Is There a Third Way? Lessons for PABS from Parallel Treaty Contexts [Guest Essay]
Newsletter Edition #140 [Treaty Talks]
Hi,
Complex policy challenges such as designing a new Pathogen Access Benefit Sharing system for global health, require focus to square the big principles with the technical details that would make such a mechanism workable.
Yet, it might serve to take a step back and also look at how other policy forums that have wrestled with similar questions.
I am very pleased to present a timely and comprehensive guest essay on the lessons for PABS from the recent negotiations on the Biodiversity Beyond National Jurisdiction (BBNJ) Agreement.
Siva Thambisetty, a scholar from the London School of Economics has worked with several delegations in shaping key features of the BBNJ agreement. In today’s edition, she has painstakingly drawn out suggestions, and cautions against pitfalls that could play out in the PABS talks - based on her first hand experience at BBNJ.
Many weeks in the making, we hope you find this analysis useful. One can also download this paper (at nearly 5,000 words!) as a pdf. Scroll below.
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I. GUEST ESSAY
Is There a Third Way?
Lessons for PABS from Parallel Treaty Contexts
By Siva Thambisetty
Thambisetty is an Associate Professor of Law at the LSE, and is the Lead for the Ocean Biodiversity Collective funded by the LSE Knowledge Exchange and Impact Initiative. She can be contacted at s.thambisetty@lse.ac.uk.
The PABS Annex negotiations suffer from the ills of the access and benefit sharing (ABS) framing in international law, which functions like a sponge soaking up many different kinds of unresolved moral and policy goals.[1]Empirical evidence indicates that in practice, benefit-sharing rarely achieves its stated objectives.[2] A compensatory model for access to genetic resources would be akin to selling genetic resources for value, but genetic resources have multiple forms of present and future value4 making contractual enforcement of such a model almost impossible. A distributional justice model requires political will to prevent ‘unjust enrichment’ and redistribute the gains evenly. Even the most enlightened developed state will hesitate to demand this outcome from private industry; and heavy-handed mandatory rules have simply not materialised in this space. A corrective model requires substantive legal doctrine which has also not been forthcoming given the disparate approaches over Digital Sequence Information (DSI) in parallel treaty contexts. Even within this limiting ABS frame, there is an opportunity to correct some conventional modalities that hurt the likelihood of benefit-sharing, while co-opting beneficial pathways such as existing scientific communities or public technical infrastructure.
Treaties do not just regulate genetic resources, they also constitute possibilities by not regulating them. Successive parallel treaties have disavowed DSI in their scope, the result of efforts seeking to ‘dis-enclose’ DSI in treaty text. Treaty provisions manifest strategic disagreements over definition, scope and value of DSI. For example, DSI is not defined in the Biodiversity Beyond National Jurisdiction (BBNJ) Agreement and it is outside the scope of the WIPO Treaty on IP, Genetic Resources and Associated Traditional Knowledge. The latter in effect facilitates capture of new forms of data capital unencumbered by sovereign rights, leading to an upward redistribution of the value of genetic resources in the form of DSI. These ‘dis-enclosures’ as I define it[3] are constitutive of the legal shape of DSI as an unregulated, intangible, highly mobile and valuable resource subject only to contingent policy meanings. Not all of the last 30 years of skewed fairness can be corrected in the PABS Annex, nonetheless there are some learnings from parallel treaties that seem unequivocal.
I worked with colleagues on Part II of the BBNJ Agreement on marine genetic resources, advising the Chair of the G77 and China group. [4] We proposed the Batch Identifier in the context of linked operative provisions brought to the negotiating table by developing countries.[5] My research group also produced the research-based language of the central paragraph 3 of Decision 16/2 of COP16[6] – a compromise that was supported by several developing and developed countries in Cali. I thank Geneva Health Files for this invitation to write an Editorial on the PABS Annex negotiations.
I offer six ways to rethink some of the more difficult aspects of these negotiations. The third way is an integrated system beyond the so-called open and closed systems, based on recognition of the link between materials and sequences, the purpose of origin information, salience of form and function of identifiers, levels of data access, the vulnerability of a closed system, the role of public databases and the thorny question of intellectual property.
