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The Procedures for negotiating and concluding managed entry agreements have been approved

01/ 02/ 2021
  The European Business Association announces the adoption by the Cabinet of Ministers of Ukraine of the resolution №61 on Some issues regarding managed entry access agreements and suspension of the first paragraph of item 12 of the CMU resolution № 333 of March 25, 2009 of January 27, 2021. The adopted resolution enables the use of managed entry agreements (MEA) in Ukraine as one of the main modern tools for ensuring patients ’access to original innovative medicines. The launch of this tool started after the adoption of amendments to the Fundamentals of Ukrainian legislation on health care on March 17, 2020. The implementation of the MEA mechanism in Ukraine will provide access to innovative drugs for the treatment of various serious diseases (including rare diseases, cancer) through the use of direct negotiation procedures that provide for confidentiality of certain conditions with manufacturers of innovative drugs. One of the main prerequisites for the conclusion of the MEA will be the assessment of medical technologies, the procedure for which was approved earlier. The European Business Association and the EBA Health Care Committee thank the Government of Ukraine, Deputy Minister of Health – Mr. Ihor Ivashchenko, representatives of the Directorates of Medical Services and Pharmaceuticals of the Ministry of Health of Ukraine for active and persistent work on implementing modern tools of access to innovative treatment in Ukraine. The European Business Association hopes that shortly the related legislation will be brought in line with the adopted resolution. Also, we hope that other business proposals will be taken into account to further improve the availability of medicines for the citizens of Ukraine, including innovative ones.

The European Business Association announces the adoption by the Cabinet of Ministers of Ukraine of the resolution №61 on “Some issues regarding managed entry access agreements and suspension of the first paragraph of item 12 of the CMU resolution № 333 of March 25, 2009 ” of January 27, 2021.

The adopted resolution enables the use of managed entry agreements (MEA) in Ukraine as one of the main modern tools for ensuring patients ’access to original innovative medicines. The launch of this tool started after the adoption of amendments to the Fundamentals of Ukrainian legislation on health care on March 17, 2020. The implementation of the MEA mechanism in Ukraine will provide access to innovative drugs for the treatment of various serious diseases (including rare diseases, cancer) through the use of direct negotiation procedures that provide for confidentiality of certain conditions with manufacturers of innovative drugs. One of the main prerequisites for the conclusion of the MEA will be the assessment of medical technologies, the procedure for which was approved earlier.

The European Business Association and the EBA Health Care Committee thank the Government of Ukraine, Deputy Minister of Health – Mr. Ihor Ivashchenko, representatives of the Directorates of Medical Services and Pharmaceuticals of the Ministry of Health of Ukraine for active and persistent work on implementing modern tools of access to innovative treatment in Ukraine.

The European Business Association hopes that shortly the related legislation will be brought in line with the adopted resolution. Also, we hope that other business proposals will be taken into account to further improve the availability of medicines for the citizens of Ukraine, including innovative ones.

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