Bart Van Vooren's commentary appears in a Health Policy Watch article about how the Nagoya Protocol of the Convention on Biodiversity has fostered a vast patchwork of laws and regulations that were originally intended to protect countries' indigenous biodiversity, but also extends to regulations on pathogen sharing, which vary from country to country. This new pandemic accord currently being negotiated could represent an opportunity to clarify the waters where open models of data and pathogen sharing that accelerated R&D during the COVID era could move more slowly in future pandemics for financial benefits or other concessions. Bart's comments are based on a webinar sponsored by the International Federation of Pharmaceutical Manufacturers and Associations following the publication of Covington's IFPMA-commissioned report on the ins and outs of pathogen sharing.
The four-part report that Bart spoke about provided a detailed review of existing networks for pathogen sample- and data-sharing, the rules governing that sharing; and perceptions of what works and does not, based upon interviews with dozens of scientists from both the public and private sector. The aim, said Van Vooren, was to inform the negotiations of the WHO pandemic accord.
“When we spoke to the interviewees on a confidential basis, whether they were from the public or private sector, whether the background is North or South, everyone agrees that something has to give. This needs to be resolved. How, of course, a different question,” Bart observed.
“Honestly, it scares me because there is a very short timeline to flesh this out in the next two years, and it could be another Nagoya Protocol. Or it could be a solution to another Nagoya Protocol. So it is concerning,” Bart said.
The core intent of the Nagoya Protocol on access and benefit sharing (ABS) of genetic resources is to regulate commercial appropriation of countries’ plant, animal species, and related genetic resources to enable countries to claim benefits for the use and development of indigenous assets.
“There are nearly 100 ABS laws in the world,” Bart stated. “Nearly 100 ABS rules to deal with 77 laws applying to viruses and 39 likely to apply for genetic sequence data. Only 12 have a public health emergency exception in place.”
Obtaining a permit to use a pathogen for pharmaceutical R&D can be a long and arduous process under many national ABS systems, even when public health exceptions are in place.
“At least five interviewees noted difficulties in getting Zika samples from Brazil, so diagnostics could not be tested against the local strain,” Bart explained.
During the recent Mpox outbreak, “a sample held by a European biobank could not be shared, and a national authority never responded to a request for a permit,” he added.
As a result, scientists in both the private and public sectors often look for workarounds, Bart said.
“They want to avoid ABS jurisdictions, with a preference for ‘unburdened’ samples. This often means waiting for the ‘returning traveller’, an infected person will ‘import’ the pathogen from which samples and data can be extracted," Bart explained.
“The intent of Nagoya is noble – equitable benefit sharing – but how it’s been implemented has completely missed the objective. The transactional approach of attaching value to pathogens but not to public health doesn’t seem to work.
“The problem is that politics have replaced science and common science. Everyone agrees that something has to give.”
Bart continues, stating, “It’s hard to quantify but we got the impression that when a public health Institute or a company for R&D wants to get access to a pathogen, very often it will work through a network of biobanks, such as the Institut Pasteur, or the European BioBank, or the American Type Culture Collection (ATCC), or BEI. So it’s completely outside the surveillance networks, and very often just through bilateral relationships between a company and a public health Institute, a university and another university."
Complicating matters further is the fact that existing systems of pathogen data and sample sharing operate in a highly decentralized and fragmented manner.
“It’s a very complex spaghetti bowl of how pathogens are really shared… what we found was a patchwork of practices, and not the very rigorous organization of how pathogen sharing works within disease surveillance networks,” Bart explains.
As examples, Bart cited four leading disease surveillance networks, hosted or supported by WHO. These include: the Global Influenza Surveillance and Response System (GISRS); Global Polio Laboratory Network; the Global Outbreak Alert and Response Network (GOARN); and the Global Antimicrobial Use and Resistance Surveillance System (GLASS).
“But there are quite a few others out there too. The animal foot and mouth networks, the arboviruses.
”There is huge diversity and a very fragmented system of disease surveillance out there. It is due to a mixture of reasons. There are scientific reasons – no pathogen is created equal, ….dengue has a kind of reverse seasonality when compared to influenza. And there are differing public health objectives that are also fragmented.”
Generally, the older networks like the influenza (GISRS) and polio networks are able to share data and samples most efficiently because they represent public-private collaborations built up over decades, including personal relationships of trust between the partners involved.
“You don’t have so much of the discussions of North versus South, or commercial versus non-commercial, private versus public,” said Bart. “The global influenza system has really managed to rise above these arguably false dichotomies, and it’s the same in the Global Polio Network. Without trust, we would not be as close as we are to global polio eradication.
“With GoARN, you don’t have the all-year-round collaboration between different members of the network. And that creates difficulties because people don’t know each other as well as they would in an all year round surveillance system.”
Within these highly fragmented, but also interconnected networks, sharing of samples and data on pathogens may be limited within the network itself; exchanged routinely within the network, but not outside of it; or sharing may also be more open to outside institutions.
Only in the GISRS, is sharing is formalized with a “standard material transfer agreement.” Bart observed. In other networks, it’s much more informal and “sometimes only on a case by case basis.”
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