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While closing the World Health Assembly on May 27, Margaret Chan, director-general of the World Health Organization (WHO), declared that an outbreak caused by a new coronavirus (a type of virus associated with respiratory illness) had become “a threat to the entire world.” Chan is right to be worried: the disease she was talking about, the Middle East Respiratory Syndrome (MERS), is deadly. And it is not just a health challenge. The outbreak has also led to a global legal controversy over ownership and sharing of dangerous viruses -- issues that Chan has promised to investigate.
On June 13, 2012, a hospital in Jeddah, Saudi Arabia, admitted a patient suffering from pneumonia and renal failure who died without an identified cause. A consulting physician, Ali Zaki, sent blood and sputum samples from the patient to the Saudi Ministry of Health, but tests for influenza and other viruses came back negative. Zaki then sent samples to the Erasmus Medical Centre in the Netherlands, which identified the culprit as a new coronavirus.
On September 20, Zaki circulated news of the discovery through ProMED-mail, a disease early-warning listserve. Using this information, physicians in London soon diagnosed a MERS infection in a patient from Qatar who had traveled to Saudi Arabia. Zaki and Erasmus researchers published their findings on the Saudi case and the novel coronavirus in mid-October. By the end of November, WHO was aware of nine confirmed cases -- five in Saudi Arabia, two in Qatar, and two in Jordan. Five of the nine patients had died.
Soon, Erasmus started sharing coronavirus samples with other laboratories across the world under a Material Transfer Agreement (MTA), which is a contract commonly used when laboratories share pathogens. It had also applied for a patent in the Netherlands on the gene sequence of the new coronavirus. With that patent, Erasmus planned to facilitate possible development of diagnostics, vaccines, or antiviral medications for MERS. Saudi Arabia was not happy. Officials argued that Zaki had violated Saudi rules and procedures by sending samples abroad and that Erasmus was wrong to assert property rights over a virus isolated in Saudi Arabia. The report from an urgent WHO-led meeting on the new coronavirus in January 2013 did not address the issue, though, and WHO declined to comment about the dispute.
Between January and the end of May, there were 50 confirmed cases of MERS, with reports of cases coming from France, Germany, Jordan, Qatar, Saudi Arabia, Tunisia, United Arab Emirates, and the United Kingdom. Of those infected, 30 died -- a fatality rate of 60 percent. By this time, MERS was being compared to the 2003 epidemic of Severe Acute Respiratory Syndrome (SARS), which killed around 770 and had also been caused by a new coronavirus. As cases of MERS mounted in Saudi Arabia, health leaders’ frustration with Saudi information sharing deepened. Also worrying was the accusation in mid-May that the Erasmus MTA was stymieing research. Canada’s National Microbiology Laboratory, for one, complained that the MTA it signed with Erasmus delayed research because of “tight restrictions . . . [and] a lot of negotiation and a lot of lawyers.”
At the World Health Assembly in late May, Ziad Memish, the Saudi deputy health minister, rejected complaints about his country’s information sharing, repeated the government's accusations against Zaki (which Zaki refuted), and pointed the finger instead at Erasmus, which, he said, was still seeking intellectual property rights on the sample obtained from Saudi Arabia, imposing restrictive conditions through its MTA, and pursuing contracts that hurt Saudi access to diagnostics. Erasmus rejected the allegations that it had adversely affected responses to MERS.
This time, the WHO director-general weighed in. In a not-so-subtle dig at Zaki and Erasmus, Chan asked why “scientists would send specimens out to other laboratories on a bilateral manner and allow other people to take intellectual property rights on a new disease,” rather than sharing them through WHO. To thunderous applause, she went on to say that “No IP should stand in the way of you, the countries of the world, to protect your people.”
This dispute raises three broad legal issues. The first involves information sharing: MERS triggers obligations under the International Health Regulations (2005), a treaty binding on all WHO members, to notify WHO of disease events that might constitute a public health emergency of international concern (MERS qualifies) and to share with WHO information about such events. As the outbreak has grown, global health concerns about Saudi information sharing, especially when it comes to cases occurring in Saudi Arabia, have increased. All this raises questions about Saudi compliance with the IHR. To date, WHO has not accused Saudi Arabia of violating those regulations; rather, it has pressed Riyadh to provide more information about MERS cases within Saudi Arabia and stressed the importance of transparency in the implementation of the IHR. But patience has been wearing thin.
Second, the controversy involves disputes about ownership of the MERS virus, and the implications of ownership on the international response to the outbreak. Saudi Arabia has not yet appealed to “viral sovereignty,” the argument that Indonesia advanced during the 2007 controversy over sharing avian influenza A (H5N1) samples, namely that the state in which a virus is isolated has sovereign rights over that virus under international law, specifically the Convention on Biological Diversity. But Riyadh’s complaints echo this reasoning: Zaki violated Saudi law, Riyadh says, so Erasmus is benefiting from an illegal act. If Saudi Arabia has sovereign rights over the sample, moreover, Erasmus is ignoring these rights and engaging in a form of “biopiracy” by exploiting a Saudi genetic resource without Saudi consent. This argument implicates the Dutch government because the Netherlands and Saudi Arabia are CBD parties, and the Dutch government has not intervened to protect Saudi Arabia’s rights recognized by this treaty.
