Sharing Genomic Data in Exchange for ‘Benefits’ and One Health: Emerging Hot Spots in Pandemic Accord 
genomics inb
Precious Matsuso, moderator for the July 2022 INB talks on a pandemic treaty, convention or other legal instrument.

The question of whether pathogens’ genomic sequences should be shared freely – or in exchange for a clear benefit – as well as the role ‘One Health’ should play in any new Pandemic Convention or legal accord were key points of emerging dispute among member states on Day 2 of the Intergovernmental Board Meeting (INB). 

Those debates, aired publicly in the first two days of the week-long meeting that aims to draw the broad outlines of a pandemic treaty, offered a good taste of the rough road ahead. 

In sharp contrast, Wednesday and Thursday are set to be closed-door sessions. There, in private, member states will make two critical decisions. 

They will decide on the legal position of the new accord under the WHO Constitution – which in turn will reflect how legally binding the agreement really will be; 

They will also decide if the negotiations should be thrown open to an as yet undefined list of more civil society and private sector groups – beyond the nearly 300 entities already recognized as “stakeholders” in the talks.  

Genomics – a hot spot

Colin McIff, Deputy Director of Global Affairs in the Office of Health and Human Services, US delegate

On the genomics issue, the United States delegate Colin McIff fired off the opening shots in what is sure to be a prolonged and painful debate, saying that countries’ agreement to grant access to pathogen sequences, should not be addressed in a “transactional way” – hinged to promises of sharing benefits from the medicines or vaccines that are later produced. 

The US concern has been echoed for months by pharmaceutical companies as well – which were able to rapidly map out vaccines for the SARS-CoV2 virus because the virus sequence was shared early on. 

However, that free tap of information could be turned off if the December meeting of the parties to the Convention on Biodiversity opts to includes “genetic information” into its existing  Nagoya Protocol on Access to Genetic Resources – initially developed to protect countries IP on indigenous plant and animal species from uncontrolled development – but now being applied to pathogens as well. 

“The sharing of benefits can be seen as a means to achieving equitable pandemic preparedness and response,” said McIff. “But our concern is that … if we continue to link access and benefits in a transactional way, that’s not really conducive to meeting public health needs, and improving pandemic preparedness.” 

The US position was quickly countered by a wide range of developing countries, including Indonesia, Malaysia and the African group of 47 countries.  

‘Fair, equitable and timely access and benefit sharing’ 

“Fair, equitable and timely access and benefit sharing is an important provision as we have clearly seen the benefits of genetic sequence sharing, like the Nipah virus, that provided a valuable contribution to the development of mRNA technology,” said Malaysia’s delegate to the talks. “Hence, we propose to strengthen this concept [in the text]….  which reads ‘measures to ensure access to pathogens and genomic sequence information as well as fair and equitable sharing of benefits arising from the utilization of pathogens and genomic sequence information to one or more standardized real time platforms available to all parties.’’

Namibia, meanwhile stressed that as long as the benefit sharing mechanism is defined up front and automatically, it would not hinder rapid pathogen sharing, saying:

“The instrument should be balanced, inclusive, global, effective and legally binding, respecting the sovereign rights of states to control access to their genetic resources and ensuring fair and equitable sharing of benefits arising from the utilization of genetic resources. 

“We also note that providing timely access to pathogens is absolutely fundamental to PPR [pandemic preparedness and response] and we therefore consider that regular upfront benefit sharing by the pharmaceutical industry from their current ongoing uses of pathogens is required to ensure that timely access to new and emerging pathogens is provided. 

“In this regard, we stress that providing access to pathogens by showing genetic sequence data must be treated as equivalent to access provided through sharing biological samples, and must therefore trigger the same benefit sharing obligations on strengthening and sustaining health systems resilience and capacities.” 

‘One Health’ not mature enough – environmental health beyond WHO’s competence 

Researcher explores evidence around the wildlife-trade- pandemic nexus

Strikingly, Namibia and other African and developing country member states expressed reluctance to incorporating so-called “One Health” concepts deeply into the new legal instrument, saying that the term has not been well defined, and 

“Regarding the emphasis some member states and regional groups have placed on the One Health approach Namibia is of the view that that this concept is not yet mature enough for it to have a central role in the instrument,  seeing as we have about 22 months until May 2024. There may indeed be further discussions and the relevance spaces in that time on One Health that may bring us to position to support its inclusion with the primacy that is being proposed.

“The issue for us is that the concept does not enjoy international consensus and has not been discussed sufficiently by member states for them to have ownership on it. As it stands, we have very grave concerns. 

“”We also think there is an overemphasis on AMR [antimicrobial resistance] and not enough consideration on food safety, for instance,” the Namibian delegate continued.. 

“Furthermore, we see animal, plant and environmental health as being beyond the competence of the WHO and that they should be thoroughly considered in the appropriate international organizations by their member states before being brought together at a global level and included as a central pillar of the instrument we are discussing.”

Canada, EU and others say One Health Should be Central

one health
EU delegate at INB meeting.

Those viewpoints, also echoed by Kenya, Botswana and South Africa, contrasted sharply with statements by Canada, the European Union and other developed countries about the centrality One Health approaches should play in the new accord – to prevent the spillover of  zoonotic diseases into human communities and food chains. 