1. Link Between Materials and Sequences: The Hinge of the PABS system
The BBNJ Intergovernmental Conferences (IGCs) were consumed by the question of separating ‘wet’ materials and ‘dry’ sequences. Genetic material and sequences are distinct entities, but they are linked. And as the first legally binding treaty to regulate DSI, the BBNJ applies the same legal treatment to marine genetic resources and DSI – in other words the operative provisions apply to both. The original concept of the identifier in the BBNJ mirrored the BioSamples database which clusters sequence data along with other coded data, to the physical samples. As Oldham observes, this allows for the identification of all biodiversity samples addressed by multiple policy processes in one place, while being respectful of the particularities of those processes.[7]
Michael Kanu, then Chair of the Africa Group observes [8] that going into the final round of negotiations there was a view that if the link between DSI and benefit sharing could be resolved, then the whole of the BBNJ Treaty would become possible as part of a domino effect. The central insight that is often missed however is that the ‘Standardised BBNJ Batch Identifier’ (Art 12(3)) was not principally about origin, though it has led to a transformed approach to disclosure of origin. The INSDC’s spatial-temporal policy introduced in 2021[9]obligates submitters to indicate origin, a move that was at least partially in response to the pressure the scientific community was coming under during these negotiations.
The transformative function of the BBNJ Batch identifier is that it groups together wet and dry. Whether this can be done scientifically and technically is not in question. How far the identifier can proliferate – that is, can it go into metabolite databases (that store and organize information on metabolites – small products that are the outcome of metabolic processes), and fully synthesised information, is an open question. The Pandemic Influenza Preparedness (PIP) Identifier does not carry over to DSI[10], and insistence on following the PIP framework (be it in reference to SMTAs or accountability) makes it challenging to account for DSI appropriately.
2. Origin of Genetic Resources: To What Purpose?
There is currently no claim that genetic resources from a particular country gives cause for disproportionate distribution of VTDs to that country beyond medical or epidemiological needs. So in the PABS context, the case for origin of genetic resources to be recorded is similar to an attribution right rather than as setting out a right to resulting products.[11] This attribution right is familiar in the WHO’s own approach to open access publications.[12]
For monetary contributions on the other hand, an agreed identifier will help with allocation according to need and origin of resources. Attribution here to the state party where the pathogen originated, via an identifier can facilitate distribution of benefits, perhaps guided by WHO regions so regional resilience may be built up.
3. Identifier- Form Must Follow Function.
The conversation around identifiers has moved on quickly in the last few weeks in the PABS context, and the idea of a ‘persistent’ identifier has taken root, which is an attribute derived from Findable, Accessible, Interoperable and Reusable (FAIR) data principles, specifically the ‘Findable’ aspect. DOIs have emerged as a possible candidate identifier. There are identifiers other than DOIs that may have all the attributes that are suitable for the PABS context.
DOIs have been implemented in the International Plant Treaty where they have a limited policy role of interoperability with existing databases. The BBNJ Batch Identifier has a much greater density of functions. It will traverse multiple information domains – products, patents and publications and will be used by cruises; and databases will biennially report on aggregate usage of marine genetic resources (MGRs) and DSI using the Batch Identifier. An informal working group that I co-lead with colleagues, are not convinced that DOIs offer sufficient ‘discoverability’ to suit BBNJ objectives.[13]
Standardisation is important in a PABS-like context to allow data analysis and tracing of data flows. Non-standard identifiers (such as cruise identifiers devised by different research groups) can have irrelevant variations that can degrade data analysis and machine learning – leading to poor quality insights and predictions. This is why the term ‘Standardised’ qualifies the ‘BBNJ Batch Identifier’. A human and machine readable, structured identifier that fulfils good data governance benchmarks, including adhering to FAIR principles requires consideration of a number of factors based on what the PABS legal and policy objectives are.
There are advantages to agreeing high-level functions and attributes of the identifier, rather than the kind of identifier, lest some important functions be foreclosed by the choice of identifier. If I may use an analogy, if you want to protect yourself from rain, you could choose an umbrella or a raincoat. ‘Protecting from rain’ is the attribute you want, if you choose an umbrella instead of the attribute, you may foreclose use of a raincoat and the functionality it provides. At a minimum, a newly minted ‘Standardised PABS Batch Identifier’ mirroring the BBNJ language will connect material to sequences and adhere to FAIR principles.
When should the identifier be generated?
