European regulatory conundrum of phage therapy

Gilbert Verbeken, Daniel De Vos, Mario Vaneechoutte, Maya Merabishvili, Martin Zizi, Jean Paul Pirnay

Research output: Contribution to journalArticlepeer-review

Abstract

The treatment of infectious diseases with antibiotics is becoming increasingly challenging. Very few new antimicrobials are in the pharmaceutical industry pipeline. One of the potential alternatives for antibiotics is phage therapy. Major obstacles for the clinical application of bacteriophages are a false perception of viruses as 'enemies of life' and the lack of a specific frame for phage therapy in the current Medicinal Product Regulation. Short-term borderline solutions under the responsibility of a Medical Ethical Committee and/or under the umbrella of the Declaration of Helsinki are emerging. As a long-term solution, however, we suggest the creation of a specific section for phage therapy under the Advanced Therapy Medicinal Product Regulation.

Original languageEnglish
Pages (from-to)485-491
Number of pages7
JournalFuture Microbiology
Volume2
Issue number5
DOIs
Publication statusPublished - Oct 2007

Keywords

  • Advanced therapy
  • Antibiotic resistance
  • Bacteriophage
  • Burn wound
  • Europe
  • Phage therapy
  • Probiotic
  • Pseudomonas aeruginosa
  • Regulatory
  • Staphylococcus aureus
  • Virus

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