[The orphan preparations: international approaches and national regulation]

The medication support of patients with rare (orphan) diseases is an actual issue, since it requires significant financial costs due to high price of medications. The accessibility of these medications to such patients should be regulated by state incentives for development of orphan medications with following taking out to the market, by procedure of composing list of medications for treatment of orphan diseases and determination of financial support sources. The article considers aspects of regulation of issues related to orphan diseases and orphan medications in the Russian Federation and Europe. On the basis of regulated list of orphan diseases in Russia, the results of comparative analysis of list of orphan medications in Russia and list published at website of the European Union are presented. On the basis of data obtained, it was established that many medications for treatment of rare diseases registered in Europe are not available in Russia. Also, many orphan drugs in Europe do not have this status in Russia. At the same time, there are no state incentives for development of orphan medications in the Russian Federation, and there are only some benefits in registration procedure of such drugs. The analysis demonstrated availability of development and taking out to the Russian pharmaceutical market large list of orphan drugs from the European listing for National corresponding manufacturers.