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Less than a month before the intended vote, the proposed changes to the International Health Regulations and the draft Pandemic Agreement are still being negotiated.  On 16 April, a new draft of the amended International Health Regulations (“IHR”) was released.

In understanding the apparent reversals of some previous proposals in the latest draft, it is important to understand that the covid-19 response demonstrated great success in imposing a new model for responding to outbreaks under the current voluntary IHR. Powerful privately owned foundations with strong connections to the pharmaceutical industry heavily directed this new response.

The newly released draft states now state it is non-binding, as is the current IHR, but otherwise, the intent of the draft is essentially unchanged.  The intent is to further centralise control of public health within WHO and base response to disease outbreaks on commodities, such as vaccines. 

By David Bell and Thi Thuy Van Dinh

For two years, the 196 State Parties to the 2005 International Health Regulations (“IHR”) – composed of 194 Member States of the World Health Organisation (“WHO”), and Liechtenstein and the Vatican – have been submitting and discussing proposed amendments to update this agreement. Introduced in the 1960s, the IHR are intended to strengthen national capacities and improve coordination among countries in the event of a health emergency. Though a legally binding agreement under international law (i.e. a treaty), most of the provisions have always been voluntary. 

The draft of the IHR amendments and an accompanying draft Pandemic Agreement are both still under negotiation a month short of the intended vote at the World Health Assembly (“WHA”) in late May. Together, they reflect a sea change in international public health over the past two decades. They aim to further centralise control of public health policy within the WHO and base response to disease outbreaks on a heavily commoditised approach, rather than the WHO’s prior emphasis of building resilience to disease through nutrition, sanitation, and strengthened community-based health care.

[Please note:  The Pandemic Treaty is also referred to as also referred to as the Pandemic Accord, Pandemic Agreement and WHO Convention Agreement + (“WHO CA+”).]

The Changing Public Health Environment

Public health’s metamorphosis responds to the increasingly directive nature of the WHO’s funding and an increasing participation of the private sector in that funding. Together with a growth of commodity-based public-private partnerships including Gavi (for vaccines) and CEPI (vaccines for pandemics), this has been heavily directed by powerful privately-owned foundations with strong connections to Pharma, who shape the work of these organisations through direct funding and through influence brought directly upon countries.

This became particularly prominent during the response to covid-19, in which prior WHO guidance was abandoned in favour of more directive and community-wide measures including mass workplace closures and mandated vaccination. The resultant concentration of wealth within private and corporate sponsors of the WHO, and increasing impoverishment and indebtedness of countries and populations, both set a precedent for such approaches and left the world more vulnerable to their imposition.

Implications of the New Draft

In understanding the apparent reversals of some proposals amending the IHR in the latest draft, it is important to understand that the covid-19 response demonstrated great success in imposing this new outbreak response paradigm under the current voluntary nature of the IHR. Pharmaceutical corporations successfully sealed highly lucrative contracts directly with States, including public funding for research and development, and liability-free advance purchase agreements. This was supported with heavy sponsorship of media, health, regulatory and political sectors enabling both the high level of compliance and the stifling of dissent.

Centralising more proscriptive powers within the WHO to repeat this business approach under a legally binding agreement would simplify future repetition, but also introduces an element of the unknown into a system already proven to work. These aspects of the previous drafts also presented an obvious focus for public opposition. Pharma has been aware of this reality during the negotiating process.

The latest version of the IHR amendments released on 16 April thus removes wording that would involve Member States “undertaking” to follow any future recommendation from the Director General (“DG”) when he/she declares a pandemic or other Public Health Emergency of International Concern (“PHEIC”) (former New Article 13A). They now remain as “non-binding” recommendations.

This change is sane, conforms with the WHO Constitution, and reflects concerns within country delegations regarding overreach. The shortened review time that passed in rather ad hoc fashion by the 2022 World Health Assembly will apply to all but four countries that rejected them. Otherwise, the intent of the draft, and how it is likely to play out, is essentially unchanged. The World Bank, IMF, and G20 have signalled an expectation that the overall plan will proceed, and rising national indebtedness further increases powers to coerce this.

States are still expected to manage dissenting opinion, and together with the accompanying Pandemic Agreement, the WHO and its partners continue to set up a highly dangerous complex (from a public health, equity, and human rights viewpoint) involving a massive and expensive surveillance system to identify natural viral variants, a requirement for rapid notification by countries, passage of samples by the WHO to pharmaceutical manufacturers of their choice, a 100-day mRNA vaccine delivery bypassing normal regulatory and safety trials, and then a mass-vaccination-based response that will, as seen in the covid-19 response, be pitched as a way to get back to normal. This can still be invoked by the DG alone, simply on his/her perception of a threat rather than actual harm. The pharmaceutical companies will be supported by public funds (See discussion on the Pandemic Agreement), but receive liability-protected profits.

An Unfit and Unready Document

This system will be overseen by the WHO, despite being a beneficiary of Pharma funding, which in turn will be the major financial beneficiary of the pandemic response. The DG personally selects the committee members who may advise and oversee this process (rather than the Member States which are supposed to ultimately be in charge). The WHO receives funding for its emergency agenda from the same organisations and private investors that stand to benefit.

