TWN Info Service on Health Issues (Aug22/02)
15 August 2022
Third World Network

WHO: PHEIC declaration on monkeypox falls short on equity

Geneva, 11 Aug (Nithin Ramakrishnan and K M Gopakumar) -- The World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus has issued a declaration characterizing multi-country outbreak of monkeypox as a Public Health Emergency of International Concern (PHEIC) under the International Heath Regulation (IHR) 2005.

This occurred on 23 July even though there was a divergence of opinion amongst members of the IHR Emergency Committee about the PHEIC status of monkeypox, and the Director-General (DG) proceeded to declare monkeypox as PHEIC and issued temporary recommendations under Article 15 of the IHR 2005.

However, this declaration shows the reluctance of the WHO Secretariat led by the DG to invoke relevant IHR 2005 provisions that could enhance the compliance of States Parties with regard to equity. It also reveals the limitations of the current functioning of IHR 2005 in addressing equity concerns during a PHEIC.

This continued reluctance to invoke IHR 2005 provisions shows where the functioning of IHR 2005 needs reforms.

There was similar reluctance to invoke IHR 2005 in the COVID-19 Recommendations as well, though some occasional and casual references to the regulations were made by the DG.

The monkeypox PHEIC declaration is accompanied by a set of temporary recommendations addressing four different groups of States Parties, as provided below.

This calls for better understanding of differentiated responsibilities and respective capabilities of Member States within the IHR framework and provisions.

Group 1 comprises States Parties with no history of monkeypox in the human population or not having detected a case of monkeypox for over 21 days.

Group 2 comprises States Parties with recently imported cases of monkeypox in the human population and/or otherwise experiencing human-to-human transmission of monkeypox virus, including in key population groups and communities at high risk of exposure.

Group 3 comprises States Parties with known or suspected zoonotic transmission of monkeypox, including those where zoonotic transmission of monkeypox is known to occur or has been reported in the past, those where presence of monkeypox virus has been documented in any animal species, and those where infection of animal species in countries may be suspected including in newly affected countries.

Group 4 comprises States Parties with manufacturing capacity for medical countermeasures.

The Group 1 States Parties are advised to intensify their detection capacities and facilities, to promote general awareness (health literacy about the disease), to engage community-based groups, to report to WHO the probable and confirmed cases as soon as they get detected and to be ready to implement the recommendations given to Group 2 States Parties as soon as the first case gets confirmed.

The Group 2 States Parties have a long list of recommendations. Primarily they are required to offer a coordinated public health response with a goal to stop human-to-human transmission with priority focus on communities with high-risk exposure and vulnerable groups, such as children, pregnant women and immuno-suppressed individuals. They are requested to report to WHO on a weekly basis.

States Parties are requested to extend technical, financial, and human resources to the extent possible to the affected communities and maintain mutual accountability with them.

They are also asked to engage communities, avoid stigmatisation of individuals or population groups, increase surveillance capacities, including laboratory capacity, international specimens referral and genomic sequencing capacities, contact tracing and isolation, follow health monitoring for 21 days, conduct pre- and post-exposure prophylaxis, convene the National Immunisation Technical Advisory Group (NITAG) for any decision about immunisation policy and to engage communities at high risk exposure in decision making about vaccine roll-outs.

They are advised on clinical management, infection prevention and control, medical countermeasures research and on international travel as well.

The Group 3 States Parties are advised to add another layer of protection by tracing zoonotic transmissions of the monkeypox viruses, both spill-overs and spill-backs.

The Group 4 States Parties having manufacturing capacities are provided with a recommendation to increase the production and availability of diagnostics, vaccines and therapeutics. Such States Parties and their manufacturers are called to "work with WHO to ensure diagnostics, vaccines, therapeutics, and other necessary supplies are made available based on public health needs, solidarity and at reasonable cost to countries where they are most needed to support efforts to stop the onward spread of monkeypox".

While the PHEIC declaration is a welcome move that recognizes differentiated responsibilities and roles of the States Parties in pursuing the common goal of containment of monkeypox viruses, the nature of these recommendations and reluctance of the WHO DG to invoke the relevant provisions of IHR 2005 continue to raise concerns.

A few benefits of declaring the monkeypox outbreak as a PHEIC were discussed in IHR Emergency Committee.

Two of them are as follows:

1. "Boosting political commitment towards response efforts; Increasing opportunities for funds to be released for response, and research purposes, as well as for the mitigation of the socioeconomic impact of the disease;

2. Boosting international coordination of response efforts, in particular to secure equitable access to vaccines and antivirals."

By not invoking the legal provisions of IHR 2005, hence, not triggering binding obligations, the above perceived benefits will be undermined, as will the recommendations for States Parties with manufacturing capacities, which are crucial in ensuring equity in public health response to monkeypox.

RECOMMENDATIONS ON STATES PARTIES WITH MANUFACTURING CAPACITY

Temporary recommendations 4.a and 4.b are specifically addressed to States Parties having manufacturing capacities, as follows:

"4.a. States Parties who have manufacturing capacity for smallpox and monkeypox diagnostics, vaccines or therapeutics should raise production and availability of medical countermeasures.