In the BBNJ it is at the point of notification of the collection of samples. In PABS I believe the appropriate time will be when a pathogen has been declared to be relevant, because it has pandemic potential. Potential surveillance needs may require this threshold for identification and collection to be lower. Careful thought must be given to the entity generating the identifier and the standardisation that is needed. The point of triggering the identifier is a key legal moment for reasons I develop below.
What information should the identifier carry?
An origin function is low hanging fruit for an identifier. Once materials and samples are connected, and an identifier labels them as falling under the PABS system - access and use will have consequences. The identifier could resolve to give notice of the terms of access and use in a highly visible way, which is essentially a licence. Such an identifier of appropriate technical specification, giving notice of a licence could potentially replace SMTAs.
What is being identified?
In the PABS context for biosafety and surveillance purposes, it seems desirable that the identifier does more than just link the pathogen with the collection site or event. More clarity is needed on how a PABS identifier may carry information on the viral strain being identified for instance, such that it raises implications for other ex situ sites where the same strain can be accessed.
Such an identifier or notification system attached to it would be flagged with repositories and databases that carry the same variant or sequences. Bringing the variant or strain itself under the PABS system rather than ‘the variant or strain from a particular collection site or event’, perhaps linked to the decision tools in Annex 2 of the IHR Guidance - may offer a pragmatic way to take due note of any bilateral agreement to gather pathogen samples, outside of the PABS system.
Non-PABS Agreements for the transfer of materials and sequences:
Bilateral agreements (such as the reportedly proposed MoUs between the US and some African countries which demands access to pathogens of ‘epidemic potential’ in return for aid tied to health outcomes) [14] or other, future regional arrangements that bypass the PABS system, raise the prospect of VTDs being produced outside of the PABS system. This would potentially leave such countries, and other low and middle income countries without access to set asides or monetary benefit sharing.
While such arrangements can fracture the delicate global compact of the PABS Annex, it is also a good reminder that a PABS system that has low barriers to entry, that recruits many, varied entities, relies on publicly available technical infrastructure and research networks, and keeps the transaction costs of using PABS material and sequences low via a licence agreement – will make it more likely that important VTDs are produced by PABS entities instead of entities functioning outside the PABS system. Ideally, it should be simpler to join the PABs system than stay outside of it; the Annex should become the default research infrastructure on pandemics, not a niche arrangement for a few civic minded corporate entities and non-commercial bodies. This is a basic premise of the elements of the integrated PABS system proposed here. Elements of this system may also offer ways to mitigate adverse implications of such bilateral agreements. It may be beneficial for example for bilateral MoUs to include a right of attribution to genetic resources and sequences, and for sequences to be published by researchers in the country before any transfer takes place – as a spoiler strategy to prevent patents, and to accelerate research on it by PABS entities.
Where will the Standardised PABS Identifier labelled materials and samples reside?
In the BBNJ, trust in public databases is built by setting out reporting obligations (Art 12(7)) using the BBNJ Batch Identifier, and by obliging state parties to ensure that repositories and databases in their jurisdiction are fulfilling their functions. Repositories and databases are allowed to recover reasonable costs associated with providing access to the marine genetic resource, data or information (Art 14(4)(b)).
Once the PABs system has an identifier of optimum technical specification that performs necessary legal and policy functions (such as connecting material and sequences, be able to navigate different databases including patent and publication databases, be findable and searchable, be used in reporting requirements, and resolve to carry terms and conditions of use), samples and sequences can reside in existing trustworthy biological repositories and public sequence databases. Reasonable costs of implementing biosafety measures or levels of access to data for PABS could be provided on the back of periodic reporting obligations on access to such materials and samples, using the PABS identifier. Culture collections that have International Depository Authority status (IDAs) under the Budapest Treaty’s Microorganism deposit system could be used as trusted entities. However, of the 52 reported IDAs only 8 are in developing countries, of which there is only 1 in Africa – in Morocco.[15]
An integrated PABS system rather than an ‘open’ system, that relies on an identifier to take advantage of the existing technical and research infrastructure may be able to accelerate research. It gives us machine-readable ways to better map data flows in publications, patents and development of VTDs. It may also help mitigate AI’s ability to put distance between collection-level events and measurable benefits. [16]
4. Registration: Less About User Identity and More About Degree of Access
I understand that in the PABS negotiations many developed countries are of the view that requiring registration information would impede research and innovation. Surely, that is a consequence that depends on the form of registration. The EU’s flagship 1+million Genomes initiative[17] for example, is building technical infrastructure for the cross-border data flow of human genomic information in a bid to facilitate infrastructure for personalised medicine. There are three levels of data access described in the technical document from 2021 – anonymous (which is public domain access), registered and controlled.[18] The highest level of access ‘controlled’, requires approval from a Data Access Committee (DAC). Technical standards for access to human data[19] are set by the Global Alliance for Genomics and Health (GA4GH) and on the basis of human rights, ethics, and biosafety. [20]
These fairly stringent constraints are seen as an appropriate transaction cost, to ease the cross-border flow of data in an ethical and safe manner; while not impeding research. It would be disingenuous to claim that what was necessary for EU citizens to have faith in the safe cross-border flow of human genomic data is not necessary to shore up biosafety and fair benefit sharing to combat pandemics.
