European regulatory conundrum of phage therapy.
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.
Verbeken
Gilbert
G
Hospital Center of the Base-Queen Astrid, Laboratory for Molecular & Cellular Technology, Burn Unit, Bruynstraat 1, B-1120 Neder-over-Heembeek, Belgium. gilbert.verbeken@mil.be
De Vos
Daniel
D
Vaneechoutte
Mario
M
Merabishvili
Maya
M
Zizi
Martin
M
Pirnay
Jean-Paul
JP
D001419:Bacteria / Q000821:virology*; D001424:Bacterial Infections / Q000628:therapy* / Q000821:virology*; D001435:Bacteriophages / Q000502:physiology*; D001691:Biological Therapy / Q000379:methods / Q000592:standards; D005060:Europe; D033161:Government Regulation; D006801:Humans; D019936:Probiotics