Within a week, the shortage of medicinal products has become a topic with a clearly expressed European and national dimension.
On October 15, 2026, the parliamentary committee on health adopted at first reading the amendments proposed by the Ministry of Health to the Law on Medicinal Products in Human Medicine.
“On October 20, we presented data and arguments why another tightening of control and the expansion of SESPA do not guarantee the solution of the problem.
On October 21, the European Medicines Agency held a meeting of the MSSG group, co-chaired by its Executive Director Emer Cooke, whose agenda included security of supply, vulnerabilities in supply chains and the development of the Critical Medicines Act.”, commented Adelina Lyubenova, Chair of the Initiative Committee of master of pharmacy in Bulgaria. Here is her full position:
This coincidence of events raises a question to which the state owes a concrete answer: why, while the European approach is developing towards risk management and sustainability of supply, the Bulgarian proposal continues to place the main emphasis on tracking, accountability and restrictions?
We do not dispute the need for control.
We dispute the replacement of the real solution with an administrative mechanism that can register the shortage without eliminating its causes.
At the press conference on October 20, we presented data from a survey among 300 pharmacies and 5 patient organizations, according to which about 90% of the identified shortages are of medicines outside the scope of the list used by SESPA. We also pointed out problems with the availability of expensive and essential medicinal products. These results require a thorough analysis of the scope of the system and the actual causes of the shortages. They cannot be dismissed with the argument that more data automatically means better supply.
The European position also does not allow for such simplification. Emer Cooke indicated in an interview with Euronews on 4 April 2024 that shortages could be driven by production constraints and economic conditions, including low margins and the pressure to supply multiple markets at low prices.
She stressed that there is no one-size-fits-all solution for all medicines. The current MSSG agenda from October 2026 shows that European work continues to focus on supply vulnerabilities and security measures for critical medicines.
This is the crux of the problem in Bulgaria. In the case of a shortage that spans several countries, we cannot rely on administrative tracking to create missing quantities.
We cannot assume that the lowest price is a sufficient guarantee of supply.
And we cannot ignore the risk that price differences and parallel trade opportunities will influence commercial decisions on where to direct limited quantities.
Article 81 of Directive 2001/83/EC provides for an obligation to ensure adequate and uninterrupted supply so that the needs of patients in the country concerned are met. The Critical Medicines Act develops the European approach to security of supply through instruments to strengthen production, diversify suppliers and more sustainable public procurement.
Against this background, we do not see in the Bulgarian proposal a sufficiently clearly formulated, comprehensive mechanism to guarantee the necessary quantities for the internal market, to provide backup sources in case of supply disruptions and to link early warning with concrete actions. The envisaged measures for stricter export controls, faster imports and more transparency may have a certain role, but they do not in themselves guarantee sustainable supply.
This is the essential gap that needs to be addressed before the final adoption of the changes.
We do not claim that the European recommendations require Bulgaria to mechanically copy a certain model or to prohibit parallel trade. We insist that national decisions be justified by data, respond to the identified reasons for the shortage and ensure effective protection of patients in compliance with European law.
We therefore insist that an impact assessment, an analysis of the data already collected by SESPA and a concrete plan for drug security be presented before the second reading. This plan should include a clear definition of shortages, measurable criteria for sufficiency, early warning, mechanisms for ensuring alternative supplies and criteria for sustainability in the supply of critical drugs. It is also necessary to assess whether the national pricing model creates sufficient incentives to maintain supplies for Bulgarian patients.
Bulgaria does not simply need stricter control over drugs.
Bulgaria needs guarantees that drugs will be available.
When Europe discusses how to reduce supply vulnerabilities, and national policy focuses primarily on reporting and traceability, the discrepancy must be made clear.
SESPA is a tool, not a drug policy. Control is a means, not an outcome. And the result by which the state should be evaluated is whether the patient receives the necessary treatment on time.
“This is our position after the press conference on October 20. We do not want less responsibility and less control. We want legislation that solves the problem for which it was adopted.”, concluded Adelina Lyubenova, chairwoman of the Initiative Committee of Master Pharmacists in Bulgaria.