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17/08/2015
1
European Reference Networks and Centres of Expertise –and Centres of Expertise The Austrian Approach
Cross-border Healthcare – Patients without BordersJM Hotel, 02.09.2015, Warsaw
Till Voigtländer, Institute of Neurology, MUWtill.voigtlaender@meduniwien.ac.at
Contents
» Definition, dimension and difficulty of rare diseasesdiseases
» European documents in the field of rare diseases
» The Austrian concept of “Centres of Expertise”p p
» The concept of European Reference Networks
» Q & A
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2
Definition of Rare Diseases
Criterion 1: The prevalence1
Any medical disease or condition affecting not more than 5 per 10.000 persons in the European Community.
Criterion 2: The severity2
All rare diseases that are either life-threatening orAll rare diseases that are either life threatening orseriously debilitating or that present as a serious and chronic condition.
1 Core criterion 2 Accessory criterion
Source: Council Recommendation on an action in the field of rare diseases. OJ C 151, 3.7.2009, p7.
Dimension and DifficultyDimension: » 6.000-8.000 distinct rare disease entities» up to 4.100 patients per disease entity in Austria» altogether approximately 450.000 affected citizens in
Austria (6-8 % of the total population)
Difficulties: Aspect of the availability of (medical) expertise» alpha 1 AT deficiency: ca. 2.000 patients» Epidermolysis bullosa simplex ca. 200 patients» Creutzfeldt-Jakob disease ca. 15 patients
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European Documents (1)» Communication from the Commission on
Rare Diseases: Europe‘s challenges (2008)
Documents of the European Commission, the Council and the European Parliament
» Council Recommendation on an Action in theField of Rare Diseases (2009): » Area IV („Centres of Expertise and European Reference
Networks for Rare Diseases“)» Cross-Border Healthcare Directive of the European
Parliament and the Council (2011)Parliament and the Council (2011)» Article 12 („European Reference Networks“) » Article 13 („Rare Diseases“)
» Delegated Decision and Implementing Decision of theCommission (2014)
European Documents (2)» Reports of the Task Force for Rare Diseases (RDTF)
regarding Centres of Expertise for Rare Diseases andf
Documents of European Committees, Groups and Projects
European Reference Netzworks (2005, 2006, 2008)
» EUCERD1) Recommendations: Quality Criteria forCentres of Expertise for Rare Diseases in MamberStates (2011)
» Recommendations of the EUROPLAN2) Project for the» Recommendations of the EUROPLAN Project for theDevelopment of National Plans for Rare Diseases (2011)
1) EUCERD: European Committee of Experts for Rare Diseases2) EUROPLAN: European Project for Rare Diseases National Plans
Development (2008-2011)
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Objectives of ERN (1)CBHD, article 12, paragraph 2 (excerpts):» Realise the potential of European cooperation
Documents of European Committees, Groups and Projects
» Realise the potential of European cooperation regarding highly specialised healthcare
» Maximise cost-effective use of resources by concentrating them where appropriate
» Help Member States with an insufficient number of patients with a particular medical condition or lackingpatients with a particular medical condition or lacking technology or expertise to provide highly specialised services of high quality
Objectives of ERN (2)CBHD, article 12, paragraph 2 (excerpts continued):» Facilitate improvements in diagnosis and the delivery of
Documents of European Committees, Groups and Projects
» Facilitate improvements in diagnosis and the delivery of high-quality, accessible and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise in medical domains where expertise is rare
» Facilitate mobility of expertise, virtually or physically, d d l h d d fand to develop, share and spread information,
knowledge and best practice and to foster developments of the diagnosis and treatment of rare diseases, within and outside the networks
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„Centres of Expertise“ for RD in AustriaModel of three different levels of specialisedcentres for rare diseases
» Type B Centre (Centre of Expertise)
» Type A Centre (Cluster of Expertise)
B
B BBB B
A
» Type C Centre (Associated Centre) C
BB B
Centre of Expertise (CoE) Typ BFeatures:» Basic principle:» Basic principle:» Basic principle:
B
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Profile:» Clinical care: General and specific quality criteria for
1 Further research activities optional
Centres of Expertise» Research: Registries 1
» Education: Specialist training in the corresponding speciality with additional focus in thearea of expertise
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Expertise Cluster Typ AFeatures:» Basic principle:» Basic principle:» Basic principle:
B BBB B
A
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Synergistic consortium of (obligatorily) ≥ 3 Type B centres and (facultatively) additional Type C centres
» Consortium accross different defined groups of rare diseases from different medical specialties (integration of expertise in a higher superordinate structure)
P fil» Profile:» Clinical care like Type B centres» Corporate integrative structures like (for example):
» Common reception centre» Common boards for people living with RD» Application of highly specialised diagnostics
Associated Centre Typ CFeatures:» Basic principle:» Basic principle:» Basic principle:
C
