(006) Comparative analysis of European healthcare systems: insights for selecting countries when designing Post-Authorization Safety Studies

Background: Selecting European countries for Post-Authorization Safety Studies (PASS) including Risk Minimization Measures (RMMs) effectiveness assessments could be challenging to ensure the representativeness in the collected data of the various European healthcare systems, as guidance and recommendations are lacking in the literature.

Objectives: To describe healthcare systems models in Europe, and to define a decision-making reference for the selection of European countries in PASS.

Methods: A 5-criteria list was defined to characterize the healthcare system per country; i) general structure of the system especially the population coverage, rights of access and the governance level, ii) funding source, private or public, through insurance premiums, social contributions or taxes, iii) conditions of primary ambulatory care services including specialty-care referal and the status of healthcare professionals, iv) balance in public or private hospital network resources and potentially gated access and v) medical density as the average number of doctors per 1,000 inhabitants. This criteria list was evaluated by searching on websites of each national healthcare organization.

Results: Three healthcare systems models were identified: the Social Health Insurance (SHI), the Welfare model and the National Health Service (NHS). Inherited from the Bismarkian model, the SHI model concerns western and central European countries. This model is underpinned by socialisation of risk with protection based on the ability of individuals to acquire rights through their professional activity. The SHI, heterogenous across countries, differs from the two other models inherited from the British economist Beveridge, offering universal health insurance for all citizens through social contributions and taxes; the homogenous Welfare model (Nordic countries) is a highly decentralised system based on high-quality public hospitals and ambulatory care mostly managed by municipal health centres, and the NHS (UK, Italy, Portugal, Spain) is inclusive in its protection of foreign residents regardless of income, age or other factors, with public hospitals providing free or low-cost healthcare services.

Conclusions: PASS designs would benefit from ensuring inclusion of at least one country per Beveridge model and multiple countries to account for SHI heterogeneity to capture variability of the diverse European healthcare systems models. Such a sampling recommendation could also provide context on drug usage, prescription, dispensation and reimbursement for interpreting study findings, considering geographical, cultural, and clinical practice diversity, as these factors are impacted by the type of healthcare system.