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TWN Info Service on Health Issues
3 October 2023
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WHO: WGIHR to discuss health emergency measures and unilateral actions

Geneva, 3 October (TWN) – The 5th Meeting of the Working Group on Amendments to the International Health Regulations 2005 (WGIHR5), scheduled for 2 to 6 October, will discuss health emergency measures and unilateral actions.

The WGIHR5 will be considering the IHR amendment proposals placed by both developed and developing countries addressing the implementation of health measures, and the obligations to initiate and complete them. Various developing country proposals focus on the need for checks and balances and other necessary safeguards that must be in place in order to ensure that the health measures are applied in a transparent, equitable and non-discriminatory manner.

WGIHR5 will take place at the WHO Headquarters in Geneva in a hybrid mode. The agenda provides 3 groups of IHR amendment proposals for consideration this week and these proposals relate to the following articles:

Group 8*:

  • Article 19 General obligations
  • Article 23 Health measures on arrival and departure,
  • Article 24 Conveyance operators,
  • Article 27 Affected conveyances,
  • Article 28 Ships and aircraft at points of entry,
  • Article 31 Health measures relating to entry of travellers.
  • Annexes 3 and 4

Group 9*:

  • Article 35 General rule,
  • Article 36 Certificates of vaccination or other prophylaxis,
  • Article 42 Implementation of health measures,
  • Article 43 Additional health measures,
  • Article 45 Treatment of personal data;
  • Article 56 Settlement of disputes
  • Annexes 6 and 8

Group 1*:

  • Article 1 Definitions;
  • Article 2 Purpose and scope;
  • Article 3 Principles.

*Numbers 8, 9, and 1 are based on a grouping that was accepted at the WGIHR2 meeting.

The group of proposals relating to Articles 19 to 31 will be considered first, then proposals relating to Articles 35 to 56 followed by proposals on Articles 1 to 3.

Health Measures at Points of Entry and Conveyances

Article 19 of IHR 2005 identified certain general obligations of States Parties relating to points of entry, amongst other obligations provided in other provisions of the IHR. These deal with capacity building, identifying competent authorities and sharing of information at the points of entry.

ERCOSUR countries have proposed to include an obligation to develop bi-national contingency plans that deal especially with plans of action relating to land borders.

Japan on the other hand has proposed to obligate States to ensure that the conveyance operators also “implement quarantine promptly on board as necessary” under Article 24. It further proposes to empower competent authorities to “demand the conveyance operators, the pilot in command of the aircraft or the officer in command of the ship to take practicable measures on the conveyance” under Article 27 and also to “notify health measures applicable to a ship or an aircraft as necessary” under Article 28.

Some of these proposals, if adopted, could be interpreted in a manner allowing the countries concerned to impose quarantine on board itself, without allowing the ships to dock or the passengers to disembark. Such an interpretation will be inconsistent with human rights of the passengers as well as the rights of the seafarers that require quarantining and/or medical care to be provided in on-shore facilities as far as possible. Thus, the proposals from Japan may involve human rights implications, especially the proposals to have quarantine on board of conveyances.

During the COVID-19 pandemic, Japan received international criticism about its varying and inconsistent approaches towards ships approaching its territorial waters and coasts. While a ship carrying a significant number of Japanese passengers was allowed to dock, a ship which carried fewer Japanese passengers was refused to dock and disembark their passengers. Further it executed on-board quarantining for the ship that it allowed to dock and this led to cluster infections on board. For several weeks passengers were not able to disembark.

Japanese law allows for its officials to take up this varying approach and quarantine persons on board with the consent of the captain of the vessel, while Japan had only limited on-shore facilities to be provided for passengers and crew arriving at its borders. Therefore, in a sense, it is possible that Japan could be seeking to legitimise or create a legal basis in international law to justify its actions and national laws. Unfortunately, its proposals provide power to national authorities to demand the captain of the vessels to take measures, and there is no clear guidance as to how this power could be exercised.

Meanwhile Malaysia has proposed changes to Article 42 which provides for the general rule regarding the implementation of health measures. Article 42 currently provides that health measures taken pursuant to regulations will be initiated and completed in a transparent and non-discriminatory manner. The Malaysian proposal makes it an explicit obligation of the States Parties that its health measure will be implemented not only in a prompt, transparent and non-discriminatory manner, but also in an equitable manner. The proposal also seeks to have States Parties ensure that the non-State actors within its territories comply with such health measures. Although these proposals provide a general protection against the abuse of the authority by the national authorities at points of entry as well as conveyance operators, it would be better if additional and specific safeguards are mentioned under Articles 24, 27 and 28.

Digitalization of health documents and the need for protection of data

Both developing and developed countries such as Brazil, Indonesia, Russia and the European Union (E.U.) have proposed digitalization of health documents. The proposals have been made to various articles such as Articles 23, 31, 35 and 36.  However the approach towards digitalization varies significantly between developed and developing countries. The E.U. prefers digital documents over paper format and wants to employ interoperability of data etc., while developing countries treat both the digital and paper formats at par.

