Do European Reference Networks fit national structures? A German perspective European Hospital Conference Düsseldorf, 22 November 2013 (European Integration) Director EU-policies/international affairs German Hospital Federation
Implementation general procedure DIR EU/2011/0024 effective since 24 April 2011 Implementation to national law till 25 October 2013 since four weeks the rights apply directly! The implementing process is fragmented : reimbursement, patient s rights, hta, ERN, interoperability, national contact point, prescriptions And organised on two different levels: EU-level and national level
Implementation on EU-level Competence for delegated acts and implementing acts: For the cooperation of member states on ERN - European Reference Networks (Art. 12) For the cooperation of member states on ehealth (Art. 14) For the cooperation of member states on hta (Art. 15) Delegated act: participation by European Parliament and Council Implementing act: only vote by the committee (Member States)
ERN s objectives - directive ERN European Reference Network (Art. 12) ERN shall have objectives: Foster research, innovation, better care Pooling of resources and knowledge Disseminate knowledge and standards To be achieved by: Should have a multi-disciplinary approach Contribute to research, teaching and training Provide high level of scientific work and outcomes Should closely network with other networks and centers COM works on criterion for participation (delegated act) COM defines structures of ERN (implementing act)
ERN s objectives delegated act Outcomes of ERN Quality/ training standards should be developed outcome and performance indicators should be designed and implemented common communication tools, methodologies or operation and coordination practices should be developed Critical: Quality standards of member states or required structures could be disrupted: Federal Joint Committee in Germany! What about possible impacts on training?
ERN s members delegated act General criterion for participation for service providers Compliance sometimes will be difficult: Transparency on outcomes, treatment options, quality and safety standards: is the German quality report sufficient? Business continuity Budget (if public hospitals) Not by law but by practice: unexpected resource failure? Critical: specialists from primary care sector are excluded High number of criterion might be unattractive or unfeasible
ERN s members delegated act Special criterion for service providers Partly unclear: Evidence of good clinical care and outcomes Characteristics of human resources (type, number, qualifications and skills = structural quality settings) Critical: minimum volumes are required. Effects on national discussions and on hospital planning are possible! Integration of EUCERD -recommendations is not clear
The way to ERN implementing act Implementing act on approval procedure (still non-paper ) Establishment by application, assessment and finally by granting of a label Application by service provider and consortium Assessment by external and independent body Approval by EU-level: Decision of European Commission and granting of the label Member of ERN European Commission facilitates conferences Critical : Decisions of planning authorities (German Bundesländer) could be precluded (prior appraisal of application by MS authority?)
The way to ERN implementing act Critical: No financing available! MS should lobby for HORIZON 2020 Critical : Sustainability/continuity of networks ERN must remain always open to new members
Source: European Commission
Source: European Commission
ERN s added value for Germany? Building of ERN is Member States task given by the directive Label Member of ERN as an incentive? Fostering of research is a real added value! Patients can benefit!
Thanks and contacts German Hospital Federation Director EU-policies/international affairs/ Health economies Wegelystr. 3 10623 Berlin, Germany Tel.: +49 (0)30 39801 1030 Fax.: +49 (0)30 39801 3011 E-Mail: m.schreiner@dkgev.de Internet: www.dkgev.de