Equity Provisions in the IHR: A Race Against Time
Newsletter Edition #63 [Treaty Talks]
“Seek, and ye shall find” - I am not sure this sermon holds true in global health negotiations.
During this week’s discussions on amending the International Health Regulations, developing countries tried relentlessly to keep the equity agenda on the table of the working group. They may have succeeded for now.
The second part of this sermon: “knock, and it shall be opened unto you: For every one that asketh receiveth; and he that seeketh findeth; and to him that knocketh it shall be opened…” (As an agnostic, I am skeptical about this.)
We will be tracking the end-game of these negotiations, to keep our readers up to speed.
IHR revisions are likely to be staid and narrow, developed countries do not have a lot of appetite for what they argue as expanding the scope of these rules.
Also, it is striking how crucial a role interpretation plays in reading “old texts”!
In case you missed it, our update from earlier in the week: Developing Countries Seek to Retain Equity Provisions in the Amendments to the IHR [WGIHR7 Update]
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I. STORY OF THE WEEK
Equity Provisions in the IHR: A Race Against Time
By Priti Patnaik & Tessa Jager
Nishant Sirohi contributed to this story
The window of opportunity to insert binding commitments to decisively address equitable access to medical products during health emergencies is closing. The ability of developing countries to be able to ensure such obligations in the current revision of the International Health Regulations will depend on their willingness and tenacity to keep that window from shutting off, against the winds of commercial interests, process limitations and against the clock.
The tug of war between countries that want to expand the scope of IHR, and other countries and stakeholders who would rather keep the focus narrow, continued this week at the meeting of the working group for amending these rules.
This story brings you a wrap on some of the ongoing dynamics in these discussions. We spoke with numerous negotiators, civil society actors and other experts to put this together. See below, also an exclusive interview with Co-Chair of the Bureau, Ashley Bloomfield who shares his thoughts on the proceedings.
We describe both process matters in the negotiations this week, and a few substantive provisions that were discussed this week.
We present this story, in continuation with our earlier update this week, Developing Countries Seek to Retain Equity Provisions in the Amendments to the IHR [WGIHR7 Update]
As with all negotiations process determines outcomes. We discuss the process that shaped discussions this week, and what this process means for the treatment of certain provisions going forward.
ON NEGOTIATING PROCESS: SOME COUNTRIES SEEK MODIFICATIONS
Many countries we spoke with, largely agreed with the way the Bureau conducted these discussions calling it “efficient”, at the same time referring to the process as being difficult. A few diplomats told us that in some cases previously submitted proposals from certain developing countries were not treated or discussed adequately.
Mostly, there has been a perception of fairness between countries, that they are heard by the Bureau. But there have also been concerns that the secretariat has in some instances not reflected the interests of the countries - their original proposals for amendments were sometimes not captured, diplomats said. It appears that some important suggestions were lost in translation so to speak – between the secretariat and the bureau - causing confusion on the status of some of the proposals made by countries, sources indicated.
Observers familiar with these processes told us, that at WHO, it is the secretariat that usually works on proposals for consideration by member-states driven bureaus.
The approach used by the Bureau has been to come up with text based on the proposals for amendments by countries, and informed by the considerations of the secretariat given their experience in implementing these rules. (See WHO’s emergencies lead Mike Ryan’s statements in an earlier story)
In an exclusive interview with us, Co-Chair Bloomfield explained how the proposals are made: “It is in fact, largely driven by the Secretariat’s understanding of the implementation of the regulations and, of course, of the legal elements behind them. Secondly, it is also, of course, looking at what our previous discussions entailed, so whether we had support, what feedback there had been, so it's a mix of the two. Then as a Bureau, we are trying to synthesise and come down the middle and say, well, this is what the Member States have said, and this is what the Secretariat experiences. And on some of the matters, you have the secretariat, and so it might be different from the Bureau's, but we are placing, making sure that placing appropriate weight on what we do.”
Some countries are keen to have to a greater say on the process of drafting – suggesting that a negotiating text as determined by countries must be reflected “on screen”, as opposed to text suggested by the Bureau.
“The WGIHR has had an easier task simply because countries already have a text to go back to (unlike the INB process for a new pandemic agreement that started from a scratch). The Bureau has also shown wisdom and judgement in consulting with proponents of amendments, using direction from the secretariat, and having an overall ownership of the process,” a developing country negotiator told us this week.
