By the ruling of the Supreme Court of the Russian Federation dated 09.21.2020 No. 310-ES20-13277 in case No. A64-3869 / 2019, it was refused to transfer the case to the Judicial Collegium for Economic Disputes of the Supreme Court. The Supreme Court confirmed the correctness of the conclusions of the Arbitration Court of the Central District, which overturned the judgments of the lower courts, which recognized the decisions of the regional Department of the Federal Antitrust Service on the groundlessness of the rejection of the bid of the procurement participant by the customer.
The reason for the appeal of the state customer to the court of the first instance was the recognition by the regional Department of the Federal Antitrust Service of a substantiated complaint of the procurement participant against the decision of the auction commission to refuse admission to participate in the auction for the supply of the medicinal product Bromhexin + Guaifenesin + Salbutamol as not complying with the requirements of the auction documentation.
The court of cassation, when canceling the judicial acts of the courts of first and appeal, proceeded from the fact that according to the information provided by the State Register of Medicines, the drug “Kashnol” (proposed by the procurement participant, whose application was rejected) with the dosage form “syrup” from the pharmaceutical substance “Bromhexine + Salbutamol + Guaifenesin + Levomenthol” is interchangeable in relation to the reference drug – “Ascoril expectorant” in accordance with the information from the card of the latter (“Bromhexin + Salbutamol + Guaifenesin”). This reference drug contains links to interchangeable drugs, including Kashnol. The State Register of Medicines is an open and accessible information resource but was unreasonably not taken into account by the auction commission when considering the first parts of applications.
The court of cassation noted that in accordance with paragraph 3 of the Rules for determining the interchangeability of medicinal products for medical use, approved by Decree of the Government of the Russian Federation No. 1154 dated 28.10.2015, the interchangeability of a medicinal product is determined in the process of its state registration based on comparison with a reference medicinal product during the examination of the medicinal product in terms of the examination of the quality of the medicinal product and (or) examination of the relationship of the expected benefit to the possible risk of using the medicinal product.
However, the cassation court indicated that having limited themselves solely to the application of the above norm, the lower courts stated that the conclusion about the interchangeability of drugs can be made exclusively by a commission of experts of the federal state budgetary institution for the examination of drugs under the jurisdiction of the Ministry of Health of Russia. At the same time, the courts did not apply the rules of law to be applied in the dispute under consideration, namely, the provisions of Part 3 of Article 3 of the Federal Law dated December 22, 2014 No. 429-FZ “On Amendments to the Federal Law dated April 12, 2010 No. 61-FZ “On Medicines”, by virtue of which information on the interchangeability of medicinal products for medical use is subject to mandatory inclusion in the State Register of Medicines from January 1, 2018.
Since the regional Department of the Federal Antitrust Service was guided by the information of the State Register of Medicines when issuing the order, the Supreme Court upheld the judicial act of the court of cassation, which recognized the decision and order of the control body as reasonable.