13.3.1 The Basic Proposal

The freedom to access and use genetic resources for global public health purposes, once confirmed by the COP, must accordingly be coupled with a corresponding duty to share proceeds from the results with the country or countries providing genetic materials – in this case, any pathogens at issue. An obligation to this effect must thus be embodied in any waiver for research purposes adopted by the parties to the CBD. Such a waiver should free scientific researchers from negotiating access and usage at the upstream, noncommercial research stage but not from the duty to report and share proceeds from all downstream commercial applications.

Ideally, any solution to the problems of conforming potential uses of pathogen GSD to the CBD requirements would ultimately be embodied in a multilateral agreement applicable to all the member states. Such a regime should incorporate a waiver of PIC and MAT for noncommercial scientific access and uses. Benefit-sharing terms would nonetheless be triggered when, and only if, commercial applications are envisioned using a “change of intent” clause that expressly guarantees compliance with the CBD’s benefit-sharing obligations.

From a purely legal perspective, the legitimacy of such an initiative would follow from Articles 4 and 8 of the Nagoya Protocol. Article 4 validates multilateral arrangements for facilitated access to genetic resources for research and applications, which would override the need to bargain directly with national governments in every case, as otherwise required under Article 8 (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015). A multilateral framework adopted to facilitate scientific research would thus be necessary to bring any given project within the scope of Article 4. Once codified by the COP, any standard-form waiver favoring pathogen research that covered specific projects should thereafter suffice (Reichman, Reference Reichman2018).

To implement such a waiver, Standard Material Transfer Agreements (SMTAs) authorizing noncommercial research under the CBD should likewise embody a “change of intent” clause and define how that clause should apply to specific collaborative ventures (Reichman, Reference Reichman2018; Ribeiro et al., Reference Ribeiro, Koopmans and Haringhuizen2018a). In principle, parties to these SMTAs would not need to expressly prohibit commercial use of public-research results, whether by private-sector or public-research entities. Instead, when applicable, drafters of both bioprospecting contracts and SMTAs to be covered by the proposed waiver should consider expressly allowing eventual commercial applications with some built-in equitable sharing of revenues if and when they are generated. Correctly devised and implemented “change of intent” clauses could thus help to stimulate both research and commercial applications.

Compliance measures of this kind could thus be validated a priori under either an amendment to the CBD or a waiver embodied in a multilateral Memorandum of Understanding (MoU) to be devised expressly for pathogen genetic resources with the collaboration and endorsement of relevant international organizations. If the global public health community were to take the lead, the proposed waiver for GSD would logically be developed by the WHO, with inputs from the microbiological community as represented by the World Federation of Culture Collections (WFCC).Footnote ¹⁷ Such an MoU would necessarily impose its waiver for noncommercial research purposes allowing unrestricted access to both pathogen materials and related data, including GSD. By the same token, the WFCC and the INSDC could conform to their standard sharing practices (Rohden and Scholz, Reference Rohden and Scholz2021), through SMTAs, notification of terms and conditions, or other access agreements. Additionally, they could provide links between the available resources and the legal (ABS) conditions of use for commercial applications, thereby acknowledging the proposed waiver for noncommercial research purposes.

In the long run, however, an MoU regulating pathogen sharing should serve as a steppingstone to a broader, more comprehensive waiver favoring noncommercial research access and use of all GSD and potentially other genetic resources – plant, animal, and microbial – under the CBD as a whole. Such a general waiver would have to be adopted by the COP. Once adopted, the resulting “change of intent” clauses to be embodied in SMTAs should enable local researchers to freely engage in international collaborations, as long as they are covered by the terms and conditions in the standard agreements.

The efficacy of such a regime would depend in part on the successful development of the tracking system under consideration at the World Intellectual Property Organization (WIPO), the WFCC, and INSDC (Bagley, Reference Bagley2016).Footnote ¹⁸ It is worth noticing, moreover, that microbes already cannot legally be exchanged for any research purposes without bearing unique identifiers that must be cited in all relevant publications (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015). The eventual ability of researchers to file SMTAs with the ABS Clearing House to be established under Article 14 of the Nagoya Protocol could then make it unnecessary for researchers engaged in international collaborations to notify their respective governments, so long as binding standard PIC, MAT, and ABS terms were embodied in the relevant SMTAs.

