Pier Luigi Lopalco

ECDC, Unit for Scientific Advice

May 11th, 2007 Rome

Vaccination strategies: an EU perspective

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 healthmany 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'

ECDC

MS

Commission

Council

EP

IndustryEU agencies

Researchcommunity

WHOOther

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

source: VENICE

no (21)

yes (8)

What happens when a vaccine has been recommended?

Recommended (not mandatory) childhood vaccines free of charge

EU + EEA countries

source: VENICE

yes (19)

no (7)

insurance scheme (3)

Hib

EU + EEA countries

source: EUVAC.NET

universal (26)

no (2)

risk groups only (1)

HBV

EU + EEA countries

source: VENICE

universal (21)

no (1)

risk groups only (7)

PNC7

EU + EEA countries

universal (11)

no (10)

source: Eurosurveillance

risk groups only (8)

Men C

EU + EEA countries

source: VENICE

universal (10)

no (17)

risk groups only (2)

Varicella

EU + EEA countries

yes (3)

no (23)

source: VENICE

adolescents only (3)

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

Elements of decision making process

Burden of disease

Politics

Costs

Public Health Organization

Alternativemeasures

Some examples from ECDC experience

Burden of disease

Politics

Costs

Public Health Organization

Alternativemeasures

BCGInfluenza

in childrenRotavirus HPV

Role of ECDC for a EU-wide decision making process

Burden of disease

Politics

Costs

Public Health Organization

Alternativemeasures

EvidenceBased

Approach

+ + -

+ - -

+ + -

+ - -

- - -

SupportEU Member

States

Status of decision making process on HPV vaccine introduction

EU + EEA countries

MoH (3)

not yet (23)

source: VENICE

National Committee (3)

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)

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