Medicinal product early access programs: experience of the BRICS group, European Union, and United States of America

Abstract

Timely accessibility of effective and safe medicinal products is one of the main tasks of healthcare. The goal of the present review is to assess various approaches that provide an early access to medicinal products within the BRICS group (list of participants as of 01.10.2023), European Union and United States of America. The stage of the life cycle of medicinal products is closely associated with their further movement in the market, patient access rate, and partially with the issues of their financing and reimbursement, which directly influence their affordability for population. The article contains data about the specifics of expanded access to unregistered medicinal products used on a compassionate basis and presenting therapy under early access programs financed by pharmaceutical companies; it also describes approaches to accelerated registration and registration of medicinal products in case of limited clinical data. Experience of the reviewed countries in early access programs is described.