ECDC – a new agency for Public Health in Europe

Karl Ekdahl Strategic Advisor to the Director

How the European Union functions on health protection • Health care is the business of Member States • The European Union and Parliament has no remit to interfere in human health care issues • Contrasts the position for animal health • But infection is an anomaly (the six Freedoms)

Internal Market – 4 Freedoms • Free Movement of People • Free Movement of Services • Free Movement of Goods • Free Movement of Capital

Internal Market – 5th & 6th Freedom • Free Movement of People • Free Movement of Services • Free Movement of Goods • Free Movement of Capital • Free Movement of Micro-organisms • Free Movement of Birds

Decision 2119/98/EC ”Network decision” • Decision of the Parliament and the Council • Community Network for epidemiological surveillance and control of communicable diseases :   Epidemiological surveillance of diseases Early warning and response system (EWRS) • Under coordination by the Commission decide on:  List of diseases under surveillance = 49       Criteria for selection of these diseases Case definitions – under revision Nature and type of data to be collected Epidemiological and microbiological surveillance methods Guidelines on protective measures (external borders) Guidelines on information and guidance to the public

”Daughter decisions” to 2119/98/EC • Decision 2000/57/EC ”EWRS decision” • Decision 2000/96 ”List of diseases under surveillance” • Decision 2002/253/EC (2002/534/EC) ”Case definitions” • Decision 2003/542/EC ”DSN decision”

Decision 2000/57/EC ”EWRS decision” • Decision of Commission • Events to be reported  Outbreaks involving more than 1 MS  National outbreaks with a risk of spread to other MS  Outbreaks outside the Community with risk of spread to MS  Appearance/resurgence of communicable diseases or infectious agents wich may require timely, coordinated Community action to contain it • Procedures for informtion, consultation and cooperation • Actors = The Commission and competent authorities in the MS, lately also ECDC

Dedicated surveillance networks • One hub with coordinator and small secretariat • 1 epidemiologist + 1 microbiologist per MS • Reporting of detailed diseases data • Detect outbreaks and follow trends • Scientific studies • Typically funded by Commission (60%) and MS (40%)

Dedicated surveillance networks • EnterNet – Salmonella + EHEC (HPA, UK) • ESSTI – STI (HPA, UK) • EU-IBIS – invasive HI and menigococci (HPA, UK) • EWGLI – Legionella (HPA, UK) • Euro-HIV – HIV/AIDS (InVS, France) • Euro-TB – TB (InVS, France) • IPSE – nosocomial infections (Université Claude Bernard, France) • EARSS – AMR (RIVM, Netherlands) • EISS – influenza (NIVEL, Netherlands) • EUVAC.NET

– VPD (SSI, Denmark) • ENIVD – hemorrhagic fevers (RKI, Germany) • ESAC – antibiotic consumption (Univ. Antwerp, Belgium)

General infrastructural networks • EPIET – training field epidemiology (SMI, Sweden) • BSN – minimal datasets of all diseases (SMI, Sverige) • IRIDE – inventory of communicable disease control resources in Europe (ISS, Italy) • • Eurosurveillance – bulletin (HPA, UK + INVS, France)

EpiNorth

– Network for CD control in Northern Europe with bulletin, website, training courses (NPHI, Norway) • EpiSouth – mirror of EpiNorth

Health threats in Europe – 21st century challenges • New threats emerge  SARS, pandemic flu, WNV, antimicrobial resistance • Old diseases reemerge  HIV/AIDS, STI, TB, food borne diseases • Threat of bioterrorism • EU without borders: free movements of goods and people • Diseases spread within hours in a globalized and interconnected world

Limitations with old setup • Surveillance networks uncoordinated and without sustained funding • No central expert authority • Limited resources for rapid response • Unflexible system (bound by contracts) • 10 new Member States • Above evident during SARS crisis  ECDC

