National policies in Europe in the field of rare diseases. Ségolène Aymé Rare DiseasesTaskForce Orphanet / Paris / France

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1 National policies in Europe in the field of rare diseases Ségolène Aymé Rare DiseasesTaskForce Orphanet / Paris / France

2 Emergence of the concept of RD prior to the EU regulation USA: 1983:Orphan drug regulation 1993: Office of Rare Diseases EU: 1985 : Denmark Rare Disorders Denmak 1989: Sweden Centres of reference and Agrenska 1995:France Office of Orphan drugs- 1996: Orphanet 1997: EURORDIS 1998: Italy Priority in Public Health

3 Rare Disease vs Genetic Diseases All genetic diseases are rare Most rare diseases are genetic but not all The concept of genetic diseases is the one used In the Netherlands: Erfocentrum / VSOP In the UK: whole set of measures for genetic diseases In the UK, rare diseases = disease treated by expensive, non affordable drug

4 A dynamic process post EU regulation 2001: Dutch Steering Committe on orphan Drugs 2002: Italian regional centres of reference 2003: German support to research networks 2003: Spanish support to research networks 2004: French National Plan 2006: ERA-NET for research programmes 2007: Portuguese national plan 2007: Romanian initiative of rare diseases 2008: Bulgarian national plan 2008: Orphanet in 38 countries

5 Areas for action in member states Axes to be considered

6 Recognition of the specificity linked to rarity and of the need for a specific approach Clinical research: Networking of research teams Shared databases / post marketing registries Innovative trial design Clinical care: Expert centres at appropriate level European networks for sharing expertise Common good practice guidelines

7 Recognition of the specificity linked to rarity and of the need for a specific approach Information Key element for appropriate diagnosis and management Common good practice guidelines emergency guidelines Directory of services in Europe / cross border health care Internet bases services and help lines in national languages Patient organisations: Need for organisations by disease at country level and of European federations or networks Need for umbrella organisation for all RD at country and EU level Importance of empowerment / financial support / political recognition / participation Respite care / summer camps / support ot family members

8 Recognition of the specificity linked to rarity and of the need for a specific approach Specificity of orphan drugs / affordability of care Cost of innovation / cost due to small market Appropriate reimbursement scheme Funding of orphan drugs at appropriate level Identified body for claims / transparent rules Multistakeholder approach Training: Need for specific training of health care professionals About the existence of RD in all medical specialties About sources of information Places for training of families and patients

9 Recognition of the specificity linked to rarity and of the need for a specific approach International dimension of solutions, but based on national initiatives Expert centres in other countries Expert laboratories for diagnosis Expert information resources International research effort Coherence of national policy: Multi stakeholder Task Force at national level Coordination Appropriate funding

10 Research funding: targeted calls Belgium: Fondation Roi Baudoin France: Annual call since 2002 Germany: funding for networks since 2002 Italy: annual calls for clinical and basic research

11 Research funding: targeted calls Netherlands: budget of 1.4 M per year Spain: CIBERER since 2004 Sweden: Swedish research council Turkey: budget of 0.5M per year Transnational funding: E-Rare

12 Expert centres for RD Group 1: Official expert centres for RD Denmark, France, Italy,Norway, Sweden Group 2: Official expert centres not specifically for RD Belgium, Croatia, Czech R., England, Finland, Grece, Ireland, Portugal Group 3: Expert centres established only by reputation Almost all other countries

13 Statements consensus reached European added value of CR Need for disseminating the information on CR Definition of what is a CR High level of expertise / high volume of activity / capacity to provide expert advice / multidisciplinary approach / links with other centres and support groups Priority for networks of centres Rejection of hierarchy between ECR and CR

14 Statements consensus reached Centres of expertise National centres Regional centres where patients may be referred VS Reference networks of centres of expertise Characterised by communication Production of guidelines Shared expertise for patients

15 Initiatives to facilitate access to OD Belgium: OD committee just established France: ATU system and national fund for OD Hungary: Committee for the treatment of rare condiation Ireland: Irish platform of patients, academics and Industry Netherlands: Dutch steering committee on OD Poland: National Forum for the treatment of orphan diseases

16 Availability at national level in 2007 of the 22 first OMPs authorised at EU level before 1 January 2006 (source: Eurordis Survey)

17 Empowerment of patients is necessary WHO definition «Process of increasing capacity of individuals or groups to make choices and to transform those choices into desired actions and outcomes» «a prerequisite for health» «Patients have to participate in the decision-making process» Sustainability of organisations is a pre-requisite

18 Patients organisations on the front line Over 1,800 organisations National umbrella org. : Feder, Uniamo, Achse, Alliance maladie rares, Gard, Vsop. Eurordis Diversity of initiatives Political lobbying Help lines / services Fund raising for research Communication