The third matter, which has received the most attention, involves the claims that the Erasmus MTA and patent application are hindering research on, and responses to, the MERS virus and outbreak. These allegations focus on the impact of Erasmus’ behavior on global health efforts rather than its legality, but this fact seems to be a symptom of a bigger problem. The International Health Regulations do not include rules covering the sharing of viruses and benefits produced from virus research. The closest thing, the non-binding agreement negotiated to govern those concerns for influenza viruses -- the WHO’s 2011 Pandemic Influenza Preparedness Framework -- does not apply to coronaviruses.
Leaving aside for a moment the lack of specific rules, the more urgent question is whether the Erasmus patent application and MTA are harming global health responses to MERS. Erasmus has only filed an application for a patent; it does not have one at the present time. And an application does not create enforceable rights. As a matter of law, then, the patent application itself is not a hindrance to Saudi Arabia, other affected countries, or WHO.
However, the Third World Network, a nongovernmental organization interested in the impact of intellectual property rights on development, argues that “labs might be able access the virus, from Erasmus or others, but don’t want to, for fear that any work they do on the virus may later be alleged to be infringement of patent claims yet to be published.” Of course, complaints would carry more weight if Saudi Arabia could show how, when, and in what circumstances the patent application has impeded its efforts, and if the Third World Network could identify researchers who acted out of fear of Erasmus’ potential patent. So far, however, they have not. In addition, it is Saudi Arabia that has reportedly been unresponsive to requests from European laboratories for help in validating diagnostic blood tests they have developed for MERS.
In terms of the Erasmus MTA, the main accusation is that the MTA is restricting research unnecessarily in order to preserve Erasmus’ contract rights over the virus sample and its potential patent on the gene sequence. Responding to these charges, Chan has argued that virus sharing should not happen bilaterally between laboratories but through WHO and its collaborating centers -- which is how WHO managed global research during the SARS outbreak and how the Pandemic Influenza Preparedness Framework operates. Erasmus claimed that it had, in fact, shared the coronavirus with 40 institutions worldwide, that “diagnostic tests were developed instantly and made freely available,” and that it continued to send the “MERS coronavirus free of charge and without restrictions to all research institutions that work to benefit public health.”
Sorting through these claims and counterclaims proves difficult because facts are missing. Only one MTA has been made publicly available -- that between Erasmus and the University of North Carolina. This MTA imposes restrictions on UNC, including on its commercial exploitation of the shared samples and transfer of the samples to other institutions. These restrictions preserve Erasmus’ ownership of the virus samples and protect its ability to obtain intellectual property rights on research outcomes. However, they do not seem unusual compared with those in other agreements governing the sharing of biological samples. Moreover, Erasmus is not the only source of MERS virus, and other suppliers -- including Saudi Arabia, other countries that have treated MERS cases, and WHO -- can share samples under whatever terms they wish without worrying about the Erasmus contracts. Indeed, the Saudi deputy minister of health acknowledged that the Erasmus MTAs have not affected research in Saudi Arabia.
All this highlights the need for more information, including the extent to which, and under what conditions, Saudi Arabia, other affected countries, and WHO have shared samples for research. One news report stated that, despite all the cases, “the genetic blueprints of only four viruses have been publicly posted for scientific scrutiny,” which includes the virus that Erasmus sequenced in 2012, two sequences from the UK, and one from Jordan. As of the end of May, Saudi Arabia had posted no sequence data. Absent more information about how other sources of MERS virus have shared samples and made available research findings, accusations that the Erasmus MTAs have harmed responses to MERS are not persuasive.
NEW LAWS NOW?
So what does this muddle mean? For one, the MERS controversy underscored the fact that there are no clear international rules on sharing samples of dangerous pathogens (excluding influenza) and benefits produced by the research on them. The Saudi deputy minister of health expressed support for creating such rules. And the WHO director-general’s argument that the MERS virus should have been shared through WHO points to one potential element of any new regime. Still, in the absence of hard evidence that the lack of specific rules actually made the MERS incident worse -- and considering just how difficult it would be to negotiate a broader agreement given contention over the role of intellectual property rights in global health -- it is premature to conclude that a new global framework is needed. Instead, the focus should be on figuring out what exactly has hindered responses to MERS thus far, including problems Saudi Arabia has caused or experienced, and addressing them.
Whether, in the end, Chan does investigate the legal implications of the MERS outbreak as she promised remains to be seen. If she does, the undertaking will be fraught with problems and could worsen the global legal imbroglio that has already flared up. Right now, with MERS a threat to the entire world, it is not a problem we are going to lawyer away.