The availability of medicines for Ukrainian patients is under threat

12/ 02/ 2025

On February 12, 2025, the Verkhovna Rada of Ukraine passed Draft Law No. 11493 in its second reading, introducing radical changes to the regulation of the pharmaceutical market. Unfortunately, these changes directly affect the circulation of medicines, leading to reduced accessibility for Ukrainian patients. For a number of medications, manufacturers, importers, and distributors will be objectively unable to meet the proposed requirements, which means certain medicines will gradually be withdrawn from circulation. The draft law contains several insufficiently developed provisions, whose negative impact on supply and, consequently, on patients’ access to medicines, is beyond doubt among experts. The EBA’s Healthcare Committee finds it necessary to warn about the destabilization of the pharmaceutical market caused by the adoption of this draft law. In recent years, the efforts of Ukrainian state authorities and international experts in the healthcare sector have been focused on comprehensive reforms, including the pharmaceutical sector. Businesses have positively evaluated and supported steps toward European integration across all healthcare domains, emphasizing compliance with EU regulations, transparency, balance, and predictability for businesses. However, the recent developments within Draft Law No. 11493 not only contradict this trajectory of implementing European practices but also pose a significant threat to the stable functioning of the pharmaceutical market and, as a result, put at risk the ability to provide patients with the necessary treatments. The stable supply of medicines for Ukrainian patients—ensured even during the most challenging period of the full-scale invasion through the joint efforts of the state and businesses—is now under threat. If Draft Law No. 11493 is enacted, this stability cannot be guaranteed. The EBA’s Healthcare Committee emphasizes that the proposed changes do not bring existing regulations closer to the best international standards and will not achieve the primary legislative goal of reducing medicine prices. The affordability of medicines is a complex issue that cannot be resolved through instruments that artificially restrict supply. The proposed amendments in Draft Law No. 11493, unfortunately, are more likely to result in the physical unavailability of medicines for patients rather than improving their price accessibility. Another critical concern is the adverse impact these changes will have specifically on medicines produced by international manufacturers—key investors in Ukraine’s healthcare sector. Experts from the Association’s Healthcare Committee urge particular attention to the following provisions of Draft Law No. 11493, which have been made available for review: 1) Implementation of the National Catalogue of medicines for all pharmaceuticals without exception. The essence of this provision is that medicines for which manufacturers objectively cannot meet the requirements regarding certain price restrictions will not be included in the catalogue and, therefore, cannot be sold. At the same time, Ukraine has not yet implemented a pricing policy that would prevent certain categories of medicines from being at risk under reference pricing. As a result, there are significant risks of reduced availability of a substantial volume of internationally manufactured medicines. Furthermore, the requirements for inclusion in the national catalogue apply even to those medicines that are not funded by the state budget. This approach is inconsistent with European practices. International pharmaceutical manufacturers acknowledge the priority of Ukraine’s state budget allocation for military needs. However, experts note that the application of existing mechanisms for reimbursing the cost of medicines with proven efficacy, funded by the state, would improve their price accessibility. Such examples have already been observed in Ukraine in the past and were positively received by both patients and pharmaceutical manufacturers. Meanwhile, as the government continues working on further expanding funding and updating the existing lists of medicines, manufacturers are taking on the role of payer—supporting patients through the implementation of special patient assistance programs and other initiatives. 2) Implementation of the quota on medicine distribution. The Associations Committee sees significant risks in the provision introducing a restrictive quota on medicine distribution. International manufacturers enter into import and distribution contracts in Ukraine in accordance with strict internal requirements and the current Ukrainian legislation on medicine importation and quality. As a result, manufacturers cooperate only with importers and distributors whose compliance with comprehensive quality and safety requirements has been verified and guaranteed. The Associations Committee hopes that high-ranking officials and members of parliament will support the position that there should be no compromises on these matters. 3) Limitation on the maximum wholesale markup. The draft law proposes that the maximum wholesale markup should not exceed 8%. Unfortunately, this approach does not take into account the existence of different financial models of international pharmaceutical companies currently operating in Ukraine. Experts from the Associations Committee emphasize that for some companies, such restrictive conditions will become a significant barrier to doing business and may lead to a reduction in their operations. The Association’s Healthcare Committee cautions against ill-conceived regulatory steps in the pharmaceutical sector, as its stability directly impacts people’s health and quality of life. The Committee calls on the President of Ukraine to veto this draft law and prevent its negative consequences on Ukrainian patients.

