TWN Info Service on Health Issues (Jan23/02)
11 January 2023
Third World Network

WHO: Developing Countries focus on equity in IHR amendment proposals

11 January 2023, Kochi/Delhi (Nithin Ramakrishnan and K M Gopakumar) – Proposals from developing countries to amend the International Health Regulations (IHR) 2005 focus on facilitating equity in health emergency preparedness and response.

The Working Group on Amendments to the IHR (WGIHR) is to negotiate various amendment proposals submitted by State Parties to IHR 2005.

Sixteen States Parties, including 4 on behalf of four different groups of states, i.e. European Union (EU), WHO Africa Region Member States, Eurasian Economic Union, and MERCOSUR (Argentina, Brazil, Paraguay and Uruguay) have submitted amendment proposals. These are Armenia, Bangladesh, Brazil, Czech Republic on behalf of the Member States of the EU, Eswatini on behalf the WHO African Region Member States, India, Indonesia, Japan, Malaysia, Namibia, New Zealand, Republic of Korea, Russian Federation on behalf of the Member States of the Eurasian Economic Union, Switzerland, the United States of America, and Uruguay on behalf of MERCOSUR. All the proposed amendments are publicly available except for the proposals from Japan.

The Executive Board Decision 150(3) titled “Strengthening the International Health Regulations (2005): a process for their revision through potential amendment”, which provides for the IHR amendment process has emphasised the need for addressing equity. It states that IHR Amendment “should be limited in scope and address specific and clearly identified issues, challenges, including equity, technological or other developments, or gaps that could not effectively be addressed otherwise but are critical to supporting effective implementation and compliance of the International Health Regulations (2005), and their universal application for the protection of all people of the world from the international spread of disease in an equitable manner”. (Emphasis added)

Nevertheless, there is very little, if not nothing, on realizing equity in the developed country proposals to amend IHR 2005. This resonates with the EU’s stated policy to narrow down the application of equity principles only to pandemic scale health emergencies. The developed countries seek to further entrench information sharing obligations and the promotion of a securitization agenda.

On the other hand, the proposals from developing countries seek to ensure equity in health emergency preparedness and response in a comprehensive manner. They seek to address issues such as scope, principles, capacity building including for surveillance and health systems strengthening, equitable access to health products, technologies and know-how, international financial assistance, implementation oversight, regulation of unilateral measures, and actions of non-state actors, each targeting the realisation of equity in health emergency preparedness and response. These equity proposals have a backing of a total of 55 developing countries.

The main equity elements reflected in the proposals outlines below are:  

·         inclusion of equitable access to the health products in the part on scope;

·         common but differentiated responsibilities in the part on principles;

·         health systems strengthening;

·         concrete proposals to ensure equitable access to health products, technologies and know-how;

·         establishment of an international financial mechanism;

·         access and benefit sharing mechanism.

(1) Scope of IHR 2005

 One of the important critiques of IHR is its silence on equitable access to health products. Article 2, which explains the purpose and scope of IHR 2005 in one sentence reads: “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.”

Developing countries like India, Bangladesh, and the Africa Region States seek to amend Article 2 not only to incorporate equitable access but also other concerns of equity such as interference with livelihood and health systems strengthening. The text to be negotiated is as follows:

“The purpose and scope of these Regulations are to prevent, protect against, prepare, control and provide a  public health response to the international spread of diseases including through health systems readiness  and resilience in ways that are commensurate with and restricted to public health risk all risks with a  potential to impact public health, and which avoid unnecessary interference with international traffic, and  trade, livelihoods, human rights, and equitable access to health products and health care technologies  and know how.”  (Bold and underline corresponds to new text additions and strikethrough corresponds to deletion.)

(2) Inclusion of Equity, Solidarity and Common but Differentiated Responsibilities as Principles

Article 3 of IHR 2005 currently sets out the principles to be applied while implementing the Regulations, and these include Human Rights, Dignity, Fundamental Freedoms, principles from the WHO Constitution of WHO and UN Charter, Sovereignty and Universal Application.

