ISSN Print 2713-0894
ISSN Online 2713-0908
Medical Ethics
BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN
REVIEW
Medicinal product early access programs: experience of the BRICS group, European Union, and United States of America
About authors
1 Center for Healthcare Quality Assessment and Control, Moscow, Russia
2 Russian Medical Academy of Continuous Professional Education, Moscow, Russia
3 First Moscow State Medical University named after Sechenov IM (Sechenov University), Moscow, Russia
Correspondence should be addressed: Nadezhda P. Rukavitsyna
Khokhlovsky per., 10, str.5, Moscow, 109028, Russia; ur.xedemsor@anystivakur
About paper
Author contribution: Оmelyanovskiy VV — text editing, preparing the manuscript for publication; Rukavitsyna NP — review of publications related to the article topic (RF, USA), writing an article, text editing, preparing the manuscript for publication; Mukhortova PA — review of publications related to the article topic (RF, EU), writing sections, text editing; Kingshott AA — writing an abstract, writing an article, text editing, preparing the manuscript for publication; Zinadinov SI — review of publications related to the article topic (South Africa), writing text sections (South Africa) and text editing; Kharitonova AG — review of publications related to the article topic (India), writing sections (India), text editing, preparing the manuscript for publication; Minakova EI — review of publications related to the article topic (Brazil), writing sections of the (Brazil) and text editing Krekhtunova LO — review of publications related to the article topic (China), writing text sections (China), text editing, preparing the manuscript for publication; Barysheva VO — text editing.
Received: 2023-10-31
Accepted: 2023-11-27
Published online: 2023-11-27
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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.
Keywords: regulatory approval of drugs, compassionate use, expanded access, expedited access, accelerated expertise, conditional registration, scientific advice, breakthrough therapy, technology transfer