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Emergent

With over 25 years of experience working with governments, intergovernmental organizations, first responders, and NGOs across the globe, Emergent seeks to be a partner in strategic preparedness against natural, accidental, and man-made public health threats.

Lobbying Activity

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

19 Nov 2025 · Health security

Response to Union prevention, preparedness, and response plan for health crises

27 Oct 2025

Emergent welcomes the Unions initiative to strengthen Europes collective health security through a comprehensive prevention, preparedness, and response plan. The explicit reference to chemical, biological, radiological, and nuclear (CBRN) threats is timely and essential, given the rise in cross-border risks and geopolitical tensions. The plans whole-of-government, whole-of-society, alongside its focus on governance and coordination, provides a strong foundation for a coherent EU-level response that complements national efforts. We welcome the plans recognition of medical countermeasures (MCMs) as a cornerstone of preparedness and response. Timely access to safe, effective, and reliable MCMs is essential to ensure coordinated and equitable protection across Member States. Development, procurement, and distribution strategies should prioritize inclusivity by supporting both EU-based and trusted international manufacturers that are ready to assist the EU and its Member States. The plan should foster robust publicprivate partnerships to address preparedness and stockpiling needs while sustaining innovation, production, and surge readiness for niche or high-risk MCMs. Industry engagement should align with Member State priorities and stockpiling strategies, ensuring clear identification and quantification of needs. Transparency on requirements and priorities is essential to enable cooperation and, where appropriate, cross-border sharing of resources during crises. Long-term collaboration, structured investment, and flexible contracting can help maintain capabilities between crises. The upcoming identification and quantification work outlined in the MCM and stockpiling strategies (July 2025) can further strengthen resilience and enable rapid cross-border response. The plan should also link to the development of Crisis Procurement Guidelines (planned for 2026 under the Stockpiling Strategy) to support Member States in efficiently procuring essential MCMs under emergency conditions. These guidelines should ensure that procurement and deployment mechanisms are fit for purpose and responsive to future health crises, as demonstrated by the joint procurement approach during COVID-19. Regulatory flexibility is critical for the swift availability of MCMs during emergencies, particularly for low-probability, high-impact threats. The plan should acknowledge regulatory barriers that can delay MCM deployment and cross-border sharing. Member States, the EU, and the European Medicines Agency (EMA) should sustain dialogue to adapt regulatory processes during emergencies. The plan should also address the current lack of clarity for cross-border deployment, providing guidance on how and when Member States can share stockpiles during crises. Interoperable surveillance, early warning, risk assessment, and crisis communication systems are essential across EU agencies and Member States. Regular exercises, testing, and continuous information exchange should be promoted to identify gaps and share best practices. Union-level and national plans should operate seamlessly in emergencies through enhanced coordination. Coordinated stockpile management, with rotation and replenishment strategies, can help maintain readiness and minimize waste. Civilmilitary cooperation should be explicitly integrated as a key element of crisis response. Emergent stands ready to support the European Commission and Member States in strengthening preparedness and response capacities under the Union plan. With decades of experience in developing, manufacturing, and supplying medical countermeasures against biological and chemical threats, Emergent remains a committed partner in advancing Europes health security. We look forward to continued collaboration to help translate the Union plans objectives into practical, sustainable, and effective preparedness measures across the EU.
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Meeting with Boriša Falatar (Cabinet of Commissioner Hadja Lahbib) and FIPRA International SRL

30 Sept 2025 · health preparedness in Europe

Meeting with Hélder Sousa Silva (Member of the European Parliament)