The developing country States Parties like India, Bangladesh, Malaysia and WHO Africa Region States seek to amend this Article 3. The new additions include principles of equity, solidarity, common but differentiated responsibilities and respective capabilities, prioritisation of establishment and strengthening of health systems capacities, and peaceful purposes. Meanwhile the EU has also sought to incorporate the precautionary approach in dealing with unknown pathogens.

(3) Capacity Building and Health Systems Strengthening

Developing countries like Bangladesh, Malaysia, India, and WHO Africa Region States have submitted proposals to ensure IHR 2005 not only mandates establishment and maintenance of surveillance capacities, but also the strengthening of health systems capacities. They have also sought to incorporate international financial, technical and technological assistance for the achievement of the same. It must be noted that the developed countries’ interests in developing country capacities are limited to surveillance and reporting capacities. The health securitization agenda of developed countries have narrowed the focus of IHR implementation without focusing on health system strengthening.

Bangladesh’s proposals focussing on the need for strengthening health systems is a key in reversing this agenda in international health law. It has proposed amendments to incorporate health systems capacities in Annex 1 of IHR 2005 which currently lists only health emergency capacities. Its proposal to amend Article 3. i.e. principles for implementation of IHR, further seeks prioritisation of health systems strengthening in the implementation of IHR 2005.

Malaysia, India, Indonesia, WHO Africa Region States also seek the improvement of capacity building provisions in the IHR 2005 and incorporate wide ranging health systems capacities within Annex 1. Bangladesh and Malaysia have explicitly called for the developed countries' assistance to the developing countries.

Developed countries like the US, New Zealand, and EU on the other hand call for an assessment mechanism for capacity building and preparedness but failed to take note of the gaps in the list of capacities identified in Annex 1 of IHR 2005.

(4) Access to Health Products, Technologies and Know-how

The most glaring inequity during the COVID-19 response was experienced in access to the health products such as diagnostics, therapeutics and vaccines. While these health products were researched and developed in the fastest possible timelines, scaling up of the production and distribution of the products were extraordinarily lagging.  Africa Region States, Bangladesh, India, Malaysia, Indonesia and Russian on behalf of Eurasian Economic Union, have therefore proposed amendments resolving this concern for future “public health emergencies of international concern” (PHEIC), the term used in IHR 2005.

The 47 Member States of the WHO Africa Region have made a compelling, clear and straightforward amendment proposal which enables access to health products, technologies and know-how required for a public health response to all on an equitable basis. So did Bangladesh. Both proposed to have an additional Article 13A which could establish obligations for States Parties and WHO to ensure equitable access to the health products and technologies. 

The Africa Region States Parties’ proposed new Article 13A is titled “Access to Health Products, Technologies and Know-How for Public Health Response”. The proposal under this new provision requires:

(a)        the WHO Director-General (DG) to:

(i)  make an immediate assessment about availability and affordability of required health products for public health response, and

(ii)   make recommendations including an allocation mechanism to avoid any potential shortage.

(b)        States Parties to:

(i)     cooperate with each other and WHO in complying with such recommendations   made by the WHO DG and to take measures to ensure equitable access to health products and technologies;

(ii)    include in their intellectual property legislations a provision for waiving or suspending intellectual property rights protection during a PHEIC,

(iii)  share the rights over products developed in the course of research partially or wholly funded by public sources,

(iv)  share regulatory dossiers with developing countries to kick start local production in their territories, and

(v)   to ensure non-state actors and manufacturers do not act contrary to the IHR 2005, recommendations and actions taken pursuant to the IHR provisions.

Bangladesh also proposed a new Article 13A, which is titled as “WHO led International Public Health Response”. Bangladesh envisages WHO as the central and coordinating authority for international public health response to PHEIC and begins with a similar proposal for assessment of availability and affordability of the health products such as vaccines, diagnostics, and therapeutics by WHO. Bangladesh further proposes:

(1)   WHO to develop an allocation mechanism in cases of expected shortages and in doing so identify and prioritise recipients of the health products and determine the required quantity of health products to meet the needs of those recipients.