The conflicts of interest and vulnerabilities to corruption in this scheme are obvious. A whole international bureaucracy is already being put in place for this, whose sole reason for existence is to determine that viral variants and minor outbreaks, a natural part of existence, are a threat requiring a specific response that they must then implement. The current DG declared a global emergency over Monkeypox, after just five deaths in a clear and relatively restricted demographic group.

Lastly, the current text of the amendments discussed below looks far from complete. There are internal contradictions, such as clauses both requiring informed consent and, strangely and alarmingly, recommending that this be overridden. The definition provided of a pandemic is as much based on the response put in place as the pathogen or disease itself. By removing the shortened review period and removing overt compulsion, the prior misrepresentation of urgency and outbreak frequency seems to have been recognised. 

Yet, this document, and the draft Pandemic Agreement, are still intended to be voted on before the end of May. This completely abrogates the legal requirement within Article 55 of the IHR (2005) and is repeated in this draft, for a four-month review period before any vote. This is not only irrational given the unfinished nature of the text, but inequitable as it disadvantages less-resourced countries in fully assessing likely impacts on health, human rights, and their economies. There are no procedural reasons to prevent the WHO from calling for a later WHA vote after the drafts have been properly reviewed. Member States should clearly demand this.

Significant Proposed Amendments and Their Implications

The key changes and implications of the current draft are summarised below. The proposed changes are found HERE.  

The proposed amendments should be reviewed in light of the lack of urgency, low burden, and currently reducing frequency of recorded infectious disease outbreaks and the huge financial requirements to countries – already heavily impoverished and indebted post-lockdowns – for setting up additional international and national bureaucracies and institutions. It must also be assessed in light of the accompanying draft Pandemic Agreement, the apparent conflicts of interest, the concentration of wealth among sponsors of the WHO during the covid-19 response, and the persistent absence of a transparent and credible cost-benefit analysis of the covid-19 response and proposed new pandemic measures from the WHO.

(Text note: Bold text below reflects its use in the draft amendments to denote new text added in this draft.)

It is useful to have a definition of “pandemic” added to the draft, as it was recently noted elsewhere that without this the entire pandemic agenda is somewhat undefinable. Note the use of “and;” all these conditions must be met.

It is, however, a technically flawed definition. While clause (i) is sensible and orthodox, (ii) will vary between States, meaning that the same outbreak may somehow be a “pandemic” in one country, but not the other. It must also be causing social, economic, or political disruption, and must additionally require a “whole of government approach.”

“Whole-of-government approaches” is an undefinable but popular term in public health, that can be argued to be almost nothing – what really requires a whole-of-government approach? Certainly, no infectious disease outbreak in the past few centuries would readily confirm, as only specific arms of most governments were involved. Some countries had a quite light approach during covid-19, with very limited government redirection, whilst attaining similar or better outcomes than neighbouring states. This would mean that covid-19 would fall outside this pandemic definition despite “spreading to and within” multiple States, and also causing illness. 

This definition appears insufficiently thought through, reflecting the rushed nature of this document and its unreadiness for a vote.

“Pandemic emergency” is a new term. The definition includes “or is likely to be,” thus substituting for the change in Article 12 in the previous version that included “potential or actual” to broaden the PHEIC scope to a perceived threat rather than an event causing actual harm. i.e. the IHR proposals are unchanged on this point.

“Pandemic emergency” appears to be used within the text as a subset of a Public Health Emergency of International Concern (“PHEIC”). This may be to ensure future conformity of the accompanying Pandemic Agreement with policy on PHEICs, as this is pandemic-specific whilst the IHR addresses declared international public health emergencies of any type.

More restricted than the previous draft, which included an option of “… and other health technologies, but not limited to this,” then defining “health technologies” as anything that improves “well-being.”

Standing Recommendations and Temporary Recommendations are now returned to being “non-binding advice,” with the previously deleted “non-binding” wording returned to the text (see also notes on Article 13A and Article 42 below).

This remains problematic, particularly for low- and middle-income countries. The “Core capacities” in Annex One include surveillance, laboratory capacity, maintenance of specialised staff and sample management. Many countries still struggle to develop and maintain these for high-burden diseases such as tuberculosis, with well-recognised mortality resulting from this lack of capacity. The Pandemic Agreement lays out these resource-intensive requirements in further detail. Low-income countries risk significant harm through resource diversion from high-burden health problems to a problem predominantly perceived as a major threat by better-off Western nations with higher life expectancies.

Interestingly, the censorship expectation “risk communication, including countering misinformation and disinformation” has also now been tucked away in Annex 1, but remains essentially unchanged.

If this means anything, the change from “should” to “shall” seems to imply that the State Party is still expected to be under some direction from the WHO. This is a return to the sovereignty issue – non-compliance could be used as a reason for enforcement such as through financial mechanisms (e.g. World Bank, IMF financial instruments).

The wording has escape clauses in “within the means and resources,” but this then begs the question of why it is deemed necessary to change “should” to “shall.”

