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IHR Amendments Open Door to Perpetual Emergencies

IHR Amendments Open Door to Perpetual Emergencies

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The 77th session of the World Health Assembly (WHA) just concluded at the World Health Organization’s (WHO) headquarters in Geneva, Switzerland. It originally intended to adopt a new pandemic treaty and amendments to the 2005 International Health Regulations (IHR) that would tie country responses to the decisions of the WHO’s Director-General. In the end, it kicked one can down the road for a year and partly filled another.

The mandate of the Intergovernmental Negotiating Body (INB) was extended to continue negotiation on the wording of the new treaty (‘Pandemic Agreement’), and the Assembly adopted a limited package of binding and non-binding amendments to the IHR. This outcome, reached during the very last hours, is disappointing from many viewpoints, yet was not unexpected

Both texts were pushed in unusual haste by those who advised, supported, and mandated catastrophic public health responses to Covid-19. Ignoring Covid’s probable lab-based origins, the official narrative backing the measures remains that “the world is unprepared for the next pandemic.” Spending over $30 billion per year on surveillance and other measures aimed solely at natural outbreaks will somehow fix this. 

The 77th WHA has sent a clear warning to the world that the global pandemic agenda is moving forward. The WHO is in the driver’s seat with States Parties’ consent to ignore procedural requirements to get the job done. The deplorable absence of serious questions at the WHA on i) the economic costs versus benefits of this agenda, ii) the potential impact of new amendments on human rights, and iii) the scientific foundations of the systematic surveillance approach, signal that the drivers are political rather than evidence-based. 

Those who seek to ensure that future pandemic preparation and response take account of the recent lessons of the Covid-19 response, and adhere to the basic principles and ethics that underlie public health, have seen another predictable setback. But overcoming vested interests with truth is an age-old battle, and takes time and courage. 

Outcomes of the Drafting Process

The INB was unable to come to sufficient consensus on a viable text to present to the WHA, despite continuing two months beyond their original deadline of March 2024. Hence, its mandate was protracted for another year, with a rotation of the Bureau’s members. A special WHA session may be convened for adoption if consensus is reached sooner. As much of the concern over the proportionality and appropriateness of the proposed Pandemic Agreement came from State delegations to the INB, the composition of its new Bureau will be crucial to its outcome.

The process for presenting the IHR amendments was remarkable, given that they are intended to be legally binding on Member States. Despite the WGIHR failing to produce a text fit for a vote until hours before the consensus text was presented to the WHA, rather than four months prior as legally required by Article 55 (2) of the IHR, it was still tabled for approval.

The negotiations even continued in parallel with the WHA session, until a final consensus text was reached. France, Indonesia, Kenya, New Zealand, Saudi Arabia, and the US authored the resolution adopting the amendments, with Canada as a co-sponsor. On the public webcast (Plenary, 1 June 2024, 20:55-22:50), the WHA Chair chose not to call for a formal vote by show of hands after the text was read aloud.

A total of 45 speakers, representing countries and regional groups and totaling 109 States Parties, expressed their commitment to this multilateral approach. Ethiopia spoke on behalf of 48 African countries, Mexico for 16 American countries, and the European Union for its 27 Members. This therefore represents a clear majority of the 196 States Parties to the IHR. Much was said on the importance of learning from the Covid-19 pandemic by adopting the amendments and continuing the INB’s work, while ignoring the failure of scientifically unfounded Covid measures and their devastating consequences on economies, societal cohesion, and non-Covid health burdens. 

The WHO immediately called this outcome “historic” and a key step for countries to “build on lessons learned from several global health emergencies.” Upcoming official speeches from the WHO’s sister organizations in the United Nations system as well as from governments may well extol it with similar rhetoric. It was nevertheless extremely disappointing for the public and numerous grassroots organizations who have manifested their opposition since the beginning of the process. While the WHA was deliberating, a rally and march of activists against the global pandemic agenda happened in front of the UN Office in Geneva. 

It is rather unfortunate that only a very small number of countries (Argentina, the Islamic Republic of Iran, Netherlands, Slovakia, Russia, and the UK) took the floor to affirm their sovereign right to examine each of the amendments at home in a rational manner, then accept or reject or make reservations as appropriate. These amendments ultimately impact health, economies, and human rights, and treaty approval often is the Parliament’s prerogative. The legal requirement of the IHR is to ensure such reflection, and in ignoring this Member States diminished their own citizenry.

