External reference pricing in the pharmaceuticals price regulation

Анотація

Regulation of drug prices is an important part of regulation of the pharmaceutical market, and requires a rationalization and systematic approach. Study of the application of an external reference pricing (ERP) should be the basis for the implementation of new legislative initiatives to avoid negative consequences on the availability of essential drugs. In order to study the experience of using ERP in different countries, learn the advantages and disadvantages of this method search and analysis of foreign literature have been made. Analysis showed that the ERP is one of the methods of a direct price control and is widely used in the EU. The majority of the EU and the OECD countries used ERP for the price regulation of patented medicines. At the same time, the method has a number of shortcomings and difficulties in the choice of reference countries, obtaining reliable and relevant information about the prices of medicines and may have negative effect on the availability of medicines. The main components of the method are: the choice of reference countries, the calculation of the reference price, the parallel use of other approaches to determine the price. The real impact of the ERP application have not been studied enough, so international experts consider the further study of the influence ERP on the pharmaceutical market essential. In developed countries, the price of drugs is based on multi-criteria approach, and the ERP is just one of many criteria. Effectiveness of the ERP as other methods of price regulation should be discussed in the context of healthcare system of the country, availability of drugs, physical and economic access to drugs, equitable access and rational use of drugs; the long-term prospects for the whole country as well as unexpected consequences that may occur should be considered.

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