EBA Highlights Systemic Drug Shortage Issues in Retail Network

According to a recent survey conducted by the European Business Association (EBA) among 17 pharmaceutical companies, a staggering 76% of respondents reported a shortage of imported medications in the retail network. This statistic underscores that the problem is not isolated but rather systemic in nature, necessitating immediate resolution.

EBA experts emphasize that various factors are influencing the stability of drug supply, including military risks, regulatory barriers, and unpredictability in procedures. Collectively, these elements create additional strain on supply chains, which, in turn, negatively affects the availability of specific medications for the population.

Pharmaceutical companies estimate that the shortage or risk of supply interruption pertains to a wide range of medications, including cardiovascular, ophthalmological, neurological, and oncological drugs, as well as biological therapies for patients with autoimmune diseases. "In several instances, there is already a real risk of losing certain therapies or a lack of therapeutic alternatives for patients," the EBA highlighted.

Among the primary causes of the shortages, the EBA identifies two key factors: prolonged and unpredictable procedures for obtaining compliance confirmation of GMP certificates in Ukraine, and the loss of stock due to missile strikes on warehouse infrastructure. These two factors indicate that 69% of respondents consider them the main reasons for supply issues.

Additionally, 56% of member companies of the health committee pointed to systemic problems with the application of the National Price Catalog, complicating the planning and import of medications. "According to respondents, applications for the inclusion of medications in the catalog or for price changes can take two months or more to process, without explanation of reasons and without a clear understanding of the status of their review," the association noted.

Other challenges faced by EBA members include low stock levels among distributors (25%), which may also result from the loss of inventory due to strikes, production or supply restrictions from manufacturers (19%), customs delays (13%), and other factors (13%).

Member companies of the EBA health committee are already taking practical measures to ensure the continuous supply of medications. These measures include alternative warehousing solutions, ordering additional production batches from parent companies, redistributing products among countries, forming additional stockpiles, and adjusting production plans. Many companies are also preparing business continuity plans in case of damage or destruction of warehouse infrastructure.

The EBA has initiated changes to licensing conditions that would allow for the engagement of additional or alternative warehouse facilities during martial law. At the same time, the association emphasized that companies are engaged in a systematic dialogue with government authorities to eliminate regulatory barriers affecting the stability of drug supply.

Some committee members predict that the situation may stabilize as early as April 2026. However, other market participants believe that without the cancellation or significant simplification of the GMP re-certification process, full stabilization is unlikely before 2027. "In the short term—from a few weeks to three to five months—partial recovery of supply is possible if lost stock due to attacks can be quickly replenished and the regulator can expedite document reviews," the EBA noted.

Long-term market stabilization is linked to systemic changes in regulatory policy, primarily the reform of GMP confirmation procedures, stable administration of the National Price Catalog, and overall predictability of the regulatory environment. Health committee members also propose several practical solutions that could significantly improve the situation, including the introduction of a mechanism for recognizing GMP certificates issued by countries with strict regulatory authorities (SRA) based on the certificate number in international databases or a certified copy of the document. This would help shorten the duration of procedures and enhance the predictability of drug supply.

The committee also reminded that at the beginning of the full-scale war, a temporary simplification was already in place, allowing the import of medications from SRA countries without the mandatory requirement for obtaining a GMP compliance confirmation in Ukraine. "For international manufacturers operating on the basis of long-term production and supply planning, stability and predictability of rules are key to decision-making regarding market presence and ensuring continuity of supply. In the context of war and simultaneous regulatory transformation, this element of predictability is currently the most lacking, which increases the risks of drug shortages," the EBA believes.