In connection with incoming requests for the application of the norms of the order of the Ministry of Health of the Russian Federation of October 26, 2017 N 871n "On approval of the procedure for determining the initial (maximum) price of the contract, the price of the contract concluded with a single supplier (contractor, performer), in the procurement of medicinal drugs for medical use” (hereinafter, respectively, Order No. 871n, Order, NMTsK) The Department of Drug Provision and Regulation of the Circulation of Medical Devices of the Ministry of Health of Russia reports the following.
In accordance with the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation on June 19, 2012 N 608 (hereinafter referred to as the Regulations), the Ministry of Health of Russia is a federal executive body that develops state policy and legal regulation in its jurisdiction. areas of activity. According to the Regulations, the Ministry of Health of Russia is not empowered to officially clarify the legislation of the Russian Federation, as well as the practice of its application.
1. Order N 871n comes into force on December 9, 2017 and, taking into account the transitional provisions provided for in paragraph 2 of this order, order N 871n does not apply to the purchase of goods to meet state and municipal needs, notices of the implementation of which are posted in a single information system in the field of procurement or on the official website of the Russian Federation on the information and communication network "Internet" for posting information on placing orders for the supply of goods, performance of work, provision of services or invitations to participate in which were sent before the day this order comes into force.
At the same time, it should be taken into account that if, during the preparation and placement of notices on the procurement of medicines, when the NMCC is recalculated in accordance with the Procedure, the size of the NMCC changes, then in accordance with paragraph 1 of part 13 of Article 21 of the Federal Law of April 5, 2013 N 44-FZ "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs" (hereinafter - Federal Law N 44-FZ), it is necessary to amend the procurement schedule.
2. The procedure provides for a certain algorithm and sequence of actions of the customer when forming the NMCC for medicines both included in the list of vital and essential medicines (hereinafter referred to as VED) and not included in this list.

If no application has been submitted for participation in the procurement, the customer may re-prepare for the electronic auction in accordance with Federal Law No. 44-FZ and the established Calculation Procedure of the NMCC.
At the same time, it is important that customers are advised to analyze the reasons for the absence of applications, including for the purpose of timely informing the FAS Russia and its territorial bodies about possible cartel collusion.
3. In order to prevent double counting of value added tax (hereinafter referred to as VAT) and wholesale markup when calculating the unit price of a medicinal product planned for purchase, it is necessary to take into account the fact that the prices in previously concluded contracts and the prices offered by manufacturers (suppliers) of medicinal products , may include VAT and wholesale surcharge<1>, while the prices of the state register of maximum selling prices of manufacturers for medicines included in the list of Vital and Essential Drugs, and reference prices do not contain them.
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<1>Order of the Ministry of Finance of the Russian Federation of November 24, 2014 N 136n "On the procedure for generating information, as well as the exchange of information and documents between the customer and the Federal Treasury in order to maintain a register of contracts concluded by customers."

At the same time, we draw your attention to the fact that this letter does not contain legal norms or general rules specifying regulatory requirements, and is not a regulatory legal act, but has an informational and explanatory character on the application of Order N 871n.

The Ministry of Health has changed the rules for calculating the NMCC for the purchase of medicines. The innovations came into force with the Order of the Ministry of Health of the Russian Federation dated June 26, 2018 No. 386n. The document introduces important changes to the Order of the Ministry of Health of the Russian Federation of October 26, 2017 No. 871n.

What has changed in the calculations

First of all, the new Order of the Ministry of Health cancels footnote 1 in paragraph 2 of Order No. 871n. This means that customers will no longer reject or refuse to conclude a contract with a participant who has offered a price higher than that indicated in the register of maximum selling prices for medicinal products, and refuses to lower it (paragraph 2 of part 10 of article 31 44-FZ). Recall that this rule applies only to drug manufacturers and is used in the procurement of medicines from the Vital and Essential Drugs Registry, the NMCC of which at the federal level exceeds 10 million rubles, and at the regional level this threshold is set by the executive authority (in this case, the limit should not exceed 10 million rubles. ).

Another important change is that now, when calculating the maximum cost, it will be necessary to take into account not concluded, but state or municipal contracts executed by the state customer. And the application of reference prices was postponed until 01/01/2019.

Now, in the calculations of the NMCC, use the unit price without VAT, taken from the concluded contracts, as the cost of one medication. And from 07/01/2019, these data must be determined on the basis of completed contracts and not only VAT, but also the wholesale surcharge should be taken away.

Changes were also made to the wholesale surcharges themselves. Their size should not exceed the limit values ​​established by the executive authorities of the constituent entities of the Russian Federation. And wholesale surcharges will apply if.

