SIGA Technologies, Inc.
SIGA is a biopharmaceutical company whose objective is to develop medicines to prevent and treat emerging infectious diseases with high unmet medical needs.
ID: 284240398066-67
Lobbying Activity
Response to Communication on the EU Stockpiling Strategy
6 May 2025
As a trusted partner in providing medical countermeasures (MCMs) against orthopoxivirus threats, including smallpox and mpox, SIGA stands ready to support a robust EU stockpiling strategy. In light of growing geopolitical instability, stockpiles should be recognized not just as a public health resource, but as a critical component of European defense and security infrastructure, supporting both civilian and military needs. Ensuring health security preparedness through stockpiling: The COVID-19 pandemic exposed vulnerabilities in the EU's stockpiling of MCMs. Coordinated stockpiling is crucial for timely and equitable access to MCMs in future crises. While RescEU currently covers a broad range of response capabilities, its scope remains too wide. Greater focus is needed on centralized medical countermeasures preparedness to complement Member States (MS) efforts and ensure equitable access in crises. SIGA supports developing and maintaining EU stockpiles to ensure resilience in health emergencies RescEU and its expansion are a crucial step to this end. The Commission should define priority MCMs for CBRN threats aligned with national and EU health security objectives to address supply chain vulnerabilities. To improve predictability and readiness for private suppliers, the EU should use multi-year contracts with purchase guarantees, streamline regulation, and clearly define trigger mechanisms for joint procurement. The strategy should be underpinned by structured public-private collaboration, coordinated decision-making involving routine communication, and transparent monitoring of stockpile deployment and restocking. Early and consistent dialogue with the private sector is essential to ensure stockpiles are fit-for-purpose and deployment-ready. The EU is uniquely placed to lead a coordinated response to a biosecurity crisis by identifying gaps through joint risk assessments, amongst MS, EU institutions and stakeholders, enabling joint procurement and efficient resource deployment. Successful models from the U.S. and Canada show how supplier engagement improves response time and stockpile appropriateness. Better coordination between HERA, EMA and national health bodies is vital to ensure better preparedness and the fastest possible response to crises. Clarity is also needed on priority threats and related MCMs. Establishing a shared baseline for threat assessment at the EU leveldeveloped in partnership with industrywould guide preparedness, enable suppliers to anticipate demand and ensure the timely availability of MCMs. Antivirals: a critical pillar of health preparedness Antivirals are critical in a comprehensive response to an infectious disease outbreak. While vaccination remains a cornerstone of infectious disease prevention and control, distribution and administration can be complex, and vaccines may not be suitable for all populations. As a complement, antivirals that are safe for mass distribution can be deployed more rapidly and across a wider segment of the population, including immunocompromised individuals. Early use of antivirals can reduce transmission, severity and mortality, making them a critical tool for improving the EUs health emergency preparedness and response agility. Leveraging dual-use technologies to address multiple threats: Antivirals also play a key role in both military and civilian preparedness. When available in oral dosage forms, they are easier to administer and can serve as a first line of biodefense for military personnel, first responders, and civilian in the event of exposure to hazardous substances or bioterror threats. The EU stockpiling strategy should prioritise dual-use technologies that address multiple threats. Products offering multiple indications against a range of biological threats should be elevated in policy planning. Structured engagement with dual-use solution providers will strengthen deployment pipelines and improve access to EU-wide stockpiling mechanisms.
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