TWN Info Service on Biodiversity and Traditional Knowledge (Aug24/01)
2 August 2024
Third World Network

THIRD WORLD NETWORK ANALYSIS

CBD: Proposed solution for digital sequence information promotes inequitable extraction of data, no foreseeable benefit sharing

By Nithin Ramakrishnan (2 August 2024)

Proposals for a multilateral mechanism for benefit-sharing from the use of digital sequence information (DSI) on genetic resources raise several concerns, including inequitable extraction of data under the guise of “open access” and illusive benefit sharing obligations.

These proposals are also inconsistent with the rights and obligations recognized under the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit Sharing, as well as the UNESCO Recommendation on Open Science 2021.

The Co-Chairs of the Committee of the Whole of the Ad Hoc Open Ended Working Group on Benefit-sharing from the Use of Digital Sequence Information on Genetic Resources (the Working Group) have proposed elements for the further development and operationalization of the multilateral mechanism, to be recommended to the CBD’s 16^th Conference of the Parties (COP-16), scheduled for October 2024 in Colombia. The Working Group will first consider these proposed elements in Montreal, at its second meeting from 12 to 16 August 2024.

The elements are contained in the Annex of document CBD/WGDSI/2/2, which contains a synthesis of information for the further development of the multilateral mechanism, including elements of a draft recommendation. The rationales for the elements that are recommended have been included in the draft; however, the suggested elements themselves are not comprehensive.

The proposal lacks a clear picture of the multilateral mechanism and does not make an effort to fully spell out the various elements relating to access to DSI and the fair and equitable sharing of benefits arising from the use of the DSI. It instead adopts a piecemeal approach, which does not improve the status quo, but in fact worsens this by taking away legitimate rights of the Parties over their genetic materials and the DSI generated from such materials.

The proposal suggests that users of DSI “will” have to contribute to the proposed global fund, and “should” share non-monetary benefits. Public databases that share DSI are “encouraged” to inform their users about the CBD multilateral mechanism, including the requirements for the users related to the benefit sharing arising from the use of DSI. Parties are expected to take administrative, policy or legislative measures to “encourage and enable” businesses to contribute to the global fund and to “facilitate or ensure” large and transnational businesses make such contributions. All the above quoted verbs clearly indicate there is no intention to generate legally binding obligations on the users of DSI to share benefits.

It is then mentioned that payments could be made directly to the global fund or through a relevant national authority. Thereafter, the proposed elements focus on elaborating the distribution of the funds collected and the review of the functioning of the multilateral mechanism. Parties are further required to “refrain from putting in place national measures that require the sharing of benefits arising from the use of DSI available in public databases”.

Further, the proposed elements emphatically state that “Users that make contributions to the fund in line with the provisions of the multilateral mechanism set out in the present decision are considered to be in conformity with the requirements related to the fair and equitable sharing of benefits arising from the use of DSI under the Convention on Biological Diversity”.

The proposed elements neither try to generate obligations to share monetary or non-monetary benefits at the global or national level, nor do they make an attempt to ensure that DSI is accessed and used legitimately. At the same time, the proposal creates a ‘charity loophole’ for industries and the scientific community to escape from fair and equitable benefit sharing obligations.

The rationale given by the Working Group Co-Chairs is that Parties need not worry about these concerns, since the proposed elements deal only with DSI that is in public databases and Parties retain their rights to regulate DSI generation, storage, sharing and usage before they are deposited in the public databases. Interestingly, there is no proposal to establish a public database to deposit DSI, that is accountable to CBD Parties. Neither are there suggestions to make existing public databases accountable to the Parties.

In short, the entire design of the multilateral mechanism is based on the central element of public databases, but there is no guarantee of the development of at least one public database that would render services to the multilateral mechanism and provide a safe, secure, accountable and trustworthy environment for Parties to share DSI.

Thus, the proposed elements raise several concerns including the following:

 

(1)  They legitimise the current unaccountable and inequitable DSI (Data) extraction by developed countries;

(2)  They generate no obligations to share benefits;

(3)  They are inconsistent with rights and obligations under CBD and its Nagoya Protocol;

(4)  They are inconsistent with universally agreed principles of open science and does not address discriminatory practices in the DSI sharing;

(5)  They ignore security threats, including cyber-biosecurity;

(6)  They are based on erroneous premises and assumptions.