Sources told us that some countries are of the view that the Bureau may have been too prescriptive and therefore sought more latitude to strike deals and make decisions on trade-offs between member states, as the negotiations draw to a close in the coming weeks. “The time now is for finding convergence on existing discussions,” a diplomat said.
Even as countries edged closer to agreement on a range of matters, a whole host of critical issues are pending – notably equity-related amendments, financing, access and benefits sharing, definition and declaration of emergencies and governance matters.
So there is a natural tension, between the pressure to conclude these negotiations on the one hand, and to ensure that the most important proposals get treated, discussed and find place in the amended IHR. Remember that the IHR negotiations are not isolated and not insular from the parallel negotiations on a new pandemic agreement.
Co-Chair Bloomfield told Geneva Health Files that there is greater coordination between the IHR and the INB processes, with representatives from WGIHR also paying attention to informal consultations occurring in the subgroups of the INB set up to forge language on key provisions from financing, ABS, production issues.
Given that the IHR come into force for all state parties, discussions here will set the tone, and have implications for the INB negotiations.
And yet, the IHR has been viewed as technical in nature even by countries themselves. “There is not enough focus on the politics in the IHR negotiations. Some developing country delegations are more focused on the INB. Mostly leads from capitals who are the responsible for technical matters are steering these delegations, who sometimes do not see the underlying politics. That is risky. It can be a missed opportunity. Countries must treat both these processes equally,” a developing country diplomat told us this week.
THE FATE OF THE EQUITY PROVISIONS
The nub of these negotiations have been the potential consideration of new equity related proposals mostly championed by Africa Group and Bangladesh in the form of the provision 13A (response) and 44A (financing), among related proposals on annexes.
As we reported earlier in the week, sources indicated that the secretariat suggested doing away with a stand-alone provision, and instead, to accommodate the elements from the suggested new provision across existing articles, and/or to cross reference these provisions in the new pandemic agreement.
So far, the proponents of 13A are keen to retain the stand-alone provision. Countries are also open to examining how language in 13A could translate into obligations on equity that will be reflected across other existing articles.
To be sure, this provision was tabled more than a year ago, but the WGIHR did not make time to discuss this sufficiently, sources said. Developed countries often pointed to ongoing discussions in the INB where equity related provisions are being discussed in detail.
“Changing strategy on treating this key article, introduces a lot of uncertainty at this stage. The provisions in the IHR are interlinked and strive to strike a balance and a coherence. It will be unclear how new equity rules can be inserted into existing text,” a legal expert explained to us.
At the close of the meeting, it was decided that a dedicated session on equity matters will be scheduled in early March in a resumed session of the WGIHR7. It is not clear whether there will be a dedicated subgroup on 13A will be established as some countries had requested.
“The biggest failures of the policy response to COVID-19 were ensuring availability and affordability of drugs. If we do not have obligations to address these shortcomings in the IHR, then these revisions will not matter much,” a developing country diplomat told us.
Sources familiar with the discussions told us that there is greater acknowledgement on the need for a new financial mechanism to help implementation of the IHR and new obligations. The INB process has undertaken substantial consultations on financing. “A new financial mechanism will serve both the IHR and a potential new treaty. It should go beyond mere of coordination of existing mechanisms. There has to be a clear principle of allocation according to the needs of the countries,” diplomats said.
Similar considerations are also being discussed for a new mechanism for access and benefits sharing. “The understanding is with respect to issues such as ABS and financing, this is being discussed without prejudice to where this text will be located. It will be applicable to both instruments”.
On financial mechanisms, Bloomfield explained, “There are two elements to the strengthening of financing. There are already considerable financing challenges. How do you make sure it's coordinated and that it is allocated in a way that is actually meeting the needs of developing countries? So, we're keen to strengthen them, and at the same time, we know there are calls from developing countries for a sort of dedicated for financing facility. And so, what we'd like if that is where the discussions in the INB process [is going], we'd like to make sure there's an appropriate reference to that in the IHR because the full implementation of the IHR is fundamentally dependent on prevention and preparedness.
