European Reference Networks Implementation Framework Directive of patients' rights in cross-border healthcare Martin SEYCHELL Deputy Director General DG SANCO European Commission
Background, Context, scope and objectives Legal measures: Criteria for networks and providers Assessment and establishment Timeline for the implementation Challenges
Key issues addressed by the Directive Directive 2011/24/EU of patients' rights in cross-border healthcare Right to choose and be reimbursed for healthcare provided by public or private providers located in the EU More transparency about their rights, treatment options or, the quality and safety levels of healthcare providers Strong focus on cooperation among Member States o Mutual recognition of prescription o ehealth o Health Technology Assessment o European Reference Networks Entry into force at National level 25 October 2013
European Reference Networks (ERN): aim of Article 12: (Directive Patient's Rights to Cross border Healthcare ) o Support the development of European Reference Networks Commission: o Support MS in the development of ERN o Adopt Delegated & Implementing Acts Member States o Connecting providers & Centres of Expertise at national level o Fostering participation in the ERN. 4
Why do we need to talk about networks and centers of expertise/reference? Increasing specialization of healthcare Fragmentation of care in complex diseases Inequality of access to care The worst inequality is a diagnostic error Patient demand for high quality and seamless care Debate: More is better? Is expertise associated with a minimum number of cases? Is expertise associated with better results? Concentration of resources required for high cost or complex technology
Scope and Context 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 multidisciplinary approach (different specialities/areas of knowledge) Added value at EU level Need of cooperation: Scarcity knowledge Need education Complexity / high cost Effectiveness in the use of resources
Legal acts on ERN Entry into force 27 May 2014
Content of the delegated decision 6 sets of Criteria for Networks 5 sets of general criteria for members 2 sets of specific criteria for members
Eligibility criteria and scope 1. Are of expertise: rare or low prevalence and complex disease 2. All Members in an ERN must have in common: (a) the expertise they specialise in (b) certain diagnostic or treatment(s) offered or (c) disease (s) or health condition(s) they focus on 3. At least 10 providers located in 8 Member States
Member s general criteria 1. Set of horizontal criteria and conditions to be fulfilled by all healthcare providers regardless of the field of expertise 5 groups 22 criteria a) patients empowerment and centred care b) organisational, management and business continuity c) research and training capacity d) exchange of expertise, information systems and e-health tools e) expertise, good practice, quality, patients safety and evaluation
Member s specific criteria Set of specific criteria and conditions may vary depending on the scope of the concrete area of expertise document competence, experience and activity provide evidence of good clinical care and outcomes characteristics of human resources Based on the evidence and consensus of the scientific, technical and professional community organisation and functioning : multidisciplinary healthcare team specific equipment within the centre or easily accessible communication / interaction at a distance capacity Bottom up proposals
Implementing Decision Main principles agreed with Member States 1. Clear and solid eligibility criteria of the Networks 2. Key role of Member States: endorsement and approval 3. Participation: voluntary and commitment with the rules 4. Transparency and efficiency of the process 5. Based on a strong independent technical assessment
priorities? MS, experts and patients to discuss on priorities and grouping of diseases Workshop in Rome (28-29 November) co-organised by the Expert group on rare diseases of the Commission, the EUCERD JA and EUROPLAN Aim to discuss/reflect with the MS and the Rare Disease community on: next steps in the implementation in ERN in the case of rare diseases The use of Structural funds for the funding of ERN
European Reference Networks: networking dimension Key issues: Exchange of expertise and clinical data through the network and across the EU Swift and smooth contact between providers and between patients and providers at a distance Collaborative/cooperative actions and systems Networking activities and availability of specific network tools -It solutions- are the basis for this project.
