[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.