OBJECTIVES: (i) To identify and analyze the trade margin regulation schemes for prescription drugs, applicable to wholesalers and pharmacists, in 15 EU member states (AT, BE, CZ, DE, DK, ES, FI, FR, GR, IE, NL, PT, SE, SK, UK); (ii) to understand and evaluate the incentives created by the former.

METHODS: Systematic review of country-specific regulatory frameworks: (i) extraction of quantitative and qualitative regulatory elements from relevant portals, (ii) interviews with national experts. Modelling and visualization of extracted information (regulated margins) in MS Excel. Bilaterally agreed rebates were not included in the analysis.

RESULTS: Four main principles of trade margin regulation in relation to product price could be identified: proportionality (constant percentage), regressivity (declining percentage), fixed markup, and ‘no regulation’ (permission/obligation to negotiate within set boundaries). Those four mechanisms are often applied jointly, a combination of fixed markup and additional declining percentage being the most common one. The basis for margin calculation is typically the ex-manufacturer price, but exceptions apply (e.g. ES). Independently of the product price, pharmaceutical counselling is remunerated separately in some countries (e.g. DK), even if the result is non-dispensing due to concerns (e.g. IE). Trade margin calculations are based on different price thresholds (giving rise to few or many price bands), with margins often being capped at a given ceiling level. Margin levels may be determined by thresholds on pharmacy sales volumes (e.g. IT) or the classification as generic/brand (e.g. SE); they may apply on a per-item, per first or per follow-up prescription level.

CONCLUSIONS: The numerous schemes unfold different incentives for stocking and dispensing behavior. Most regulations are plausible; some appear rather random, a few seem implausible. Regulations may impact professional behavior as well as quality and timeliness of access to medicines. Thus, their scrutiny and interpretation are vital to professional deontology and public health.