Phage Therapy in Europe: Regulatory and Intellectual Property Protection Issues

Abstract

Bacteriophages (phages for short) are increasingly put forward as potential (additional) tools in the fight against the worldwide antibiotic crisis. However, the setup of clinical trials, which are necessary to demonstrate the efficacy of phages and to optimize their clinical application protocols, and consequently to their implementation in the clinic is still hindered by the lack of an adapted regulatory framework. Although some (local) progresses have been made in recent years, no real paradigm shift has occurred. This chapter discusses the current status in Europe with regard to the two most pertinent barriers to phage therapy: the regulatory and intellectual property protection issues.