Sofia is trying to balance fiscal discipline and medicines access against a turbulent pricing debate
Bulgaria has no plans to alter its policy of requiring the lowest available price when registering medicinal products for sale on the domestic market, maintaining that the practice is fully compliant with EU regulations, the health ministry has told Euractiv.
The country follows a reference pricing system, in which prices of medicinal products are determined by comparing prices in ten EU countries, with the lowest-price principle applied in accordance with national legislation.
“The national regulatory framework governing medicinal products is harmonised with the applicable European legislation, including with regard to marketing authorisation, pharmacovigilance, pricing, access to treatment and patient protection,” the ministry said, responding to questions on whether Sofia had faced pressure from European partners to change its pricing policy.
Bulgaria’s international impact