Remote training Secure exchange of Patient information, databases/registries Remote guidance and Diagnosis Member Virtual clinical/tumour boards European Reference Network Remote monitoring and follow-up Member Local Healthcare Provider Tele-medicine Tele-consultation Members Networking elements, communication and ehealth solutions
Examples of IT tools and services Clinical and Tumour Boards are recognized as an essential component of excellence in cancer care and complex diseases. They bring together a range of medical disciplines for discussions on how to best care for the patient. Using ehealth & telemedicine technology, teams of specialists of the Members of the future NETWORKS across the EU would meet in videoconferences called "Virtual Clinical or Tumour Boards" to share medical information and agree on treatment options. Virtual clinical and tumor boards
How to assess and approve the Networks?
ERN Scenario Call for Networks Open application Individual Providers Network proposals Individual application Eligibility check Technical Assessment (criteria & conditions) Positive Assesment Approval of Network Establishment and Membership Players Networks Functioning Logo award 1 HCP & Network proyects 2 3 4 SANCO Member States Technical Independent Body Confirmation (ERN and Members) Evaluation (criteria, performance and cooperation)
Strong assessment methodology How: A solid Assessment Manual and toolkit (based on the legal criteria) Support and guidance for DG SANCO along the complete process, Legal criteria into operational criteria. Timeline: 16 months contract Evaluation ongoing Contract November 2014 WHO: Assessment bodies to perform the assessment of Networks proposals Call in 1st quarter 2015 Competitive Calls Institutions or entities with a solid background and experience
Communication & awareness activities Webpage Conference on ERN June 2014 (300 participants) Ads in Scientific journals (more than 30) Meetings with stakeholders and participation in conferences Discussions with advisory groups to the commission (Rome workshop 28 & 29 on Rare diseases and ERN) Conference in 2015 (preparatory for the call)
Examples Pilot networks of cooperation under Directive 2011/24/EU (Public Health WP 2013) Network of Pediatric Oncology Centers dealing with low prevalence and rare solid tumors EXPO-r-NeT, European Expert Pediatric Oncology Reference Network for Diagnostics and Treatment was awarded with the grant Network of complex neurologic diseases- Refractory Epilepsy E-Pilepsy 21
ERN tentative timeline & milestones May 2014 July 2014 IV quarter 2014 IV quarter 2015 II quarter 2016 Entry into force legal acts Call for Assessment Manual Call for selection independent body(ies) Call for Networks Establishment of Networks
The challenges
Key role of MS in the implementation of ERN MS responsible of: ENDORSEMENT of applications of healthcare providers Recognition of centers at national level. (important differences) MS with systems in place (minority) Board of MS: first meeting 5 December 2014. Rules and procedures February 2015 APPROVAL of Networks (once positively assessed) Be prepared in advance!!
Challenges Approve and attract the right Networks and Healthcare providers (the added value) Stronger engagement of MS to ensure sustainability Avoid fragmentation / duplication of efforts Develop/ use standardised tools Increase the capacity of healthcare providers by the "real" exchange of knowledge and cooperation (virtual tumour boards, etc..) Strength the "partnerships" between Experts, Scientific Societies, National authorities and EU institutions 25
Possible sources of support and financing at EU level 1.- Reimbursement of services (referrals and telemedicine) as established by the Social Security Regulation and Cross-border Healthcare Directive 2.- Formal establishment and designation of Centres of Expertise and Networks (source Health Programme) Assessment Establishment and designation process (Logo award) Periodic evaluation Independent body and its activities 3.- Project grants: Temporal financial support to a short list of established and awarded ERNs 4.- IT platform and conferences: exchange of information on the establishment and evaluation of the Networks (source Health Programme) 5.- Better position for other competitive calls RTD horizon 2020 : 2016 research on networks organizational models Connecting European Facilities (CEF): the ehealth dimension Structural funds (cross border cooperation) Social funds (training and better skills) 6.- Industry and other interested stakeholders (clinical trials, HTA, etc.)
Don t forget that this will be a long journey Int J Integr Care. 2005 Jul-Sep; 5: e01. Published online 31 August 2005. Evaluating integrated health care: a model for measurement Bengt Ahgren and Runo Axelsson, PhD, Professor of Health Management
Thank you! Further information: www.ec.europa.eu/join-ern