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 making a purchase 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 a single information system in the field of procurement, excluding VAT and wholesale mark-ups;
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 per indicator standard deviation.
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 - unit price value medicinal substance, received 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 price value contained in the state register of registered maximum selling prices(http://www.grls.rosminzdrav.ru/) manufacturers for drugs included in the list of vital and essential drugs, 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 social economic development RF, and 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 Russian Federation for the relevant industry in accordance with Decree of the Government of the Russian Federation of November 14, 2015 No. 1234 “On the procedure for developing, adjusting, monitoring and controlling the implementation of the forecast for the socio-economic development of the Russian Federation for the medium term and declaring certain acts of the Government of the Russian Federation as invalid.” |
6. To participate in the purchase of a medicinal product, not included in 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
When calculating NMCC, customers are required to apply the provisions 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. About the priority of this method, including when drugs are purchased from VED list this 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 medical institution, is obliged to request commercial proposals directly from potential procurement participants who have a license to pharmaceutical activities with the right to carry out wholesale trade (or with the right to carry out wholesale trade of medicines for medical use), or a production license medicines. 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 a purchased international non-proprietary name with certain technical characteristics several trade names are suitable, 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.
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 preparations for medical use" (hereinafter referred to as order N 871n, Procedure, NMCC) Department drug provision and regulation of circulation medical products 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 body executive power, carrying out the development of state policy and legal regulation in the areas of activity assigned to its jurisdiction. 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 medicines 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 regulatory legal act, but has an informational and explanatory nature on the application of Order No. 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 Order of the Ministry of Health of the Russian Federation dated October 26, 2017 No. 871n.
What has changed in the calculations
First of all new Order 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 offered a price higher than that indicated in the register of maximum selling prices for medicines and refuses to lower it (Clause 2, Part 10, Article 31 44-FZ). Let us remind you that this rule applies only to drug manufacturers and is used in the procurement of drugs from the VED register, 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 (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 government customer. And the application of reference prices was postponed until 01/01/2019.
Now, in the calculations of the NMCC, as the cost of one medication, use the unit price excluding VAT, taken from the concluded contracts. And from 07/01/2019, these data must be determined based on executed contracts and deduct not only VAT, but also the wholesale markup.
The changes also affected the wholesale markups themselves. Their size should not exceed the maximum values established by the executive authorities of the constituent entities of the Russian Federation. And wholesale markups will be applied if.
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER
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 for medical use
Lost force on January 4, 2020 on the basis
Order of the Ministry of Health of Russia dated December 19, 2019 N 1064n
____________________________________________________________________
____________________________________________________________________
Document with changes made:
(Official Internet portal of legal information www.pravo.gov.ru, 07.25.2018, N 0001201807250022).
____________________________________________________________________
In accordance with Part 22 of Article 22 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” (Collected Legislation of the Russian Federation, 2013, N 14, Art. .1652; 2014, art. 2925, no. 6637; 2015, no. 1418; 4342, no. 26; , Art. 3890; 2017, N 31, Art. 4780) and paragraph 1 of the Decree of the Government of the Russian Federation of February 8, 2017 N 149 “On the federal executive body authorized to establish the procedure for determining the initial (maximum) contract price, contract price concluded with a single supplier (contractor, performer) when purchasing medicines for medical use" (Collected Legislation of the Russian Federation, 2017, No. 7, Art. 1088; No. 23, Art. 3359)
I order:
1. Approve the attached Procedure for determining the initial (maximum) contract price, the contract price concluded with a single supplier (contractor, performer), when purchasing medicines for medical use.
2. This order 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 for posting information about placing orders for 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.
Minister
V.I.Skvortsova
Registered
at the Ministry of Justice
Russian Federation
November 27, 2017,
registration N 49016
The procedure for determining the initial (maximum) contract price, the price of a contract concluded with a single supplier (contractor, performer) when purchasing medicines for medical use
APPROVED
by order
Ministry of Health
Russian Federation
dated October 26, 2017 N 871н
1. This procedure defines uniform rules for the calculation by customers of the initial (maximum) contract price, the contract price concluded with a single supplier (contractor, performer) (hereinafter referred to as the NMCC) when purchasing medicines for medical use (hereinafter referred to as medicines) to provide state and municipal needs.
