Verbeken G, Pirnay JP, Lavigne R, Ceulemans C, De Vos D and Huys I
Resistance of bacteria to antibiotics just keeps growing. Industry’s antibiotic pipeline is running dry. Before the pharmaceutical development of antibiotics, natural bacteriophages (=bacterial viruses) were commercialised and used to kill pathogenic bacteria. This therapeutic application of natural bacteriophages was called “bacteriophage therapy”. Today, countries like Poland, Georgia and Russia are still practising bacteriophage therapy. The European Union and “modern” medicine as a whole needs an urgent return of bacteriophage therapy as part of its armamentarium to fight bacterial resistance to antibiotics. This paper reflects on the issue and proposes a European regulatory frame that could fit the re-introduction of bacteriophage therapy without losing sight of safety, quality and efficacy aspects.