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Ukraine will have accelerated access to COVID-19 vaccines

04/ 11/ 2020
  Currently, there is a rapid increase in the incidence of COVID-19 in the world and in Ukraine. As there is currently no specific treatment, the rapid development of an effective and safe vaccine against COVID-19 and its early use is a vital measure to reduce the spread of infection and related morbidity and mortality. Thus, according to the experts of the EBA Clinical Trials Subcommittee, the vaccines have the greatest potential to combat the COVID-19, therefore global pharmaceutical companies focus their research on vaccine development. According to the WHO, there are currently 198 vaccine candidates under development in the world, 42 of which are in the clinical stage of development. At the same time, there are more than 240 active clinical trials of vaccines worldwide. Unfortunately, Ukraine has not yet been included in any of these clinical trials of COVID-19 vaccines. This requires changes to Ukrainian legislation. The EBA Clinical Trials Subcommittee asked MPs to initiate changes to the legislation that would allow attracting international clinical trials of drugs to Ukraine not only for the treatment of patients with COVID-19 but also for the prevention of this disease, namely the creation and clinical study of vaccines, as well as to reduce the state registration of vaccines or other drugs for the prevention of coronavirus disease and extend the validity of these amendments to the Law of Ukraine №539-IX until the end of the quarantine period. Currently, the relevant draft law №4314 of November 4, 2020, has been registered in the Verkhovna Rada of Ukraine. The business would like to thank MPs and the authors of the draft law for their quick response to the challenges associated with the pandemic by preparing the draft and registering it. We hope for prompt consideration and approval of the draft law in the Verkhovna Rada. By attracting clinical trials of COVID-19 vaccines to Ukraine, it will be possible to vaccinate a certain part of the population of Ukraine against COVID-19 as a part of conducting such trials. In turn, the reduction of the term of state registration of vaccines from COVID-19 will help accelerate the full-scale use of effective and safe vaccines. Therefore, businesses hope to further support the draft law.   For reference: The business community expresses its gratitude to: Ms. Olha Stefanyshyna - Member of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance Mr. Mykhailo Radutsky - Chairman of the Verkhovna Rada on Public Health, Medical Assistance and Medical Insurance Mr. Serhiy Kuzminykh - Chairman of the Subcommittee on Pharmacy and Pharmaceutical Activity of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance Mr. Yaroslav Yurchyshyn - First Deputy Chairman of the Verkhovna Rada Committee on Anti-Corruption Policy Mr. Yaroslav Zheleznyak - First Deputy Chairman of the Verkhovna Rada Committee on Finance, Tax and Customs Policy Ms. Tetyana Dumenko - Director of the State Expert Center of the Ministry of Health of Ukraine Ms. Kovtun Lyudmyla - Deputy Director for Clinical Affairs of the State Expert Center of the Ministry of Health of Ukraine Lana Sinichkina - Partner, Attorney-at-Law, Artzinger      Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

Currently, there is a rapid increase in the incidence of COVID-19 in the world and in Ukraine. As there is currently no specific treatment, the rapid development of an effective and safe vaccine against COVID-19 and its early use is a vital measure to reduce the spread of infection and related morbidity and mortality.

Thus, according to the experts of the EBA Clinical Trials Subcommittee, the vaccines have the greatest potential to combat the COVID-19, therefore global pharmaceutical companies focus their research on vaccine development.

According to the WHO, there are currently 198 vaccine candidates under development in the world, 42 of which are in the clinical stage of development. At the same time, there are more than 240 active clinical trials of vaccines worldwide. Unfortunately, Ukraine has not yet been included in any of these clinical trials of COVID-19 vaccines. This requires changes to Ukrainian legislation.

The EBA Clinical Trials Subcommittee asked MPs to initiate changes to the legislation that would allow attracting international clinical trials of drugs to Ukraine not only for the treatment of patients with COVID-19 but also for the prevention of this disease, namely the creation and clinical study of vaccines, as well as to reduce the state registration of vaccines or other drugs for the prevention of coronavirus disease and extend the validity of these amendments to the Law of Ukraine №539-IX until the end of the quarantine period.

Currently, the relevant draft law №4314 of November 4, 2020, has been registered in the Verkhovna Rada of Ukraine. The business would like to thank MPs and the authors of the draft law for their quick response to the challenges associated with the pandemic by preparing the draft and registering it. We hope for prompt consideration and approval of the draft law in the Verkhovna Rada.

By attracting clinical trials of COVID-19 vaccines to Ukraine, it will be possible to vaccinate a certain part of the population of Ukraine against COVID-19 as a part of conducting such trials. In turn, the reduction of the term of state registration of vaccines from COVID-19 will help accelerate the full-scale use of effective and safe vaccines. Therefore, businesses hope to further support the draft law.

 

For reference:

The business community expresses its gratitude to:

Ms. Olha Stefanyshyna – Member of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance

Mr. Mykhailo Radutsky – Chairman of the Verkhovna Rada on Public Health, Medical Assistance and Medical Insurance

Mr. Serhiy Kuzminykh – Chairman of the Subcommittee on Pharmacy and Pharmaceutical Activity of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance

Mr. Yaroslav Yurchyshyn – First Deputy Chairman of the Verkhovna Rada Committee on Anti-Corruption Policy

Mr. Yaroslav Zheleznyak – First Deputy Chairman of the Verkhovna Rada Committee on Finance, Tax and Customs Policy

Ms. Tetyana Dumenko – Director of the State Expert Center of the Ministry of Health of Ukraine

Ms. Kovtun Lyudmyla – Deputy Director for Clinical Affairs of the State Expert Center of the Ministry of Health of Ukraine

Lana Sinichkina – Partner, Attorney-at-Law, Artzinger

  

 

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

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