Coronavirus pandemic exposes legal gaps for sharing virus samples

Amid escalating geopolitical tensions and efforts to trace the origin of the novel coronavirus, experts say an international legal framework is needed for sharing biological samples and genetic data during pandemics.

The big picture: This pandemic is exposing legal gaps for sharing virus samples and sequencing data that could hinder responses to international health emergencies, according to a new paper in the journal Science.

Background: China published the SARS-CoV-2 genetic sequence on a public database in January and researchers around the world immediately began developing diagnostic tests for the virus and used the sequence to create an infectious clone.

But efforts to gain access to virus samples from China haven't been fruitful.

• The first physical samples of the virus outside China were isolated by scientists in Australia at the end of January from a traveler from Wuhan and, around the same time, researchers at the U.S. Centers for Disease Control and Prevention isolated the country's first sample from a patient in Washington state.

Scientists interviewed by Axios say there is less need now for early samples of the virus to develop vaccines and treatments as it has spread itself around the world.

• But it could help to understand the virus' origins and, they say, sharing of genetic information and samples is key to understanding what other viruses are out there and for responding to future outbreaks.
• "I think we've made good progress, but we have to have even better international conventions on sharing the materials themselves, not just the genetic sequences, so that we can do a little bit better next time," says Scott Weaver, who is director of the World Reference Center for Emerging Viruses and Arboviruses (WRCEVA) at the University of Texas Medical Branch in Galveston, Texas.
• WRCEVA has shared samples of SARS-CoV-2 virus, RNA and clones with 90 hospitals, diagnostic companies and other institutions and more than 120 scientists in the U.S., Canada, India, Chile and other countries, according to associate director Kenneth Plante. China has not provided a sample and has not requested one from the center, he says.

Where it stands: A patchwork of legal frameworks, binding and nonbinding, pertaining to some types of viruses and information but not others means access to valuable data isn't a guarantee and depends on scientific collaboration in an increasingly politicized world.

• The WHO's international health regulations currently require members to share “public health information” related to potential international outbreaks but that doesn't include physical samples or genetic sequencing data.
• The pandemic influenza preparedness (PIP) framework outlines nonbinding access among WHO member states, industry and others to physical samples of influenza viruses with human pandemic potential.
• Existing UN protocols, set up to protect biodiversity, give countries the ability to determine who gets access to genetic resources within their borders and how any associated benefits of those resources are shared.

What to watch: In the future, genomic sequencing data may not be as readily shared, says Lawrence Gostin, an author of the paper and a professor of law at Georgetown University.

• He warns that researchers who use genetic data to synthesize a virus could sidestep rules that obligate the benefits of research to be shared and, in turn, make others hesitate to share genomic data. During a pandemic, that could be "catastrophic," he and his colleagues write.

• They propose expanding either PIP to cover other viruses and genetic sequencing data or the WHO's International Health Regulations to include sharing pathogen samples and genome sequencing data during potential international outbreaks.

Yes, but: There are barriers rooted in the divide and distrust between countries based on past experience of governments, companies and researchers cutting out collaborators in countries providing resources.

• "Limiting access to these resources on the basis of state sovereignty may be one of the few points of leverage available to developing countries hoping to negotiate fair and equitable access to benefits from research and development, such as diagnostics, treatments, and vaccines," Gostin and his co-authors write.
• During the 2016 Zika outbreak in Brazil, samples of the virus were difficult to get out of the country.
• "It has gotten better, but there is a historical hierarchy in which the ones who have the ability to extract, produce and write have done so and the countries in which some of the information and reagents have come from have not gotten the full benefit that they see appropriate," says virologist Richard Kuhn of Purdue University.
• Gostin says it would be difficult to adjust the legal frameworks but, in the wake of the pandemic and the upheaval it is creating, he thinks it is possible.

The bottom line: "If we want to survive the next pandemics, we need open scientific sharing and to find an international mechanism that allows for that," Gostin tells Axios.

Go deeper: As U.S. and China fight, their scientists collaborate