If the CBD’s COP or the WHO eventually decided to establish a consortium for purposes of exploiting pathogens and GSD on a globally regulated basis, they could also adopt a liability rule – that is, a “take and pay” rule – for commercial applications of GSD taken from the commons (or semi-commons, as the case may be) (Calabresi and Melamed, Reference Calabresi, Douglas Melamed and Segerson2018; Reichman and Lewis, Reference Reichman, Lewis, Maskus and Reichman2005). In assessing payment options, moreover, it seems worthwhile to consider the methods already adopted for such a purpose by the multilateral regime governing the Crop Commons, as established under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) in 2001 (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015). This approach entails a built-in “take and pay” rule for plant cultivars taken from the Crop Commons by commercial plant breeders. Suppose a similar scheme were to be adopted by the proposed multilateral regime to cover GSD under the CBD. In such a case, a liability rule could then require payment of a small percentage of any future commercial revenues back to the CBD’s commons to support the costs of the sharing enterprise.

Under this approach, a percentage of any commercial revenues stipulated ex ante must be paid either to the provider country when known or to the General Fund of the CBD under Article 10 of the Nagoya Protocol, if undetermined. Smaller access charges could also be required to support the costs of any global public repositories to be devised for GSD under pending proposals. As matters stand, the CBD already requires firms undertaking commercial applications to engage in prior benefit-sharing negotiations (bilaterally) with countries that provide relevant genetic resources or with other designated authorities covered by the treaty in certain cases. Under the aforementioned proposal, the obligation to share benefits with provider countries would instead be expressly incorporated into the waiver to be adopted by the multilateral regime for this purpose.

13.3.2 Further Implications of the Proposed Waiver

One persuasive argument for a codified waiver allowing research access and uses of pathogen GSD is that the concomitant obligation to share any proceeds from commercial applications would likely yield more monetary benefits for CBD countries that possess relevant genetic resources over time than any policy that otherwise restricted upstream scientific research. That realization should, in turn, make provider countries more willing to allow bioprospecting under the proposed waiver for research uses than at present. A case can also be made that such a waiver should lead to more nonmonetary societal benefits for all CBD member states in the form of better public health outcomes and more innovation. So, in the spirit of the CBD enhancing fairness in the utilization of genetic resources, such a multilateral system can also raise more funds to address inequalities in research capacity and strengthen public health response efforts.

Transnational collaborations to support responses to outbreaks also illustrate how the timely sharing of pathogen genetic resources benefits society, irrespective of whether they originated from provider or user countries. Experience with regard to the 2013–16 Ebola outbreak in West Africa supports this thesis. During that crisis, gaps in the sharing of viral samples and (meta)data, coupled with delays in the public release of GSD, led to speculation about the sources of infection, the possibilities of diagnosing the infection with available assays, and possible mutations over time that increased transmissibility (Dudas et al., Reference Dudas2017; Ribeiro et al., Reference Ribeiro, van Roode, Haringhuizen, Koopmans, Claassen and van de Burgwal2018b). Although at later stages of that outbreak, the near real-time sequencing of strains did finally provide essential information directly to public health officials, the suboptimal sharing of data throughout the outbreak eventually allowed the virus to spread to other countries in the region and evolve into a global health crisis.

It is also worth noting that the measures proposed in this chapter would not necessarily exclude other ancillary approaches. For example, even if global repositories for sharing pathogen GSD were eventually established, the contractual waiver proposed earlier in this chapter would remain viable and important in keeping with the goals of the CBD. Consider, for example, that the mere existence of publicly available repositories would not ensure that all relevant data would end up in such repositories (apart from the definitional issues concerning the scope of GSD/DSI discussed earlier) (Ribeiro et al., Reference Ribeiro, Koopmans and Haringhuizen2018a). A globally adopted waiver under the auspices of the CBD would, instead, apply to all relevant uses of pathogen data and materials, whether or not stored in public repositories, and the implementing instrument should expressly prohibit SMTAs from overriding the proposed waiver by contract.

In other words, once embodied within the CBD and its Nagoya Protocol, the waiver would become useful in every case. At the same time, any pooling of relevant repositories under the CBD, if successful, would further enhance the global scientific infrastructure. However, the willingness of biodiversity-rich countries to accept such a built-in waiver cannot be taken for granted. Besides concerns about enforceability, their participation may depend on estimates of the nonmonetary benefits likely to flow from open-data sharing and on the misconception that all genetic resources are likely to generate revenues for benefit-sharing purposes (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015).

In this context, the prospect of greater access to public databases (and possibly related technology) may seem to be an insufficient incentive to potential providers, especially if biodiversity-rich countries lack adequate molecular research capacity or biotechnology infrastructure to make domestic use of any resulting global repositories. The prospect of shipping samples abroad for sequencing is also an enduring concern for local governments that fear losing control over genetic resources whose data could easily be loaded into public databases. There have been cases, for instance, where samples initially shared for purposes of analysis were later presented at international meetings without advance notification or attribution to providers as authors (Sedyaningsih et al., Reference Sedyaningsih, Isfandari, Soendoro and Supari2008).

