agreement protocol, forms the 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 manufacturer's actual price.

Thus, the formation of the selling price for medicines by wholesale organizations and pharmacies is carried out on the basis of the manufacturer's actual selling price, which does not exceed the registered price, and wholesale and (or) retail mark-ups that do not exceed, respectively, the maximum wholesale and retail mark-ups established in the subject of the Russian Federation. ...

A medicinal product, the price of 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 medicinal product may be less than or equal to the price of state registration. It is prohibited by law to sell medicines at a price that exceeds the registered price.

In addition, marginal wholesale and retail markups 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 ensured by law, remains a paramount issue today. Analysis of the current legislation and regulations in this area showed their inconsistency and fragmentation. It can be argued that there is still no systemic and complete state regulation of the sphere of pricing and drug provision of funds, and the role of state bodies in this regard has been weakened.