The Russian Ministry of Health is introducing a new procedure for justifying the price of medicines. It retains the principle of choosing the minimum price from four calculated ones. In the article, you will learn the better the new procedure and how to apply it to the customer when justifying the price.
Order of the Ministry of Health dated 10.26.2017 No. 871n is no longer valid. The procedure is determined by the new order of the Ministry of Health No. 1064n dated 12/19/2019. It retains the principle of choosing the minimum price from four calculated using the method of comparable market prices, the tariff method for the VED list, at the weighted average price from the concluded contracts and the reference price in the EIS.
The customer considers the NMCK for each of the four methods, and chooses the smallest one as the final one. He calculates the unit price of a drug excluding VAT. Wholesale markups can only be applied to drugs from the VED list. In all other cases, you calculate the price without wholesale markups.
What drugs were removed from the procedure for determining the NMC for the purchase of drugs
The new procedure is not applied to all drugs. The procedure does not apply to drugs that are not in serial production and are manufactured directly by pharmacy organizations - extremporal drugs. When purchasing from a supplier in the case of medical care in urgent and emergency situations, customers may not apply this procedure. You can justify the price only by the method of comparable market prices and purchase the necessary medicine.
The Russian Ministry of Health is introducing a new procedure for justifying the price of medicines. It retains the principle of choosing the minimum price from four calculated ones. From the article you will learn the better the new procedure and how to apply it to the customer when justifying the price.
Read new rulesFive exceptions when calculating the weighted average price for a new order
Do not take into account the weighted average contract price if:
1. the contract was concluded by the 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, and you purchase multiple-component drugs or kits. This exclusion does not apply if the contract for the one-way drugs was awarded through a competitive procedure;
3. a contract with a medicine that no longer circulates in the Russian Federation. You can find out this information on the website roszdravnadzor.ru;
4. the remaining shelf life of the supplied medicine under the contract differs by 20% or more from that provided for in the contract. For example, the contract specifies a residual shelf life of 12 months, and the supplier supplied with a residual shelf life of 24 months.
5. contracts with fines and penalties due to default or improper performance of obligations by the supplier.
How the customer was punished for an error in one of the three ways of substantiating the NMCC by Order of the Ministry of Health No. 871-n
The hospital purchased the INN medicine Vinpocetine with NMCC RUB 273,093. When the contract manager used three methods to justify the price of a drug to derive the average, he made a mistake. In the tariff method, he took the price of 3.23 rubles. for 1 ml, but should have taken 1.62 rubles. When choosing such a value from the state register of the maximum selling prices of manufacturers for medicines, he overestimated the NMCK by 29,380 rubles. FAS found the specialist guilty and ordered him to pay a fine of 20 thousand rubles. (Resolution on the appointment of an administrative penalty No. 69-12-34 / 2018/48 of 30.08.2018).
Attached files
- Model contract for the supply of a medicinal product for medical use.docx
In connection with the incoming requests on the application of the norms of the order of the Ministry of Health of the Russian Federation of October 26, 2017 N 871н "On approval of the Procedure for determining the initial (maximum) contract price, drugs for medical use "(hereinafter respectively - order N 871н, Order, NMTSK) The Department of drug supply and regulation of the circulation of medical devices of the Ministry of Health of Russia reports the following.
In accordance with the Regulation on the Ministry of Health of the Russian Federation, approved by the Resolution of the Government of the Russian Federation on June 19, 2012 N 608 (hereinafter referred to as the Regulation), the Ministry of Health of Russia is a federal executive body that develops state policy and legal regulation within its jurisdiction. areas of activity. According to the Regulation, the Ministry of Health of Russia is not empowered to officially explain the legislation of the Russian Federation, as well as the practice of its application.
1. Order No. 871n comes into force on December 9, 2017 and, taking into account the transitional provisions provided for in paragraph 2 of this order, order No. 871n does not apply to the procurement of goods to meet state and municipal needs, notifications of the implementation of which are posted in a single information the procurement system or on the official website of the Russian Federation in 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 date of entry into force of this order.
