The Enactment Gap: A Comparative Diagnosis of Institutional Health in Pharmaceutical Governance

Comparative work on pharmaceutical governance is dominated by two questions: how much a country regulates, and how well its system performs. Both leave a prior question unasked — whether the institutions doing the regulating are themselves in sound condition. This article develops the enactment gap, the measurable distance between what a governance rule promises and what stakeholders actually experience, as a diagnostic of institutional health at system level. Five countries with sharply different regulatory architectures are compared: Denmark, Germany, Malaysia, Brazil and Türkiye, with Iran as a reference case drawn from the author’s earlier firm-level study. The design is a structured focused comparison built on a purposive corpus of thirty-one regulatory, agency and evaluative documents published between ۲۰۱۰ and ۲۰۲۶. Each country is assessed twice on the five dimensions of the Institutional Health Profile — functional integrity, burden parsimony, responsiveness to suffering, trustworthiness and regenerative capacity — once against its formal rules and once against documented outcomes, with the divergence between the two readings coded on an ordinal three-band scale. The central finding is that the width of the enactment gap tracks neither regulatory density nor national income. Denmark and Germany occupy opposite extremes of rule density yet both keep narrow gaps, while Türkiye and Brazil are comparably dense and diverge sharply. What separates them is the presence of a corrective channel: a routine, low-cost, institutionally protected route through which the gap is surfaced and made costly to the rule-maker. Where such a channel exists, gaps close without reform; where it is absent, formal rule quality does not prevent hollowing. A four-cell typology is derived, and the implication for Iran is that investment in gap-surfacing infrastructure is likely to yield more than further rule-making.

کلیدواژه ها:

Institutional health ، enactment gap ، pharmaceutical governance ، comparative institutional analysis ، regulatory decoupling