EU-Ukraine bilateral meetings on consumer protection and healthcare took place in Brussels
On 10-12 February, 2025, a bilateral meeting between representatives of Ukraine and the European Commission took place in Brussels, Belgium, as part of the official screening of the compliance of Ukrainian legislation with EU law under Title 28 “Consumer Protection and Healthcare”, which belongs to Cluster 2 “Internal Market”. This meeting is part of the negotiation process of Ukraine’s accession to the European Union.
It should be recalled that the screening of Ukrainian legislation is an analysis of the adaptation of Ukrainian legislation to the EU law in the context of the European Council’s decision of 14 December, 2023, to start negotiations with Ukraine on EU membership and the results of the agreements between President of Ukraine Volodymyr Zelenskyy and President of the European Commission Ursula von der Leyen.
Representatives of the Ministry of Health, the Government Office for Coordination of European and Euro-Atlantic Integration of Ukraine, the Ministry of Agrarian Policy, the State Service of Ukraine on Food Safety and Consumer Protection, the State Expert Center, the State Service of Ukraine on Medicines and Drugs Control, the Kyiv City Center for Disease Control and Prevention of the Ministry of Health of Ukraine, the Coordination Center for Mental Health under the Cabinet of Ministers of Ukraine, the Center for Public Health, and the National Health Service of Ukraine took part in the offline and online meetings from the Ukrainian side. The healthcare negotiating team was headed by Maryna Slobodnichenko, Deputy Minister of Health for European Integration.
During the screening meeting, the negotiation team presented Ukraine’s achievements in European integration and announced plans to regulate medicines, medical devices, blood, tissue and organ cell donation, and revealed challenges in healthy lifestyles, mental health, non-communicable diseases, digitalization, etc.
Among the key tasks that the Ukrainian delegation presented in Brussels during the bilateral meetings under Title 28 “Consumer Protection and Healthcare” were the implementation of European regulations on medical devices and in-vitro devices, shifting the focus from state control of medicines to the responsibility of the importer or manufacturer when importing medicines, mandatory introduction of the institution of an authorized person for pharmacovigilance, as well as GMP, GDP and GPP certification. The Ministry of Health of Ukraine is also working to bring the dossiers for medicinal products in line with modern technological requirements.
“During the screening process, Ukraine declared accelerated integration, which is something we can get even in the candidate status if the implementation of the acts progresses. So now, together with the EU, we are working on the possibility of expanding the ACAA agreement to the pharmaceutical industry; access to the platform of the European market surveillance authorities for cosmetics (PEMSAC), EMVS, to the EudraVigilance database; access to information on approved active ingredients of biocidal products and the possibility of using it in Ukraine when registering biocidal products.”
The priorities include joining the Protocol to Eliminate Illicit Trade in Tobacco Products and launching a unified labeling system for human anatomical materials. These decisions have realistic implementation mechanisms, considering transition periods for businesses and the state.
“Ukraine is making steady progress in the implementation of EU acts and should complete full implementation by 2027. To do so, it is crucial not only to fulfill the technical requirements but also to actively engage in trainings and in-depth cooperation with EU institutions. The European Commission will support this process by organizing consultations on the implementation of the SOHO regulations and considering Ukraine’s accession as an observer to the EMA Committees. It also praised our efforts in building a mental health system and invited us to share our experience. Participation in EU multidisciplinary mental health programs will be a mutually beneficial cooperation.”
Following the completion of the Cluster 2 screening meetings, the European Commission will prepare a report on their results within six weeks. It will serve as a basis for determining our next steps and priorities.
During the visit, Maryna Slobodnichenko and her delegation also met with representatives of the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and visited the headquarters of Enabel, the Belgian development agency.
For reference
The consumer protection legislation covered by Title 28 deals with the safety of consumer goods and the protection of the economic interests of consumers in specific sectors. Member States need to implement EU law into national legislation and establish independent administrative structures and enforcement bodies that will allow for effective market surveillance and ensure compliance with the law. It is also necessary to ensure proper judicial and extrajudicial dispute resolution mechanisms, consumer information, and the role of consumer organizations. In addition, the chapter covers specific mandatory rules in the healthcare sector.
GMP (Good Manufacturing Practice), GDP (Good Distribution Practice) and GPP (Good Pharmacy Practice) are international standards that ensure the quality of medicines at all stages of their life cycle. GMP regulates production, controls manufacturing processes to ensure the safety and efficacy of drugs. GDP defines requirements for storage, transportation and distribution, and ensures proper logistics conditions. GPP sets standards of pharmaceutical practice aimed at quality patient care and rational use of medicines. These practices form the basis of the quality control system in the pharmaceutical sector and meet the regulatory requirements of the EU and WHO.
According to the Decree of the President of Ukraine dated 21.06.2024 No. 365/2024, a delegation of Ukraine was formed to participate in negotiations with the EU on the conclusion of an agreement on Ukraine’s accession to the European Union, which included Deputy Minister of Health for European Integration Maryna Slobodnichenko.
Resolution of the Cabinet of Ministers of Ukraine No. 987 of August 27, 2024 approved a working (negotiation) group to prepare Ukraine’s negotiating positions during negotiations with the European Union on the conclusion of an agreement on Ukraine’s accession to the European Union on consumer protection and healthcare. The negotiating group includes representatives of the government, parliament, civil society and business.