It should be borne in mind that if during the preparation and placement of notices on the procurement of medicinal products when recalculating the NMCC in accordance with the Procedure, the size of the NMCC changes, then in accordance with clause 1 of part 13 of article 21 of Federal Law No. 44-FZ of April 5, 2013 "On the contractual 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 order provides for a certain algorithm and sequence of actions of the customer in the formation of the NMC for drugs both included in the list of vital and essential drugs (hereinafter - VED) and not included in this list.
In the event that no bids have been submitted for participation in the procurement, the customer can re-prepare for the electronic auction in accordance with Federal Law No. 44-FZ and the established Procedure for calculating the NMCK.
At the same time, it is important that customers are advised to analyze the reasons for the absence of applications, including in order to timely inform the FAS of Russia and its territorial bodies about possible cartel arrangements.
3. In order to prevent double counting of value added tax (hereinafter - VAT) and wholesale mark-up when calculating the unit price of a drug planned for purchase, it is necessary to take into account the fact that prices in previously concluded contracts and prices offered by manufacturers (suppliers) of drugs , 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 VED list and their 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 prescriptions, and is not a normative legal act, but has an informational and explanatory nature on the application of Order No. 871n.
The procedure for determining the initial (maximum) contract price, the price of a contract concluded with a single supplier (contractor, performer) in the procurement of medicines for medical use ", approved. (Hereinafter referred to as the Procedure).
The purpose of the algorithm is to highlight the key stages or steps for applying the new Order. Therefore, let's start with clause 5 of the Procedure, which determines the first actions of the customer:
STEP 15. For the price of a unit of a medicinal product planned for procurement, the customer shall take the minimum value of the price calculated by him in accordance with paragraph 3 of this Procedure.
Clause 3 of the Procedure establishes several methods of calculation, subparagraphs a), b), c):
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application of the methods specified in parts 2 - 6 and 8 Article 22 Federal Law "On the contractual system in the field of procurement of goods, works, services to meet state and municipal needs", excluding VAT and wholesale mark-up |
Current methods, according to the methodology of the Ministry of Economic Development (Order No. 567): market analysis method. |
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payment weighted average price on the basis of all state (municipal) contracts or agreements concluded by the customer for the supply of a medicinal product planned for procurement, taking into account equivalent dosage forms and dosages for 12 months preceding the month of calculation (hereinafter - the weighted average price), with the exception of state (municipal) contracts or contracts for supply of medicinal products necessary for prescribing to a patient in the presence of medical indications (individual intolerance, for health reasons) by decision of the medical commission of a medical organization |
New method, described in order 871n |
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use of the price, which is calculated automatically in the unified state information system in the field of health care (hereinafter - reference price) in accordance with clause 4 of this Procedure, information about which is provided to a unified information system in the field of procurement through information interaction between these systems. |
The method has not yet been applied: The provisions of sub-clause "c" of clause 3 are not applied until July 1, 2018 in relation to the use of the reference price when calculating the NMCK. |
Those. according to the note to subparagraph c) of paragraph 3, reference prices are not applied until the corresponding subsystem of the EIS is launched. The note is contained in the text of the Procedure itself (subparagraphs c), clause 3), therefore, such a calculation is not necessary.
In fact, according to paragraph 5 of the order, the task for calculating the NMCK is now to make a calculation according to a) those. current methodology (order No. 567 of the Ministry of Economic Development, market analysis method). Then compare the resulting unit price with the result for item b)- calculation of the weighted average price (STEP 2). The concept of "weighted average price" is new, it has not previously been found in the law and by-laws.
To deal with it, it is necessary to analyze the definition given above. Let's try to "pull" the important points out of it:
- all state (municipal) or contracts concluded by the customer for the previous 12 months are taken into account
- equivalent dosage forms and dosages are taken into account
- excludes contracts or agreements for the supply of drugs necessary for prescribing to a patient in the presence of medical indications (individual intolerance, for health reasons) by decision of the medical commission of a medical organization
- the weighted average price is calculated as the unit price of a medicinal product excluding VAT and wholesale mark-up (this is already taken from the formula that is given after the definition)
STEP 2 So, the unit price formula. It is no more complicated than just the arithmetic mean:
STEP 3... After the unit price of the drug by the methods a) and b)(according to the STEP 1 table) is calculated, you need to compare them and choose the smallest one. It should be noted that for (a)- according to the Methodology of the Ministry of Economic Development (Order No. 567), when using the base prices of previous periods obtained from the register of contracts in the calculation of the NMC, they can be indexed to the consumer price index (CPI). In calculating weighted average prices (b) there is no such possibility, therefore there is reason to believe that the weighted average prices will be lower.
