Access to Advanced Therapy Medicinal Products (ATMPs) in Low- and Middle-Income Countries LMICs: A Systematic Review

OBJECTIVES: Advanced therapy medicinal products (ATMPs) represent a medical revolution that could address major gaps in healthcare worldwide. Despite their transformative potential, these therapies face several obstacles that prevent them from spreading throughout the world, particularly in low- and middle-income countries (LMICs). Our research aims to compare different strategies used in LMICs to improve access to these therapies.

METHODS: We conducted a systematic literature review (SLR) on MEDLINE, SCIENCEDIRECT and SPRINGER from January 2009 to December 2023 following PRISMA guidelines. We also searched the regulatory agencies websites of the countries included to complete the data collection. Screening and data extraction were performed by two researchers; and disagreements between reviewers were resolved by a principal researcher.

RESULTS: 15 articles were selected, covering 8 LMICs engaged in this domain. The data was categorized according to seven criteria: legal classification, regulatory entities involved, ATMP laws and regulation, funding models, resources and investment, access and early access models, and the current status of ATMPs. The analysis of the extracted data shows a disparity within the countries included regarding the processes put in place : Pakistan (1/8) has only participated to a global Managed access program for one ATMP, Tanzania, and Uganda (2/8) are at early stages of regulation implementation through international cooperation, South Africa and Thailand (2/8) are working on specific regulation and access is limited to clinical trials; Brazil, China, and India (3/8) have the greatest experience now utilizing ATMPs through specific regulation, early access programs, research and development and many ATMPs approved.

CONCLUSIONS: Despite limited available resources in LMICs, some of them have found the way to improve access to ATMPs by implementing specific strategies. These examples can serve as a source of inspiration for the rest of LMICs such as Algeria.