Business supports the need to create a single state control body in the field of medicines

01/ 03/ 2024

The Law on Medicinal Products in Ukraine provides for the state control body establishment - a central executive body with a special status that implements the state policy in the field of creation, market authorization, quality control, safety, and efficacy of medicinal products. The organizations powers will extend to the pharmaceutical sector and medical devices, tissue and cell transplants, special food products, biocidal agents, cosmetics, borderline products, and other medical technologies. In the future, veterinary medicines and veterinary medical devices may also be included. Currently, some of the powers of this new structure are exercised by the Ministry of Health, the State Service of Ukraine on Medicines and Drugs, etc. It is worth noting that the EBA business welcomes this decision of the Ministry of Health to create a new model state body that will meet modern requirements for transparency and efficiency, as well as the practice of EU member states. This is an integral part of ensuring proper conditions and further development of Ukraines healthcare system. At the same time, the community proposes to consider several organizational, financial, and legal aspects in the creation and development of the new body to maximize its effectiveness. Thus, the formation of the new body should include a gradual transfer of powers, taking into account the need for time, human, and other resources. In the first place, according to the EBA member companies, the UMA should exercise the powers currently held by the SEC, the State Service on Medicines, and the Ministry of Health in clinical trials and state registration of medicines, control over their circulation, pharmacovigilance, licensing of economic activities in the production, import, wholesale and retail trade of medicines. At the same time, an essential component is the autonomy and independence of the authority. It seems advisable to abandon the current practice of transferring some or all of the powers and services to state-owned enterprises and institutions, which the business entity has to apply to, and pay for the cost of services on its own. The UMA should provide all necessary services within its competence. If necessary, the structure may engage third parties only on a transparent and market-based basis. In addition, it is important to provide detailed conditions for the formation of a new team to attract new professional managers, not old specialists, to leadership positions, promoting a new culture of management, responsibility, and efficiency. We, as a country, and the healthcare sector in particular, need to change our approaches, principles, and work culture. At the same time, it is crucial to provide for transition periods to fully complete the procedures initiated at the SEC, the State Service of Ukraine on Medicines and Drugs and/or its territorial bodies, and the Ministry of Health to ensure the smooth continuation of all procedures in the newly created body. Therefore, the European Business Association appeals to the Minister of Health Viktor Liashko, Chairman of the Verkhovna Rada Committee on National Health, Medical Assistance and Health Insurance Mykhailo Radutskyi consider the communitys proposals!

The Law on Medicinal Products in Ukraine provides for the state control body establishment – a central executive body with a special status that implements the state policy in the field of creation, market authorization, quality control, safety, and efficacy of medicinal products.

The organization’s powers will extend to the pharmaceutical sector and medical devices, tissue and cell transplants, special food products, biocidal agents, cosmetics, borderline products, and other medical technologies. In the future, veterinary medicines and veterinary medical devices may also be included. Currently, some of the powers of this new structure are exercised by the Ministry of Health, the State Service of Ukraine on Medicines and Drugs, etc.

It is worth noting that the EBA business welcomes this decision of the Ministry of Health to create a “new model” state body that will meet modern requirements for transparency and efficiency, as well as the practice of EU member states. This is an integral part of ensuring proper conditions and further development of Ukraine’s healthcare system.

At the same time, the community proposes to consider several organizational, financial, and legal aspects in the creation and development of the new body to maximize its effectiveness.

Thus, the formation of the new body should include a gradual transfer of powers, taking into account the need for time, human, and other resources. In the first place, according to the EBA member companies, the UMA should exercise the powers currently held by the SEC, the State Service on Medicines, and the Ministry of Health in clinical trials and state registration of medicines, control over their circulation, pharmacovigilance, licensing of economic activities in the production, import, wholesale and retail trade of medicines.

At the same time, an essential component is the autonomy and independence of the authority. It seems advisable to abandon the current practice of transferring some or all of the powers and services to state-owned enterprises and institutions, which the business entity has to apply to, and pay for the cost of services on its own. The UMA should provide all necessary services within its competence. If necessary, the structure may engage third parties only on a transparent and market-based basis.

In addition, it is important to provide detailed conditions for the formation of a new team to attract new professional managers, not old specialists, to leadership positions, promoting a new culture of management, responsibility, and efficiency. We, as a country, and the healthcare sector in particular, need to change our approaches, principles, and work culture.

At the same time, it is crucial to provide for transition periods to fully complete the procedures initiated at the SEC, the State Service of Ukraine on Medicines and Drugs and/or its territorial bodies, and the Ministry of Health to ensure the smooth continuation of all procedures in the newly created body.

Therefore, the European Business Association appeals to the Minister of Health Viktor Liashko, Chairman of the Verkhovna Rada Committee on National Health, Medical Assistance and Health Insurance Mykhailo Radutskyi consider the community’s proposals!