On August 31, 2020, the decree of the Ministry of Health of the Russian Federation of May 15, 2020, N 450n “On approval of the procedure for determining the initial (maximum) contract price, the price of a contract concluded with a single supplier (contractor, performer), and the initial unit price of goods” came into force, work, services in the procurement of medical products.
The formula for calculating the initial (maximum) initial (maximum) procurement price of medical devices is the following:
n - number of items of purchased medical devices;
IUP – initial unit price of the “i” position of a medical device, determined in accordance with this procedure (as applicable);
VAT – value-added tax (if applicable for the purchased medical device);
Vi – quantity (volume) of the “i” position of the purchased medical device.
As a general rule, it is established that the initial unit price of a medical device is set as the weighted average value (or not more than the weighted average price) of prices collected by the customer excluding VAT based on the use of one or a combination of:
• method of comparable market prices (market analysis);
• information contained in the Register of contracts confirming the performance by the participant (excluding the succession) within 3 years before the date of filing an application for participation in the procurement of 3 contracts executed without the application of penalties (fines, penalties) to such a participant. When applying the latter method, the customer takes into account at least 3 prices for contracts concluded on the basis of competitive purchases and executed within 3 years within the constituent entity of the Russian Federation where the customer is located. If there are no similar contracts in a given constituent entity of the Russian Federation, then contracts executed in adjacent constituent entities of the Russian Federation are considered.
This legal act contains various formulas for calculating the initial unit price of a medical device, depending on the need for maintenance of the medical device and the need to purchase consumables for its use.
The method of comparable market prices is used to calculate:
• The initial unit price of a medical device and (or) consumables and (or) maintenance services for the period of the warranty period of the medical device;
• The initial (maximum) price of a contract with a single supplier for technical devices of rehabilitation, which relates to medical devices, provided for by the Federal list of rehabilitation measures, technical means of rehabilitation, and services provided to a disabled person.
The method of comparable market prices, as well as the tariff method, can be used to calculate the initial price of a unit of a medical device, for which state regulation of prices has been established and which is included in the State register of maximum selling prices of manufacturers for medical devices. In this case, the price indicated in the procurement documentation should not exceed the price calculated by the tariff method.
In a number of cases, the use of exclusively the market analysis method is possible when purchasing from a single supplier (for example, when purchasing for the performance of work on mobilization training in the Russian Federation, if it is necessary to provide emergency medical care, as part of some purchases by enterprises of the penal system, etc.).
It is noteworthy that the new procedure for calculating the Initial (maximum) price of a contract for medical devices established that in order to form the cost of consumables and maintenance for the warranty period of a medical device, the warranty period is set by the customer in accordance with the operational documentation of the medical device and must be at least 12 months. In the absence of information on the warranty period in the operational documentation, such a period is recognized as equal to 24 months from the date of transfer of the medical device to the customer. The procedure provides decoding of the concept of “consumables”, which includes products and components that ensure the use and operation of medical devices, as well as information about which is contained in the relevant operational documentation.
It is important to note that the adopted new procedure for calculating the Initial (maximum) contract price applies only to purchases, notices of the implementation of which were posted after its entry into force, that is, from August 31, 2020.
Also, the Decree does not apply when:
• procurement of medical devices included in the list of disposable (use) medical devices made of polyvinyl chloride plastics, originating from foreign countries, in respect of which admission restrictions for the purposes of public procurement are established by the Decree of the Government of Russia dated February 05, 2015 N 102;
• procurement of medical devices that are radio-electronic products, in the event of a restriction on the admission of such products originating from foreign countries (in accordance with the provisions of the Decree of the Government of the Russian Federation dated July 10, 2019 N 878);
• procurement under the state defense order.
September 9, 2020
Lawyer of BRACE Law Firm ©