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Business discussed with the Ministry of Health priority steps for clinical trials on the path to sectoral integration with the EU

16/ 02/ 2024
  On February 12, another meeting was held at the Ministry of Health dedicated to European integration processes in the pharmaceutical sector. Representatives of the Ministry of Health, the Verkhovna Rada of Ukraine, the State Expert Center, the SSMDC, international partners, and businesses discussed the vision and approaches to the creation of a state control body - a single regulatory authority, which is referred to as the Ukrainian Medical Agency (UMA), taking into account European legislation and the provisions of the new Law of Ukraine On Medicinal Products. In particular, it was noted that one of the priority areas for this year is preclinical and clinical trials (CT). Marina Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, thanked the EBA  Clinical Trials  Subcommittee and the State Expert Center for their joint contribution to the analysis of EU legislation and the preparation of a roadmap for the implementation of the EU acquis in the field of CT. She also emphasized the importance of establishing interaction between EU Member States and Ukraine in the field of inspection of CT. For CT, regulatory acts requiring changes were identified as a matter of priority, namely, the Order of the Ministry of Health dated September 23, 2009, No. 690 On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expertise of Materials of Clinical Trials and the Model Regulation on Ethics Committees, and the Order of the Ministry of Health dated August 24, 2022, No. 1525 On Approval of the Procedure for Approval and Implementation of the Expanded Access Program for Patients to Unregistered Medicinal Products and the Access Program for Trials Subjects  (Patients) to the Investigational Medicinal Product After Completion of Clinical Trials. The responsibility for preparing the relevant changes lies with the State Expert Center. Regarding the issue of establishing a state control body (SCB) following the Law of Ukraine On Medicinal Products No. 2469-IX dated July 28, 2022, a strategy for the transitional period during the creation and start of operation of the SCB was presented, as well as approaches and principles laid down regarding its financing and tariff planning. During the discussion of the creation and start of operation of the SCB, taking into account the European integration processes and the requirements of the new Law of Ukraine On Medicinal Products, Irina Magdik, Executive Director of the Clinical Trials Subcommittee of the Association, emphasized the importance of the following issues for the CT sector: regarding the establishment of tariffs for the new SCB for the expertise of materials for the approval of CT and the approval of substantial amendments - the tariffs should be adequate and competitive compared to the tariffs of other countries (especially in Eastern Europe) that are actively developing the CT sector, as the CT sector in Ukraine essentially requires rebuilding from scratch because of the full-scale invasion of the rf. establishment of a procedure for conducting and approving low-intervention CTs, requirements for the State Register of CTs. establishment of a procedure for conducting and approving CTs of medical devices, due to the transfer of functions from the SSMDC to the SCB. the need to maintain the deadlines for the entry into force of the provisions of the Law on Medicinal Products regarding the inspection of the investigational medicinal product and the licensing of the import of the investigational medicinal product, namely the second paragraph of the sixteenth part of Article 10 and the second part of Article 42 of the Law On Medicinal Products, from January 1, 2028 (the Association categorically does not support the postponement of deadlines specified in the Law on Medicinal Products to an earlier date). The implementation of these provisions from the beginning of the SCBs operation will require further refinement and optimization of all relevant SCB processes, which may negatively affect the start and conduct of CT, as well as require the involvement of additional resources and sponsor funding. The resumption of patient recruitment in ongoing CTs and Ukraines inclusion in the conduct of new international CTs depends on many factors, and any additional barriers can only worsen the situation with the attraction of CT to Ukraine. Delaying the resumption of international CTs in Ukraine will have undesirable consequences both for seriously ill Ukrainian patients due to limiting their access to innovative drugs and for the state, considering the negative economic consequences regarding the attraction of investments within the framework of CTs of international sponsors. Such an approach may nullify the already existing improvements in the state regulation of the CT sector in Ukraine, which was recently introduced to preserve and support Ukraines competitiveness among other countries in the global CT market, considering its significant medical, scientific, and economic components in the development of innovative drugs. More details on the expectations of the CT sector from the new state control body can be found here. We express hope for further effective cooperation to restore clinical trials in Ukraine.
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On February 12, another meeting was held at the Ministry of Health dedicated to European integration processes in the pharmaceutical sector. Representatives of the Ministry of Health, the Verkhovna Rada of Ukraine, the State Expert Center, the SSMDC, international partners, and businesses discussed the vision and approaches to the creation of a state control body – a single regulatory authority, which is referred to as the “Ukrainian Medical Agency” (UMA), taking into account European legislation and the provisions of the new Law of Ukraine “On Medicinal Products.”

