EVAg

Discussing with Amber Scholz on Access and Benefit Sharing.

Towards the end of her degree in Biology and not really seeing herself based in the lab ... Amber Scholz quickly discovered that what she was truly passionate about was science policy questions. "It all comes down to identifying the right piece of information that is instrumental to a certain person in a certain position, in order for them to answer a specific question". Lucky enough to have good mentors, Amber chose to pursue further studies in Science Policy. Currently, Amber Scholz is Head of the Science Policy and Internationalisation department at the Leibniz Institute DSMZ (Braunschweig, Germany), where she leads a team interested in addressing national and international policymaking questions related to Access and Benefit Sharing (also known as ABS). An important part of the team's work is on the implications of ABS on daily scientific practice (1-3). Recent work from her team involves an Open letter to the WHO, in response to the Zero draft CA+, with recommendations on critical aspects of sharing pathogens and digital sequence information that need to been taken into consideration when thinking of pandemic prevention, preparedness and response.

While Access and Benefit Sharing as a term may sound vague, the implications of ABS are palpable. ABS refers to the right of a Country to allow access to their genetic resources and the benefits this Country will receive from the use of those resources by a user. Needless to point out the many terms in this phrase that, despite their definition in the official documentation, are still open to interpretation. What do we mean by genetic resources? What is access? Who can this access be granted by and who can obtain benefits from it? What kinds of benefits? Who are the stakeholders concerned by all this?

The concepts and the questions

How has Access and Benefit Sharing (ABS) of genetic resources become a hot topic of negotiation at a global level? The context goes back through the centuries to past injustice regarding the misuse of genetic resources across countries. What are these genetic resources..? It could be a plant of cultural significance for the local community that also happens to have medicinal properties. Or, a genetic resource could also be a pathogen. A long history of colonialism established unsustainable "all you can eat" practices of natural wealth exploitation in colonised countries (4). Not surprisingly, today low and middle income countries (LMIC) are aware of their wealth in genetic resources and come back with leverage; for them to preserve their genetic resources through sustainable and environmentally-friendly policies, they need something in return: money, capacity building etc. This sounds like a fair request and, in fact, it is; ABS aims to be the modern answer to responsible and sustainable use of genetic resources.

"Change at the planetary level means finding areas of compromise" says Amber, and environmentally conscious policies is definitely a field where countries need intrinsic motivation in order to integrate and apply them.

The first mention of ABS as a basic ethical request, started in 1992 during the signing of the Convention of Biological Diversity at the Rio Earth Summit. For allowing scientists to have access to native genetic material, countries established that they would need, in return, to have a share in the benefits resulting from the use of these resources (4). What's more, genetic resources are nowadays accessible in the form of digital sequence information (DSI) (5), adding another layer of complexity in the regulation of ABS. The Nagoya Protocol in 2010, established bilateral agreements between countries defining the ABS conditions of use of their genetic resources. What does the implementation of such stipulations translate into for scientists? Not only does it require an additional layer of bureaucracy for applying and obtaining permits, often through unorganized processes, but it is also unclear how and what benefit-sharing measures would be suitable. This is especially true for academic research that does not always include a "conservation and sustainable use" component. Additionally, during public health emergencies, ABS processes can delay the speed of material exchange and have serious implications on the health sector (6).

It translates into an additional layer of bureaucracy due to having to deal with an environmental ministry of a given country that is looking for economic benefits, while having authority over many organisms that can cause a lot of public health damage. It sounds like a nightmare especially during an outbreak, when response time is at the essence.

"It s a case where the policy vision makes sense but its implementation does not necessarily provide neither subject-specific rules nor think about how science really functions" Amber points out.

ABS for pandemic prevention, preparedness and response

The SARS-CoV-2 pandemic perfectly illustrates the impact that bilateral ABS agreements could have on the timely response to a crisis. Using the example of the Covid-19 material distributed by the European Virus Archive, a recent article, coordinated by Amber's team and signed by the EVA consortium, aims to portray how ABS does not, or cannot, stringently apply during pandemic outbreaks. In the case of SARS-CoV-2, the material shared came from 12 countries that do not have access regulations in place, yet benefited many different countries (including LMIC). The majority of resources where distributed free of charge to the public sector worldwide. Half of the resources distributed outside of Europe were to LMICs (1). In other words, the SARS-CoV-2 benefit sharing analysis by EVA indicates that pathogen genetic resource sharing does not necessarily or always fit the bilateral access and benefit sharing model.

