“Just” Sharing: The Virtues of Digital Sequence Information Benefit-Sharing for the Common Good
Margo A. Bagley
Genome sequence information is being used to develop improvements in diverse product areas from agriculture to therapeutics. In fact, the rapid development of COVID-19 vaccines required access to the genome sequence of the virus. Beyond the COVID- 19 context, however, vast amounts of what is being called digital sequence information (DSI) are being used and patented, without permission from the countries that own the genetic resources from which the sequences are derived. This issue is stymieing negotiations in several international fora, including the UN Convention on Biological Diversity (“CBD”) and its Nagoya Protocol. These treaties obligate users of genetic resources to share the benefits of resource utilization with the resource providers. But parties disagree profoundly on whether these obligations extend to DSI. And as DSI often obviates the need for access to tangible material, monetary benefits are likely to decline even further.
This Article identifies challenges to and opportunities for achieving “just” sharing outcomes on DSI under the CBD and Nagoya Protocol and argues for the development of a global multilateral benefit-sharing mechanism as a more just and efficient vehicle for compliance with benefit-sharing obligations while retaining open access to sequence information. The prime benefit-sharing beneficiaries are intended to be the indigenous peoples and local communities who conserve and safeguard global biodiversity, yet who often are the most socioeconomically deprived among us. As such, this Article also situates the DSI benefit-sharing controversy within the larger societal moments focused on justice for the vulnerable and climate change mitigation.
“When we’re not hungry for justice, it’s usually because we’re too full with privilege.” — Carlos A. Rodríguez
INTRODUCTION
What do the World Health Organization, the Convention on Biological Diversity, the Convention on the Law of the Sea, and the Food and Agriculture Organization have in common? In addition to being United Nations (“UN”) bodies or treaties, they are some of the fora where issues of access and benefitsharing in relation to digital sequence information (“DSI”) are under active, sometimes contentious, discussion. What is DSI and why is it engaging the international community? The development of a treatment for Ebola provides one illustration of the nature of concerns regarding DSI.
Zaire ebolavirus is a horrifying virus. In humans, its symptoms include fever, intense vomiting, and diarrhea. Because the virus causes levels of blood-clotting cells to drop, patients often present with uncontrollable internal and external bleeding, including from the nose and eyelids. So news that the US Food and Drug Administration (“FDA”) had finally approved a treatment for Ebola in October 2020 was cause for great celebration. However, there is a wrinkle in the otherwise positive narrative surrounding the drug’s development: the potential inaccessibility of the drug to Africa’s neediest patients, despite Regeneron’s reliance on West African genetic sequence data in creating the drug.
Ebola is not a new disease; the first reported Ebola outbreak was in Zaire in 1976. But because it appeared sporadically and only in poor African countries, directing enough effort and funding to develop a cure was not a priority for Western drug developers.
That changed in 2014 with the Ebola outbreak in West Africa that resulted in at least 28,000 infections, with a 40% fatality rate. The disease eventually entered the United States, which made finding a treatment a national security matter. Enter Regeneron Pharmaceuticals, developer of the Ebola drug REGN-EB3, now known as Inmazeb™. The drug was developed in part through use of a virus strain sequence obtained by Regeneron from the publicly accessible database GenBank operated by the US National Center for Biotechnology Information (“NCBI”). The sequence information for the strain had been uploaded without restriction to the GenBank database by the Bernard Nocht Institute for Tropical Medicine (“BNITM”), a member of the German Leibniz Association, and had been sequenced from a survivor of the 2014 Guinean Ebola outbreak.
BNITM required recipients of physical samples of the virus to sign a material transfer agreement (“MTA”), affirming the need to negotiate benefitsharing arrangements with Guinea for any commercial products developed using those samples in accordance with the United Nations Convention on Biological Diversity (“CBD”). However, BNITM did not require such an agreement for the use of the uploaded sequence information.
REGN-EB3 attracted over US $400 million in research and development commitments from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (“BARDA”). It also received “Orphan Drug” designation from both the US Food and Drug Administration and the European Medicines Agency, providing its private sector developer Regeneron with — inter alia — tax breaks for R&D expenditures and time-bound market exclusivity for the drug. In addition, more than 100 patent applications have been filed on the drug worldwide, with some already granted in the United States, Nigeria, and South Africa.
Once the drug was shown to work — so effectively that clinical trials were cut short — BARDA contracted to purchase all the drug Regeneron could produce in order to create a domestic stockpile. Moreover, when new outbreaks of Ebola occurred in the Congo in 2020 and 2021, BARDA agreed to provide the drug to the Congolese government for free.
Regeneron stands to profit quite handsomely from its development of Inmazeb™, and it certainly should be well-compensated. However, the Guinean virus strain appears to have been a crucial link in the development of the drug, and while the Guinean government is the sovereign owner of the tangible virus sample from which the sequence was derived, Regeneron is under no obligation to share any monies with that government nor provide special pricing or other benefits related to Inmazeb™. In fact, Guinea and other African countries will be dependent on the goodwill of the United States to make the drug available at an affordable cost even though the drug could not have been developed without sequence information from African genetic resources.
