The Russian Ministry of Health is introducing a new procedure for justifying prices for medicines. It retains the principle of choosing the minimum price out of four calculated ones. In the article you will learn why the new procedure is better and how the customer can use it when justifying the price.

Order of the Ministry of Health dated October 26, 2017 No. 871n is no longer valid. The procedure is determined by the new order of the Ministry of Health No. 1064n dated December 19, 2019. It retains the principle of choosing a minimum price from four calculated using the method of comparable market prices, the tariff method for the list of vital and essential drugs, the weighted average price from concluded contracts and the reference price in the Unified Information System.

The customer calculates the NMCC for each of the four methods, and selects the smallest one as the final one. He calculates the price per unit of medicine excluding VAT. Wholesale surcharges can only be applied to drugs on the Vital and Essential Drugs list. In all other cases, you calculate the price without wholesale markups.

Which drugs were removed from the procedure for determining the NMCC for the purchase of drugs

The new procedure does not apply to all medications. The procedure does not apply to drugs that are not mass-produced and are manufactured directly by pharmacies - extemporaneous drugs. When purchasing from a food supplier in the event of providing medical care in urgent and emergency situations, customers may not apply this procedure. You can justify the price only using the method of comparable market prices and purchase the necessary medicine.

The Russian Ministry of Health is introducing a new procedure for justifying prices for medicines. It retains the principle of choosing the minimum price out of four calculated ones. From the article you will learn why the new procedure is better and how the customer can use it when justifying the price.

Five exceptions when calculating the weighted average price under the new order

Do not take into account the weighted average price of contracts if:

1. the contract was concluded by decision of the medical commission for a specific patient with individual intolerance or for health reasons;

2. The contract specifies unit prices for single-component drugs, but you are purchasing multi-component drugs or kits. This exception does not apply if the contract for single-component drugs was concluded as a result of a competitive procedure;

3. a contract with a medicine that is no longer circulated in the Russian Federation. You can find out such information on the website roszdravnadzor.ru;

4. the remaining shelf life of the medicine supplied under the contract differs by 20% or more from that stipulated in the contract. For example, the contract specifies a residual shelf life of 12 months, but the supplier supplied with a residual shelf life of 24 months.

5. contracts with fines and penalties in connection with non-fulfillment or improper fulfillment of obligations by the supplier.

How the customer was punished for an error in one of the three methods of justifying the NMCC according to Order of the Ministry of Health No. 871-n

The hospital purchased the drug INN Vinpocetine with NMCK for 273,093 rubles. When the contract manager used three methods to justify the price of a drug to arrive at an average, he made a mistake. In the tariff method, he took the price of 3.23 rubles. for 1 ml, but should have charged 1.62 rubles. When choosing this value from the state register of maximum selling prices of manufacturers for medicines, he overestimated the NMCC by 29,380 rubles. FAS found the specialist guilty and ordered him to pay a fine of 20 thousand rubles. (Resolution on imposing administrative punishment No. 69-12-34/2018/48 dated 08/30/2018).

Attached files

• Model contract for the supply of a medicinal product for medical use.docx

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 a contract, the price of a contract that is concluded with a single supplier (contractor, performer) when purchasing medicines intended for medical use.

Calculation of NMCC

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

, Where:

n - quantity of medicines 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 - volume of supply of the i-th drug.

Unit price of the medicinal product planned for purchase

The calculation of the unit price of a medicinal product planned for purchase is established by:

• international nonproprietary name (INN)

or

• group 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 by:

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 based on all contracts or agreements concluded by the customer for the supply of a 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:

Ts 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. Using a price that is calculated automatically in the unified state information system in the field of healthcare (reference price). Information from the Unified State Information System in the field of healthcare is provided to the Unified Information System in the field of procurement through information interaction between these systems.

Calculation of reference prices

Reference prices are calculated in the unified state information system in the field of healthcare (Uniform State Health Information System) automatically as of the beginning of the quarters of the current calendar year.

Calculations are made within one name (if there is an INN) or by group or chemical name, as well as the composition of the combined medicinal product, taking into account equivalent dosage forms and dosages (if there is no INN).

When calculating reference prices, the following formula is used:

, Where:

C ref - prices per unit of a 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 markups;

V i - volume of supply of a medicinal product for a separate group of medicinal products;

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

The unit price of a medicinal product planned for purchase is taken to be the minimum price:

• 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).

