An Unofficial Q&A on International Health Regulations

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By David Bell and Thi Thuy Van Dinh

6/23/2023Updated: 6/23/2023

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Commentary

1.Why this unofficial Q&A?

The World Health Organization (WHO) includes a Q&A of its proposed health emergency instruments on its website. This document inadequately characterizes draft amendments that carry significant consequences for basic human rights and democratic process. Therefore, the proposals and their implications are explained further here, based on the WHO’s drafts, to support informed decision-making by States, legislators, elected persons, and the public.

2. What are the IHR (2005)?

The International Health Regulations form a legally-binding international instrument adopted under Article 21 of the WHO’s Constitution which requires acceptance by only a simple majority of Member States. It was first adopted in 1951 and has been periodically modified. The current version was adopted in 2005 and entered into force in 2007. It has 196 States Parties, including the 194 WHO Member States.

The purpose of the IHR (2005) was to improve coordination of international surveillance and response to health emergencies, particularly pandemics, to; “prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.”

3. What are the obligations of States Parties?

The IHR (2005) contain provisions and annexes with different levels of obligations for States Parties, covering surveillance of disease outbreaks, reporting, information-sharing, and capacity-building of national health authorities.

The Regulations as they currently stand aim to respect States’ sovereignty, leaving much flexibility, discretionary consideration, and decision-making to States with regard to outbreaks to be assessed, but include some required measures to be taken.

4. What are the current powers of the WHO under the IHR (2005)?

The WHO Director-General (DG) has the power to declare a public health emergency of international concern (PHEIC). WHO is mandated to inform other States, even without the concerned State’s consent, and to convene the Emergency Committee. Although pandemics are historically rare, this power has been used 3 times since 2020, regarding SARS-CoV-2, Mpox (formerly monkeypox) and Ebola.

The DG has the power to make temporary recommendations to States under a PHIEC regarding persons, cargo, containers, conveyances, goods and postal parcels. These include restrictive measures such as border closure, forced quarantine of people, mandated medical examinations, testing and vaccination, contact tracing and screening (art. 18). The WHO is also vested to make “standing recommendations of appropriate health measures” in order to ensure better implementation of the Regulations (art. 16).

5. Are the current temporary and standing recommendations by the WHO binding?

No. These recommendations are non-binding advice (art. 1), meaning that States can choose not to follow them without consequences. This was required by the States who adopted the IHR (2005), as a means to preserve their sovereignty against potential abusive powers of unelected international officials.

6. Why are amendments being proposed?

Arguments have been made that the IHR amendments are needed due to an increasing pandemic risk, but as the WHO reports these are historically unfounded, with mortality reducing over the past 120 years with the advent of antibiotics, better medical care, and better living conditions.

Similarly, arguments that human-animal interaction is increasing are incompatible with a steady loss of habitat and biodiversity, and reduced numbers of humans living in close and prolonged contact with farm or wild animals.

Private investors and commercial interests have become increasingly prominent in WHO funding, whilst both private and State-based funding is now “specified,” meaning funders decide how the WHO will spend the funding provided. The pharmaceutical industry that dominates corporate funding, and the main private funders, have amassed considerable wealth through the COVID-19 response. These funders also direct parallel vaccine-focused organizations, the Gavi alliance and CEPI. The two main State funders, the United States and Germany, have heavy investments in vaccine-based responses for health emergencies.

The WHO is also strongly influenced by non-democratic political interests through the appointment of the DG and senior officials, the make-up of the Executive Board, and its governing body, the World Health Assembly (WHA). Its actions and policies are therefore not based on the approaches to human rights and individual freedom that ostensibly guide most constitutional democracies.

It thus appears that commercial and other vested interests are providing significant impetus to greater centralization of control in health emergencies, probably driven by opportunity for profit, whilst prioritization based on disease burden and human rights norms appear to be less significant drivers.

7. Who is behind the amendment process?

The decision to launch the amendment process was made by the Executive Board composed of 34 individuals from elected Member States in January 2022, claiming a need for urgent action to address potential international health emergencies.

As is common practice in the United Nations system, the process is probably instigated and supported by a group of powerful States, working closely with the WHO secretariat to achieve their intended results through the intergovernmental process. The prior proposed amendments discussed and approved in 2022 by the WHO’s governing body, the WHA, were all proposed by the United States of America. The new proposals call for better compliance to the IHR, more WHO and States’ control over the activities of citizens, and consequently less human rights and freedom for individuals. This is promoted in the name of equity and a greater good, reflecting the policies implemented in response to COVID-19 against prior public health guidance and human rights norms.

