Transcript Dr Pier Luigi Lopalco

Vaccination strategies: an EU perspective
Pier Luigi Lopalco
ECDC, Unit for Scientific Advice
May 11th, 2007
Rome
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
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
… 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)
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)
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
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)
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
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'
Commission
EP
MS
Council
Industry
ECDC
EU agencies
WHO
Research
community
Other
countries
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…
Differences at sub-national level in
immunization programs
EU + EEA countries
no (21)
yes (8)
source: VENICE
What happens when a vaccine
has been recommended?
Recommended (not mandatory)
childhood vaccines free of charge
EU + EEA countries
yes (19)
insurance scheme (3)
no (7)
source: VENICE
Hib
EU + EEA countries
universal (26)
risk groups only (1)
no (2)
source: EUVAC.NET
HBV
EU + EEA countries
universal (21)
risk groups only (7)
no (1)
source: VENICE
PNC7
EU + EEA countries
universal (11)
risk groups only (8)
no (10)
source: Eurosurveillance
Men C
EU + EEA countries
universal (10)
risk groups only (2)
no (17)
source: VENICE
Varicella
EU + EEA countries
yes (3)
adolescents only (3)
no (23)
source: VENICE
DT doses <18 years administered to a EU
citizen depending on his/her residence
18
16 countries
number of countries
16
14
12
10
8 countries
8
6
4
3 countries
2 countries
2
1 country
0
4 doses
5 doses
6 doses
7 doses
8 doses
Elements of
decision making process
Burden
of disease
Costs
Alternative
measures
Public Health
Organization
Politics
Some examples from ECDC
experience
Burden
of disease
Costs
Alternative
measures
Public Health
Organization
Politics
BCG
Influenza
in children
Rotavirus
HPV
Role of ECDC for a EU-wide
decision making process
Burden
of disease
++-
Costs
+--
Alternative
measures
++-
Public Health
Organization
+--
Politics
---
Evidence
Based
Approach
Support
EU Member
States
Status of decision making process on
HPV vaccine introduction
EU + EEA countries
MoH (3)
National Committee (3)
not yet (23)
source: VENICE
Status of decision making process on Rota
vaccine introduction (including negative decision)
EU + EEA countries
MoH (4)
National Committee (3)
not yet (22)
source: VENICE
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
Thank You
www.ecdc.europa.eu