Tomteboda – Home of ECDC

ECDC milestones • July 2003: Commission’s proposal to establish ECDC • December 2003: Council decision that Sweden will host the Centre • April 2004: Regulation 851 establishing the Centre • December 2004: Director Zsuzsanna Jakab nominated • March 2005: Director takes office (start-up phase) • May 2005: Centre operational • October 2005: Move to own facilities at Tomteboda • 2007: Evaluation of the possible need to extend the scope of the Centre’s mission

Very broad mandate Founding Regulation 851/2004/EC • Close cooperation with MS and EU bodies • Surveillance • Risk identification and risk assessment • Preparedness planning • Response to health threats and events • Training • Communication • Scientific opinions and guidelines

Staffing and budget (2004 cost) • 2005: • 2006: Proposal • 2007: • 2008: • 2009: • 2010-2013: 29+20 staff 50+40 staff 90+60 staff 120+80 staff 150+100 staff 180+120 staff 5 M € 18 M € 27 M € 36 M € 45 M € 50 M €

ECDC Organigramme

Director Scientific Advice

Scientific Panels Guidelines Advanced Analysis Knowledge Base

Director’s Cabinet

External Relations Country Strategies Governance Media & Information Secretarial support

Surveillance and Communication

Data Management Surveillance

Preparedness and Response

Threat Assessment Capacity Building Crisis Operations

Administrative Services

Finance & Budget Human Resources ICT & Logistics Publications & Info

Matrix organisation

Director and Director’s Cabinet Scientific Advice Surveillance & Communication Preparedness & Response Administrative Services Influenza Antimicrobial Resistance HIV/AIDS and other STI and bloodborne viral infections Other horizontal Working Groups and Task Forces

ECDC horizontal actions • Forming partnerships • Risk assessment • Enhance surveillance activities • Developing guidance and scientific opinions • Disseminate information • Assess country preparedness and capacity (country visits) • Advocacy

Director’s Cabinet • Overall co-ordinating responsibility of all ECDC activities • Governance (AF and MB) • Integrated information system • Communication strategies, media relations, Eurosurveillance, website • External relations

“I would like to consult Europe – but I don’t know the number there” Henry Kissinger

Commission EP MS Networks ECDC Council EU agencies WHO Industry Research community CDCs Other countries NGOs

Framework for Country Strategy • Directory of contact points  MB appoint and publish competent bodies • Overview of health systems  Detailed inventory of resources and expertise (build on IRIDE) • Identification of need for support  Action plan for 5 countries in 2006 • Working with regional networks  EpiNorth, EpiSouth

Scientific Advice Unit (I) • Provide sound and independent technical and scientific advice  Questions, guidelines, toolkits  No own research capacity • Well acquainted with the front-line of research in all areas of CD control  Actively participate in key scientific conferences and meetings

Scientific Advice Unit (II) • Network of experts and scientists in Europe  Roster of experts  Network of European reference laboratories • Strong on new and emerging health threats • Cooperation with laboratories • Support member states in national endeavours  Turn policies/guidelines into action if needed  Advocacy

Process for scientific questions • Competence in house?

• Competence in one of the DSNs?

• Competence in one of the Scientific Panels?

• In real life, probably combination of these.

Surveillance and Communication Unit • Gradually coordinate/integrate surveillance networks into ECDC • Consolidate surveillance with DSN’s and national surveillance institutes • Prepare case definitions • Set up data-bases at ECDC • Receive data from DSNs • Technical assistance to MS on surveillance issues • Surveillance  public health action

Output of surveillance data • “Surveillance is data for action” • Data dissemination through various means  Eurosurveillance scientific voice of ECDC  Public and privileged web pages  Surveillance reports  Articles in scientific journals  All necessary data should be easily available through the ECDC web portal  Strategic partnership with the EpiNorth network and bulletin