Part of the first set of amendments was adopted in May 2022 by consensus through Committee A of the 75th WHA, hence without a formal vote. These amendments, to enter into force in two years (2024), will reduce the period for rejections and reservations to (future) amendments to the IHR from 18 months to 10 months.

8. What is being proposed to reduce State and individual sovereignty?

Several proposals aim at extending the purpose and scope of the IHR to “all risks with a potential to impact public health” (amendment to art. 2). Non-binding recommendations would become binding (amendments to art. 1 and new art. 13A).

Many of the proposals aim to reduce States’ sovereignty and give WHO officials (DG, Regional Directors, technical staff) new and extensive powers, including the issuing of binding recommendations. States not rejecting the amendments “undertake” to follow the DG’s recommendations (art. 13A). These are accompanied by proposals to establish a broader public health bureaucracy at the national, regional and international level, as well as new entities and platforms to monitor and ensure State’s compliance.

Under the current proposals, intellectual property holders will be forced to waive their exclusive rights under pandemics when the WHO applies its “allocation mechanism” aimed at ensuring access to medical supplies equitable to the WHO’s views (new art. 13A).

If passed, the WHO D-G would be able to dictate restrictions and other measures at any time for any potential risk.

Freedom to discuss and oppose the WHO’s recommendations will also be curtailed. Proposals call for the WHO and States to counter mis- and dis-information (amendment to art. 44.2), on the assumption that scientific knowledge and public health correctness arise from a single organization and those collaborating with it, rather than from a continuing open process of enquiry and discussion.

9. What current optional recommendations would become obligatory?

Standing recommendations and temporary recommendations, both currently being mere advice from the WHO and non-binding, will become binding (art. 1 and 13A). Standing recommendations will also include those “on the access and availability of health products, technologies, and know-how, including an allocation mechanism for their fair and equitable access” (amendment to art. 16), implying mandatory requisition and transfer of health products on demand of the WHO.

Currently, States can assess public health events and decide what measures and policies to take. Under the new proposals the WHO can declare an emergency, including for mere potential threats, without State consent, and dictate public health measures to be followed (amendment to art. 12, new art. 13A).

The recommendations (art. 18.1) regarding persons include:

• review travel history in affected areas; • review proof of medical examination and any laboratory analysis; • require medical examination; • review proof of vaccination or other prophylaxis; • require vaccination or other prophylaxis; • place suspect persons under public health observation; • implement quarantine or other health measures for suspect persons; • implement isolation and treatment of affected persons; • implement tracing of contacts of suspect or affected persons; • refuse entry of suspect and affected persons; • refuse entry of unsuspected persons to affected areas; and • implement exit screening and/or restrictions on persons from affected areas.

New compliance mechanisms (Universal Health Periodic Review, “a strengthened review mechanism to the IHR”) and authorities (Implementation Committee, Compliance Committee) are being proposed to ensure State’s compliance (respectively, amendment to art. 5.1, new art. 53A, and new chapter IV).

10. What is the timeline?

The amendment process is in the hands of a WHO Working Group (WGIHR) tasked to streamline, review, and negotiate an outcome regarding more than 300 proposed amendments. It was announced that the WGIHR will present the final text to the 77th World Health Assembly in May 2024 for consideration. If passed (requiring agreement of 50 percent of those present), States will have 10 months to reject, after which it will come into force for non-rejecting States 2 months later.

11. How likely is it that these amendments will be accepted?

If submitted for a vote, their adoption only requires a simple majority of the 194 World Health Assembly’s States present and voting (but the pandemic treaty will require a two-thirds majority vote). Alternatively, a committee of the Assembly may be tasked to negotiate and simply reach a consensus.

Either path seems to be likely to result in adoption. To prevent this, a majority of States present would need to actively vote against them. Little dissent is apparent among the delegations of Member States, but it is likely that some wording will be refined, and some amendments may not be put to the 2024 vote.

12. How will it affect ordinary people?

If the amendments are adopted, people will have lockdowns, border closures, quarantine, testing, and vaccination requirements imposed on them by WHO officials in headquarters (Geneva, Switzerland) or a WHO Regional Office (amendment to art. 18). Such mandates affect rights to individual and bodily sovereignty, including the right to choose medical management, rights to work, education, travel, and to follow cultural, family, and religious practice. Experience from the COVID-19 response indicates that these restrictions are likely to be applied irrespective of individual risk, including the institution of mass vaccination irrespective of individual risk or prior disease exposure.

These measures will negatively affect national economies through border closures, restrictions on commerce, and supply line interruption. Reductions in international trade and tourism, a major contributor to many smaller and low-GDP economies, will aggravate this. Increased poverty is associated with reduced life expectancy, and in particular with higher infant mortality in low-income countries.