(2)   WHO to develop and maintain databases which contain all sorts of information required by potential manufacturers in order to start manufacturing in their facilities.

(3)   States Parties with production capacities to diversify production including to developing countries upon request of WHO.

(4)   States Parties to ensure that the manufacturers operating from their territories shall supply WHO the requested quantities of health products in a timely manner.

The Africa Region States Parties and Bangladesh have also suggested some minimal changes to Article 13, which currently deals with public health response to public health risks and PHEIC. These aim to create two obligations on IHR State Parties: to provide support and assistance to affected States Parties when requested by the WHO, and also to ensure that health response measures of one State Party do not affect another’s ability to respond to health emergencies respectively.

India, Malaysia, Indonesia, and Russia also seek to address issues relating to access to health products in their own terms, that complement the proposals made by Bangladesh as well as Africa Region States Parties.

With the aim of achieving equitable access to health products, Indonesia has proposed to amend Article 44 which currently deals with collaboration and assistance. India, Russia and Malaysia propose to amend Articles relating to the WHO’s power to make recommendations during a PHEIC to address issues relating to equitable access. 

India, Bangladesh and the Africa Region States Parties also seek to incorporate production and supply capacities within the scope of Annex 1 of IHR 2005 such that international financial and technological resources can be mobilised for the establishment and development of such capacities.

With regard to WHO’s authority to make recommendations, India has proposed to incorporate a new paragraph 2bis to Article 15 of IHR 2005, which reads as follows:

“Temporary recommendations should be evidence based as per real time risk assessment of a potential or declared PHEIC, and the immediate critical gaps to be addressed for an optimal public health response, that shall be fair and equitable. The recommendations based on these assessments shall include:

a.      support by way of epidemic intelligence surveillance, laboratory support, rapid deployment of expert teams, medical countermeasures, finance as well as other requisite health measures to be implemented by the State Party experiencing the Public Health Emergency of International Concern, or

b.      prohibitive recommendations to avoid unnecessary interference with international traffic and trade”

(5) Financial Mechanism

During the COVID-19 response, the lack of sufficient finance and funding both at the in the  IHR review committee that reviewed COVID-19 response, but all the previous IHR review committees had stressed upon this issue. The IHR Review Committee on COVID-19 response records thus in its report: “All previous IHR Review Committees have highlighted the need for sufficient resources to be allocated to the implementation of the Regulations. This includes national funding for strengthening detection and response capacities in the context of building resilient health systems. It also includes funding for WHO to enable it to lead an effective, coordinated, multisectoral and evidence-based global effort to protect humanity against public health risks. Financial support mechanisms are also needed for some countries.”

Bangladesh, Malaysia, Eswatini for the Africa Region Parties States, Brazil for MERCOSUR Parties States proposed amendments to address this gap. MERCOSUR States Parties seek to include specific mention of international financial assistance to prevent international spread of disease. In Paragraph 3 of Article 13, MERCOSUR States Parties propose that WHO cooperate with Member States in seeking support and international financial assistance to facilitate the containment of risks at source.

Bangladesh and Malaysia further suggest having a dedicated international financial mechanism to support the implementation of health emergency preparedness and response under Article 44. The WHO Africa Region Parties States on the other hand, seek to incorporate and describe a new financial mechanism under Article 44A. This fund, which is proposed to provide grants and concessional loans to developing countries, shall operate under the guidance of, and be accountable to, States Parties of IHR 2005. States Parties shall decide and review its policies, programme priorities and eligibility criteria on a periodic basis. A proposal is also made to mandate the World Health Assembly to set up this fund within 24 months of the adoption of the provision. Amongst the funding priorities the following are explicitly mentioned:

“(i) building, developing, strengthening, and maintaining of core capacities mentioned in Annex 1;

