European Reference Networks and Centres ofof Expertise ...

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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, [email protected]

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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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


» 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


» 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)



» 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



» 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(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

[email protected]@goeg.at

European Reference Networks and Centres ofof Expertise ...

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