In the last five years, Europe has experienced outbreaks and increased incidence of vaccine-preventable diseases, notably measles, across the region. In the first six months of 2018, over 41,000 children and adults in the World Health Organization (WHO) European Region were infected with measles, exceeding 12-month reports for the eight previous years. This is a dramatic change from 2013, when the WHO European Region achieved an immunization coverage rate of almost 95 percent – the rate at which communities are best protected against vaccine-preventable disease. Since then, countries from in the region have made notable changes to frameworks for immunization legislation.

The Sabin Vaccine Institute (Sabin) examined these legislative changes in detail in “Legislative Approaches to Immunization Across the European Region.” This study, (also available in Russian and Romanian) carried out by Sabin in partnership with the O'Neill Institute for National and Global Health Law at Georgetown Law, is the first and only systematic review of immunization legislation that includes all 53 countries in the WHO European region and provides a comprehensive overview of these legal frameworks. Countries considering legislative changes or provisions as a means to improve their immunization coverage can now utilize this review and accompanying resources as a resource.

The study found that legislative approaches to immunization in the European region vary greatly; there is no “one size fits all” legal framework for healthcare or immunization. Approaches range from voluntary or recommended (the state asks that individuals seek out immunization) to mandatory (the state requires that individuals are immunized). The Sabin research team developed eight key questions to help define the level of mandatory immunization. The responses to these questions are presented in a Matrix. Based on this Matrix, researchers classified each country in a Likert Scale ranging across five levels from recommended to mandatory immunization with robust monitoring and follow-up. Both of these resources serve as tools for comparison, and ideally in the future to display trends as legislation in the region changes and evolves over time. The project also developed five country case studies, examining in greater detail the legislative approaches in two regions (the Baltic States and the Nordic countries) and three countries (France, Moldova and Ukraine).

This review provokes many questions for policy decision makers: What factors have led to success following mandated immunization law? What conditions have led to resistance to mandates? Which countries have high immunization coverage rates under legislation that recommends immunization?

One of the key findings of the study is there is no “best approach” for immunization legislation. Researchers see high and low coverage rates across the spectrum of approaches. Instead, the research reinforces the principle that country context, capacity of the immunization system, economics, social dynamics, political realities and the constitutional relationship between a government and its citizens all play a role in how a country should approach its legislative framework for immunization. The Sabin review reiterates this finding from previous studies, and verifies that further research and analysis over time is needed to determine long-term correlations between immunization legislation and vaccine coverage.

This study builds upon Sabin’s work in Eastern Europe through the Sustainable Immunization Financing Program, through which Sabin worked closely with national leaders to enable countries to take long-term financial ownership of their immunization programs. In the Republic of Georgia, Sabin conducted an in-depth review of the country’s immunization program, presenting evidence for potential policy solutions to address challenges of low immunization coverage. In 2017 and 2018, in partnership with the Parliament of Georgia and Ministry of Health, Labour and Social Affairs, Sabin hosted policy dialogues to build political will among parliamentarians for immunization and encourage evidence-based policy decision making.

In recent months, the Parliament of Georgia has announced policy changes supporting their immunization program, including a bill making immunization mandatory for children, to go into effect in June 2019. At a Sabin-hosted meeting in December 2018, stakeholders in Georgia used “Legislative Approaches to Immunization Across the European Region” to inform the country’s strategy for implementing the new law. Georgia is exemplary of the way Sabin hopes countries will use this report – building an evidence base to support policy changes and carefully considering the particular historical, economic and political factors to best support legislative action.

This study is part of Sabin’s work to help countries make evidence-based decisions on immunization policy and paves the way for further analysis of immunization legislation in the region.

To learn more, view the webinar recording on key takeaways with our research team.