19 Information sources at country level National Information centres: France and Sweden National website/helpline by governmental agencies Belgium, Bulgaria, Denmark, France, Netherlands, Norway, Sweden In preparation: Greece, Hungary, Italy National website/helpline by patient/professional organisation Italy, Netherland, Spain, UK

20 Orphanet in European countries

21 National dimension of Orphanet Directory of expert resources 1,275 medical laboratories, 5,392 research projects, 879 clinical trials, 365 registries, 3,382 expert clinics, 11,381 professionals, 1,803 patient organisations Language issue: nb of documented diseases in Orphanet English: 2,553 French: 2,480 Italian: 2,248 German: 2,071 Spanish: 932 Portuguese: 225 Necessity to have more languages Swedish: 220 diseases Share the workload to develop information for patients and for professionals / adaptation Committment of MS in the funding National funding from Germany, Israël, Italy, Spain, Switzerland only

22 Orphanet directory of 2,500 rare diseases published at national level

23 National plans on the way National Plan with results: France only National plan adopted: Portugal and Bulgaria Process to a national plan Austria, Belgium, Germany, Hungary, Romania, Spain, Turkey Set of measures Denmark, Ireland, Italy, Netherlands, Norway, Sweden, UK

24 France:Ten strategic priorities and 100 Millions Euros 1- Increase knowledge of the epidemiology of RD 2- Recognise the specificity of RD 3- Develop information for all stakeholders 4- Train professionals 5- Organise screening and access to diagnostic tests 6- Improve access to treatment and healthcare provision 7- Continue effort in favour of Orphan Drugs 8- Respond to social needs and support patients organisations 9- Promote research and innovation 10- Develop national and European partnership

25 Achievements: Specificity of RD Development of national protocols for diagnosis and care by the HTA agency (HAS) Reimbursement of drugs and devices with no official indication for RD, or outside the usual reimbursement scope (on request of centres of reference or patients organisations) Reimbursement of transport costs to attend clinics at centres of reference Establishment of a RD office at the national health insurance agency to deal with all problems and jharmonise practices in the regions

26 Achievements: Information New services at Orphanet Encyclopaedia for patients in French Emergency guidelines Search by sign facility Introduction of classifications to improve search facility Portal accessible to disabled Publication of a book distributed to professionals Emergency cards Produced by the Ministry / distributed by the centres of reference Support to Helpline

27 Achievements: Training Introduction of two hours in the cursus of medical students: existence of RD + how to access relevant information Optional modules for medical students 30 hours course Similar measures for non MD health professionals

28 Achievements: Screening Screening/Testing Nothing done for political reasons Project: establish a committee to assess population screening proposals and review outcomes Testing To improve availability of diagnostic tests Organisation of networks of laboratories (oncogenetics, neurogenetics, mental retardation, neurosensory genetics ) Reference laboratories Funding of testing activities (20 Millions)

29 Achievements: Healthcare provision Establishment of centres of reference Establishment of a national committee Through annual call for proposals National coverage / based on scientific expertise + volume of activity + real 5 year plan to improve care 132 centres approved and funded (over 100 M Euros already) 200 new positions for MD new positions for non MDs: permanent Mission of expertise, information, training and research / self assessment at 3 years / external assessment at 5 years Establishment of centres of competence At the request of patients organisations At regional level Network common to several centres of reference sometimes

30 Achievements: Support orphan drugs Preservation of existing situation Exemption for the promoters of OD with respect to taxes and payments due OD on the list of innovative and expensive health products to be systematically covered Prevention of unavailability of marketed OD «Autorisation temporaire d utilisation» scheme to be continued

31 Achievements: Promotion of Research Annual call for proposals for preclinical research GIS-Institut des maladies rares Networks, registries, platforms and all types of research projects 30 M Euros Annual call for proposals for clinical research For hospital-based teams Academic trials and clinical research in general 26 M Euros Annual joint call with some othe EU countries E-Rare: 9 M Euros first year (2.4 from France)

32 Achievements: Partnerships National coordination of all stakeholders Follow-up committee Support to the Rare Diseases Platform in Paris GIS maladies rares- Orphanet Alliance Maladies Rares Eurordis Helpline Hosting of 200 meetings per year Communication Contribute to European policy Orphanet in 38 countries Rare Diseases Task Force secretariat Eurordis Proactive Ministry of Health / contribution to the EC Communication

33 Evaluation fo the national plan Assessment of the French national plan : By High level Public Health Committee in Early 2009 Difficult to document yet the objective effects Very positive feeling of stakeholders Continuous support for most initiatives Second national plan already announced Lessons to be shared with other MS

34 Conclusion Enough agreement in Europe to establish the list of objectives to establish the catalogue of measures which look relevant Enough of good will to share experiences Necessity to have a tailor-made approach Due to specificities of the healthcare systems Due to necessary incremental process and empowerment of all stakeholders Due to past history of targeted measures

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