The tailor-made approach and sustainable nature of traditional phage therapy and IP issues may hamper pharmaceutical companies in the worldwide marketing of generic phage preparations. Nonprofit/public institutions such as (university) hospitals that would like to develop flexible and sustainable tailor-made (i.e., to an outbreak) phage therapy and are not necessarily disheartened by the IP issues and the subsequent uncertainty of large profits are generally unable to generate the necessary funding. In addition, the prescribed medicinal product development and licensing pathways cancel the advantages of phage therapy over antibiotics. It is thus difficult to reconcile a flexible and sustainable phage therapy concept with the current (western) medical and pharmaceutical environment (Figure 2). As a result of this conundrum, only local and sporadic phage applications have been performed in the western world to date, often based on individual approval governed within the 'Declaration of Helsinki' framework. In Poland, an EU member state, a specific national adaptive regulation, based on the Declaration of Helsinki, was issued to regulate phage therapy. A medical doctor is allowed to apply phage therapy where proven therapeutic methods do not exist or have been ineffective (e.g., in MDR infections) and provided that the patient or their legal representative gives informed consent. In France, Alain Dublanchet, a veteran of phage therapy, occasionally applies phages in hopeless osteomyelitis cases. In Australia, phage therapy was recently applied under the umbrella of 'compassionate use' for the successful treatment of refractory P. aeruginosa urinary tract infection in a cancer patient.
Future Virology. 2012;7(4):379-390. © 2012 Future Medicine Ltd.