2. Calculation of NMCC is carried out according to the formula:
Where:
n- quantity of medicines supplied;
- price per unit planned for purchase i-th medicinal product taking into account value added tax (hereinafter - VAT) and wholesale markup;
_______________
The footnote has become invalid since August 5, 2018 - order of the Russian Ministry of Health dated June 26, 2018 N 386n..
- scope of supply i-th medicinal product.
2_1. When calculating NMCC, wholesale markups, the amount of which should not exceed size limits wholesale markups established by the executive authorities of the constituent entities of the Russian Federation ((Collected Legislation of the Russian Federation, 2010, No. 16, Art. 1815; 2015, No. 29, Art. 4367) are applied when purchasing medicines that are included in the list of vital and essential medicines (except for cases of purchase from the manufacturer of medicines):
a) to meet federal needs, if the NMCC does not exceed ten million rubles, and also if the NMCC exceeds ten million rubles, provided that the price of a unit of a medicinal product planned for purchase does not exceed the price of such a medicinal product contained in the state register of maximum selling prices of manufacturers for medicinal products drugs included in the list of vital and essential drugs;
b) to meet the needs of a constituent entity of the Russian Federation, municipal needs, if the NMCC does not exceed the size established by the highest executive body state power of a constituent entity of the Russian Federation and amounts to no more than ten million rubles, and also if the NMCC exceeds the amount established by the highest executive body of state power of a constituent entity of the Russian Federation or exceeds ten million rubles, provided that the unit price of the medicinal product planned for purchase does not exceed the price of such medicinal product, contained in the state register of maximum selling prices of manufacturers for medicines included in the list of vital and essential medicines.
(The item was additionally included from August 5, 2018 by order of the Russian Ministry of Health dated June 26, 2018 N 386n)
3. The unit price of a medicinal product planned for purchase is established by one name (international nonproprietary name, in the absence of such a name - by group or chemical name, as well as the composition of the combined medicinal product) taking into account equivalent dosage forms and dosages by:
a) application of the methods provided for in parts 2 and 8 of Article 22 of the Federal Law “On the contract system in the field of procurement of goods, works, services to meet state and municipal needs”, excluding VAT and wholesale markups;
b) calculation of the weighted average price based on all state (municipal) contracts executed by the customer or agreements for the supply of a medicinal product planned for purchase, taking into account equivalent dosage forms and dosages for the 12 months preceding the month of calculation (hereinafter referred to as the weighted average price), with the exception of state (municipal) ) contracts or agreements for the supply of medications necessary for prescription to a patient in the presence of medical indications (individual intolerance, according to vital signs) by decision of the medical commission medical organization:
by order of the Russian Ministry of Health of June 26, 2018 N 386n.
Where:
- unit price of the medicinal product excluding VAT and wholesale markup;
k- the number of purchased drugs in equivalent dosage forms and dosages.
c) using the price that is calculated automatically in the unified state information system in the field of healthcare (hereinafter referred to as the reference price) in accordance with paragraph 4 of this Procedure, information about which is provided to the unified information system in the field of procurement through information interaction between these systems.
_______________
Paragraph thirteen of paragraph 13 of Article 3 of the Federal Law of July 29, 2017 N 242-FZ “On amendments to certain legislative acts of the Russian Federation on the use of information technologies in the field of health protection” (Collected Legislation of the Russian Federation, 2017, N 31, Art. .4791).
The provisions of subparagraph "c" of paragraph 3 of this Procedure do not apply until January 1, 2019 with regard to the use of the reference price when calculating the NMCC.
(Footnote as amended, put into effect on August 5, 2018 by order of the Ministry of Health of Russia dated June 26, 2018 N 386n.
Decree of the Government of the Russian Federation of December 23, 2015 N 1414 “On the procedure for functioning of the unified information system in the field of procurement” (Collected Legislation of the Russian Federation, 2016, N 2, Art. 324; 2017, N 17, Art. 2565).
4. Calculation of reference prices is carried out automatically taking into account purchase volumes through the use of the resources of the unified state information system in the field of healthcare (hereinafter referred to as the Uniform State Health Information System) as of January 1, April 1, July 1 and October 1 of the current year within one name (international generic name, in the absence of such a name - by group or chemical name, as well as the composition of the combined medicinal product) taking into account equivalent dosage forms and dosages (hereinafter referred to as the group of medicinal products) according to the following formula:
Where:
- 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;
(Paragraph as amended, put into effect on August 5, 2018 by order of the Ministry of Health of Russia dated June 26, 2018 N 386n.
