|
||
|
TWN
Info Service on Biodiversity and Traditional Knowledge CBD: Developing countries call for peer review of flawed study on database accountability Nairobi, 11 August 2026 (Nithin Ramakrishnan) - The study on tools and models, such as databases, for making digital sequence information (DSI) on genetic resources publicly available and accessible in a transparent and accountable manner, is regrettably flawed and incomplete on several counts. Methodological shortcomings, potential conflicts of interest, and the lack of peer review cast doubt on the integrity of the study, process and its conclusions. As such many developing country Parties to the Convention on Biological Diversity (CBD) have called for a peer review of the study, before using it as the basis of policy recommendations. The study was commissioned by the Secretariat of the CBD, pursuant to Decision 16/2 adopted by the Conference of the Parties (COP) at its sixteenth meeting in 2024. The study, contained in document CBD/SBI/7/INF/15, together with the accompanying Secretariat note, is currently before the seventh meeting of the Subsidiary Body on Implementation (SBI-7), being held in Nairobi from 4-12 August 2026, and is expected to inform future policy decisions on this issue. Decision 16/2, as part of operationalizing the CBD’s multilateral mechanism for fair and equitable sharing of benefits arising from the use of DSI, initiated the exploration of possible new tools and models, including databases, for making DSI on genetic resources publicly available and accessible in a transparent and accountable manner to all Parties. The emphasis on accountability to all Parties is fundamental. Most major public DSI databases are owned or managed by institutions in the Global North and are accountable primarily to the jurisdictions in which they are established. In practice, these databases frequently pay little attention to national access and benefit-sharing (ABS) legislation, permit anonymous access to DSI, enabling users to bypass ABS obligations, and publish DSI without verifying whether submitters possess the legal authority to make such data publicly available. These shortcomings have direct implications for the operation of the CBD’s multilateral mechanism, including its Cali Fund. Without accountable and transparent databases, neither users of DSI or authorities from the Parties nor the Secretariat can verify whether the use of DSI falls within the scope of the multilateral mechanism. If existing databases remain unaccountable to Parties, they will continue to facilitate digital biopiracy, while allowing access to DSI to remain controlled by a small number of institutions and governments in the Global North, contrary to the broader objectives of equitable access. The absence of accountable databases also affects fair and equitable benefit-sharing. The Cali Fund will remain unable to consider the geographical origin of the genetic resources from which DSI is derived, leading to inequitable distribution of monetary benefits amongst provider countries. Equally important, non-monetary benefits, including research partnerships, capacity-building, access to technologies and medicines, and other meaningful outcomes arising from the use of DSI, will remain uncertain and unevenly distributed. To address these concerns, COP16 decided to explore tools and models, including databases, to make DSI publicly accessible and available in a transparent and accountable manner to all Parties. The commissioned study was supposed to aid this process. Despite some merits such as its identification of some gaps in current DSI-sharing practices, and collection of important information, the study risks prejudging it by misunderstanding its mandate, presenting incomplete information, conveying inconsistent messages and reaching reductionist conclusions. Identified gaps and tools The study identifies a few major gaps concerning making DSI on genetics resources publicly available and accessible in a transparent and accountable manner, as well as in creating a fair and equitable system for sharing the benefits of DSI through the CBD’s multilateral mechanism: (i). Lack of transparency on the part of many databases that are accessing and using DSI; (ii). Lack of compliance information associated with DSI made available within the databases, for example, metadata relating to permits by which data submitters obtain rights to make DSI publicly available; (iii). Lack of awareness of DSI users regarding ABS obligations of the CBD and lack of understanding of policy makers on how DSI is being accessed and used; (iv). Inequitable geographic distribution of public DSI databases globally and consequently geographical inequity concerning who gets to set and shape the policies surrounding public DSI storage, submission, access and reuse; (v). Public DSI databases have not yet allocated the time and resources necessary to consider how to align with the CARE principles, the UN Declaration on the Rights of Indigenous Peoples (UNDRIP) and the materials developed by the CBD on Article 8(j) implementation, to act as responsible stewards of the DSI and traditional knowledge of indigenous peoples and local communities. The study lists 13 proposals for new tools, models, and databases, along with five proposals for tools to support greater transparency, accountability and accessibility for DSI associated with indigenous peoples and local communities. These include:
Skewed and incomplete conclusions The study, after the identification of the potential tools and models, classified these into: (1) proposed database solutions, (2) potential modifications to existing databases, (3) tools, models and database considerations for indigenous peoples and local communities. It made the following conclusions without a systematic analysis (emphasis added):