Under Article 23, the E.U. has proposed the following text for a new paragraph 6:

“… documents containing information concerning traveller’s destination (hereinafter Passenger Locator Forms, PLFs) should preferably be produced in digital form, with paper form as a residual option. Such information should not duplicate the information the traveller already submitted in relation to the same journey, provided the competence authority can have access to it for the purpose of contact tracing. The Health Assembly may adopt, in cooperation with the International Civil Aviation Organization (ICAO) and other relevant organisations, the requirements that documents in digital or paper form shall fulfil with regard to interoperability of information technology platforms, technical requirements of health documents, as well as safeguards to reduce the risk of abuse and falsification and to ensure the protection and security of personal data contained in such documents. Documents meeting such requirements shall be recognized and accepted by all Parties. Specifications and requirements for PLFs in digital or paper form shall take into account existing widely used systems established at the regional or international level for the issuance and verification of documents. Parties which are low and lower middle-income countries shall receive assistance in accordance with Article 44 for the implementation of this provision”.

Under Article 35 a new paragraph 2 has been proposed by the E.U as a general rule:

“Health documents may be produced in digital or paper form, subject to the approval by the Health Assembly of the requirements that documents in digital form have to fulfil with regard to interoperability of information technology platforms, technical requirements of health documents, as well as safeguards to reduce the risk of abuse and falsification and to ensure the protection and security of personal data contained in the health documents. Health documents meeting the conditions approved by the Health Assembly shall be recognized and accepted by all Parties. Specifications and requirements for certificates in digital form shall take into account existing widely used systems established at the international level for the issuance and verification of digital certificates. Parties which are low and lower middle-income countries shall receive assistance in accordance with article 44 for the implementation of this provision”.

The proposals under Article 23 pertain to passenger locator forms, while Article 35 deals with health documents in general. There is difference in the proposals under Article 23 and 35. While both promote digitalization of health, proposals under Article 23 simply say safeguards against risk of abuse, falsification and infringement of right to privacy of the individuals “may be” adopted by the World Health Assembly (WHA). Further the E.U also makes a mention of existing systems established at the international level for issuance and verification of digital certificates and the need for taking them into account. Thus the E.U.’s proposal is to clearly expand and promote continuation of digital health, whether there is development of safeguards or not.

It is important to establish systems for verification of health documents without necessarily transferring data from one jurisdiction to another. Developed countries or other agencies while providing assistance to low and lower middle-income countries should not use the opportunity to establish systems that automatically transfer data from these countries. Otherwise, it may compromise national sovereignty in data governance.

Under Article 45, which deals with treatment of personal data, Japan, Indonesia and the Africa Group have however placed certain safeguards. Irrespective of the digital or paper format, Japan requires all recipient State Parties of information from WHO and other States Parties, to seek consent of the provider State Party, before the disclosure of personal data is made to a third party. Further, such disclosures must only be made where it is essential.

Indonesia proposes that the information be shared with only internal and relevant personnel.  The Africa Group, on the other hand, seeks to limit cross-border data transfers by proposing that States Parties processing the personal data have to do so without duplicating or storing data, unless they have obtained permission from provider States Parties. It is important that these proposals be extended to all of the health data and not just to personal data.

Additional Health Measures and the need for discipline

Article 43 of the IHR 2005 allows for the States Parties to take additional health measures over and above what is recommended by WHO; nevertheless there should be a sound scientific and public health rationale behind such measures. This is one of the provisions significantly abused by the developed countries against developing countries for restraining the entry of persons and goods coming from developing countries to developed countries during public health emergencies or outbreak of diseases. Although Article 43 empowers WHO to assess the additional health measures and to issue recommendations or requests to the implementing States Parties for necessary adjustments, this does not bind the States Parties. There is no guarantee that WHO will exercise this authority in a prompt manner.

To overcome these shortcomings the Africa Group has made some significant amendment proposals to Article 43. Firstly, to introduce a new paragraph 3bis, which could reduce the risk of additional health measures causing impediments to the WHO’s allocation mechanism or any other State Party’s access to health products, technologies and know-how.

Secondly, changes are proposed to paragraphs 4 and 6, by which a time-bound process is designed for the assessment of additional health measures and making any necessary modifications such that other States Parties’ rights or the human rights of the people are not unduly affected. Brazil also has proposed resolving disputes relating to additional health measures through a process under Article 56 for settlement of disputes.

The E.U. also has a proposal under Article 43; however, it is specifically limited to set certain standards to be applied for employing additional health measures. According to the E.U., such measures shall be based on regular risk assessments, provide a proportionate response to the specific public health risks, and be reviewed on a regular basis. It also proposes that additional health measures should not be more invasive or intrusive to persons than reasonably available alternatives that would achieve or attain the appropriate highest achievable level of health protection.

Amendment proposals to Article 1 – Definitions

There are two important categories of proposals to amend Article 1 on definitions; first to incorporate definitions for health products and technologies, and second to modify the definitions of temporary and standing recommendations.

