Involvement in EU Policies

European flagsThe large number of rare diseases awaiting treatment presents an important public health issue. Due to the low prevalence typical of each rare disease, medicines manufacturers are reluctant to develop treatments for these conditions. EURORDIS, representing the rare disease patient community in Europe, advocates for policies and initiatives that promote the development and equitable distribution of treatments. EURORDIS was instrumental in the adoption of the:

  • EU Regulation on Orphan Medicinal Products in 1999
  • EU Regulation on Paediatric Drugs in 2006
  • EU Regulation on Advanced Therapy Medicinal Products in 2007
  • EU Directive on Patient’s Right to Cross-Border Healthcare in 2011


Ongoing legislative processes in which we are involved include the EU Data Protection Regulation, the EU Clinical Trials Directive, and the EU Transparency Directive. EURORDIS is also active in EU level processes to promote access to rare disease medicinal products, such as the Clinical Added Value of Orphan Medicinal Products (CAVOMP), the Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) and Managed Entry Agreements, Patient Progressive Access/Adaptive Licensing, European Reference Pricing, Differential Pricing, European HTA Network and HTA methodology.

Page created: 07/08/2013
Page last updated: 06/11/2014
The voice of rare disease patients in EuropeEURORDIS The international voice of people living with rare diseasesRare Disease International Bringing together patients, families and experts to share experiences in a moderated multi-language forum. RareConnect The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiativeEuropean Conference on Rare Diseases