To address these remaining inequalities, rather than restricting access based on bilateral benefit sharing, a situation that is likely to be technically and logistically infeasible and would only benefit a few, a multilateral system for GSD would generate more access, use, and therefore benefits. These monetary and nonmonetary benefits could be directed to capacity-building initiatives in developing countries, such as bioinformatics training, building data infrastructures, and developing and providing data-analytical tools.

Still, it remains true that big companies and well-endowed research institutions may sometimes profit more from open-access policies and an expanding public domain than smaller competitors. For example, big players may find it easier to file patent applications on genetic markers, targets, specific genotypes, and the like (disregarding variations by country in what qualifies as patentable subject matter) (Bagley, Reference Bagley2016). Meanwhile, smaller enterprises that lack such capacity may be locked out.Footnote ¹⁹ Nevertheless, since such unequal opportunities are built into any competitive economic system, they constitute a fact of life that the COP cannot fully resolve.

One way around this problem is through the formation of a patent-holding consortium, whereby each contributor to the knowledge valorization process, including providers of genetic resources, researchers, and both large and small enterprises, are rewarded with a share of any funds arising from the resulting property rights (Simon et al., Reference Simon, Claassen, Correa and Osterhaus2005). Such a de facto patent pool could become a recognized component of ABS obligations under the CBD as a form of monetary benefit sharing. Moreover, properly devised “change of intent” clauses would further enable provider countries to benefit from foreign patents by means of built-in sharing conditions applicable to patents, patent pools, or other monetary sources.

To date, very few examples exist of patent pools during epidemics (Simon et al., Reference Simon, Claassen, Correa and Osterhaus2005). In May 2020, the WHO launched the COVID-19 Technology Access Pool (C-TAP) for developers of COVID-19 therapeutics, diagnostics, vaccines, and other health products to share their intellectual property through nonexclusive licenses in a patent pool. Nevertheless, the C-TAP failed to engage the major vaccine developers, which resulted in inequality in access to vaccines in developing countries (Van de Pas et al., Reference Van De Pas, Widdowson, Ravinetto, Srinivas, Ochoa, Fofana and Van Damme2022). This means that for such mechanisms to work during a crisis, they need to be embedded in a structured, democratic, multilateral governance framework and not dependent on political willingness and pressure during a crisis, guided mainly by narrow national interests.

In any event, steps should be taken to ensure that commercial entities identifiable by their Internet URLs are not excluded a priori from accessing and using pathogen GSD covered by the proposed waiver. A treaty-based waiver for pathogen genetic resources, including GSD, must recognize that “noncommercial” refers to the nature of the use and not the users. Commercial entities, not-for-profit organizations, and academic institutes should be allowed to use GSD for noncommercial research purposes. In contrast, their actual undertaking of commercial applications should always trigger the duty to pay reasonable royalties under the GSD waiver and the corresponding “change of intent” clause.

As regards the modality of implementing monetary obligations for both the commercial use of pathogen resources and funding for the multilateral system, as noted earlier, we endorse a built-in “take and pay” rule (i.e., “liability rule”) under which a small percentage of any commercial revenues stipulated ex ante must be paid either to the provider country or to a General Fund when that country remains unknown. In so doing, the COP might well consider that a simple set of standardized royalty obligations, like those of the ITPGRFA, would engender more upstream uses of GSD, which in the long run might create more likelihood for commercial revenues to be shared under the CBD.

One must recognize that some stakeholders may still cling to the notion that all uses of GSD should require prior negotiation on ABS. The fallacy of such a position is that neither side can accurately predict which products or revenues, if any, would ever result from upstream scientific research (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015). Moreover, an ex ante liability rule would significantly lower transaction costs for all relevant parties and clarify potential risks and costs for commercial entities when engaging in product development.

Will the CBD countries insist on some advance payment even for noncommercial or potentially commercial research using pathogenic resources? As previously noted, a relatively small “user’s fee” might become tenable when pathogen GSD are taken from a global commons or semi-commons, as the case may be, because such fees would help defray the costs of upkeep for the repositories in question (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015). Absent such an approach, the idea of charging substantial amounts for upstream research would almost certainly foster a needless barrier to both science and global public health, one that scientists will resist, disregarding any difficulties of implementation and enforcement.

