If it didn’t help, then it wasn’t worth it – Kommersant

The Ministry of Health, the Ministry of Finance and the Federal Antimonopoly Service are discussing the possibility of a risk-sharing mechanism in the Russian Federation for public procurement of expensive innovative drugs. If amendments to the law on public procurement are adopted, pharmaceutical companies will be able to receive payment for medicines only if the condition of the patient who took them improves. The profile commission under the Ministry of Health will have to fix the result of treatment and revise the contracts.

The Ministry of Health, the Ministry of Finance and the Federal Antimonopoly Service, together with State Duma deputies, are working on amendments to Federal Law-44 on public procurement and Federal Law-326 “On compulsory medical insurance”, which will allow government customers to purchase innovative drugs using the risk-sharing mechanism. Kommersant has the correspondence in which the departments comment on the amendments developed by the deputies.

As follows from the explanatory note to the draft amendments to Federal Law-44, it is becoming more difficult for the government to provide patients with increasingly expensive medicines. In international practice, contractual models are increasingly used, which provide for the introduction of additional obligations for manufacturers of such drugs or a reduction in the volume of obligations of the buyer, depending on the results of the use of the drug – in the form of agreements on sharing the risks of therapy failure (risk sharing). This allows you to ensure the maximum effectiveness of budget spending, eliminating or minimizing unproductive spending.

In order for a similar mechanism to appear in the Russian Federation, the authors of the amendments propose to supplement FZ-44 (“On the contract system”, the law on public procurement) with a new article – now it does not contain provisions that would allow government customers to conclude contracts for the supply of medicines with additional obligations of the supplier in conjunction with the effectiveness of therapy. According to the proposed article, government customers will be able to provide for “additional obligations of the supplier and other features of the execution of the contract, due to the results of the execution of the contract and (or) the results of the use of drugs supplied under the contract.” The new powers of state customers will apply to the purchase of original or reference drugs that have no registered analogues. The specific terms of such contracts, as well as the maximum unit price of the drug, will have to be approved by the commission of the Ministry of Health before the conclusion, it will also review the contracts if their conditions regarding the effectiveness of therapy are violated.

Amendments to FZ-326 clarify the rules for setting tariffs for the introduction of drugs purchased under the new rules in state medical institutions.

As follows from the correspondence between the Ministry of Health, the Ministry of Finance and the FAS, they received the first version of the amendments in 2022 and at the beginning of 2023 proposed a number of changes to it. The FAS had the fewest comments – the agency suggested that the authors of the initiative exclude from the amendments the provision on the purchase from a single supplier – the holder of the registration certificate for the drug, with which they agreed. The Ministry of Finance also proposed clarifying the grounds for changing concluded contracts if the drug is ineffective – but even taking into account the clarifications, according to the department, the mechanism may be too risky for pharmaceutical companies.

According to one of the authors of the amendments, a member of the inter-factional working group of the State Duma on improving the “drug” legislation Airat Farrakhov, work on the amendments began in 2020, but was suspended due to the pandemic. “The latest version of the amendments takes into account the comments of relevant departments, and I hope they will approve it. In this case, changes in federal laws could come into force as early as next year,” he notes. The risk-sharing mechanism, emphasizes Mr. Farrakhov, is the main tool for reducing spending on drugs that have no alternative, in particular, expensive drugs for gene therapy. “The need for amendments to Federal Law-44, which will allow the use of alternative contract models for public procurement of drugs, including risk sharing, is long overdue. Some regions have already begun to implement such mechanisms on their territory for certain nosologies. In particular, several years ago, the Moscow Region applied a risk-sharing mechanism when purchasing drugs for the treatment of hepatitis C,” said Vadim Kukava, head of the Infarma Association of International Pharmaceutical Companies.

Patient organizations have also repeatedly spoken about the need for risk sharing, especially when purchasing drugs for orphan patients, said Yury Zhulev, co-chairman of the All-Russian Union of Patients. “Although they pass all the necessary tests before entering the market, due to the rarity of diseases, clinical trials of therapeutic properties can be carried out on a smaller sample of patients than usual, and risk sharing is a reasonable way to distribute risks between the buyer and the seller,” he says.

As follows from the data of the consulting company GlobalData Plc, over the past 10 years, purchases of drugs with a risk-sharing mechanism have been recorded in 28 countries with the participation of more than 100 pharmaceutical companies, including Bayer, AstraZeneca and Novartis. In 2021-2022, the annual number of such transactions in the world exceeded a hundred. Almost half of them (52%) are oncological drugs, drugs for infectious diseases are in second place, and drugs for diseases of the nervous system are in third place. Most often, such contracts were used in the UK (56% of transactions), Australia (11%) and the USA (5%). In the Russian Federation, the introduction of risk-sharing could probably begin with the purchase of the state fund “Circle of Good” – it is his patients who receive the most expensive innovative medicines that have no analogues. Among them is Zolgensma by Novartis, the cost of packaging of which in the fund’s purchases reaches 100 million rubles.

Anastasia Manuylova