Multilateral Matters
An occasional blog on International developments related to intellectual property, innovation, development and public policy.
Preface by Adjunct Professor Wend Wendland
International law already regulates access to and fair and equitable benefit-sharing in genetic resources located within the territories of countries.
However, it was not clear what legal regime applies to marine genetic resources (MGRs) in areas beyond national jurisdiction – such as in the high seas and the seabed beyond the limits of national jurisdictions.
Therefore, member countries of the United Nations (UN) began to develop a new international legally binding instrument on MGRs beyond national jurisdiction. This negotiation took place under the United Nations Convention on the Law of the Sea, 1982 (UNCLOS).
Multilateral Matters # 2 (November 2018) and Multilateral Matters #10 (September 2021) explained, analyzed and reported on this negotiation up to November 2018 and September 2021, respectively.
Since then, the negotiating body – an Intergovernmental Conference (abbreviated as “IGC” or “the Conference”) – has met three times, most recently in February 2023. In the most recent meeting, negotiators finally agreed on the text of an international legally binding instrument under UNCLOS on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction.
Nabanji Nanjomwa Nebwe, currently at the World Intellectual Property Organization (WIPO) as part of the Young Experts Program, has been working with me since early 2022, and is well placed to provide Multilateral Matters readers with a report on the concluding development in this intriguing, challenging and important negotiation.
Nabanji, over to you.
Let’s catch up – where are we now?
Picking up where Multilateral Matters #10 left off, IGC 4 (which had been postponed due to the COVID 19 pandemic) was finally convened from March 7 to 18, 2022. During the session, delegations prepared and submitted textual proposals, often jointly, in order to make progress on the draft text. Agreement was reached on some issues, but there remained diverging views on the establishment of an access and benefit-sharing (ABS) mechanism, amongst others. At the close of the session, the IGC considered that an additional session was required.
For that reason, IGC 5 was convened from August 15 to 26, 2022 and the methodology of “informal informals” was maintained, covering, as before, the four thematic clusters under negotiation: marine genetic resources (MGRs); area-based management tools; capacity building; and, the transfer of marine technology. Progress was made on the revised draft text, with countries finding agreement on a number of issues but not all.
However, the Conference was suspended on the final day and in a statement, the President of the IGC, Rena Lee (Singapore), expressed her view that the revised draft text was not reflective of agreement on all issues but rather of the direction in which most delegations were willing to proceed and of the compromises made on key issues[1].
Finally, on Saturday, 4 March 2023, following almost 36 hours of consultations, delegates agreed on the draft agreement under UNCLOS on the conservation and sustainable use of BBNJ[2] (“the final agreement”).
This blog post will analyze the text of the final agreement from an intellectual property (IP) perspective, building on some of the discussions previously addressed in Multilateral Matters with regard to ABS and IP rights. It will also address traditional knowledge (TK) of Indigenous Peoples as well as local communities (IPLCs) in the context of the new agreement.
Let’s dive in.
Intellectual Property
The draft text discussed during IGC 5 (and previous sessions of the IGC) contained Article 12 which covered IP rights. The intention of the provision was to address patents on inventions arising from the commercialization of MGRs from areas beyond national jurisdiction, however, delegations failed to find agreement on the wording of the article[3]. Some delegations identified WIPO as the appropriate forum to address these issues, with emphasis on the recent resolution by WIPO to convene a diplomatic conference on an international legal instrument to address genetic resources and associated TK[4]. However, in the end, there remained split views on whether to address IP at all and, if so, the manner in which it should be done[5].
The final agreement clearly reveals that a decision was finally made to do away with Article 12 addressing IP. Nonetheless, a few IP issues still arise from the final agreement; let us begin with TK and the rights of IPLCs.
Article 13
Traditional knowledge of Indigenous Peoples and local communities associated with marine genetic resources in areas beyond national jurisdiction
Parties shall take legislative, administrative or policy measures, where relevant and as appropriate, with the aim of ensuring that traditional knowledge associated with marine genetic resources in areas beyond national jurisdiction that is held by Indigenous Peoples and local communities shall only be accessed with the free, prior and informed consent or approval and involvement of these Indigenous Peoples and local communities. Access to such traditional knowledge may be facilitated by the clearing-house mechanism. Access to and use of such traditional knowledge shall be on mutually agreed terms.
The above article recognizes the right of IPLCs to grant access to their TK through free prior and informed consent (FPIC). This is a positive outcome for the recognition of IPLCs’ rights despite most instruments addressing FPIC operating as soft law rather than being legally binding[6]. The adoption of the FPIC principle under this agreement underscores the great importance of TK in promoting scientific advancement and discovery and more importantly enforces, with greater emphasis, the need for legitimate and authorized access to TK.
