Strengthening biosecurity and biosafety oversight: CEPI publishes its first Biosecurity Policy

Dr. Jane Shallcross, Senior Lead for Biosecurity and Biosafety Oversight, and Dr. Andrew Hebbeler, Director of Biosecurity
Biosecurity icon

Today marks an important milestone for CEPI’s biosecurity program: the publication of CEPI’s first-ever Biosecurity Policy and associated FAQ. This Policy, a key activity set out in CEPI’s Biosecurity Strategy and Implementation Plan, is the result of extensive consultation, technical review, and engagement across sectors. It reflects a growing recognition that rapid advances in vaccine R&D and manufacturing, which are essential to realising the ambition of the 100 Days Mission, must be matched by clear, robust and responsible safeguards.

Biosecurity is not the responsibility of any single institution. It is a shared obligation across the global research and funding ecosystem. Funders, in particular, play a critical role: defining baseline expectations, incentivising good practice, and helping to reduce vulnerabilities before they become risks. This Policy is CEPI’s contribution to that collective effort and demonstrates our commitment to reducing biosecurity and biosafety risks in support of the International Bio Funders Compact

Why a Biosecurity Policy?

The pace of scientific innovation continues to accelerate. Advances in synthetic biology, AI-enabled design tools, and increasingly interconnected global research networks are expanding what is possible in epidemic and pandemic preparedness. These developments are enabling faster, more flexible responses, but they also increase the importance of safeguarding how biological materials, data, technologies, and research practices are employed. 

Without adequate biosafety and biosecurity oversight and mitigations, the likelihood of accidental or deliberate misuse increases. While the core principles of biosecurity and biosafety are well established, their practical implementation differs across geographies, institutions and research contexts. For funders supporting complex international R&D portfolios, this variability creates challenges. 

CEPI’s Biosecurity Policy sets out a clear, systematic approach to identifying and mitigating biosecurity and biosafety risks across CEPI-funded research. The objective is straightforward but essential: to ensure that the benefits of CEPI-supported research always outweigh the risks, that risks are identified and mitigated where they arise, and that all research is conducted to the highest appropriate standards of biosecurity and biosafety.

What the Policy outlines

The Policy defines expectations for CEPI awardees, partners, and collaborators across nine key areas, including:

  1. Adhere to appliable Biosecurity and Biosafety legislation, regulation, and policies;
  2. Conduct Biosecurity and Biosafety risk assessments;
  3. Deliver effective organisational management and oversight;
  4. Collect, manage and store samples in accordance with best practice;
  5. Define and manage emergency response plans;
  6. Ensure appropriate protection and information security for Biosecurity sensitive data;
  7. Assess activities for the potential to generate viruses with enhanced epidemic or pandemic potential (VEEPP);
  8. Ensure responsible procurement of nucleic acid synthesis services and equipment;
  9. Promote responsible emerging and converging technologies development and applications.

By consolidating these expectations into a single policy, CEPI is establishing a consistent, transparent, and equitable approach to biosecurity across our diverse R&D portfolio. Importantly, this is not about creating parallel systems or additional administrative burden, but about clarifying expectations and aligning practice with existing global norms.

Enabling fast, responsible innovation for the 100 Days Mission

Effective biosecurity is not a barrier to innovation and the 100 Days Mission, but an enabler. With the appropriate controls in place, researchers can work quickly, safely, securely, and confidently. Clear expectations around the handling of biological materials support collaboration across borders. Thoughtful oversight of data, genome synthesis, and AI-enabled tools, enable scientific advances without increasing risk to people or communities. 

CEPI’s approach is deliberately practical, flexible, and partnership-oriented. The Policy is designed to support awardees in strengthening internal systems, aligning with global guidance, including from WHO and other relevant international bodies, and scaling protections in line with the ambition of the 100 Days Mission. At the same time, it reflects the role funders can play in reinforcing good practice across the wider research ecosystem.

Next steps

Publication of the Policy is only the beginning. Over the coming months, CEPI will provide resources to help awardees implement the Policy effectively, demonstrate compliance, and identify opportunities to strengthen risk reduction. The rollout of the Policy will begin with new awardees while working with existing partners and will be incorporated into CEPI’s updated Third Party Code, expected to enter into force in mid-2026. In parallel, we will continue engaging with the global biosecurity community to refine approaches as the field evolves, while strengthening support systems to ensure the Policy is practical, effective, and future-ready.

As biological risks evolve, responsible science requires more than innovation alone. It requires integrity, foresight, and collaboration. CEPI’s Biosecurity Policy ultimately reflects our commitment to ensuring that cutting-edge research advances global health securely and equitably, and to working with partners across the funding ecosystem to reduce biosecurity and biosafety risks for all.