Malaysia and the Africa Group propose the definition of health products to be incorporated under Article 1. Though slightly different from each other, they rely on an adaptation of the definition as used in the WHA Resolution 72.8. Malaysia contends that they prefer to define this phrase alongside “health technologies”.

The second category of the amendment proposals to Article 1 is made by Bangladesh and it is to modify the definition of temporary and standing recommendations. Currently, they are defined as “non-binding advice” and Bangladesh proposes to delete the term “non-binding”.

This proposal is important in the light of a combined proposal by the Africa Group and Bangladesh for a new provision, Article 13A, which employs temporary or standing recommendations to facilitate equitable access to health products and technologies. Under their proposal on Article 13A, States Parties are required to comply with recommendations issued for ensuring equitable access to health products and technologies.

Retaining the word “non-binding” before “advice” in the definition of recommendations would cause interpretative inconsistency between Articles 13A and 1. The proposal to delete “non-binding” will avoid this inconsistency and at the same time will maintain the non-binding nature of the other temporary and standing recommendations issued by WHO, because “advice” are in general “non-binding” under international law. The effect of the deletion of “non-binding” however enables States Parties to agree upon certain selected recommendations such as for “equitable access” and to make these binding or attach legal consequences to the non-performance of recommendations.

Proposals for restating the scope and purpose of IHR 2005

Currently Article 2 of the IHR 2005 states thus: “The purpose and scope of these Regulations are 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.”

Although IHR 2005 addresses internationally coordinated approaches towards health emergency preparedness and response, the experiences of the past one and half decades are very clear that IHR 2005 continues to operate in a manner which does not ensure equity. Therefore, countries like India, Bangladesh and the Africa Group have proposed changes to Article 2. While India wants an explicit mention of the need for “preparedness”, Bangladesh wants to include “health systems readiness and resilience” and the Africa Group seeks an explicit clause for “equitable access to health products and technologies within the text of Article 2”.

It must be noted that these proposals are not expanding the scope of the IHR 2005 or are beyond the scope of the Article 21 of the Constitution of WHO under which IHR 2005 is adopted by the WHA. It merely brings certain aspects to proper attention and visibility such that the importance of those elements is not anymore neglected. It is simply a restatement of the existing purpose and scope of the IHR 2005.

Proposals to incorporate principles of CBDR and peaceful purposes

Article 3 of the IHR 2005 currently has four paragraphs and delineates principles to be applied while implementing the regulations. However, there are several proposals from India, Malaysia, Bangladesh and the U.K. to incorporate more principles into the provision. While the U.K. wants to incorporate a precautionary approach towards the diseases caused or events relating to unknown pathogens, others want to incorporate principles of equity, fairness, common but differentiated responsibilities (CBDR), as well as prioritisation of health systems strengthening in capacity building.

CBDR as a principle becomes important given the resource-intensive nature of the capacity building obligations identified in the IHR 2005 and also certain new proposals expanding the scope of such capacities. Application of this principle has become a necessity and obligatory on the part of the developed countries, given the neo-colonial trends that IHR 2005 followed in its implementation in the last decade or so.

The disparities in the surveillance capacities and response capacities, weakened health systems and inequitable access to health products and technologies are the results of an international health emergency law that is blind towards the development divide between countries and the non-binding approach it employs in the provisions addressing international cooperation.

The only way out from this conundrum is by developing legally binding obligations to address health inequities within IHR 2005 and with a reasonable differentiation between the obligations to be discharged by the developed and developing countries. Since IHR 2005 is the only existing legal instrument, addressing this gap within IHR 2005 is important.

The principle of CBDR is gaining acceptance beyond international environmental law especially among Global South leaders. In the Inaugural Leaders’ Session of Voice of Global South Summit 2023, Prime Minister of India, Narendra Modi called on other leaders to recognize that the principle of CBDR applies to “all global challenges.”

Malaysia additionally has proposed to incorporate a peaceful purposes clause on the exchange of information. Given the proposals to amend IHR 2005 by the developed countries like the U.S. and the E.U. which promote rapid and indiscriminate sharing of information with multiple actors, it is important that the data provided are used only for public health purposes. This proposal has become more important than ever given that the U.S. has also proposed to consider genetic sequence information of pathogens as part of the public health information to be shared under Article 6 of IHR 2005.

It must be noted that ever since the advancement of synthetic biology, and recent developments such as DNA printers, the scope of misutilization of the genetic information by actors that contribute to proliferation of biological weapons as well as bioterrorism has increased. Not only exchange of biological materials but also biological information also needs to be protected in this scenario.

A possible attempt for Early Harvest Approach by the Bureau

At the time of the writing of this article, it is reported that the WGIHR Bureau has circulated Co-chairs’ text relating to Articles 4, 5, 18, 48, 49 and Annex 2.  They have requested the Member States to be prepared to negotiate on the said text as well in the coming week. A developing country delegate who spoke to TWN in this regard said “this is the approach we were fundamentally against from the beginning. The gaps identified in COVID-19 Pandemic response was that of equity, it seems like North wants to force a consensus on all other issues except equity.”

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