Boryana Marinkova: Drug Shortages - Between Expert Dialogue and Shifting Responsibility

Boryana Marinkova heads the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD) and is responsible for cooperation with institutions and projects aimed at improving access to therapy. She has 11 years of experience as Marketing Director of Tokuda Hospital. She earned a Master’s degree in Marketing from the University of National and World Economy (UNWE) in 2004, following a Bachelor’s program in Media Economics at the same university. She completed two certification programs at BEIED – Professional Marketing Management and Professional Executive Management. She holds a PhD in Public Administration from UNWE after defending a dissertation on “Public Healthcare Crisis Management with a Marketing Approach.” Boryana Marinkova is also a habilitated lecturer in integrated marketing communications and healthcare crisis management.

The expert dialogue regarding drug shortages in Bulgaria has long since ceased to exist; instead, we are currently witnessing a shift of responsibility from the competent authorities to members of parliament. On December 3, the Ministry of Health submitted a draft law to the Council of Ministers as a shortcut to a parliamentary vote, proposing a ban on the export of medicines from Bulgaria. The European Commission has published numerous criticisms of this draft on its official website. The primary concerns involve a lack of proportionality and violations of the principles of European law and the free movement of goods within the single market. Furthermore, the EC expresses several doubts regarding the effectiveness of the measures in overcoming shortages and advises the Ministry of Health to reconsider the proposed measures in light of European best practices.

WHAT DOES THE DRAFT LAW OF THE MINISTRY OF HEALTH PROVIDE?

On August 12, 2025, the Ministry of Health (MoH) uploaded amendments to the Law on Medicinal Products in Human Medicine (LMPHM) for notification on the European Commission’s TRIS platform. This Ministry project is not new, dating back to the caretaker cabinets of 2022. However, it was only this summer that the project was submitted for approval by European authorities, which is mandatory when draft texts affect other member states. In its reasoning, the MoH states that this project will combat drug shortages in the country, primarily focusing on their export from Bulgaria to the European Economic Area. The draft law stipulates an amendment to the scope of medicines whose export to other member states would be prohibited in the event of a deficit. Currently, this applies only to medicines fully or partially reimbursed by the NHIF, but the changes aim to include all prescription products.

ATTEMPTS TO VALIDATE ISSUED EXPORT ORDERS, WHICH ARE CURRENTLY SUBJECT TO JUDICIAL REVIEW

The export ban orders that have existed for years, which the MoH has issued every month for two consecutive years, demonstrate that bans solve nothing if the authorities claim a shortage persists. Under the project, these orders are to be legalized within the LMPHM, with the MoH relying on data from the National Health Information System, the Bulgarian Drug Agency, regional health inspectorates, or other institutions. Members of the Bulgarian Association for Medicines Parallel Trade Development are challenging the practice of issuing such orders, as they believe they are not based on objective information. Despite repeated requests, the MoH analyses used to justify these orders for the past two years have not been provided under the Access to Public Information Act.

INSULIN BANNED FOR EXPORT IN BULGARIA IS DESTROYED DUE TO EXPIRATION

Furthermore, one of the definitive examples of the ineffectiveness of the introduced restrictions is that insulin worth tens of thousands of levs was destroyed in Bulgaria this year due to expiration.

PARALLEL IMPORTED INSULIN IS ALSO BEING DESTROYED

Parallel imported insulin was also destroyed, as the issue of patient access to parallel imported medicines reimbursed by the National Health Insurance Fund remains unresolved. For years, BAMPTD has appealed for pharmacies to be allowed to dispense the same product prescribed by a doctor and paid for by the NHIF, regardless of the marketing authorization holder in Bulgaria.

I emphasize that we are talking about the same medicinal product in terms of trade name, form, and dosage units. Although the necessary technical infrastructure has been established and this is possible for antimicrobial agents, for example, it is not applied to medicines on the Positive Drug List.

All of this raises doubts about the MoH’s actual commitment to developing effective measures against drug shortages and calls into question the expediency of including yet another instrument.

Instead of adopting the products included in the European Medicines Agency’s shortage list, the MoH proposes that the list of medicines banned for export be supplemented with medicines subject to notification of temporary or permanent discontinuation of sales in Bulgaria. It appears that faster mechanisms to prohibit the movement of medicines in Europe are preferred, regardless of whether their shortage is confirmed by continental big data or not.

100% EXPORT BAN OR CLOSING BULGARIA TO THE SINGLE MARKET

The Ministry is taking a further step by changing the algorithm for calculating the shortage of prescription medicinal products (SESPA).

It is proposed that the calculation threshold be increased to 100%, up from the current 65%. The question of why this change is necessary has been raised repeatedly, given that the 65% threshold was established following a consensus and a broad expert dialogue during the public discussion of the LMPHM amendments in 2019; it is clear that 100% availability of every medicine is not possible at all times.

