[Blog] Changes in the Bulgarian legislation to overcome the cases of shortage or lack of medicinal products in the country
Bulgaria undertakes measures for more stringent control of drug traceability
Drug shortages are a pan-European problem that the European Medicines Agency (EMA) attributes to multifactorial causes. The shortage of medicines in Bulgaria has escalated in recent months. Since the previous formula for drug supply was determined to be ineffective, the Ministry of Health proposed changes to the legislation to determine the actual availability of drugs in the pharmacy network, with a change to the formula.
The proposed amendments are in different directions, mainly affecting the strengthening of control and digitization, concerning the wholesale and retail trade of medicinal products, parallel importation, the improvement of a specialized electronic system for tracking and analyzing medicinal products and other administrative regulations. The main objective is to achieve effective traceability of medicines throughout the supply chain, specifying the obligations of all actors in the chain.
The changes to the Law on Medicinal Products in Human Medicine were adopted in mid-February 2024.
What are the adopted changes?
- The Bulgarian Drug Agency undertakes to provide the National Council on Prices and Reimbursement on a daily basis with the code of the products for which a prescription is required. Those for whom such information is missing will be excluded from the positive drug list and will not be paid with public funds for the period of default;
- Ensuring interoperability and connectivity for automated data exchange in machine-readable real-time format of the National Health Information System between all institutions* involved in the drug supply process;
* The Ministry of Health, the Bulgarian Drug Agency, the National Council on Pricing and Reimbursement of Medicinal Products, the National Health Insurance Fund (NHIF), the Bulgarian Medicines Verification Organization, wholesale and retail authorization holders of medicinal products, medical facilities, centers and hospices
- Fines are imposed if the Bulgarian Medicines Verification Organization refuses to provide information requested by the competent authorities;
- Fines in the amount of BGN 5,000 to BGN 55,000 have been set in case of non-fulfillment of the obligations by the above-mentioned institutions.
The changes in the law enter into force on 14.02.2024. Medicinal products that have not been authenticated through the safety indicators and the individual identifier in the registry system have not been deactivated shall not be paid for with public funds. There is a 6-month entry into force period for the fulfillment of this obligation.
The results of the connectivity and the implemented verification system in Bulgaria to date
- According to BGMVO (Bulgarian Drug Verification Organization), 3,251 pharmacies, 202 hospital pharmacies and 190 wholesalers are connected to the Bulgarian Drug Verification System
- In 2023, more than 4 million verifications are performed in the System each week, which means that more than 75% of prescription drugs are written off in the System, which is a 50% increase compared to the previous year 2022.
- 251 companies deliver prescription drugs in Bulgaria and send data to the Verification System, of which 33 are Bulgarian
- The signals that are generated during the verification of medicinal products in Bulgaria have decreased below 0.08%
The verification system in Bulgaria is an integral part of the European system for drug verification, with the overall performance and availability indicators of the System in 2023 being over 99%. This project in the health care of Bulgaria ensures transparency of the process and prevents the risks of financial abuses, setting goals to maintain a positive trend in 2024.
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Sources:
https://dv.parliament.bg/DVWeb/showMaterialDV.jsp?idMat=207142
