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Playing poker with pathogens

We’re entering the third year of the COVID-19 pandemic, while we deal with a virus that evolves and tries to outmaneuver us. Scientists continue to monitor the spread of the virus and whether it is acquiring new characteristics that have the potential to evade the vaccines, treatments and diagnostics that have been developed to fight against it.

For the next pandemic, we are aiming to speed up the delivery of vaccines to 100 days. 

Sharing data on pathogens remains voluntary. Most scientists operate in a spirit of global collaboration, so we’ve been lucky. In January 2020, Chinese scientists posted the new coronavirus’ original genetic makeup on the GISAID platform,[1] enabling researchers at universities and drug companies around the world to hit the ground running. Speed was of the essence: phase one clinical trials for vaccines began just 66 days after the SARS-CoV-2 sequence was known. Thanks to regulatory cooperation, the approval of a vaccine came 326 days after the sequence was shared. Within the first year of COVID-19 vaccination, almost 20 million lives were saved globally.[2] This is unprecedented. For the next pandemic, we are aiming to speed up the delivery of vaccines to 100 days. 

However, while the practice of sharing potentially dangerous pathogens to avert pandemics is well established, politics and bureaucratic structures risk undoing this.

Thomas Cueni | via IFPMA

The basis for governments to undermine the rapid pathogen sharing so critical in the response to COVID-19 is the Nagoya Protocol, a supplement to the 1993 Convention on Biological Diversity[3], and the subsequent access- and benefit-sharing (ABS) rules implemented into national laws. These agreements give countries the authority to assert property rights claims over their ‘genetic resources’ — products derived from flora and fauna — and to share in benefits derived from them.

However, the worthy goal of the Nagoya Protocol to protect the biodiversity of our flora and fauna should have never been allowed to be extended to pathogens. Obviously, pathogens are not the sort of genetic resource that the world ought to conserve in the name of biodiversity. By leaving it to countries to include pathogens in their definition of ‘genetic resources’ the Nagoya Protocol creates a perverse incentive that could lead countries to stack the deck in their favor — or even use them as a bargaining chip in negotiations.[4]

There are documented cases where access to pathogens was either blocked or delayed.

A new report, carried out independently by Covington, with the support of IFPMA, reveals eight examples across seasonal influenza, SARS-CoV-2, zika, mpox, Japanese encephalitis, foot and mouth disease, ebola, and African swine fever.

The report found that delays or refusals for pathogen-sharing have led to suboptimal vaccine composition, diagnostics that were not tailored or tested against original or new variants of pathogens or skewed and nonrepresentative epidemiology in genomic surveillance.

In my view, reasons behind the failure to share data on pathogens vary widely, from lack of capacity to national pride to efforts to gain a geopolitical upper hand. Over the past two decades, some countries have even claimed a national right to withhold samples or data on pathogens found in their territory.[5]

The Nagoya Protocol creates a quid pro quo that works against our collective ability to stop pandemics in their tracks.

In practice, such perverse interpretation of the Nagoya Protocol means that nearly 100 countries require a permit each time a researcher wishes to access that country’s pathogens, even just for R&D. This leads to red tape, but also concern among researchers, who may decide to steer clear of working with certain pathogens for fear of the full force of the law falling on their shoulders. Only 12 countries that are party to the Nagoya Protocol have a public health emergency clause. But, even in the case of an outbreak, the majority of public health exceptions still require some form of negotiation, however expedited it may be.

The Nagoya Protocol creates a quid pro quo that works against our collective ability to stop pandemics in their tracks. It creates a detrimental, transactional approach. The ABS provision of the protocol makes sense for protecting the biodiversity of our fauna and flora, in so far as biodiversity is seen as a global public good. But the public good of pathogens is not the protection of their diversity but the public health benefit of the countermeasures developed thanks to the rapid sharing of pathogens or their genetic sequences. Submitting them to ABS rules of the Nagoya Protocol is fundamentally flawed because it attaches value to pathogens, not global health. As a result, countries that exercise sovereignty over pathogens are incentivized against free and rapid sharing for global public health in order to obtain nonmonetary and monetary ‘benefits’.

The inequitable rollout of COVID-19 vaccines during the current pandemic is clearly something which needs to be corrected in a future pandemic. However, ABS laws, which would potentially allow a country in which a pathogen is detected — such as SARS-CoV-2, causing the death of millions of people and an estimated $13 trillion economic loss — to claim royalties, for example from companies developing vaccines or treatments which helped to contain and put an end to the pandemic, seems quite at odds with the spirit of the Convention on Biodiversity.

Scientists need swift, certain, and unrestricted access to pathogens and their genetic information to keep humanity safe.

In short, a transactional approach to ABS laws for pathogens leads to a loss of trust between public and private stakeholders in global disease response, a reduction in overall pathogen sample sharing, a decrease in associated innovation and a false sense of security for developing countries that base their pandemic response plans on the expectation that they will receive benefits in the form of vaccines and antivirals[6].

This ‘politicization’ of access to pathogen samples and their sequence information puts a strain on global health security and the ability to quickly develop the vaccines, treatments and diagnostics needed.

It’s time to put the cards on the table. Scientists need swift, certain, and unrestricted access to pathogens and their genetic information to keep humanity safe. Designing any new framework meant to better prepare us for future pandemics won’t succeed unless all countries commit to sharing data on emerging pathogens straight away. A new model to address equity in the context of pathogen sharing is needed to ‘unlock’ them from the transactional grip of the Nagoya Protocol.

[1] https://www.statnews.com/2020/02/05/novel-coronavirus-exposes-nagoya-protocol-flaw/

[2] https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00320-6/fulltext

[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308583/

[4] https://www.statnews.com/2021/11/28/nagoya-protocol-shouldnt-shield-not-sharing-pathogens-genetic-sequences/

[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7226898/

[6] S0020589321000294jra 825..858 (cambridge.org)

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