Phage EU
We are a coalition of likeminded stakeholders who represent phages in industry, the scientific community and civil society.
ID: 174779050296-36
Lobbying Activity
Response to European Research Area (ERA) Act
5 Sept 2025
PhageEU is a coalition of like-minded stakeholders representing phages in industry, academia and civil society www.phageurope.eu. Companies and research institutions involved in development of phage technologies, treatments and products are to a wide extend innovative start-ups. This is why PhageEU has contributed to a consultation on EU startup and scaleup strategy, which is interlinked with the initiative on European Research Area. PhageEU believes, that in order to improve the general environment for generating innovation, reducing fragmentation and boosting the EUs competitiveness, obstacles to innovative companies and research institutions with regards to research and development must be eliminated. PhageEU members have reported a number of obstacles that hamper R&D in Europe as well as free movement of knowledge and talent across Europe, from the perspective of companies and research institutions. 1. Excessively long delays for public funding: Some grant programs take years before providing a response, making planning difficult. Moreover, they often cover only 50% of expenses, forcing startups and research institutions to secure additional private funding for R&D, which adds another layer of complexity. 2. High tax and social security burden: In some EU countries social security contributions represent the largest expense for innovative startups and research institutions, regardless of revenue. Many startups operate with revenue far below their expenses, yet they still face an average 50% payroll tax. While R&D benefits from some support, these incentives are gradually being reduced. 3.Talent acquisition hindered by excessive payroll taxes: Startups and research institutions find it challenging to offer competitive salaries to top talent, such as key opinion leaders (KOLs) or senior researchers, compared to large corporations. Due to high payroll taxes, startups and reproach institutions are often forced to offer lower net salaries, making it difficult to attract the expertise necessary for scaling up. In order to address this situation several actions must be implemented, especially: 1. Access to public funding should be accelerated and simplified, with a maximum six-month response time for grant applications and an increase, if possible, in grant coverage to 70-80% in certain cases. 2. Tax burden on entities engaged in R&D must be reduced by establishing tax incentives. 3. Free and open access to publicly funded R&D results to knowledge and data should be significantly strengthened as well as cooperation between academia and industry.
Read full responseResponse to Biotech Act
28 May 2025
In the context of increasing antimicrobial resistance (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. Innovative and alternative technologies, such as bacteriophage technology, should be part of a future-oriented biotech agenda. Bacteriophages offer solutions to fight AMR and reduce the use of antibiotics. This is especially important now, when antimicrobial resistance (AMR) is on its rise despite various efforts at European and global level. The potential of bacteriophages has been already recognised by various decision makers, including Members of the European Parliament in their Resolution from June 2023. The same year EMA has issued scientific guidelines on quality, safety and efficacy of veterinary medical products designed for phage therapy and launched a consultation on the development of human medicinal products tailored to phage therapy. EFSA is currently working on a new guidance document on characterisation and risk assessment of microorganisms used in the food chain. Despite these developments the access of EU patients, consumers, farmers or food producers to phage technology is significantly limited. In order to speed up access of European patients, farmers and consumers to innovative biotechnology, such as bacteriophage technology, PhageEU is calling on decision makers to: 1. Adapt authorisation procedures under the future EU Biotech Act to enable access to emerging biological therapies, through proportionate and flexible regulatory approaches, while maintaining high standards of safety, quality and efficacy. We need proportionate authorisation pathways that reflect challenges in bringing biological innovations to market, especially where traditional frameworks are too rigid (like in the case of phages). 2. Develop regulatory mechanisms that allow biological therapies to evolve over their lifecycle, including the ability to update or adapt composition or manufacturing processes, where supported by scientific or clinical evidence. It is very relevant for adaptable or personalized biological treatments (like phages) and supports regulatory flexibility. 3. Adapt regulatory and access frameworks to the specific characteristics of emerging biological therapies and develope proportionate pathways for clinical evidence generation, quality standards, and lifecycle management to facilitate their safe and effective integration into healthcare system. 4. 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. In that respect PhageEU recommends the establishment of a coordinated European biobanking infrastructure, as critical step for advancing novel antimicrobials. This would support translational pipelines from R&D to clinical use, especially in AMR and pandemic readiness. 5. Establish dedicated funding instruments and innovation support for SMEs developing novel biological therapies, including bacteriophage-based treatments, recognising their high public health relevance and the challenges associated with early-stage development and scale-up. Reinforce Horizon Europe and EIC priorities on biotech innovation. 6. 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 (see details in PhageEU position paper on Pharmaceutical Package).