The order of the Ministry of Health of the Russian Federation dated October 26, 2017 No. 871n was published on the official Internet portal of legal information.

With this document, the Ministry of Health of the Russian Federation establishes the procedure for determining the initial (maximum) price of the contract, the price of the contract, which is concluded with a single supplier (contractor, performer) when purchasing medicines intended for medical use.

NMTsK calculation

To calculate the initial (maximum) price of the contract, the price of the contract concluded with the EP when purchasing medicines for medical use to meet state and municipal needs, the following unified formula is applied:

, where:

n - the number of drugs supplied;

C i - unit price of the i-th medicinal product planned for purchase, taking into account value added tax and wholesale markup (clause 2 of part 10 of article 31 of Law 44-FZ);

Vi - scope of supply of the i-th medicinal product.

Unit price of the medicinal product planned for purchase

Calculation of the unit price of the medicinal product planned for purchase is determined by:

• international non-proprietary name (INN)

or

• grouping or chemical name, as well as the composition of the combined medicinal product, taking into account equivalent and dosages ( in the absence of INN! ).

Such calculations are carried out through:

1. The method of comparable market prices (parts 2-6 of article 22 of Law No. 44-FZ) and the tariff method (part 8 of article 22 of Law No. 44-FZ), excluding VAT ;

2. Calculation of the weighted average price on the basis of all contracts or agreements concluded by the customer for the supply of the medicinal product planned for purchase, taking into account equivalent dosage forms and dosages over the past 12 months.

The weighted average price is calculated using the following formula:

Where:

C 1 - unit price of the medicinal product, excluding VAT and wholesale markup;

k - the number of purchased drugs in equivalent dosage forms and dosages.

3. Use of a price that is calculated automatically in the unified state information system in the field of healthcare (reference price). Information from the USIS in the field of healthcare is provided to the USIS in the field of procurement through information interaction between these systems.

Reference price calculation

Reference prices are calculated in the Unified State Health Information System (EGISZ) automatically as of the beginning of the quarters of the current calendar year.

Calculations are made within the framework of one name (in the presence of INN) or by grouping or chemical name, as well as the composition of the combined medicinal product, taking into account equivalent dosage forms and dosages (in the absence of INN).

When calculating reference prices, the following formula is applied:

, where:

C ref - prices per unit of the medicinal product according to contracts for the 12 months preceding the month of calculation, from the unified information system in the field of procurement, excluding VAT and wholesale markup;

Vi - the volume of supply of the medicinal product for a separate group of medicinal products;

C i - unit price of a medicinal product for a separate group of medicinal products.

For the price of a unit of a medicinal product planned for purchase, the minimum price value is taken:

• calculated by the method of comparable market prices (market analysis);
• calculated by the tariff method;
• calculated weighted average price;
• calculated using the Uniform State Health Information System (reference price).

Purchase failed

1. Not a single application for participation in the procurement has been submitted for the NMCC with the unit price of the medicinal product planned for purchase, determined by:

• comparable market prices method (market analysis), tariff method,

or

• weighted average price,

when the next purchase is announced, as the unit price of the medicinal product planned for purchase is taken reference price (until 07/01/2018, when the next purchase is announced, the price of a unit of a medicinal product is considered to be the next minimum value calculated by the method comparable market prices (market analysis)).

2. Not a single application for participation in the procurement was submitted for the NMCC, calculated on the basis of:

• reference price,

when announcing the next purchase, the unit price of the medicinal product planned for purchase is determined by increasing the reference price on the standard deviation.

This calculation is performed automatically by the software and hardware of the Unified State Health Information System (EGISZ) according to the formula below:

Where:

σ - indicator of standard deviation;

C i - value of unit price of medicinal substance obtained for contract number i;

n - the number of values ​​used in the calculation;

<ц> - the arithmetic mean of the drug unit in the sample.

3. Not a single application for participation in the purchase with an increased reference price was submitted and the purchase was declared invalid, - unit price of the medicinal product planned for purchase re-increased by the standard deviation .

It should be noted that if the price is increased again by the standard deviation, the price cannot exceed the maximum price contained in the state register of registered maximum ex-works prices (http://www.grls.rosminzdrav.ru/) of manufacturers for medicines included in the list vital and essential drugs, taking into account equivalent dosage forms and dosages.

