Clinical application of bacteriophages in Europe

Bacteriophages could help address the antibiotic resistance crisis that impacts health systems all over the world. In 2011, the European Commission formally confirmed that phage products used as therapeutics are medicinal products and thus manufacturers need to navigate the extremely arduous and enormously expensive medicine development and marketing pathway. However, up until now, not one therapeutic phage product has made it to the European market, and yet clinicians are under increasing pressure to use phages in the treatment of multidrug-resistant bacterial infections. While a handful of small European enterprises are struggling to squeeze therapeutic phage products through the conventional and centralised European medicinal products funnel, some clinicians and academics are exploring (European) national solutions to accelerate the availability of phages for the treatment of an increasing number of desperate patients. This mini-review summarises the actual status and perspectives of clinical phage application in Europe. Two decades before the advent of antibiotics, bacteriophages (or phages) were sporadically used to treat bacterial infection across the world. By 1940, therapeutic phage preparations were commercialised by renowned pharmaceutical companies such as Eli Lilly. After World War II, broad spectrum antibiotics were established as the antibacterial agents of choice, but isolated from Western advances in antibiotic production, scientists in the Soviet Union continued to develop phage therapy, with the George Eliava Institute in Tbilisi, Georgia, as the epicentre of these activities.