Read full responseResponse to EU Strategy on medical countermeasures
8 May 2025
Bacteriophages offer solutions to fight AMR and reduce the use of antibiotics. This is especially important now, when antimicrobial resistance (AMR) is on its rise despite various efforts at European and global level. According to WHO estimations 1.91 million people could potentially die as a direct result of AMR in 2050. This situation requires urgent responses, such as development of alternative medical countermeasures, including bacteriophage products. The potential of bacteriophages has been already recognised by various decision makers, including Members of the European Parliament in their Resolution from June 2023. The same year EMA has issued scientific guidelines on quality, safety and efficacy of veterinary medical products designed for phage therapy and launched a consultation on the development of human medicinal products tailored to phage therapy. EFSA is currently working on a new guidance document on characterisation and risk assessment of microorganisms used in the food chain is currently open for public consultation. Despite these developments none of the phage products has been authorised so far to be widely available to EU patients, consumers, farmers or food producers. PhageEU is calling on EU regulators to speed up European authorisation procedures of phage therapies and products in line with available regulations and cover remaining regulatory loopholes. As antibiotic resistance continues to rise, bacteriophages provide an effective and natural solution. They can be used both preventively and therapeutically, reducing reliance on conventional antibiotics and supporting more sustainable methods of managing bacterial threats. In addition, they can be used alongside antibiotics, offering an additional strategy to help address antibiotic-resistant infections. Public Health Protection Phage-based solutions support public health by reducing the risk of antimicrobial resistance (AMR). Promoting these technologies is key to tackling bacterial infections that are increasingly difficult to treat with conventional methods. EU companies are facing a number of challenges in the development and supply of MCMs based on bacteriophage technology. Therefore, PhageEU is suggesting the following elements to be in place in order to develop bacteriophage- based medical countermeasures against public health threats, such as AMR: Targeted EU funding under Horizon Europe and EU4Health for phage-related R&D, clinical validation, and GMP-compliant manufacturing infrastructure. Fast-track regulatory pathways tailored for biologics and precision antimicrobials like phages, to enable flexible and adaptive approval processes. Support for coordinated EU-wide clinical trials, ensuring cross-border validation, data harmonization, and faster access across Member States. Inclusion of phage therapies in EU stockpiling and emergency preparedness frameworks, allowing rapid deployment during AMR outbreaks or future pandemics. Recognition and investment in existing EU-based manufacturing capacity for phages, with potential to scale production rapidly in times of crisis. Integration of phage-based solutions into the EUs strategic autonomy agenda, reducing dependency on external suppliers and strengthening Europes innovation leadership in health. Support for Start-ups developing innovative and alternative treatments such as phages: access to public funding should be accelerated and simplified, with a maximum six-month response time for grant applications and an increase, if possible, in grant coverage to 70-80% in certain cases. Tax burden on startups must be reduced by establishing a dedicated startup tax status with lower social security contributions during the first years of operation, extending beyond just R&D positions. In this respect we would also like to draw the attention to PhageEU position on Pharmaceutical Package (attached).
Read full responseMeeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)
17 Mar 2025 · Pharma Package
Response to EU Start-up and Scale-up Strategy
14 Mar 2025
1. Do you agree that startups and/or scaleups face the hurdles identified in this document? PhageEU: Yes, we totally agree. 2. Are there any additional hurdles faced by startups and/or scaleups? PhageEU: Yes, we identified these additional obstacles reported by our members: Excessively long delays for public funding: Some grant programs take years before providing a response, making planning difficult. Moreover, they often cover only 50% of expenses, forcing startups to secure additional private funding, which adds another layer of complexity. High tax and social security burden: In France, for example, URSSAF contributions represent the largest expense for startups, regardless of revenue. Many startups operate with revenue far below their expenses, yet they still face an average 50% payroll tax. While R&D benefits from some support, these incentives are gradually being reduced, making it almost impossible to hire outside of R&D roles. Difficulties in securing contracts with large European companies: Startups struggle to have contacts, discussion, and integration into the supply chains of major corporations due to a lack of effective incentive mechanisms. It is very difficult for a startup to get in contact with decision-making person in large European companies. Talent acquisition hindered by excessive payroll taxes: Startups find it challenging to offer competitive salaries to top talent, such as key opinion leaders (KOLs) or senior researchers, compared to large corporations. Due to high payroll taxes, startups are often forced to offer lower net salaries, making it difficult to attract the expertise necessary for scaling up. 3. What actions do you think the EU and/or its Member States should take to address these hurdles? PhageEU: Several actions must be implemented, especially: Access to public funding should be accelerated and simplified, with a maximum six-month response time for grant applications and an increase, if possible, in grant coverage to 70-80% in certain cases. Tax burden on startups must be reduced by establishing a dedicated startup tax status with lower social security contributions during the first years of operation, extending beyond just R&D positions. Taking into account, that tax matters are in national competence, European Union could establish a European Startup Status and encourage MSs to allow startups to apply reduced social taxes so that they can grow and improve their financial standing.
Read full responseMeeting with Tiemo Wölken (Member of the European Parliament)
29 Jul 2024 · Exchange on Bacteriophages (staff level)