Unaccountable and inequitable extraction of DSI

Currently, DSI is shared through public databases, primarily sponsored by certain European governments and Japan (all Parties to the CBD) along with the United States, which is not a Party to the CBD and Nagoya Protocol. These databases work in collaboration and are jointly known as the International Nucleotide Sequence Database Collaboration (INSDC).

Though they share the DSI widely and transfer DSI across borders and to several jurisdictions, they take very limited due diligence measures, if any, to ensure that the DSI shared by them is legitimately generated from the genetic materials, with the permission of the country of origin. The same is the case with most of the other public databases with varying degrees of moral commitment shown towards such legitimacy.

INSDC has a policy that claims to promote free and unrestricted access to all, with no restrictions or licensing requirements attached to the sequence information. It even provides “anonymous access to DSI'' making governments blind to the users of the DSI. This database collaboration and the data sharing practices were formed ahead of the adoption of the CBD in 1992, and they were promoted with an assumption that they could prevent patenting of the primary sequence information from biological materials by making the data available in the public domain with no user restrictions.

However, even after three decades since the adoption and entry into force of the CBD, these public databases continue to be reluctant to respect the legitimate sovereign rights of the Parties over their biological resources. Similarly, they continue to neglect the rights of indigenous peoples and local communities over their genetic materials. Meanwhile, scientific lobbies and businesses have also found several ways of subjecting sequence information to intellectual property rights. (See this TWN report compiling information on patents that cover DSI.)

Most problematically, the databases are able to transfer DSI from the jurisdictions of Parties to the United States, a non-Party, undermining the ability of Parties to govern access to DSI as well as for securing fair and equitable benefits. Once INSDC-like databases accept DSI, without background checks on the submitter and the submitted DSI, it becomes difficult even to assert the rights of the country of origin over such DSI.

The proposed elements do not suggest any measures to address these problems. Instead, they suggest that Parties have the right to decide what should happen with the DSI generated from its genetic resources. They can decide where it should be deposited and stored and how it should be subjected to further use, and what benefits must be shared from the use etc., but all these rights have to be waived the moment DSI is submitted to a public database. However, this is not at all an adequate solution, given the current inequities.

With current advancement in technologies and interoperability, the DSI deposited in one of these databases will be transferred to multiple anonymous users in no time. This means that by the time a Party takes cognizance of the violation of its law that determines any of the above conditions by a submitter of DSI to one of these databases, it would have lost several significant rights over its genetic resources.

Thus, unless there is a public database that provides a safe, secure, accountable and trustworthy platform to share DSI, these problems cannot be solved, but the proposed elements have nothing to offer in this regard. This situation favours neither the multilateral mechanism nor the Parties to secure benefits from the use of the DSI or to ensure their genetic materials and information are accessed legitimately. It only favours technologically advanced countries, including non-Parties to the CBD and Nagoya Protocol and their private sector, allowing them to extract DSI inequitably, in particular from weaker developing countries.

Although some may defend these databases and argue that they provide open access to DSI, it must be noted that INSDC and other similar databases do not actually guarantee open access. Instead, the databases retain the right to always unilaterally suspend or terminate access, with no accountability to CBD Parties. A few of them, in particular INSDC, also retain the right to perpetually store the DSI submitted to them, even if the DSI is submitted without the knowledge of the country of origin of the genetic material.

At the same time, such databases could subject DSI sharing and usage to the policies of the United States, a non-Party to the CBD or Nagoya Protocol, by locating their servers there. The United States could then easily make policies that could frustrate benefit sharing from the use of the DSI, as well as to curtail future access to DSI.

No foreseeable benefits

As mentioned above, the proposed elements do not make any suggestion to generate an obligation to share monetary and non-monetary benefits, either at the international or at the national level. At the same time, it requires Parties to refrain from adopting national access and benefit sharing measures seeking benefits from the use of the DSI from public databases.

Parties are required to adopt administrative, policy and legal measures to encourage and enable users to make contributions to the global fund. The phrase “encourage and enable” does not indicate any intention to obligate users to share monetary benefits to the global fund. 

