OBJECTIVES: To evaluate the potential for RSA implementation in Bulgaria and to outline the necessary legislative changes. METHODS: A literature review of the existing in EU RSA schemes and review of the local legislation were done to identify the laws and regulations intended for changes. RESULTS: Bulgarian government has recently carried out major changes within the Health Insurance Act. The adopted texts introduced a “no discount - no reimbursement” rule, creation of HTA body and formal HTA assessment for all new and existing medicines with re-assessment every three years. The new HTA body is expected to adopt a threshold for cost-effectiveness. Companies will be allowed to provide discounts for new medicines before reimbursement decision hence to influence the cost-effectiveness. The new measures are focusing mainly on the prices of the medicines, as were the old one (voluntary discounts to NHIF). The National Health Insurance Fund (NHIF) should consider other options which will give them opportunity for broader based negotiations with the MAHs. As such option could be considered the implementation of RSA through legislative changes. Formal RSA should be mainly a non-outcome based as from health outcome based pay for performance looks the most feasible, considering the local NHIF capacity. Legislation changes should be made in chapter 12 of the Drug act, article 45 of the Insurance act and to be created new section within chapter 4 of Ordinance 10 of NHIF. RSA implementation will improve the access to lifesaving treatment options for the patients with unmet medical needs while the scarce NHIF budget will be preserved within endorsed limits. CONCLUSIONS: RSA seems promising solution for balancing uncertainties for payers with market access for new and existing medicines, thus will allow NHIF efficiently to control and spend their limited budget while providing quality treatment to more patients in need.