What is the WHO BioHub System?       

The COVID-19 pandemic, along with other recent outbreaks and epidemics, has underscored the importance of rapid and broad sharing of pathogens for effective surveillance and the timely development of medical response products such as diagnostics, therapeutics or vaccines. Currently a great deal of pathogen sharing is done bilaterally and on an ad hoc basis, which can be inefficient and risks both leaving some countries out and not covering important, emerging pathogens.

The world needs a system to rapidly, safely and efficiently share biological materials with epidemic or pandemic potential, and expertise to conduct thorough risk assessments that can be rapidly shared with all countries, and in time, to develop medical countermeasures that can be equitably shared with all countries in need.

The WHO BioHub System will offer a reliable, safe, and transparent mechanism for WHO Member States to voluntarily share novel biological materials, without replacing or competing with existing systems. Sharing of biological materials with epidemic or pandemic potential will be done through one (or more) of the laboratories designated as a WHO BioHub Facility. 

This will allow WHO Member States and partners to work in a better and faster way, to advance research, and to be more prepared for health emergencies as well as ensure fairness in access to benefits arising from this sharing.

 

WHO BioHub System Pilot Testing Phase for non-commercial sharing: Documents package to facilitate sharing of SARS-CoV-2 (as BMEPP)

The following package of two documents is to be used for the WHO BioHub System Pilot Testing Phase for the non-commercial sharing of Biological Materials with Epidemic or Pandemic Potential (BMEPP) through the WHO BioHub System. During this Pilot Testing Phase, SARS-CoV-2 will be used as a ‘test BMEPP’– for sharing into and from a WHO BioHub Facility for non-commercial purposes only. This package contains the following documents:

(click on the image to download the document)

 

To engage in the sharing of SARS-CoV-2 (as BMEPP) for the Pilot Testing Phase, the corresponding Standard Material Transfer Agreements and their Annex 2 will need to be signed and filled in. If you would like to provide or request SARS-CoV-2 samples to and from the WHO BioHub System, please contact [email protected].

 

 

 

What are the objectives of the WHO BioHub System?

The objectives of the WHO BioHub System are to:

  • Promote rapid and timely sharing of biological materials with epidemic or pandemic potential;
  • Facilitate rapid access to such pathogens and their information by relevant, interested, and qualified entities for the development of effective and safe public health products including diagnostics, vaccines and therapeutics; and
  • Ensure fair and equitable access to such products by all countries, based on public health needs.

 

What are the guiding principles of the WHO BioHub System?

The WHO BioHub System will be based on the guiding principles detailed below: 

A voluntary system for global public health

All contributions of biological materials with epidemic or pandemic potential to the WHO BioHub will be entirely voluntary, based on the desire for rapid generation of information and other resources for global public health.
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Timeliness

To enable an effective public health response, the end-to-end system from sample collection to shipping and generation of scientific information must function with urgency. Data and analyses will be made publicly available in a timely manner, while respecting all applicable WHO, international, and national regulations and standards, and communicated promptly to decision-makers in the affected countries as well as more broadly to all WHO Member States to support effective and timely response measures.
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Equity and fairness

Equity and fairness, as well as public health risk and need, will govern access to biological materials with epidemic or pandemic potential contributed to the WHO BioHub System, and the research, data, and other materials resulting from the WHO BioHub System.
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Transparency

Terms and conditions with respect to the use of biological materials with epidemic or pandemic potential, sequence data and information from the WHO BioHub System will be made publicly available, as will criteria to receive biological materials with epidemic or pandemic potential.
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Acknowledgement and co-authorship

The contributions of collaborators to the WHO BioHub System, including laboratories providing biological materials with epidemic or pandemic potential or genetic sequence data, will be appropriately acknowledged in presentations and publications, using guidelines such as those outlined by the International Committee of Medical Journal Editors. To the extent possible, entities using biological materials with epidemic or pandemic potential in scientific research projects will seek the participation of scientists from the originating laboratory or countries and make efforts to engage them in preparation of manuscripts for presentation and publication.
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Sustainability and maximal preservation

The biological materials with epidemic or pandemic potential and associated data (e.g epidemiological information), available through the WHO BioHub System, will be critical for understanding diseases with epidemic and pandemic potential and developing tools to combat them. These important resources will need to be maintained and managed over the longer term. The WHO BioHub System will, therefore, be established and managed with longer term sustainability and maximal preservation in mind.
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Collaboration & Cooperation

The WHO BioHub System will promote collaboration and cooperation with existing networks, repositories, and scientific groups to strengthen knowledge and contribute to the advancement of effective, efficient, fair and equitable response to epidemic or pandemic public health events
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Best practices for safety and security

The WHO BioHub System will follow procedures that ensure that biological materials with epidemic or pandemic potential, which are shared, have been properly characterized, usually through culture and sequencing for pathogen materials. They will be prepared, dispatched, received, processed, stored and shipped to qualified recipients according to current, applicable national and international biosafety and biosecurity standards.
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Consistency with applicable law

The WHO BioHub System will be established and operated in a manner consistent with applicable law, regulations, rules, and standards, including under national and international law
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Consistency with applicable ethical regulations, norms, and standards requirements

The WHO BioHub System will be established and operated in a manner consistent with applicable WHO, international, and national ethical regulations, norms, and standards.
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What is the approach to the development of the WHO BioHub System?

The development of the WHO BioHub System will follow a phased approach. In 2021 a first pilot phase will take place. This will focus on using the sharing of SARS-CoV-2 variants as a test case to ensure an operational foundation and start developing a fair and equitable system to share benefits that may arise from sharing of biological materials with epidemic or pandemic potential.

WHO is periodically organizing Member State briefings as well as information sessions for non-state actors to gather feedback on the progress and developments of the WHO BioHub System.

Please use the Contact details for any enquiries and follow the News and events section for announcements on briefings and information sessions

Contact

WHO BioHub
World Health Organization
Avenue Appia 20
1211 Geneva 27
Switzerland 
Email: [email protected]