1. Pier Luigi Lopalco ECDC, Unit for Scientific Advice May 11th, 2007 Rome Vaccination strategies: an EU perspective

2. The European Union Not a state, but more than just an international organisation Common institutions to which Members States delegate some sovereignty Three central institutions: Council (the Prime Ministers) Parliament (elected EU-wide every 5 years) Commission (EU administration, mostly in Brussels) Real power lies with Council: all Member States must agree on important decisions

3. An EU Agency Similar idea as national / federal agencies or institutes: technical body for specific area outside Commission sphere some independence own budget About 25 total: aviation, tele communications, police school, etc

4. … six concerned with health EEAEnvironment Agency (Copenhagen) EMCDDAMonitoring Centre for Drugs & Drug Addiction (Lisbon) EMEAMedicines Agency (London) EU-OSHAAgency for Safety and Health at Work (Bilbao) EFSAFood Safety Authority (Parma) ECDCCentre for Disease Prevention and Control (Stockholm)

5. Milestones July 2003: Commission proposal to establish ECDC December 2003: Council decision that Sweden will host the Centre April 2004: Regulation 851 establishing the Centre May 2005: Centre operational 2007-9: Evaluation of possible extension of Centre's remit (outside infectious diseases)

6. Broad mandate Close cooperation with MS and EU bodies Surveillance Communication Preparedness planning Response to health threats and events Risk identification and risk assessment Training Scientific advice - opinions and guidelines

7. Level of authority Important difference between EU central power as regards agriculture, food safety, animal health, etc. on one hand – and public health on other: very little central power in public health many Member States want to keep control over actions and measures 'Four legs good, two legs bad' (George Orwell)

8. Similarities US - EU CDC US CDCECDC Outbreak detectionYes Outbreak teamsYes Union-wide surveillanceYes Guidelines/ recommendations Yes Risk assessmentsYes Field epi trainingEISEPIET

9. Differences US - EU CDC US CDCECDC Staff8,0003-400 Labs on siteYesNo Wider remit than infections YesNo Responsibility for risk management SomeLittle External remitYes'No'

10. ECDC MS Commission Council EP Industry EU agencies Research community WHO Other countries

11. Who takes decisions on vaccine schedules in EU? National Vaccination Committees exist in 22 MS MoH (usually) decides the national recommendation following the advice of the Vaccination Committees or National Institutes But…

12. Differences at sub-national level in immunization programs EU + EEA countries source: VENICE no (21) yes (8)

13. What happens when a vaccine has been recommended?

14. Recommended (not mandatory) childhood vaccines free of charge EU + EEA countries source: VENICE yes (19) no (7) insurance scheme (3)

15. Hib EU + EEA countries source: EUVAC.NET universal (26) no (2) risk groups only (1)

16. HBV EU + EEA countries source: VENICE universal (21) no (1) risk groups only (7)

17. PNC7 EU + EEA countries universal (11) no (10) source: Eurosurveillance risk groups only (8)

18. Men C EU + EEA countries source: VENICE universal (10) no (17) risk groups only (2)

19. Varicella EU + EEA countries yes (3) no (23) source: VENICE adolescents only (3)

20. DT doses <18 years administered to a EU citizen depending on his/her residence

21. Elements of decision making process Burden of disease Politics Costs Public Health Organization Alternative measures

22. Some examples from ECDC experience Burden of disease Politics Costs Public Health Organization Alternative measures BCG Influenza in children RotavirusHPV

23. Role of ECDC for a EU-wide decision making process Burden of disease Politics Costs Public Health Organization Alternative measures Evidence Based Approach + + - + - - + + - + - - - - - Support EU Member States

24. Status of decision making process on HPV vaccine introduction EU + EEA countries MoH (3) not yet (23) source: VENICE National Committee (3)

25. Status of decision making process on Rota vaccine introduction (including negative decision) EU + EEA countries MoH (4) not yet (22) source: VENICE National Committee (3)

26. Prospects? EU is a very complex environment Any decision towards an harmonization of vaccination strategies has to be taken on the basis of a large consensus The ECDC can act as a catalyst sharing best practice, promoting research and providing evidence to MS to choose between different policy options In the vaccine field there are difficulties in providing an evidence based approach universally accepted, as the relevant information reflects factors which may have certain degrees of uncertainty and depends on different value judgements

27. Thank You www.ecdc.europa.eu