OBJECTIVES: Pricing regulation in Greece provides that generics are priced at 65% of the reference off-patent’s price, while off-patents are priced at the minimum between a decrease of 50% of their latest on -patent price and the average of the three lowest originator prices in the EU. The purpose of this study is to assess the impact of the pricing regulation for generics in Greece.

METHODS: Official pricing data from the December 2016 price bulletin were used to stratify the generisized active substances per pricing regulation category.

RESULTS: CONCLUSIONS: The current pricing system in Greece, in which price increases are not allowed, drives generic prices to a downward pricing spiral, while generic penetration remains at the comparatively low level of 25% in volume. By continuously correlating generic prices with the prices of their respective reference product a significant portion (15%) is priced lower than the provisions of the 65% of the average price of the three lowest prices in EU. Moreover, half of the substances are marketed with extremely low net prices, equal or lower to 2.90€ after deducting the obligatory paybacks of approximately 30% in 2016. The above, combined with the lack of demand-side measures to foster the use of generics, question the medium/long-term viability of generics. In that light, correlation of pricing with market penetration, poses as a more appropriate approach ensuring sustainability of generics.