Viruses that specifically attack certain bacteria, so-called bacteriophages (»phages« for short), were first described in the 1910s. Soon afterwards, they were researched and developed as a therapeutic option to fight bacterial infections. After the discovery of antibiotics (individual chemical compounds with antibacterial properties, such as penicillin) and their widespread use, phages have been used since the 1940s basically only in countries of the former Soviet Union (especially Russia and Georgia) as well as in Poland for the treatment of bacterially induced diseases in humans.

For some time now, however, phages have been receiving more attention worldwide as a possible solution to the increasing problem of antibiotic-resistant pathogenic bacteria. Meanwhile, individual patient treatments (such as under compassionate use conditions) with bacteriophages have also been facilitated in some western countries, such as Belgium, France and the USA. In addition, clinical trials for the treatment of infections induced by antibiotic-resistant bacteria are being conducted in various countries in Europe (Belgium, France, Great Britain, Switzerland). For this, both individual phage isolates and combinations of different phages (»phage cocktails«) as well as isolated phage proteins are being examined.

Bacteriophages are also being researched for agriculture and the food industry and are already being commercially marketed in some cases, e. g. to fight bacterial plant diseases, to keep poultry, cattle or bees healthy or to treat them, and to control pathogenic bacteria such as listeria, salmonella and EHEC on meat, fish and in dairy products.

Other options for application in humans include the use of bacteriophages as a highly sensitive detection method for bacterial infections. In addition, phages might be developed and used for therapeutic or even preventive interventions in the intestinal microbiome (the complex ecosystem in the intestine consisting of different bacteria and their respective phage species as well as fungi), which plays an important role with regard to various diseases. Besides the large variety of naturally occurring bacteriophages, they can be provided with new properties or optimised for various applications through targeted genetic modifications. Recently, a first clinical trial has been started in the USA with regard to evaluating a bacteriophage genetically modified using the CRISPR/Cas system and intended to fight urinary tract infections.

In view of increasing research, development and commercialisation activities of phage-based applications, an investigation of the innovation potential as well as of possible regulatory and safety issues appears to be of great relevance for research policy. So far, however, more comprehensive policy-oriented elaborations on the topic do not seem to exist.

Objectives and approach

Against this background, the TAB project – which was initiated by three committees of the German Bundestag – shall provide a broad but concentrated analysis of the opportunities, risks and possible approaches with regard to promoting and regulating the use of bacteriophages in medicine, agriculture and the food industry. The aim is to develop an orientation guide for elected political representatives to describe the innovation potentials against the background of emerging regulatory issues in health, consumer and environmental protection. The analysis shall be carried out both with regard to research and development activities as well as innovation policy framework conditions and with regard to legal regulation from a comparative international perspective.

Project progress

For the preparation of the final report, two external expert reports on the status of research, development and application, on safety and regulatory issues as well as on existing barriers (and how they could be overcome) were evaluated – one with regard to the field of medicine, one with regard to agriculture and food industry. The final report written by TAB is currently being approved by the TA Rapporteur Group.