Rather than focus on registration, negotiators may get more purchase by discussing levels of control over access to data which would be pre-determined and set out in the framework agreement PABS entities would enter into. Trust-worthy PABS entities could be given highest level of access, which creates an incentive for such entities to participate, others could have public domain access to data of lower value or sensitivity. Among other undertakings, trust may be generated by non-commercial public bodies or commercial entities with a desirable track record, by those who commit to capacity building and technology transfer, those who agree to share benefits as set out in the Annex, or undertake regular reporting obligations, even those who voluntarily contribute to the Cali Fund.
With materials and sequences circulating in credible databases, marked by a Standardised PABS Batch Identifier, it may become possible to control access to data in a way that participating public databases can implement.
A lesson from the BBNJ experience is that the scientific community wants to be part of the solution, and public databases tend to be responsive to the community of scientists they serve.[21] The BBNJ Identifier for instance has been received positively by the marine scientist community as it provides a chance to harmonise and streamline data flows.
What is the role of the framework agreement?
The reported resistance to include a ‘registration’ process combined with a stated desire by some developed member states to make the Annex implementable without domestic legislation, points to the need for a framework agreement that sets out conditions of access to materials and sequence data. In effect, the contractual purchase many developing states want with SMTAs would move upstream to the entry point at which different kinds of entities are recruited into the PABS system. PABS entities get the legal certainty to incentivise them to join the system, and developing state parties can be reassured that all entities understand what their obligations are. Such a framework agreement may also include undertakings to not obtain materials and sequences outside of the PABS system unless such materials or sequences are not available through PABS entities.
5. PABS system: Accounting for non-PABS pathogens of pandemic potential
If it is not a novel pathogen, the moment a known pathogen of pandemic potential is identified, it will draw attention to pre-Pandemic Agreement materials and sequences in repositories and databases, some of which may already be patented. At this point, if identified pathogenic samples and sequences can only be acquired from a contained database, it creates an ‘in’ and ‘out’ of the PABS system. It may motivate non-PABS entities to attempt to access materials and sequences elsewhere; even PABS entities may assume that acquiring materials and sequences outside of the system can lead to legitimate non-benefit sharing pathways to research and commercialisation.
If PABS materials and sequences are integrated into public repositories and databases there could be an honour system set up to flag materials and sequences similar to those attached to a PABS identifier. How would this be enabled? State parties under whose jurisdiction repositories and databases function, would ensure that such entities notify non-PABS submitters that their samples and sequences have been identified as being of pathogenic potential due to which additional terms of access and use may apply (language could mirror state responsibility in Art 14(6) of the BBNJ), unless other, equivalent means of benefit sharing had been agreed at point of collection.
Would the user of such materials and sequences (without any other benefit sharing arrangement) be ethically obliged to share benefits on the lines set out in the PABS Annex, despite such materials and sequences having been uploaded prior to Pandemic Agreement? In a world serious about pandemic preparedness, yes.