How will access to TK be achieved?
As highlighted, the clearing-house mechanism under the agreement may be used for this purpose, with Article 51 3 (c) being the article most relevant to TK.
Article 51
Clearing-house mechanism
3. The clearing-house mechanism shall:
(c) Provide links to relevant global, regional, subregional, national and sectoral clearing-house mechanisms and gene banks, repositories and databases, including those pertaining to relevant traditional knowledge of Indigenous Peoples and local communities and promote, where possible, links with publicly available private and non-governmental platforms for the exchange of information;
. . .
As provided, the mechanism will operate to provide links with other clearing-houses, repositories or databases including those that house relevant TK of IPLCs. It will also promote exchange of information with relevant private and public platforms, and this is an excellent approach. It will be interesting to see how these linkages will advance the documentation of TK on MGRs in areas beyond national jurisdiction.
Access and Benefit-sharing; Digital Sequence Information (DSI) and Scientific Data
The main goal of access to and benefit-sharing in GRs is to make it possible for the fair distribution of benefits between the users of the resources and the providers of the resources. The net result of this exchange is increased innovation and incentives for the conservation of biodiversity for both parties[7]. Naturally, the situation is a bit more obscure when everyone is considered a provider of the resource and a user of the resource at the same time.
How far should we go?
Article 14 below highlights how the final agreement has dealt with the issue. I reproduce only certain parts of the Article:
Article 14
Fair and equitable sharing of benefits
. . .
2. Non-monetary benefits shall be shared in accordance with this Agreement in the form of, inter alia:
(b) Access to digital sequence information in accordance with current international practice.
(c) Open access to findable, accessible, interoperable and reusable (FAIR) scientific data in accordance with current international practice and open and responsible data governance.
. . .
4. Access to marine genetic resources and digital sequence information on marine genetic resources of areas beyond national jurisdiction in the repositories and databases under a Party’s jurisdiction may be subject to reasonable conditions as follows:
(a) The need to preserve the physical integrity of marine genetic resources;
(b) The reasonable costs associated with maintaining the relevant database, biorepository or gene bank in which the sample, data or information is held;
(c) The reasonable costs associated with providing access to the marine genetic resource, data or information;
(d) Other reasonable conditions in line with the objectives of this Agreement; and opportunities for such access on fair, most favorable terms, including on concessional and preferential terms, may be provided to researcher and research institutions from developing countries.
5. Monetary benefits from the utilization of marine genetic resources and digital sequence information on marine genetic resources of areas beyond national jurisdiction, including commercialization, shall be shared fairly and equitably, through the financial mechanism established under article 52, for the conservation and sustainable use of the marine biological diversity of areas beyond national jurisdiction.
. . .
Digital Sequence Information (DSI)
The question of access to DSI has plagued decision-makers at the international level for years. There is still no set definition of DSI at international level and access to it has not been standardized, thereby resulting in a lack of uniform understanding as well as creating legal uncertainty[8].
During the discussions at the conference, delegates acknowledged that there was no definition of DSI, but that the term had been used as a placeholder in discussions under the auspices of the Convention on Biological Diversity (CBD). Nonetheless, it is clear that the delegations felt that the subject of DSI was worth including in the final agreement[9].
The publication of DSI does not on its own create monetary value, but it creates a resource that generates scientific value and has economic potential. One of the arguments against open access to DSI has been its potential to be abused by allowing the free downloading of the data as an alternative to obtaining the physical MGRs in situ. This would, amongst other things, permit individual gain through commercialization at the expense of the scientific community, which makes the DSI openly available for everyone’s benefit[10].
It appears that to curb this threat, the agreement mandates open access to MGRs of ABNJ and DSI. This is to be achieved through open access to databases/repositories, subject of course to the reasonable costs of operating the platforms. Furthermore, the sharing of any monetary benefits arising from the use of MGRs and DSI including commercialization is mandatory.
Therefore, inventions made using MGRs of ABNJ and DSI are protectable under patents, which allow for commercialization, but, for any financial gain, contributions must be made through the financial mechanism under the agreement. This appears to be a win-win outcome for the scientific community and for all countries championing the inclusion of DSI in ABS regimes.
One of the challenges that has been identified, with monetary contributions for use of DSI, is the difficulty in tracing its use, principally once it has been synthesized into a compound and blended into a final invention. In addition, the complexity of the situation increases where several genes from different organisms are combined in a single product[11].
