Countries debate plan to equate digitized DNA data to biological material

Researchers teasing out genetic codes from plants, animals, fungi, and microbes of all sorts have deposited quadrillions of digital nucleotide sequences in open access databases. Scientists sorting through these vast lists may uncover ways to engineer crops to resist drought. Or they could craft new lifesaving antibiotics, natural fragrances, or even building blocks for novel organisms that synthetic biologists are stitching together.

Now, more than 110 countries are considering a proposal that would affect scientists’ ability to use these data. The aim is for the users to share benefits—financial or otherwise—that accrue from application of this information with the countries that are home to the organisms whose genes were sequenced. Such benefit sharing could take the form of fees on commercial products developed from these genetic sequences. The funds would go to protect the diversity of life on Earth, the source of genetic prospecting.

The proposal is controversial, and negotiations on it are scheduled for Nov. 17–29 in Egypt’s Red Sea coast city of Sharm el-Sheikh. The talks are taking place under an international agreement designed to combat biopiracy. That accord has a long official name: the 2010 Nagoya Protocol on Access to Genetic Resources & the Fair & Equitable Sharing of Benefits Arising from Their Utilization. The Nagoya treaty is an extension of the United Nations’ landmark 1992 Convention on Biological Diversity, which recognizes that countries have sovereign rights to biological resources within their borders. Both pacts exclude human genetic resources.

The idea behind the Nagoya protocol is that sharing benefits from the use of genetic resources creates an incentive for conservation and sustainable use of biodiversity. The treaty requires users of genetic resources to obtain consent in advance from nations that are so-called donor countries. Even though the U.S. isn’t a partner to the Nagoya protocol or the biodiversity convention, U.S. researchers are obliged to abide by it if they want to obtain genetic material from a nation that has ratified the treaty.

The Nagoya protocol has always applied to biological material—stems, roots, and leaves of plants or flesh, skin, and bones of animals. At the talks in Egypt, negotiators will consider whether and how to equate digitized DNA information to actual genetic materials in biological samples. A draft decision for the meeting says that “the creation of digital sequence information requires initial access to a physical genetic resource, and ... therefore, a benefit arising from the utilization of digital sequence information should be shared fairly and equitably.”

Scores of developing countries, many of which harbor much of the world’s biodiversity, are pressing for the change. They say treating digital data the same as biological material is essential.

If genetic sequence information isn’t subject to the Nagoya protocol, the pact could lose effectiveness “and biodiverse countries would lose control over their biodiversity,” says Oscar Lizarazo Cortés. He’s an associate professor of law and political and social sciences at the National University of Colombia, Bogotá. Lizarazo says researchers are increasingly using the growing body of genetic sequences to engineer bioproduct-synthesizing organisms that replace native organisms collected or cultivated by indigenous peoples or local communities. Eliminating the use of native organisms hurts those communities and boosts global inequities.

An example, Lizarazo tells C&EN, is stevia, a popular sweetener derived from a plant of the same name. The indigenous Guarani communities of Paraguay and Brazil have used the plant for centuries. Stevia is an important cash crop for farming communities in Paraguay, according to the PureCircle Stevia Institute, an industry group. Meanwhile, biotechnology companies and food and beverage makers are starting to produce stevia through fermentation rather than extract it from plant material. Without benefit-sharing agreements for the genetic sequences used to engineer microbes to do the fermentation, the Guarani face loss of income.

On the other hand, many industry and academic groups argue it’s paramount that genetic sequence information stay freely accessible globally. Thomas B. Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), says inclusion of genetic sequences under the Nagoya protocol “would fundamentally hinder R&D.” He adds, “It would either dramatically restrict the data available in public data banks or else introduce excessive obligations which would deter potential users.”

Several industry and science groups agree. “Barriers to the sharing and use of DSI [digital sequence information] would discourage innovation and scientific research. Extensive tracking and tracing mechanisms would be needed—if they were even possible—ultimately making downstream uses more complex and costly, and products and technologies less accessible,” they say in a joint statement.

They continue, “The unencumbered access to and use of DSI now in the public domain benefits countries at all levels of development—it supports conservation, fosters research into technological solutions to tackle societal challenges, and benefits the population as a whole.” Open sharing of this digital information is a form of nonmonetary benefit, they maintain.

Organizations signing the statement include IFPMA, the International Council of Biotechnology Associations, plant biotechnology and pesticides group CropLife International, the International Fragrance Association, the American Institute of Biological Sciences, and the Personal Care Products Council.

Some also argue that requiring benefit-sharing agreements for sequence data could endanger public health. For instance, Cueni of IFPMA says the global pharmaceutical industry is increasingly worried that the way some countries are implementing the Nagoya protocol will add to the cost and time to bring therapeutics and vaccines to market.

Likewise, Dutch researchers warn that controlling access to digital data on genetic sequences could impede timely sharing of essential information about pandemic viruses, bacteria, or other pathogens. “The ability to respond to outbreaks that require international data sharing is likely to be severely hampered,” they predict (Science 2018, DOI: 10.1126/science.aau5229). If genetic sequence data fall under the Nagoya protocol, “the free sharing of sequences for surveillance and tracking of pathogens and outbreaks could become illegal,” says the team, led by Carolina dos S. Ribeiro of the Dutch National Institute for Public Health & the Environment.

However, the World Health Organization has established precedent for agreements to exempt some genetic-resource sharing from the Nagoya protocol. One notable example is the 2011 pandemic influenza preparedness framework for sharing samples of the flu virus.

While negotiators haggle in Egypt, some countries are already defining their domestic genetic resources to include digitized sequence data, attorney Bruce S. Manheim Jr. notes. A partner at the Washington, D.C., law firm WilmerHale, he represents life sciences companies.

For example, Brazil has adopted legislation that defines its genetic resources as encompassing digital information, Manheim points out. Brazil isn’t yet a partner to the Nagoya protocol—it has signed but not officially ratified the deal. But the nation’s law means researchers from outside the country need to obtain permission to use genetic sequences sourced from Brazil—even after the fact—and strike a deal to share benefits if they expect to get a Brazilian patent for products made from these sequences.

India, meanwhile, criminalizes the commercialization of products from its biodiversity resources by non-Indians unless they get permission in advance and agree to share a portion of the profits with the country’s National Biodiversity Fund. Other nations rich in biodiversity are looking to Brazil and India as role models, Manheim says.

These domestic laws and the proposal pending at the Nagoya talks are causing many researchers to take a measured view about where to invest their time and money. “There continues to be this tremendous uncertainty around the legality of utilizing this material,” Manheim tells C&EN. “It’ll be difficult to incentivize investment and continued development of the technology.”

The overall challenge facing negotiators in Egypt is how to take into account arguments from developing countries as well as researchers and businesses, says Margo A. Bagley, a professor at Emory University School of Law.

In the talks, negotiators are obliged to maintain focus on the Nagoya protocol’s aim of stemming the loss of biodiversity by providing incentives to protect it.

Likely to get hashed over at the meeting is the possibility of creating a fund called a “multilateral benefit-sharing mechanism” that could collect and distribute money from the commercialization of genetic resource information. Key to creating the fund will be determining how to fill its coffers in a way that maintains incentives for innovation and minimizes transaction costs for users while providing financial benefits for the conservers and sustainers of biodiversity in provider countries, Bagley tells C&EN.

Hammering out a workable solution won’t be easy, Bagley says. But she hopes that negotiators can come up with a feasible scheme to make it easy for researchers to comply with sharing the benefits of digital DNA data. If that happens, Bagley expects researchers will join in because the goal is to protect biodiversity. “Many researchers want to do the right thing,” she says.