Will new global health rules help make the world safer?

Countries are meeting next week in hopes of finalizing new amendments to the International Health Regulations, the internationally binding agreement that defines countries’ rights and obligations during public health emergencies. Among the issues they are expected to hammer out are new texts related to equitable access to health products and financing under Articles 13 and 44. “As you know, those two Articles were the focus of a full day of discussions on 8 March and the Bureau proposals build on the outcome of those discussions, taking into account the range of views and feedback provided,” Ashley Bloomfield, co-chair of the working group on the IHR amendments, wrote to Devex. The bureau refers to the group of WHO member states coordinating the work on the IHR amendments. Countries are also expected to discuss new proposed options on how the World Health Organization should alert countries when it comes to health events and a combined proposal for an Implementation and Compliance Committee for these IHR. The COVID-19 pandemic gave the world some hard lessons, including the realization that the global system for responding to health emergencies is flawed and requires fixing. That prompted the process in 2022 to craft a new pandemic agreement and amend the IHR. Countries are supposed to provide WHO with “all relevant public health information” of an unexpected or unusual public health event happening within its territory “irrespective of origin or source” under Article 7 of the IHR. But China failed to provide WHO with early information about atypical pneumonia cases circulating in Wuhan, according to a report by the Independent Panel for Pandemic Preparedness and Response. “Think of COVID. By the time it was a full-blown pandemic, it was spinning completely out of control. … We don’t want to repeat that failure.” --— Lawrence Gostin, founding O'Neill chair in global health law, Georgetown University When South Africa shared information on omicron, a new variant of COVID-19, a number of high-income countries imposed travel bans on travelers from several southern African countries. WHO declared COVID-19 a public health emergency of international concern, or PHEIC — the highest level of alert of a health crisis under the IHR — in January 2020. Yet some countries moved timidly to heed the warning. Later on, when COVID-19 became a full-blown pandemic, some governments, particularly the U.S. under former President Donald Trump, blamed the WHO for being slow in sounding the alarm. There’s been a huge interest in crafting a mid-alert system for emergencies that have not yet become a global crisis, or one that falls short of the criteria for a PHEIC. Although a review committee of the IHR previously warned that an intermediate level of alert would not solve countries’ inactions to WHO recommendations and advice. A new alert system The new amendments text from the bureau, published on Thursday, include a proposal for the issuance of an “early action alert” to countries in cases when a health event does not constitute a PHEIC. Meanwhile, if the WHO director-general determines that an event is a PHEIC, they should also establish if it’s a “pandemic emergency.” The text defines a pandemic emergency as “a public health emergency of international concern that is infectious in nature and: (i) is, or is likely to be, spreading to and within multiple States Parties across WHO Regions; and (ii) is exceeding, or is likely to exceed, the capacity of health systems to respond in those States Parties; and (iii) is causing, or is likely to cause, social and/or economic and/or political disruption in those States Parties; and (iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.” According to Lawrence Gostin, founding O'Neill chair in global health law at Georgetown University and a member of the WHO’s IHR review committee, “hidden behind that language is the question of what is the scope of the IHR, and also, what is the scope of the pandemic agreement and the new [Pathogen Access and Benefit-Sharing] mechanism when it's adopted? Will it only occur when there's a formal determination that there's a pandemic emergency?” But a pandemic emergency suggests that a health event is already under a full-blown emergency before the world is called to respond forcefully. “The idea is to prevent outbreaks from becoming pandemics. And so the idea of a pandemic emergency, once you determine that, it's really almost too late to do anything about it,” Gostin told Devex. “Think of COVID. By the time it was a full-blown pandemic, it was spinning completely out of control,” he added. “We don’t want to repeat that failure.” A more gradual system of alerts that triggers greater response would be more helpful. One that, Gostin said, starts with alerting the world to a potential public health emergency of international concern, then to an intermediate declaration of an emergency, then to a PHEIC. If the outbreak continues to spread and cause disruptions, the next step would be alerting the world to a public health emergency of international concern with pandemic potential. Such a gradual system of alerts gives the world an opportunity to prevent an emergency or a pandemic. It would allow the early triggering of the pathogen and benefit-sharing system that is currently being negotiated in the pandemic agreement. And it would save WHO from being labeled a crying wolf, which it was accused of doing when it declared the 2009 outbreak of swine flu a pandemic. Simplifying the language helps remove confusion. The IHR text makes two separate definitions for a pandemic and a pandemic emergency. But it can be difficult, especially for the public, to distinguish between the two. “I think for communication reasons … it should be a PHEIC with pandemic potential [and not pandemic emergency]. I think that's what the Africa group would want,” Gostin said. “You're talking about a kind of spaghetti soup of terminology that nobody's going to understand,” he