The Legal Nature of Managed Entry Agreements (MEAs) in the Coronavirus Response System

Abstract

This article elaborates on the admission procedure for vaccines against COVID-19 in various European countries and the United States. Neither the EU countries nor the United States has applied for a full license to manufacture or issue a coronavirus vaccine registration certificate. At best, it is an emergency use authorization or conditional marketing authorization. A particular focus will be on the Legal Nature of Managed Entry Agreements (MEAs) in the Coronavirus Response System. The use of MEAs allows not only to legalize emergency use authorization or conditional marketing authorization as a way to combat coronavirus infection, but also others, including for treating, preventing, or diagnosing seriously debilitating or life-threatening diseases. That includes orphan medicines. However, Ukraine and Russia have followed the path of simplifying the registration and full admission of vaccines for further use. Russia registered vaccines against COVID-19 of its own development, however, in Ukraine, there is a situation when it fully legalizes vaccines against COVID-19 earlier than the countries of this vaccine’s origin. This is due to ignoring the regulations and the experience of using MEAs both by Ukraine and Russia.