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. Calculation of NMC when purchasing medications

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Order of the Ministry of Health dated October 26, 2017 No. 871n is no longer valid.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 serially 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.

Read the new rules

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 NMCP 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 contract price 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:

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. 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.

The forecast value of the deflator index is established by the Ministry of Economic Development of the Russian Federation for the relevant industry in accordance with the Decree of the Government of the Russian Federation dated November 14, 2015 No. 1234 “On the procedure for developing, adjusting, monitoring and controlling the implementation of the forecast of socio-economic development of the Russian Federation for the medium term and recognition as invalid of certain acts of the Government of the Russian Federation.”

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

Neither the Methodological recommendations of the Ministry of Economic Development on definition of NMCC, approved by Order No. 567 dated October 2, 2013, do not contain such a definition. The reference price (RP) is an indicator that reflects the actual average cost for a certain group of goods. In the public procurement system - under similar concluded contracts, executed by suppliers in full without the application of fines and penalties.

How to use

The first area in which it is planned to use the technique is the pharmaceutical field. The Ministry of Health has developed a project that provides for the re-registration of maximum price tags for reference prices during procurement vital and essential medicines.

Reference prices for medicines are expected to be calculated as follows:

1. Set the cost of the medicinal product planned for purchase to be the same as in its previous purchase.
2. Compare the previous cost with the RP contained in a specially created information and analytical system.

If the previous one is lower, then the formula for calculation is:

NMCC = previous cost * quantity of the purchased drug.

If below (and also for failed orders):

NMCK = RC * quantity.

Advantages and disadvantages of the method

The purchase of drugs without taking into account the specifics of their pharmacokinetics and pharmacodynamics, additional characteristics that change the rate of delivery, absorption, etc., only based on the cost of previous purchases, is incorrect for the following reasons:

1. The introduction of interchangeability not only within one international nonproprietary name, but also in the form of release may mean a massive replacement of more modern forms of drugs with outdated ones. For example, purchasing a medicine in a bottle is not as convenient for the patient as in the pen form. Naturally, the cost of the bottle is much lower, but purchasing a cheaper one does not mean it is of higher quality and functionally advantageous.
2. Lack of allowance for allowances. For example, it is necessary to take into account the difference in costs for the delivery of medicines depending on the delivery point, because surcharges are one of the main reasons for the difference in the cost of orders in the constituent entities of the Russian Federation.
3. The peculiarities of bidding for the purchase of medicines carried out in mixed lots are not taken into account.

It is worth noting that the reference price for medicines is a method of constantly using weighted average prices, leading to a steady decrease in the RP, and therefore the NMCP, to the minimum possible level. Under the conditions of a ban on the purchase of medicines at a price above the RP, there may be a risk of production cessation, and therefore a shortage of medicines.

The project is currently undergoing discussion and anti-corruption examination.

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 calculated 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.