PHAGE THERAPY: LEGISLATIVE ISSUES AND IMPLEMENTATION MODELS ACCESSIBLE TO LOW AND MIDDLE-INCOME COUNTRIES

Abstract

Introduction. Antimicrobial resistance is a phenomenon that is evolving at a worrying rate and requires the implementation of effective interventions and therapies. Bacteriophage therapy has evolved for over 100 years and has been proven effective against multi-drug-resistant bacteria. The specificity of the therapy, the cost of production and social scepticism has not allowed its uniform implementation worldwide. This manuscript is written to present a comprehensive overview of the regulation of bacteriophage therapy, and changes over time, from a legislative point of view worldwide. At the same time, this article will analyze the best models of regulation and implementation of bacteriophage therapy that can be borrowed by low- and middle-income countries.

Material and methods. For this study, SCOPUS, PubMed, and Google Scholar databases were searched using the keywords and BOOLEAN operators: "AND", "OR" and "NOT". The search returned 649 scientific papers. After applying the inclusion/exclusion criteria, 32 papers were included in the final stage of the study.

Results. The review of the literature revealed several plausible forms of use of bacteriophages existing worldwide: experimental therapy under the umbrella of clinical trials, compassionate use, and drug products for advanced therapy; each having a specific regulation. The analysis of each form of use and established policies has shown that for low- and middle-income countries, the only options for introducing bacteriophage therapy in human medicine as a method to combat antimicrobial resistance are experimental therapy or compassionate use.

Conclusions. Bacteriophage therapy is continuously evolving and the regulatory framework is not yet adapted to new trends. Models for the regulation and successful use of this therapy need to be adapted to the specifics of countries irrespective of economic class to ensure equitable and homogeneous access to this treatment method for patients worldwide.