Getting bacteriophages into the EU market: challenges, experiences and current outlook

The webinar offered an interesting discussion on how bacteriophages will be part of the framework to tackle challenges such as AMR and the EU One Health approach.

Dr. Alison Low from the Roslin Institute at the University of Edinburgh presented about scientific hurdles to designing a phage cocktail. She confirmed, that “selection of phage to target a specific infection can present a hurdle for phage therapy “. This is why researchers at the Roslin Institute are using a genomics driven approach to predict active phage cocktails from the DNA sequence of the infecting bacterial strain.

A bacteriophage case study, based on the registration process of BAFASAL® has been presented by Dr. Elinor McCartney, Technical Director at Pen & Tec Consulting. Dr. McCartney believes, that “we are at the brink of a phage paradigm shift in the EU”. Since 2017, BAFASAL®, a pioneering bacteriophage cocktail used as a feed additive targeted at Salmonella in poultry, and produced by Proteon Pharmaceuticals, has been subjected to intense scrutiny from EFSA and EU Member States. Finally, there has been some positive developments in the recent months. In early 2023 EFSA issued an opinion confirming BAFASAL®’s efficacy against Salmonella serotypes having already approved the product’s safety and quality in 2021, in compliance with exacting EU standards. A few questions will remain to be answered, but according to Dr. McCartney “once BAFASAL® is approved in the EU, there will be a template for development of ground-breaking phage products in poultry and other food -producing animals, as well as many other serious bacterial pathogens in companion animals and humans”.

A growing interest in phage therapy among EU decision makers has been also confirmed by Margareta Przybyla, EU Public Affairs Advisor and Brussels representative of PhageEU. “While AMR as well as the One Health approach, fight against climate change and establishment of sustainable food subsystems have been recognized by all EU institutions as priority issues, there are growing opportunities to  position phages in the political discussion and raise awareness about their potential” explained Mrs. Przybyla. In order to speak with one strong voice and be able to shape the legislative and regulatory environment in the EU a few like minded stakeholders have established in late 2022 a Phage EU coalition. “We see positive developments in the political discourse however a lot s&ll remains to be done. This is why we encourage partners from all around the world to join us and make our voice event stronger” adds Margareta Przybyla.

In his closing remarks Professor Jaroslaw Dastych, CEO of Proteon Pharmaceuticals S.A. and founding member of PhageEU underlined, that when it comes to the authorisation, regulatory process, and political debate the main barrier is the acceptance and increasing the awareness of the phage technology. He confirmed, therefore, that “the Phage EU coalition will continue its efforts in raising awareness about phages and their potential so that the voice of the phage community is heard and taken into account”.

There has been a significant interest in attending the webinar from representatives of industry and academia worldwide. Over 250 participants registered in only a few days. This confirms the importance of the issue on how to get bacteriophages into the EU market. The webinar was an opportunity to discuss technical challenges to designing bacteriophage products, the regulatory hurdles in Europe for this new product category as well as to analyse the recent political debate in the EU institutions and the future outlook.