29 Sept 2025 · Discussion around the EU preparedness agenda, the next MFF, and EU defence against CBRN threats

Response to Communication on the EU Stockpiling Strategy

5 May 2025

Ensuring an EU stockpile of MCMs The strategy should support the availability and timely deployment of critical MCMs such as vaccines, diagnostics, and therapeutics during health emergencies. These resources are important for a coordinated and effective response across Member States (MS). We welcome the expansion of the rescEU stockpiles, as outlined in the EUs Preparedness Union strategy. This can complement national efforts, mitigate inequities among MS, and be a buffer in times of drug shortage. The strategy should also include specific provisions of MCMs for CBRN threats, given the evolving risk and growing geopolitical tensions. Enhancing stockpiles should be a cornerstone of the broader strategy. Current capabilities should not only be preserved but also scaled up to address strategic gaps. Mapping EU and MS stockpiling needs The lack of visibility into national reserves and preparedness levels is a stockpiling challenge. The EU should map MS and EU-level needs to identify gaps and coordinated responses. The Commission should assess existing reserves, define priority MCMs, and align national and EU priorities. Information sharing, joint scenario planning, and coordination among MS, EU institutions, and stakeholders support decision-making and address supply chain or manufacturing bottlenecks. Joint procurement and regulatory access Joint procurement is a powerful tool in health crises. The strategy should consider integrating long-term joint procurement mechanisms for essential MCMs, including clear legal and operational frameworks, predictable funding, and pre-negotiated supplier agreements. The expectation is that stockpile products have EU licensure before procurement consideration. EMA should harmonize requirements for MCMs and also enable access to products manufactured outside of the EU. A pan-EU strategy could include mechanisms for regulatory reliance and mutual recognition agreements among EU countries, e.g., regarding inspections, serialization, labeling, pharmacopoeia standards, plasma sourcing, and in-country testing. This could help mitigate challenges for MCMs often produced on a campaign basis, with no commercial market. Better coordination between EMA, HERA, and national bodies, especially for procurement, will help clarify expectations for manufacturers and support market entry, so that MCMs can be available when needed. Due to current challenges, manufacturers may be discouraged from seeking market authorization, which may risk the availability of critical MCMs across Europe. In Canada, procurement is negotiated before the regulatory approval process, which provides a clear signal and accelerates access to MCMs. Public-Private partnerships and sustainable supply chain Public-private collaboration is central to the success of the strategy, which may include agreed-upon frameworks for surge production, risk-sharing mechanisms, and coinvestment in manufacturing capacity. Engaging the private sector early and systematically can help ensure that stockpiles remain relevant, scalable, and ready for deployment. Advance purchase agreements and flexible contracting mechanisms can help support mobilization of MCMs. Governance Crisis preparedness is a shared responsibility requiring close coordination between the Commission, MS, EU agencies, and cross-sector stakeholders. The governance of the strategy should therefore include structured mechanisms for cooperation, including regular communication, shared decision-making processes, and transparent reporting on stockpile use and replenishment. The role of DG HERA and DG ECHO will be central in this regard, particularly in aligning health preparedness objectives with civil protection and humanitarian mandates. A strong HERA is crucial for effective MCM stockpile governance, ensuring clear leadership and coordination across EU institutions and MS, avoiding fragmentation of responsibilities, streamlining decision-making, and leading strategic policy initiatives.
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Response to EU Strategy on medical countermeasures

5 May 2025

Development, procurement, and distribution The strategy should prioritize the development and procurement of MCMs from both EU-based and trusted international manufacturers. Many MCMs are manufactured outside the EU; inclusive procurement and regulatory strategies should help the EU respond more effectively. Facilitating market access for non-EU suppliers diversifies the availability of MCMs in a crisis. Strengthening supply chains and stockpiling Strengthening MCM supply chains is necessary for crisis response. This includes prepositioned stockpiles supported by real-time data, forecasting tools, and rapid deployment infrastructure. Stockpiling strategies should be well-funded, harmonized across Member States (MS), and aligned with EU-level policies. Streamlined procedures for importing, storing, and deploying MCMs from trusted international partners are also needed. Regulatory requirements and market access The EU regulatory framework should adapt to facilitate the availability and deployment of MCMs during crises. The current framework is challenging for products designed for low-probability, high-impact events. A flexible, purpose-built approach is necessary for proactive support and fast-track approvals when a public health emergency (PHE) is declared. Approaches like the Temporary Emergency Marketing Authorisation (TEMA) from the EU General Pharmaceutical legislation are welcome. EMA should harmonize requirements for MCMs and also enable access to products manufactured outside of the EU. A pan-EU strategy should include mechanisms for regulatory reliance and mutual recognition agreements among EU countries, e.g., regarding inspections, serialization, labeling, pharmacopoeia standards, plasma sourcing, and in-country testing. This could help mitigate challenges for MCMs often produced on a campaign basis, with no commercial market. Better coordination between EMA, HERA, and national bodies, especially for procurement, will help clarify expectations for manufacturers and support market entry, so that MCMs can be available when needed. A pre-PHE regulatory status with defined flexibilities could facilitate early market access and government procurement, for readiness without delay. MCMs are typically procured by governments; this provides additional control over their use, which could provide for flexibilities/incentives. Pragmatic, risk-based regulatory approaches are needed. Facilitating emergency procurement of non-approved MCMs The EU should consider policies that allow for advance procurement and stockpiling of MCMs not approved at EU level but by national frameworks or in advanced regulatory development. Several MS, including DE and NL, have laws for such government procurement. These frameworks provide a foundation for creating an EU-wide approach. Public-Private Partnerships and innovation Engaging private stakeholders will help build a resilient MCM innovation ecosystem. Incentivizing R&D and production with shared investment models, joint R&D programs, and coordinated policy guidance will help maintain and grow Europe's technological and industrial capacity. Coordination Poor coordination, particularly between civil and military health systems and across MS, can weaken EU preparedness. Harmonized policies and interagency collaboration are critical for a unified MCM strategy, including stockpiling coordination, preparedness exercises, and response protocols for threats that cannot be addressed through standard supply chains. Structured dialogue between the European Commission, MS, industry, and experts is vital for overcoming bottlenecks and enabling rapid action. This strategy could help forge a more proactive and resilient EU, to effectively address emerging CBRN threats. The complexity of natural and engineered bio-threats, and rapid technological advancement, means that health security should be an integrated component of Europes security and defense strategy.
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Meeting with Eero Heinäluoma (Member of the European Parliament) and SSAB AB

