title: Population access to new vaccines in European countries.
abstract: Time from registration to population access to new vaccines can take considerable time in European countries. Reasons might be found in the regulatory framework, decision-making processes or the assessment of vaccines by evaluating bodies. The aim of this study was to determine whether some decision-making processes can explain between-country differences in the time to population access to new vaccination programs. Information gathered from a survey among European National Vaccine Industry Groups was combined with information from official health authorities, vaccine manufacturers and literature published. Firstly, a retrospective survey was conducted to measure access time to new vaccines against three diseases in 17 European countries. Secondly, qualitative information on the country-specific decision-making frameworks for the introduction of new "vaccination programs" was identified in a cross-sectional survey. Spearman's rank correlation coefficients (ρ) were used for data analysis. The median access time to new vaccines was 6.4 years (95% confidence interval: 5.7-7.1 years) post marketing authorization. National assessments underlying immunization policy decisions (recommendation phase) absorbed most of the access time. Correlation analysis suggested that processes with established timelines and clarity in regard to vaccine evaluation criteria used could ameliorate the effectiveness of the decision-making process. In order to reduce the time to access for new, beneficial vaccines, the underlying vaccination recommendation, implementation and funding process needs to be understood and optimized, where necessary.
authors: Institute of Pharmaceutical Medicine, University of Basel, Klingelbergstrasse 61, 4056 Basel, Switzerland. patricia.blank@ifspm.uzh.ch
authors: Patricia R
authors: PR
authors: Blank
authors: Matthias
authors: M
authors: Schwenkglenks
authors: Christelle Saint
authors: CS
authors: Sardos
authors: Julien
authors: J
authors: Patris
authors: Thomas D
authors: TD
authors: Szucs
mesh_terms: D003659:Decision Making, Organizational; D005060:Europe; D006291:Health Policy; D006801:Humans; D017589:Immunization Programs / Q000191:economics; D053918:Papillomavirus Vaccines / Q000191:economics; D022242:Pneumococcal Vaccines / Q000191:economics; D012189:Retrospective Studies; D022243:Rotavirus Vaccines / Q000191:economics; D014611:Vaccination; D014612:Vaccines / Q000191:economics
chemical_list: D053918:Papillomavirus Vaccines; D022242:Pneumococcal Vaccines; D022243:Rotavirus Vaccines; D014612:Vaccines