title: The European union policy in the field of rare diseases.
abstract: BACKGROUND
  Rare diseases (RDs), including those of genetic origin, are defined by the European Union (EU) as life-threatening or chronically debilitating diseases, which are of low prevalence (fewer than 5 per 10,000). The specificities of RDs - a limited number of patients and scarcity of relevant knowledge and expertise - single them out as a unique domain of a very high European added value.
  
  
  METHODS
  Legal instruments at the disposal of the EU, in terms of Article 152 of the Treaties, are very limited. However, a combination of instruments using the research and the pharmaceutical legal regulations, an intensive and creative use of funding from the Second Health Programme, the adoption of the Commission Communication in November 2008, the Council Recommendation in June 2009, and the Directive on cross-border healthcare in 2011 have permitted the creation of a solid basis that Member States have considered as sufficient to place RDs in a privileged position in the health agenda.
  
  
  RESULTS
  As a result, an operational framework to act in the field of RDs with European coordination in several areas would be possible (orphan medicinal products, national plans on rare diseases, ICD-10 revision, European Reference Networks, European Platform for Rare Diseases registration, IRDiRC, European Committee of Experts, etc.).
  
  
  CONCLUSIONS
  RDs is a field with an enormous potential for European cooperation.
authors: Directorate of Public Health, European Commission, Luxembourg, Luxembourg.
authors: A
authors: A
authors: Montserrat Moliner
authors: J
authors: J
authors: Waligóra
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D016208:Databases, Factual; D005062:European Union; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D007391:International Cooperation; D035583:Rare Diseases / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control