Association of Unregistered Medicine Importers Opposes Legislative Changes Threatening Patients

The Association of Importers of Unregistered Medicinal Products for the Treatment of Rare Diseases has expressed a categorical position against Bill No. 52-654-01-95 dated July 16, 2026. According to the organization, the proposed amendments to Article 266a of the Law on Medicinal Products in Human Medicine threaten access to treatment for patients with severe conditions in Bulgaria.

Demands to Legislators

In an official declaration addressed to the Chairperson of the National Assembly, Mihaela Dotova, the importers insist that paragraph 2 of the bill be withdrawn immediately. Copies of the document have been sent to Prime Minister Rumen Radev, Minister of Health Katya Ivkova, and the Chairperson of the Parliamentary Health Committee, Prof. Kostadin Angelov.

Sector representatives are calling on Members of Parliament to reject these texts during voting. Instead of a complete removal of the current procedure, they propose optimizing existing mechanisms through greater transparency, accountability, and public disclosure of prices and information.

Risks of a Legal Vacuum and Interruption of Therapies

According to the Association, the administrative removal of the current procedure for providing medicines will create a legal vacuum that will prevent medical institutions from ordering specific therapies for their patients. This could lead to a halt in the supply of medications for which there is no alternative in Bulgaria, putting the lives of hundreds of people at risk.

The importers emphasize that pricing issues should be resolved through stricter control over the expenditure of funds and along the path indicated by the Commission for Protection of Competition, rather than through administrative obstacles.

Call for Consultations

The organization insists on conducting mandatory consultations with non-governmental organizations, leading medical specialists, and healthcare institutions before such changes are adopted. The declaration emphasizes that the legislator must assess the social impact of the changes so as not to turn procedural deadlines into a barrier to saving human lives.