The DG alone retains the power to declare a PHEIC or pandemic emergency (See Chapter III provisions below regarding DG power over committees).

As above – this needs to be optional as appropriate in many circumstances. The alternate (bis) version following it is far more appropriate and consistent with equity:

The Director-General retains sole authority to declare and cease a PHEIC, with the emergency committee and Member States giving advice only.

It is hoped this reflects some recognition of the harm done in the covid-19 response through the effect of international travel on economies. People starve to death in low-income countries, and lose their incomes and future education, especially women, when tourism is stopped. However, it appears confined to health staff.

Article 31, paragraph 2 (below) quoted here actually supports mandatory vaccination, clashing with informed consent provisions above, and therefore one or other needs rewording (one hopes this is Article 31).

Using vaccination status as a criterion for right of entry, a country’s sovereign right though used egregiously in the covid-19 response, may serve a purpose when a vaccine blocks transmission of a serious disease not already prevalent in the country concerned.

I.e. Contrary to Article 23, informed consent will not be a requirement for a Member State to perform medical examinations or inject people.

Vaccination at time of entry is of no use in preventing disease importation, as it will not stop an established infection in the traveller, so mandatory vaccination at time of entry is not a legitimate public health measure, irrespective of human rights concerns.

Requirement of medical examinations, or isolation on refusal, would be broadly considered as a last resort in highly dangerous infectious diseases, but should not be imposed lightly.

This is, obviously, inappropriate for the head of an organisation directly funded by those who benefit from the countermeasures promoted, due to conflict of interest. State Parties should, as owners of the WHO, surely be providing experts from their own national pool. This would reduce conflict of interest and help ensure diversity and representativeness.

See note on Article 47.

As above, the DG has sole authority. This underlines the importance of keeping compliance with the IHR voluntary. The current Director-General declared a Public Health Emergency of International Concern for Monkeypox, after just five deaths in a very specific demographic group. This would, under the new Pandemic Agreement and the provisions here, allow the DG to trigger the whole process of recommending lockdowns, rapid vaccine development, promotion of mandatory vaccination, and resultant profits flowing to entities currently involved in funding WHO’s pandemic agenda.

As above. A review committee must be independent to function properly, and therefore cannot be selected by the same people they are reviewing. All the more so here, as conflicts are so likely as private beneficiaries of the proposed approach also sponsor part of the process.

It is extraordinary for a review committee that only those appointed by a person whose actions are a subject of the review would have a right to vote and make any determination. However, this has crept in here, and there is no attempt by Member States to provide a mechanism for serious oversight.

More of the WHO reviewing itself, but…then:

This alternate Article 54 seems an attempt by some Member State(s) to wrest some oversight back from the DG, ensuring Member States nominate committee members with an actual decision-making role. If so, it may benefit from tightening of the wording.

This is, of course, completely incompatible with a vote on these proposed amendments in May 2024.

Time to review implications is of course essential. Four months is short for this, four weeks would be ridiculous.

This Article will be modified based on the resolution accepted previously by most States at the WHA in 2022 (excepting those who rejected prior to the end of 2023), reducing the review time. This is clarified in a report from the DG: “27. The amendments to Articles 55, 59, 61, 62 and 63 of the Regulations, adopted by the Seventy-fifth World Health Assembly through resolution WHA75.12 (2022), will enter into force on 31 May 2024. As communicated to all States Parties, the Islamic Republic of Iran, the Kingdom of the Netherlands, New Zealand and Slovakia notified the Director-General of their rejection of the above-referenced amendments.”

The new Articles now come into force 12 months after a vote (Article 63).

For the four States that reject any amendment during the review period, then prior versions of these Articles apply. As before, however, active rejection is required, within 10 or 18 months respectively, or these legally binding Articles automatically apply (Article 61).

Other issues

A general note on terminology.

“Developed” and “developing” countries. It is perhaps time that the WHO moved on from the assumption that some countries are more “developed” than others. Perhaps “high-income,” “middle-income” and “low-income,” reflecting World Bank custom, are less colonialist. Have “developed” countries attained all that progress and technology can provide?

This would of course mean that they were “undeveloped” 20 years ago and that technology is the only measure of development, rather than culture, art, political maturity, or a preference for not bombing less powerful countries. The WHO considers countries such as India, Egypt, Ethiopia, and Mali, with thousands of years of written history and civilization, less “developed.” Words matter. They promote, in this case, an impression of a hierarchy of countries (and therefore people) in terms of attainment or importance, based on a very materialistic worldview.

About the Authors

David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is a former medical officer and scientist at the World Health Organisation, Programme Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and Director of Global Health Technologies at Intellectual Ventures Global Good Fund in Bellevue, WA, USA.

Dr. Thi Thuy Van Dinh (LLM, PhD) worked on international law in the United Nations Office on Drugs and Crime and the Office of the High Commissioner for Human Rights. Subsequently, she managed multilateral organisation partnerships for Intellectual Ventures Global Good Fund and led environmental health technology development efforts for low-resource settings.