Changes to Ordinance 10: Ministry of Health Tightens Control Over Unapproved Medicines

The Ministry of Health has initiated changes to Ordinance 10, which aim to optimize the process of supplying and paying for medicines not approved for use, as well as compassionate use products. The proposed draft has been announced for a one-month public consultation.

Digitalization of Documents
One of the key changes is the transition to a fully electronic format. Paper protocols, through which specific medicines are prescribed, will be replaced by electronic documents that must be mandatorily approved by the head of the respective medical facility.

Increased Accountability for Distributors
The new regulations impose additional obligations on wholesalers. For every delivery, they will be required to provide a declaration of compliance with Good Distribution Practice, information on the exact number of packages, and written confirmation of the remaining shelf life of the medicines in relation to the contractual terms with the hospitals.

Transparency and Cost Control
The Bulgarian Drug Agency (BDA) will introduce a new electronic report. It will collect detailed information – from the name of the distributor and the international nonproprietary name of the medication to the specific therapeutic regimen and the international disease code. This database will serve the Ministry of Health in conducting audits and analyzing the costs of these specific therapies.

Market Mechanism via Lowest Price
The draft also provides for a new model for selecting a supplier, based on the criterion of the lowest offered price per unit of the medicinal substance. To ensure competition and transparency, all offers and requirements will be published publicly on the websites of the hospitals, the Ministry of Health, and the BDA. The only exception for changing the criterion will be in the interest of the urgent need for quality and delivery speed for the patient's health.