BRACE Law Firm informs that from February 1, 2018, state customers, when purchasing medicines for medical use, are obliged to use the standard contract form.
The form of a standard contract for the supply of medicinal products for medical use was approved by Order No. 870n of the Ministry of Health of the Russian Federation of October 26, 2017 (entered into force on 01.01.2018) and placed in the UIS on 16.01.2018. After 30 calendar days from the date of placement of the form in the UIS, the state customers have a duty to use it.
Scope of the standard contract form
The typical form of the contract will be used for public procurements of any medicinal products for medical use, regardless of the initial (maximum) price of the contract, the number and methods of supply. The approved form does not apply to the supply of drugs for veterinary medicine.
At the same time, there are quite wide exceptions from the scope of application. So, the form is not applicable:
- with respect to procurements under the state defense order;
- in relation to the procurement of goods for the provision of state and municipal needs, the notice of implementation of which is placed in the EIS until January 1, 2018.
It should also be took into account paragraph 18 of the Rules for the development of standard contracts, standard terms of contracts (approved by the RF Government Decree No. 606 of 02.07.2014), which also provides for a whole list of exemptions. If the need to apply a model contract, standard contract terms is not provided for by an information card, the form is also not applied in the following cases:
- procurements for cash;
- when conducting a request for quotations to support the activities of the customer in the territory of a foreign state;
- when requesting quotes for the provision of emergency medical services, including emergency medical assistance, in urgent or urgent form and for normal life support of citizens;
- in case of procurements for state needs from a single supplier determined by a decree or an order of the President of the Russian Federation or in cases established by instructions of the President of the Russian Federation from a supplier specified in a resolution or order of the Government of the Russian Federation - if the legal acts of the President or Government indicate the possibility of concluding a contract without using a standard contract, typical conditions of the contract;
- for procurements due to an accident, other emergencies of a natural or man-made nature, force majeure, when there is a need to provide emergency medical care or to provide emergency medical assistance (if the goods are not included in the list of goods required by the Government of the Russian Federation for provision of humanitarian assistance or liquidation of the consequences of natural or man-made emergency situations) and the use of other methods for determining the supplier that require the removal at the time, it is impractical;
- for the procurements of medicinal products that are intended for prescribing to the patient in the presence of medical indications (individual intolerance, according to vital indications) by the decision of the medical commission.
Main provisions of the model contract
The standard contract includes standard formulations for drug delivery. Thus, the template contract regulated the subject and price, the order of interaction of the parties, the procedure for packaging, transportation and delivery of goods, the procedure for its acceptance and random inspection, the procedure for payment and enforcement of the contract, the responsibility of the parties to the contract, its validity.
Among the key provisions of the model contract for the supply of medicines for medical use, it should be noted:
- in a contract it is necessary to indicate how the delivery will be carried out: with or without discharge;
- the obligation of a supplier to attract co-executors is established in the event that such condition was stipulated by a procurement documentation, as well as a list of information on co-executors that will need to be provided to the state customer within 5 working days from the date of signing the contract with the co-executor;
- detailed requirements for packaging and labeling of medicines;
- the procedure for conducting a customer's random inspection of goods is reflected;
- it has been established that samples of medicinal products for carrying out laboratory tests are not included in the quantity of the goods stipulated by the contract and are provided by the supplier at their own expense;
- the maximum period for acceptance and signing of the acceptance certificate of the goods by the customer is fixed - 15 working days;
- the right of the customer to demand replacement of all delivered goods is established or to check each delivered unit at the supplier's expense, but only if, based on the results of a spot check of the goods, it turns out that it does not meet the requirements of the contract. At the same time, the deadline for such verification is not established by a standard contract;
- a large number of applications, both mandatory (specification, technical specifications, calendar plan, certificate of acceptance and transfer of goods, reconciliation statement), and additional (shipping order, consolidated register of commodity invoices for the delivery of goods, an act on the performance of obligations under the contract).
Terms of payment
Payment for a standard contract is always made in a non-cash form, with the presence or absence of an advance payment, as well as the source of funds for payment for the delivery. In addition, the contract contains a list of documents provided by the supplier for payment of delivery, as well as requirements for their registration. Terms of payment cannot exceed 30 days, and if the supplier belongs to the subjects of SMB (small and medium business) - 15 working days from the moment the customer signs the act of transfer and acceptance of goods / act on performance of obligations under the contract. It is allowed both phased payment and payment upon delivery of the entire product.
Change in the conditions of the template contract
According to paragraph 7 of the Rules for the development of standard contracts, standard terms of contracts (approved by the RF Government Decree No. 606 of 02.07.2014), standard contracts, standard terms of contracts consist of the following parts:
a) a permanent part that is not subject to change when applied in a particular procurement;
b) a variable part providing for the possibility of selecting one or more variants of conditions (data) from the proposed exhaustive list of such variants of conditions (data) specified by the responsible authority in the model contract, the standard terms of contracts, as well as the possibility of entering information on the conditions (data), the content of such conditions (data) and the procedure for determining such content.
A mandatory part of a standard contract for the procurement of medicines includes, for example, the procedure for changing prices, conditions for packaging and labeling, the procedure for accepting goods, the conditions for selective testing and quality of the goods.
The variable part that can be changed by a customer includes: the order and method of delivery, the method of payment, the period for refunding the security of the contract.
The supplier can only register the disagreement protocol for the variable parts.
Liability of the parties to a template contract
The contract establishes the amount of the responsibility of the customer and the supplier for the delay in meeting the obligations - a fine of one three hundredth the refinancing rate of the Central Bank of the Russian Federation effective on the date of payment of interest. There is also a system of penalties, which one party is entitled to recover from the second party for each failure to fulfill the obligations stipulated in the contract (except for their delay). At the same time, the total amount of fines and penalties accrued to the guilty party is limited to the price of the contract.
In the case of co-executors involved in the execution of the contract, the supplier is liable to the customer for failure to perform the obligations under the contract. In addition, the supplier is liable to the customer for non-involvement of co-executors in the amount stipulated in the contract, as well as for late submission of documents or submission of documents containing inaccurate information.
Unclear provisions of the model contract causing questions
Some provisions of the model contract raise questions. For example, the condition for drawing up a contract in several identical in content and having equal legal force copies (which implies a paper carrier), although most of the contracts for the supply of medicines have long been in the form of an electronic document.
Also raises questions about the VAT clause. It is unclear who and at what stage can change the condition of the contract "including VAT" on the wording "(if VAT is not levied, indicate the basis ...)". The given question is actual, for example, for those cases when the supplier applies STS (simplified taxation system).
The document itself contains a lot of explanations for its completion. Also, an information card for a standard contract for the supply of medicines for medical use has been approved, which provides indicators for the application of a standard contract (name of the goods, code for ACPA 2 - All-Russian classifier of products by types of economic activity, size of the IMCP - initial maximum contract price). In addition, the Ministry of Health of Russia, in a letter dated 14.02.2018 No. 418/25-5, provided answers to frequently asked questions in the preparation of the contract.
However, despite this, some formulations of the model contract continue to be insufficiently defined and unambiguous. And some of its items do not correspond to the new version of Law No. 44-FZ, which comes into force on July 1, 2018. For example, according to the new 44-FZ norms, the customer obligatorily establishes the requirement for security of the application only if the IMCP exceeds 5 million rubles; there is no such clause in the model contract.
In this regard, customers at first can face difficulties in preparing both the contract itself for the standard form, and its annexes.