On February 12, 2025, the Verkhovna Rada of Ukraine passed Draft Law No. 11493 in its second reading, introducing radical changes to the regulation of the pharmaceutical market. Unfortunately, these changes directly affect the circulation of medicines, leading to reduced accessibility for Ukrainian patients. For a number of medications, manufacturers, importers, and distributors will be objectively unable to meet the proposed requirements, which means certain medicines will gradually be withdrawn from circulation. The draft law contains several insufficiently developed provisions, whose negative impact on supply and, consequently, on patients’ access to medicines, is beyond doubt among experts.

The EBA’s Healthcare Committee finds it necessary to warn about the destabilization of the pharmaceutical market caused by the adoption of this draft law.

In recent years, the efforts of Ukrainian state authorities and international experts in the healthcare sector have been focused on comprehensive reforms, including the pharmaceutical sector. Businesses have positively evaluated and supported steps toward European integration across all healthcare domains, emphasizing compliance with EU regulations, transparency, balance, and predictability for businesses. However, the recent developments within Draft Law No. 11493 not only contradict this trajectory of implementing European practices but also pose a significant threat to the stable functioning of the pharmaceutical market and, as a result, put at risk the ability to provide patients with the necessary treatments.

The stable supply of medicines for Ukrainian patients—ensured even during the most challenging period of the full-scale invasion through the joint efforts of the state and businesses—is now under threat. If Draft Law No. 11493 is enacted, this stability cannot be guaranteed.

The EBA’s Healthcare Committee emphasizes that the proposed changes do not bring existing regulations closer to the best international standards and will not achieve the primary legislative goal of reducing medicine prices. The affordability of medicines is a complex issue that cannot be resolved through instruments that artificially restrict supply. The proposed amendments in Draft Law No. 11493, unfortunately, are more likely to result in the physical unavailability of medicines for patients rather than improving their price accessibility.

Another critical concern is the adverse impact these changes will have specifically on medicines produced by international manufacturers—key investors in Ukraine’s healthcare sector.

Experts from the Association’s Healthcare Committee urge particular attention to the following provisions of Draft Law No. 11493, which have been made available for review:

1) Implementation of the “National Catalogue” of medicines for all pharmaceuticals without exception. The essence of this provision is that medicines for which manufacturers objectively cannot meet the requirements regarding certain price restrictions will not be included in the “catalogue” and, therefore, cannot be sold. At the same time, Ukraine has not yet implemented a pricing policy that would prevent certain categories of medicines from being at risk under reference pricing. As a result, there are significant risks of reduced availability of a substantial volume of internationally manufactured medicines.

Furthermore, the requirements for inclusion in the “national catalogue” apply even to those medicines that are not funded by the state budget. This approach is inconsistent with European practices. International pharmaceutical manufacturers acknowledge the priority of Ukraine’s state budget allocation for military needs. However, experts note that the application of existing mechanisms for reimbursing the cost of medicines with proven efficacy, funded by the state, would improve their price accessibility. Such examples have already been observed in Ukraine in the past and were positively received by both patients and pharmaceutical manufacturers.

Meanwhile, as the government continues working on further expanding funding and updating the existing lists of medicines, manufacturers are taking on the role of “payer”—supporting patients through the implementation of special patient assistance programs and other initiatives.

2) Implementation of the “quota” on medicine distribution. The Association’s Committee sees significant risks in the provision introducing a restrictive “quota” on medicine distribution. International manufacturers enter into import and distribution contracts in Ukraine in accordance with strict internal requirements and the current Ukrainian legislation on medicine importation and quality. As a result, manufacturers cooperate only with importers and distributors whose compliance with comprehensive quality and safety requirements has been verified and guaranteed. The Association’s Committee hopes that high-ranking officials and members of parliament will support the position that there should be no compromises on these matters.

3) Limitation on the maximum wholesale markup. The draft law proposes that the maximum wholesale markup should not exceed 8%. Unfortunately, this approach does not take into account the existence of different financial models of international pharmaceutical companies currently operating in Ukraine. Experts from the Association’s Committee emphasize that for some companies, such restrictive conditions will become a significant barrier to doing business and may lead to a reduction in their operations.

The Association’s Healthcare Committee cautions against ill-conceived regulatory steps in the pharmaceutical sector, as its stability directly impacts people’s health and quality of life. The Committee calls on the President of Ukraine to veto this draft law and prevent its negative consequences on Ukrainian patients.