A new European Biotech Act was announced in the political guidelines for the European Commission 2024-2029. This new act should make it easier to bring biotech from the laboratory to the factory and then onto the market. The biotech sector plays a critical role in several areas of the EU economy. It is research-driven, fast-moving and requires substantial public and private investments. This is why the European Commission has launched a call for evidence.
The aim of this consultation was to ensure that all stakeholders concerned express their views and share insights on the main challenges faced by the sector across the EU, the measures proposed, and their likely impact.
In its contribution PhageEU has made it clear, that the EU BiotechAct should also cover alternative approaches towards antimicrobial resistance. In the context of increasing AMR, the EU Biotech Act should recognize the role of innovative biological therapies, products and applications, such as bacteriophages, in supporting the Unions One Health objectives, strengthening health resilience, and promoting sustainable and targeted biocontrol.
PhageEU contribution
- Adapt authorisation procedures under the future EU Biotech Act to enable access to emerging biological therapies, through proportionate and flexible regulatory approaches;
- Develop regulatory mechanisms that allow biological therapies to evolve over their lifecycle, including the ability to update or adapt composition or manufacturing processes;
- Adapt regulatory and access frameworks to the specific characteristics of emerging biological therapies and develop proportionate pathways for clinical evidence generation, quality standards, and lifecycle management;
- Improve the knowledge and technology transfer between academia and industry to ensure EU-funded biotech and biomanufacturing research leads to commercial applications and industrial deployment (establishment of a coordinated European biobanking infrastructure);
- Establish dedicated funding instruments and innovation support for SMEs developing novel biological therapies, including bacteriophage-based treatments;
- Ensure coherence between the EU Biotech Act and the Pharmaceutical Package, in particular with regard to incentive mechanisms for antimicrobial innovation, regulatory sandbox initiatives, and lifecycle flexibility for biologics.
Full PhageEU contribution is available here.
Phage EU is a coalition of likeminded stakeholders who represent phages in industry, the scientific community and civil society. We want to realize the full potential of phages in Europe.
Media Contact and Secretariat
Margareta Przybyla
PhageEU Secretary General
Contact Details
mprzybyla@phageurope.eu
Tel: 0032 476 591 091