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Establishment of a new single authority in the pharmaceutical sector “on the basis” of the existing one is a way back in time

31/ 08/ 2023
  Business calls for the creation of a new regulatory body in the pharmaceutical sector from scratch. On August 29, 2023, the EBA Healthcare Committee appealed to the Prime Minister of Ukraine, the Minister of Health of Ukraine, and the Head of the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance and the Ministry of Health of Ukraine to establish a new single state control body in the pharmaceutical sector as an exclusively independent body. The independence of the new state control body excludes its creation based on any of the existing bodies or state-owned enterprises. As a reminder, the new Law of Ukraine On Medicinal Products No. 2469-IX of July 28, 2022, provides for the establishment of a new single State Controlling Body (SCB) as a central executive body with a special status implementing state policy in the field of creation, market authorization, quality control, safety and efficacy of medicinal products. This Law provides for a new body creation, not the reform of one of the existing ones.   Taking into account the latest information posted on the official website of the Ministry of Health of Ukraine regarding the creation of a new single SCB on the basis of another body, the EBA considers this issue to be extremely urgent and significant within the framework of the entire strategy for further reforming the pharmaceutical sector and its further European integration.   According to the EBA experts, the basic approach to the creation of a new single SCB in the pharmaceutical sector should be clearly defined at the beginning of the journey and ensure the construction of a new single SCB on the principles of transparency, openness, impartiality and taking into account the need to build it as a new model body. Such an approach should provide for the exclusive independence of such a body and its further functioning as a modern European institution, which is highly demanded and long-awaited by the pharmaceutical community.   At the same time, the EBA Committee expresses its gratitude for the support of the initiative to consider revising the terms of entry into force of the new Law No. 2469-IX, which is a prerequisite for the launch of the new single SCB, as well as initiating the use of the Twinning tool in the creation of the SCB.   Moving towards the creation of a new single SCB as an independent one would send an important political signal to Ukraines international partners and confirm the impartiality of the state authorities and a genuine desire to implement the best international practices of regulation and control in the pharmaceutical sector. It would also help to strengthen the international communitys readiness to continue providing technical, financial, and expert assistance, including for the construction and development of a new unified SCB, which is a desirable and necessary contribution to accelerating European integration processes in Ukraine. The EBA Committee experts are convinced that the creation of a body on the basis of another would have a negative impact on Ukraines European integration processes.   The EBA Committee members also emphasize the need to preserve the professional and expert potential when creating a new single SCB, a significant part of which relates to the registration of medicines and the examination of clinical trial materials. In addition, the business asks to ensure public discussion of the issue of creating a new SCB and the involvement of national and international partners in this process, including the business community, until final decisions are made.

Business calls for the creation of a new regulatory body in the pharmaceutical sector from scratch. On August 29, 2023, the EBA Healthcare Committee appealed to the Prime Minister of Ukraine, the Minister of Health of Ukraine, and the Head of the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance and the Ministry of Health of Ukraine to establish a new single state control body in the pharmaceutical sector as an exclusively independent body. The independence of the new state control body excludes its creation “based on” any of the existing bodies or state-owned enterprises.

As a reminder, the new Law of Ukraine “On Medicinal Products” No. 2469-IX of July 28, 2022, provides for the establishment of a new single State Controlling Body (SCB) as a central executive body with a special status implementing state policy in the field of creation, market authorization, quality control, safety and efficacy of medicinal products. This Law provides for a new body creation, not the reform of one of the existing ones.
 
Taking into account the latest information posted on the official website of the Ministry of Health of Ukraine regarding the creation of a new single SCB “on the basis” of another body, the EBA considers this issue to be extremely urgent and significant within the framework of the entire strategy for further reforming the pharmaceutical sector and its further European integration.
 
According to the EBA experts, the basic approach to the creation of a new single SCB in the pharmaceutical sector should be clearly defined at the beginning of the journey and ensure the construction of a new single SCB on the principles of transparency, openness, impartiality and taking into account the need to build it as a “new model” body. Such an approach should provide for the exclusive independence of such a body and its further functioning as a modern European institution, which is highly demanded and long-awaited by the pharmaceutical community.
 
At the same time, the EBA Committee expresses its gratitude for the support of the initiative to consider revising the terms of entry into force of the new Law No. 2469-IX, which is a prerequisite for the launch of the new single SCB, as well as initiating the use of the “Twinning” tool in the creation of the SCB.
 
Moving towards the creation of a new single SCB as an independent one would send an important political signal to Ukraine’s international partners and confirm the impartiality of the state authorities and a genuine desire to implement the best international practices of regulation and control in the pharmaceutical sector. It would also help to strengthen the international community’s readiness to continue providing technical, financial, and expert assistance, including for the construction and development of a new unified SCB, which is a desirable and necessary contribution to accelerating European integration processes in Ukraine. The EBA Committee experts are convinced that the creation of a body “on the basis” of another would have a negative impact on Ukraine’s European integration processes.
 
The EBA Committee members also emphasize the need to preserve the professional and expert potential when creating a new single SCB, a significant part of which relates to the registration of medicines and the examination of clinical trial materials.

In addition, the business asks to ensure public discussion of the issue of creating a new SCB and the involvement of national and international partners in this process, including the business community, until final decisions are made.

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