Business welcomes the conclusion of the first 9 managed entry agreements for medicines

14/ 12/ 2022

The EBA Health Care Committee welcomes the procurement of 9 medicines by the Ministry of Health of Ukraine for 2023 using a new mechanism for Ukraine – managed entry agreements (MEA). Work on the implementation of the MEA in Ukraine, which implies direct contracts between pharmaceutical manufacturers and the state to provide improved access to innovative medicines for patients at the expense of the state budget, began in 2017. The implementation of the MEA mechanism in Ukraine expands patients access to innovative medicines for the treatment of serious diseases, namely, rare (orphan), and oncological diseases, which are included in the priority areas of healthcare development for 2023. The MEAs are concluded through direct negotiation procedures between the customer on the part of the state (the Ministry of Health, SE Medical Procurement of Ukraine) and the manufacturer and provide for the confidentiality of certain conditions, namely, the final price of the subject of procurement. This procurement tool is widely used in many developed countries. It allows manufacturers and the state to obtain mutually beneficial conditions for providing patients with single-source medicines, given the lack of competition in the market of the respective country. In turn, patients receive medicines procured by the state free of charge. According to the EBA Committee, the conclusion of the first MEAs is a significant achievement for Ukraine, which became possible thanks to the long-term hard work of the Government of Ukraine, the Ministry of Health of Ukraine, experts of the USAID SAFEMed international technical assistance project, the State Enterprise Medical Procurement of Ukraine, the team of the State Expert Center of the Ministry of Health of Ukraine for the evaluation of medical technologies, business associations and experts from international pharmaceutical manufacturers. We are confident that the MEA mechanism will continue to prove its effectiveness as one of the modern mechanisms of access to innovations, and its application will be further developed in Ukraine, providing patients with state-of-the-art therapy at the expense of the state budget and helping to save the lives of hundreds of seriously ill people. According to the EBA Committee, the next step in the application of the MEA mechanism could be procurement within the framework of targeted regional programs. Also, international experts on the use of MEAs in other countries confirm that by concluding MEAs for a period of more than 1 calendar year, even more benefits can be achieved in the procurement of medicines for the relevant category of patients. The EBA Committee welcomes the conclusion of the MEA for the treatment of patients with SMA (spinal muscular atrophy) for a period of 3 years. The European Business Association and the EBA Health Care Committee would like to express their gratitude to the Government of Ukraine, the teams of the Ministry of Health of Ukraine and SE Medical Procurement of Ukraine, the negotiation team, as well as Professor Rabia Kahveci, SAFEMed Senior Technical Advisor for Pharmaceuticals Policy and Governance and Governance and the entire SAFEMed project team for their dedicated and effective work. We are also grateful to the representatives of international pharmaceutical companies, who, despite the existing conditions and operational risks caused by russias war against Ukraine, continue their main mission to provide medicines to Ukrainian patients, develop investment projects and launch new innovative products that provide our citizens with life-saving treatment. For reference: One of the main prerequisites for the conclusion of the MEA is the assessment of medical technologies. The basis for the functioning of this mechanism was the adoption by the Verkhovna Rada of Ukraine of amendments to the Fundamentals of Legislation of Ukraine on Healthcare on March 17, 2020. The procedure for concluding contracts and the negotiation procedure were approved by the Government on January 27, 2021.

The implementation of the MEA mechanism in Ukraine expands patients’ access to innovative medicines for the treatment of serious diseases, namely, rare (orphan), and oncological diseases, which are included in the priority areas of healthcare development for 2023. The MEAs are concluded through direct negotiation procedures between the customer on the part of the state (the Ministry of Health, SE “Medical Procurement of Ukraine”) and the manufacturer and provide for the confidentiality of certain conditions, namely, the final price of the subject of procurement. This procurement tool is widely used in many developed countries. It allows manufacturers and the state to obtain mutually beneficial conditions for providing patients with “single-source” medicines, given the lack of competition in the market of the respective country. In turn, patients receive medicines procured by the state free of charge.

According to the EBA Committee, the conclusion of the first MEAs is a significant achievement for Ukraine, which became possible thanks to the long-term hard work of the Government of Ukraine, the Ministry of Health of Ukraine, experts of the USAID SAFEMed international technical assistance project, the State Enterprise “Medical Procurement of Ukraine”, the team of the State Expert Center of the Ministry of Health of Ukraine for the evaluation of medical technologies, business associations and experts from international pharmaceutical manufacturers.

We are confident that the MEA mechanism will continue to prove its effectiveness as one of the modern mechanisms of access to innovations, and its application will be further developed in Ukraine, providing patients with state-of-the-art therapy at the expense of the state budget and helping to save the lives of hundreds of seriously ill people. According to the EBA Committee, the next step in the application of the MEA mechanism could be procurement within the framework of targeted regional programs. Also, international experts on the use of MEAs in other countries confirm that by concluding MEAs for a period of more than 1 calendar year, even more benefits can be achieved in the procurement of medicines for the relevant category of patients. The EBA Committee welcomes the conclusion of the MEA for the treatment of patients with SMA (spinal muscular atrophy) for a period of 3 years.

The European Business Association and the EBA Health Care Committee would like to express their gratitude to the Government of Ukraine, the teams of the Ministry of Health of Ukraine and SE “Medical Procurement of Ukraine”, the negotiation team, as well as Professor Rabia Kahveci, SAFEMed Senior Technical Advisor for Pharmaceuticals Policy and Governance and Governance and the entire SAFEMed project team for their dedicated and effective work.

We are also grateful to the representatives of international pharmaceutical companies, who, despite the existing conditions and operational risks caused by russia’s war against Ukraine, continue their main mission to provide medicines to Ukrainian patients, develop investment projects and launch new innovative products that provide our citizens with life-saving treatment.

For reference:

One of the main prerequisites for the conclusion of the MEA is the assessment of medical technologies. The basis for the functioning of this mechanism was the adoption by the Verkhovna Rada of Ukraine of amendments to the Fundamentals of Legislation of Ukraine on Healthcare on March 17, 2020. The procedure for concluding contracts and the negotiation procedure were approved by the Government on January 27, 2021.