Chair of Public Law, Law School, Faculty of Law, Economics and Business, Martin-Luther-University Halle-Wittenberg, 06099 Halle an der Saale, Germany.
Viruses. 2024 Mar 12;16(3):443. doi: 10.3390/v16030443.
Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, the article shows how the planned legislative revisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 may affect the legal future of phage therapy.
噬菌体疗法是治疗细菌感染的一种很有前途的方法。由于抗生素耐药性的增加和新抗生素的开发进展缓慢，噬菌体疗法的研究和开发正在加强。噬菌体疗法利用噬菌体（即噬菌体）特异性靶向并杀死病原菌。这种疗法的合法处理提出了几个问题。其中包括噬菌体疗法是否属于受特别监管的一类药物，以及在制造和管理噬菌体疗法的各种技术方法方面应遵循哪些法律框架。本文表明，来自野生型噬菌体和基因修饰（设计）噬菌体的噬菌体疗法属于或不属于哪种类别的药物。此外，本文还解释了制造和管理以统一、不依赖于患者的方式预先制造的噬菌体疗法以及针对特定患者的定制噬菌体疗法的相关法律框架。为了系统地、连贯地翻译噬菌体疗法，本文考虑了药品法和相关的法律领域，如基因工程法。最后，本文展示了指令 2001/83/EC 和法规 (EC) No 726/2004 的计划立法修订可能如何影响噬菌体疗法的法律前景。