Regarding large and transnational companies, there is another standard mentioned whereby countries are to take measures to “facilitate or ensure” contributions to the global fund. This also gives Parties an option to choose to facilitate rather than to ensure, again meaning there is no proposal either for a strong obligation for large transnational companies to share monetary payments.

Further, there is no element proposed by the Co-Chairs in operationalizing non-monetary benefit sharing, except for the proposal that all users should share non-monetary benefits subject to their individual circumstances. The proposal means that the user is not required to share non-monetary benefits if they claim their individual circumstances do not allow them to do so. It completely erases the rights of the country of origin of the genetic materials from which the DSI is generated and prevents such Parties or the multilateral mechanism from making any demands for non-monetary benefit sharing.

Above all, the proposed elements rely only on national measures to encourage benefit sharing, and do not attempt to develop a multilateral mechanism that obligates users of the DSI to share benefits contractually, regardless of the jurisdiction in which they operate. The proposed elements fail to take into account that a majority of users of DSI are under U.S. jurisdiction and the U.S., being a non-Party, has no obligation to adopt any national measures to ensure the users from their jurisdiction will contribute to the global fund.  

Thus, the proposed elements do not add up to a legal scenario in which benefit sharing will be legally certain, predictable, fair and equitable. Covid-19 vaccine development and production are classic examples where users avoided sharing both monetary and non-monetary benefits, because they could effectively use the DSI from the public databases, and bypass contractual benefit sharing obligations.

Furthermore, it is a fundamental error to classify users of DSI or genetic resources according to the nature and size of the users and propose that only large transnational companies might be subjected to an obligation to pay benefits. Benefit sharing should not be calculated based on the nature and size of the user but based on the nature and size of the outcomes of the utilisation of the genetic resources.

For example, even a small-scale company or a not-for-profit research organisation may find a breakthrough medicine for cancer that can make huge profits using an endemic plant from a developing country. This organisation should also share benefits. Just because the entity is small-scale and not-for-profit, they cannot be exempted from the benefit sharing obligation. If they are exempted, it will lead to a situation where the medicine can be expensive and denies equitable access to most affected people. At the same time, the provider country of origin of the endemic plant species would also be denied a fair share of profits which the company makes.

In short, the elements proposed do nothing but perpetuate the current inequitable situation. It sets the stage for continued avoidance of obligations to share benefits fairly and equitably.

Inconsistency with the CBD and Nagoya Protocol

The proposed elements are inconsistent with the CBD and Nagoya Protocol. The proposals undermine the sovereign rights of States over genetic resources. The proposed elements take it for granted that all Parties should cease to apply national access and benefit sharing (ABS) measures on DSI available in the public databases. This is inconsistent with the CBD and Nagoya Protocol on several counts.

First, it is for the Parties to decide whether they should apply the multilateral mechanism or national ABS measures on the DSI available in the public databases. Article 15 of the CBD, read with Article 1, not only recognizes sovereign rights over genetic materials, but guarantees full autonomy to the Parties in deciding on the modes and conditions of access to genetic materials as well as appropriate use of the same. Generating DSI and providing access to DSI for further research and development are included in this bundle of rights, because providing access to DSI is also considered as a method of providing access to genetic materials. The rights are reiterated in the Nagoya Protocol.

Second, Article 19 of the CBD mandates that benefits “arising from the biotechnologies based upon provided genetic resources” should be shared fairly and equitably. Under Article 5 of the Nagoya Protocol read with Article 2 of the Protocol, benefits arising from the utilisation of the genetic resources “including through application of biotechnology” and “its subsequent application” should be shared fairly and equitably. Therefore, DSI is clearly a product of application of biotechnology on genetic materials and its subsequent applications are subject to benefit sharing obligations mandated by the Parties.

Third, under Article 17 of the CBD, Parties have a right to repatriation of the information generated as a result of technical, scientific and socio-economic research, meaning Parties have a right to request illegitimate users of information from its resources to stop further utilising such information or distributing such information to others. 

