Discussion of the draft Law on Medicines continues within the Working Group

25/ 06/ 2021

On June 22, 2021, the discussion of draft Law №5547 on Medicine continued in the format of the Working Group, chaired by Serhii Kuzminykh – Chairman of the Subcommittee on Pharmacy and Pharmaceutical Activity, with the participation of Oleksandr Komarida – Deputy Minister of Health of Ukraine for European Integration and representatives of the EBA Health Care Committee. The working group was established d on the meeting of the EBA Health Care Committee with the Chairman of the Verkhovna Rada Committee on Nation Health, Medical Care and Health Insurance – Mykhailo Radutsky, the Chairman of the Subcommittee on Cancer Prevention and Control – Valery Zub and Serhii Kuzminykh on June 15, 2021. Thus, the business proposed to completely transfer the procedures for drug registration and clinical trials into electronic eCTD format. MPs-members of the VRU Committee fully supported the gradual refusal of paper communication within a transition period of 2.5 years and noted that such changes to the draft law will be considered before the second reading. The possibility of faster entry into the market of innovative medicines due to the simplified procedures for registration established by current legislation has become controversial. Currently, the proposed draft law does not provide for simplified procedures for EU member states and countries with strict regulatory policies that currently exist. According to the EBA experts, the complete abolition of procedures may have a negative impact on the timely receipt of appropriate medicines by the state and rapid access to innovative treatment. At the same time, the EBA Committee companies agree that some improvements are needed. This discussion issue will be addressed in the Working Group, taking into account the need for a stable supply of necessary medicines for patients in Ukraine. It is also necessary to address the issue of proper liability for the safety, efficacy, quality of the medicinal product, as well as the accuracy of the materials submitted in the registration dossier for the medicinal product by the manufacturers. Thus, the requirements and liability control tools should be established for the owner of the registration for a medicinal product and/or his authorized representative in Ukraine. Special emphasis was made on the need to implement the system of verification of medicines (a special 2D-code marking) and the principles of its implementation in Ukraine. Only by implementing EU regulation and building the system following the EU principles and rules, we can make the best use of the system and achieve the goals set by the state. The participants of the meeting unanimously agreed with this approach. Business representatives also shared their views on building a new unified regulatory body for medicines. The participants of the meeting agreed that qualitative transformations in this regard should not consist only in changing the name and/or transferring functions of drug registration, pharmacovigilance, approval of clinical trials, etc. under the control of a newly established public authority. Such a new body can be created with a special status - as the only body that will cover certain functions of the State Expert Center of the MoH Ukraine and the State Service of Ukraine on Medicines and Drug Control. This important issue of harmonization with EU practices and enhancement of regulatory practices in the pharmaceutical sector of Ukraine has already been addressed within the EBRD project Advice on Regulatory Improvements in Ukraines Pharmaceutical Sector. The Coordinating Committee of the project includes representatives of relevant public authorities/enterprises, the Ministry of Health Ukraine, and the professional community of associations. Therefore, it is expedient now to thoroughly elaborate the recommendations on the establishment of a unified body with a special status, provided by consultants within the EBRD project, for their inclusion in the draft Law. According to business, if the process of the creation of a unified regulatory body continues, then it is necessary to ensure transparency of functions, selection of management on a competitive basis, financial stability, and digitalization of all procedures. It is also extremely important for our state not to lose the healthcare legacy built so when creating a new structure. Therefore, EBA representatives advocate the preservation of professional and expert potential, in particular, in the field of drug registration and examination of clinical trial materials. During the meeting, we also discussed issues related to the draft law, such as GMP certification in Ukraine and quality control for EU member states, harmonization of Ukrainian legislation on the exclusivity of registration dossier data, the conclusion of an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA), proper regulation of clinical trials, etc. The participants emphasized their further elaboration. Besides, other issues of health care were considered, which also need the attention and support of the relevant Committee of the Verkhovna Rada, namely: further plans for the development of the Medical Guarantees Program 2022, preparation of draft law №4662 on procurement of medicines under managed entry agreements to the second reading, provision of the SE Medical Procurement of Ukraine with the full status of the central procurement organization (CPO). The clear support for the proper implementation of the managed entry agreements in Ukraine by the Chairman of the Verkhovna Rada Committee, confirmed during the meetings, gives hope for access to innovative medicines for patients and is positively assessed by the professional community. Also, the peoples deputies of the Verkhovna Rada Committee confirmed their understanding of the need for the status of CPO for the State Enterprise Medical Procurement of Ukraine, which will help optimize the procurement process and further save the state budget. The European Business Association thanks Mykhailo Radutsky, Serhii Kuzminykh, Valery Zub, and Oleksandr Komarida for the professional discussion on the main document that will regulate the pharmaceutical industry, and the readiness for further cooperation. We hope that the proposals discussed during the meetings will be carefully analyzed and taken into account in the Working Group for the balanced elaboration of the draft Law of Ukraine On Medicine, one of the practical objectives of which is to improve access to quality, effective and safe medicinal products, regardless of the origin of their developers and manufacturers. Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

Thus, the business proposed to completely transfer the procedures for drug registration and clinical trials into electronic eCTD format. MPs-members of the VRU Committee fully supported the gradual refusal of paper communication within a transition period of 2.5 years and noted that such changes to the draft law will be considered before the second reading.

The possibility of faster entry into the market of innovative medicines due to the simplified procedures for registration established by current legislation has become controversial. Currently, the proposed draft law does not provide for simplified procedures for EU member states and countries with strict regulatory policies that currently exist. According to the EBA experts, the complete abolition of procedures may have a negative impact on the timely receipt of appropriate medicines by the state and rapid access to innovative treatment. At the same time, the EBA Committee companies agree that some improvements are needed. This discussion issue will be addressed in the Working Group, taking into account the need for a stable supply of necessary medicines for patients in Ukraine.

It is also necessary to address the issue of proper liability for the safety, efficacy, quality of the medicinal product, as well as the accuracy of the materials submitted in the registration dossier for the medicinal product by the manufacturers. Thus, the requirements and liability control tools should be established for the owner of the registration for a medicinal product and/or his authorized representative in Ukraine.

Special emphasis was made on the need to implement the system of verification of medicines (a special 2D-code marking) and the principles of its implementation in Ukraine. Only by implementing EU regulation and building the system following the EU principles and rules, we can make the best use of the system and achieve the goals set by the state. The participants of the meeting unanimously agreed with this approach.

Business representatives also shared their views on building a new unified regulatory body for medicines. The participants of the meeting agreed that qualitative transformations in this regard should not consist only in changing the name and/or transferring functions of drug registration, pharmacovigilance, approval of clinical trials, etc. under the control of a newly established public authority. Such a new body can be created with a special status – as the only body that will cover certain functions of the State Expert Center of the MoH Ukraine and the State Service of Ukraine on Medicines and Drug Control. This important issue of harmonization with EU practices and enhancement of regulatory practices in the pharmaceutical sector of Ukraine has already been addressed within the EBRD project “Advice on Regulatory Improvements in Ukraine’s Pharmaceutical Sector”. The Coordinating Committee of the project includes representatives of relevant public authorities/enterprises, the Ministry of Health Ukraine, and the professional community of associations. Therefore, it is expedient now to thoroughly elaborate the recommendations on the establishment of a unified body with a special status, provided by consultants within the EBRD project, for their inclusion in the draft Law. According to business, if the process of the creation of a unified regulatory body continues, then it is necessary to ensure transparency of functions, selection of management on a competitive basis, financial stability, and digitalization of all procedures. It is also extremely important for our state not to lose the healthcare legacy built so when creating a new structure. Therefore, EBA representatives advocate the preservation of professional and expert potential, in particular, in the field of drug registration and examination of clinical trial materials.

During the meeting, we also discussed issues related to the draft law, such as GMP certification in Ukraine and quality control for EU member states, harmonization of Ukrainian legislation on the exclusivity of registration dossier data, the conclusion of an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA), proper regulation of clinical trials, etc. The participants emphasized their further elaboration.

Besides, other issues of health care were considered, which also need the attention and support of the relevant Committee of the Verkhovna Rada, namely: further plans for the development of the Medical Guarantees Program 2022, preparation of draft law №4662 on procurement of medicines under managed entry agreements to the second reading, provision of the SE “Medical Procurement of Ukraine” with the full status of the central procurement organization (CPO). The clear support for the proper implementation of the managed entry agreements in Ukraine by the Chairman of the Verkhovna Rada Committee, confirmed during the meetings, gives hope for access to innovative medicines for patients and is positively assessed by the professional community. Also, the people’s deputies of the Verkhovna Rada Committee confirmed their understanding of the need for the status of CPO for the State Enterprise “Medical Procurement of Ukraine”, which will help optimize the procurement process and further save the state budget.

The European Business Association thanks Mykhailo Radutsky, Serhii Kuzminykh, Valery Zub, and Oleksandr Komarida for the professional discussion on the main document that will regulate the pharmaceutical industry, and the readiness for further cooperation.

We hope that the proposals discussed during the meetings will be carefully analyzed and taken into account in the Working Group for the balanced elaboration of the draft Law of Ukraine “On Medicine”, one of the practical objectives of which is to improve access to quality, effective and safe medicinal products, regardless of the origin of their developers and manufacturers.

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