Overview and Outlook of Phage Therapy and Phage Biocontrol
Phage Therapy, used in synergy with antibiotics, has the potential to combat the global threat of antimicrobial resistance. However, a proper regulatory frame for the approval and marketing authorisation of phage preparations is missing. The current long and costly marketing authorisation procedure for pharmaceutical drugs does not meet the needs of a personalised and adaptive phage cocktails development. Phage therapy is therefore mainly authorised in compassionate use only. Harmonised European guidelines are also missing for clinical study protocols. Finally, a better knowledge about the interaction of phages with the human microbiome and the environment still requires scientific investigation. It is highly important to avoid repeating the same mistake as with antibiotics leading to the development of possible phage resistance.
Besides Phage Therapy for humans and animals, some phage products are already approved for Phage Biocontrol, to combat plant diseases and ensure food safety. The bacteria Xylella fastidiosa is of particular concern and rapidly spreading in Europe. The use of phages to combat this bacteria is promising and under investigation.
This report, compiled by the Joint Research Centre (JRC) on request of the European Parliament (EP) to serve as bases of discussion at the EP, describes the advantages and disadvantages of phages, for phage therapy and phage biocontrol, as well as the regulatory gaps and existing initiatives.
TOUSSAINT Brigitte;
MUNOZ PINEIRO Amalia;
PIRNAY Jean-Paul;
2024-03-18
Publications Office of the European Union
JRC135367
978-92-68-09579-9 (online),
1831-9424 (online),
EUR 31738 EN,
OP KJ-NA-31-738-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC135367,
10.2760/71288 (online),
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