2025 EU Enlargement Report: significant progress in the health sector

On 4 November, the European Commission released the 2025 EU Enlargement Package, which includes the Ukraine 2025 Report. This document provides an annual assessment of reform progress and alignment with EU legislation and standards. The Report will serve as the basis for determining the next steps toward EU membership for both Ukraine and its European partners.

According to this year’s Report, Ukraine demonstrated its best results in the past three years. The report includes 36 assessments by chapter, along with specific roadmaps. The European Commission noted positive progress in all areas, with no negative assessments issued. Notably, 12 chapters were assessed as showing “good progress,” and improvements were highlighted in 15 chapters compared to the previous year.

The assessment was based on two criteria: the overall level of the country's preparedness for EU membership (i.e., the extent to which Ukrainian legislation aligns with the EU acquis) and the progress made over the past year.

The Report specifically highlights Ukraine's significant progress in the healthcare sector under Chapter 28, “Consumer and health protection,” and highlights a number of important steps taken by Ukraine to align its healthcare system with the EU acquis. This Chapter was rated as demonstrating good progress, receiving 4 out of 5 points.

In particular, Ukraine approved the Strategy for Healthcare System Development and the Strategy and Action Plan to Combat Antimicrobial Resistance. Additionally, sanitary and anti-epidemic regulations for pharmacies were updated to align with European standards, with the relevant Order of the Ministry of Health coming into effect in July 2025.

Ukraine has also strengthened cancer screening and addressed gaps in the prevention and management of non-communicable diseases (NCDs).

The Report highlights notable progress in the development of e-Health systems while also emphasizing the need for further alignment with EU recommendations on e-Health and the EU General Data Protection Regulation (GDPR). 

Measures have also been implemented to ensure the effective operation of the National Blood System. In March 2025, the Cabinet of Ministers of Ukraine approved a new Procedure for the provision of donor blood and its components, including methods for cost calculation, as well as amendments to the licensing conditions for medical institutions providing blood transfusion services. In accordance with this Procedure, the Ministry of Health approved a list of reference entities within the blood system, established the average reference cost of producing donor blood and its components, and set the average reference price for donor blood and its components. Starting in June 2025, the licensing of activities related to the collection, testing, processing, storage, distribution, and transfusion of donor blood and its components began under the supervision of the State Service for Medicines and Drugs Control (Derzhliksluzhba).

Significant progress has been achieved in the regulation of medicines. The Law of Ukraine on Medicinal Products has been adopted to harmonize national legislation with the EU acquis on medicinal products for human use. The Law provides for the establishment of a new regulatory body in January 2027, with certain provisions, notably the mandatory implementation of a medicine verification system, taking effect in January 2028.

In April 2025, Ukraine joined the EU Joint Procurement Agreement of Medical Countermeasures, allowing the country to participate in joint procurement procedures with EU Member States and other participants of the Agreement. This enables the timely procurement of essential medicines, innovative drugs, vaccines, antivirals, and other countermeasures in response to pandemics, shortages of essential medicines, and other cross-border health threats.

In January 2025, Ukraine adopted a new law on the mental health care system, which is a national priority, and shifts the focus towards community-based care

The Report highlights that Ukraine has partially aligned its legislation with the EU Regulation on Health Technology Assessment (HTA), leveraging its existing national HTA framework.

Ensuring transparency in the healthcare sector remains a key priority, particularly in the areas of medical procurement, licensing and accreditation, conflict of interest management, and financial oversight. In line with this goal, the Supervisory Board of the State Enterprise “Medical Procurements of Ukraine” was established in January 2025.

Given the cross-cutting nature of the healthcare sector, progress is evident across multiple chapters, including those related to justice, freedom and security, and the freedom of movement for workers.

Ukraine has taken initial steps to implement the European Health Insurance Card under Chapter 2: Freedom of Movement for Workers. These efforts include launching a National Health Insurance Card and adapting national policies in accordance with Directive 2011/24/EU, which guarantees patients access to healthcare abroad.

Progress has been made in developing addiction prevention and harm reduction policies under Chapter 24: Justice, Freedom, and Security. This includes the adoption of the Drug Policy Strategy through 2030 and its 2025–2027 operational implementation plan. These documents provide a comprehensive framework addressing prevention, treatment, reintegration, and approaches aligned with best practices in EU countries. The strategy emphasizes a systemic approach to addiction treatment, transformation of societal attitudes, and the implementation of high-quality, evidence-based, patient-centered models consistent with contemporary international standards.

Ukraine has introduced a Global Innovation Development Strategy through 2030 to foster innovation by improving infrastructure, reducing regulatory barriers, enhancing access to financing, and establishing centers of excellence in the defense and healthcare sectors.

Nevertheless, several steps remain necessary to further harmonize legislation with EU standards. These include formal accession to the WHO Protocol to Eliminate Illicit Trade in Tobacco Products, integration of the epidemiological surveillance system with the relevant EU systems, and adoption of a national public health emergency preparedness plan (including inter-ministerial governance mechanisms). They also include alignment with the EU early warning and response system.

Ukraine is recommended to develop a roadmap for implementing the Regulation on standards of quality and safety for substances of human origin intended for human use and to enhance its administrative capacity and oversight to ensure proper implementation and enforcement.

Ukraine has clearly defined next steps to align with EU standards and fulfill its commitments within the negotiation process.

The Ministry of Health of Ukraine continues to align the national healthcare system with EU standards, aiming to provide patients with access to safe, high-quality, and modern medical care while fulfilling Ukraine’s commitments on the path to European Union membership.