The Ukrainian Parliament Adopts the Law on the Prevention of COVID-19
On December 4, 2020 the Ukrainian Parliament adopted the Law No. 4314 on the prevention of coronavirus disease (COVID-19). The aim of the Law is to secure access of the population of Ukraine to safe and effective vaccines against COVID-19.
The Law provides for reduction of term of approval of clinical trials to 5 working days and conducting state registration relating to vaccines and other medical immunobiological preparations for specific prevention of coronavirus disease (COVID-19) to 7 working days in total. The similar provisions adopted previously relate to medicinal products intended for treatment of coronavirus disease only and do not spread to vaccines. The Law sets the validity term of such provisions for medicinal products and now also for vaccines intended for treatment of COVID-19 until the end of quarantine established by the Cabinet of the Ministry of Ukraine. Previously, the validity term of the provision in respect of medicinal products was until January 31, 2021.
For the moment Ukraine has not been included in any vaccines clinical trials which are being tested worldwide in view of the fact that the usual term of approval of clinical trials in Ukraine constituted 4-5 months making Ukraine an unfavorable choice for vaccines developers. The adoption of the Law will contribute to attracting relevant international clinical trials to Ukraine and thus also reduce the burden on the health care system of Ukraine by starting vaccinating a significant number of patients within the clinical trials. The adoption of the Law is also supposed to provide a quick entry into the Ukrainian market for vaccines that will successfully pass the clinical trials.