Macroeconomic Regulation of Drug Expenditures in Europe: Lessons for the French Safeguard Clause From a Scoping Review

OBJECTIVES: The regulation of drug expenditures is a key concern in many European countries. In France, this is managed through various instruments, including the safeguard clause, a collective regulatory tool applied retrospectively when expenditures exceed a certain threshold. Introduced in 1999 and reformed multiple times since 2010, the contributions required from pharmaceutical companies under this clause have surged, reaching 1 billion euros in 2023. Despite its significance, little is known about similar a posteriori regulatory mechanism. This study aims to identify and analyze comparable models used in other European countries to derive lessons for the French system.

METHODS: A scoping review was conducted to explore macroeconomic levers for healthcare expenditure regulation used by European governments. The review targeted mechanisms similar to France's safeguard clause, involving collective and retrospective regulation of drug expenditures. The search utilized PubMed, Ovid, and a comprehensive review of grey literature.

RESULTS: Through the scoping review 27 relevant sources were identified, including 9 articles from PubMed and Ovid databases, 13 grey literature pieces, and 5 official regulatory documents. The countries examined were France, Germany, the United Kingdom, Spain, Italy, and Greece. Three categories of macroeconomic regulation emerged: threshold-based models where expenditures beyond a certain limit are not fully covered by national health insurance (France, Greece); models imposing fixed rebates on all pharmaceutical industries based on revenue (Spain); mixed models incorporating both thresholds and fixed rebates (Italy, Germany, United Kingdom).

CONCLUSIONS: The increasing financial contributions required from pharmaceutical companies, through rebates or revenue caps, are leading to frequent regulatory changes. While no single approach guarantees long-term expenditure control, these evolving mechanisms demonstrate a strong governmental resolve to manage drug expenditures. Insights from this comparison can inform improvements in the French safeguard clause system.