The Ebola drug development scenario is not an isolated instance. Sequence information from untold numbers of organisms is being used to develop improvements in diverse product areas from agriculture to therapeutics. Quite often, such information is being used, and patented, without regard to the origin of the particular organism from which it was derived; in fact, the researcher may not even know or be able to easily trace the original provider country. However, the Nagoya Protocol on Access and Benefit-Sharing (“Nagoya Protocol”) to the CBD requires that users of genetic resources share the benefits of such utilization with the providers of the original resources. Although copious monetary benefits are being generated from genetic resource sequence information-based products, there is little evidence to indicate that any meaningful, formal, benefit-sharing is taking place.
The issue of whether or to what extent DSI is subject to such treaty obligations is a point of significant controversy in negotiations in several international fora, most particularly the CBD and its Nagoya Protocol. Importantly, an increasing number of countries are amending their legal regimes to either constrain access to DSI, impose benefit-sharing obligations on the fruits of DSI utilization, or both. A recent study of domestic measures on DSI and benefit-sharing commissioned by the CBD Secretariat identified at least five different approaches that countries are taking, creating an alarming web of rules for scientists seeking to use genetic resources and the DSI they contain.
The controversy over DSI is an example of a technological advance that has the potential to impact the interpretation of several international agreements and corresponding legal obligations. The idea that technological advancements can create the need for new domestic laws or international agreements or necessitate changes in the interpretation of existing laws and agreements is not new. On the domestic level, examples include railroads, in vitro fertilization, and DNA testing. On the international level, the ability to create virtually identical digital copies of music and movies — and the concomitant reduction in revenue potential for content creators and providers — led to new forms of protection embodied in the World Intellectual Property Organization’s (“WIPO”) copyright treaties. The rise of the digital economy precipitated the inclusion of new e-commerce provisions in regional trade agreements to fill gaps in the world trading regime. And climate change effects continue to stymie the effectiveness of negotiated agreements.
In each of these cases, a scenario that parties did not fully contemplate or address undermines fundamental assumptions in a way that changes the expected bargain of the agreement to the perceived detriment of some participants. Much as the digitization of music and movies facilitated a flood of online peer-to-peer copying that threatened the prime revenue streams of the music and movie industries, the monetary benefits that developing countries were expecting to flow from the Access and Benefit-Sharing (“ABS”) regime instituted through the Nagoya Protocol are seemingly being threatened by the declining need for researchers to seek access to tangible genetic resources once sequence information from those resources has been made publicly accessible. Moreover, differing perspectives on the ownership and value of genetic resources and DSI is presenting a clash of fundamental conceptualizations, with many users articulating positions akin to “what’s yours is mine and what’s mine is mine” while some providers adopt “what’s mine is mine and what’s yours is mine” stances, neither of which is helpful in reaching consensus on a way forward.
The specter of domestic DSI access constraints is concerning. Indeed, the rapid development of mRNA vaccines against the SARS-CoV-2 virus that causes COVID-19 was facilitated by Chinese researchers’ open sharing of the genome sequence of the virus in January 2020. Nevertheless, the concerns of provider countries are legitimate. Notions of justice and fairness permeate the CBD and underlie its objectives. The preamble to the CBD states that “economic and social development and poverty eradication are the first and overriding priorities of developing countries.” These priorities are intimately intertwined with the biodiversity conservation goals of the treaty, as the prime benefit-sharing beneficiaries are intended to be the indigenous peoples and local communities (“IPLCs”) who conserve and safeguard global biodiversity. However, they are often the most socioeconomically deprived and vulnerable members of our global society.
Monetary benefit-sharing, though challenging to operationalize, is just and necessary both to fulfill all three objectives of the CBD and perhaps even to basic human flourishing. Without monetary benefitsharing, necessary investments of financial and human resources to conserve biodiversity (which benefits us all) and aid in socioeconomic development for the most vulnerable among us are unlikely to occur, at least not as soon as they are needed.
Achieving “just” monetary and non-monetary benefit-sharing will require an adjustment of legal obligations and privileges on an international scale. However, the Nagoya Protocol is a relatively new treaty and its strictures in relation to rapid technological advances, such as in synthetic biology, are only just beginning to be understood. It thus is not surprising that there is a dearth of legal scholarship exploring these issues as many scholars may not be aware of the brewing controversy.
This Article seeks to fill this lacuna by identifying challenges to, and opportunities for, achieving “just” sharing outcomes on DSI under the CBD and Nagoya Protocol for the common good. Part I provides background on the CBD and Nagoya Protocol implementation issues that are affecting DSI access and benefit-sharing discussions in treaty negotiations. Part II examines the definitional and scope issues raised by DSI in relation to domestic ABS regimes and the complexity of DSI use scenarios that threaten benefit-sharing goals. Part III considers possible ways forward, by first highlighting the justifications for benefit-sharing and then exploring policy options and principles for creating a global multilateral benefitsharing mechanism as a more effective vehicle for users to comply with treaty obligations which are not amenable to the current bilateral negotiation model. The Article concludes that “just” benefit-sharing can improve conservation and socioeconomic development while maintaining access and innovation, but getting there will require adjustments in mindset from “mine” to “ours” for both users and providers of physical genetic resources and DSI.
— from “Just” Sharing: The Virtues of Digital Sequence Information Benefit-Sharing for the Common Good 63 (1) Harvard International Law Journal 1 (2022)