The International Health Regulations are in need of reform, experts say – to create a more nuanced system of alerting the public about international health emergencies that goes beyond the existing yes-no decision, and to improve compliance to IHR laws by member states during such outbreaks.
A high level panel of experts reviewed key concerns and possible solutions last week at the Geneva launch of the Legal Determinants of Health – The Lancet Commission, Global Health & the Law Report – hosted by UNAIDS on the margins of WHO’s Executive Board meeting.
The report, first published in 2019 at the height of the Democratic Republic of Congo’s Ebola outbreak, noted that implementation of the IHR, which is a binding legal convention between WHO member states, has been “plagued by incomplete state compliance”.
The issues surrounding the IHR’s use and compliance have received further attention within the public health community during the present coronavirus emergency (COVID-19)– where declaration of a Public Health Emergency of International Concern (PHEIC) was delayed because the dimensions of the crisis were initially unclear.
When an Emergency was finally declared on 30 January WHO Director General Dr Tedros Adhanom Ghebreyesus said at the time that “along with a red and a green light” the system needed a “yellow light” so that health systems could begin to prepare even before a full-blown international crisis had emerged.
The Lancet report on “harnessing law for global health and sustainable development” lays out a broader framework for why global health law is relevant to public health professionals.
The report shines light on certain systemic weaknesses of existing legal instruments, and argues that non-state actors could potentially drive change in reforming and ensuring stronger legal frameworks. The authors describe four legal “determinants of health” that they argue most fundamentally influence health and equity. And they recommend a slew of strategies that could make legal frameworks a more central imperative in the governance of global public health.
The “Legal Determinants of Health” & Recommendations for Action
The report lists four “legal determinants” of health that can “demonstrate the power of law to address the underlying social and economic causes of injury and disease.” These determinants also highlight areas of law where lawmakers can successfully intervene to improve health as follows:
- SDG vision to action – Law can translate vision into action with respect to Sustainable Development Goals, in particular in laying the foundations for Universal Health Coverage. International institutions can set standards and support implementation and for national governments to create rights-based legal frameworks.
- Strengthened governance – Law can strengthen the governance of national and global health institutions. These institutions, both at international and national levels, can used law to improve governance and safeguard public health and safety. (The report also notes that “domestic and international law are inter-related and bidirectional in their impact on health and justice)
- Evidence-based health interventions – Law can be used to implement fair and evidence-based health interventions, drawing from examples of cases from communicable and non-communicable diseases and injuries. The report suggests WHO can increase legal capacity to spearhead the development of a global evidence-base for public health.
- National legal capacity – National governments must build legal capacities to enact and effectively implement public health laws. On a global level, the report recommends that WHO create an independent standing commission on global health law.
On Reforming the IHR
The panel in Geneva largely agreed that the IHR, which has its origins in the International Sanitary Regulations first adopted in 1851 to standardize quarantine measures for cholera, plague and yellow fever, needs another revision, especially in the light of the COVID-19 outbreak.
On the other side of the WHO campus, meanwhile, senior officials had just informed the Executive Board that WHO would convene experts to work on an intermediate level of alert, to integrate more nuance into the current binary system that governs “yes or no” declarations of a Public Health Emergency of International Concern (PHEIC).
Speaking at the event, Gian Luca Burci, adjunct professor at the Graduate Institute, former WHO legal counsel, and one of the co-authors of the Lancet report, said that in exploring the gaps and weaknesses in the IHR, there is a need to look at the “design and politics” behind the law, not only how the existing law is being implemented.
The latest version of the IHR, adopted by WHO member states in 2005, served to codify much of what was already existing WHO practice for emergency response and management. However, a number of political compromises as well as assumptions were built into the design of the instrument, including the “assumptions that governments will act transparently, in good faith and in a spirit of solidarity. “Now these assumptions are getting tested. We do see instances of excesses and stigmatizing that result during outbreaks,” he said.
He recounted that the last version of the IHR, adopted in 2005, was also revised within a very short period of time between January 2004 to May 2005, in the aftermath of the outbreak of Severe Acute Respiratory Syndrome (SARS).
“This may explain some of the flaws we are witnessing, and perhaps there is a need to take a step back and rethink the design of the IHR with an open mind,” said Burci.
There are two approaches on reforming the IHR, Burci said. “One is to say that let’s not touch the text and try to improve its implementation. As a result we have seen the emergence of the global health security agenda and efforts at voluntary evaluations conducted outside the IHR framework.