After that, you can proceed to point 2 of the Order, i.e. from the preparation of base unit prices, in fact, to the calculation of the NMC. Everything seems to be simple here - the unit price is multiplied by the volume. NMTSK for different medicinal products (if the delivery involves the number of names of more than 1) are added.
The price in this formula should already take into account VAT and the wholesale markup (although they are not taken into account in the previous formula for calculating the base weighted average price). And this is where difficulties are possible - you will have to reduce the purchase prices of previous periods (C1) for VAT and a wholesale markup. How to do it correctly and what is the point - it is not yet clear from the order, details are being specified ...
The link in the Procedure, the symbol -1- to paragraph 2) of Part 10 of Article 31 44-FZ, also causes doubt and misunderstanding here. According to part 10 of Article 31 of the Law, when purchasing medicinal products that are included in the VED list, in addition to the grounds provided for in part 9 of Article 31 of the Law, the procurement participant is removed from participation in determining the supplier (contractor, performer) or the refusal to conclude a contract with the winner determination (contractor, performer) is carried out at any time before the conclusion of the contract, if the customer or the procurement commission discovers that:
(clause 2 part 10) the price offered by such a procurement participant for the purchased medicinal products exceeds their maximum selling price and the procurement participant refuses to reduce the proposed price when concluding the contract.
So, while such a chain has turned out (if you consistently make the calculation according to the points of the Order)
STEP 1: point 5 - STEP 2: point 3 a) and b) - STEP 3: point 2
STEP 4.
This is not an obligatory stage, but the Order, and after it we designate it. The situation when the auction did not take place. Clause 6 of the Order says:
In the event that not a single application has been submitted for participation in the procurement for the NMC with the price of a unit of a drug planned for procurement, determined in accordance with subparagraph "a" of paragraph 3 of this Procedure or the weighted average price, when announcing the next procurement as the price of a unit planned for procurement the drug is taken reference price <5> .
Again, the note that is given with the icon is important here. <5> :
<5> Until July 1, 2018, when announcing the next purchase, the unit price for the purchase of a medicinal product is considered next 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 procurement of goods, works, services to meet state and municipal needs."
Those. before July 1, 2018, the reference price is closed. Instead, as in paragraph a) STEP1 tables - market analysis method. But what is meant by "next minimum value"? There is no such concept either in the law or in the methodology of the Ministry of Economic Development (Order No. 567). So far, we can only assume that this is not the base price that was calculated at STEP 1, but the one obtained as a result of the recalculation.
TOTAL: The algorithm is clear, it is not complicated, but labor-intensive, 50% of the labor is postponed until 07/01/2018. Execution questions still remained.
Heads of executive
authorities of the constituent entities of the Russian Federation
in the field of health
In connection with the incoming requests on the application of the norms of the order of the Ministry of Health of the Russian Federation of October 26, 2017 No.
No. 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) in the procurement of medicinal products for medical use" ensuring and regulating the circulation of medical devices, 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 No. 608 on June 19, 2012 (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 Regulation, the Ministry of Health of Russia is not empowered to officially explain the legislation of the Russian Federation, as well as the practice of its application.
1. Order No. 871n comes into force on December 9, 2017 and, taking into account the transitional provisions provided for in paragraph 2 of this order, order No. 871n does not apply to the procurement of goods to meet state and municipal needs, notifications of the implementation of which are posted in a single information the procurement system or on the official website of the Russian Federation in 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 entry into force of this order.
It should be borne in mind that if during the preparation and placement of notices on the procurement of medicinal products 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 Federal Law No. 44-FZ of April 5, 2013 "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs" (hereinafter - Federal Law No. 44-FZ), it is necessary to amend the procurement schedule.
