The American Chamber of Commerce in Bulgaria expresses deep concern regarding the proposed administrative reform, which calls for the dissolution of the National Council on Pharmaceutical Pricing and Reimbursement as an independent legal entity and the transfer of its functions to the General Directorate for Pharmaceutical Policy within the Ministry of Health (MoH).
The American Chamber of Commerce has addressed its position to Rumen Radev, Prime Minister of the Republic of Bulgaria, Gulub Donev, Deputy Prime Minister and Minister of Finance, Katya Ivkova, Minister of Health, and the Members of the 52nd National Assembly of the Republic of Bulgaria
Established in 2013 pursuant to the specific provisions of the Law on Medicinal Products for Human Use, the Council was established as an independent and specialized body of the executive branch with clearly defined regulatory functions and an expert mandate aimed at overcoming systemic deficiencies, subjectivity, and administrative delays in the regulation of the pharmaceutical market that had accumulated over the years.
Over the past decade, the Council has succeeded in developing significant and internationally recognized expertise in the areas of pricing, reimbursement, and health technology assessment. As a result, it has become a key guarantor of transparency in the use of public resources and of timely access for Bulgarian patients to innovative therapies.
In this regard, AmCham believes that eliminating the institutional autonomy of the Council and transforming it into a unit within the general administration of the Ministry of Health carries the risk of eroding the expertise and functional capacity built up over the years, of undermining the institutional independence of the evaluation and decision-making process, as well as of causing difficulties and delays in the performance of key regulatory functions.
Some of the risks that will result from the closure of the Council are:
- Risk of administrative gridlock and delays in access,
- Loss of highly specialized expert capacity,
- Decreased transparency and increased risk of corruption,
- Negative reaction from the patient community and expert circles.