17 Apr 2024 · Topical issues

Meeting with Tomislav Sokol (Member of the European Parliament) and Insightec Ltd.

6 Dec 2023 · Health priorities

Response to European Health Emergency Response Authority

24 Feb 2021

Emergent BioSolutions applauds the Commission’s intention to set up a European Health Emergency Preparedness and Response Authority (HERA), and appreciates the opportunity to provide initial feedback. Please see attached letter for further details.
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Response to Miltiannual Financial Framework: Union Civil Protection Mechanism (rescEU) 2021-2027

2 May 2019

Emergent BioSolutions would like to congratulate the European Commission, the European Parliament and the Member States with the revised framework for a Union Civil Protection Mechanism (UCPM). The newly created RescEU pool will guarantee quick interventions in emergency situations and will provide capacity to optimize human resources and related financial costs. We fully support the selection of prioritized capacities that would be eligible for EU financial support: aerial forest fires fighting, CBRN response and emergency medical response. In particular, Emergent BioSolutions welcomes the consolidated European approach towards low probability high impact events, which also include CBRN risks. In terms of the biological component of CBRN, preparedness in emergency situations must include access to specific medical capacities. In order to save lives, any action requires highly specialized health experts that are trained to work in specific conditions and have the required knowledge to deploy medical products. Additionally, for first responders and health experts to optimally function during such situations, sufficient protection through access to equipment and medical countermeasures is also required. We understand that provision of medical countermeasures is one component of preparedness and consider that a means of logistics, co-ordination and distribution will be beneficial in deriving full benefit in the event of an emergency. We welcome potential use of the UCPM to achieve this. Chemical incidents require action within minutes whereas biological threats might take some time to be identified, affecting a larger population with every hour passing. For these reasons, Emergent BioSolutions would be available to contribute to better training and preparation of medical CBRN teams within the RescEU’s capacity pool. We are delighted to see that the approval of the renewed UCPM is aligned with several other European initiatives such as the Commission’s CBRN Action Plan, the Council Conclusions on Hybrid Threats and the European Parliament Terrorism Committee report. Emergent BioSolutions also welcomes the establishment of national Task Force Groups on CBRN and emergency medical response that will agree on a common vision, priorities, and budgets and looks forward to a helpful focus on cross-border biological and medical incidents. We could share our expertise and scientific information on medical preparedness against CBRN threats and we remain available to present our findings at one of the Task Force meetings or provide more specific recommendations per type of threat. CBRN risk is present and growing and we are strongly committed to protect all involved in public health emergencies and the general population. Finally, we welcome the European Commission’s proposal of 7 March 2019 on the budgetary implications and practical procedures. Emergent BioSolutions would strongly recommend to use the Joint Procurement Mechanism, that recently has proven its efficiency in the case of pandemic flu medical countermeasures. The Joint Procurement Mechanism and the common establishment of CBRN priorities will assist Member States in guaranteeing better resilience against a wide variety of CBRN threats. It is essential to align the budgetary provisions with the European ambitions and to boost the synergies with other European initiatives on civil protection. ——- About Emergent BioSolutions (www.emergentbiosolutions.com) Emergent BioSolutions is a global life sciences company seeking to protect and enhance life by providing specialty products for civilian and military populations that address intentional and naturally emerging public health threats. The company is headquartered in Gaithersburg, Maryland, USA, and has manufacturing facilities across the globe, including also in Europe.
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Meeting with Silvio Mascagna (Cabinet of Commissioner Julian King)

13 Sept 2017 · CBRN-E