For those states who would argue that they cannot possibly ask their private companies (whether they are PABS entities or not) to commit to such ‘benefits’ when they use materials and sequences outside of a PABS system – it is the pandemic preparedness system generated by the Pandemic Agreement that will enable speedy identification of pathogens of pandemic potential. Every commercial and non-commercial entity engaged in research benefits from that pivotal moment of identification and surveillance that precedes it. The PABS system when it comes into effect, will be a public good - that is, it is valuable even to those who do not participate in it. Therefore, it is appropriate for such a system or coda to support benefit-sharing in a publicly integrated system. Ethically motivated data infrastructure can help prevent a two-tier research and innovation model that further corrodes credibility of the ABS framing.
The Cali Fund: Is there a problem of ‘stacking’:
The claims about so-called ‘stacking’ of monetary contributions is the potential problem of repetitive payments for use of the same genetic resources. The Cali Fund contributions which are voluntary (unlike what is being proposed under PABS), is based on direct and indirect use of DSI. Contributions are to be made based on indicative rates of payment - 1% of profit or 0.1% of their revenue [22].
Monetary contributions in the PABS Annex, I believe are being discussed on the basis of percentage of revenue from products developed from PABS materials and sequences. Cali Fund contributions can be calculated by removing the revenue generated from products that are specifically made using PABS materials and sequences. A declaration to this effect can be made under para 5 of Decision 16/2 – which allows companies to state that they are not using DSI directly or indirectly; and be taken into account under para 15 where in each year that entities make contributions a certificate will indicate that they have fairly and equitably contributed monetary benefits sharing from the use of DSI.
It is worth noting that for both PABS and the Cali Fund, developed state parties have shifted responsibility for making monetary contributions to private entities, because both systems are ostensibly under an ABS framing derived from the Convention on Biological Diversity, where the focus is on ‘users’. Some of the claims of ‘stacking’ obligations would be more credible if industry bodies encouraged private companies to start making contributions to the Cali Fund, which has not happened yet.
6. Text or ‘No-Text’: Intellectual Property
In the BBNJ the G77 plus China did not have internal consensus on IP which damaged the ability to achieve anything other than the ‘no-text’ option. For PABS, there is a maximalist and a minimalist option on IP, and a worst-case scenario outside of both of these. The minimalist approach is to exclude the possibility of patent claims to pathogenic microorganisms isolated from the environment, and any genomic sequence information with only trivial changes for all, not just for entities in the PABS system.[23]
The justification for this proposal is as follows: We have to assume that older samples, or samples concurrently collected outside of the PABS system (through bilateral agreements such as the US MoUs for instance) may already exist in public and private databases; if this is the case, it is likely that the microorganism, gene or protein sequences are patented in some form (many patents on the coronavirus category existed before the Covid-19 pandemic struck).
If relevant samples and sequences already in a public or private repositories are not patented (which is unlikely), then the newly declared pathogen will create a patent race. (Within 15 days of the SARS-CoV-2 genome being published, the first patent had been filed for Novavax’s spike protein vaccine[24] and others followed quickly). It would be desirable to take the heat out of that race, and focus the incentive of IP rights on useful technologies rather than on the isolated pathogen itself. For example, the US CDC patented the isolated SARS virus, its genes, its proteins and the methods to detect it and the infection it was causing in 2004, presumably to help speed up development for upper respiratory tract infections which the virus was known to cause by that time.[25]
The rationale for the move to deny the claims within patent applications for isolated gene sequences, a position endorsed by the US Supreme Court in Myriad is relevant here.[26] The conventionally pro-patent Court recognised that such patents could ‘tie up’ the use of basic scientific tools and potentially inhibit future scientific progress in genetic diagnostics and medicine. It should be noted that the decision does not extend to isolated microorganisms, which can along with their parts, be patented in almost all jurisdictions. A patent holder that is not a PABS entity could prevent further work on this pathogen, or at least slow down necessary innovation.
In my view, it would not require an amendment of TRIPS for an exclusion from patentability of claims to microorganisms that are also pathogens of pandemic potential and associated genomic sequences to be implemented by patent offices under the ‘morality’, or the ‘utility’ exclusion.
Equally where patents to isolated microorganisms have already been granted prior to the Pandemic Agreement, and are necessary for future research, we would need to enable some form of licence or assignation[27] to an intermediary organisation or directly to PABS entities in an equitable manner. An explicit reference to such licences in the PABS Annex may act as an incentive to participate in the PABS system.
The worst-case scenario would be to prevent IP rights only for those who are part of the PABS system, as it is stated in the current draft text of the Annex. As such constraints will not apply to those outside the system, it will become a good reason not to join the PABS system.
