The so-called ‘orphan drugs’ are intended to treat diseases so rare that sponsors are reluctant to develop them under usual marketing conditions.
Efforts have been jointly made at national and European levels by industry and health authorities (EMEA – European Medicines Evaluation Agency), in order to offer the incentives required to stimulate the development of orphan drugs. The goal was to rapidly make available, for rare diseases, drugs with a level of quality equivalent to that required for any other drug.
https://www.orpha.net/en/other-information/about-orphan-drugs?stapage=europe
Lynch Syndrome Ireland 