Just 66 days after the SARS-CoV2 genetic sequence was shared by a Chinese scientist online, the first COVID-19 vaccines went into production – in record time for R&D that yielded the first approved vaccines less than a year later. 

But there are looming concerns that the relatively open models of data and pathogen sharing that oiled the wheels of R&D during the COVID era could turn more slowly in future pandemics if countries, scientists or research institutions decide to hold back know-how about critical genome sequences and samples in order to reap financial benefits or other concessions.

Already, the Nagoya Protocol of the Convention on Biodiversity has fostered a vast patchwork of laws and regulations, originally intended to protect countries’ indigenous biodiversity, but also extending to regulations on pathogen sharing, which vary from country to country. 

A new pandemic accord currently being negotiated could represent an opportunity to better clarify the muddied waters.  But there is a risk that accord rules could also make sharing even more difficult, said Bart Van Vooren, an European Union jurist and life sciences expert. 

Van Vooren spoke at a webinar sponsored by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) following the recent publication of an IFPMA-commissioned report on the ins and outs of pathogen sharing, by the UK-based law firm Covington, where Van Vooren is a partner.  

A growing flashpoint in negotiations

The four-part report provides 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, is to inform the negotiations of the WHO pandemic accord.

Linking access to pathogen data to the sharing of benefits from drugs and vaccines developed to combat these pathogens is a growing flashpoint in the pandemic accord negotiations. 

Feelings run particularly high in developing countries that were unable to get early access to COVID-19 tests, treatments and vaccines – largely because these were hoarded by rich countries.  To make matters worse, countries like South Africa were punished by travel sanctions after reporting on the emergence of the SARS-CoV2 Omicron variant, including the publication of its genomic sequence, as the variant swept across southern Africa in late 2021, and the world in early 2022. 

At the same time, the pharmaceutical industry and many researchers have argued that rapid and transparent sharing of such data is critical to mount an effective public health response.

“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,” observed Van Vooren. 

“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”, said Van Vooren, who is regarded as an international expert on the protocol.

Nagoya Protocol: 92 countries have laws; 12 have a public health emergency exception  

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.  

However, the system has led to a global patchwork of diverse rules and regulations, and 92 countries have enacted their own distinct legislation.  Only 12 of the 92 countries that have put regulations in place make provision for public health emergencies.

“There are nearly 100 ABS laws in the world,” said Van Vooren. “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,” said Van Vooren.

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, he said. 

“They want to avoid ABS jurisdictions, with a preference for ‘unburdened’ samples,” he said. “This often means waiting for the ‘returning traveller’”, an infected person will ‘import’ the pathogen from which samples and data can be extracted. 

“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.”

Networks for sharing pathogen samples are ‘like a bowl of spaghetti’ 

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.” 

As examples, he 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 Van Vooren. “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.” obsrved Van Vooren.  In other networks, it’s much more informal and “sometimes only on a case by case basis.” 

Multiple biobanks and networks 

And that’s not the end of it. Extensive sharing of biological data and samples also takes place via a parallel universe of global and regional databases and biobanks. 

In terms of databases, leaders include, GSAID, global influenza database [also being used for SARS-CoV2], as well as GenBank, the US National Institutes of Health Genetic Sequence database.

Then there are the biobanks, which are large repositories of physical pathogen samples. 

“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,” Van Vooren said. 

Decentralization is an asset and a limitation

While the systems in place may sound chaotic, they offer some advantages: decentralization can enable more rapid response to certain emergencies. And they offer diverse specializations and response capacities.  

“Physically decentralized structures are uniquely prepared in these early stages. They are quick to pick up a pathogen and to enable quick sharing with your R&D community. 

“What many interviewees told us is that especially these networks like European BioBank,BEI, or Institut Pasteur, that has a presence in Paris but also in Dakar and other locations, these kinds of network biobanks … that offer access to physical materials, are essential in order to respond to the early stage of an outbreak.

“I think it’s really important to keep in mind when all the participants look at what is being negotiated under the pandemic accord and the International Health Regulations. It is not really a centralized network, and as far as we are told, it also cannot be.”