The new amendments may be used to justify adoption of laws and regulations criminalizing mis- and dis-information, referring to information and opinion contrary to those of the WHO (amendment to art. 44).

13. How likely is WHO to enact these requirements?

In mid-2022 the DG declared a PHEIC over monkeypox, against the advice of the Emergency Committee, and after just 5 people had died globally, within a very clearly-defined demographic. The declaration remained in place until May 2023, despite only 140 deaths globally.

The COVID-19 outbreak PHEIC continued for over 3 years, although mortality was highly confined to old age with certain comorbidities, post-infection immunity was shown to be highly protective within the first year, and with infection mortality rates at a global level being closely equivalent to influenza. The proposed pandemic treaty accompanying the IHR amendments introduces the One Health concept, expanding potential threats to any potential change in the biosphere that may influence human health and well-being, whilst the IHR amendments stress the inclusion of “potential” harm, rather than demonstrated harm, providing very broad scope to justify a PHEIC.

The WHO’s statements regarding the potential threat of a “next pandemic” are inconsistent with its own historical record regarding pandemic rarity. Significant commercial and private interests that have gained from the COVID-19 response are also heavily involved in the health emergency agenda, and direct funders of WHO outbreak response activities.

It therefore appears highly likely that the PHEIC declarations will be imposed with increasing frequency in coming years, as these declarations will provide clear benefit to those influencing the process.

14. What is the draft pandemic treaty?

In parallel to this process, a pandemic treaty or “accord” (CA+) is being prepared with similar motivations and likely arising from the same group of States. The same timeline was also announced. Unlike the proposed amendments which can be approved by simple majority or by consensus, the treaty will probably require an assenting vote of at least two-thirds of Member States present and voting. Thirty States must then ratify it, and it may come into force 30 days later. Some provisions may be brought into effect earlier.

15. Is pandemic preparedness justified?

Pandemics have played an important part in human history. Historically, most were due to bacterial infections, often exacerbated by poor sanitation. Such pandemics are now readily controllable. In the last severe pandemic, the Spanish flu (influenza) of 1918–19, most deaths are thought to have occurred due to secondary bacterial infections that would now be treated with antibiotics. The WHO records influenza pandemics only 3 times in the following 100 years, each killing far less than currently die annually from tuberculosis. Mortality in the COVID-19 outbreak is difficult to assess, as definitions and reporting varied, average age of associated death was over 75 years, and the public health response raised mortality from other diseases.

Most COVID-19 mortality was associated with severe comorbidities, particularly those associated with metabolic syndrome such as diabetes, mellitus, and obesity. Up to a third of COVID-associated deaths were also linked to impaired immunity due to vitamin D deficiency and other micronutrient deficiencies.

Pandemics are therefore rare and of relatively low health burden in the modern era, particularly compared to growing metabolic disease burdens, and endemic infectious diseases in lower-income countries. Preparedness, in terms of reducing mortality, is probably best achieved by addressing underlying impairment of innate immunity, including micronutrient and vitamin deficiencies, metabolic diseases and possibly stress-related illness.

Such approaches also produce clear health benefits between outbreaks of infectious disease. As demonstrated through COVID-19 response, it is highly questionable whether surveillance, border closures, restrictions on activity, and mass vaccination improve outcomes, whilst they do have heavy costs in other areas, particularly for lower-income people. This was the basis of the WHO’s advice against border closures and other “lockdown” type measures in its 2019 pandemic influenza guidelines.

16. What can you do?

To assess the implications of where the IHR amendments and accompanying pandemic treaty seek to take us, we need to step back and ask some further basic questions:

Does this resemble equality and democratic process, or totalitarianism?

Should WHO officials have power to declare an emergency in your country and dictate measures? Does their track record of managing recent outbreaks, and the conflicts of interest and political leanings of entities that fund and direct them, impact on this?

Do we want a society that can be shut down anytime by non-accountable people, who can then mandate that we and our children take weekly tests and regular vaccines to be able to go to a park?

Why is there an urgency to reduce our freedom of action and expression now, for perceived emergencies that are historically rare? Is this a better and necessary approach to life compared to that followed over the past 100 years?

We invite you to learn about this and form your own opinions.

We encourage you to share your concerns with your elected representatives, local leaders and people around you.

We would all be delighted if you join the global concern regarding this process in any way you could. This includes encouraging open discussion with neighbors and friends.

Freedom is not something that someone grants you, it is your birthright. But history shows us that it is also easily stolen.

The WHO has become a tool of those who would manipulate us for greed and self-interest. In previous eras, people have stood against those who sought to exploit and enslave them, reclaimed their rights and saved society for their children. What we are facing is not new; society periodically faces and overcomes such challenges.