CRITICISM FROM EUROPE – LACK OF PROPORTIONALITY AND DOUBTS ABOUT EFFECTIVENESS

The EC published its position regarding the impact of the draft law on other member states. In its comments to the MoH, it notes that while it recognizes the challenges, it believes the project “raises concerns regarding the free movement of medicines within the internal market.” The Commission recalls that Article 35 of the Treaty on the Functioning of the European Union prohibits national restrictions on exports. “Member states may take measures affecting exports only if they are justified, i.e., appropriate, necessary, and proportionate to the pursued public objective,” the EC emphasizes. They also remind the MoH of Article 81, second paragraph, of Directive 2001/83/EC (2), which stipulates: “The holder of a marketing authorization for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorized to supply medicinal products so that the needs of patients in the Member State in question are covered.”

EC: A BAN IS NECESSARY ONLY IN THE ABSENCE OF ANY ALTERNATIVES

“We would like to invite the Bulgarian authorities, through clarifications and amendments to be included in the notified project, to ensure that any decision to subject medicinal products to an export ban to other member states is proportionate and appropriate for achieving their objectives,” the European Commission stated. It noted that the consequence of the notified project would be an export ban for any product where supply does not meet 100% of demand. Although such bans are argued to protect against the negative consequences of shortages, the EC notes that these bans prevent adaptation to an unstable market situation and do not account for the severity of the disease or the indication for which the medicine is intended, nor the existence and availability of suitable therapeutic alternatives.

The European Commission is clear: “An export ban, which severely violates the principle of free movement of goods, should be considered only if there are no suitable alternatives that achieve the same objective with less impact on the free movement of goods.”

THE EC’S DISREGARDED INVITATION FOR EXPERT DIALOGUE IN EUROPE

The ban on the export of prescription medicines would also not be proportionate if such a ban does not take into account the overall health status of our population, European authorities state. “The Commission invites the Bulgarian authorities, before deciding to include prescription medicines in the export ban list for other member states, to contact the Single Point of Contact (SPOC) Working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products of the European Medicines Agency (EMA) via their designated national SPOC in the event of a critical shortage,” Europe declares, attempting to return the conversation to an expert rather than a political level. They remind us that the MoH can utilize the structures and processes established by the EMA to address drug shortages in accordance with European law and their competencies in managing crises related to medicines and medical devices. The ultimate goal of the expert network is to ensure that shortages are managed appropriately and mitigated effectively. Furthermore, the EC reminds the Bulgarian authorities of their obligation to notify it of all export restrictions, regardless of their form, at the draft stage.

Repeatedly during the public consultation of the draft law, BAMPTD pointed out that the planned measures were disproportionate and ineffective. We are now seeing that these are the primary objections of the European Commission to the new texts in the LMPHM. The main issue is that this law achieves none of the promises made in its reasoning—namely, improving access to medicines and combating shortages.

WHAT ARE THE REAL REASONS FOR DRUG SHORTAGES IN EUROPE

Manufacturing issues account for 50% of shortage cases in Europe, according to an analysis by EU drug agencies conducted in 2022–2023. Every second case of medicinal product shortage is caused by manufacturing problems. This is indicated in the recently published report following a pan-European analysis of the problem by the European drug agencies’ CHESSMEN project. CHESSMEN is an acronym for the Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network. This network aims to support EU member states in implementing a harmonized approach to mitigate the consequences of shortages and to assist in developing an appropriate and timely system of measures to improve access to medicinal products. CHESSMEN brings together 22 countries, 21 of which are EU members, including Bulgaria and Norway, as well as 5 organizations. Coordination within the network is carried out by the Italian Medicines Agency – Agenzia Italiana del Farmaco, AIFA.

The results of their analysis show that manufacturing problems are the cause of half of the reported shortage cases (50.6%). These are followed by unexpected overconsumption or increased demand (16.7%), commercial reasons (11.2%), and distribution problems (10.6%).

Identifying the root causes of drug shortages is essential for mitigating their impact and preventing future deficit situations, as stated in the report and the objectives for establishing the network of drug agencies of EU member states. A proper understanding of the cause leading to a shortage will allow member states to implement practical measures to ensure drug availability and/or develop strategies to reduce the risk of shortages, CHESSMEN emphasizes. They provide an example: if a shortage is due to a problem with the manufacturer of the active pharmaceutical ingredient and a new manufacturer is proposed, the national competent authority (the drug agency in the country) can expedite the procedure to add them to the medicinal dossier. Identifying root causes will also help the marketing authorization holder take appropriate measures to ensure drug supplies, minimize duration, and reduce the severity of the shortage.

THE REAL REASONS FOR DRUG SHORTAGES IN BULGARIA ARE EVEN MORE TELLING

Bulgaria is no exception to this European trend. Notifications for temporarily or permanently discontinued sales in the BDA register exceed 730 over a period of 47 months. Data from the “Find Your Medicine” application show that 67% of the medicines reported by patients are available and can be found in the same locality. 32% of the reports are related to an objective shortage—every third report concerns a product with temporarily or permanently discontinued sales in the country. There are 4,025 reports to date since March 29, 2024.