Fourth, under Articles 15 and 17 of the Nagoya Protocol, Parties are under an obligation to cooperate in cases of alleged violation of domestic ABS legislation or regulatory requirements that provide for genetic resources utilised within its jurisdiction to have been accessed in accordance with the domestic access and benefit-sharing legislation or regulatory requirements of the other Party.

Thus, under the CBD as well as based on basic principles of international law, Parties have full policy space to apply national ABS measures on the DSI generated from their genetic materials, whether such DSI is deposited in public databases or not. Parties to the CBD have the obligation to respect such exercise of the rights by other Parties.

For example, country A could establish a national public database, and require all legitimate recipients of their genetic materials that sequence such material, to deposit the DSI into the national public database or a nationally designated database. Country A could also request other databases, upon receiving DSI generated from its genetic resources, to repatriate such DSI to the national database. Country A could require users of the national public database to contribute to a national fund, a certain amount or percentage of the revenue generated. It can also require users to report back outcomes of their research and development and to enter into negotiation with national authorities for sharing non-monetary benefits, fairly and equitably. Country B should provide all legal assistance and a better environment where the users of Country A’s public database from Country B’s jurisdiction complies with the terms and conditions set by Country A.

However, the proposed elements completely deny all these possibilities by requiring Parties to refrain from adopting national ABS measures on the use of DSI from public databases and at the same time, propose no good governance measures relating to the sharing and use of the DSI. Interestingly, there is not even a proper definition or characterization of what a public database is. There are no proposals to establish or identify databases that will be accountable to the CBD and its Parties. The proposal not only leads to a precarious situation where small developing countries must rely on predatory databases, but also to a situation where developing countries cannot even establish a national public database and roll out national ABS measures for the use of DSI.

Thus, the proposed elements are inconsistent with the CBD and Nagoya Protocol.

Inconsistency with universally agreed principles of open science

The proposed elements are also inconsistent with universally agreed principles of open science, in particular the principles and provisions of the UNESCO Recommendation on Open Science 2021.

The recommendation clearly defines both open scientific knowledge and open research data as applicable to open access to DSI. It explicitly recognises that such open access to scientific knowledge or data is subject to conditions, and licences in accordance with good data governance. Collective benefit, equity and fairness are a few core values that are recognized by the recommendation.

More importantly, the recommendation identifies elements of good governance principles of open science. The proposed elements however neglect these elements of good governance, and allow the continuation of current disorderly, fragmented and unaccountable DSI sharing, which undermines benefit sharing as well as open access.

It must be noted that (i) public accountability, (ii) sensitivity to conflicts of interest, (iii) vigilance as to possible social and ecological consequences of research activities, (iv) intellectual integrity and (v) respect for ethical principles and implications pertaining to research, are clearly identified as elements of good data governance under the recommendation. The current practices of DSI sharing are inconsistent with all these elements.

First, public databases, particularly the INSDC database collaboration, allow for anonymous downloads and do not undertake responsibility for guaranteeing access to DSI, neglecting the need for public accountability. 

Second, these databases refuse to obligate the users of DSI to share benefits fairly and equitably and assume they will voluntarily undertake such obligations and share benefits. This does not take into account the conflicts of interest users have when it comes to sharing benefits with provider communities, fairly and equitably.

Third, DSI involves biological information that can be subjected to dual use. However, there is no due diligence undertaken by the databases such as verification or know-your-customer policies to reduce potential illegal and dual use. Thus, there is no vigilance exercised by the databases as to the consequences of use of DSI.

Fourth, these databases allow users to submit and share DSI through them, even when they do not disclose the country of origin. While non-disclosure is a clear disregard of intellectual integrity, the current databases do not care about such an attitude. For nearly three decades they have not mandated country of origin as an important data point in sharing DSI. Recently, they have started asking for geospatial and time coordinates, however this is with exceptions.

Fifth, public databases on one hand consider benefit sharing as an ethical issue, while benefit sharing is a clear obligation under the law. On the other hand, these databases do not make any effort to monitor, encourage or create an atmosphere where such ethical considerations could be delivered in reality.

