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Pharmaceutical regulation in 15 European countries review
Dimitra Panteli1, Francis Arickx, Irina Cleemput
1European Observatory on Health Systems and Policies.
Health Systems in Transition
|December 9, 2016
Summary
European health systems use various regulations to balance medicine access and costs. However, definitive evidence linking these cost-containment measures to patient outcomes is still lacking.
Area of Science:
- Health Policy
- Pharmaceutical Economics
- Regulatory Science
Background:
- Pharmaceutical care policy faces challenges in balancing patient access to medicines with rising costs.
- Policy-makers need guidance on regulatory measures impacting pharmaceutical expenditure and patient access.
- Existing regulatory frameworks vary significantly across European health systems.
Purpose of the Study:
- To investigate regulatory measures influencing pharmaceutical expenditure and patient access in 16 European health systems.
- To inform health policy discourse by focusing on patient-centered questions regarding medicine access and affordability.
- To analyze the configurations and rigor of regulatory mechanisms across diverse healthcare settings.
Main Methods:
- Comparative analysis of regulatory measures in 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Scotland, Spain, Sweden).
- Examination of regulations from marketing authorization to generic substitution and their impact on pharmaceutical price levels.
- Assessment of the influence of regulatory variations on publicly financed pharmaceutical costs.
Main Results:
- All studied countries utilize a combination of regulatory mechanisms to control pharmaceutical spending and ensure quality of care.
- Significant variations exist in the implementation and stringency of these regulatory measures across European health systems.
- Observed differences in pharmaceutical expenditure are influenced by consumption patterns, price levels, and dispensing practices.
Conclusions:
- No conclusive evidence currently exists demonstrating the impact of specific cost-containment strategies on patient outcomes.
- The choice of regulatory levers should be tailored to national policy priorities to ensure affordable and appropriate pharmaceutical care.
- Further research is needed to establish definitive links between regulatory interventions and patient health outcomes.
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