As matters stand, any researcher wishing to publish internationally must lodge data with the open-access system, including researchers from biodiversity-rich countries working on domestic species (Rohden and Scholz, Reference Rohden and Scholz2021). However, if governments restrict this practice over time, it will become hard for local researchers to collaborate and publish internationally. Ironically, if publication or GSD use becomes restricted by governments, or if the industry cannot acquire legal certainty to use these resources, research may shift (and already has in some cases) to countries that do not have ABS measures or to nonparties to the Nagoya Protocol. This can not only limit the understanding of Earth’s biodiversity but also bias global scientific and public health research and development, such as in the case of the annual development of globally comprehensive seasonal influenza vaccines.Footnote ²⁰

Although many scientific journals still impose restricted (paid) access on their publications, after the genomic revolution – with the Human Genome Project and the adoption of the Bermuda Principles (Collins et al., Reference Collins, Morgan and Patrinos2003)Footnote ²¹ – there has been a strong trend toward the Open Science movement, with free sharing of GSD and related scientific data. Restricting this previously achieved freedom in data access, use, and sharing would constitute a regrettable step backward.

13.4.1 The Key Role of Open and Semi-Open Repositories for GSD

The use of sequencing technologies revolutionized the scientific community’s understanding and management of plant, animal, environmental, and human health. However, their optimal use has been dependent on the willingness and ability of countries to share relevant GSD. In this context, GSD function as inputs and outputs of the research process that should be made widely available for further research and public health purposes. This dual functionality has, in turn, elicited growing demands to place GSD in public repositories (WHO, 2017). Such repositories can be open to all legitimate users in the form of what is often labeled as a “commons” (Ostrom, Reference Ostrom1990). In appropriate cases, access and use may be limited to specified communities that have collectively contributed to and managed the repositories in question, as would occur under a “semi-commons” (Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015).

The most prominent open-access approach to sharing pathogen GSD is the INSDC in which 95 percent (705 out of 743 at the time of writing) of all relevant databases directly link to or download their sequence data (Rohden and Scholz, Reference Rohden and Scholz2021).Footnote ²² The INSDC has adopted a policy that rejects conditions that impose any restrictions on accessing its stored data, thereby enabling every person and institution, regardless of their background and intended use, to access these resources (Brunak et al., Reference Brunak, Danchin, Hattori, Nakamura, Shinozaki, Matise and Preuss2002). This data-access model is the most prominent example of an existing repository completely compatible with the Open Science movement. At this time, however, its very openness also poses the biggest challenges for monitoring ABS compliance. Efforts to make the INSDC open-access policies consistent with the multilateral approach proposed in this chapter could facilitate ABS implementation for pathogen resources generally. This follows because the GSD could be freely shared for noncommercial uses in keeping with the recognition of the nonmonetary benefits of Open Science. By the same token, a “change of intent” clause with regard to monetary benefit sharing could later be imposed through binding SMTAs as needed.

In contrast, a good example of a semi-commons model for sharing pathogen GSD was established by the Global Initiative on Sharing All Influenza Data (GISAID EpiFlu) (n.d.) as the global database for sharing influenza gene sequences and related metadata. GISAID plays an essential role in sharing influenza sequences among the WHO Collaborating Centers and National Influenza Centers under the WHO’s Pandemic Influenza Preparedness Framework for biannual influenza vaccine virus recommendations (WHO, 2014). The GISAID (2011) data-access policy is based on a legally binding agreement that every user must sign before being granted access. Users are not allowed to share GISAID’s sequence data with other nonsignatories to the agreement. GISAID thus provides an alternative to public domain databases in which data providers and users are not identified. Through its access agreement, GISAID could likewise provide a basis for monitoring and enforcing compliance with ABS obligations under the CBD. The GISAID model also addresses some of the inequality issues in open-access systems through the binding conditions in its data-access agreement, which stipulate that users acknowledge data providers in future publications and, when possible, engage them in research efforts.

Another recent initiative of interest was the Collaborative Management Platform for Detection and Analyses of (Re-)Emerging, and Foodborne Outbreaks in Europe (COMPARE) (2015), a major European Commission research project to which some of the authors of this chapter were external advisors and others were Consortium members. This project addressed the need to make sequence data broadly available to support rapid containment, identification, and mitigation of emerging infectious diseases and foodborne outbreaks. To accomplish this goal, COMPARE developed a database and sharing platform for GSD from diverse pathogens, enabling stakeholders in the human health, animal health, and food safety domains to readily access and use these same resources under a One Health approach (Gibbs, Reference Gibbs2014).Footnote ²³ To address inequalities in bioinformatics and data-analytics capacity, COMPARE (2015) also offered free online analytical tools that could help scientists and other users from ill-equipped institutions and countries to analyze and interpret the available data without having to mobilize large amounts of resources in computer memory and data storage.

