The court suspended the execution of the state contract between Primapharma and the Ministry of Health for the supply of lenalidomide

The court suspended the execution of the state contract between Primapharma and the Ministry of Health for the supply of lenalidomide

As Kommersant found out, the Moscow prosecutor’s office succeeded in suspending the execution of a state contract for the supply of lenalidomide for patients with multiple myeloma. The distribution company Primapharm has shipped the entire volume stipulated by the contract, but due to the imposed measures, it cannot receive more than 1 billion rubles from the customer – one of the structures of the Ministry of Health. According to the supervisory authority, the parties committed a violation by adding another drug to the list during the execution of the government contract. The law allows, during the execution of a government order, to change products to a similar product, but of better quality, experts say.

On February 1, 2024, the Moscow Arbitration Court, at the request of the capital’s prosecutor’s office, imposed interim measures, suspending the execution of the government contract signed between the distribution company Primapharma and the structure of the Ministry of Health – the Federal Center for Planning and Medical Provision of Citizens (FCPiLO). Kommersant found this information in the file cabinet of arbitration cases. We are talking about supplies totaling 3.1 billion rubles. within the framework of the state program “14 high-cost nosologies” in 2023-2024, lenalidomide for 3.46 thousand patients with multiple myeloma, according to court materials. It also states that the measures have been imposed on supplies for 2024. The prosecutor’s office responded after Pharm-Sintez contacted the supervisory agency. Initially, under the contract concluded in June 2022, Primapharm was supposed to supply this company’s drug, myelanix based on lenalidomide, to the Federal Center for Medical and Physical Medicine. But a week later, the parties signed an additional agreement, adding lenalidomide from Vikram Punia’s Pharmasintez to the list of supplies. In fact, only the Pharmasyntez product was supplied under this contract, Kommersant discovered in government procurement materials.

Back in the spring of 2023, the supervisory authority issued an order to the FCPiLO to eliminate violations and bring the perpetrators to disciplinary action. The structure of the Ministry of Health challenged this order in arbitration court in December 2023. The capital’s prosecutor’s office and Pharm-Sintez filed an appeal against this decision, as follows from the file of arbitration cases. In parallel, Pharm-Sintez filed a separate claim “for compulsion to fulfill obligations in kind”: it was accepted for proceedings on January 30.

The Ministry of Health, Pharm-Sintez, Pharmasyntez, and Primapharma did not respond to Kommersant’s request.

From the same court materials, it turns out that the reason for signing an additional agreement between Primapharm and the Federal Center for Pilots and Logistics was the distributor’s concern about possible difficulties with the supply of mielanix and a possible delay in the execution of the contract. The court took into account that both drugs are interchangeable and identical in form and dosage, as well as the expert’s opinion that the secondary packaging of lenalidomide has better characteristics compared to the packaging of mielanix.

Meanwhile, as follows from the government procurement data, Primapharm, within the framework of the state contract, supplied the FCPiLO with the volume of the drug envisaged for 2023, receiving 1.64 billion rubles. In January 2024, the distributor shipped lenalidomide for the remaining 1.45 billion rubles, but this part of the government contract is listed as unpaid on the government procurement website.

Aleksey Fedorov, an expert at the All-Russian Patients’ Union, points out that while interim measures are in effect, the Federal Center for Pilots and Logistics cannot pay Primapharma. He notes that the law “On the Contract System” allows the replacement of a product originally provided for in a contract only with one that has improved characteristics. The court of first instance, which satisfied the requirements of the Federal Center for Pilots and Laws, indicated that the subject of the contract was de facto not changed, since an interchangeable drug was supplied, adds Pepeliaev Group partner Konstantin Sharlovsky.

The fact that in fact only the Pharmasyntez drug is supplied does not contradict the terms of the government contract. This is confirmed by Alexey Fedorov, explaining that in the additional agreement the Pharmasyntez drug was included in the contract without specifying a specific volume and the supply could be carried out in any shares.

Polina Gritsenko

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