Observations of the Amendment Process 

Unprecedented mobilizations of the public have occurred locally and globally by groups and individuals concerned with the WHO’s pandemic preparedness agenda. This probably modified the direction of the IHR race car, through influence on politicians and maybe on delegates during the negotiations. For example, the proposal on making all the WHO’s recommendations mandatory for countries was on the table until it was dropped in March 2024. Growing concerns over proportionality and risks have also struck a chord with those in the process, many of whom, in working for a good outcome, find themselves struggling with opaque or misrepresented claims by institutions backing the agenda.

The WHO’s response to much of this has been to denigrate the public, applying terms such as ‘anti-vaxxer’ to people promoting orthodox public health processes. This has undoubtedly undermined public trust. Politicians brave or concerned enough to speak out have tended to belong to opposition parties, or been relegated to them by those wielding power. However, the issues at stake – international rule of law, human rights, and fundamental freedoms, especially the right to bodily autonomy and the necessity of informed consent – should not be political.

With few exceptions, leaders in power have relentlessly affirmed their support to the WHO projects. The mainstream media, in turn, have been surprisingly quiet and prefer not to question the official narrative. Thus, despite the potential impact of the agenda, there may be little hope that a large number of countries will choose to exercise their right to reservation and rejection in the permissible 10 months (according to amendments to Articles 59 and 61 IHR, made in 2022 and just entered into force on 31 May 2024).

Overall, the process has seriously altered public perceptions and trust in the United Nations system in general, and in the WHO in particular. Supranational bodies, typically located in safe and rich cities, detached from people’s daily lives and conditions and increasingly allying themselves with the rich, discuss and make decisions on all sorts of questions that many of us barely hear about. As demonstrated in this case, they can be as lawless as they wish with little or no consequence. They are constantly seeking to make themselves relevant by producing more and more of what may be qualified as “soft laws” – declarations, agendas, policy guidelines, and strategies – which in turn may pave the way for mandatory rules to come. This is not what democracy is about, but what previous pro-democracy movements stood against.

Conclusion

Good policy takes time and requires honest and open discussion. In vilifying opposing views and misrepresenting risk, the WHO is not serving Member States well as the secretariat and technical input to the WHA. This is reflected in the 77th WHA outcomes. If the WHO is to serve a useful and positive role in global health, populations must demand better of their governments, who in turn must require a return to evidence-based and proportionate public health policy. 

In its concentration on pandemics above other priorities, the WHO appears to have forgotten that it was set up to serve the people, especially the poor and vulnerable. By recklessly pushing its agenda forward at the expense of other health issues, it has forgotten the most fundamental principle proclaimed in its 1946 Constitution: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”

Analysis of New Amendments

Most of the new amendments are derived from the April draft previously analyzed, and will enter into force in 12 months’ time. All States Parties, except four who rejected the 2022 amendments (Islamic Republic of Iran, Netherlands, New Zealand, and Slovakia), will have 10 months to reject or make reservations.

The final package concentrates particularly on expanding an intrusive and expensive surveillance system targeting natural variants at the country level. It therefore is not targeted at ‘stopping the next Covid-19 – an outbreak probably arising from human manipulation in a lab – but the small burden of naturally derived acute outbreaks.

The following commentary focuses on the most problematic amendments. As in the WHO document, new text is in bold font.

Article 1. Definitions

“National IHR Authority” means the entity designated or established by the State Party at the national level to coordinate the implementation of these Regulations within the jurisdiction of the State Party;

“pandemic emergency” means a public health emergency of international concern that is caused by a communicable disease and:

(i) has, or is at high risk of having, wide geographical spread to and within multiple States; and

(ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and

(iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and

(iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches. 

The definition of pandemic emergency was modified compared to the one in the April draft. From now on, the emergency will include not only pandemic but also threats of pandemic, events “at high risk of…” Notably, subparagraph (iii) refers to events or potential threats causing “substantial social and/or economic disruption.” In view of the (recently lowered) thresholds to disrupt businesses, close schools, and cull livestock, many public health concerns once considered small will already meet the definition of a pandemic emergency.

Subparagraph (iv), using the terms ‘whole-of-government” and ‘whole-of-society” is a formal break by the WHO from evidence-based public health. Previously, the known impacts of poverty and stress on human life expectancy and overall health (in the WHO)’s definition of physical, mental, and social well-being” meant that disruption should be focused and kept to a minimum, with most of society continuing as normal. This ensures the continuance of a healthy economy to support physical, mental, and social health. Destroying a child’s education in order to ‘protect’ a grandparent, a catch-cry during the Covid response, is contrary to prior epidemic management but clearly the intent here.

