Can the world come together to share benefits of genetic data?

Robust international rules are needed to govern ownership and use of genetic codes so that all of humanity benefits. This would help close the North-South gap, cure ills denying us good health and address food shortages exacerbated by climate change. Allowing the status quo to continue promises greater inequities while worsening risks of widespread harm. Several factors are blocking a global agreement to improve access to digital sequence information (DSI) and equitably distribute its benefits. The most fundamental of these is the primacy of commercial and national interests over the virtues of sharing for the common good. The stakes are enormous. The United Nations estimates DSI will generate more than US$1.5 trillion in global revenue this year and US$2.3 trillion by 2030. Demand for this data is escalating. Researchers in China have joined with 14 countries to form an alliance that proposes sequencing the genomes of more than 1 per cent of the world’s population. Given the tenacity of disagreements and the scale of money involved, however, significant progress is doubtful at next month’s UN Biodiversity Conference in Cali, Colombia, one of several forums negotiating improvements to terms and mechanisms for genetic resources. Geostrategic tensions are likely to spill into these talks and undermine hopes of progress, as are other ethical, legal and social challenges. DSI refers broadly to genomic sequence data which delineates the order of biochemicals in genes. Once scientists find a useful gene, they can insert a version into microbes such as bacteria or yeast which then produce compounds for a wide variety of beneficial uses. Technological advances have significantly increased the speed and lowered the cost of generating DSI. However, the existing treaties only vaguely define DSI. There is no international consensus on what should be included within its scope, creating an enormous obstacle to progress. Some see the definition as being limited to DNA and RNA – which are responsible for storing and reading the genetic information that underpins all life – while others argue it should encompass behavioural data and information on ecological relationships that change cells’ functions. The Convention on Biological Diversity, adopted in 1992, is the foundation of a global approach to share genetic resources while conserving biological diversity, promoting sustainability and ensuring equitable sharing of benefits from DSI. Even so, some signatories remain committed to treating genetic resources as the sole property of sovereign nations in which the genes reside. This treaty was amended in 2010 in Nagoya, Japan, through a binding protocol that clarified both access and minimum benefit-sharing obligations while establishing a clearing house for countries’ laws. However, countries joining the protocol differ widely on whether DSI is included as “genetic material” and thereby subject to the protocol’s obligations. Adopting the Kunming-Montreal Global Biodiversity Framework in December 2022 signalled a new and critical phase by committing countries to create a mechanism for sharing benefits from DSI as part of efforts to reverse the global loss of biodiversity. In preparation for the gathering in Cali, a working group of the Convention on Biological Diversity met in Toronto in August, but they only achieved a “heavily bracketed recommendation”. Their work “resulted in a better understanding of the issues’ complexities” but failed to make the political compromises essential to implementing solutions, according to a report by the International Institute for Sustainable Development. Is there a way forward? Agreement on a definition for DSI would help clarify the scope of negotiations and agreements. Continuing to use the term as a place holder only compounds the difficulties in resolving highly contentious issues. The lack of a widely accepted definition has heightened legal uncertainties that weaken global agreements and allow governments to enact national laws that vary widely from one country to another. These uncertainties hold back research as scientists and companies stay away from certain genetic resources over compliance concerns. Creating a means for sharing benefits requires innovation and experimentation. Rapid development of Covid-19 vaccines was made possible by Chinese researchers’ sharing of the virus’s genome in January 2020. This success attests to the necessity and advantages of sharing genetic data freely. Developing better means to recognise and reward countries for sharing DSI would encourage governments to be more committed and proactive. Establishing a multilateral fund would offer more efficient ways to share monetary and non-monetary benefits in a transparent, credible process. This fund could work with the World Health Organization to prioritise the most urgent responses to global crises. Partnering with the World Bank and the International Monetary Fund could leverage DSI-generated revenue to reduce sovereign debt. This fund’s success will depend on a regulatory regime that levies fees on accessing DSI and extends time-based rights to use genetic data. These rules should err in favour of promoting open access. Agreeing to have national laws conform to global rules will be difficult, but starting with standardising functional rules and routine cooperation could be a bridge to more difficult limits on country-specific laws and regulations. The clearing house established in the Nagoya Protocol must be rapidly developed to provide more services that help researchers more easily identify genetic resources, depositories, research uses and intellectual property laws. Building on the momentum of the research consortium established by institutes in China and 14 other countries offers this and other solutions. A rising tide lifts all boats. It’s a hard sell in a world starkly divided between rich and poor, but all countries have genetic resources that equalise their leverage. Small successes can make countries eager to do more. All will benefit from jointly promoting scientific inquiry and innovation.

Can the world come together to share benefits of genetic data?

.css-1c6uqr6{color:inherit;font-weight:inherit;font-size:inherit;font-family:inherit;line-height:inherit;overflow-wrap:break-word;}Digital sequence information holds great promise, but disagreements on definitions and national interests are slowing progress

Digital sequence information holds great promise, but disagreements on definitions and national interests are slowing progress