Legislative Approaches to Immunization Across the European Region

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1 Legislative Approaches to Immunization Across the European Region December

2 OUR MISSION To make life-changing vaccines more accessible, enable innovation & expand immunization across the globe. 2

3 ACCOMPLISHING OUR MISSION Enabling Access & Uptake Advancing Knowledge & Innovation Supporting Research & Development Strengthening global and national immunization policy and financing Increasing equitable coverage of new and underutilized vaccines Engaging on critical vaccine topics Building capacity of the next generation of immunization leaders Better understanding demand drivers Contributing to meaningful advancements in vaccine science Building partnerships to advance disease targets and/or new scientific approaches 3

4 EUROPEAN REGION LEGISLATIVE LANDSCAPE REVIEW Outcomes Final report highlighting legislative approaches, trends and practices 5 case studies, highlighting country- and regional-level insights on approaches First and only systematic review of immunization legislation that includes all 53 countries in the Euro Region Matrix categorizing country laws and policies to provide an overview of the degree of immunization oversight Likert Scale to further classify country immunization legislation across 5 levels Dynamic, online repository of all legislative documents to facilitate further analysis The study can be used as a point of reference to evaluate legislative frameworks for immunization law 4

5 European Region Matrix: Immunization Legislation Categorizing countries under 8 questions identifying frameworks of immunization legislation

6 8 QUESTIONS OF THE EURO REGION MATRIX Is the right to health in this country s constitution? Is it mandatory for people to be immunized? Is immunization required to attend an educational institution? Has the judiciary court ruled on mandatory immunization? Is it mandatory for the government to provide immunization? Does the government verify that the individual has been immunized? Are there penalties in cases of noncompliance? Does the government finance immunization? 6

7 EUROPEAN REGION MATRIX: IMMUNIZATION LEGISLATION Categorizing the 53 countries of the Euro Region 7

8 Likert Scale: Assessing Levels of Immunization Legislation Classification of 53 countries of the Euro Region 8

9 LEGISLATIVE FRAMEWORKS FOR IMMUNIZATION LIKERT SCALE Recommended Recommended with robust monitoring and follow-up Recommended with mandatory requirements for school attendance Mandatory immunization with monitoring and follow-up Mandatory immunization with robust monitoring and follow-up 9

10 LIKERT SCALE: ASSESSING LEVELS OF IMMUNIZATION LEGISLATION 10

11 LIKERT SCALE: ASSESSING LEVELS OF IMMUNIZATION LEGISLATION **Partially shaded countries could not be definitively categorized by researchers; the color represents their probable categorization 11

12 COMPARISON OF SABIN REVIEW TO PREVIOUS RESEARCH 12

13 Country and Regional Case Studies

14 THE NORDIC COUNTRIES The recommended approach in practice 14

15 THE NORDIC COUNTRIES The recommended approach in practice Likert Scale Category: Recommended Denmark, Finland, Norway and Sweden Immunization is voluntary and provided free of charge to children; immunization not required for school entry 15

16 THE NORDIC COUNTRIES The recommended approach in practice Key takeaways: A recommended legislative approach can attain high levels of immunization Reliable, universal surveillance systems tracking coverage, disease incidence and AEFIs are critical Analysis of declining coverage and hesitancy bolsters efforts to raise coverage Targeted information campaigns from trusted sources influence coverage 16

17 THE BALTIC STATES A comparison of legislative approaches across 3 countries with similar historical, geographic and health contexts Likert Scale Categories: ESTONIA LATVIA LITHUANIA Recommended with robust monitoring and follow-up Mandatory immunization with monitoring and follow-up Recommended Despite different approaches, these countries with similar backgrounds maintain high immunization coverage rates 17

18 THE BALTIC STATES A comparison of legislative approaches across 3 countries with similar historical, geographic and health contexts 18

19 THE BALTIC STATES A comparison of legislative approaches across 3 countries with similar historical, geographic and health contexts Immunization coverage of 90-99%, and limited vaccine hesitancy and refusal compared to neighbors Utilize additional approaches to improving coverage including: Reforming health systems and NIPs to guarantee immunization financing Improving data collection and monitoring Ensuring strong political champions for vaccines Facing high vaccine prices due to a small market share, the Baltics are implementing a joint procurement mechanism for purchasing vaccines to lower cost of vaccines 19