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Specialised centre for a defined group of rare diseases(e.g. inherited bullous skin diseases) (disease group oriented definition)
» Specialised centre for a defined group of rare diseases(with less or not long-term guaranteed human and technical resources) (disease group oriented definition)
» Profile:» Clinical care: General and specific quality criteria for
Associated Centres» Research: Registries (if possible)» Education: Specialist training in the corresponding
speciality with additional focus in thearea of expertise (if possible)
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Integration into Austrian Healthcare System (1)
Centre of Expertise Type BCluster of Expertise Type A
B BBB
B
B
B
B
B
B
B
B
A
Cluster of Expertise Type A
B
B
BBB
B
Integration into Austrian Healthcare System (2)
Networking of the Expertise Clusters(„National Cluster of Expertise“)
B
B
B
B
B
B
B B
B
BB B
BB B
A
A
A
B
B
BBB
BBB BB
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Integration into Austrian Healthcare System (2)Additional networking in the
healthcare SystemB
B
B
B
B
B
B
B
BBB B
BB B
A
A
A∙ Centres of Expertise
B
B
BBB
BBB BB
Integration into Austrian Healthcare System (3)Additional networking in the
healthcare SystemB
B
B
C
B BBB
A
N SpSp
Sp
NN
N
N
NN
Sp
∙ Associated Centres Type C∙ Primary, secondary and
tertiary level hospitals∙ Primary care sector
CSpN
N NN
Sp
Sp
B B
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Summary of the Austrian centre model» Equal level of clinical care in all three types of centres
(no hierarchical graduation)» Clear assignement of a defined centre to a defined group
of rare diseases (Type B centre)» Utilization of the additive potential of disease- and
specialty-spanning structures (Type A centre)» Implementation of new diagnostic and care options for so
far undiagnosed patients (national/virtual Type A network)far undiagnosed patients (national/virtual Type A network)» Fostering of existing and establishment of new care
pathways (from the primary sector to specialised centres)» Establishing the structural framework for the integration of
Austrian expertise in European Reference Networks
The Concept of Centres of Expertise and ERN» Centres of Expertise (CoE):
» National centres offering» National centres offering» Concentration of expertise» High degree of quality assurance based on
Europe-wide uniform quality criteria» Sustainability of the facilities
E R f N k (ERN)» European Reference Networks (ERN):» Networking of medically and thematically
corresponding centres of expertise on the European level
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The Concept of Centres of Expertise and ERN
EC EC EC
» Centre of Expertise
EC ECECEC EC
Cluster
» European Reference Netzwork EC
The ERN concept in a computer animation
EC
EC
EC EC
ECEC ECECEC
Cluster
ECEC
EC
EC
EC
EC
EC
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The ERN concept in a computer animation
EC
EC
EC EC
Ichthyosis
ECEC ECECEC
Cluster
ECEC
EC
EC
Inherited epidermolysis
bullosa
Hereditary
Hair and nail anomalies
EC
EC
EC
ypalmoplantarkeratoderma
The ERN concept in a computer animationEC
EC
EC
EC
EC
EC EC
EC
ECEC ECECEC
Cluster
EC
EC
EC
ECEC
EC
EC
EC
EC
EC
EC
EC
EC
ECEC
EC
ECEC
EC
EC
European Reference Networks (ERNs) of Centers of Expertise
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Designation of ERN
» Application of a network and all participating healthcare providers / membersp
» Eligibility check and technical assessment» Formal approval of positively assessed networks and
participating members» Limited designation of the network and award of the
ERN lERN logo» Regular cycle of re-evaluation and re-designation
ERN Scenario
Call for Networks
Technical Assessment(criteria &
Positive Assesment
Eligibility h k
Network proposalsNetwork proposals
Networks Functioning
(criteria & conditions)
Open application Individual Providers
check
Logo awardPlayersHCP & Network
proyects1
Establishment and Membership
Approval of Network
Individual applicationIndividual application
Health andConsumers
Evaluation(criteria,
performance and cooperation)
Confirmation(ERN and Members)
SANCO
Technical Independent
Body
Member States
proyects1
2
3
4
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Timeline ERN
Ad ti
Entry into force ERN Call ERN approval
2014
Adoption ERN establishment
I Conference ERN
MediaCamp I
Set-up board MS
II Conference ERN
MediaCamp II 2015 2016
III Conference ERN
ERN assessment
2017
ERN services study
Health andConsumers
25
Tender FrameworkA. bodies
TenderManual
Acknowledgements» National Coordination Centre for Rare diseases
» Florian Bachner, GÖG» National Coordination Centre for Rare diseases
» Florian Bachner, GÖG, GÖG» Christine Leopold, GÖG» Joy Ladurner, GÖG» Ursula Unterberger, MUW
» Austrian Ministry of Health» Magdalena Arrouas, BMG III/2
,» Joy Ladurner, GÖG» Christine Leopold, GÖG» Ursula Unterberger, MUW
» Austrian Ministry of Health» Magdalena Arrouas, BMG III/2
» European Commission DG Sante» Enrique Terol
» European Commission DG Sante» Enrique Terol
Funding:
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Summary
» Definition, dimension and difficulty of rare diseasesdiseases
» European documents in the field of rare diseases
» The Austrian concept of “Centres of Expertise”p p
» The concept of European Reference Networks
» Q & A
The ERN concept in a computer animationEC
EC
EC
EC
EC
EC EC
EC
ECEC ECECEC
Cluster
EC
EC
EC
ECEC
EC
EC
EC
EC
EC
EC
EC
uh
http://ec.europa.eu/health/ern/board_member_states/index_en.htm
EC
ECEC
EC
ECEC
EC
EC
till.voigtlaender@meduniwien.ac.attill.voigtlaender@goeg.at
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