By Ruling No. 310-ES20-13277 dated September 21, 2020, in case No. A64-3869/2019, the Supreme Court of the Russian Federation denied the transfer of the case to the Judicial Chamber for Economic Disputes of the Supreme Court. The Supreme Court affirmed the soundness of the conclusions reached by the Commercial Court of the Central District, which had overturned the judicial acts of the lower courts that erroneously invalidated the decision of the Regional Directorate of the Federal Antimonopoly Service (UFAS) regarding the state customer’s unjustified rejection of a bidder’s application.

The state customer initiated proceedings in the court of first instance after the UFAS sustained a bidder's complaint against the auction commission’s decision to disqualify it from participating in a public auction for the supply of the pharmaceutical product "Bromhexine+Guaifenesin+Salbutamol" on the grounds of non-compliance with the auction documentation.

In reversing the judicial acts of the courts of first and appellate instances, the court of cassation determined that, according to data from the State Register of Medicines (GrLS), the medicinal product "Kashnol" (proposed by the rejected bidder) in the dosage form of "syrup" derived from the pharmaceutical substance "Bromhexine+Salbutamol+Guaifenesin+Levomenthol" is interchangeable with the reference medicinal product "Ascoril Expectorant," as confirmed by the records of the latter (INN Bromhexine+Salbutamol+Guaifenesin). The profile of this reference drug contains explicit links to interchangeable products, including "Kashnol." The auction commission unlawfully failed to consider the GrLS during the review of the first parts of the bid proposals, despite the fact that the GrLS constitutes an open and publicly accessible information resource.

The court of cassation noted that pursuant to Clause 3 of the Rules for Determining the Interchangeability of Medicines for Medical Use, approved by Government Decree of the Russian Federation No. 1154 dated October 28, 2015, the regulatory authorities establish drug interchangeability during the state registration process based on a comparison with a reference medicinal product during the mandatory expert evaluation of the quality of the medicine and/or the assessment of its expected benefit-to-risk ratio.

However, the court of cassation pointed out that by limiting their analysis exclusively to the aforementioned provision, the lower courts erroneously concluded that only an expert commission of the federal state budget institution responsible for conducting evaluations of medicines under the Ministry of Health of the Russian Federation could determine drug interchangeability. In doing so, the lower courts failed to apply the statutory provisions governing the dispute, namely Part 3 of Article 3 of Federal Law No. 429-FZ dated December 22, 2014 "On Amending the Federal Law 'On the Circulation of Medicines' No. 61-FZ," which mandates the compulsory inclusion of data regarding the interchangeability of medicinal products for medical use into the GrLS starting January 1, 2018.

Given that the Regional Directorate of the Federal Antimonopoly Service relied directly on GrLS data when issuing its regulatory enforcement order, the Supreme Court upheld the judicial act of the court of cassation, validating both the decision and the directive of the regulatory authority.