The United States took a middle-of-road view, with Colin McIff, Deputy Director of Global Affairs in the Office of Health and Human Services, saying,  “On One Health. We recognize the critical role that One Health plays in preventing future pandemics. We would appreciate further member state discussions with input from non governmental stakeholders to understand the specific commitments being sought from member states that will make a meaningful difference in advancing pandemic prepared prevention preparedness and response. 

“For example, we imagine that additional discussions are needed on how to improve interoperability of [human and environmentally-based] bio-surveillance and reporting systems, the role of non governmental stakeholders; measures that would help prevent and detect pandemics and reduce opportunities for zoonotic spillover, and how the WHO instrument will relate to other key actors such as FAO OIE [World Organization for Animal Health) and UNEP.”

Civil society calls for pandemic treaty that won’t ‘waste their time’

Medicus Mundi International

Civil society groups attending the public INB session, meanwhile, reiterated the need for a substantive, meaningful pandemic treaty –  that strengthens transparency, funding and equity for marginalized groups in the global health landscape. 

“The relevance of the substantive elements of the pandemic treaty will finally determine if all of us currently take part of a historic process, or if you just waste our time with the compilation of an uninspirational and encyclopedic document,” said the delegate from advocacy group Medicus Mundi International.

“[A document] that will not change any realities, that will keep people sick, keep health systems vulnerable, and keep national health authorities depending on national charity, instead of having the needs for caring for the health and wellbeing of their people.”

Transparency for R&D and clinical trial costs 

Knowledge Ecology International (KEI) called for an item on transparency to be included, specifically for R&D and clinical trial costs, as well as information on the research itself and the outcomes.

The medicines access advocacy group also proposed measures to incentivize persons or entities to openly share access to biological data, resources, and know-how as a public good, and also noted a need to fund such research in the first place.

“[We would also like to see] measures for norms for the funding of R&D by national governments that provide flexibility in terms of methods, management and control, funding consistent with transparency and best incentives to collaborate,” said KEI’s director, Jamie Love. 

Thorny question of private sector participation 

Another issue of concern is the role the private sector may play in negotiations over, and governance of, the pandemic agreement, Love added.  

“The United States made this mention of including other actors, including the private sector in the conversation. And I think from our point of view, we would have concerns if you had drug companies, vaccine manufacturers, and people that manufacture diagnostic tests involved in the governance in different ways. Because of the conflicts of interest they present. And so I wanted to flag that.” 

He also protested against the outsized influence wielded by the Gates Foundation in debates over technology sharing and intellectual property rights – which are also emerging as thorny points in the INB deliberations.  

“If you look at the Global Fund, or UNITAID, some committees created by the World Bank, Gavi and CEPI, you see, the Gates Foundation playing the central role in all these institutions as the largest non-actor state and sometimes the largest discretionary funder, period, to the WHO.    

“And yet, they play a controversial role, particularly on the issues of sharing of technology and technology transfer and intellectual property rights. And so I just don’t know if it’s helpful to have one institution run by you know, one guy or you know, his family or whatever, you know, having an excessive amount of influence on these decisions. 

“We’re more comfortable with, with something that did not give, for example, the Gates Foundation or its surrogates a role in the governance.” 

IFPMA offers to set aside fixed amounts of pandemic products in ‘real-time’ for poor countries  

James Anderson, IFMPA Executive Director for Global Health

As one solution to ongoing controversies over IP rights and, related to that, equitable access to medicines and vaccines,  International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) pledged to set aside an “allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable”.

The IFPMA’s  ‘Berlin Declaration’ unveiled at Tuesday’s INB meeting, aims to overcome the huge inequities seen during the COVID crisis by rich countries’ pre-purchase and stockpiling of vaccines and health products – before poorer countries could get in line.   

See related story here:

Big Pharma Offers to Reserve Pandemic Products for Poorer Countries in Future – Albeit With Prerequisites

The joint declaration by major pharma innovators – Biopharmaceutical Industry Vision for Equitable Access in Pandemics – 

However, this commitment will only succeed “if other stakeholders also play their parts,” said IFPMA’s James Anderson, executive director for global health. The declaration calls upon the G7 and G20 to contribute more to strengthening health systems in low- and middle-income countries so they can absorb new health products.  

“Without robust plans to deliver pandemic vaccines, treatments, or diagnostics, and ongoing care to populations in all countries,” said Anderson, “attempts to improve equity will not succeed.” 

Equity must be prioritized 

Women in Global Health delegate Shubha Nagesh

Other groups, such as Women in Global Health and Sightsavers highlighted the need for equity in the treaty for marginalized groups.

“Too often women from the global south are marginalized in health leadership,” Shubha Nagesh, the delegate from Women in Global Health. “Women have made an exceptional contribution during COVID-19, but are often clustered into lower or unpaid roles with reduced status.”

Sightsavers strongly supported the right to health and human rights, with an emphasis on equity, to be embedded in the treaty, particularly for individuals and groups disproportionately at risk, including persons with disabilities and those in vulnerable situations. 

“To achieve equity, instruments should really affirm human rights obligations to those that are at higher risks from pandemics,” said Sightsavers’ delegate.

Image Credits: Wildlife Conservation Society, Wildlife Conservation Society .

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