Changes in the state procurement procedure for medicines, medical devices and consumables

1. Additional grounds for purchases to be made from a sole supplier

1.1. Until 8 March 2024 state and municipal medical institutions may purchase medicines, medical devices and consumables from a sole supplier, if the following conditions are met:

• the purchase is made in electronic form;

• the sole producer is located in Russia or in a country that has not introduced sanctions against Russia;

• the founder of the medical institution has approved the purchase;

• the annual volume of purchases on such ground does not exceed RUB 50 million for medicines or consumables and RUB 250 million for medical devices.

1.2. The law announces that a Register of Sole Suppliers is to be created. Companies entered into the Register will be able to conclude a contract for the purchase of medicines and medical devices without any bidding being held regardless of the contract amount and the annual turnover. The Register will only include companies which are not residents of “hostile countries” and which produce medicines and medical devices which have no Russian equivalents. The Russian Government should determine the rules for keeping the Register shortly.

1.3. The maximum contract price has been increased from RUB 1 million to RUB 1.5 million for the purchase from a sole supplier of medicines which are purchased for a specific patient (on such grounds as a life-saving need or an individual intolerance).

1.4. The procedure has been simplified for the Social Insurance Fund to purchase technical tools for rehabilitation and services from a sole supplier. Such purchase may be carried out without additional limitations if the following conditions are met simultaneously:

• the purchase is made in electronic form;

• the sole producer is located in Russia or in a country that has not introduced sanctions against Russia.

2. The right to change the material terms of a contract

The parties to a state contract are entitled to amend by mutual agreement material terms and conditions of contracts concluded before 1 January 2023 if the contract cannot be performed owing to unforeseen circumstances. However, what specific circumstances are meant remains unclear. At the same time, for the right to be exercised a resolution is needed which is provided by the Russian Government, the supreme executive authority of the region or by the local administration.

3. Procurement of medical devices has been simplified

The government has implemented the right provided for by the Law to increase the maximum starting price of a contract and the annual purchase volume of individual nomenclatures of medical devices which are purchased through requesting quotations electronically (please see Resolution No.297 of the Russian Government dated 6 March 2022). Simplified rules and revised limits may apply to such purchase if the following conditions are met:

• the subject matter of the purchase includes medical equipment and relevant consumables as well as technical tools for the rehabilitation of disabled people (exceptions: disposable medical devices, absorbent linen, diapers, support surfaces and pillows);

• the maximum starting price of the contract does not exceed RUB 50 million;

• the annual purchase volume must not exceed RUB 750 million.

The measures which the Government has approved in this respect will be in force until 1 August 2022. However, we believe that the specified term may be subsequently extended.

Help from your adviser

Taking into account the new developments in legislation, Pepeliaev Group's lawyers are ready to provide professional assistance and to advise on complicated and/or complex issues of the legislation on the state procurement of medicines, medical devices or other products intended for the protection of human life and health, as well as to provide other legal services connected with launching pharmaceutical products on the markets of Russia and the Eurasian Economic Union.