ABSTRACT

In the EU, the heterogeneity of vaccination schedules has arisen for essentially historical reasons. In the past, vaccines were registered in an individual country according to licensing requirements that might vary substantially from country to country. Although licensure in a given country is still possible under restricted conditions, the marketing authorization of a new vaccine in the EU currently follows a unified process, either through mutual recognition or a centralized procedure. Nonetheless, there is no European legislation that reinforces harmonization of immunizations programs across the 27 countries of the EU. Public health policy, including immunization policy, is the responsibility of the member state under the principle of subsidiarity. Consequently, each country relies on a national advisory body that makes recommendations on immunization policies to the Ministry of Health [e.g., the Joint Committee on Vaccination and Immunisation (JCVI) in the United Kingdom, or the Sta¨ndige Impfkommision am Robert Koch Institut (STIKO) in Germany]. In addition, within a country, the level of centralization in public health policy and funding influences the recommendations and implementation of immunization programs. For example, in Spain, each ‘‘autonomous region’’ decides on its own immunization program, and recent recommendations on group C meningococcal (MenC) vaccines illustrate the lack of harmonization in this country as a result of regional decision making. Furthermore, in countries within the WHO European region, immunization policy is influenced by policies and objectives that have been set by WHO Regional Office for Europe (2).