Preparedness and Response Unit (I) • Epidemic intelligence  Keep track of emerging health threats inside and outside the EU  ProMed, GOARN, GPHIN, GIDEON and other Community alert systems • Timely advice on such threats • Assisting the Commission by operating the Early Warning and Response System (EWRS) with a 24h/7d duty system

Preparedness and Response Unit (II) • Provide technical assistance in outbreak investigation and response  Identify outbreak assistance teams  Identify and mobilize lab capacity  Training activities  MoU with international partners (WHO)  Inventory and development of response guidelines

Output of epidemic intelligence data • European Commission  Commissioner briefing • Member States  Early Warning and Response System  ECDC threat assessment weekly bulletin • Public  Eurosurveillance weekly  ECDC website

www.ecdc.eu.int

Training activities • Activities in 2005  Development of a training strategy document (with EPIET)  Consultation of Member States  Participation to training on ad-hoc basis  Planning an outbreak team leader course • Planned Activities in 2006-2007  Transition of EPIET  Identify training needs and topics  Short courses on national level  Develop training materials and manuals (web based)

Scope of ECDC from 2010 • First rock solid in CDs = priority 1 • Review starts in May 2007  Co-decision of Council and EP needed to extend scope • Even if this happens not before 2010  5 years only for CDs • If extended - gradual process:  Starting with health monitoring, analysis and reporting?

 Additional resources needed

Key message • ECDC could only be strong if built on strong European networks and ideas • ECDC will provide needed services and give a clear added value to the European CD control • ECDC will channel the best available resources (own and others) to where they will be best needed

How the European Union is Pr eparing for Influenza - a Persp ective from the ECDC

European Union – many strengths • Well resourced compared to other global regions • Some strong centralised health systems • Some strong public health systems • Enthusiasm to make EU and ECDC work • World class laboratories • Good vaccine manufacturing base • Innovative approaches x 25 + • European wide and international perspective

Controlling spread of influenza?

Influenza milestones • March 2005 - Euro Pandemic Preparedness Workshop 1 – Luxemburg • May 2005 – ECDC became operational • European Commission Generic and Pandemic Documents Launched • October 2005 Euro Pandemic Preparedness Workshop 2 Copenhagen • November 2005 – First Europe wide command post exercised (’Common Ground’) • May 2006 Euro Pandemic Preparedness Workshop 3 Uppsala

There have also been ’events’ - mostly around bird flu • H5N1 approaching relentlessly from the East • Dead gull in September 2003 • Poultry outbreaks in Romania and Turkey Autumn 2005 • Human outbreaks on the fringes – Turkey January 2006 • Political events – London, Beijing etc

Aims of the Workshops • Coordinated approach European Commission, WHO/Europe and ECDC • 52 European countries • Share best practice  All European countries have pandemic plans • Inform about developments • Latterly maintain momentum

Intensive ECDC activities between workshops - examples • Detailed influenza assessments in EU MS  National and local  Pandemic, seasonal and avian influenza  Public health and microbiology • Planning on surveillance • Modelling • Guidance Production

Work on H5N1 • Essential but rather a distraction • Huge opportunity costs for ECDC • Kept the political momentum

Recommendations from Uppsala Workshop, May 2006 • Complete toolkit and training packages for AI in humans • Further country visits in EU and WHO region • Sub-regional meetings to address interoperability and practical preparedness issues • Further work on indicators • Next EU / WHO plenary workshop will be July 2007

Issues for the EU – lots of these • Interoperability issues • Variable uptake of influenza seasonal vaccination • Adjusting to H5N1 being either endemic or an occasional visitor • A common anti-viral policy?

• Agreement on public health measures to be recommended • Local preparations only starting • Intersectoral work (Ministries of Health, Agriculture, Education etc working together) • Interpreting Ferguson et al 2006 for policy development

What’s going to happen with H5N1 in the bird and the pandemic

“It is difficult to make

predictions, ….especially about the future

”

Yogi Berra Baseball Player & Sage