Parliament extended COVID-19 treatment law
The Verkhovna Rada adopted the law “amending section II” Final provisions of the “Ukrainian law” amending certain Ukrainian laws on the treatment of coronaviruses (COVID-19) “(extension of the term due to the threat of a increased incidence of coronaviruses in the population (COVID -19) “No. 3636.
The decision was supported by 311 deputies, reports the correspondent of Ukrinform.
The adopted document extends the validity of the law “amending certain laws of Ukraine concerning the provision of coronavirus treatment (COVID-19)” until January 1, 2021.
“The bill was drafted with the aim of ensuring access to medicines for coronavirus patients and preventing the spread of coronavirus disease (COVID-19) among the population of Ukraine,” says the explanatory note. .
It is also noted that with the adoption of the law “amending certain laws of Ukraine regarding the provision of coronavirus treatment (COVID-19)”, it has become possible to use unregistered drugs recommended by the official body of the United States of America, member countries of the European Union, for the treatment of patients with COVID-19 The Union, Great Britain, the Swiss Confederation, Japan, Australia, Canada, China, the State of Israel, as well as drugs registered according to indications not specified in the instructions for medical use if there is a proven efficacy in the treatment of coronaviruses and recommended by the official body of the countries above.
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In addition, the adoption of the law created the legal basis for the approval of protocols for clinical trials of drugs for the treatment of COVID-19 and significant modifications of the latter up to 5 calendar days; review of registration material and material on changes to drug registration material for the treatment of coronaviruses up to 5 calendar days; take decisions on state registration or on state refusal to register these drugs within a period not exceeding 2 working days depending on the results of the examination of registration documents (dossier d ‘registration) and document review of clinical trials of drugs for the treatment of coronaviruses (COVID-19) in time up to 5 calendar days.
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However, these standards expire on July 1, 2020.
At the same time, given the high probability of an increase in the coronavirus pandemic, particularly during the fall-winter period, the authors of the bill consider it highly desirable to extend the validity of the law “amending certain laws of Ukraine concerning the provision of treatment against coronaviruses (COVID-19)” in order to preserve the life and health of Ukrainians, provide them with timely medical care and medicines in case of illness.
As Ukrinform reported, on March 30, the Verkhovna Rada adopted a law amending certain legislative acts of Ukraine concerning the provision of treatment for the coronavirus disease COVID-19 (Bill No. 3268).
This law introduced the practice of using medicines registered in Ukraine for indications which are not included in the approved instructions for use as one of the means of solving the problem of the availability of pharmacotherapy during the period of coronavirus epidemic.
With regard to the analysis of the evidence and, consequently, the decision on the possibility of using registered medicines for indications which are not included in the approved instructions for use, it would be desirable to combine them with the ” development of medical and technological documents for the standardization system (clinical guidelines and medical care protocols).
According to the materials: ukrinform.ru