Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2014 Apr;62(2):117-29.
doi: 10.1007/s00005-014-0269-y. Epub 2014 Feb 6.

Call for a dedicated European legal framework for bacteriophage therapy

Gilbert Verbeken  1 , Jean-Paul Pirnay, Rob Lavigne, Serge Jennes, Daniel De Vos, Minne Casteels, Isabelle Huys
Affiliations
Review

Call for a dedicated European legal framework for bacteriophage therapy

Gilbert Verbeken et al. Arch Immunol Ther Exp (Warsz). 2014 Apr.

Abstract

The worldwide emergence of antibiotic resistances and the drying up of the antibiotic pipeline have spurred a search for alternative or complementary antibacterial therapies. Bacteriophages are bacterial viruses that have been used for almost a century to combat bacterial infections, particularly in Poland and the former Soviet Union. The antibiotic crisis has triggered a renewed clinical and agricultural interest in bacteriophages. This, combined with new scientific insights, has pushed bacteriophages to the forefront of the search for new approaches to fighting bacterial infections. But before bacteriophage therapy can be introduced into clinical practice in the European Union, several challenges must be overcome. One of these is the conceptualization and classification of bacteriophage therapy itself and the extent to which it constitutes a human medicinal product regulated under the European Human Code for Medicines (Directive 2001/83/EC). Can therapeutic products containing natural bacteriophages be categorized under the current European regulatory framework, or should this framework be adapted? Various actors in the field have discussed the need for an adapted (or entirely new) regulatory framework for the reintroduction of bacteriophage therapy in Europe. This led to the identification of several characteristics specific to natural bacteriophages that should be taken into consideration by regulators when evaluating bacteriophage therapy. One important consideration is whether bacteriophage therapy development occurs on an industrial scale or a hospital-based, patient-specific scale. More suitable regulatory standards may create opportunities to improve insights into this promising therapeutic approach. In light of this, we argue for the creation of a new, dedicated European regulatory framework for bacteriophage therapy.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Overview of methodological approach of the interviews
Fig. 2
Fig. 2
Proposal for a new European directive for bacteriophage therapy
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Ackermann HW. Who went into phage research? Bacteriophage. 2012;2:55–59. doi: 10.4161/bact.18680. - DOI - PMC - PubMed
    1. Brüssow H. Phage therapy: the Escherichia coli experience. Microbiology. 2005;151(Pt 7):2133–2140. doi: 10.1099/mic.0.27849-0. - DOI - PubMed
    1. Brüssow H. What is needed for phage therapy to become a reality in Western medicine? Virology. 2012;434:138–142. doi: 10.1016/j.virol.2012.09.015. - DOI - PubMed
    1. Bruttin A, Brüssow H. Human volunteers receiving Escherichia coli phage T4 orally: a safety test of phage therapy. Antimicrob Agents Chemother. 2005;49:2874–2878. doi: 10.1128/AAC.49.7.2874-2878.2005. - DOI - PMC - PubMed
    1. Caplin J. Bacteriophage: old treatment, new focus? Microbiologist. 2009;10:20–23.

Substances

-