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Optimizing the European Regulatory Framework for Sustainable Bacteriophage Therapy in Human Medicine

  • Gilbert VerbekenEmail author
  • Jean-Paul Pirnay
  • Daniel De Vos
  • Serge Jennes
  • Martin Zizi
  • Rob Lavigne
  • Minne Casteels
  • Isabelle Huys
Review

Abstract

For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe’s current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. Decades worth of historical clinical data on bacteriophage therapy (from Eastern Europe, particularly Poland, and the former Soviet republics, particularly Georgia and Russia, as well as from today’s 27 EU member states and the US) have not been taken into account by European regulators because these data have not been validated under current Western regulatory standards. Consequently, applicants carrying out standard clinical trials on bacteriophages in Europe are obliged to initiate clinical work from scratch. This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.

Keywords

Bacteriophage Therapy Human European Regulatory Legal 

Notes

Acknowledgments

The authors would like to thank Professor Carl Ceulemans from the Military Higher Institute of Defence (Chair of Philosophy, Faculty of Social and Military Sciences, Royal Military Academy, Brussels, Belgium) for his honest, coherent and beneficial interactions concerning the re-introduction of phage therapy in routine clinical settings.

Conflict of interest

The authors have no potential conflicts of interest directly relevant to the content of this manuscript.

Supplementary material

5_2012_175_MOESM1_ESM.doc (39 kb)
Supplementary Materials Online Resource 1 (DOC 39 kb)

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Copyright information

© L. Hirszfeld Institute of Immunology and Experimental Therapy, Wroclaw, Poland 2012

Authors and Affiliations

  • Gilbert Verbeken
    • 1
    • 2
    Email author
  • Jean-Paul Pirnay
    • 1
  • Daniel De Vos
    • 1
  • Serge Jennes
    • 3
  • Martin Zizi
    • 4
    • 5
  • Rob Lavigne
    • 6
  • Minne Casteels
    • 2
  • Isabelle Huys
    • 2
    • 7
  1. 1.Laboratory for Molecular and Cellular Technology, Burn Wound CentreQueen Astrid Military HospitalBrusselsBelgium
  2. 2.Department Pharmaceutical and Pharmacological Sciences, Centre for Pharmaceutical Care and PharmacoeconomicsKU LeuvenLeuvenBelgium
  3. 3.Burn Wound CentreQueen Astrid Military HospitalBrusselsBelgium
  4. 4.Department of PhysiologyFree University BrusselsBrusselsBelgium
  5. 5.Section Health of the Division Well-Being (Belgian Defense Staff)Queen Astrid Military HospitalBrusselsBelgium
  6. 6.Laboratory of Gene TechnologyKU LeuvenLeuvenBelgium
  7. 7.Center for Intellectual Property RightsKU LeuvenLeuvenBelgium

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