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: 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

16. Very broad mandateFounding 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 staff 27 M € • 2008: 120+80 staff 36 M € • 2009: 150+100 staff 45 M € • 2010-2013: 180+120 staff 50 M €

18. ECDC Organigramme

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

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. 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

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

23. Commission EP MS Council ECDC Networks EU agencies WHO NGOs Researchcommunity Other countries Industry 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 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

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. “It is difficult to make predictions, ….especially about the future” Yogi Berra Baseball Player & Sage What’s going to happen with H5N1 in the bird and the pandemic