20 MOLDOVA Reviewing a recommended approach with mandatory requirements for school attendance 20

21 MOLDOVA Reviewing a recommended approach with mandatory requirements for school attendance Likert Scale Category: Recommended with mandatory requirements for school attendance Though not mandated by health legislation, children must meet all routine immunization requirements to enter educational and other collective institutions 21

22 MOLDOVA Reviewing a recommended approach with mandatory requirements for school attendance Key takeaways: Illustrates the value of targeted activities to strengthen the immunization system rather than a change to legislative framework Historically a strong performer in vaccine coverage (except for a recent dip and measles outbreaks) Both legal challenges and vaccine hesitancy make upholding the school mandate difficult Targeted information and communications campaigns from trusted sources influence coverage 22

23 FRANCE Moving toward a more coercive approach to immunization 23

24 FRANCE Moving toward a more coercive approach to immunization Likert Scale Category: Mandatory immunization with robust monitoring and follow-up All routine childhood immunizations are mandatory In response to rising hesitancy and measles outbreaks, increased mandated vaccines from 3 to 11 in

25 FRANCE Moving toward a more coercive approach to immunization Marisol Touraine, Former French Minister of Solidarity and Health ( ) Increased mandated vaccines from 3 to 11 in 2017: Highest rate of death due to measles in Euro region prior to legislative changes in 2017 and growing vaccine hesitancy Conducted citizen consultation prior to solicit citizen feedback and socialize the mandate Established government committee to guide legislation Reduced and removed criminal penalties for noncompliance Implemented mandate nationally Photo credit: Laurent Guedon 25

26 FRANCE Moving toward a more coercive approach to immunization Key takeaways: Ministers of Health were vocal immunization advocated and championed legislation Socialized the legislation and sought public input on legislation, ensuring buy-in Sustained political will is essential to avoid weakening or reversal of the legislation, as has occurred elsewhere in the region Immunization mandate came into effect in 2018; it is premature to correlate a longterm effect on coverage Agnés Buzyn, French Minister of Solidarity and Health (assumed office May 2017) Photo credit: Amélie Tsaag Valren 26

27 UKRAINE Exploring factors that undermine a robust mandatory legislative framework for immunization 27

28 UKRAINE Exploring factors that undermine a robust mandatory legislative framework for immunization Likert Scale Category: Mandatory immunization with robust monitoring and follow-up Fulfills the most immunization legislation provisions of any country categorized Despite a mandatory approach with robust monitoring, coverage is in decline and measles outbreaks are on the rise 28

29 UKRAINE Exploring factors that undermine a robust mandatory legislative framework for immunization Rampant measles outbreaks: Over 12,000+ people infected with measles in 2018 Declining coverage of second recommended dose of measlesmumps-rubella (MMR) 2008: received by 95% of eligible children 2016: only received by 31% of eligible children Lowest coverage in the Euro Region and among the lowest in the world Source: Ukraine restores immunization coverage in momentous effort to stop measles outbreak that has affected more than this year. World Health Organization [online] May 4. Euro.who.int. Available from: 29

30 Key takeaways: UKRAINE Exploring factors that undermine a robust mandatory legislative framework for immunization Mandatory legislative immunization approach has not resulted in high coverage Underfunded immunization program: Despite mandate for the government to fund, economic factors undermine the immunization system Corruption and procurement challenges: Procurement is nontransparent, seeding distrust among citizens Mistrust of vaccines: Healthcare workers do not advocate effectively for immunization; misinformation is spread through the media Legislation unclear to health workers: Roles, responsibilities, and implementing procedures are not understood No penalties for non-compliance: Undermines the mandate 30

31 KEY FINDINGS Wide variety across the region does not point to any best approach Need to look beyond health legislation for additional tools to improve coverage Immunization coverage varies across legislative approaches No observable correlation between any given legislative approach and coverage rates 31

32 SUPPORTING CONDITIONS NEEDED Legislation can be an effective tool to ensure universal access to immunization, but key system functions need to be in place to ensure uptake Financial Stability Uninterrupted supply Equity of services Monitoring Strong public communications No fault compensation mechanisms 32

33 FURTHER ANALYSIS The Sabin review verifies former studies, suggesting further research is needed to draw correlation between immunization legislation and coverage rates: Tracking immunization legislation and policy changes over time Further detailed regional and sub-regional analyses Additional study on other aspects of legislative frameworks for immunization 33

34 A scientist who is also a human being cannot rest while knowledge which might be used to reduce suffering rests on the shelf. Albert B. Sabin 34

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