The EBA Health Care Committee has summed up its work for 2021

29/ 12/ 2021

On December 21, 2021, the EBA Health Care Committee held its Annual General Meeting, which was attended by members of the Board and member companies of the Committee. The results of the activities of the EBA Committee in 2021 were presented at the meeting. One of the main areas of work was the development of proposals for draft Law №5547On Medicinal Products. The professional community noted the constructive cooperation with the Verkhovna Rada Committee on Health of the Public Health, Medical Care, and Health Insurance, and expressed hope that the key business proposals will be reflected in the results of consideration of the draft law in the second reading. Such proposals include particularly the introduction of a system of verification of medicines in accordance with EU regulations; maintenance of the GMP certification procedure for SRA countries; establishment of balanced transition periods for new provisions; consolidation of provisions aimed at expanding patients access to medicines (“compassionate use”, “emergency use”, “off-label use”, etc.); introduction of full-fledged electronic communication between business and government agencies (electronic applications and documents, eCTD), etc. The EBA Committee also actively participated in the formation of a strategic vision for the development of the health care system, particularly, in the creation of the State National Economic Strategy for 2030. The EBA also prepared 2 strategic documents, covering the medical and pharmaceutical spheres: Guide to reforms 2030 and a List of problematic issues and proposals for their solution. The Committees activities in response to the COVID-19 pandemic were also notable. These include the launch of the COVID-19 Vaccination Info Portal for Business in collaboration with the United Nations Childrens Fund (UNICEF) – https://covidbiz.info/. The portal contains advice from doctors and UNICEF experts, official materials from the Ministry of Health of Ukraine, the Center for Public Health, and the Communication Center for Vaccination against COVID-19. The project is supported by the United States Agency for International Development (USAID). The main activities of the EBA Subcommittee on Medical Devices in 2021 were the development of the draft Law On Medical Devices, proposals for the draft Law On Chemical Safety, as well as the renewal of the registration of disinfectants, technical regulations in accordance with EU, National Classification of Medical Devices. The Subcommittee has also been active in preventing the return of non-market pricing for medical devices; coordinated cooperation of law enforcement and other state bodies to prevent the circulation of illegal products. Work on promoting the signing of an ACAA agreement with the EU on medical devices remains a priority. The EBA Subcommittee on Clinical Trials has taken important steps towards eurointegration and improvement of the regulation of clinical trials (CT). The Subcommittee has developed proposals for amendments to the laws of Ukraine on the regulation of the scope of CT of medicines in draft Law №5547 On Medicinal Products; insurance requirements in the CT (draft law №5315); provision of patients with compassionate medicines (draft laws №5736 and №5737); improvement of mechanisms and grounds for criminal prosecution provided for in Article 3212 of the Criminal Code (Draft Law №5815); regulation of the scope of CT of medical devices in the draft Law On Medical Devices; introduction of digitalization in the field of CT (proposals for changes to the order of the Ministry of Health №690). Thanks to the joint work of the Subcommittee with the Ministry of Health and the State Expert Center of the Ministry of Health, operational processes have been improved with the introduction of the possibility of prepayment for the examination of CT materials in the SEC, the shortened deadline for approval of the CT, etc. at the initiative of the Subcommittee. Also, the TrialsTruth Awareness Project of the EBA Subcommittee on Clinical Trials received support from the State Expert Center of the Ministry of Health and the Patients of Ukraine Charitable Foundation, and together we prepared a new explanatory video on clinical trials. The video of the project gained popularity among researchers, patients, sponsors and gained 19,125 views on YouTube and information resources of the Ministry of Health of Ukraine. During the panel discussion at the EBA Committees Annual General Meeting, participants raised the following important health issues: the state of implementation and regulation of the procedure for confirmation of GMP requirements in Ukraine; further development and institutionalization of medical technologies assessment, managed access agreements; digitalization of the industry; expansion of the National List of Essential Medicines and transition to a single positive list; prospects and necessary steps to accelerate the signing of the ACAA agreement with the EU on medical devices and GMP for medicines; fight against falsification of pharmaceutical products and gray imports, etc. The EBA Health Care Committee would like to thank the members of the Management Board and the member companies of the Committee for their active participation in the work of the Committee. We hope for further fruitful cooperation in 2022 with the Ministry of Health of Ukraine, the Verkhovna Rada Committee, the National Health Insurance Fund, the SEC, and the Committees partners!