(ii)  strengthening of Health Systems including its functioning capacities and resilience;

(iii) building, developing and maintaining research, development, adaptation, production and distribution capacities for health care products and technologies, in the local or regional levels as appropriate; and

(iv) addressing the health inequities existing both within and between States Parties such that health emergency preparedness and response is not compromised;”

These proposals for a financial mechanism aim to address the gaps and deficiencies associated with the pandemic fund constituted at the World Bank. The Pandemic Fund is primarily managed by a group of donors and a group of recipients with no accountability to health assembly. India has also proposed to strengthen WHO’s capacity to provide sustainable financing for managing health emergencies by suggesting that global level capacities be incorporated in the Annex 1 of IHR 2005.

(6) No Sharing of Genetic Resources without Guarantee on Benefit Sharing

The 47 Africa Region States Parties and Namibia in particular, India and Malaysia call for Access and Benefit sharing for genetic resources, including genetic materials and sequence information. India and Malaysia have called for access and benefit sharing capacities in the Annexures to IHR 2005.

The EU and the Republic of Korea have shown some interest in addressing this subject matter. The EU without using the words “benefit sharing” has stated that the sharing of information shall be based on modalities agreed by the World Health Assembly in that regard. The Republic of Korea, on the other hand, emphasised the need for establishing a system for sharing benefits derived from the sharing of genetic information.

Nevertheless, the Africa Region States Parties and Namibia in particular have indicated there shall be no sharing of genetic sequence information without the guarantees on fair and equitable sharing of benefits derived therefrom. The Africa Region in its proposal seeks to incorporate an explicit paragraph 3 which states as follows:

“No sharing of genetic sequence data or information shall be required under these Regulations.  The sharing of genetic sequence data or information shall only be considered after an effective and  transparent access and benefit sharing mechanism with standard material transfer agreements  governing access to and use of biological material including genetic sequence data or information relating to such materials as well as fair and equitable sharing of benefits arising from their  utilization is agreed to by WHO Member States, is operational and effective in delivering fair and  equitable benefit sharing. ”

Namibia in its communication sent to WHO in this regard takes note of the on-going discussions under the Convention on Biological Diversity and has stated as follows:

“Namibia therefore reserves its right to introduce additional proposals on ABS and GSD/GSI at a later stage, if needed. Namibia is of the view that nothing is agreed until everything is agreed.” 

Uncertainty over IHR Review Committee’s approach to Equity

The IHR Review Committee established by the WHO DG is expected to submit its report to WGIHR in mid-January. The terms of reference of the committee were under severe criticism by the States Parties and civil society in the first face-to-face meeting. The method of work adopted by the IHR Review Committee has also attracted criticism as it seeks to examine the appropriateness and consistency of the IHR amendment proposals submitted by States Parties by asking questions such as (i) whether the proposed amendment is suitable for achieving the “intended purpose” of this Article and other related IHR provisions; and (ii) whether the proposed amendment “is in line with the scope, purpose and other IHR provisions, the WHO Constitution and relevant existing” international legal instruments.

Though the Executive Board Decision 150(3) stressed the need for addressing equity issues as part of the amendments the WHO DG has requested the Review Committee “to advise on definitions of terms, either new or existing terms the meaning of which might be changed following the proposed amendments, to ensure clarity and consistency; as well as to advise on whether the inclusion, in the text of the IHR, of an explicit taxonomy related to the nature of amendments (e.g., targeted amendments, conforming amendments, technical adjustments, updates, “reopening the instrument”) is warranted and, if so, to formulate a proposal in that respect.” The apprehension is that the IHR Review Committee may use these reference questions to make adverse recommendations on the equity-related proposals or limit such proposals’ scope.

Therefore, it would be interesting to see the approach of the Review Committee towards the amendment proposals made by developing countries that emphasise equity in health emergency preparedness and response. However, according to several observers and government delegations, States Parties are free to pursue their IHR amendment proposals during the negotiations and have full freedom to reject the recommendations of the Review Committee.+