Meeting with EMA: cooperation in the field of ERNs. Enrique Terol DG SANTE European Commission
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1 Meeting with EMA: cooperation in the field of ERNs Enrique Terol DG SANTE European Commission London 16 May 2017
2 The road to European Reference Networks (ERNs) Imagine if the best specialists from across Europe could join their efforts to tackle complex or rare medical conditions that require highly specialized healthcare and a concentration of knowledge and resources. Health and Consumers
3 The ERNs Chapter IV Cooperation between MS Article 12 European Reference Networks Networks of healthcare providers aiming at improving quality, and safety and access to highly specialised healthcare Patients affected by rare or low prevalence and complex diseases Added value at EU level Multidisciplinary approach (different specialities/areas of knowledge) Need of cooperation: Scarcity knowledge Need education Complexity / high cost Effectiveness in the use of resources "The knowledge travels, not the patient
4 Common ERN objectives To ensure that ERNs are operational To improve access to clinical advise, diagnosis, treatment and follow-up of patients To optimise patient outcomes by combining expertise To promote education and training To reinforce clinical research To ensure access to high quality healthcare services To guarantee that knowledge is spread outside the ERN
5 Clinical virtual care Remote monitoring & follow-up Remote guidance and diagnosis
6 Outcome call Full Member Affiliated partner (late 2017?) Networks 26 COUNTRIES
7
8 (24) BOND ERN CRANIO Endo-ERN EpiCARE ERKNet ERN GENTURIS ERN-EYE ERNICA ERN-LUNG ERN-RND Bone Diseases Craniofacial anomalies and ENT disorders Endocrine Conditions Rare and Complex Epilepsies Kidney Diseases Genetic Tumour Risk Syndromes Eye Diseases inherited and congenital anomalies Respiratory Diseases Neurological Diseases EuroBloodNet Onco-Hematological Diseases EUROGEN EURO-NMD Urogenital Diseases Neuromuscular Diseases GUARD-HEART Diseases of the Heart ITHACA Congenital Malformations and Intellectual Disability MetabERN Hereditary metabolic diseases PaedCan-ERN Paediatric Cancer RARE-LIVER Hepatological Diseases ReCONNET Connective Tissue and Musculoskeletal Diseases RITA Immunodeficiency, AutoInflammatory and Auto Immune Diseases TRANSPLANT-CHILD Transplantation in Children ERN-Skin Skin Disorders VASCERN Multisystemic Vascular Diseases EURACAN Solid Adult Cancers
9 Research, innovation & knowledge generation Key Elements of ERNs A framework for structured cooperation to maximise cross-country expertise through joint research projects and clinical trials ERN provide an opportunity to build top level translational and basic research around shared strategies Dissemination of research results, education & training activities
10 Research and ERNs PATIENT CARE Patient clinical unmeet needs (treatment/diagnosis) RESEARCH Research question/gap Prospective/translational research Clinical trials Patient Data Population Cohorts/Concentration of cases Secured Databases Clinical/Imaging/ Biological Data Genetics, Molecular Pathology IT Solutions / Communication between HCP common elements, principles and requisites
11 Phases of the ERN life cycle Legislation and initial planning Directive Implementing decisions Awareness and communication project cycle re-initiation Implementation: (Approval stage) Design and development Assessment tools Call for ERN Assessment of Network proposals Approval of ERNs 2021 Evaluation and update Implementation: (deployment stage) Establishment Initial organizational phase Functioning (initial actions and services) Partial service production Consolidation Full service production Continuous monitoring Performance indicators and initial outcome assessment
12 Actors involved in the ERN implementation ERNs BoMS ERNs' Coordinators National Healthcare System Patients organisations Professional / scientific organisations
13 ERN Board of MS Affiliated partners ERN & Industry ERN IT platform ERN monitoring and assessment system (June 2017) Link national networks/highly specialised centres to ERNs Support to Network coordinators and members of the ERN
14 ERN Coordinators Group ( ERN-CG) Network of the Networks body Set up 8.10 March Meetings: April; 20 June; 30 October Governance model Priorities & work plan Transversal & technical issues Crosslink Set-up working groups, goals and deliverables
15 ERN's IT Platform and tools (under development ) IT tools CLINICAL Online patient management July 2017 Communication and collaboration March 2017 Web/video conferencing, Virtual clinical meetings Exchange of Images (Radiology), diagnostic tests & pictures (genetics, pathology etc., (PACS) Exchange of clinical information and patient data Management /governance tools Communication/conferencing tools
16 Funding/support
17 EMA and ERNs: cooperation based on mutual benefits
18 EMA and ERNs: bringing mutual benefits Common areas of interest / action Approval of new drugs for the benefit of patients Strong innovation dimension Knowledge generation (Clinical guidelines, evidence etc..) Low prevalence and complex diseases (Orphan drugs) Advanced therapies: Genetic origin of diseases: Scientific and expert advise Interaction between research, clinical care and healthcare provision organisation
19 EMA and ERNs: bringing mutual benefits Capacities of the ERNs Sustainable and robust structure Scientific and clinical expertise ( best in class ) Data collection capacity (IT clinical platform) Commercial & non commercial clinical trials Long term follow up EU cohorts of patients Post-commercial studies: Off label use of medicines Repurposing Compassionate use Patient safety / adverse events analysis and reporting
20 EMA and ERNs: bringing mutual benefits Common challenges Ethical concerns Data management/protection/ownership Information to patients Patient registries strategy Standards in clinical practice and clinical guidelines development
21 5 year planning Integration of policies Funding Tools Member States role Network outcomes
22 Challenges General Framework Definition of the legal status of ERNs Referral of patients (Social Security and CBHC Directive) ERNs & national healthcare systems Integration Liability & Data protection ERN IT solutions Coordination relevant funding streams UK HCPs in a post-brexit scenario Sustainability of ERNs and opportunities for continued funding post-2022 Specific tasks of ERNs ERN management (coordinators) Clinical virtual care Coordination within the Network Knowledge generation & dissemination Development of patient pathways & shared clinical guidelines ERN crosslink Clinical outcomes Research leadership
23 Further information:
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