What is the current legal situation for human phage application?
Currently, the problem in Europe is the missing regulatory framework for therapeutical use of phages that would explicitly mention and acknowledge the specific concept and unique mode of clinical use.
The legal framework for use of medicines in Europe, mainly dictated by EU Directive 2001/83 on medicinal products for human use is over ten years old and leaves open whether phages should be assigned medicinal products or differently.
Phage therapy is neither “illegal” nor explicitly defined in the a.m. directive, phages are not mentioned. Would phages according to the directive be defined as medicinal products, clinical trials would become necessary. Nonsensical for an individual phage application as each novel therapy phage is specific (the strength of phage therapy): therapy phages shall be applied ad hoc.
A number of clinical trials was or is running in western Europe to demonstrate the safety and efficiency of phages. In contrast, phage therapy is routine in e.g. Georgia or Poland. Phages remain to be defined as therapeutics and integrated into a redesign of the EU directive.
When a patient and the medical practitioner wish phage therapy, it is a precondition to use purified, characterized and strictly highly lytic phages.
For comprehensive biological phage characterization, a large body of data for comparison and modern laboratory methods are available. The physician, together with the patient will decide about the successive therapy plan. Further reading: article by Isabelle Huys et al., see Literature recommendations.