4.b. States Parties and manufacturers should work with WHO to ensure diagnostics, vaccines, therapeutics, and other necessary supplies are made available based on public health needs, solidarity and at reasonable cost to countries where they are most needed to support efforts to stop the onward spread of monkeypox."

The context for manufacturing capacity is narrow in the recommendation to mean only States Parties that currently have (the capacity in) producing vaccines, diagnostics, or therapeutics for monkeypox. This excludes the potential manufacturers.

It is noteworthy that while the temporary recommendations stress the need to scale up production, they do not indicate scaling up of production through diversification.

Interestingly, unlike in the case of COVID-19 temporary recommendations, the DG has not yet called for transfer of technology to low- and middle-income countries in his monkeypox recommendations.

WHO also has not proposed an allocation mechanism to address shortages, even though there is only a very limited number of manufacturers currently producing vaccines and therapeutics.

The inequitable allocation and availability of vaccines and antivirals are evident again in the case of monkeypox.

While there are about 76 countries that are currently infected with monkeypox virus, there are very few countries that control the production of antivirals and vaccines. Although most antivirals and vaccines that are developed for smallpox viruses are re-purposed for restraining monkeypox virus infection and spread, they are distributed in the developed countries where recent outbreaks occurred.

Africa, where the disease has been endemic for decades and where there is the highest case fatality rate, is yet to receive vaccines and other health response products. Even in major manufacturing countries like the United States, vaccine shortage has been reported.

At the time of writing, only a couple of vaccines and medicines are projected as usable for preventing the spread of monkeypox virus. Most of them, as noted above, are developed for addressing the smallpox virus - another virus belonging to the orthopox family as is the monkeypox virus.

There is only one vaccine and one medicine that have received formal approvals from regulatory agencies of at least some countries. They are Modified Vaccinia Ankara by Bavarian Nordic and Tecovirimat by Siga Technologies.

Bavarian Nordic's headquarters are in Denmark, however, it has presence in Germany, Switzerland and the United States. Siga Technologies is based in the United States.

Apart from these two medical products, Emergent BioSolutions has the smallpox vaccine ACAM2000, which the US Centers for Disease Control and Prevention argue, can protect against monkeypox because the two viruses are close relatives.

Some other products, such as LC16m8 vaccine which is used against smallpox, are also being reviewed for re-purposing to address monkeypox.

It is important to see that while WHO is still developing its allocation plans and mechanism, the developed and rich countries have already placed advance purchase agreements for their national stockpiles.

A WHO official has been quoted as saying: "We'll have to watch out for this... Our mantra has been and continues to be that we want equity. If WHO needs to say that louder and stronger for those countries who are not getting access, we will continue to do that. We can't have a monkeypox response that's only responding to the UK, Canada, the United States. We need a response that also addresses what's happening in the DRC right now; in Nigeria where cases are going up".

Unfortunately, this caution has not been translated into effective use of the existing provisions in IHR 2005 to scale up production through diversification of manufacturing base.

IMPLEMENTATION OF TEMPORARY RECOMMENDATIONS & THEIR LEGAL NATURE

As of now, there is no clear understanding on how international coordination in the public health response to monkeypox is going to roll out.

Compliance with WHO coordinated response remains undermined as WHO is yet to invoke legal provisions of IHR 2005. Responses so far from the manufacturers and the countries having manufacturing capacity for vaccines to the PHEIC declaration show no indication of active partnerships or diversification of production to developing countries.

Even the "fill-and-finish" offers from WHO and manufacturers from developing countries have not received a positive response.

Currently, countries do not consider the WHO coordinated response, largely through temporary recommendations, as a binding obligation during a PHEIC.

This creates a lot of compliance issues as seen during the COVID-19 response, such as non-adherence to vaccine allocation plans developed by the WHO, excessive imposition of travel bans against the Omicron variant, rolling out of booster dose vaccinations etc.

Similar issues will arise in the monkeypox response as well since the neglect of recommendations 4.a. and 4.b. will further entrench inequities in the public health response to monkeypox.

States Parties continue to do so because Article 1 of IHR 2005 defines temporary recommendations from the WHO DG as "non-binding advice", although the temporary recommendations generally set the standard of health measures during a PHEIC.

Article 15(1) of IHR 2005 obligates the DG to issue temporary recommendations whenever there is a public health emergency of international concern occurring as declared under Article 12. Temporary recommendations may include health measures "regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic".

States Parties are further obligated under Article 42 of IHR 2005 to implement the health measures without delay in a transparent manner without discrimination. Article 42 states: "Health measures taken pursuant to these Regulations shall be initiated and completed without delay and applied in a transparent and non-discriminatory manner".

These health measures may be as recommended by WHO or as the States Parties may decide.

WHO may also request States Parties to reconsider their health measures under Article 43(4) of IHR 2005 in so far as they are not consistent with the public health rationale or scientific principles. Moreover, under Article 54, States Parties should report on implementation of IHR to the World Health Assembly.

During the 5th issuance of the temporary recommendations for COVID-19, the DG had called on States Parties to report back on the implementation of the temporary recommendations. This means the temporary recommendations can be obligatory although the definition characterises them as non-binding.