2. The order provides for a certain algorithm and sequence of actions of the customer in the formation of the NMC for drugs both included in the list of vital and essential drugs (hereinafter - VED) and not included in this list.
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Item Order |
For medicinal products included in the list VED |
For medicinal products not included in the list VED |
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Selecting the minimum price value based on the results: |
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nn. "A" clause 3 of the Procedure |
method of comparable market prices: analysis of information on the website http://zakupki.gov.ru, request for proposals from manufacturers (suppliers) |
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tariff method (analysis of the price register) |
does not apply |
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nn. "B" clause 3 of the Procedure |
weighted average price calculation |
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announcement of an auction at the lowest possible price per unit of a drug planned for procurement |
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If no bids have been submitted for participation in the procurement, the customer can re-prepare for the electronic auction in accordance with Federal Law No. 44-FZ and the established Procedure for calculating the NMCK.
3. In order to prevent double counting of value added tax (hereinafter - VAT) and wholesale mark-up when calculating the unit price of a drug planned for purchase, it is necessary to take into account the fact that prices in previously concluded contracts and prices offered by manufacturers (suppliers) of drugs , may contain VAT and a wholesale markup, and the prices of the state register of maximum selling prices of manufacturers for drugs included in the VED list and reference prices do not contain them.
At the same time, we draw your attention to the fact that this letter does not contain legal norms or general rules specifying regulatory prescriptions, and is not a regulatory legal act, but has an informational and explanatory nature on the application of the order No. 871n.
Director of the Department of Medicines
ensuring and regulating circulation
medical devices of the Ministry of Health of Russia E.A. Maksimkina
1 Order of the Ministry of Finance of the Russian Federation of November 24, 2014 No. 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."In accordance with the Order of the Ministry of Health of the Russian Federation No. 871n dated October 26, 2017, from 09.12.2017, the NMCC or the price of contracts concluded with a single supplier for the state purchase of medicines will need to be determined using the new procedure. For purchases, notices for which were published in the EIS before December 9, 2017, this procedure is not used. How the unit price of a medicinal product is calculated The price is determined by one INN, but if there is no INN, then grouping or chemical names are used. When purchasing a combined medicinal product, its composition is calculated. When calculating, it is necessary to take into account the dosage, as well as equivalent dosage forms. The unit price of the drug is determined without taking into account the wholesale mark-up and VAT.
Nmc calculation of medicinal products from 09.12.2017
At the same time, VAT and a wholesale mark-up must be taken into account in the price of a drug unit. When a customer purchases several types of drugs, it is necessary to repeat the calculation for each type, and then add the obtained values.
How to recalculate the NMCK, if bids for participation in the procurement were not received If no one began to participate in the procurement, during the next NMCK it is considered an easier way. For example, when calculating the NMC, the unit price of the drug was used, determined using the comparable market price method, the tariff method or the weighted average price.
No bids have been submitted to participate in such a procurement. When announcing the next purchase, the customer must use the next minimum value calculated using the comparable market price method as the unit price of the drug.
Note that from July 1, 2018, the reference price will need to be used instead of this minimum value.
Company
After the unit price of the drug is calculated by methods a) and b) (according to the STEP 1 table), it is necessary to compare them and select the lowest one. It should be noted that for (a) - according to the Methodology of the Ministry of Economic Development (Order No. 567), when using the base prices of previous periods obtained from the register of contracts in the calculation of the NMC, they can be indexed to the consumer price index (CPI).
In calculating weighted average prices (b), this is not possible, so there is reason to think that weighted average prices will be lower. After that, you can proceed to point 2 of the Procedure, i.e.
from the preparation of base unit prices, in fact, to the calculation of the NMC. Everything seems to be simple here - the unit price is multiplied by the volume. NMTSK for different medicinal products (if the delivery involves the number of names of more than 1) are added.
Contractual Relations Forum
We believe that it should be used when purchasing drugs from the VED list; - by calculating the weighted average price based on contracts (agreements) for the supply of such a drug, concluded by the customer for 12 months preceding the month of calculation. Contracts (agreements) for the supply of drugs for prescribing to a patient by the decision of the medical commission are not taken into account.
