Publication | Open Access
Pharmaceutical regulation in 15 European countries review.
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2016
Year
Patient AccessPharmacotherapyMarketing AuthorizationPrimary CarePharmaceutical PracticePublic HealthHealth Services ResearchDrug SafetyRising CostsHealth PolicyHealth InsuranceOutcomes ResearchPharmacoeconomicsCost EffectivenessPublic Health PolicyEconomic EvaluationPharmacologyPharmaceutical RegulationMedical Device RegulationRegulatory ApprovalHealth EconomicsHealth Care CostMedicineRegulation
Pharmaceutical policy must balance patient access, affordability, and rising costs, yet evidence on how different cost‑containment measures affect patient outcomes remains lacking. The study aims to guide health‑policy discussions by examining regulatory measures—from marketing authorization to generic substitution—across 16 European health systems. It analyzes regulatory mechanisms and resulting price levels across 16 European health systems. The study finds that regulatory variations affect publicly financed pharmaceutical costs, and that policy levers must be tailored to each country’s priorities and consumption patterns.
In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices.