Among the priorities of the VRU Public Health Committee in 2021 is the approximation of national medical legislation to EU norms

22/ 04/ 2021

This was announced by Mykhailo Radutskyi, Chairman of the Parliamentary Committee on Nation Health, Medical Care, and Health Insurance, during a meeting with the European Business Association on April 21. To achieve this goal, the Verkhovna Rada Committee will work on a number of systemic legislative acts this year which implies improvement of the new version of the law of Ukraine on the Fundamentals of the Ukrainian Health Legislation, development of the law on co-payment, revision of the draft law on the self-government of medical professions, clarification of specialized provisions in the legislation regarding concessions in the field of health care and approval of a new version of the Law of Ukraine On Medicinal Products. Separately, Mr. Radutskyi stressed the importance of modernizing the Fundamentals of the Ukrainian Health Legislation and the Law on Medicinal Products, which were adopted in the 1990s and no longer meet the needs of Ukraines medical system. Regarding the Law on Medicinal Products, Mr. Radutskyi assured that the preparation of the new version of the law is already completed and its text complies with the provisions of Directive 2001/83 / EC. Among the most important innovations provided by the updated version of the law is the mandatory introduction of 2D coding of medicines to combat drug counterfeiting. The law will also introduce the practice of personal responsibility for quality control of medicines imported to Ukraine. The Verkhovna Rada Committee reaffirmed its intention to foster the development of clinical trials in Ukraine, based on European standards. It has been announced that the relevant by-laws will be amended, but the development of a separate law on clinical trials is not currently being considered by the Committee. Instead, some provisions on the regulation of clinical trials of medicines will be added to the Law of Ukraine On Medicinal Products. According to Mr. Radutskyi, the Verkhovna Rada Committee together with the Office of the President of Ukraine are currently studying the experience of compulsory health insurance in other countries and regions of the world. The most promising for Ukraine is the use of Catalan, Israeli or British insurance models, but the necessary conditions for this will appear in the country no earlier than 2023. We are talking about the reform of the tax system and the de-shadowing of labor relations - which is also emphasized by Ukraines international partners, in particular the World Bank. Besides, the Working Group was established to elaborate the provisions of the law On state financial guarantees of medical care on co-payments, as well as the development of voluntary health insurance. The representatives of the European Business Association and other business communities also took part in the work of this Group. Regarding the application of managed entry agreements, the Committee submitted to the Verkhovna Rada draft law №4662, which stipulates that until December 31, 2023, the Law On Public Procurement will not apply to the procurement of original (innovative) medicines which are to be procured under managed entry agreements. Mr. Radutskyi also spoke about the gradual expansion of the reimbursement program. At the same time, he expressed the opinion that the additional UAH 2.8 billion which was allocated from the state budget to reimburse the cost of medicines in 2021 is insufficient and hopes that next year the state will increase funding for the program. The business was also interested in the vision of the Parliamentary Committee on digitalization of the industry. According to Mr. Radutskyi, it is critical now to launch the eCTD system without which the implementation of the updated law on medicinal products will be incomplete. According to the Ministry of Health, this year already manufacturers will have the opportunity to submit regulatory information on medicines in electronic form. During the meeting, we also discussed draft law № 4358, and the EBA proposals to it were considered by the Committee for further elaboration. On behalf of the European Business Association, we thank Mr. Radutskyi and his team for an expert discussion on perspectives of the industry reform! We hope that the movement towards European standards in the regulation of health care will continue. Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

This was announced by Mykhailo Radutskyi, Chairman of the Parliamentary Committee on Nation Health, Medical Care, and Health Insurance, during a meeting with the European Business Association on April 21.

To achieve this goal, the Verkhovna Rada Committee will work on a number of systemic legislative acts this year which implies improvement of the new version of the law of Ukraine on the Fundamentals of the Ukrainian Health Legislation, development of the law on co-payment, revision of the draft law on the self-government of medical professions, clarification of specialized provisions in the legislation regarding concessions in the field of health care and approval of a new version of the Law of Ukraine “On Medicinal Products”.

Separately, Mr. Radutskyi stressed the importance of modernizing the Fundamentals of the Ukrainian Health Legislation and the Law on Medicinal Products, which were adopted in the 1990s and no longer meet the needs of Ukraine’s medical system.

Regarding the Law on Medicinal Products, Mr. Radutskyi assured that the preparation of the new version of the law is already completed and its text complies with the provisions of Directive 2001/83 / EC. Among the most important innovations provided by the updated version of the law is the mandatory introduction of 2D coding of medicines to combat drug counterfeiting. The law will also introduce the practice of personal responsibility for quality control of medicines imported to Ukraine.

The Verkhovna Rada Committee reaffirmed its intention to foster the development of clinical trials in Ukraine, based on European standards. It has been announced that the relevant by-laws will be amended, but the development of a separate law on clinical trials is not currently being considered by the Committee. Instead, some provisions on the regulation of clinical trials of medicines will be added to the Law of Ukraine “On Medicinal Products”.

According to Mr. Radutskyi, the Verkhovna Rada Committee together with the Office of the President of Ukraine are currently studying the experience of compulsory health insurance in other countries and regions of the world. The most promising for Ukraine is the use of Catalan, Israeli or British insurance models, but the necessary conditions for this will appear in the country no earlier than 2023. We are talking about the reform of the tax system and the de-shadowing of labor relations – which is also emphasized by Ukraine’s international partners, in particular the World Bank. Besides, the Working Group was established to elaborate the provisions of the law “On state financial guarantees of medical care” on co-payments, as well as the development of voluntary health insurance. The representatives of the European Business Association and other business communities also took part in the work of this Group.

Regarding the application of managed entry agreements, the Committee submitted to the Verkhovna Rada draft law №4662, which stipulates that until December 31, 2023, the Law “On Public Procurement” will not apply to the procurement of original (innovative) medicines which are to be procured under managed entry agreements.

Mr. Radutskyi also spoke about the gradual expansion of the reimbursement program. At the same time, he expressed the opinion that the additional UAH 2.8 billion which was allocated from the state budget to reimburse the cost of medicines in 2021 is insufficient and hopes that next year the state will increase funding for the program.

The business was also interested in the vision of the Parliamentary Committee on digitalization of the industry. According to Mr. Radutskyi, it is critical now to launch the eCTD system without which the implementation of the updated law on medicinal products will be incomplete. According to the Ministry of Health, this year already manufacturers will have the opportunity to submit regulatory information on medicines in electronic form.

During the meeting, we also discussed draft law № 4358, and the EBA proposals to it were considered by the Committee for further elaboration.

On behalf of the European Business Association, we thank Mr. Radutskyi and his team for an expert discussion on perspectives of the industry reform! We hope that the movement towards European standards in the regulation of health care will continue.

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