“relevant health products” means those health products needed to respond to public health emergencies of international concern, including pandemic emergencies, which may include medicines, vaccines, diagnostics, medical devices, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies;

The definition of “health products” has been considerably broadened compared to the April draft, to encompass “personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies.” Basically, any products marketable in the health sector will meet the definition. This is important to establish, in view of the requirement in the current Pandemic Agreement drafts for countries to provide a portion of such products free to the WHO when requested.

Article 3. Principles

1. The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons, and shall promote equity and solidarity.

During the last two years of negotiations, a modification to the principles of “dignity, human rights and fundamental freedoms of persons” was finally dropped. The presence of such wording, however, did not stop States from uniformly adopting and enforcing disproportionate emergency measures during the Covid response, abrogating norms and principles of human rights. Health emergency situations have become a solid pretext for forced and mandated quarantine, testing, and vaccinations, with courts widely backing policies of established health institutions over individual rights.

Countries now chose to add “equity and solidarity,” with probable meaning that it shall be at all levels, nationally, regionally, and globally. It is unclear how that will be determined. In light of the Covid experience, this is likely another feel-good slogan for the international community and an excuse for, rather than a moderator of, emergency measures.

Article 4. Responsible authorities

1. Each State Party shall designate or establish, in accordance with its national law and context, one or two entities to serve as National IHR Authority and National IHR Focal Point, as well as the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations.

1 bis. The National IHR Authority shall coordinate the implementation of these Regulations within the jurisdiction of the State Party.

(…)

2 bis. States Parties shall take measures to implement paragraphs 1, 1 bis, and 2 of this Article, including, as appropriate, adjusting their domestic legislative and/or administrative arrangements.

Amendments to Article 4 bring details to the National IHR Authority definition in Article 1. Logically, the Authority should also act as the Focal Point.

New paragraphs 1bis and 2bis require States to modify their legislative and/or administrative arrangements so that the National IHR Authority takes charge of IHR implementation. Hence, this authority will be calling the shots for monitoring and surveillance, as well as preventive measures and responses. 

Article 5. Surveillance

1. Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the core capacities to prevent, detect, assess, notify and report events in accordance with these Regulations, as specified in Annex 1. 

The amended Annex 1, analyzed below, now contains a broad list of surveillance and reporting activities for States. This is an obligation for States according to Article 19(a). If not in place within 5 years, the WHO may make standing recommendations (under Article 16) toward compliance.

Article 12. Determination of a public health emergency of international concern, including a pandemic emergency

1. The Director-General shall determine, on the basis of the information received, in particular from the State(s) Party(ies) within whose territory(ies) an event is occurring, whether an event constitutes a public health emergency of international concern, including, when appropriate, a pandemic emergency, in accordance with the criteria and the procedure set out in these Regulations.

4 bis. If the Director-General determines that an event constitutes a public health emergency of international concern, the Director-General shall further determine, having considered the matters contained in paragraph 4, whether the public health emergency of international concern also constitutes a pandemic emergency.

This amendment maintains the DG as the sole person who declares a PHEIC, including a pandemic emergency. Read together with the definition of pandemic emergency in Article 1, more frequent pandemic declarations may be expected. The current DG has declared an emergency for monkeypox after just five deaths globally, within a restricted demographic. 

Article 13. Public health response, including equitable access to relevant health products

7. WHO shall support States Parties, upon their request or following acceptance of an offer from WHO, and coordinate international response activities during public health emergencies of international concern, including pandemic emergencies, after their determination pursuant to Article 12 of these Regulations.

This amendment gives the WHO a mandate to coordinate international responses to public health activities during PHEIC and pandemic emergencies. However, the WHO can only intervene at the request of a country, or after a country’s acceptance of WHO’s offer to help.