01/

On December 21, 2021, the EBA Health Care Committee held its Annual General Meeting, which was attended by members of the Board and member companies of the Committee.

The results of the activities of the EBA Committee in 2021 were presented at the meeting. One of the main areas of work was the development of proposals for draft Law №5547″On Medicinal Products”. The professional community noted the constructive cooperation with the Verkhovna Rada Committee on Health of the Public Health, Medical Care, and Health Insurance, and expressed hope that the key business proposals will be reflected in the results of consideration of the draft law in the second reading. Such proposals include particularly the introduction of a system of verification of medicines in accordance with EU regulations; maintenance of the GMP certification procedure for SRA countries; establishment of balanced transition periods for new provisions; consolidation of provisions aimed at expanding patients’ access to medicines (“compassionate use”, “emergency use”, “off-label use”, etc.); introduction of full-fledged electronic communication between business and government agencies (electronic applications and documents, eCTD), etc.

The EBA Committee also actively participated in the formation of a strategic vision for the development of the health care system, particularly, in the creation of the State National Economic Strategy for 2030. The EBA also prepared 2 strategic documents, covering the medical and pharmaceutical spheres: Guide to reforms 2030 and a List of problematic issues and proposals for their solution.

The Committee’s activities in response to the COVID-19 pandemic were also notable. These include the launch of the COVID-19 Vaccination Info Portal for Business in collaboration with the United Nations Children’s Fund (UNICEF) – https://covidbiz.info/. The portal contains advice from doctors and UNICEF experts, official materials from the Ministry of Health of Ukraine, the Center for Public Health, and the Communication Center for Vaccination against COVID-19. The project is supported by the United States Agency for International Development (USAID).

The main activities of the EBA Subcommittee on Medical Devices in 2021 were the development of the draft Law “On Medical Devices”, proposals for the draft Law “On Chemical Safety”, as well as the renewal of the registration of disinfectants, technical regulations in accordance with EU, National Classification of Medical Devices. The Subcommittee has also been active in preventing the return of non-market pricing for medical devices; coordinated cooperation of law enforcement and other state bodies to prevent the circulation of illegal products. Work on promoting the signing of an ACAA agreement with the EU on medical devices remains a priority.

The EBA Subcommittee on Clinical Trials has taken important steps towards eurointegration and improvement of the regulation of clinical trials (CT). The Subcommittee has developed proposals for amendments to the laws of Ukraine on the regulation of the scope of CT of medicines in draft Law №5547 “On Medicinal Products”; insurance requirements in the CT (draft law №5315); provision of patients with compassionate medicines (draft laws №5736 and №5737); improvement of mechanisms and grounds for criminal prosecution provided for in Article 3212 of the Criminal Code (Draft Law №5815); regulation of the scope of CT of medical devices in the draft Law “On Medical Devices”; introduction of digitalization in the field of CT (proposals for changes to the order of the Ministry of Health №690). Thanks to the joint work of the Subcommittee with the Ministry of Health and the State Expert Center of the Ministry of Health, operational processes have been improved with the introduction of the possibility of prepayment for the examination of CT materials in the SEC, the shortened deadline for approval of the CT, etc. at the initiative of the Subcommittee.

Also, the TrialsTruth Awareness Project of the EBA Subcommittee on Clinical Trials received support from the State Expert Center of the Ministry of Health and the Patients of Ukraine Charitable Foundation, and together we prepared a new explanatory video on clinical trials. The video of the project gained popularity among researchers, patients, sponsors and gained 19,125 views on YouTube and information resources of the Ministry of Health of Ukraine.

During the panel discussion at the EBA Committee’s Annual General Meeting, participants raised the following important health issues:

the state of implementation and regulation of the procedure for confirmation of GMP requirements in Ukraine;
further development and institutionalization of medical technologies assessment, managed access agreements;
digitalization of the industry;
expansion of the National List of Essential Medicines and transition to a single positive list;
prospects and necessary steps to accelerate the signing of the ACAA agreement with the EU on medical devices and GMP for medicines;
fight against falsification of pharmaceutical products and gray imports, etc.

The EBA Health Care Committee would like to thank the members of the Management Board and the member companies of the Committee for their active participation in the work of the Committee. We hope for further fruitful cooperation in 2022 with the Ministry of Health of Ukraine, the Verkhovna Rada Committee, the National Health Insurance Fund, the SEC, and the Committee’s partners!