At SPIEF, it was proposed to test the risk-sharing mechanism in the procurement of orphan drugs

The State Fund “Circle of Kindness”, which provides medicines for children with rare and serious diseases, could test the risk-sharing mechanism when purchasing drugs for such patients. Alexander Tkachenko, head of the fund, made such a proposal during the SPIEF. So far, the Ministry of Health, the Ministry of Finance and the Federal Antimonopoly Service, for various reasons, treat such initiatives with caution, believing that the amendments to the legislation necessary for this require careful study. The State Duma also notes that such purchases could be subject to an experimental legal regime that allows temporary derogation from existing norms.

The Circle of Kindness Foundation may become a participant in an experiment to introduce a risk-sharing mechanism for drug purchases at the federal level. To clarify, this mechanism involves the use of contractual models in procurement, which makes it possible to establish additional requirements for manufacturers, such as reducing the volume of buyer obligations depending on the result of using the drug in a particular patient. In theory, risk sharing increases the efficiency of budget spending by eliminating or reducing wasteful spending (more like see “Kommersant” dated May 22). First of all, the use of risk-sharing is justified for the purchase of super-expensive drugs used for monotherapy of any disease.

As Alexander Tkachenko, head of the Circle of Kindness, said at the SPIEF, this mechanism could be tested at the federal level by purchasing his fund.

Now the fund provides medicines to 7.2 thousand children with serious and rare diseases, including those with spinal muscular atrophy (SMA), for the treatment of which drugs are used with a course cost of tens of millions of rubles.

Alexander Tkachenko recalled that drugs are included in the lists purchased by the fund after they are analyzed by structures subordinate to the Ministry of Health and discussed by the expert council of the organization, which implies their effectiveness. Vitaly Omelyanovsky, Director General of the Center for Expertise and Quality Control of Medical Care of the Ministry of Health, noted that interest in risk-sharing for the purchase of drugs for the treatment of orphan diseases is justified because now more and more drugs are entering the market in a very short time. As a result, he says, “there is less opportunity to adequately collect data on their clinical performance.” Therefore, as Elena Maksimkina, director of the Federal Center for Planning and Organization of Drug Provision of Citizens, stressed, risk-sharing is beginning to be applied in many countries.

It should be noted that the relevant departments involved in the regulation of public procurement of medicines – the Ministry of Health, the Ministry of Finance and the Federal Antimonopoly Service, have already discussed with the inter-factional working group of the State Duma on improving the “drug” legislation the possibility of amending the law on public procurement, which would allow using the risk-sharing mechanism. However, for now, as a source in the Ministry of Finance told Kommersant, “each of the departments has its own reasons why the initiative needs to be improved.” Thus, the Federal Antimonopoly Service considers supplier competition to be the best mechanism for reducing costs, the Ministry of Finance opposes amendments to Federal Law-44, and the Ministry of Health has questions about how to combine the requirements for the effectiveness of drugs when they are brought to the market with the additional conditions of the risk-sharing model .

One of the authors of the initiative to “legalize” risk-sharing, State Duma deputy Airat Farrakhov, notes that the practice of regions in which the mechanism is being implemented in a pilot mode has shown the need for changes in legislation.

“Perhaps, in order to introduce risk sharing, it would be necessary to create an experimental legal regime by analogy, for example, with “digital sandboxes”, which would allow government customers, for example, “Circle of Good”, to temporarily not focus on the norms of the current legislation that are incompatible with this mechanism,” says the deputy. The head of the Inpharma Association, Vadim Kukava, believes that after testing, risk sharing could also be used for public procurement of a larger list of drugs under other state drug supply programs.

Anastasia Manuylova