After calculating by the indicated methods, the customer chooses the minimum value. This will be the price per unit of the medicinal product. From July 1, 2018, the use of the reference price will be added to the specified calculation methods.
Attention
It will be calculated automatically, and information about it will appear in the EIS. Thus, from July 1, 2018, it will be necessary to choose the minimum value taking into account the reference price.
How to calculate the NMCK To determine the NMCK, it is necessary to multiply the unit price of the purchased drug by the volume of its supply.
State order - practice. how to calculate nmc for government procurement of drugs?
Info
When calculating NMCK, customers are obliged to apply the provisions of Article 22 of Federal Law No. 44-FZ. There are several of the most common methods of calculating NMC, which are used by customers when dealing with the purchase of medicines.
1. Method of comparable market prices (market analysis). If you rely on clause 6 of article 22 of the Federal Law No. 44-FZ of 05.04.2013. the method of comparable market prices (market analysis) is the most important in determining and justifying the NMC, regardless of what type of goods will be purchased by the customer. The priority of this method, including when drugs from the VED list are purchased, are also discussed in the letter of the Ministry of Economic Development of the Russian Federation dated March 18, 2016 No. D28i-693.
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 the recognition as invalid of certain acts of the Government of the Russian Federation ”. 6. For participation in the procurement of a medicinal product not included in the VED list, not a single application has been submitted under the NMC, calculated by:
- an increase by the deflator index by type of economic activity,
- the price calculated on the basis of proposals from manufacturers (suppliers) of medicinal products is taken as the unit price of a medicinal product planned for procurement.
How to calculate nmc for drugs using a new calculation example
For participation in the procurement, not a single application has been submitted for the NMCC with the price of a unit of the drug planned for procurement, determined by:
- method of comparable market prices (market analysis), tariff method,
- weighted average price,
when announcing the next purchase, the reference price is taken as the unit price of the medicinal product planned for procurement (until 01.07.2018, when announcing the next procurement, the price of the medicinal product unit is considered the next minimum value calculated by the method of comparable market prices (market analysis)). 2.
In this case, several methods can be applied: tariff (it is usually used when purchasing drugs included in the VED list), the method of market comparable prices, as well as the method of calculating weighted average prices based on government contracts for the supply of such drugs, concluded for the calendar year preceding the calculation month. Contracts for the supply of drugs for prescribing to patients in accordance with the decision of the medical commission should not be taken into account.
After carrying out the calculation by the above methods, the customer must choose the minimum value, which will be the price of the drug unit. From 01.07.2018, the application of the reference price will be added to the specified calculation methods, which will be calculated automatically, and information about it should appear in the EIS.
That is, from July 1, 2018, the minimum value will need to be selected, taking into account the reference price.
Again, the note that is given with the icon is important here.<5: <5 До 1 июля 2018 года при объявлении следующей закупки ценой единицы планируемого к закупке лекарственного препарата считается следующее минимальное значение, рассчитанное в соответствии с частями 2 — 6 статьи 22 Федерального закона от 5 апреля 2013 г. N 44-ФЗ «О контрактной системе в сфере закупок товаров, работ, услуг для обеспечения государственных и муниципальных нужд» .
Those. before July 1, 2018, the reference price is closed. Instead, as in point a) of the STEP1 table, there is a market analysis method. But what is meant by "next minimum value"? There is no such concept either in the law or in the methodology of the Ministry of Economic Development (Order No. 567). So far, we can only assume that this is not the base price that was calculated at STEP 1, but the one obtained as a result of the recalculation.
Use of the price, which is calculated automatically in the unified state information system in the field of health care (reference price). Information from the EGIS in the field of health is provided to the EIS in the field of procurement through information interaction between these systems.
Attention! When calculating the NMCK before July 1, 2018, reference prices are not taken into account. Calculation of reference prices Reference prices are calculated in the Unified State Information System in the Healthcare Sector (Unified 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 a grouping or chemical name, as well as the composition of a combined medicinal product, taking into account equivalent dosage forms and dosages (in the absence of an INN).
