When a deadly disease breaks out and threatens the world, countries are obliged to share laboratory samples and other information to help fight it, right?
Wrong. In 2007, Indonesia refused to give the World Health Organisation samples of an H5N1 influenza strain from an outbreak in the country until it was guaranteed fair access to any vaccines created from the material. Welcome to the world of “viral sovereignty”.
The ownership of pathogens and related data that emerge in one country is part of a long-standing debate that touches a colonial exploitative nerve: wealthy countries plundering the natural resources – including biodiversity – of poorer nations and profiting from it.
With the coronavirus death toll nearing 300,000, the Covid-19 pandemic has revived the issue of whether countries can claim ownership of pathogens that have emerged within their borders, according to the authors of a paper published in the Policy Forum in Science magazine on Friday.
“The problem here is that the international community has failed to reach a consensus on what obligations, if any, countries have to share viruses and share genetic sequence data. That is an incredibly important public health good on the international stage,” Dr Mark Eccleston-Turner, who co-authored the paper with Dr Alexandra Phelan, told the South China Morning Post.
Indonesia is not the only country involved in the debate. In 2018, without explanation, China withheld laboratory samples of the H7N9 bird flu, despite repeated requests from the United States and Britain to share the material.
With the virus that causes Covid-19 first identified in the central Chinese city of Wuhan, the cooperation spotlight is again on China, especially as the US has accused Beijing of concealing information about the outbreak, claims the Chinese authorities have angrily rejected.
The genetic sequence data for the new coronavirus that causes Covid-19 was shared by Chinese researchers from Shanghai’s Fudan University on January 10 and two days later the Chinese Centre for Disease Control and Prevention submitted the sequence officially to the WHO.
Researchers in several countries have noted that this was a quick turnaround, given that China first informed the WHO of the outbreak on December 31.
But it was researchers in Australia who first sent a physical sample of the virus to the WHO and other laboratories after isolating it from a traveller from Wuhan at the end of January.
Now scientists are concerned that the soured political atmosphere, combined with loopholes in existing international frameworks, could impede the sharing of genetic data and virus samples in the future.
The term “viral sovereignty” was coined after Indonesia cited the Nagoya Protocol under the UN’s Convention on Biological Diversity, a treaty on environmental conservation, as the basis for its sovereignty claim over viruses isolated in the country, according to Phelan, an adjunct professor in global and public health law at Georgetown University.
The WHO tried to resolve the issue with the introduction of the Pandemic Influenza Preparedness Framework in 2011, but the new rules affirmed sovereignty as a legal norm and imposed no direct legal ramifications for not sharing influenza viruses with the WHO. This framework also did not apply to Covid-19, Phelan said.
Other rules like the WHO’s International Health Regulations (IHR), require member states to notify the WHO within 24 hours of all relevant “public health information” on anything that may constitute a public health emergency of international concern.
But those rules do not classify genetic sequence data as health information and physical pathogen samples are not regarded as health information either, according to the Science article.
Regulations published by Beijing’s State Council in May 2019 set up hurdles for any exports of genetic material. The rules prohibit the export of such samples by any foreign entity and require a number of steps for an authorised party to do so.
For example, the rules say that shipments of genetic material sources in China must “comply with ethical principles and be subject to ethical review in accordance with relevant national regulations”.
They also require prior informed consent of the providers and say shipments must comply with “technical regulations” formulated by the State Council’s Science and Technology Administration.
“If a scientist wants to export a virus or samples containing viral gene sequences, they should get an export permit and meet hygiene, quarantine, and inspection [criteria] so they can get that export approval, so they can ship those samples outside of China,” said Katherine Wang, a Shanghai-based partner at law firm Ropes & Gray specialising in life science regulatory law.
While the US has accused China of withholding virus samples, the US is also not party to the Convention on Biological Diversity or the Nagoya Protocol, which could have facilitated the transfer of such samples, according to the authors of the paper.
Phelan added that the US allegations did not carry much weight because the genetic sequence data for the virus was shared by China. “The reality of modern technologies, a lot of things that we need to find out from a sample, we can do on the basis of that genetic sequence data,” she said.
A Swiss laboratory says it has already been able to do just that.
The lab says it has synthesised the new coronavirus genome using the publicly available genetic sequence, although there were difficulties in creating some fragments in the genome and it required a physical virus sample from a patient, according to paper by the Institute of Virology and Immunology in Bern.
But what’s at stake, other researchers say, is the scientific cooperation that allowed the sharing of influenza and Covid-19 data. The concern is that political tensions may jeopardise this work without the protection of a legal framework.
Dr Gavin Smith, a professor from Duke-NUS Medical School in Singapore, is active in influenza surveillance, a process that includes researchers from all over the world uploading genetic sequences of viruses to repositories to help monitor potential outbreaks.
Smith said there had been very open sharing of data in previous outbreaks such as H1N1 pandemic, Ebola and Zika and now with Sars-CoV-2, the official name for the virus that causes Covid-19.
“Respiratory viruses are not constrained by borders and there’s just a moral obligation to be open about the sequence data that we have,” he said. “A lot of the data sharing is done by the scientists and the clinicians because that’s naturally what we do.”
Dr Adolfo Garcia-Sastre, a professor of microbiology at Icahn School of Medicine at Mount Sinai in New York, was one of the researchers to identify the origins of the 2009 H1N1 flu strain. He said he was concerned that political tensions could affect scientific collaboration.
“This pandemic looks like it is creating a lot of tension between different countries in the world that may actually put a strain on the ties that were already put together for having a global surveillance and a direct deposit of influenza virus sequences for everybody,” he said.
Garcia-Sastre said that if a country banned scientists from sharing pathogen data, scientific sharing would be at risk. This was not a problem now but it might happen, he said.
This is why Smith in Singapore said that having a formalised agreement on sharing would be useful.
“There’s always the possibility, because governments change, that if an outbreak starts in a country where at the political level they don’t want to share, and scientists might think we’re going to share this data anyway. I can see how it would be useful to have something like that formalised,” he said.
The authors of the Science article said a quicker solution might be to update the definition of “public health information” under the IHR to include genetic sequence data and pathogens during potential and actual public health emergencies of international concern. This approach might not require the regulations to be rewritten, said Eccleston-Turner.
“So we could have a situation where the WHO operates like a clearing house for viruses, and a clearing house for genetic sequence data, where all member states have to give all their virus samples.”