OTHER PROVISIONS DISCUSSED THIS WEEK
The proposals for amendments to existing provisions were discussed in this grouping:
Group 1: Article 35, Article 36, Annex 6, Annex 8, Article 37, and Annex 3
Group 2: Article 4, Article 1, Article 5, Article 9, Annex 2, and Article 45
Group 3: Article 15, Article 16, Article 17, and Article 18
Group 4: Article 42, Article 43, and Article 56
Group 5: Article 24 and Annex 4
Countries made progress on the following provisions including, Art. 4: responsible authorities; Art. 5: surveillance; Art. 15-18: temporary and standing recommendations; Art. 24: conveyance operators; Art. 35 and 36: health documents; Art. 42: implementation of health measure; Annex 4 and Annex 6, among others.
In the course of the week, the Bureau also tabled proposals for Art. 13, Art. 44 and Annex 1 on ccollaboration, capacity building, financing. These were discussed. In addition, the Bureau is expected to follow up with a proposal in 44A (one of the key provisions suggested by some developing countries).
ANALYSIS OF SOME PROVISIONS DISCUSSED THIS WEEK
The following analysis is based on the bureau’s proposals circulated to member states at the beginning of the meeting. Geneva Health Files has reviewed these proposals and tried to capture some of the key issues and matters of contention. (Please note that actual positions have moved in real-time in the course of this week.) We present these here to represent some of the matters discussed this week.
Health documents and vaccination certificates:
Annexes 6 and 7 of the current IHR provide for the possibility of giving out international vaccination certificates. Annex 7 provides a model for such certification and Annex 6 provides the regulatory boundaries thereto: only vaccines or prophylaxis that have been subject to approval by WHO are allowed to be subject to certification.
One of the proposed changes to Annex 6 by the Bureau was to change the wording of “approval by the WHO” to “prequalified or listed for emergency use by WHO”, as the WHO, strictly speaking, does not approve vaccines, but assesses whether WHO standards for vaccines and medicines are met.
This provision was suggested by developed countries. It is understood that some developing countries asked for deletion and to retain the wording “approval”, added with the possibility that this approval can also be given by a national or regional regulatory authority of the territory in which the vaccine was administered.
Temporary and standing recommendations:
The Articles 15 to 18 of the current IHR create a legal basis for the Director-General to issue temporary and standing recommendations. After a Public Health Emergency of International Concern (PHEIC) has been declared, the Director-General may recommend Member States to take one or more measures described in Article 18. Some of these measures include the requirement of medical examination, the implementation of quarantine or other health measures for suspected persons, or to refuse entry of suspected and affected persons. It is also possible that the Director-General decides under Article 18 that no specific measure is necessary to address the PHEIC.
As the recommendations seek to balance unnecessary interference with traffic and trade with the protection of public health, they must be taken carefully as to not invoke any unnecessary restrictions. Therefore, Article 17 lists a number of entities and/or criteria that must be consulted and/or heard before issuing recommendations.
The Bureau’s proposal for this Article proposes to include in the consideration the availability of relevant health products, technologies and know-how, including in the context of a WHO-coordinated mechanism for access to and allocation of health products
Article 15 and 16 concern the issuing of temporary and standing recommendations.
The most important amendment to the possibility of issuing temporary and standing recommendations is that the new Bureau texts for both types of recommendations holds that the Director-General shall endeavor to provide information to States Parties on access to, and allocation of, health products, technologies and know-how through WHO-coordinated mechanisms in the issuing of these recommendations. This proposed text follows a large number of proposals on the precise terminology. This includes China’s suggestion that the Director-General “should”, instead of “shall”, provide information. Countries also disagreed on whether the Director-General would have to issue recommendations upon request of Member States, and on whether a Member State would have to be affected in order to be able to request such a recommendation.
The current IHR contain an obligation for Member States in Article 4 to designate a so-called “National Focal Point” responsible for the national implementation of the Regulations. Countries and the Bureau suggested to designate three different authorities thereto instead of one: one National IHR Focal Point, a National IHR Authority and a National Competent Authority. They proposed that of these entities is be entrusted with a different responsibility. The Bureau clarified that if countries do not have the capacity to have different entities involved, one entity may exercise all tasks.
The rationale behind designating three different national authorities for tasks related to the implementation of the IHR largely lies in the attribution of responsibility. Whereas some entities will have a more political task, others would be more operational. This would enhance the accountability of each of the three organs. This proposal was not accepted by countries.
CONVERGENCE BETWEEN TWO PROCESSES
A number of issues are linked between IHR and INB processes.
