TWN Info Service on Health Issues (Apr23/03)
17 April 2023
Third World Network

WHO: Negotiations on equity proposals for IHR amendments to start

Geneva 17 April (K M Gopakumar and Nithin Ramakrishnan) – The third meeting of the Working Group on Amendments to the International Health Regulations (WGIHR-3) started today to negotiate proposals on equity.

The meeting is in hybrid mode from 17-20 April at the WHO Headquarters in Geneva.

According to the provisional agenda, the WGIHR-3 meeting is to consider amendment proposals, which include amendments to existing provisions as well as new articles. These have been submitted by the Africa Group, Bangladesh, India, Malaysia, Mercosur countries, Russia, the European Union and the USA. Some of the key proposals will consider in the following order:

• Establishment of implementation committee (Article 53A)
• The compliance committee (New Articles 53bis, 53ter, 53quater)
• Amendments to Article 5 on surveillance
• Amendments to Article 13 on public health response
• New Annex 1A on core capacity requirements for surveillance and health response
• New Annex 10 on obligations of duty to cooperate
• Proposals on new Article 13A to facilitate equitable access to medical products, technologies and know-how
• Amendment to Article 44 on collaboration and assistance
• Proposal on new Article 44A to establish a financial mechanism for equity in health emergency preparedness and response.

Equitable Access to Health Products

The most important shortcoming of the International Health Regulations (IHR) 2005 is the absence of any provision to facilitate access to health products required for preparedness and response to a public health emergency of international concern (PHEIC).

IHR obligates State Parties to inform on all diseases outbreak “which may constitute a public health emergency of international concern within its territory” or any unusual public health events that occur within its territory but might have originated from elsewhere. This sharing of information would facilitate the WHO Director-General to take a decision on whether to declare such events as PHEIC.

However, there is no clear provision to guarantee assistance to provide access to health products to State Parties to effectively respond to PHEIC. As a result, IHR effectively functions as a mechanism to inform other State Parties regarding the outbreak of a potential PHEIC disease and to facilitate those State Parties having access to required health products to protect their own population. This leaves the State Parties providing information through IHR with no legally guaranteed assistance.

Since most of the disease outbreaks that fall within the scope of IHR occur in developing countries, the information helps the developed countries to take measures to prevent the spread. Thus, the IHR system practically functions as a mechanism to inform the North about outbreaks of diseases by the South without any corresponding obligation to provide the latter with access to health products.

Proposals to introduce a new Article 13A by the Africa Group and Bangladesh aim to address the issue of equitable access through diversification of production. Proposals under Article 13 create the following obligations on WHO and State Parties:

• WHO to make an assessment of the availability and affordability of PHEICC-related health products and develop an allocation mechanism to facilitate equitable access in case of a potential shortage;
• WHO to publish a list of PHEIC-related products required for various PHEIC and maintain a database containing the detailed specifications of those products to facilitate manufacturing of those products without a formal technology transfer by those manufacturers having skill in the art;
• WHO to also establish:
• Database of raw materials for the known PHEIC products
• Repository of cell lines to facilitate rapid non-originator production of vaccines and biotherapeutics
• Appropriate regulatory pathway to facilitate non-originator/generic production of relevant PPHEIC health products;
• State Parties to compulsorily cooperate to follow WHO recommendations on access to health products including adherence to the WHO allocation mechanism;
• State Parties to provide a temporary exemption to intellectual property protection on PHEIC-related health products;
• State Parties to share the regulatory dossiers at the request of another State Party to facilitate the scaling up of the production of health products required for PHEIC response. This would help to overcome the trade secret barrier around health products, especially vaccines and biotherapeutics like monoclonal antibodies;
• State Parties to license publicly funded technologies on PHEIC-related products, especially to manufacturers from the developing countries;
• State Parties to ensure adherence to WHO recommendations by the PHEIC-related health products manufacturers, including sharing regulatory dossiers and deposit of cell-lines.

Assistance to build core capacities

To have the ability to provide timely information to WHO on the potential PHEIC events such as disease outbreaks, and nuclear or chemical accidents the States parties are under an obligation to maintain core capacities on surveillance (Article 5) and public health response (Article 13).

These core capacities are elaborated under Annex 1. Article 5.1 obligates all State Parties to “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 capacity to detect, assess, notify and report events in accordance with these Regulations, as specified in Annex 1″.

Similarly, under Article 13.1, “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 capacity to respond promptly and effectively to public health risks and public health emergencies of international concern as set out in Annex 1“.

The obligations under Articles 5 and 13 ignore the development divide existing between developing and developed country State Parties, especially in terms of finance and technology. Though Article 5 creates an obligation on WHO to assist State Parties upon their request in achieving core capacity in surveillance, there are no such corresponding provisions on core capacity on public health response. Thus the obligation of WHO to assist is very generic in nature and limited to Article 5.

Another provision under Article 44.2(c) states that WHO, upon request from State Parties to the extent possible, assists “the mobilization of financial resources to support developing countries in building, strengthening and maintaining the capacities provided for in Annex 1″. The qualification in the provision makes it ineffective. Further, WHO is an organisation that always struggles for financial resources and would not be in a position to assist developing countries without the cooperation of developed countries.

