Pharmaceutical policy in Russia

Abstract

Pricing and reimbursement policies have changed significantly in Russia during the last 20 years, largely due to ongoing reform processes within the healthcare system. The current structure of the Russian healthcare system includes federal and regional levels with different requirements and funding allocations due to diversity in the population (average and population density), overall and per capita income, and other factors. The federal level is governed by the Federal Ministry of Health, which is responsible for the pricing and reimbursement policies in the country. Federal budgeting covers the majority of healthcare programs, while the regional budget provides additional financing for regional needs. Reimbursement of drugs is incorporated in these programs, along with other expenses (hospitalization, laboratory testing, and so forth). In terms of pharmaceutical policy, inclusion of medicines into reimbursement lists includes two staged steps in Russia. In the first step, the drug must be included in the Essential Drug List (EDL) and a pricing cap is then applied. The upper margin of the drug price is determined as a referral price for imported medicines (based on a basket of 21 countries). It can also be based on drug development and manufacturing expenses and include regional markups specified for each region. Cost-effectiveness analysis is part of the requirement for submission of an EDL dossier in Russia. The second step in the process is the inclusion of EDL-listed drugs into federal healthcare disease specific programs (oncology, HIV, and so forth). Regions can establish healthcare programs in addition to the federal activity based on regional requirements and their own regional funding allocations and budgets. There are different needs within the healthcare system at federal and regional levels; including hospital and industrial corporations who have their own healthcare services. This can contribute to challenges in implementation of uniform approaches to Health Technology Assessment (HTA) at different levels and in the different regions.