Within its broad investigation of barriers to data sharing, the COMPARE project identified specific stakeholder groups with different interests to be taken into account when devising their roles as potential users of the COMPARE platform (Ribeiro et al., Reference Ribeiro, van Roode, Haringhuizen, Koopmans, Claassen and van de Burgwal2018b). The project nonetheless recognized that even these legitimate concerns should not block the timely and open sharing of data, which would compromise the project’s primary objectives. In addressing this quandary, COMPARE established separate data hubs in which sensitive data could be shared only among an agreed group of stakeholders under confidentiality terms, on the condition that after a reasonable period (six to twelve months, in general), that same data could ultimately be placed in the public domain. By means of this temporary embargo, which could be deemed a semi-commons arrangement, a delay in public sharing became acceptable when necessary. This model also addressed other key barriers to data sharing, including the need to allow a priority of use for analyzing the data by local researchers in provider countries while also enabling long-term access and use of the same data for legal research purposes. The model thus established a trusted environment for the prepublication of data with relevant stakeholders who might otherwise have been reluctant to deposit the data directly in the open-access site.

13.4.2 Further Policy Considerations

Looking beyond the question of access to pathogen GSD via either public or more restricted repositories, the sharing process under the CBD still requires attention to other important policy issues. First, the nature of the benefits at stake has evolved, with research collaborations, capacity building, and technology transfer modalities taking on new forms through the sharing of software, analytical tools, and other technologies, as well as increased sharing of GSD (and components thereof). As previously discussed, promising new research arrangements in the form of “global commons” or “semi-commons” (Reichman and Okediji, Reference Reichman and Okediji2012, Reichman et al., Reference Reichman, Uhlir and Dedeurwaerdere2015) both retain attribution and coauthorship as benefits and, in some cases, authorize more complex research collaborations in lieu of monetary rewards. These approaches are especially useful in precompetitive phases, when commercial applications for the resources or knowledge at issue are not yet, or may never be, established.

In addition, distinctions between “commercial” and “noncommercial” research should yield different implications for benefit sharing under the CBD. Yet, the lines between these two categories have become blurred in recent decades, as academic and government researchers increasingly partner with industry or otherwise act commercially (Overmann and Scholz, Reference Overmann and Scholz2017), and as the industry itself also contributes noncommercial findings and research to upstream research projects. In the public health field, this distinction becomes even more complex, given that the development of pharmaceutical products to respond to epidemics and other disease outbreaks sometimes generate low-profit margins (if any) and are increasingly subsidized by governments and health agencies in public–private partnerships (Van de Burgwal et al., Reference Van de Burgwal, Ribeiro, Van der Waal and Claassen2018).

Although a multilateral system could authorize noncommercial research under SMTAs, while a “change of intent” clause would still cover subsequent decisions to use research results in commercial applications (art. 8(a) of the Nagoya Protocol), the practical distinctions concerning when and in which specific cases commercial use is to be triggered would need to be defined. In practice, the authors acknowledge that there are limits to the technical legal device of “change of intent” clauses, especially in cases where GSD are shared in the public domain. Because such sequences move fluidly between commercial and noncommercial institutions, once uploaded to open-access databases, they become available for all to use, regardless of the distinction between the two types of use.

Tracking and tracing GSD to monitor their access, use, and sharing are also essential steps to the enforcement of ABS compliance and, at the same time, constitute a major challenge for the inclusion of GSD within the scope of the Nagoya Protocol. From a purely technical perspective, these issues depend on the implementation of technologies that enable the tracking, tracing, and monitoring of genetic resources (Rohden and Scholz, Reference Rohden and Scholz2021). But even when tracking becomes technically more reliable, it may not fully resolve some managerial problems. For example, with or without tracking, questions could remain as to who did the work that led to commercialization; what GSD they employed; who the owners of the sequences in question are; and what rights they should have, if any, against those who solved the problem that produced a commercial application (Butler, Reference Butler2013).Footnote ²⁴ Moreover, monetary benefits flowing from the use of GSD remain inherently speculative due to challenges in identifying both the provenance and value of any given sequence or its components in complex applications.

Another fundamental issue to be addressed under a multilateral framework is ensuring that benefits are shared with legitimate providers and that they otherwise contribute to the original objectives of the CBD and its Nagoya Protocol. Grantors that fund research projects likely to involve pathogens and other related sequence data should expressly require grantees to comply with the CBD and Nagoya Protocol and, in particular, their ABS obligations. This approach would thus resemble the typical requirements of grantees to respect intellectual property rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). In appropriate cases, funders could also require that GSD resulting from a grantee’s project be deposited in designated and certified repositories.