1. ECDC – a new agency for Public Health in Europe Karl Ekdahl Strategic Advisor to the Director

2. 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)

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

4. 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

6. 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

7. 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

8. 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

9. 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%)

10. 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)

11. 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

12. 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

13. 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

14. Tomteboda – Home of ECDC

15. ECDC milestones July 2003: Commissions 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 Centres mission

16. 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

17. Staffing and budget (2004 cost) 2005: 29+20 staff 5 M 2006: 50+40 staff 18 M Proposal 2007: 90+60 staff27 M 2008:120+80 staff36 M 2009:150+100 staff45 M 2010-2013:180+120 staff50 M

18. ECDC Organigramme Director Scientific Advice Scientific Panels Guidelines Advanced Analysis Knowledge Base 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 Directors Cabinet External Relations Country Strategies Governance Media & Information Secretarial support

19. Matrix organisation Director and Directors 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

20. 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

21. Directors Cabinet Overall co-ordinating responsibility of all ECDC activities Governance (AF and MB) Integrated information system Communication strategies, media relations, Eurosurveillance, website External relations

22. I would like to consult Europe – but I dont know the number there Henry Kissinger

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

24. 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

25. 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

26. 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

27. 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.

28. Surveillance and Communication Unit Gradually coordinate/integrate surveillance networks into ECDC Consolidate surveillance with DSNs 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

29. 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

30. 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

31. 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

34. 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

36. www.ecdc.eu.int

37. 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)

38. 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

39. 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

40. How the European Union is Preparing for Influenza - a Perspective from the ECDC

41. 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

42. Controlling spread of influenza?

43. 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

44. 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

45. 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

46. 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

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

48. 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

49. 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

50. Whats 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