Malaysia proposed under Articles 5 and 13 to create a moderate obligation on developed countries and WHO to assist developing countries to achieve the core capacities under Annex 1. The proposal reads: “Developed State Parties and WHO shall offer assistance to developing State Parties depending on the availability of finance, technology and know-how for the full implementation of this article, in pursuance of the Article 44“.

Though the proposal still contains qualifications like “availability of finance, technology and know-how” it clearly sets out the obligations of WHO and developed countries to assist developing countries to achieve the capacities. In the absence of effective assistance to build the core capacities, the global average capacity remains at 66% based on the reports of State Parties.

The silence on addressing the development divide and solution to the lack of core capacities goes against the spirit of the WHO Constitution. The preamble of the WHO Constitution reads thus: “The achievement of any State in the promotion and protection of health is of value to all. Unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger.”

Apart from the above-mentioned amendment proposal, the scope of core capacities is also expanded by various proposed amendments to Annex 1, which sets the scope of core capacity requirements for surveillance and response. India proposed to expand the scope of the Annex from core capacity requirements for surveillance and response, to core capacity requirements for disease detection, surveillance and health emergency response. Further, India proposes many elements under the public health response provision.

Similarly, the Africa Group proposed changes on core capacity related to both surveillance and response, including among other things the health system’s capacity to respond to PHEIC.

Bangladesh also proposes health system strengthening as part of core capacity under Annex 1. This effectively expands the scope of required assistance under Articles 5 and 13, which has the potential to change the IHR from an instrument to facilitate information from South to North to a system based on mutual cooperation.

Proposals on duty to cooperate

Various State Parties including the Africa Group, Bangladesh, Russia and Mercosur countries proposed amendments to Article 44.  This Article contains obligations on the duty to cooperate between State Parties as well as between WHO and State Parties, which includes mobilization of financial resources to support developing countries in building, strengthening and maintaining the capacities provided for in Annex 1.

The amendment proposal from the Africa Group proposed a dedicated new Annex 10 to govern the assistance under Article 44. Bangladesh proposed equitable access to health products within the scope of Article 44.

New financial mechanism

The Africa Group proposed the creation of a financial mechanism to provide assistance to developing country State Parties and WHO for the effective implementation of IHR. This proposal resembles the Green Climate Fund established under the United Nations Framework Convention on Climate Change (UNFCCC). If agreed this could provide the needed support to developing countries and WHO to build core capacities.

The World Bank has set up a Pandemic Fund, which has emerged from G-20 initiatives but this is still based on voluntary contributions mainly from developed countries. The apprehension about the Pandemic Fund is that it may not serve the purpose of IHR implementation and priorities identified by IHR State Parties.

Proposals to subvert technical assistance

Developed countries led by the USA and EU have made proposals to add conditions to obtain assistance under IHR. Currently, provisions for assistance under Articles 5.3, 13.3 and 44 are based upon request from the concerned State Party. There is burden of proof on the State Party requesting the assistance to show the need for support.

The USA proposed the following amendment proposal to Article 5.1, which states: “This capacity will be periodically reviewed through the Universal Health Periodic Review mechanism, in replacement of the Joint External Evaluation that began in 2016. Such review shall / Should such review identify resource constraints and other challenges in attaining these capacities, WHO and its Regional Offices shall, upon the request of a State Party, provide or facilitate technical support and assist in the mobilization of financial resources to develop, strengthen and maintain such capacities”.

Thus the proposal restricts the scope of obligation to assist developing country State Parties to only the WHO. Further, it makes it conditional upon the findings of the Universal Health Periodic Review mechanism.

Apart from Article 5, it is understood that the USA has informally proposed a revised proposal on the Compliance Committee with dedicated articles on Universal Health and Preparedness Review (UPHR) changing the term contained in its proposal to amend Article 5.1 i.e. Universal Health Periodic Review mechanism. According to the USA proposal the aim of UPHR “is to serve as a State Party-to-State Party intergovernmental dialogue to review and assess capacities and identify needs for assistance“.

This would effectively institutionalise the norms on limited assistance, which is to be available upon request and to be conditional on the findings of UPHR. Further, the proposal explaining the procedure of conducting UPHR states:

“The UHPR mechanism shall base its work on the following documentation, among others, as available:

(a) the State Party Annual Self-Assessment Report (SPAR);

(b) the Joint External Evaluation;

(c) National Action Plan for Health Security, as well as a report, to be drawn up by the Secretariat pursuant to its responsibility, based on the information available to it provided by the State Party or States Parties concerned. The Secretariat should seek clarification from the State Party or States Parties concerned of their health and preparedness policies and practices;

(d) Simulation Exercises;

(e) Intra- and After-Action Reviews; and

(f) The reports by the State Party under review and by the Secretariat, together with the minutes of the respective meeting of the UHPR, shall be published promptly after the review.”

Thus State Parties will have to undergo various evaluation initiatives currently carried out by the WHO Secretariat to obtain assistance. Further, such proposed amendments would also institutionalize all such initiatives except SPAR wherein participation is voluntary. The EU also circulated a draft titled “Compliance and Implementation Committee” containing the almost same proposal, which makes assistance on core capacity conditional upon various evaluations. +