In summary:
Learning from parallel treaty contexts, an integrated PABS system will ideally include the following twelve points in some form:
1. Use a batch identifier to connect materials and sequences, designate when and who will grant the identifier; (investigate link to strain rather than just collection site/event).
2. Focus on increasing the number, range and type of PABS entities to increase chances of VTDs being developed by a PABS entity rather than by non-PABS entity.
3. Use a low barrier framework agreement for PABS entities setting out levels of access to data; and obligations to share benefits.
4. Replace SMTAs with a PABS licence to access and use materials and sequences attached to an identifier, include terms of use in the framework agreement, and bring use of sequences under same licence.
5. A PABS licence may include commitments to maintain low barriers for access to future innovations directly and indirectly[28] derived from PABS materials and sequences where it is not explicitly covered by language in the Pandemic Agreement (based on [4.2] OECD Best Practices, Recommendation on Licensing of Genetic Inventions)[29] This may be presented to PABS entities as further incentive.
6. Take due note of monetary contributions to the PABS system set out as indicative rates ‘based on’ revenue from products developed (‘directly’ and ‘indirectly’ – from the Cali Fund, or ‘based on’ as in the WIPO Treaty) using PABS materials and sequences.
7. Obligate public repositories and databases that hold known variants and strains, PABS and non-PABS materials and sequences to report on access periodically (possibly biennially as in BBNJ) for purposes of biosafety, surveillance and accountability.
8. Include a periodic obligation on the part of PABS entities to report on material outcomes like patents, publications and any products, using the PABS identifier
9. State parties to facilitate public repositories and databases to speed up the process of ethical changes to technical data infrastructure.
10. Use monetary contributions to enhance the ability of public databases to participate in an integrated PABS system (cost of monitoring access, providing samples, for example).
11. Include language to highlight that patentability of unmodified pathogens of pandemic potential would be contrary to morality; pandemic potential being the rare circumstance justifying the exclusion of such patent claims in patent office practice, and guidelines.
12. Where patents are already granted to known pathogens and are deemed of critical importance, facilitate licenses to PABS entities as an incentive to join the system.
DOWNLOAD PAPER HERE
[1] S Thambisetty ‘The Equity Trap’ (Feb 6 2025) The Ideas Letter Available at <https://www.theideasletter.org/essay/the-equity-trap/>
[2] A Martin and others ‘Just Conservation? On the Fairness of Sharing Benefits’ in T Sikor (ed) The Justices and
Injustices of Ecosystem Services (Routledge 2013) 69. As reported by Elisa Morgera Morgera, Elisa, ‘An International Law Phenomenon’, Fair and Equitable Benefit-sharing in International Law (online edn, Oxford Academic, 23 May 2024) https://doi.org/10.1093/oso/9780198862130.003.0001
[3] A concept that I explore in ‘The Paradox of DSI: From Material Access to Informatic Extraction’ forthcoming (please contact author at s.thambisetty@lse.ac.uk):
[4] See Siva Thambisetty, Paul Oldham, and Claudio Chiarolla, ‘The Expert Briefing Document: A Developing Country Perspective on the Making of The BBNJ Treaty’ (September 21, 2023). LSE Legal Studies Working Paper No. 30/2023, Available at http://dx.doi.org/10.2139/ssrn.4580046 (This is the Briefing document that allowed internal consensus amongst the G77 plus China Group going into the final BBNJ round of negotiations).
[5] P Oldham and S Thambisetty ‘ONEST: The Middle way for Monetary Benefit Sharing in BBNJ Negotiations https://zenodo.org/record/7573700#.Y9KmR- zP27B Also see Paul Oldham, Claudio Chiarolla, and Siva Thambisetty ‘Digital Sequence Information in the UN High Seas Treaty: Insights from the Global Biodiversity Framework-related Decisions’ (January 30, 2023). LSE Law - Policy Briefing Paper No. 53, Available at http://dx.doi.org/10.2139/ssrn.4343130
[6] Decision 16/2 Digital Sequence Information on Genetic Resources (Hereafter Decision 16/2) <https://www.cbd.int/doc/decisions/cop-16/cop-16-dec-02-en.pdf>
[7] ibid p 17
[8] Michael J Kanu ‘The Ship Has Reached the Shore: The BBNJ Treaty and Contributions of the Africa Group’ (25th April 2023) Available at https://www.ftbchambers.co.uk/elblog/view/the-ship-has-reached-the-shore-the-bbnj-treaty-and-contributions-of-the-african-group.
