Timophey Nizhegorodtsev: drug price-setting should be based on the indicative method

Experts supported FAS proposals on new methods for registering and reregistering the ceiling ex-works prices for the drugs included in the list of vital and essential drugs

FAS Expert Council on developing competition in the social sphere and health care was in session on 23 June 2017.

Experts discussed a draft Decree of the Government of the Russian Federation “On state registration and re-registration of ceiling ex-works prices for the drugs in the list of vital and essential drugs” published by the Ministry of Health Care for public discussion on http://regulation.gov.ru.

“Amending the Decree on price registration and re-registration, we proceeded from the fact that price-setting for generic drugs should be based on the indicative method”, reported Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev, opening a discussion. “Another principal issue for us is to suppress possibility of arbitrary return of the petitioners’ documents based on complication of the submitted package”.

FAS proposes to use differentiated decreasing coefficients depending on the price group of drugs rather than the countries of manufacturing. The document obligates producers to review drug prices if prices for those medicinal drugs go down in the reference countries. “Price for generic drugs cannot exceed the price for a references drug.  We also insist that the list of reference countries should become more flexible”, emphasized Timophey Nizhegorodtsev.

At the same time, the antimonopoly body does not support the proposals of the Ministry of Health Care of Russia to establish a special Commission to solve controversies (since it is the judicial system that is designed to solve such issues), as well as proposals to apply the declarative principle for reviewing price register, on mutual relations between price registration and the procurement system and data from the Integrated Information System, on the obligation of Russian producers to maintain cost effectiveness of reference drugs no higher than 30%.

“Restricting net profit margin of the reference drugs manufactured by Russian producers can adversely affect research opportunities”, stated Head of FAS sectoral Department of the Federal Antimonopoly Service.

To review the price register, FAS proposes to reregister prices for reference drugs under new rules at the first stage, and then review prices for generic drugs, taking into account new “reducing coefficients” (without submitting petitions and documents from the petitioners).

Summing up, Timophey Nizhegorodtsev said: “Many thanks to the colleagues for a constructive dialogue, the highlighted proposals and support to FAS comments about the draft Decree. We shall certainly consider all expressed and officially submitted proposals from pharmaceutical associations and take them into account when refining the project”.