pier luigi lopalco ecdc, unit for scientific advice may 11th, 2007 rome vaccination strategies: an...
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Pier Luigi Lopalco
ECDC, Unit for Scientific Advice
May 11th, 2007 Rome
Vaccination strategies: an EU perspective
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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
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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
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… six concerned with health
EEA Environment Agency (Copenhagen)
EMCDDA Monitoring Centre for Drugs & Drug Addiction (Lisbon)
EMEA Medicines Agency (London)
EU-OSHA Agency for Safety and Health at Work (Bilbao)
EFSA Food Safety Authority (Parma)
ECDC Centre for Disease Prevention and Control (Stockholm)
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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)
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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
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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 healthmany Member States want to keep control
over actions and measures
'Four legs good, two legs bad' (George Orwell)
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Similarities US - EU CDC
US CDC ECDC
Outbreak detection Yes Yes
Outbreak teams Yes Yes
Union-wide surveillance Yes Yes
Guidelines/
recommendations
Yes Yes
Risk assessments Yes Yes
Field epi training EIS EPIET
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Differences US - EU CDC
US CDC ECDC
Staff 8,000 3-400
Labs on site Yes No
Wider remit than infections
Yes No
Responsibility for risk management
Some Little
External remit Yes 'No'
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ECDC
MS
Commission
Council
EP
IndustryEU agencies
Researchcommunity
WHOOther
countries
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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…
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Differences at sub-national level in immunization programs
EU + EEA countries
source: VENICE
no (21)
yes (8)
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What happens when a vaccine has been recommended?
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Recommended (not mandatory) childhood vaccines free of charge
EU + EEA countries
source: VENICE
yes (19)
no (7)
insurance scheme (3)
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Hib
EU + EEA countries
source: EUVAC.NET
universal (26)
no (2)
risk groups only (1)
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HBV
EU + EEA countries
source: VENICE
universal (21)
no (1)
risk groups only (7)
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PNC7
EU + EEA countries
universal (11)
no (10)
source: Eurosurveillance
risk groups only (8)
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Men C
EU + EEA countries
source: VENICE
universal (10)
no (17)
risk groups only (2)
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Varicella
EU + EEA countries
yes (3)
no (23)
source: VENICE
adolescents only (3)
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2 countries
8 countries
16 countries
3 countries
1 country
0
2
4
6
8
10
12
14
16
18
4 doses 5 doses 6 doses 7 doses 8 doses
num
ber
of c
ount
ries
DT doses <18 years administered to a EU citizen depending on his/her residence
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Elements of decision making process
Burden of disease
Politics
Costs
Public Health Organization
Alternativemeasures
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Some examples from ECDC experience
Burden of disease
Politics
Costs
Public Health Organization
Alternativemeasures
BCGInfluenza
in childrenRotavirus HPV
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Role of ECDC for a EU-wide decision making process
Burden of disease
Politics
Costs
Public Health Organization
Alternativemeasures
EvidenceBased
Approach
+ + -
+ - -
+ + -
+ - -
- - -
SupportEU Member
States
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Status of decision making process on HPV vaccine introduction
EU + EEA countries
MoH (3)
not yet (23)
source: VENICE
National Committee (3)
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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)
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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
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Thank You
www.ecdc.europa.eu