4. Not a single application has been submitted for participation in the procurement of a medicinal product included in the list of vital and essential drugs (VED) and it was declared invalid, while:

• no reference price

or

• the reference price is increased by the standard deviation,

When announcing the next purchase, the unit price of the medicinal product planned for purchase is taken to be the maximum price value provided for by the register of maximum selling prices, taking into account equivalent dosage forms and dosages.

5. To participate in the procurement of a medicinal product, not a single application was submitted and it was declared invalid, while:

No reference price

or

The reference price is increased by the standard deviation,

When announcing the next purchase, the unit price of the medicinal product planned for purchase increases by index deflator by types of economic activity determined by the Ministry of Economic Development of the Russian Federation as part of the development of the socio-economic development of the Russian Federation, while the price cannot be higher than the maximum value of the proposals of manufacturers (suppliers) of medicines.

6. To participate in the procurement of a medicinal product, not included in the list of vital and essential drugs no bids have been submitted for the NMCC, calculated by:

• increase by deflator index by type of economic activity,

The unit price of the medicinal product planned for purchase is the price calculated based on the proposals of manufacturers (suppliers) medicines.

Results

The procedure for determining the initial (maximum) price of a contract, the price of a contract concluded with a single supplier (contractor, performer), when purchasing medicines for medical use, by Decree of the Government of the Russian Federation No. except for the use of reference prices when determining the contract price, since this possibility of their application will be available only from July 1, 2018.

Also, it must be taken into account that the provisions of this document should not be applied to procurements, notices of which are posted in the unified information system in the field of procurement (UIS) or on the official website of the Russian Federation for posting information about the bidding (https:/ /torgi.gov.ru/), the invitation to participate in which was sent before November 28, 2017.

Procurement Information Portal

When calculating the NMTsK, customers are required to apply the provisions of Federal Law No. 44-FZ. There are some of the most common methods of calculating the NMCC that customers use when dealing with the purchase of medicines.

1. Method of comparable market prices (market analysis).

If you rely on paragraph 6 of article 22 of the Federal Law No. 44-FZ of 04/05/2013. the method of comparable market prices (market analysis) is the most important in determining and justifying the NMCC, regardless of what type of goods will be purchased by the customer. The priority of this method, including when drugs from the Vital and Essential Drugs list are purchased, is also discussed in the letter of the Ministry of Economic Development of the Russian Federation dated March 18, 2016 No. D28i-693.

With all this, the customer, being a medical institution, is obliged to request commercial offers directly from potential procurement participants who have a license for pharmaceutical activities with the right to wholesale trade (or with the right to wholesale trade in medicinal products for medical use), or a license for the production of medicinal products. funds. The customer has the right to apply the recommendations for the calculation of the NMTsK, which are approved by the Ministry of Economic Development of the Russian Federation by order of 02.10.2013 N 567.

If the purchased drugs are medicines from the list of Vital and Essential Drugs, then when calculating the NMCC, attention should be paid to the fact that the prices offered by potential participants (and, accordingly, the estimated prices per unit of production) are not higher than the maximum selling prices of manufacturers (hereinafter referred to as POCP) + wholesale regional surcharges + VAT (10%).

2. Tariff method of calculation of the NMTsK.

When the subject of procurement is a drug from the list of Vital and Essential Drugs, and no response was received to the supplier's request for a commercial offer, the customer has the right to use the tariff method to calculate the NMCC.

But it should be borne in mind that the tariff method will include PSPP + VAT (10%) without taking into account regional wholesale surcharges.

The Ministry of Economic Development of the Russian Federation adheres to the same position on the technology of calculating the tariff method, publishing it in a letter dated 12.01.2015 No. D28-11. If suddenly several trade names are suitable for the purchased international non-proprietary name with certain technical characteristics, the customer has the right to choose both the highest and the lowest manufacturer's marginal price.

3. Another method for calculating the NMTsK.

Reading paragraph 12 of article 22 of the Federal Law No. 44-FZ, you can see that if it is impossible to determine the NMCC by other methods listed in part 1 of article 22, the customer has the right to resort to other calculation methods. In this way, as an example, customers can use subject to limited funding from higher budgets.

The customer calculates the NMTsK using one of the above methods, and if the price received exceeds the allocated limits for this article for a specific purchase, the customer reduces the NMTsK to the amount of the allotted appropriations.

When purchasing medicines under paragraph 4 of part 1 of Art. 93 of Law No. 44-FZ, is the customer obliged to conduct a justification in accordance with the order of the Ministry of Health of the Russian Federation of October 26, 2017 No. 871n? Or, when substantiating, it is possible to confine Art. 22 of Law No. 44-FZ, requesting 5 commercial offers and making a calculation on these commercial offers?

Answer