One of the more critical ones are those relating to definitions and declarations. Countries have had several discussions on the public health alert – PHEIC – pandemic continuum. These were led by Bureau Vice-Chair Ambassador Rivasseau, with support from Co-facilitators the USA and Zambia. The said articles include 1, 6, 7, 10, 11, 12, 48 and 49 related to the public health alert – PHEIC – pandemic continuum. Updated proposals are expected from the Bureau on these matters.
Sources said that there was emerging consensus across both the definitions and the process of a declaration of a pandemic or “a pandemic emergency” - that these should be elaborated in the IHR. It would need to be referenced in the INB process because the declaration will might be a trigger for provisions and whatever agreement is finalised, a person familiar with the discussions said.
On the linkages between the two processes, Co-Chair Bloomfield told us, “we are closely following and linking to the INB discussions and then again, it will need to be coherent across the two documents, to make sure there are appropriate cross references.”
It has been decided that a joint plenary session will be held by WGIHR and INB during the next meeting of the INB on Friday, 23 February 2024.
At the close of the meeting, the working group discussed an interim report – this was webcast. It was decided that the meeting will be resumed in the first week of March between the two INB marathon negotiating sessions (February 19-29th and March 18th-28th)
The dedicated session in early March was a demand from developing countries to ensure that equity related provisions would be treated and as a matter of priority.
The language from the report reads thus: ‘’The Working Group further agreed that a dedicated session should be held to discuss the Bureau text proposals on Articles 13A and 44A and other Articles addressing equity not covered during the week. The Working Group supported the Bureau proposal to suspend this seventh meeting of the WGIHR and hold a resumed session ahead of its eight meeting. The date, which is proposed to be during the period 4-15 March, and modalities would be determined and announced by the WHO Secretariat as soon as possible. Articles 13A and 44A will also be considered by the Drafting Group first at WGIHR8.”
In a statement made by the Equity group, Egypt said (excerpt), “…we note that the Bureau's text on equity-related proposals still requires adequate and sufficient time or effort. Therefore, we agree with the Bureau for their proposal to conduct a resumed IHR session, to be fully dedicated to equity-related issues, and help us move forward as per Articles 13A and 44A.”
The EU cautioned against duplicating some of the discussions: “We would expect this work to be fully aligned- or joined up with the work in the other work stream. We are not going to do the same discussion, or to address the same issues, like the financial mechanism…doing two financial mechanisms: one here and one there, is not going to be possible; it’s not efficient….I think there should be an understanding that there are a number of issues, like sharing of countermeasures or access to countermeasures, whatever you want to define it as. The financial issues are very large, and some governance are entirely connected. They cannot be addressed in isolation: otherwise, we have never solved it. I think it is already difficult; it would make it even more difficult.”
In the coming days, the Bureau is expected to circulate proposals on the following: Articles 53A, 53 bis-quarter, 54 and 54 bis, related to Governance, monitoring and oversight. Updated text proposals including on Articles 44A and 13A and new Annex 10 is also expected to be circulated.
In his remarks, WHO’s emergencies chief, Mike Ryan said:
“It's a very precious process. One that has taken decades to develop; WHO’s mandate, but also the last revision of IHR. So: just to say what you're discussing here, sometimes seem like wordsmithing, not necessarily having an immediate impact on the world. It will, because it will define the next 10 years of global surveillance and of collective security when it comes to health emergencies and particularly high impact epidemics.”
“So, while you the shoemakers make the shoes, we'll be in the basement, doing the work of the elves that are needed to work with your institutions at national level. Remember: all of this, is happening with your national public health authorities, your National Institutes of Health, your partners, your cluster partners, WHO collaborating centers, the focal points for the IHR. This is a collective process. It provides a safety net, it provides protection for all our communities. You have treated this process with tremendous care and professionalism. I just would urge you again, as the DG has, get this done by May, and give us back the IHR in better shape than it's ever been: and we will be forever grateful.”
Although the finish line is within grasp for countries with respect to the IHR negotiations, disinformation and a loss in political momentum can jeopardise efforts and progress of the last three years. It will also depend on the fairly uncertain outcomes on the INB process.
“The IHR has served us well, we will be ok if we go back to the original text,” a developed country negotiator told us.
It will be a different story for developing countries though, already hamstrung by a lack of adequate financing to implement existing IHR provisions, and potentially, a lost opportunity to include strong obligations on response measures in these rules.
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