“The second approach, which I consider more useful, is that we have a binding legal instrument, and if there is a flaw, may be there should a good faith attempt to sit back and find out how to change it. Sometimes, there is a need to amend the law, changing the assumptions, especially if proposals for new measures are inconsistent with the clear letter of the instrument as in the case of the binary approach to alert,” he explained.
However, Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University and a lead author on the report, expressed concerns that in light of current global trends, reopening the IHR’s formal texts could risk weakening the text, giving greater leeway for decisions driven by populist governments and sentiments rather than evidence.
For instance, the IHR was meant to be seen as an instrument to balance human rights and public health objectives, he said. At the same time, in the current COVID-19 crisis, WHO has been “looking the other way,” even as China had restricted movement in affected areas.
On the politics of dealing with an outbreak, Burci said, “There are a number of variables that explain how states respond to a crisis of this magnitude. There are cultural, political, domestic and other factors that shape responses.
“Major crises are political events and governments do not simply respond by looking at epidemiological evidence”. Locking down an area, for example, may slow down the spread of the disease but may also create hardship for the affected population which encourages people to escape – the exact opposite of what is needed, he added.
A number of speakers underscored the importance of considering the principle of ‘proportionality’ based on rational evidence while evaluating states’ responses during an outbreak. The panel referred to the non-binding Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political Rights (ICCPR) 1985 that asks states to strike a balance between protecting liberties and securing population health.
Lessons from Tobacco Control for Alcohol
Along with a consideration of the IHR’s legal frameworks, the Geneva panel discussion also discussed the potential role of law in responding to other public health challenges, including: tobacco control; the harmful use of alcohol; access to medicines; and the discrimination of marginalised people.
Despite uneven compliance with WHO’s Framework Convention on Tobacco Control (FCTC), the Lancet report credits the FCTC as having had a substantial impact in the uptake by many countries of legal measures that advance: smoking bans and marketing restrictions, such as pictorial warnings on packages, among others. Experts believe that lessons from tobacco control could be applied to other public health challenges.
Nina Renshaw, director of Policy and Advocacy at the NCD Alliance, said that political leaders were nonetheless reluctant to go beyond tobacco and craft laws that might curb the harmful use of alcohol and unhealthy foods that are the cause of many noncommunicable diseases, and were pushing instead for voluntary commitments. However, ultimately fighting NCDs requires legislation upstream of food and beverage industries, she asserted. “There need to be legal underpinnings to follow up on this,” she said.
“There is a desperate need for legally binding measures to address alcohol related death,”, she said, speaking even as countries attending the WHO Executive Board huddled not far away, to reach agreement on a new global action plan to address the harmful use of alcohol. Renshaw also advocated greater use of fiscal measures, e.g. excise duties or taxation, to both reduce harmful alcohol consumption and to increase public revenues to promote health.
Legal and regulatory interventions to prevent non-communicable diseases can promote “small changes across entire populations for a mass impact”, observes the Lancet report, noting that “law has the power to facilitate profound changes in behaviour.”
ACCESS TO MEDICINES
Speaking on the use of law for improving the access to medicines, Mariângela Simão, assistant director-general of Access to Medicines and Health Products at WHO, said, affordability is partly patent-related, but also emphasized on the importance of a legal framework to govern transparent procurement and pricing negotiations.
Simão said, “access to medicines is an excellent proxy for the right to health.” The situation in China also shows that in a globalised world no country is alone, she said referring to the current outbreak. The access to safe, quality drugs is important, including access to active pharmaceutical ingredients, she added.
To improve access to medicines and technologies, the Lancet report suggests “regulatory frameworks need to be reformed, or made more flexible to support development, deployment of effective therapeutic countermeasures. Legal obstacles to the effective deployment of counter-measures should be addressed and resolved in advance of future pandemics.”
Improving Legal Capacities
Overall, the Lancet report calls for building disciplinary bridges in order to build legal capacities by getting legal and medical professionals together. It also noted the contribution of effective health diplomacy in complex negotiations that resulted in the FCTC, the IHR or the PIP Framework.
But experts at the event, also noted that in reality, member states are not often keen on doing the hard legal work implicit in promulgating new laws, partly due to uneven their legal capacity. “We cannot cut and paste legal solutions from one country to another,” a senior WHO official present at the event cautioned.
The IHR, and its application, is to be the focus of another public lunchtime session this Wednesday, at the Geneva Graduate Institute – The global governance of outbreaks: from Ebola to the novel Coronavirus.