These conclusions reveal a fundamental weakness in the study. None of them explain or propose one or more solutions regarding how transparency and accountability to all Parties, as required by Decision 16/2, can actually be achieved when making DSI publicly available and accessible. Nor does the study evaluate the proposed tools and models against paragraph 1(a) of the Annex to Decision 16/2, which establishes that the multilateral mechanism applies only to the use of DSI that has been made publicly available in compliance with applicable national legislation. This omission is particularly significant because verifiable compliance information with national legislation is indispensable to the effective operation of the multilateral mechanism. Without it, the Cali Fund risks becoming a mechanism that inadvertently legitimizes the unlawful extraction and use of DSI, rather than preventing it. Finally, the study does not demonstrate how the proposed tools and models address the very gaps it identifies. It catalogues deficiencies, lists possible solutions and presents conclusions, but does not systematically analyse whether those proposed solutions are capable of remedying the identified deficiencies. Methodological shortcomings The study suffers from several significant methodological shortcomings that undermine the credibility of both its analysis and its conclusions. These include misunderstanding the mandate established by Decision 16/2; misunderstanding of who the relevant stakeholders are; failure to adequately consider potential conflicts of interest among stakeholders; reliance on stakeholder views rather than substantive evidence and analysis; lack of conceptual clarity; and potential conflicts of interests and lack of peer review of the study. Misunderstood mandate: The fundamental flaw The most fundamental error lies in the study's misunderstanding of the mandate given by the COP. The objective described in the study differs significantly from the mandate established under Decision 16/2. According to the study, “The main goal for this study is to examine existing and emerging tools and models, including databases, that promote the availability and accessibility of digital sequence information (DSI) in an accountable and transparent manner and to assess their benefits and limitations.” This formulation selectively reproduces elements of Decision 16/2 while omitting the relevant elements. Paragraph 6(b) requested a study examining options for making DSI publicly available and accessible in a transparent and accountable manner. The focus was therefore not merely on tools and models, but on identifying practical options through which transparency and accountability could be achieved. Although the study appears to rely on paragraph 4 as the basis for examining tools and models, it overlooks one of its most important requirements mentioned in the same paragraph: that accountability and transparency should be ensured to all Parties. This omission has significant consequences. Accountability and transparency to all Parties is the central policy objective that the study was expected to examine. By overlooking this element, the study narrows both its methodology and its analysis, inevitably influencing its conclusions. For instance, the same misunderstanding is reflected in the accompanying Secretariat note, which states that the COP decided to explore new tools and models, including databases, for making DSI publicly available and accessible in a transparent and accountable manner, while omitting the words "to all Parties" as stipulated in paragraph 4 of Decision 16/2. Other shortcomings of the methodological design The study employed five methodological steps: rapid content analysis of submissions by Parties and stakeholders; informal interviews; rapid content analysis of those interviews; surveys; and an implementation feasibility assessment of the proposals developed through the preceding stages. Interviews were conducted with governments, indigenous peoples, academic researchers, database managers, industry representatives and local communities to (i) understand the perceived benefits and limitations of establishing a new DSI database managed by a neutral entity designated by the Parties; (ii) identify governance gaps within the current DSI database network; and (iii) identify tools and models capable of addressing those gaps. The study also conducted additional and separate surveys only for academia and the private sector to (i) assess whether a new DSI database is needed; (ii) identify governance gaps; and (iii) explore possible solutions. It justified this approach on the basis that many major DSI databases operate outside the jurisdiction of the Convention and therefore cannot be required to implement decisions adopted by the COP. It therefore argued that any future changes would require the “buy-in” of the scientific community and private-sector users. The report states: “This was particularly important as some of the current DSI database network lies outside or is funded partially or impartially by countries that have not ratified the CBD. Therefore, they are under no obligation to implement any changes just because those changes are decided upon as a preferred direction of travel by the Conference of the Parties of the CBD. However, DSI databases are expected to be responsive to the needs of their users (i.e., the U in TRUST principles means User focus and means that databases should be responsive to the needs of their users). So, if any modifications are preferred by the Conference of the Parties, they would also need buy-in from the academic and private sectors.” The assumption that DSI databases operate outside the jurisdiction of the Convention and therefore cannot be required to implement decisions is another fundamental mistake. Firstly, while databases may be funded partially or fully by countries not party to the Convention, Parties to the Convention have undertaken to ensure databases operating under their jurisdiction support the implementation of Decision 16/2. Secondly, nothing stops the Convention from seeking support of one or more specific databases to act as service providers in the implementation of Decision 16/2, in particular to promote legal certainty in ABS for both providers and users. The multilateral mechanism does not need all the databases to change their status quo, but it needs at the very least one database, to be fully accountable and transparent to all Parties. Misunderstanding the relevant stakeholders It can be seen from the above quote that the study misunderstands who the relevant stakeholders are. This is most evident in its treatment of database users. The surveys were directed at academic researchers and the private sector, implicitly treating them as the principal users of DSI databases. This overlooks the fact that provider countries, indigenous peoples and local communities can also use databases to share DSI derived from their