Business position on the situation with the State Expert Center of the Ministry of Health

06/ 11/ 2020

The European Business Association appeals to the President of Ukraine Volodymyr Zelenskyy and the Prime Minister of Ukraine Denys Shmyhal to guarantee the stable and uninterrupted operation of the SEC provided by its staff, as well as to promote the further development of the SEC and to continue the gradual implementation of legislation and modern practices of the member states of the European Union. Thus, given the global coronavirus pandemic COVID-19, which is an extremely serious challenge for the health sector and, in particular, government regulatory and expert bodies, whose activities are related to providing conditions for business to market access, supply, and circulation of medicines, it is critical to ensure the proper functioning of all units involved in ensuring that patients in Ukraine receive timely the necessary treatment. The SEC is the first tier in the system of access to the market of medicines of both domestic and foreign production. This state agency conducts the examination of clinical trial materials, registration materials for medicines to register, re-register, and/or make changes to registration materials. Given the situation in Ukraine and the world, any structural or personnel changes in institutions that are the first and main in the chain of ensuring the entry of drugs and vaccines into circulation in Ukraine, conducting clinical trials of new drugs for the treatment or prevention of serious and incurable diseases, including COVID-19, in our opinion, can cause significant negative consequences. The Community believes that during this period it is necessary to provide comprehensive support and assistance to the management, specialists, experts, and other employees of such institutions in their work. In particular, this applies to the SEC as an expert body, whose activities have their own specifics, which differ significantly in scope and complexity from the examination work carried out in other expert institutions for other types of products than medicine. In essence, the specialists and managers working in the SEC, as well as specialists who simultaneously have experience in both the field of drug registration expertise and management, represent the potential of Ukraine, which should be maintained and multiplied by ensuring appropriate policies and measures by the state. The smooth operation of the SEC is of strategic importance for the national security of the state, life, and health of citizens, especially in a pandemic. Providing the population with medicine and vaccines directly depends on the effective, timely, and unhindered work of these state structures. Suspension or disruption of the SEC caused by any factors will inevitably lead to the lack of timely marketing of drugs for patients and/or disruption of clinical trials involving critically ill and incurable patients, which may lead to interruption of their treatment, which is perhaps their only effective treatment and chance at life. Destabilization of the SEC may lead to a delay in the examination and approval of clinical trial protocols and loss of Ukraine’s image in the field of clinical trials at the international level, refusal of sponsors to involve Ukraine in international clinical trials of innovative drugs, including clinical trials of drugs for the treatment and prevention of COVID-19, and, accordingly, to the loss of opportunities to provide free innovative treatment to seriously ill patients, as well as to the loss of Ukraine’s investments of international sponsors in the field of health care and additional opportunities for the development of domestic medicine. It should be noted that in recent years, the work of the SEC is characterized by increased transparency in registration procedures and examination of clinical trial materials, open and constructive dialogue with the European Business Association, and the EBA Health Committee, which contributes to a balanced problem solution in the pharmaceutical field. The business positively notes the following measures: introduction of electronic procedures, transparency of processes, creation of a separate department for evaluation of medical technologies, the introduction of a new system of “service center” in the SEC as a mechanism for optimizing the activities of SEC experts and reducing subjective factors in the interaction between applicants and SEC experts. Therefore, we hope that the voice of business will be heard, and the stable and uninterrupted work of the SEC will be preserved. Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

Thus, given the global coronavirus pandemic COVID-19, which is an extremely serious challenge for the health sector and, in particular, government regulatory and expert bodies, whose activities are related to providing conditions for business to market access, supply, and circulation of medicines, it is critical to ensure the proper functioning of all units involved in ensuring that patients in Ukraine receive timely the necessary treatment. The SEC is the first tier in the system of access to the market of medicines of both domestic and foreign production. This state agency conducts the examination of clinical trial materials, registration materials for medicines to register, re-register, and/or make changes to registration materials.

Given the situation in Ukraine and the world, any structural or personnel changes in institutions that are the first and main in the chain of ensuring the entry of drugs and vaccines into circulation in Ukraine, conducting clinical trials of new drugs for the treatment or prevention of serious and incurable diseases, including COVID-19, in our opinion, can cause significant negative consequences.

The Community believes that during this period it is necessary to provide comprehensive support and assistance to the management, specialists, experts, and other employees of such institutions in their work. In particular, this applies to the SEC as an expert body, whose activities have their own specifics, which differ significantly in scope and complexity from the examination work carried out in other expert institutions for other types of products than medicine. In essence, the specialists and managers working in the SEC, as well as specialists who simultaneously have experience in both the field of drug registration expertise and management, represent the potential of Ukraine, which should be maintained and multiplied by ensuring appropriate policies and measures by the state.

The smooth operation of the SEC is of strategic importance for the national security of the state, life, and health of citizens, especially in a pandemic. Providing the population with medicine and vaccines directly depends on the effective, timely, and unhindered work of these state structures. Suspension or disruption of the SEC caused by any factors will inevitably lead to the lack of timely marketing of drugs for patients and/or disruption of clinical trials involving critically ill and incurable patients, which may lead to interruption of their treatment, which is perhaps their only effective treatment and chance at life. Destabilization of the SEC may lead to a delay in the examination and approval of clinical trial protocols and loss of Ukraine’s image in the field of clinical trials at the international level, refusal of sponsors to involve Ukraine in international clinical trials of innovative drugs, including clinical trials of drugs for the treatment and prevention of COVID-19, and, accordingly, to the loss of opportunities to provide free innovative treatment to seriously ill patients, as well as to the loss of Ukraine’s investments of international sponsors in the field of health care and additional opportunities for the development of domestic medicine.

It should be noted that in recent years, the work of the SEC is characterized by increased transparency in registration procedures and examination of clinical trial materials, open and constructive dialogue with the European Business Association, and the EBA Health Committee, which contributes to a balanced problem solution in the pharmaceutical field.

The business positively notes the following measures: introduction of electronic procedures, transparency of processes, creation of a separate department for evaluation of medical technologies, the introduction of a new system of “service center” in the SEC as a mechanism for optimizing the activities of SEC experts and reducing subjective factors in the interaction between applicants and SEC experts.

Therefore, we hope that the voice of business will be heard, and the stable and uninterrupted work of the SEC will be preserved.

Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.