________________
Until July 1, 2019, data from concluded contracts excluding VAT are taken into account when calculating the price per unit of a medicinal product; after this date, data from executed contracts excluding VAT and wholesale markup are taken into account.
(Footnote additionally included from August 5, 2018 by order of the Russian Ministry of Health dated June 26, 2018 N 386n)
- volume of supply of a medicinal product for a separate group of medicinal products;
- unit price of a medicinal product for a separate group of medicinal products.
5. For the price of a unit of a medicinal product planned for purchase, the customer accepts the minimum price value from the prices calculated by him while simultaneously using the methods provided for in paragraph 3 of this Procedure.
by order of the Russian Ministry of Health of June 26, 2018 N 386n.
6. If no application for participation in the procurement has been submitted under the NMCC with the unit price of the medicinal product planned for purchase, determined in accordance with subparagraph “a” of paragraph 3 of this Procedure or the weighted average price, when announcing the next purchase as the unit price of the planned The reference price is accepted for the purchase of a medicinal product.
_______________
Until July 1, 2018, when the next purchase is announced, the unit price of the medicinal product planned for purchase is considered to be the following minimum value, calculated in accordance with parts 2 - 6 of Article 22 of the Federal Law of April 5, 2013 N 44-FZ "On the contract system in the field of procurement" goods, works, services to meet state and municipal needs" (Collected Legislation of the Russian Federation, 2013, N 14, Art. 1652; N 52, Art. 6961; 2014, N 23, Art. 2925; N 48, Art. 6637; 2015, No. 10, Art. 1418; No. 29, Art. 4342, Art. 4346; 2016, No. 26, Art. 3890).
7. If not a single application for participation in the procurement has been submitted for the NMCC, calculated on the basis of the reference price, when announcing the next purchase, the price of a unit of the medicinal product planned for purchase is determined by increasing the reference price by the standard deviation indicator, which is calculated automatically using the Uniform State Health Information System according to formula:
Where:
- standard deviation indicator;
- the value of the unit price of the medicinal substance obtained for the contract with number i;
n is the number of values used in the calculation;
- arithmetic mean value of a unit of a medicinal product in the sample.
8. If a purchase with an increased reference price is declared invalid, if no applications have been submitted for participation in the purchase, the unit price of the medicinal product planned for purchase is again increased by the standard deviation. At the same time, the unit price of a medicinal product planned for purchase should not exceed the maximum value of the price contained in the state register of registered maximum selling prices of manufacturers for medicinal products included in the list of vital and essential medicinal products (hereinafter referred to as the register), taking into account equivalent dosage forms and dosages.
9. In relation to a medicinal product included in the list of vital and essential medicinal products (hereinafter referred to as VED), for which there is no reference price, or the purchase with the NMCC calculated in accordance with paragraph 8 of this Procedure is recognized as failed if participation not a single application has been submitted in the procurement; when announcing the next procurement, the unit price of the medicinal product planned for procurement is taken to be a price not higher than the maximum price provided by the register, taking into account equivalent dosage forms and dosages.
(Clause as amended, put into effect on August 5, 2018 by order of the Ministry of Health of Russia dated June 26, 2018 N 386n.
10. In relation to a medicinal product not included in the Vital and Essential Drugs, for which there is no reference price, or the purchase with the NMCC calculated in accordance with paragraph 8 of this Procedure is recognized as failed if no application for participation in the purchase is submitted, upon announcement next purchase, the unit price of the medicinal product planned for purchase increases by the deflator index for the types of economic activity determined by the Ministry of Economic Development of the Russian Federation as part of the development of a forecast for the socio-economic development of the Russian Federation and cannot exceed the maximum value of offers from manufacturers (suppliers) of medicinal products.
_______________
The forecast value of the deflator index is used, 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 of November 14, 2015 N 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 the recognition as invalid of certain acts of the Government of the Russian Federation" (Collection of Legislation of the Russian Federation, 2015, N 47, Art. 6598; 2017, N 38, Art. 5627), - "Chemical and production of rubber and plastic products."
If no application for participation in the procurement has been submitted under the NMCC, calculated by increasing by the deflator index by type of economic activity, the unit price of the medicinal product planned for purchase is the price calculated on the basis of proposals from manufacturers (suppliers) of medicinal products.
Revision of the document taking into account
changes and additions prepared
JSC "Kodeks"