The purchase did not take place

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

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

or

• weighted average price,

when announcing the next purchase, The unit price of a medicinal product planned for purchase is taken as reference price (until July 1, 2018, when announcing the next purchase, the unit price of the medicinal product is considered to be the following minimum value calculated by the method comparable market prices (market analysis)).

2. Not a single application has been submitted for participation in the procurement according to 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 to the standard deviation indicator.

This calculation is carried out automatically by the software and hardware of the Unified State Information System in the field of healthcare (Uniform State Health Information System) according to the formula below:

Where:

σ - standard deviation indicator;

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

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

<ц> - arithmetic mean value of a unit of a medicinal product in the sample.

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

It is worth considering that when the price increases again by the standard deviation indicator, the price cannot exceed the maximum value of the price contained in the state register of registered maximum selling prices (http://www.grls.rosminzdrav.ru/) of manufacturers for medicines included in the list vital and essential medications, taking into account equivalent dosage forms and dosages.

4. Not a single application was submitted for participation in the purchase 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 maximum price value provided for by the register of maximum selling prices, taking into account equivalent dosage forms and dosages, is taken as the unit price of the medicinal product planned for purchase.

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

No reference price

or

The reference price has been increased by the standard deviation,

When announcing the next purchase, the unit price of the medicinal product planned for purchase increases by the deflator index by types of economic activities 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 offers from manufacturers (suppliers) of medicines.

6. To participate in the purchase of a medicinal product, not included in the list of vital and essential drugs not a single application was submitted for the NMCC, calculated by:

• increase by deflator index by type of economic activity,

The unit price of a medicinal product planned for purchase is taken to be the price calculated based on proposals from manufacturers (suppliers) medications.

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 of October 26, 2017 No. 871n, shall be fairly applied from the date of its official publication, with the exception of the use of reference prices when determining the contract price, since this opportunity to use them will be available only from July 1, 2018.

Also, it is necessary to take into account that the provisions of this document should not apply to procurements, notices of which are posted in the unified procurement information system (UPI) or on the official website of the Russian Federation for posting information on tendering (https:/ /torgi.gov.ru/), the invitation to participate in which was sent before November 28, 2017.

Procurement information portal

In connection with incoming requests for the application of the norms of the order of the Ministry of Health of the Russian Federation dated October 26, 2017 N 871n “On approval of the Procedure for determining the initial (maximum) contract price, the price of a contract concluded with a single supplier (contractor, performer), when purchasing medicines drugs for medical use" (hereinafter referred to as Order No. 871n, Procedure, NMCC) The Department of Drug Supply and Regulation of Medical Products of the Russian Ministry of Health 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 areas within its jurisdiction areas of activity. According to the Regulations, the Ministry of Health of Russia is not vested with the authority to officially explain the legislation of the Russian Federation, as well as the practice of its application.
1. Order N 871н comes into force on December 9, 2017 and, taking into account the transitional provisions provided for in paragraph 2 of this order, Order N 871н does not apply to the procurement of goods to meet state and municipal needs, notices of the implementation of which are posted in the unified information system in the field of procurement or on the official website of the Russian Federation on the Internet information and communication network to post information about the placement of orders for the supply of goods, performance of work, provision of services or invitations to participate in which were sent before the date of entry into force of this order.
It is necessary to take into account that if, when preparing and posting notices on the procurement of medicines when recalculating the NMCC 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 referred to as Federal Law No. 44-FZ), it is necessary to make changes to the procurement schedule.
2. The procedure provides for a certain algorithm and sequence of actions by the customer when forming a NMCC for drugs both included in the list of vital and essential drugs (hereinafter referred to as VED) and not included in this list.

If no applications have been submitted to participate in the procurement, the customer may make repeated preparations for the electronic auction in accordance with Federal Law No. 44-FZ and the established Procedure for calculating the NMCC.
At the same time, it is important that customers are recommended to analyze the reasons for the lack of applications, including for the purpose of timely informing the FAS Russia and its territorial bodies about possible cartel agreements.
3. In order to avoid double accounting 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 contain VAT and wholesale surcharge<1>, and the prices of the state register of maximum selling prices of manufacturers for drugs included in the list of vital and essential drugs and reference prices do not contain them.
———————————
<1>Order of the Ministry of Finance of the Russian Federation dated 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 for the purpose of maintaining a register of contracts concluded by customers.”

