On May 24, 2021, the World Health Organization (WHO) announced it singed an MoU with Switzerland to host the WHO’s first BioHub Facility, which is part of the new BioHub System first announced at the World Health Assembly in November 2020.

The stated purpose of the WHO BioHub is to set up a system that guarantees the timely sharing of biological material (e.g., clinical samples, specimens, isolates, cultures) for emerging pathogens, so as to ensure their faster identification and characterization and enable risk assessments and the rapid development of countermeasures (e.g., vaccines, diagnostics and therapeutics).

According to the WHO, the BioHub is needed because not all countries have the capacity to quickly perform sophisticated analysis on these pathogens. The Swiss biosafety laboratory in Spiez will be used for the safe receipt, sequencing, storage and preparation of the biological materials, which will be later distributed to other laboratories and entities.

In a briefing to the industry on May 17, 2021, the WHO further explained that the system is voluntary and that Member States will be free to decide whether they want to donate their biological materials to the BioHub Facility. The BioHub is not intended to replace any existing and future sharing agreements such as the Pandemic Influenza Preparedness Framework or the Nagoya Protocol on Access and Benefit-sharing. It will be up to the WHO Member States to donate their pathogens, and to provide for a transparent framework and clear conditions under which the materials are sent and can be received.

The BioHub system is projected to be based on a number of material transfer agreements (MTAs). First, the donating country will sign a standard MTA with the BioHub Facility. WHO’s intention is to draft a standard MTA (SMTA1) that will ensure that the sharing is for the public benefit of all humanity (and not merely a bilateral benefit sharing). Next, once the material is in the BioHub Facility, the latter will facilitate its transfer to the qualified entities (i.e., entities that have certain biosafety and biosecurity standards and consequently qualify as receiving entities). The BioHub Facility should then be able to transfer the material based on two types of SMTAs: one for non-commercial uses (SMTA2) and one for commercial uses (SMTA3). All these MTAs are still being drafted, and the difference between commercial and non-commercial is yet to be clarified.

In terms of timing, the BioHub will be rolled out in two phases. The first phase will last until the end of 2021. Within this timeframe the WHO expects to develop the SMTA1 and SMTA2 with the help of a core group of Member States that agreed to share their pathogens. The WHO will also test the feasibility of the system through the sharing of SARS-CoV-2 variants (only). In the second phase, starting in 2022, the WHO will develop the SMTA3 and endeavor to extend the system to other laboratories (not only in Switzerland) and to newly emerging, highly hazardous pathogens with endemic or pandemic potential.

Companies active in developing vaccines, diagnostics and treatments relating to infectious diseases are well advised to closely monitor the WHO BioHub.