Bulgaria has changed the way pharmaceutical budget overruns are recovered by the National Health Insurance Fund (Национална здравноосигурителна каса, NHIF), removing generics and several related medicine categories from the mechanism and redistributing liability across the remaining market.
The National Health Insurance Fund Budget Act for 2026 (Закон за бюджета на Националнатаздравноосигурителна каса за 2026 г., 2026 NHIF Budget Act), adopted on 22 July and published on 28 July, limits the mechanism to reference medicines and specified combination products. Generics and products authorised under Articles 29 and 30 of the medicines law – including hybrid and biosimilar routes and well-established-use products – are excluded. (Parliament.bg)
The law also changes how overspend is allocated. Company liability must reflect both its share of NHIF’s net expenditure and growth in spending on its medicines compared with 2025. The draft 2026 mechanism and methodology published by NHIF on 31 July propose equal weighting: half of any quarterly overrun would be allocated according to expenditure share and half according to each company’s share of positive net expenditure growth.
The mechanism applies retrospectively from 1 January 2026. Existing contracts covering the newly exempt products must also be terminated from that date, with NHIF refunding amounts already paid under them. On 6 August, NHIF published the additional-agreement documentation required to implement those terminations. (Parliament.bg)
Companies whose products remain within the mechanism must conclude the required contracts or addenda after the final mechanism is published or lose NHIF reimbursement. The reform therefore concentrates pharmaceutical budget-overrun exposure on reference and specified combination products, while linking each company’s liability more directly to both its market weight and its contribution to expenditure growth.
Source: National Assembly of the Republic of Bulgaria
Link: Закон за бюджета на Националната здравноосигурителна каса за 2026 г. (National Health Insurance Fund Budget Act for 2026)
Date: 28 July 2026
Source: National Health Insurance Fund
Link: Проект на Механизъм, гарантиращ предвидимост и устойчивост на бюджета на НЗОК за 2026 г. (Draft mechanism guaranteeing predictability and sustainability of the NHIF budget for 2026)
Date: 31 July 2026
Source: National Health Insurance Fund
Link: Съобщение относно допълнителни споразумения за пълно или частично прекратяване на сключенитедоговори (Notice concerning additional agreements for full or partial termination of concluded contracts)
Date: 6 August 2026