genetic resources, in order to advance research and development, identify potential collaborators, and secure both monetary and non-monetary benefits arising from the utilization of those resources. By overlooking these legitimate interests, the study assumes that databases must be responsive only to the needs of the users of the database that access DSI, but not of the users of the databases that share DSI. This misunderstanding has significant consequences. It reduces the relevance of database functionalities that may be designed to serve the interests of real providers. For example, databases can integrate two key features: a privacy-first messaging system, enabling immediate push notifications and standardized collaboration offers (designed by the providers themselves), and a data access contract that obligates users to inform the providers about the use and to share resulting benefits or enter into mutually agreed terms for the same. For example, databases mentioned in the study such as GISAID and AOTEAROA GENOMIC DATA REPOSITORY provide such facilities. The importance of these tools and similar provider interests have been, however, diminished in the study. Failure to address potential conflicts of interest among stakeholders The misunderstanding of stakeholders also affects the study's treatment of potential conflicts of interest. The surveys primarily targeted those stakeholders who would become subject to additional obligations if databases become more transparent and accountable, while excluding those who would benefit from such reforms. Unsurprisingly, this risks producing conclusions that favour maintaining the status quo. This concern is particularly important given the well-documented scepticism towards ABS within parts of the scientific community. The issue is not whether individual respondents acted in good faith, but whether the methodology adequately recognised the existence of systemic interests and institutional biases when selecting participants for the survey and interpreting their views. A study by researchers at Leiden University, Revealing Private Interests of Non-State Actor Coalitions in Negotiating Access and Benefit Sharing, explains how scientific coalitions opposed bringing benefit-sharing from the use of DSI within the scope of the Convention, using the argument that it would undermine open science. Similarly, a report commissioned by the FAO Commission on Genetic Resources for Food and Agriculture observed that the academic literature exhibits a tendency to emphasise implementation problems associated with ABS, while paying comparatively little attention to its contributions to recognising the sovereign rights of States over genetic resources, farmers' rights and the rights of indigenous peoples. It must be noted that the objective of the surveys and interviews was not merely to understand or identify gaps and solutions, but also to understand the benefits and limitations of establishing a new DSI database. The first objective of the survey of the academic community and private sector was to “gain insights into whether a new DSI database is needed”. Similarly, the first objective of the interviews was also to understand “the benefits and limitations of establishing a new DSI database that would be established, maintained and sustained by the neutral entity, decided upon by Parties”. The study regrettably did not explain how its methodology insulated itself from the positions of these stakeholders who have real economic and professional interests at stake, while asking them questions on whether a new DSI database is needed. Lack of systematic analysis of evidence The study’s implementation feasibility assessment was not undertaken in a systematic manner. Mainly informed by the interviews and survey, it focused largely on views and opinions, comparatively making little effort to gather independent technical, legal or financial information or evidence against which those views could be tested. Consequently, many of the study’s conclusions regarding feasibility appear to rest primarily on perceptions or reductionist assumptions, rather than detailed analysis or demonstrable evidence. The
report provides little explanation of the methodology used to assess
feasibility, the criteria applied such as a realistic budget/resource
estimates or information on the potential of mobilizing resources,
and of Lack of conceptual clarity The study also does not attempt to describe the essential characteristics of an ideal DSI database, capable of serving the interests of provider countries, data submitters and data users simultaneously, while complying with ABS requirements. Such an exercise could have been one of the study's most valuable contributions. Although individual features are discussed throughout, they are never brought together into a coherent prototype or conceptual model. The feasibility assessment is conspicuously reductionist. The study states “It is impossible to estimate the total cost of building a database with all the functionalities of the current DSI database network, as outlined in Section I. D, especially if both primary and secondary DSI databases are considered”. Rather than estimating the costs of developing an accountable database prototype designed specifically to implement Decision 16/2, the study compares the operating costs of the CBD Secretariat with the estimated budgets of existing global database networks. It provides little explanation as to why these comparisons are appropriate or why a new accountable database would necessarily need to replicate the full functionalities of the existing global “DSI database network”, which includes several primary and secondary databases. It is not clear why the entity managing the “accountable DSI database” should cover the costs of the entire network. The DSI database network comprises 2,000-6,000 databases, of which 52 are high quality globally significant databases. The study further assumes that the CBD Secretariat would act as a neutral entity to develop, maintain and sustain a DSI database, and compares its current proposed operating budget (approximately USD 45.8 million) with the annual operating costs of the International Nucleotide Sequence Database Collaboration (INSDC) (approximately USD 50 million). The INSDC is a collaboration of three databases, the European Nucleotide Archive (ENA), GenBank of the US National Library