EU Action on Rare Diseases John F. Ryan

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1 EU Action on Rare Diseases John F. Ryan Acting Director - Public Health DG Health and Consumers, European Commission

2 Policy framework Commission Communication on Rare Diseases: Europe's Challenge COMM(2008)679 Council Recommendation on action in the field of rare diseases 2009/C 151/02

3 Why a European strategy on rare diseases? million people in the EU affected Highly specific public health area limited number of patients scarcity of knowledge and expertise economics of scale at EU level High potential for effectiveness and efficiency recognition and visibility of rare diseases support rare diseases policies in the MS cooperation, coordination and regulation at EU level

4 National plans and strategies In January Member States had national plans or strategies adopted before 2009 January 2014 advanced stage of preparation

5 Definition, codification and inventorying definition - a disease affecting no more than 5 per 10,000 persons Member States with adopted plans or strategies comply with the EU definition for the Union level policy. codification ICD system ORPHANET inventorying ORPHANET

6 Research Seventh Framework Programme for Innovation and Technological Development ( ) - close to 120 collaborative projects (EUR 620 million) Stimulating, coordinating and maximising output E-RARE-2 IRDiRC

7 Research activities in Member States Member States with rare diseases funding programmes/calls

8 Patient registries and databases 588 rare diseases registries: 62 European, 35 global, 423 national, 65 regional and 3 undefined (according to an Orphanet report) European Platform on Rare Diseases Registration

9 Centres of excellence European Reference Networks List of pilot European Reference Networks for Rare Diseases Cross-border Healthcare Directive - Directive 2011/24/EU Dyscerne: European Network of Centres of Reference for Dysmorphology ECORN CF: European Centres of Reference Network for Cystic Fibrosis PAAIR: Patient Associations and Alpha1 International Registry European Porphyria Network, EPNET European Network of Rare Bleeding Disorders, EN-RBD Paediatric Hodgkins Lymphoma Network European Reference Networks Criteria and conditions 10 pilot ERNs for rare diseases NEUROPED: European Network of Reference for Rare Paediatric Neurological Diseases EURO HISTIO NET: A reference network for Langerhans cell histiocytosis and associated syndrome in EU TAG: TogetherAgainstGenodermatoses CARE NMD: Dissemination and Implementation of the Standards of Care for Duchene muscular Dystrophy in Europe

10 National centres of expertise on Rare Diseases officially designated centres non-designated centres recognised by reputation/selfdeclared

11 Empowering patient organisations Participation in EU expert groups and committees Member States dialogue with patient organisations Supporting patients umbrella organisations operating grants 2512 rare diseases specific patients organisations including 2161 national, 213 regional, 72 European and 61 international organisations

12 Improving health care for rare diseases Regulation on Orphan Medicinal Products [Regulation (EC) No 141/2000] more than 1000 designated orphan medicines more than 90 orphan medicinal products authorised Facilitating access to orphan medicinal products assessment of new medicines, exchange of information and knowledge Working group 'Mechanisms of Coordinated Access to Orphan Medicinal Products' European Reference Networks (ERNs)

13 Newborn screening report on newborn screening in Member States variation in the number of rare diseases screened 1 in Finland to 29 in Austria EU Committee of experts on rare diseases - Opinion on potential areas of European Collaboration in the field of newborn screening.

14 Governance and coordination at EU level European Union Committee of Experts on Rare Diseases 5 sets of recommendations 1 opinion bi-monthly newsletter annual report on 'State of the Art of Rare Diseases Activities in Europe' Commission expert group on rare diseases first meeting on Feb 2014

15 Global dimension EU strategy aims to foster cooperation on rare diseases at international level EU leadership in developing actions on rare diseases inspiring developments in non-european countries positive impact on other countries' rare diseases policy Inspiring international cooperation International Rare Disease Research Consortium ORPHANET a global source of information on RD Joint Action contributing to the ICD-10 update

16 In conclusion Objectives of the strategy good progress have served to strengthen the cooperation between the EU, the MS and all relevant stakeholders Active exchange of experiences Member States national strategies and plans

17 Towards the future Coordination at EU level National RD Plans and Strategies 3 rd Health Programme Horizon 2020 International Rare Disease Research Consortium Codification Inequalities European Reference Networks benefiting from the Directive on cross-border healthcare cooperation and interoperability ehealth solutions European Platform on rare diseases registration Continue to play a global role

18 Thank you!

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