The Ministry of Health was offered to purchase unique medicines under the program “14 high-cost nosologies” without holding auctions. Such a letter to the department and the government was sent by the All-Russian Union of Patients… Direct purchasing is essential to speed up the process. Today it takes an average of 1.5 months, although the same companies participate in the auction from year to year – one in each. While the formal procedure is being carried out, patients are waiting for vital drugs. The Ministry of Health is ready to consider the possibility of amending the legislation if the initiative is supported by the government, the department told Izvestia.
The All-Russian Union of Patients (VSP) sent letters to the government and the Ministry of Health with a proposal to adjust the drug procurement mechanism within the framework of the program for centralized provision of high-cost nosologies (VZN). The appeals are at the disposal of Izvestia. The VSP is confident that the existing procedure interferes with prompt drug supply.
In the letter, the VSP proposes to allow the Ministry of Health to carry out direct purchases of unique medicines (which have no analogues in the international non-proprietary name), without holding auctions.
Photo: Izvestia / Konstantin Kokoshkin
– When the Ministry of Health purchases unique drugs, there is no competition in the auctions, because only one supplier participates in them. Which turns the auction into a formal procedure. At the same time, it takes more than a month: 15 days for the submission of applications, two more for the registration and placement of the protocol, 10 working days for approval by the FAS Russia, while the contract cannot be concluded earlier than 10 days from the date of posting the final protocol. And in a situation where the supplier, for some reason, did not submit an application (he was late, made a mistake), these terms are doubled– VSP expert Aleksey Fedorov explained to Izvestia.
According to him, this is an additional drug-free period for patients.
– On average, the cycle from procurement to delivery of drugs can be 1.5 months. But it is not clear what the practical meaning of the auctions is. There is no competition in this segment among manufacturers, there are no analogues, from year to year the same companies go to the auction, without even changing the cost of their drugs, – added VSP co-chairman Yuri Zhulev.
VSP also considers the auction procedure unnecessary for additional purchases of drugs. The organization asks the government and the Ministry of Health to allow a change in the amount of purchased drugs during the execution of the contract by 30% of the originally envisaged. Now the law restricts customers in changing the quantity of goods – by a maximum of 10% within the framework of the concluded contract.
– Expansion of the contract will give the Ministry of Health the opportunity to quickly respond to changes in the Federal Register of VZN within a year – for example, when new patients appear in it. Instead of holding a new auction, additional drugs can be purchased within the framework of an existing contract, – Alexey Fedorov explained.
The main problem is that people for whom they do not have time to buy drugs have to wait a long time for them.
Photo: RIA Novosti / Valery Melnikov
– The regions draw up a list of their patients and defend their applications in October-November. If new patients are added to the list later, they have to wait almost a year for new purchases. Sometimes pharmaceutical companies can provide humanitarian aid, but literally for a month or two, no more– said the chairman of the interregional public organization “Assistance to people with disabilities from childhood, suffering from Gaucher disease, and their families” Marina Terekhova.
The existing volume limitation of 10% is really important for ordinary purchases, where a significant change could affect the competitive environment, said Alexey Fedorov. But within the framework of centralized purchases of the Ministry of Health, the largest supply volumes in the country are being played out, and the expert is sure that single suppliers can cope with such contracts.
VSP also proposes to reduce to three working days the terms of agreement on the conclusion of contracts. This year a new procedure appeared in procurement – if there was only one bid in the auction, then the materials must be sent for approval to the FAS Russia. It takes 10 business days.
– We understand that the spending of budgetary funds requires strict control, but at the same time we believe that procurement of medicines cannot be considered by the control authorities in the order of priority after the procurement of paper clips and nails and within the same timeframe, says the letter of the GSP to the government and the Ministry of Health.
Photo: RIA Novosti / Igor Maslov
According to Yuri Zhulev, it was the bureaucratization of all procedures that led to the repeated cancellation of auctions for the purchase of a vital drug for patients with Gaucher disease. Izvestia wrote about this problem earlier.
“We believe it is necessary to further improve the VZN, and this applies not only to increasing the budget for this program, but also to the procurement system itself,” emphasized Yuri Zhulev.
The Ministry of Health of Russia is ready to consider the possibility of amending the legislation governing the procurement of medicines, in case of receipt of a corresponding instruction from the government of the Russian Federation, the department told Izvestia. He added that it is advisable to consider this issue taking into account the opinion of the Ministry of Finance and the Federal Antimonopoly Service.
Izvestia sent inquiries to the government and the antimonopoly department with a request to indicate its position on the organization’s proposals.
The last year has shown that the number of purchased drugs in many nosologies is not enough, says Irina Myasnikova, Chairman of the Board of the All-Russian Society of Orphan Diseases (VOOZ). We have to make additional purchases, since there is no stock of medicines. Previously, it was formed for 15 months, but now it is done only for a year.
– Previously, drugs in the VZN program were purchased with a margin, so that in the first quarter of the new year, patients did not sit without drugs. They don’t do that now. Usually the program ran like clockwork. Problems started last year. Patients with multiple sclerosis, hemophilia, Gaucher disease, cystic fibrosis experienced a drug shortage… Of course, the VZN program needs changes, – said Irina Myasnikova.
Photo: RIA Novosti / Vladimir Song
The stock was necessary for newly identified patients or emergency situations when someone did not fit the drug and needed to buy another, added Marina Terekhova.
Earlier, Izvestia wrote that the All-Russian Union of Patients sent a letter to the Federation Council with a request to pay attention to failures in the implementation of the program “14 high-cost nosologies.” Last year, many patients with multiple sclerosis and hemophilia were left without medication for the first time. After examining plans to fund the program in 2021, GSP fears that people will again face a shortage of essential drugs. According to the Union’s estimates, 255 thousand people need them today.