Benefitting the host country is ‘insane’  

Prior to the COVID pandemic, the intricacies of pathogen and genome data sharing were a “niche area” of interest, observed Thomas Cueni, the IFPMA’s Director-General, who also spoke at the forum about the broader policy implications of the current systems.  

“When I started to talk about the Nagoya Protocol, no one understood. The pandemic changed that. It showed how fundamental these things are. 

The fact that only 66 days after the SARS CoV2 genome sequence was first published by a Chinese scientist on an open-access platform in January 2020 clinical trials began, underlined to the broader public the significance of such data sharing.  

“And yet the sharing of data and pathogens remains voluntary, which really begs the question of how something so vital to our global health security, how can we leave that to chance?” asked Cueni. 

“During the COVID pandemic, nobody really cared about Nagoya’s ABS provisions because basically everybody agreed that public health should predominate. My concern is that this might change… countries may be tempted not to facilitate this interactive sharing of pathogens that is so much needed to respond to epidemics. 

“Conservatively COVID-19 cost us $15 trillion in economic losses, apart from the millions of lives lost. And yet based on Nagoya, you would give a benefit to the country from which SARS CoV 2 emanated, which is pretty absurd. Actually one could even say that it’s a little bit insane.

“And at the end of the day, pathogens in today’s world are travelling fast, which means that if you try to create obstacles in terms of pathogen sharing it’s just a question of days or weeks before they show up in genetic sequencing in the UK or the US, or another country, which hopefully does have a public health exception (to the Nagoya Protocol).”

COVID-19 was the ‘exception’, not the rule

Furthermore, Cueni adds, while the COVID pandemic drew multiple pharma actors into the fray of rapid-fire R&D, this is “the exception rather than the rule” when emerging diseases are concerned. 

In most other global public health emergencies recognized by the WHO over the past 15 years, it has been difficult to identify pharma partners to develop vaccines and treatments, he contended.  Not incidentally, most of those viruses also leapt from animals to humans in low- and middle-income countries where the risks of infection by communities living around degraded forests, or engaging in unsafe contact with wildlife or domestic animal production, are much higher.

“When I look at seven cases where WHO so far has declared a Public Health Emergency of International Concern – whether it was swine flu, Ebola, Zika or more recently, monkeypox, COVID was the exception rather than the rule. In most instances, basically you had to search for more than a couple of companies willing to run the risk; willing to invest. And we really need to be careful not to create obstacles, which would delay and maybe hinder our ability to have rapid countermeasures… in other important outbreaks, such as Ebola.”   

Sharing benefits – with the world

At the same time, the IFPMA director-general admits that for “common sense” to prevail in global rules around pathogen data sharing, the benefits of tests, treatments and vaccines thus developed will also have to be shared more equitably. 

But that means sharing benefits with the world, not only with the country from which the pathogen first emerged. 

“I do hope that common sense prevails,” he said with reference to language in the current “zero draft” of the treaty, which he argues risks creating more obstacles to sharing. “But I do believe that, in order for that to happen, we from the private and  the public sector need to come up with a response. 

“How can we create trust that, in the next pandemic, we will have a more equitable rollout of these vaccines, tests and treatments? We need to address that,” he admits.

The pharma industry’s recent Berlin Declaration takes a big step in the right direction, he argues:  “Industry has expressed our commitment to early access, to learn from what went wrong during the COVID pandemic, namely, companies willing to reserve an allocation of real-time production of vaccines, treatments and diagnostics for priority population in lower-income countries and to take measures to make them available and affordable.

“But this industry commitment will not really work unless countries with manufacturing capacity, big countries such as the US or India are also willing to sign up.

“We actually wholeheartedly say that more needs to be done in the future to address the shortcomings of COVID response. Each partner in the global health space …. has a role to play in the overall social contract to address future pandemic preparedness and response and ensure equity is at the forefront.”

Image Credits: NIAID-RML (https://www.niaid.nih.gov/, Convginton , Covington, Covington .