Now data can substitute for materials, international agreements on biodiversity need updating, says Charles Lawson
Biological science has long relied on access to physical materials, both to provide an account of nature and to harness nature to solve human problems through medicines, devices, foods, fibres and so on.
But the advent of huge amounts of digital information, and the increasing capacity to mine that information for insights and inventions, mean that access to physical biological material is no longer always critical to this research. This creates both threats and opportunities for research. This is a significant moment, as choices are now being made in international agreements about the control of biological materials and information.
What now seems like aeons ago, the emerging post-colonial countries sought a new deal on the global economic order. This included the spoils from natural resources exploited in their newly minted countries.
In the case of biological resources, this expressed itself in the 1980s as a conflict about the reach of plant breeders’ right over and patents on genetic resources. The initial debates were about limiting plant breeders’ rights over farmers’ plant varieties in the International Undertaking on Plant Genetic Resources, and potentially giving farmers free access to protected plant varieties. By the 1990s, this had crystallised into an express recognition of each country’s sovereignty over its physical genetic resources, and a process to gain access and share benefits, set out in the UN Convention on Biological Diversity (CBD), which came into force in 1993.
The CBD was a grand bargain. Countries would make their physical genetic resources accessible in exchange for sharing the benefits from exploiting those resources. The object of exchange was the physical materials. The associated information—on taxonomy, characteristics, biology and DNA sequences—was seen as a complementary benefit that needed to be openly shared.
Over the next quarter of a century, the scope of regulation expanded. The 2010 Nagoya Protocol set out more detailed rules about the CBD framework. The UN Food and Agriculture Organization’s 2004 International Treaty for Plant Genetic Resources for Food and Agriculture (commonly known as the Plant Treaty) and the World Health Organization’s 2011 Pandemic Influenza Preparedness (PIP) Framework, created specific regimes for some plant genetic resources and some pandemic viruses respectively.
New schemes are being negotiated for the biological resources of the high seas; there are also calls for schemes for microbes, viruses and other organisms. Activity will intensify with the approach of the fourth meeting of the parties to the Nagoya Protocol, part of the 15th Conference of the Parties to the CBD. This will take place in Kunming, China, next May, having been postponed from October owing to the Covid-19 pandemic.
The original CBD grand bargain of the 1990s was intended to ensure that the countries with the most science, technology and industry did not exploit those predominantly poor tropical countries with the most biodiversity. It also aimed to promote conservation by recognising the economic value of biodiversity and delivering that value as finance and technology. This was, at least in part, intended as a plank in a new global economic order for poor countries with rich biological resources.
Under the current CBD and Nagoya Protocol, a party seeking to access what these agreements call “genetic resources”—generally anything that traces its origin back to a living organism—negotiates a binding contract with the holder of those resources. Together they agree on the terms and conditions about how to exploit those resources and share the resulting benefits.
The contract is unique to each engagement. This creates a bureaucratic and negotiating burden that requires a big commitment from both parties, although the Plant Treaty and PIP Framework provide a shortcut through a standard agreement to cover all transactions.
Each of these contract models enshrines the ideal of openly and freely sharing information as a key form of benefit-sharing. But they did not anticipate that, in the digital age, it would become possible to analyse, or even synthesise, biological materials based on data alone.
Contracts are now being modified to limit how this information is accessed and used, but they are complex and difficult to enforce, and go against the spirit of openness in science. The practical effect is to impose yet more cost and inefficiency at the early stages of research projects, especially as the materials under negotiation often have little prospect of being commercially useful and expectations about the size of benefits are often unrealistic.
Unfulfilled expectations
While 25 years of discussing and implementing the CBD has seen some successes, overall there is widespread dissatisfaction around these agreements. The returns have been smaller than some expected, countries’ implementation of laws on access and benefit-sharing have not matched their commitments, and many of the rifts that were reduced to agreeably vague diplomatic language remain unresolved, particularly over access to technology predominantly held by private, non-state sectors. Recent developments, such as bringing these debates onto the agenda for the UN’s Sustainable Development Goals, highlight the failure to create the hoped-for new global economic order.
These basic problems are not easily resolved; it takes a long time for poor countries to build the necessary legal structures and cultures that provide the enforceable legal certainty needed to attract long-term private capital from rich countries.
The most significant concern of many countries is the lack of concrete financial returns. This has coincided with massive increases in what is known in policy and diplomatic circles as digital sequence information. Globally accessible and free DNA sequence databases allow biological questions in areas such as development, disease, resistance and cell functioning to be investigated without access to physical materials. This undermines the CBD by sidestepping contracts for access and benefit-sharing, allowing information to be exploited without any obligation to the owner of the physical biological materials. The result has been a renewed focus on the unmet expectations of the 1990s.
These are still early days: the problem is still being delineated, terminology is being developed, and countries are deciding their diplomatic and political stances. There is no doubt this is a real issue, with significant consequences for biological research in the form of both opportunities and complications.
Next May’s CBD conference is set to be a first act for the steps ahead and a measure of the gravity of these issues for many developing countries. The stakes are likely to be high, with poor countries with rich biological resources seeking increasingly onerous conditions on access to physical resources and controls that severely limit the way in which information about resources is accessed and shared.
New approaches
One opportunity is for a new approach to accessing and using physical biological materials and information—one that addresses the issues of equity and justice in how benefits are shared. Delivering on the Sustainable Development Goals is also good for everyone,
offering the prospect of better social, economic and environmental outcomes across the globe.
The present focus, however, is almost universally on payments from corporations and governments in rich countries to those in poor countries. The options currently on the table include: distributing benefits through some version of a collecting society, similar to those that many countries use to collect and distribute copyright fees for authors; up-front payments through a tax or levy for users of material or information; a global fund with mandatory contributions from big corporations and governments; and taxes on plant seeds in developed countries.
The Plant Treaty and PIP Framework already have financial mechanisms that impose mandatory benefit-sharing between those that hold materials and those that use them. These are models for how returns might be distributed through a central mechanism.
For the Plant Treaty, the money collected is used to support poor farmers; for the PIP Framework, it pays for global influenza surveillance and early warning. But both systems are limited in scope, and neither currently delivers benefits on a significant global scale that will address the needs and wants of poor countries set out in the Sustainable Development Goals.
Such standard contracts have the advantage that debates and negotiations about benefits take place in the halls of international diplomacy in Geneva, Rome and New York rather than using up time and resources in contract negotiations between researchers and resource providers. But this also brings the significant disadvantage of moving debates about issues such as digital sequence information away from the participants dealing with the practicalities, towards those negotiating for political ends.
All these mechanisms risk imposing legal constraints on the use of physical and information resources in research that go against the spirit of openness in science. No solution will be simple; there will always be disagreement and conflict about the terms and conditions of agreements, and the size and distribution of payments.
Even so, pursuing the prospect of better social, economic and environmental outcomes across the globe is a worthy aim. The challenge is to find a balance that allows biological research to achieve its potential through appropriate access to physical materials and information, and that shares the benefits of this research, including cash and technology, equitably and justly. Most importantly, working biologists need to be involved to make sure the negotiated outcomes are credible, practical and lead to more and better research.
Charles Lawson is a professor in the Law School at Griffiths University, Brisbane, Australia
This article also appeared in Research Europe