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What is the current legal situation for human phage application?

Currently, the situation in Europe is the yet missing regulatory framework for therapeutical use of phages that would explicitly mention and acknowledge the specific concept and unique mode of their clinical application. Apart from the fact that the World Health Organization (WHO) mentions phage therapy as a potential additional option to fight the increasing global antimicrobial resistance (AMR) crisis, the legal framework for use of medicines in Europe, mainly as required by EU Directive 2001/83 on medicinal products for human use does not include phages and their regulatory allocation. The usual licensing pathway of pharmaceutical products / medicines has to be adapted considerably to phage preparation development and use.

Furthermore, licensing authorities require to evaluate more data originating from randomized controlled clinical trials on phage application including pre-clinical data. Such trials are highly cost-intensive and up to now still rare. Predominantly, efficiency of phage application rather than safety issues has to be demonstrated to allay last doubts. To foster human phage therapy, additional preclinical and clinical studies involving phages are currently in process. Following expert conferences on European level, the complex policy issue is currently handled with great care by the national and European authorities (Europe: European Medicines Agency, EMA).   
A number of systematic clinical trials was or is running in western Europe to demonstrate safety and efficiency of phage preparations. In single cases, individual patients may be treated directly by their responsible physician under the WMA Helsinki Declaration (Par. 37).


When a patient and the medical practitioner wish phage therapy, it is a precondition to use purified, characterized and strictly lytic phages and the bacterial causative pathogen must be known before therapy to identify suitable phages in a phagogram for the individual case. Such therapy is also called experimental therapy and must be documented in detail and the clinical case must be communicated in transparent manner to the experts.  
 

Important:
Please, be aware that the DSMZ does not convey phage therapy to requesters and does not recommend any contacts of specialized medical doctors. Also, the DSMZ does not perform phagograms for single patient cases or recommend any specific phage preparations. Further reading: article by Isabelle Huys et al., see Literature recommendations.