Regardless, the final agreement focuses on the sharing of benefits for the use of MGRs and DSI irrespective of how they are combined or synthesized.
- Access to Scientific Data
As per Article 14 (a), open access to ‘findable, accessible, interoperable and reusable’ (known as FAIR) scientific data of MGRs in ABNJ is mandatory. Nevertheless, the nature of open access to data is in direct opposition to the principles governing the protection of IP. In this area, IP has been seen as inhibiting the participation of economic agents in the development of knowledge by imposing a limitation on how they can participate (i.e. through licenses and exceptions)[12].
One may wonder about the relevance of the FAIR scientific data principles. In order to ensure good scientific data practices, the processing of increased volumes of scientific data requires uniform standards to ensure findability, accessibility, interoperability and reusability. This is particularly necessary for machine processing, which is now the principal tool by which data is sourced, processed and utilized[13].
The principle is well placed within the agreement, as ensuring that the scientific data of MGRs in ABNJ complies with the FAIR data principles overrides potential disparities in the access to and quality of data.
In relation IP rights (in particular copyright applicable to databases), they cannot operate to impede access. This, of course, is in line with the ‘common heritage of humanity’ principle, which is one of the governing principles of the agreement and highlights that marine resources in ABNJ belong to all humanity. Nonetheless, it is interesting to see how IP rights have been respected in provisions relating to access to MGRs and DSI by permitting commercialization, but overridden in relation to access to scientific data. Patents appear to have an upper hand over copyright in this case.
Conclusion
It is apparent that the failure to agree on whether to address IP under the agreement ultimately led to its exclusion. This is perhaps primarily due to questions of whether this was the appropriate forum to do so. However, it is clear that the parties could not completely do away with matters of IP, as these would naturally arise when dealing with MGRs and questions of access to samples and data.
In addition, the recognition of traditional knowledge and the rights of IPLCs is commendable and is more than likely to be well received by Indigenous Peoples, as well as local communities, around the world.
Concluding such an agreement was no small feat! Its application is fundamental in advancing the protection of MGRs of ABNJ and ensuring global benefits, whilst recognizing the need to promote innovation and ensure conservation of BBNJ.
This blog is written in the author’s personal capacity and does not represent the view of the organization or institution. This blog was written in August 2023.
Endnotes
[1] UN document A/CONF.232/2022/9.
[2] Earth Negotiations Bulletin: BBNJ IGC-5 Highlights: 20 February – 4 March 2023
https://enb.iisd.org/marine-biodiversity-beyond-national-jurisdiction-bbnj-igc5-resumed-summary (Accessed March 2023)
[3] Earth Negotiations Bulletin: BBNJ IGC-5 Highlights: Thursday, 18 August 2022 https://enb.iisd.org/marine-biodiversity-beyond-national-jurisdiction-bbnj-igc5-daily-report-18aug2022 (Accessed March 2023).
[4] Earth Negotiations Bulletin: BBNJ IGC-5 Highlights: Monday, 29 August 2022. https://enb.iisd.org/marine-biodiversity-beyond-national-jurisdiction-bbnj-igc5 (Accessed March 2023)
[5] UN document A/CONF.232/2022/9 Annex p.4
[6] T. Ward, The Right to Free, Prior, and Informed Consent: Indigenous Peoples’ Participation Rights within International Law (2011) Northwestern Journal of International Human Rights, Vol 10 Article 2 p. 58
[7] Aysegul Sirakaya, Balanced Options for Access and Benefit-Sharing: Stakeholder Insights on Provider Country Legislation (2019) https://www.frontiersin.org/articles/10.3389/fpls.2019.01175/full (accessed March 2023).
[8] C Seitz 2020 IOP Conf. Ser.: Earth Environ. Sci. 482 012002
[9] Earth Negotiations Bulletin: BBNJ IGC-5 Highlights: 20 February – 4 March 2023
[10] FAIR Principles https://www.go-fair.org/fair-principles/ (Accessed April 2023)
[11]Olive Heffernan Who Owns the Ocean’s Genes? Tension on the High Seas (2022). https://www.scientificamerican.com/article/who-owns-the-ocean-rsquo-s-genes-tension-on-the-high-seas/
[12] R.M. Unger, The Knowledge Economy, p. 54 (2019) https://www.oecd.org/naec/THE-KNOWLEDGE-ECONOMY.pdf (Accessed April 2023)
[13] UN document A/77/L.62 https://undocs.org/Home/Mobile?FinalSymbol=A%2F77%2FL.62&Language=E&DeviceType=Desktop&LangRequested=False (Accessed April 2023)