8. WHO shall facilitate, and work to remove barriers to, timely and equitable access by States Parties to relevant health products after the determination of and during a public health emergency of international concern, including a pandemic emergency, based on public health risks and needs. To that effect, the Director-General shall:

(a) conduct, and periodically review and update, assessments of the public health needs, as well as of the availability and accessibility including affordability of relevant health products for the public health response; publish such assessments; and consider the available assessments while issuing, modifying, extending or terminating recommendations pursuant to Articles 15, 16, 17, 18, and 49 of these Regulations;

(b) make use of WHO-coordinated mechanisms, or facilitate, in consultation with States Parties, their establishment as needed, and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate timely and equitable access to relevant health products based on public health needs;

(c) support States Parties, upon their request, in scaling up and geographically diversifying the production of relevant health products, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, subject to Article 2 of these Regulations, and in accordance with relevant international law;

(d) share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented, within 30 days of receiving such request, for the purpose of facilitating regulatory evaluation and authorization by the State Party.; and

(e) support States Parties, upon their request, and, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, pursuant to subparagraph 8(c) of this Article, to promote research and development and strengthen local production of quality, safe and effective relevant health products, and facilitate other measures relevant for the full implementation of this provision.

These amendments are newly added and will considerably expand the WHO’s mandate. Subparagraph (c) refers to the WHO’s mandate to scale up and diversify the product of relevant health products. Briefly, a whole industry of pandemic products will be facilitated and rolled out by the WHO, without any oversight, transparency, and accountability mechanisms to be established under the IHR to avoid or minimize huge and obvious conflicts of interest and corruption risks.

9. Pursuant to paragraph 5 of this Article and paragraph 1 of Article 44 of these Regulations, and upon request of other States Parties or WHO, States Parties shall undertake, subject to applicable law and available resources, to collaborate with, and assist each other and to support WHO-coordinated response activities, including through:

(a) supporting WHO in implementing actions outlined in this Article;

(b) engaging with and encouraging relevant stakeholders operating in their respective jurisdictions to facilitate equitable access to relevant health products for responding to a public health emergency of international concern, including a pandemic emergency; and

(c) making available, as appropriate, relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency.

This amendment contains an obligation for States parties who have requested or accepted the WHO’s intervention, to collaborate with other States parties or the WHO, regarding access and equitable distribution of relevant health products. 

Article 15. Temporary recommendations

1. If it has been determined in accordance with Article 12 that a public health emergency of international concern, including a pandemic emergency, is occurring, the Director-General shall issue temporary recommendations in accordance with the procedure set out in Article 49. Such temporary recommendations may be modified or extended as appropriate, including after it has been determined that a public health emergency of international concern, including a pandemic emergency, has ended, at which time other temporary recommendations may be issued as necessary for the purpose of preventing or promptly detecting its recurrence.

2. bis. The Director-General, when communicating to States Parties the issuance, modification or extension of temporary recommendations, should provide available information on any WHO- coordinated mechanism(s) concerning access to, and allocation of, relevant health products, as well as on any other allocation and distribution mechanisms and networks.

Article 15, as previously, confers to the WHO’s DG the power to make temporary recommendations (listed under Article 18, including for example, travel history, medical examinations, required vaccinations, contact tracing, etc) to States during a PHEIC. This is now extended to pandemic emergency situations, perhaps for compatibility with a future Pandemic Agreement. The list of health measures to be included is broadened to “relevant health products.” It should be remembered that countries do not have an obligation to implement recommendations made under Article 15 (though non-compliance proved controversial during the Covid-19 response). 

Article 17. Criteria for recommendations

When issuing, modifying or terminating temporary or standing recommendations, the Director shall consider:

(d bis) availability of, and accessibility to relevant health products

Subparagraph (d bis) is added to the list of criteria considered by the WHO DG prior to making recommendations.

Article 18. Recommendations with respect to persons, baggage, cargo, containers, conveyances, goods and postal parcels

3. Recommendations issued by WHO to State Parties shall, as appropriate, take into account the need to:

(a) facilitate international travel, particularly of health and care workers and persons in life-threatening or humanitarian situations. This provision is without prejudice to Article 23 of these Regulations; and

(b) maintain international supply chains, including for relevant health products and food supplies.

The well-known lists of Article 18 include recommendations with respect to persons (mandated medical examinations, isolation, vaccination etc.), and transport of cargo that the WHO may make to States parties. The amendments add a third paragraph to recognize two special groups, “health and care workers” and “persons in life-threatening or humanitarian situations.” Other people, such as those who need to visit their families, study, or earn an income, remain unaddressed.

Article 35 General rule

2. Health documents under these Regulations may be issued in non-digital format or digital format, subject to the obligations of any State Party regarding the format of such documents deriving from other international agreements.

