Overview of National Rare Disease Policies

Over the past 30 years, people living with a rare disease, their families and other patient advocates have fought to make their voice heard on a national level, as well as on the European political scene. The rare disease community has in turn contributed to the adoption of concrete national measures.

During this time, advocacy actions led by patient organisations and involving many other stakeholders, including academia, healthcare professionals, industry and policy makers, have culminated in two essential policy texts:

  1. The EU Commission’s Communication Rare Diseases: Europe's challenges (11 November, 2008)
  2. The Recommendation of the Council of the European Union on an action in the field of rare diseases (9 June, 2009)

The 2009 Council Recommendation was instrumental in the development of national rare disease plans as it recommended that all EU Member States adopt a national plan or strategy by the end of 2013.

Following the Recommendation, a European Commission Expert Group on Rare Diseases was created, bringing together EU Member State representatives, the EU Commission and representatives from industry, academia and patient organisations. This group supports the Commission in shaping European-specific measures in rare disease policy.

The political landscape for rare diseases has substantially changed across EU Member States over the last five years; 19 Member States now have rare disease plans or strategies, as compared to only 4 in 2008, while a significant number are close to adopting one.

We have also witnessed a spillover effect across the world. From Australia to North America, South America and Asia, many countries are working on a national strategy to improve the lives of people living with a rare disease.

EURORDIS is actively involved in the process of national plan establishment, notably through involvement in the European Project for Rare Diseases National Plans Development (EUROPLAN), which is embedded in the EUCERD Joint Action for Rare Diseases. In line with its mission statement, EURORDIS will continue to support progressive measures for patients.

National Plans in Europe

Details of each existing national rare disease plan can be found here:

Overview of Rare Disease Policies

EUCERD (the European Union Committee of Experts on Rare Diseases), which has now been replaced by the European Commission Expert Group on Rare Diseases, has published  a yearly report since 2011 on initiatives taken and policies adopted for rare diseases on both a national and EU level. The latest edition of the Report on the State of the Art of Rare Disease Activities in Europe is now available in 5 parts, as listed below.

2014 Report on the State of the Art of Rare Disease Activities in Europe:

Part I: Overview of Rare Disease Activities in Europe
Part II: Key Developments in the Field of Rare Diseases in
Part III: European Commission Activities in the Field of Rare Diseases
Part IV: European Medicines Agency Activities and Other European Activities in the Field of Rare Diseases
Part V: Activities of European Member States and Other European Countries in the Field of Rare Diseases

All EUCERD members, as well as a wide range of stakeholders including patient organisations, were consulted in the development of this report. From research to prevention tools, diagnosis and care, the report presents how EU countries and institutions respond to the rare disease challenge in all relevant fields.

Please note, the information provided, although accurate, is not exhaustive and is not an official position of the EU Commission, its agencies or national health authorities.

Page created: 28/02/2012
Page last updated: 11/03/2015
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