[9] https://www.insdc.org/news/spatio-temporal-annotation-policy-18-11-2021/
[10] https://extranet.who.int/ivtm2/
[11] See Paul Oldham and Siva Thambisetty, ‘The Pandemic Access and Benefit Sharing System: Four Elements of a Trusted System’ (June 26, 2024). LSE Legal Studies Working Paper No. 10/2024, Available at http://dx.doi.org/10.2139/ssrn.4877517
[12] ‘The WHO uses two main Creative Commons Licences for its publications: CC-BY 3.0 IGO and CC-BY-NC-SA 3.0 IGO. CC-BY requires attribution but can be used for any purpose, CC-BY-NC-SA requires attribution, use for non-commercial purposes (NC) and share alike (SA)… The WHO also makes three health related classifications available under a CC-BY-ND licence requiring attribution, permitting any use but with no derivative works (ND).’ Ibid p 13 (at fn 34)
[13] Siva Thambisetty, Muriel Rabone, Paul Oldham ‘From Paper to Practice: Operationalising the Standardized Batch Identifier in the BBNJ Framework’ (August 20, 2025). Available at http://dx.doi.org/10.2139/ssrn.5398819
[14] Sara Jerving ‘US Template for Bilateral Health Deals Bypasses WHO Pandemic Negotiations’ (7 Nov 2025) https://www.devex.com/news/us-template-for-bilateral-health-deals-bypasses-who-pandemic-negotiations-111285
[15] https://www.wipo.int/en/web/budapest-system
[16] Living Data 2025 Report on ‘Ethics of Environmental and Biodiversity Data: When Data Travel, Do the Benefits Return?’ presented in Bogota November 2025. < https://zenodo.org/records/17538314 (mooting the idea of data passports to ensure measurable return of benefits).
[17] https://digital-strategy.ec.europa.eu/en/policies/1-million-genomes
[18] Beyond 1million Genomes: Secure cross-border data access roadman (version 23/11/2021) para 2.2.1 < https://zenodo.org/records/5018526#.YXGlNNbMKdY>
[19] Ibid para [2.3]
[20] 1+MG Roadmap 2023-2027 Available here < https://digital-strategy.ec.europa.eu/en/news/1million-genomes-initiative-new-roadmap-adopted-scale-and-sustainability-phase>
[21] For example Living Data 2025 event held this November in Bogota, Colombia - a joint meeting of TDWG, GBIF, OBIS, and GEO BON.
[22] Saipriya Kamath, Siva Thambisetty, and Paul Oldham, ‘A Tiered Sales-Based Approach: Digital Sequence Information and Monetary Contributions from Industry’ (October 21, 2024). LSE KEI Fund 2024 http://dx.doi.org/10.2139/ssrn.5038410; and here Siva Thambisetty and others ‘Identifying Ways Forward: The LSE Roundtable on Global Biodiversity and Digital Sequence Information’ (October 15, 2024). LSE KEI fund 2024 http://dx.doi.org/10.2139/ssrn.5038854
[23] The general rule is that discoveries cannot be patented, but if you can show a use for it, the discovery itself can be claimed as part of the invention. Under the European Patent Convention, this makes discoveries a so-called ‘soft’ exclusion from patentability. CFPH LLC v Patent Office [2005] EWHC 1589 (pat)
[24] Storz, U. The COVID-19 vaccine patent race. Nat Biotechnol 40, 1001–1004 (2022). https://doi.org/10.1038/s41587-022-01376-1
[25] Jonathan Jarry ‘Patently False: The Disinformation Over Coronavirus Patents’ (Aug 2020) McGill University Office for Science and Society < https://www.mcgill.ca/oss/article/covid-19-pseudoscience/patently-false-disinformation-over-coronavirus-patents>
[26] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576
[27] Compulsory Licenses can only be given to domestic entities, unless falling under the Doha Agreement.
[28] Language from Decision 16/2 on Digital Sequence Information (setting up the Cali Fund)
[29] https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0342 (2006)
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