13 September 2022 – Today, WHO issued the Global guidance framework for the responsible use of the life sciences. The Framework calls on leaders and other stakeholders to mitigate biorisks and safely govern dual-use research, which has a clear benefit but can be misused to harm humans, other animals, agriculture and the environment.
This is the first global, technical and normative framework for informing the development of national frameworks and approaches for mitigating biorisks and governing dual-use research. It aims to safely unlock the great promise for new and improved ways to improve global health offered by life sciences and related technologies.
The Framework addresses the decades-long challenges of preventing the accidental and deliberate misuse of biology and other life sciences, as well as how to manage governance and oversight to both accelerate and spread innovation, while mitigating negative impacts. The life sciences are increasingly crossing over with other fields, such as chemistry, artificial intelligence and nanotechnology, which changes the landscape of risks, with those that span multiple sectors and disciplines more likely to be missed.
“Life sciences and technologies offer many opportunities to improve our health, our societies and our environment” said Dr Soumya Swaminathan, WHO Chief Scientist. “However, developments and advances in life sciences and associated technologies could pose risks caused by accidents during experiments, inadvertent and deliberate misuse.”
Looking at how to manage the increasing pace of advances in the life sciences, the Framework outlines the need for anticipatory and responsive governance mechanisms, including foresight approaches, which are participatory and multi-disciplinary ways of exploring trends, emerging changes, systemic impacts and alternative futures.
To help manage risks, it covers issues such as preventing misinformation and disinformation, as well as managing large health data sets. Other topics include: increasing awareness and capacities for biorisk management, navigating the particular challenges around research on infectious diseases and preventing the misuse of research and technologies through collaboration among different actors and sectors.
The Framework is intended as the go-to starting point for the development and strengthening of biorisk management, which relies on three core pillars: biosafety, laboratory biosecurity and the oversight of dual-use research. Accounting for different contexts, resources and priorities, the Framework is designed to be adapted by Member States and other stakeholders, depending on their needs and perspectives.
Ministries of health are called upon to work with other ministries, including of science and technology, education, agriculture, environment and defense, along with other key stakeholders, to assess the risks posed by life sciences locally and nationally, and identify appropriate risk mitigation measures to strengthen governance for biorisks and dual-use research.
The document aims to raise awareness about the importance of biorisk management in the context of the One Health approach to optimize the health of people, animals and ecosystems; provide a set of values and principles to guide decision-making; and identify tools and mechanisms for biorisk management. Practically focused, it also sets out a six-step approach for implementation; checklists for various stakeholders; and scenarios and case studies to illustrate issues and options in the governance of biorisks and dual-use research.
Recognising that awareness and resources will be limited in low- and middle-income countries (LMICs), the Framework calls for providing these countries with technical and financial support and empowering their scientists through opportunities to pursue and govern life sciences. It also highlights the importance of developing more context-specific materials for awareness raising, education, capacity-building and training.
The life sciences include all sciences that deal with living organisms, including humans, nonhuman animals, plants and agriculture, and the environment, or products of living organisms or that incorporate components derived directly or synthetically from living organisms; the life sciences include but are not limited to biology, biotechnology, genomics, proteomics, bioinformatics, pharmaceutical and biomedical research and technologies.
WHO activities to support the Framework’s worldwide implementation include:
Leveraging existing efforts and initiatives, including those on laboratory biosafety, biosecurity and ethics;
Maintaining different stakeholders and local champions to monitor and evaluate the measures developed and implemented at local, national, regional and global levels;
Conducting awareness-raising activities, including regional and global dialogues, to support the sharing of experiences, lessons learned and best practices;
Developing trainings and tools to evaluate progress.
While governance of biorisks cannot be under the sole responsibility of one international body, WHO, through its leadership, aims to harness the developments of the life sciences to improve global health while anticipating and mitigating risks posed by such developments. Implementing the Framework will be done at country and local levels, with efforts supported by WHO regional offices and other partners.