In particular, it was noted that one of the priority areas for this year is preclinical and clinical trials (CT). Marina Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, thanked the EBA  Clinical Trials  Subcommittee and the State Expert Center for their joint contribution to the analysis of EU legislation and the preparation of a roadmap for the implementation of the EU acquis in the field of CT. She also emphasized the importance of establishing interaction between EU Member States and Ukraine in the field of inspection of CT.

For CT, regulatory acts requiring changes were identified as a matter of priority, namely, the Order of the Ministry of Health dated September 23, 2009, No. 690 “On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expertise of Materials of Clinical Trials and the Model Regulation on Ethics Committees”, and the Order of the Ministry of Health dated August 24, 2022, No. 1525 “On Approval of the Procedure for Approval and Implementation of the Expanded Access Program for Patients to Unregistered Medicinal Products and the Access Program for Trials Subjects  (Patients) to the Investigational Medicinal Product After Completion of Clinical Trials.” The responsibility for preparing the relevant changes lies with the State Expert Center.

Regarding the issue of establishing a state control body (SCB) following the Law of Ukraine “On Medicinal Products” No. 2469-IX dated July 28, 2022, a strategy for the transitional period during the creation and start of operation of the SCB was presented, as well as approaches and principles laid down regarding its financing and tariff planning.

During the discussion of the creation and start of operation of the SCB, taking into account the European integration processes and the requirements of the new Law of Ukraine “On Medicinal Products,” Irina Magdik, Executive Director of the Clinical Trials Subcommittee of the Association, emphasized the importance of the following issues for the CT sector:

  • regarding the establishment of tariffs for the new SCB for the expertise of materials for the approval of CT and the approval of substantial amendments – the tariffs should be adequate and competitive compared to the tariffs of other countries (especially in Eastern Europe) that are actively developing the CT sector, as the CT sector in Ukraine essentially requires rebuilding from scratch because of the full-scale invasion of the rf.
  • establishment of a procedure for conducting and approving low-intervention CTs, requirements for the State Register of CTs.
  • establishment of a procedure for conducting and approving CTs of medical devices, due to the transfer of functions from the SSMDC to the SCB.
  • the need to maintain the deadlines for the entry into force of the provisions of the Law on Medicinal Products regarding the inspection of the investigational medicinal product and the licensing of the import of the investigational medicinal product, namely the second paragraph of the sixteenth part of Article 10 and the second part of Article 42 of the Law “On Medicinal Products,” from January 1, 2028 (the Association categorically does not support the postponement of deadlines specified in the Law on Medicinal Products to an earlier date). The implementation of these provisions from the beginning of the SCB’s operation will require further refinement and optimization of all relevant SCB processes, which may negatively affect the start and conduct of CT, as well as require the involvement of additional resources and sponsor funding. The resumption of patient recruitment in ongoing CTs and Ukraine’s inclusion in the conduct of new international CTs depends on many factors, and any additional barriers can only worsen the situation with the attraction of CT to Ukraine.

Delaying the resumption of international CTs in Ukraine will have undesirable consequences both for seriously ill Ukrainian patients due to limiting their access to innovative drugs and for the state, considering the negative economic consequences regarding the attraction of investments within the framework of CTs of international sponsors. Such an approach may nullify the already existing improvements in the state regulation of the CT sector in Ukraine, which was recently introduced to preserve and support Ukraine’s competitiveness among other countries in the global CT market, considering its significant medical, scientific, and economic components in the development of innovative drugs.

More details on the expectations of the CT sector from the new state control body can be found here.

We express hope for further effective cooperation to restore clinical trials in Ukraine.

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