Finally, the several databases that are recognized as public and open by the developed country governments have heavily one-sided terms and conditions enabling them to discontinue their services partially or fully, to certain or all users. At least one such database, important for public health research, has been involved in several discriminatory practices in screening users as well as in providing its services. In short, none of these databases are accountable to the CBD and its Parties, neither do they guarantee open access to all.

Thus, the proposed elements ignore these inconsistencies with universally agreed open science and open access principles, and do not address the inequities created in DSI use and benefit sharing.

Biosecurity concerns ignored

Use of DSI can lead to several biosecurity concerns such as the synthetic creation of pathogens that had been eliminated (e.g. Variola virus), gain of function research resulting in enhanced pathogenicity, development of biological or biochemical weapons that might not only target humans, but also food systems and agriculture.

Quite surprisingly, regulations in the biotechnology sector are very minimal compared to the risks it poses. Several guidelines and regulations focus on synthetic biology and service providers who take orders to synthesise biological materials from clients. Such service providers are required to put in place “know your customer” policies or measures to ensure that their services are available only for lawful and peaceful purposes. Similarly, in the U.S. framework, the service providers are also required to screen their orders to review whether the customer is ordering the synthesis of sequences of concern, meaning sequences having dual use. In contrast, there are no such requirements on the databases that provide DSI or other service providers who deploy sequencing technologies on genetic materials.

The proposed elements also do not take into account these implications. They could have at least proposed a know-your-customer policy for public databases, to infuse more accountability and transparency in DSI sharing. Recently, even the U.S. has started to articulate that the focus of biosecurity measures should be expanded to all sequences and it should no more be limited to sequences of concern. The advancement of science and technology, such as benchtop DNA printers, raises concerns in this regard.

Studies undertaken on public databases sharing genetic information show that their structure and back-end systems are prone to cyber-biosecurity threats. Concerns have been expressed by scholars over anonymous access to DSI of pathogens in these databases. One of the basic suggestions put forward in ensuring better cyber biosecurity is to stop models of anonymous usage. These studies appear to have been ignored while developing the Co-Chairs’ proposal.

Flawed premise and assumptions

The proposals made by the Co-Chairs appear to rest on the European position on the use of DSI and benefit sharing. The E.U. claims that once the DSI gets deposited in public databases, then the use of such DSI by others should be considered to be out of scope of ABS regulations, while the E.U. also recognizes that Parties can exercise their sovereign rights and ensure that the DSI generated from their genetic materials are governed by their national laws, before it lands up in the public databases.

This view is fully adopted by the Co-Chairs without thorough examination of the underlying assumptions, their validity and future implications. This view of the E.U. is highly erroneous with regard to their understanding of public databases. The so-called public databases, be it INSDC or a few others like GISAID or GBIF, do not say that the DSI is free from national benefit sharing rights and obligations. On the other hand, the databases take a hypocritical position that they are not responsible for any infringement of such third-party rights by the users.

For instance, paragraph 4 of the EMBL ENA’s terms of use under the section on Data states thus: “The original data may be subject to rights claimed by third parties, including but not limited to, patent, copyright, other intellectual property rights, biodiversity-related access and benefit-sharing rights. For the specific case of the EGA database and human data consented for biomedical research, these rights may be formalised in Data Access Agreements. It is the responsibility of users of EMBL-EBI Data Resources and Tools to ensure that their exploitation of the data does not infringe any of the rights of such third parties.”

The E.U. also assumes that other Parties cannot develop public databases and host DSI, with better data sharing practices, including better respect for the rights of the country of origin and obligation to share benefits arising from the use of DSI. This assumption is reflected in the Co-Chair’s proposal, whereby they require Parties to refrain from developing national ABS measures on DSI hosted in public databases.

The European countries are seeking to use their hegemonic position as one of the three sponsors of the INSDC to frustrate benefit sharing from the use of DSI from such databases and at the same time, to continue having control over the world's genetic resources through digital means. Unfortunately, the Co-Chair’s proposals coincide with these views, backed by other developed countries, certain industries and scientific lobbies.

The views of developing countries and other stakeholders such as civil society organisations that have called for accountable public databases, indigenous peoples who have called for their rights over DSI generated from their genetic materials and members of scientific communities who have called for guaranteed and non-discriminatory access to DSI for all, are regrettably not included in the proposals.+