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.

 

Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

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