of Medicine-National Centre for Biotechnology Information (NLM-NCBI), and the DNA Database Bank of Japan (DDBJ). The study only reveals the annual running costs of the DDBJ, which is USD 7 million, while the ENA and GenBank costs are mentioned in terms of the budget of their respective parent organisations, i.e. USD 50 million and USD 497.5 million. These organisations have several other functionalities and operations, beyond managing the ENA or GenBank. GenBank, which is the largest of the three, receives around USD 35 million from the NCBI budget, according to a previous CBD-commissioned study. It must be noted that despite differences in the budgets and sizes of the databases, these databases mirror each other and give access to one single global dataset on DSI. The study is not clear as to why it compares the costs for a new DSI database with the annual operations costs of INSDC as a whole (around USD 50 million), and not with the costs of the DDBJ and Genbank, which would be at the lower (USD 7 million) and higher (USD 35 million) ends of the scale, respectively. The study is silent on the funding currently available for bioinformatic projects around the world, which could be also leveraged for a new DSI database. For example, the Earth Biogenome Project works on a comparable estimate of USD 4.7 billion, which is around 90-100 times of the annual running costs of the INSDC. Recent information on this project shows how the costs of such projects are decreasing. Furthermore, the study also excludes from the feasibility assessment, the idea of the CBD Secretariat entering into agreement with one or more databases to facilitate services for the implementation of Decision 16/2 and for support for the implementation of national ABS systems. For instance, in the context of the ABS negotiations on pandemic potential pathogens at the WHO, databases like Pathoplexus have come forward to offer potential solutions with respect to ABS, when it comes to DSI from pathogens with pandemic potential.
The study also fails to take into account the fact that many countries are now developing their own national databases and/or regional databases, which may adopt or adapt ABS- compliant standards to promote a fair and equitable R&D atmosphere around DSI and genetic resources, and the possibility for collaboration with each other or with the CBD Secretariat, including through a trusted research environment (TRE) or such other facilities. A TRE means a secured digital environment that allows authorized users to access and analyse DSI under pre-defined conditions and in this context with Party-determined safeguards for data governance, security, traceability and compliance with applicable ABS requirements. There are more conceptual and analytical shortcomings observed in the study, for example a less-than-full understanding and reflection of the UNESCO Recommendation on Open Science 2021 and the limited attention to biosafety and biosecurity concerns. The study did not take into account the failure of prominent databases to be consistent with the UNESCO Recommendation. Similarly, the study simply assumes, with no legal or factual basis, that the INSDC is a provider of open access, while a database requiring user registration is not. Potential conflicts of interest and lack of peer review of the study The cumulative effect of these methodological shortcomings lead the study to recommend the weakest solutions to the identified gaps, which are favourable only to the existing databases, academics and private sector from the Global North, who benefit most from the status quo. This makes transparency regarding the preparation of the study particularly important. The report does not identify the consultant or disclose relevant institutional affiliations. Although this does not, in itself, establish a potential conflict of interest, it makes it difficult for Parties to assess the independence of the analysis or to consider whether appropriate safeguards against systemic and institutional bias were in place. Sources informed Third World Network that the study was prepared by a member of a scientific stakeholder network that has consistently characterized anonymous access to DSI as synonymous with open access. This raises legitimate questions as to whether some of the conceptual shortcomings identified in the study may have arisen from this underlying perspective. Such a position appears difficult to reconcile with the governance principles set out in the 2021 UNESCO Recommendation on Open Science, which equates greater openness with greater responsibility and calls for vigilance against the use of open scientific information. At a minimum, the study should have been subjected to external peer review. Instead, the report states only that it underwent internal review within the Secretariat. This issue has already attracted significant attention during SBI-7. More than seventy Parties, including the African Group and the Like-minded Megadiverse Countries, have called for peer review of the study and an opportunity for Parties to submit comments before it informs future policy decisions. The African Group in their opening statement said: “the African Group recognizes the study on options for making digital sequence information publicly available and accessible as a useful technical input. Nevertheless, given its potential implications for future policy decisions, its findings should be subject to further scientific and technical validation. This should include independent peer review, as appropriate, and an opportunity for Parties, indigenous peoples and local communities, database operators and relevant experts to provide comments before the study is used as a basis for further policy recommendations. Work on databases should also address provenance, lawful submission, transparency of access and use, and accountability to all Parties, while maintaining open access in accordance with agreed decisions” Civil society organisations belonging to the CBD Alliance also said: “we are concerned that the commissioned study on database accountability has not been subjected to peer review, despite being undertaken by a member of a stakeholder group that has consistently characterized anonymous access to DSI as synonymous with open access, while overlooking the importance of transparency, accountability and measures necessary to prevent digital biopiracy.” +
|
||