3. Regardless of the format in which health documents under these Regulations have been issued, said health documents shall conform to the Annexes, referred to in Articles 36 to 39, as applicable, and their authenticity shall be ascertainable.

4. WHO, in consultation with States Parties, shall develop and update, as necessary, technical guidance, including specifications or standards related to the issuance and ascertainment of authenticity of health documents, both in digital format and non-digital format. Such specifications or standards shall be in accordance with Article 45 regarding treatment of personal data.

Two new paragraphs were added to Article 35 regarding health documents for travelers. Although the original provision affirms that “no health documents, other than those provided for under these Regulations or in recommendations issued by WHO, shall be required in international traffic” with few exceptions already established domestically and geographically (specific diseases such as yellow fever, malaria, etc.), the move to establishing a giant surveillance bureaucracy at all levels will undoubtedly threaten human rights and fundamental freedoms (e.g. the right to travel under the Universal Declaration of Human Rights).

The problem doesn’t reside in whether health certificates should be in digital or non-digital format, or in their verification. The real problem is that the people, notably, travelers and migrant workers, and their families, will increasingly be coerced to be tested and vaccinated and divulge this. This risk is real when a simple threat can be declared an emergency, and this was widely applied during the Covid response, increasing profits from vaccines. 

Article 44. Collaboration, assistance and financing

2 bis. States Parties, subject to applicable law and available resources, shall maintain or increase domestic funding, as necessary, and collaborate, including through international cooperation and assistance, as appropriate, to strengthen sustainable financing to support the implementation of these Regulations.

2 ter. Pursuant to subparagraph (c) of paragraph 1, States Parties shall undertake to collaborate, to the extent possible, to:

(a) encourage governance and operating models of existing financing entities and funding mechanisms to be regionally representative and responsive to the needs and national priorities of developing countries in the implementation of these Regulations;

(b) identify and enable access to financial resources, including through the Coordinating Financial Mechanism, established pursuant to Article 44bis, necessary to equitably address the needs and priorities of developing countries, including for developing, strengthening and maintaining core capacities.

2 quater. The Director-General shall support the collaboration work in paragraph 2 bis of this Article, as appropriate. The States Parties and the Director-General shall report on its outcomes as part of the reporting to the Health Assembly.

The bureaucracy being built needs funding. The WHO and the World Bank estimate at least $31.1 billion will be required annually to support the pandemic agenda. This amounts to up to 40% of current overseas development assistance for health, and existing intra-country financing. The opportunity costs and costs of diversion of resources from other programs (financial and human) will be considerable but are not addressed by the WHO or other parties.

Article 54. bis States Parties Committee for the Implementation of the International Health Regulations (2005)

1. The States Parties Committee for the Implementation of the International Health Regulations (2005) is hereby established to facilitate the effective implementation of these Regulations, in particular of Article 44 and 44bis. The Committee shall be facilitative and consultative in nature only, and function in a non-adversarial, non-punitive, assistive and transparent manner, guided by the principles set out in Article 3. To this effect:

(a) The Committee shall have the aim of promoting and supporting learning, exchange of best practices, and cooperation among States Parties for the effective implementation of these Regulations;

(b) The Committee shall establish a Subcommittee to provide technical advice and report to the Committee.

2. The Committee shall be comprised of all States Parties and shall meet at least once every two years. Terms of reference for the Committee, including the way that the Committee conducts its business, and for the Subcommittee shall be adopted at the first meeting of the Committee by consensus.

3. The Committee shall have a Chair and a Vice-Chair, elected by the Committee from among its State Party members, who shall serve for two years and rotate on a regional basis.

Until now, there is no Conference of States parties in the IHR, although the Regulations are binding. A small Secretariat composed of the WHO is tasked to support the implementation process. However, the new mechanism of “States Parties Committee” will be established. It will meet biannually as a rule and likely exceptionally when circumstances so require. 

ANNEX 1

A. CORE CAPACITIES

1. States Parties shall utilize existing national structures and resources to meet their core capacities requirements under these Regulations, including with regard to:

(a) their prevention surveillance, reporting, notification, verification, preparedness, response and collaboration activities; and

(b) their activities concerning designated airports, ports and ground crossings.

2. Each State Party shall assess, within two years following the entry into force of these Regulations for that State Party, the ability of existing national structures and resources to meet the minimum requirements described in this Annex. As a result of such assessment, States Parties shall develop and implement plans of action to ensure that these core capacities are present and functioning throughout their territories as set out in paragraph 1 of Article 5, and paragraph 1 of Article 13 and subparagraph (a) of Article 19.