Post Covid-19, the idea of facilitating access to pathogens has become increasingly clearer and more pressing. The concept behind the Pandemic prevention, preparedness and response accord, including Pathogen Access and Benefit Sharing system (PABS), is to allow and enable the distribution of pathogens for health purposes, when speed is at the essence for developing countermeasures against a given pathogen. In an ideal world, this would mean that pathogens in the human-animal-environmental interface, and their related sequence data, would fall under the scope of the new WHO treaty and not under the Nagoya Protocol. Starting to think of ABS for digital datasets comes with additional complications. Datasets are spread across a range of databases hosted in different countries, meaning that sharing these datasets would fall under the ABS agreements set by the respective countries. Can data be shared through a single database? Or certain databases be exempt from the Nagoya Protocol? And if so, on what criteria would this selection be made?

 

What s DSI got to do ... got to do with it?

(Yes, I am a Tina Turner fan.) Digital sequence information (DSI) was first brought into the discussion during the UN Biodiversity Conference (COP13) in Cancun, 2016, and followed up in COP14 in Egypt, 2018. Digital sequence information refers, among others, to genomic sequences of microorganisms. Open access to digital data which, by the way, is part of the FAIR (Findable Accessible Interoperable and Reusable) principle, is required in numerous aspects of scientific research (such as grant applications, peer reviewed publications) and also by the Global Biodiversity Framework (7), yet it seems to be against the ABS concept and stipulations! Does this mean new rules need to be made?! Can a nucleotide sequence belong to a country? Aside from the regulatory logistics, what is not being said here is that scientific data is a continuum rather than a quantum model. In other words, for scientists and research it is nearly impossible, to classify data as "useful" or not, "pathogen-related" or not, "restricted-access" or not. Data that may appear unnecessary in a study may become useful as new evidence surfaces, during the outbreak of a pathogen. Vice versa: in order for scientists to trace the evolution and origins of a pathogen and of its variants, let alone develop therapeutics and vaccines against it, they need to access genomic sequence data across different species, regardless of whether they refer to organisms that are classed as potential pathogens or not.

Keeping in mind how the Convention on Biological Diversity functions (only countries can talk and write text, countries can be informed by anyone, the EU speaks for member states, anyone can attend as an observer), it is crucial that scientists are part of the discussion as stakeholders. However, "Hands off DSI!" is not good enough. It is only through evidence-based arguments that we can have an impact. While, it is an undeniable fact that genetic sequence data has led, among others, to vaccine development, evidently producing benefits, bilateral agreements stipulated by the Nagoya Protocol are not going to work when millions of sequences are being used for comparison. Certain conditions (open access for instance) need to be maintained and standardised, in order to implement ABS without disrupting the scientific ecosystem.

The Kunming-Montreal Global Biodiversity Framework (GBF) (Dec 2022), produced during the COP15, sets out, for the first time ever in biodiversity conservation, quantitative goals for monitoring and protecting biological diversity. Money, resource mobilisation, capacity building and a new agreement on digital sequence information need to be offered, in exchange for countries to apply the new strategic plan for biodiversity conservation. As an indicator of the political pressure involved, DSI was as a make-or-break point for reaching political consensus (1), in a meeting where decisions can only be made as a "package deal". The GBF of December 2022 concluded that countries agree to establish a multilateral agreement mechanism for access and benefit sharing of DSI.

 

The Zero draft and the Open Letter

Having said all that, the WHO zero draft aims to define conditions that should apply in the Pandemic, Prevention, Preparedness and Response accord in order to adapt to the exceptional needs that arise in an outbreak situation. While the WHO acknowledges that bilateral agreements are not functional during virus emergence, some crucial points remain undefined or are still open to interpretation. According to the current version of the zero draft, the exchange of physical material related to pathogens of "pandemic potential" will be exempt from the Nagoya Protocol. In addition, only WHO-recognised labs will be allowed to exchange such material, raising the question of how will such laboratories be chosen. (And what would this mean for the EVA partner laboratories for example?). While valid agreements for physical genetic material will be handled under the Pathogen Access and Benefit Sharing (PABS) regulations, such agreements cannot apply as easily to DSI. Finally, having to sign documentation, such as a standardised material transfer agreement, for a dataset sounds like hell. Data grows so fast, changes so fast, an SMTA can simply not apply.