At the same time, please note that this letter does not contain legal norms or general rules specifying regulatory requirements, and is not a regulatory legal act, but is of an informational and explanatory nature on the application of Order No. 871n.

By letter No. 418/25-5 dated February 14, 2018, the Ministry of Health sent clarifications to the heads of all executive authorities of the constituent entities of the Russian Federation in the field of health care. Thus, the Ministry of Health decided to respond to numerous requests for organizing and conducting procurement of medicines. Let us remind you that several important documents have recently come into force that relate specifically to this type of government procurement. Therefore, the explanations are not meaningless.

The document specifies:

• how to correctly calculate the NMCC;
• how to describe the procurement object;
• how to use a standard contract.

We talked about the purchase of medicines in detail in a separate article. Below we will clarify the recommendations of the Ministry of Health.

Nuances of drug descriptions

First of all, the Ministry of Health explained the procedure for applying Decree No. 1380. 10 frequently asked questions received clarification:

1. Description of medicines in packages.
2. Indication in the documentation of the possibility of supplying drugs in multiple equivalent dosages.
3. Implementation of government orders for insulin and accounting for delivered syringes.
4. Drawing up technical specifications for multicomponent (combined) medicinal products.
5. Justification of certain characteristics.
6. Selection of correct equivalent dosage forms.
7. Correct indication of the concentration of liquid and soft dosage forms.
8. Dosage conversion.
9. Fixing the filling volume of the primary packaging.
10. Establishing a ban on specifying a fixed temperature regime.

Subtleties of determining NMCC

Then the Ministry of Health did not ignore Order No. 871n and commented on the most pressing issues of determining the initial maximum contract price (IMCP), which included the following situations:

1. Determination of the unit of measurement of the drug.
2. Recalculation of the cost of the dosage form.
3. Establishing a wholesale markup.
4. The procedure for applying Order 567 to justify the NMCC of drugs.
5. Selected issues of calculating the weighted average price.
6. What to do if this is your first purchase and it is impossible to determine the weighted average price.

What is important to consider when filling out a standard contract

The following interpretations were given to the norms of Order No. 870n on the algorithm for working with a standard contract. The Ministry of Health covered the following hot topics:

1. Is it necessary to use a standard contract?
2. Is it necessary to include clauses, sections, and appendices in the contract?
3. How to apply section 4 of the standard packaging contract.
4. Are samples for laboratory tests included in the quantity of goods?
5. When the customer has the right to demand replacement of all delivered goods.

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

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

If we rely on clause 6 of Article 22 of 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 proposals directly from potential procurement participants who have a license for pharmaceutical activities with the right to carry out wholesale trade (or with the right to carry out wholesale trade in medicines for medical use), or a license for the production of medicines funds. The customer has the right to apply recommendations for calculating the NMCC, which were approved by the Ministry of Economic Development of the Russian Federation by order No. 567 dated October 2, 2013.

If the purchased drugs are drugs from the list of vital and essential drugs, then when calculating the NMMC, attention should be paid to ensuring that the prices offered by potential participants (and, accordingly, the estimated prices per unit of product) are not higher than the maximum selling prices of manufacturers (hereinafter referred to as the MSP) + wholesale regional surcharges + VAT (10%).

2. Tariff method for calculating NMCC.

When the subject of purchase is a drug from the Vital and Essential Drugs list, and the supplier’s request for a commercial proposal has not been responded to, the customer has the right to use the tariff method to calculate the NMCC.

But it is worth considering that the tariff method will include PPSP + VAT (10%) without taking into account regional wholesale markups.

The Ministry of Economic Development of the Russian Federation adheres to the same position on the technology of calculation by the tariff method, publishing it in letter No. D28-11 dated January 12, 2015. If suddenly several trade names are suitable for a purchased international non-proprietary name with certain technical characteristics, the customer has the right to choose both the highest and the lowest manufacturer’s limit price.

3. Another method for calculating the NMCC.

Reading paragraph 12 of Article 22 of Federal Law No. 44-FZ, one 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. This method, as an example, can be used by customers subject to limited funding from higher budgets.

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