3. States Parties and WHO shall support assessments, planning and implementation processes under this Annex.

4. Pursuant to Article 44, States Parties shall undertake to collaborate with each other, to the extent possible, in developing, strengthening and maintaining core capacities.

A. CORE CAPACITIES REQUIREMENTS FOR PREVENTION, SURVEILLANCE, PREPAREDNESS AND RESPONSE

41. At the local community level and/or primary public health response level (hereinafter the “Local level”), each State Party shall develop, strengthen and maintain the core capacities:

(a) to detect events involving disease or death above expected levels for the particular time and place in all areas within the territory of the State Party; and

(b) to report all available essential information immediately to the appropriate level of health-care response. At the community level, reporting shall be to local community health-care institutions or the appropriate health personnel. At the primary public health response level, reporting shall be to the intermediate or national response level, depending on organizational structures. For the purposes of this Annex, essential information includes the following: clinical descriptions, laboratory results, sources and type of risk, numbers of human cases and deaths, conditions affecting the spread of the disease and the health measures employed; and

(c) to prepare for the implementation of, and implement immediately, preliminary control measures;

(d) to prepare for the provision of, and facilitate access to health services necessary for responding to public health risks and events; and

(e) to engage relevant stakeholders, including communities, in preparing for and responding to public health risks and events.

52. At the intermediate public health response levels (hereinafter the “Intermediate level”), where applicable, each State Party shall develop, strengthen and maintain the core capacities:

(a) to confirm the status of reported events and to support or implement additional control measures; and

(b) to assess reported events immediately and, if found urgent, to report all essential information to the national level. For the purposes of this Annex, the criteria for urgent events include serious public health impact and/or unusual or unexpected nature with high potential for spread.; and

(c) to coordinate with and support the Local level in preventing, preparing for and responding to public health risks and events, including in relation to:

(i) surveillance;

(ii) on-site investigations;

(iii) laboratory diagnostics, including referral of samples;

(iv) implementation of control measures;

(v) access to health services and health products needed for the response;

(vi) risk communication, including addressing misinformation and disinformation;

(vii) logistical assistance (e.g. equipment, medical and other relevant supplies and transport); and

63. At the national level

Assessment and notification. Each State Party shall develop, strengthen and maintain the core capacities:

(a) to assess all reports of urgent events within 48 hours; and

(b) to notify WHO immediately through the National IHR Focal Point when the assessment indicates the event is notifiable pursuant to paragraph 1 of Article 6 and Annex 2 and to inform WHO as required pursuant to Article 7 and paragraph 2 of Article 9.   

Public health prevention, preparedness and response. Each State Party shall develop, strengthen and maintain the core capacities for:

(a bis) rapidly determining the control measures required to prevent domestic and international spread;

(b) surveillance;

(c) deploying specialized staff,

(d) laboratory analysis of samples (domestically or through collaborating centres);

(e) logistical assistance (e.g. equipment, medical and other relevant supplies and transport);

(f) to providing on-site assistance as required to supplement local investigations;

(g) developing and/or disseminating guidance for clinical case management and infection prevention and control;

(h) access to health services and health products needed for the response;

(i) risk communication, including addressing misinformation and disinformation;

(j) provide a direct operational link with senior health and other officials to approve rapidly and implement containment and control measures;

(k) providing direct liaison with other relevant government ministries;

(l) providing, by the most efficient means of communication available links with hospitals, clinics, airports, ports, ground crossings, laboratories and other key operational areas for the dissemination of information and recommendations received from WHO regarding events in the State Party’s own territory and in the territories of other States Parties;

(m) establishing, operating and maintaining a national public health emergency response plan, including the creation of multidisciplinary/multisectoral teams to respond to events that may constitute a public health emergency of international concern;

(m bis) coordinating activities nationally and supporting Local and Intermediate levels, where applicable, in preventing, preparing for and responding to public health risks and events; and

(n) providing the foregoing on a 24-hour basis.

