FABENTECH
Founded in 2009, Fabentech specialises in the development and production of broad-spectrum therapeutics for fighting high-priority biological agents which could threaten public health.
ID: 055505446104-20
Lobbying Activity
Meeting with Laurent Muschel (Director Health Emergency Preparedness and Response Authority) and
10 Nov 2025 · Medical countermeasures developed by Fabentech
Response to Union prevention, preparedness, and response plan for health crises
28 Oct 2025
Fabentech welcomes the European Commissions initiative to strengthen its response to health crises through the creation of a unified Plan. The EUs security depends not only on its military capabilities but equally on its capacity to tackle public health threats both natural and man-made. As a pillar of societal resilience, health security is a cornerstone of societal stability, economic resilience, and strategic autonomy. To be successful this plan needs to address the fragility of the European Medical countermeasures (MCMs) supply chain. Today, the European market for MCMs remains excessively dependent on external suppliers, particularly from Asia and United-States. This overreliance exposes the Union to vulnerabilities stemming from geopolitical tensions, trade disruptions, and supply chain fragilities. To mitigate these risks, the European Union should explicitly recognise the pharmaceutical sector as a strategic industry central to Europes competitiveness, resilience, and sovereignty. In line with the recommendations of the Draghi Report, this recognition must translate into concrete action through the strengthening of publicprivate partnerships to reinforce pharmaceutical production capacity within Europe and the increase of need/market-driven investments in R&D. A major challenge also lies in the unpredictability and unsustainability of the preparedness market. Industrial actors currently lack visibility regarding future demand for MCMs, particularly in the context of stockpiling. This uncertainty discourages long-term investment and sustained production, especially for niche products. Without predictable demand and funding mechanisms, manufacturers will struggle to scale up production rapidly in the event of a new health emergency, leading to delayed responses and reduced readiness across the continent. To this end, the European Union should provide greater predictability of funding for research, procurement, and stockpiling. Greater clarity is needed on the 2025 Health Threat Prioritisation Assessment under the EU Medical Countermeasures Strategy. With the process still in development, industry seeks clear signals on which threats and countermeasures will be prioritised, and how procurement, manufacturing and regulatory frameworks will work, so that investment and production decisions can be made. Moreover, regulatory pathways particularly for novel countermeasures where standard human efficacy trials are infeasible should be streamlined and harmonised (including adoption of an analogous to the U.S. Animal Rule), to facilitate timely access to next-generation MCMs across the Union. The COVID-19 pandemic and current geopolitical tensions have underscored the high price of underinvestment in preparedness. Delayed responses led to avoidable human suffering and severe economic disruption. In contrast, proactive and coordinated EU-level preparedness not only mitigates immediate risks but also underpins long-term economic stability and strategic independence from external suppliers. The European Union now stands at a decisive moment for strengthening its collective security and crisis preparedness. Again, achieving the goals of the Union Prevention, Preparedness and Response Plan requires strong public-private cooperation. The upcoming Multiannual Financial Framework will be essential in achieving the Plans objectives, with its preparedness funding aimed at supporting both private stakeholders (such as industry and MCM manufacturers) and strengthening public bodies like the Health Emergency Preparedness and Response Authority (HERA). Finally, the full and harmonised implementation of the EU Preparedness Union Strategy, the EU Medical Countermeasures Strategy, and the EU Stockpiling Strategy will be essential to ensuring a resilient and secure Europe capable of responding swiftly and effectively to future health crises.
Read full responseMeeting with Pierre Jouvet (Member of the European Parliament)
14 Oct 2025 · Lutter contre les nouvelles maladies infectieuses émergentes présentant un risque pandémique
Response to Communication on the EU Stockpiling Strategy
29 Apr 2025
Fabentech supports the establishment of a robust EU stockpiling strategy to enhance supply chain resilience through an all-hazard, forward-looking framework. As a SME based in France, we would like to contribute the following points to support the development of an effective stockpiling approach.....1 Enhancing transparency and predictability of EU-level stockpiling. Having engaged with the Commission during the development of rescEU stockpiles, Fabentech sees this initiative as a vital tool to ensure timely access to critical medical countermeasures (MCMs) during health emergencies. It complements national efforts and helps prevent shortages during crises. We fully support expanding rescEU stockpiles as outlined in the EU Preparedness Union Strategy. While rescEU covers a broad range of emergency suppliesfrom firefighting equipment to MCMs for CBRN threats greater emphasis should be placed on expanding its medical stockpiles to better complement Member States capabilities. Currently, there is limited visibility on which products are prioritized for stockpiling at both EU and national levels. This lack of transparency makes it difficult for local manufacturers to align production and investment. We encourage the Commission to establish a clear framework indicating which MCMs are considered essential, along with clear evaluation criteria and indicative timelines. Greater predictability would strengthen preparedness and enable more effective public-private cooperation..........2 Streamline stakeholder engagement and procurement. Engaging with 27 different MS, each with its own procurement processes and priorities, places a significant burden on SMEs with limited capacity. This fragmentation reduces efficiency and delays the delivery of critical goods.We urge the Commission to establish more centralized or harmonized mechanisms for supplier engagementsuch as EU joint procurement, coordinated stakeholder dialogues, or a single EU-level contact point. These steps would significantly lower entry barriers for SMEs and promote broader market participation across the Union...........3 Improve regulatory pathways for MCMs. In a crisis, speed is critical. Yet SMEs developing novel MCMs, especially for CBRN threats, face long and complex regulatory processes that delay deployment. These low probabilityhigh impact products often require small volumes, but the regulatory burden remains high. Article 5(2) of Directive 2001/83/EC allows Member States to authorize unapproved medicines in emergencies, but the EU lacks a clear, centralized mechanism for the regulatory approval and stockpiling of MCMs. This contrasts with systems like that of the United States (US), where the FDA can issue Emergency Use Authorizations (EUAs) rapidly and centrally during public health emergencies. We recommend creating agile, fit-for-purpose regulatory pathways for emergency-use products. This should include fast-track approval procedures, clearer data expectations, and early access to scientific advice to support innovation without compromising safety or efficacy. In particular, guidance is needed on stockpiling strategies when time-sensitive crises make certain studies for MCMs infeasible...............4.Support local production and strategic autonomy. Ongoing geopolitical tensions have revealed the EUs reliance on external supply chains. Local production must be a central pillar of a resilient EU stockpiling strategy to ensure strategic autonomy in health emergencies. We call on the Commission to include targeted support for European manufacturers, especially SMEs within the stockpiling strategy. This could involve financial incentives to scale production, support for innovation, and long-term inclusion in EU procurement frameworks.In conclusion, a transparent, coordinated, and innovation-friendly stockpiling strategycombined with targeted support for local productionwill strengthen Europes resilience and autonomy in the face of future health threats
Read full responseMeeting with Christian Ehler (Member of the European Parliament) and Orgalim – Europe's Technology Industries and
4 Sept 2024 · Implementation of Horizon Europe
Meeting with Christian Ehler (Member of the European Parliament)
30 Aug 2024 · Preparation meeting