rec_55
(55) Rare diseases are those that meet a prevalence threshold of not more than five affected persons per 10000, in line with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products OJ L 18, 22.1.2000, p. 1. , and they are all serious, chronic and often life threatening. Some patients affected by rare diseases face difficulties in their quest for a diagnosis and treatment to improve their quality of life and to increase their life expectancy, difficulties which were also recognised by the Council Recommendation of 8 June 2009 on an action in the field of rare diseases OJ C 151, 3.7.2009, p. 7. .
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Source: EUR-Lex (Cellar) · retrieved 2026-10-11 · Text as adopted (Official Journal); later amendments are not incorporated in this text.