B. CORE CAPACITIES REQUIREMENTS FOR DESIGNATED AIRPORTS, PORTS AND GROUND CROSSINGS

1. At all times, each State Party shall develop, strengthen and maintain the core capacities:

(a) to provide access to (i) an appropriate medical service, including diagnostic facilities located so as to allow the prompt assessment and care of ill travellers, and (ii) adequate staff, equipment and premises;

(b) to provide access to equipment and personnel for the transport of ill travellers to an appropriate medical facility;

(c) to provide trained personnel for the inspection of conveyances;

(d) to ensure a safe environment for travellers using point of entry facilities, including potable water supplies, eating establishments, flight catering facilities, public washrooms, appropriate solid and liquid waste disposal services and other potential risk areas, by conducting inspection programmes, as appropriate; and

(e) to provide as far as practicable a programme and trained personnel for the control of vectors and reservoirs in and near points of entry.

2. For responding to events that may constitute a public health emergency of international concern, each State Party shall develop, strengthen and maintain the core capacities:

(a) to provide appropriate public health emergency response by establishing and maintaining a public health emergency contingency plan, including the nomination of a coordinator and contact points for relevant point of entry, public health and other agencies and services;

(b) to provide assessment of and care for affected travellers or animals by establishing arrangements with local medical and veterinary facilities and laboratories, for their isolation, and treatment, the analysis of their samples, and other support services that may be required;

(c) to provide appropriate space, separate from other travellers, to interview suspect or affected persons;

(d) to provide for the assessment and, if required, quarantine of suspect travellers, preferably in facilities away from the point of entry;

(e) to apply recommended measures to disinsect, derat, disinfect, decontaminate or otherwise treat baggage, cargo, containers, conveyances, goods or postal parcels, including, when appropriate, at locations specially designated and equipped for this purpose;

(f) to apply entry or exit controls for arriving and departing travellers; and

(g) to provide access to specially designated equipment, and to trained personnel with appropriate personal protection, for the transfer of travellers who may carry infection or contamination.

The development of the capacities listed in Annex 1 seems on a superficial level to be a public good. The WHO will be monitoring compliance, which many will justify as for the good of other countries that may ultimately be affected by a major outbreak. The reality on the ground is different. All WHO Member States have disease burdens far higher than that posed over the past four years by Covid-19. Much of the 1.3 billion population of sub-Saharan Africa, for example, faces continuing high burdens of malaria, tuberculosis, and HIV/AIDS, now being exacerbated by an increase in food insecurity and malnutrition. Most of these countries have major gaps in basic management of these diseases, all of which are preventable or treatable.

The IHR is now requiring them to shift resources from higher-burden diseases to an area that has little impact on their populations. External aid, not a bottomless bucket, will also be diverted. While there is some crossover in benefit of surveillance, the surveillance for scattered zoonotic spillover outbreaks envisioned by the IHR and draft pandemic agreement are very different from those of endemic diseases. There is therefore little doubt that the diversion of resources from high- to low-burden problems will have overall negative outcomes on health, particularly in lower-income States.

Nowhere in the costing documents behind the IHR amendments and draft pandemic agreement is this issue addressed. The WHO has been essentially silent on the issue. The only clear beneficiaries would appear to be the public health research establishment, manufacturers of surveillance and diagnostic technologies, and the makers of pharmaceuticals used when such outbreaks are detected. These are concentrated in wealthier Western countries, and to a lesser extent India and China. This appears to undo the equity provisions on which the pandemic agenda is claimed to be built.

There is little doubt that the infrastructure to be developed here will find natural variants of viruses and other pathogens that could be construed to pose a theoretical threat. Such a threat can qualify as a pandemic emergency under the amended IHR, triggering further recommendations. The WHO, and the Member States, are building a program that by nature will drive increasing lockdown-type responses and pharmaceutical/vaccine responses, with little or no evidence that this can have a substantial impact on overall health outcomes.

ANNEX 2 [See Annex 2 flow diagram here.] 

Any event of potential international public health concern, and those of unknown causes or sources, in particular clusters of cases of severe acute respiratory disease of unknown or novel cause, and those involving other events or diseases than those listed in the box on the left and the box on the right shall lead to utilization of the algorithm.

This wording extends the decision diagram for reporting an outbreak or risk of an outbreak to any unknown pathogen or known pathogen of theoretical risk, beyond named diseases previously considered to be high-risk. It is similar to having an open-ended list of notifiable diseases. Coupled with Annex 1, it heightens the risk of imposing restrictions and economic harm by declaring emergencies for natural, low-risk events.



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Authors

  • Thi Thuy Van Dinh

    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 organization partnerships for Intellectual Ventures Global Good Fund and led environmental health technology development efforts for low-resource settings.

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  • David Bell

    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 Organization (WHO), 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.

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