The Open letter,> on behalf of EVA, was submitted to the Intergovernmental Negotiating Body of the WHO CA+, and provides recommendations for the broadening of definitions regarding pathogens and the creation of ABS rules that are appropriate for DSI. Furthermore, it highlights how established infrastructures, such as EVA, need to be preserved and promoted as instruments for preparedness and response.

No one is right, everyone is right.

Countries have the right to regulate access to their genetic resources and benefit from their use. LMICs have been, historically, supressed by colonialism so that their reluctance to trust a western regulatory document, such as the Nagoya Protocol, to defend their rights is not surprising. This is further complicated by the western divide between the concepts of "nature" and "culture", that is completely foreign to many indigenous communities for which genetic resources are tightly knit to tradition, culture and local know-how (4). From their perspective, the battle between bilateral versus multilateral agreements is understandable. From the point of view of the scientific community, the functional aspects of scientific research are already complex enough to bare additional bureaucratic burdens. Having a say into the discussion boils down to consistency. Scientists need to be aware and keep showing-up, in order to put forward the conditions necessary for scientific and scientific research "well-being". The DSI scientific network provides case studies and other evidence-based material on the topic of ABS around digital sequence information. Finally, from the Public Health point of view, the capacity to ensure timely response in the case of an outbreak is of outmost importance. Given the above parameters, multilateralism is to be reconsidered under certain conditions, as well as the need to decouple ABS into OA (open access) and BS (benefit sharing) (3). EVA is a model of multilateral sharing of material that brings non-monetary benefit sharing (1). Such established research infrastructures, with experience in sharing material, should be consulted in discussions around policy-making.

Text by Semeli Platsaki, PhD

 

References

1.      Scarlett Sett, Carolina dos Santos Ribeiro, Christine Prat, George Haringhuizen, European Virus Archive principal investigators, Amber Hartman Scholz. (2022) Access and benefit-sharing by the European Virus Archive in response to COVID-19. Lancet Microbe.

 

2.      Hartman Scholz A., Lange M., Habekost P., Oldham P., Cancio I., Cochrane G., Freitag J. (2021) Myth-busting the provider-user relationship for digital sequence information. GigaScience. doi.org/10.1093/gigascience/giab085

 

3.      Hartman Scholz, Freitag J., Lyal C. H. C., Sara R., Cepeda M. L., Cancio I., Sett S., Hufton A. L., Abebaw Y, Bansal K., Benbouza H., Iddi Boga H., Brisse S., Bruford M. W., Clissold H., Cochrane G., Coddington J. A., Deletoille A-C., Garcia-Cardona F., Hamer M., Hurtado-Ortiz R., Miano D. W., Nicholson D., Oliveira G., Ospina Bravo C., Rohden F., Seberg O., Segelbacher G., Shouche Y., Sierra A., Karsch-Mizrachi I., da Silva J., Hautea D. M., da Silva M., Suzuki M., Tesfaye K., Keambou Tiambo C., Tolley K. A., Varshney R., Zambrano M. M., Overmann J. (2022) Multilateral benefit-sharing from digital sequence information will support both science and biodiversity conservation. Nature Communications, 13:1086 doi.org/10.1038/s41467-022-28594-0

 

4.      Fredriksson M. (2021) Dilemmas of protection: decolonising the regulation of genetic resources as cultural heritage, International Journal of Heritage Studies, 27:7, 720-733, DOI: 10.1080/13527258.2020.1852295

 

5.      Heinrich M., Scotti F., Andrade-Cetto A., Berger-Gonzalez M., Echeverra J., Friso F., Garcia-Cardona F., Hesketh A., Hitziger M., Maake C., Politi M., Spadafora C. and Spadafora R. (2020) Access and Benefit Sharing Under the Nagoya Protocol-Quo Vadis? Six Latin American Case Studies Assessing Opportunities and Risk. Front. Pharmacol., 11:765. doi: 10.3389/fphar.2020.00765

 

6.      dos S Ribeiro C., van Roode M., Farag E., Nour M., Moustafa A., Ahmed M., Haringhuizen G., Koopmans M., van de Burgwal L. (2022) A framework for measuring timeliness in the outbreak response path: lessons learned from the Middle East respiratory syndrome (MERS) epidemic, September 2012 to January 2019. Euro Surveill. 27(48): 2101064. doi.org/10.2807/1560-7917.ES.2022.27.48.2101064

 

7.      IPBES (2019) Global assessment report on biodiversity and ecosystem services of the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services. Zenodo https://doi.org/10.5281/zenodo.3831673.