It must be noted that there are other IHR provisions which WHO can invoke to enhance the compliance of its temporary recommendations and also to call for the effective prevention of and response to PHEIC.

It is the obligation of States Parties to support the WHO coordinated public health response activities under Article 13, which sets out the core obligation with regard to the response to health risks and PHEIC.

Article 13(5) states: "When requested by WHO, States Parties should provide, to the extent possible, support to WHO-coordinated response activities."

While States Parties can retain their discretion to provide the assistance, they have the burden of proof to show that the requested assistance has been provided to the fullest of their respective abilities.

However, WHO and the DG seldom invoke this provision. The WHO's requests for assistance and call for support clearly falls under Article 13(5). But this is not made clear in the PHEIC recommendations. Neither is there a recorded history of formal requests being sent under this Article.

This reluctance to make formal requests under this provision allows States Parties to side-line the call for collaboration and to support WHO coordinated response without being accountable for the same in any manner.

Similarly, Article 44 of the IHR 2005 establishes a general obligation on States Parties to collaborate and assist each other in health emergency preparedness and response, including through technical cooperation, logistic support for health supplies, mobilization of financial resources, and through legal and administrative arraignments.

WHO is also obligated to provide financial, technical and logistical support under paragraph 2 of Article 44 of the IHR 2005.

As a component of its technical support, WHO publishes a response toolbox for almost all PHEICs. However, the toolbox published by the WHO for the monkeypox outbreak does not indicate a list of health products required for effectively responding to the disease.

The toolbox could also include the list of countries which manufacture health products as well as the status of current market access, including cost of production and pricing.

This will provide transparency in the market relating to health products and should be considered as an important element of the response toolbox. This will even facilitate developing country States Parties to request assistance from the manufacturing states under Article 44(1).

It must be recalled that the provisions like Articles 13(5) and 44 were incorporated into the IHR 2005 text as a result of the developing countries' demand for equity in public health response delivery during the revision of the IHR in 2004-05.

These provisions are therefore central to the intergovernmental agreement made in adopting IHR 2005. Reluctance in using them is contrary to the principle of good faith and pacta sunt servanda that says, "the agreements must be kept".

In fact, the monkeypox Emergency Committee had alluded to the spirit of Article 44 after its first meeting on 23 June, although the PHEIC status of monkeypox was not determined then.

The Emergency Committee then advised the DG that "countries should collaborate with each other and with WHO in providing the required assistance through bilateral, regional or multilateral channels, and should follow the guidance provided by WHO".

Nevertheless, a month later, when the DG issued the first set of temporary recommendations, he did not invoke or refer to Article 44 of IHR 2005.

IHR 2005 AMENDMENTS & EQUITY

The monkeypox PHEIC declaration has come at a point of time where there is ample movement amongst States Parties to amend the existing IHR 2005 to address challenges on realizing equity in international health emergency preparedness and response.

The 75th Session of the World Health Assembly (WHA75), in its decision WHA75(9), mandated the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) to work exclusively on consideration of proposed targeted amendments to the IHR 2005, consistent with decision EB150(3) earlier in 2022, under a new title, Working Group on Amendments to International Health Regulations 2005.

The PHEIC declaration on monkeypox is thus timely in that it also provides at least the following insights for amending the IHR 2005.

First, "temporary recommendations" should not be defined as non-binding in Article 1 of IHR 2005.

Instead, it should be considered as a soft regulation, wherein deviations from such recommendations and unilateral measures are permitted but with sufficient explanations based on national circumstances considering the public health rationale and scientific principles.

This will help temporary recommendations of the WHO DG to become a "minimum standard" to be followed during a PHEIC.

Second, the DG should have a clearer mandate under Articles 13, 43, and 44 to request specific States Parties to comply with the request of WHO and other States for the better coordination of public health response to PHEIC, especially in the area of diversification of production of health products and compliance with WHO allocation plans for health products facing supply shortage.

Third, it should be noted that diversified research, development, manufacturing, and distribution capacities are important public health response capacities, and these should be explicitly included in IHR 2005 as core capacities.

This will help mobilize financial and technological response for establishment, development, and maintenance of such capacities.

These amendments could address the equity gaps within the functioning of IHR 2005 as observed by WGPR.

They are also central to the interests of developing countries in attaining a better coordinated international public health response to the diseases affecting them.

It should be also noted that the monkeypox PHEIC declaration casts away the doubts regarding the scope of Article 21 of the Constitution of WHO, under which IHR 2005 was adopted.

It was a misconception spread during the 2nd Session of the Intergovernmental Negotiating Body (INB2) for the new pandemic instrument in July 2022, that the scope of Article 21 is limited in the sense that the instruments developed under the said provision cannot address issues relating to equitable access to medicines during public health emergencies.

The monkeypox temporary recommendations, on the other hand, clearly shows that this is not the case as they make explicit calls for increasing the production of health products, enhancing access to health products at affordable costs and also for extension of technical, financial and human resources for addressing monkeypox PHEIC under Article 15 of IHR 2005, an Article 21 instrument. +