said. “The last thing a legal document wants to do is create chaos and confusion.” Gostin said he supports the new draft — but it “can and should be clearer and more precise.” Improving compliance Whether a new alert system would actually get countries to respond is uncertain. But it is hoped that a compliance committee can help. One thing that disappoints observers is the lack of a compliance mechanism for the IHR, and the Africa group, the European Union, and the United States each proposed improving the regulations’ compliance mechanism. The latest text of the bureau takes this into account and proposes the establishment of an Implementation and Compliance Committee. The committee will be composed of state parties to the IHR and will serve for a set number of years, although at present it’s not yet decided how many members it will have per WHO region, and for how long they will serve. The committee’s job, among other things, is to assist countries “to comply with their obligations and strengthen core capacities.” But its work won’t be punitive in nature, as per the text. Gostin is delighted that this provision made it in the draft so far. A norm on paper without compliance and accountability “has no meaning,” he said. “There is pushback against it. But I think the fact that it was initially proposed by the US, [and] Africa had a similar provision, and that it survived until this very late date and is in the agreement as it is, that gives me very high hopes and expectations that this compliance committee will be formed in May,” he said. He hopes this committee will cover both the IHR and the pandemic agreement. But also that it would serve as a forum for countries to hold states that do not conform to the provisions of the IHR into some form of accountability. COVID-19 fueled distrust both within and between governments. China’s failure to alert the world early on what was going on within its borders and its refusal to allow further WHO investigation into the origins of COVID-19 served ample ammunition for conspiracy theories. “There's nothing in the new IHR that would require a country to allow independent scientists or WHO scientists … to evaluate and monitor and help the response. That would have been fantastic. But … in America, certainly, they're protecting against the far right that believes that the pandemic agreement and IHR violate our sovereignty,” Gostin said. No additional obligations without additional finance Next week’s meeting is expected to continue the discussions on access to health products and finance, two big-ticket items that have also been the subject of much debate in the pandemic agreement negotiations but are important for equity. Gostin thinks it’s important to have a coordinated financing mechanism that covers both the pandemic agreement and the IHR, but at present, it’s lacking in both documents. He said low- and middle-income countries don't want to accept binding obligations that are costly when there's no financial mechanism. During the Geneva Graduate Institute event this week, Shanchita Haque, deputy permanent representative of Bangladesh to the U.N. and other international organizations in Geneva, said one of the limitations of the IHR was the lack of implementation of its provisions by countries, particularly low- and middle-income countries. “And why did they fail? They failed because there was no support,” she said. A financial mechanism isn’t just for the additional obligations coming out of the process for countries, but also for WHO. “How can low-income countries expect to be assisted in all the responsibilities they're taking on, without some tangible mechanism and funding plan? The same thing is true with WHO. Basically, they're engaged in imaginary thinking. [They] have to do all these new things. [They] have to hire all these new people. But emergency funding is stretched throughout the world,” Gostin said. Helen Clark, co-chair of the Independent Panel for Pandemic Preparedness and Response, shared similar concerns on the pandemic agreement. She questioned where the money will come from for both the additional processes to take place after the World Health Assembly and for WHO to implement whatever is agreed upon in the text. But the IHR text on financing has a provision under Article 44 that could lead to the establishment of a dedicated funding mechanism to help countries strengthen and maintain their capacities under the IHR if it was found that gaps exist in financing IHR implementation during a review two years after it entered into force. “Whether that will ever materialize, we'll never know. And there are many people who would be pessimistic given the history. But at least it's a recognition of the seriousness of the problem,” Gostin said. Discussions on equitable access to financial products are similarly critical for the IHR, not just for the pandemic agreement. “You've got [196] parties to the IHR. You'll never even get close to that with the pandemic agreement. And so there's every reason to push hard on the IHR, and not just say, ‘Oh, well, the pandemic agreement will deal with this,’” he said. Proposed text under Article 13 of the latest document instructs the WHO director-general to conduct a review of the availability and affordability of health products, once they’ve determined a health event as a PHEIC. They shall also help countries access health products through the use of existing WHO-coordinated allocation mechanisms and networks and share documents related to a health product to requesting countries that need them for regulatory approval. The latter should have the manufacturer's consent and be done within 30 days of a request. Meanwhile, state parties to the IHR are also asked to support each other and WHO in response to a health emergency by engaging and encouraging nonstate actors to contribute to equitable access to health products, and by publishing “relevant terms” of government-funded research agreements for health and their pricing policies to facilitate equitable access.