Health Assembly to finalize nature of new pandemic instrument

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1 August, Geneva (Third World Network) – The 2nd Session of the Intergovernmental Negotiating Body (INB2) entrusted the World Health Assembly (WHA) to decide on the legal nature of the pandemic instrument to be adopted.

The INB2 met on 18 to 22 July at the WHO headquarters in Geneva in a hybrid mode, and agreed that the WHA will determine the relevant provision of the World Health Organization’s Constitution to finalize the nature of the instrument.

If it chooses Article 19 of the Constitution, the new instrument will be an “opt-in” convention or agreement, being operative on a Party only upon its ratification of the instrument. If the WHA chooses Article 21, the new instrument will be an “opt-out” regulatory instrument. This means that the instrument will enter into force for all Member States of WHO on a particular date if they have not notified WHO to opt out of the instrument. Article 21 allows the WHA to adopt international regulations in five specific areas including that related to prevention of international spread of disease.

Both are considered as “legally binding treaty” under the Vienna Convention on the Law of Treaties that governs international treaty making.

The INB2 compromise was reached when several Member States continued to express doubts as to whether it is premature to identify the relevant legal provisions of the WHO Constitution, especially without having a clear understanding about the provisions that may be included in the new instrument.

[As a part of its working methods, the INB is mandated by the WHA Special Session Decision SSA2(5) to identify the constitutional provision under which a new instrument should be developed i.e., whether the new instrument should be developed under Article 19, 21 or 23 of the WHO Constitution. Article 23 allows WHO to adopt recommendations as opposed to treaties in Articles 19 and 21.]

During the deliberations many Member States, mainly belonging to the Friends of the Pandemic Treaty, preferred the new instrument to be under Article 19. Other Member States expressed the view that the instrument could be even under Article 21. Several also spoke about the utility of the Article 23 option.

Statements of the regional groups on 20 July on this agenda item clearly showed that there was no consensus among the various regions regarding the identification of the constitutional provision under which the new instrument is to be adopted.

This divided opinion led to the following compromise which is included in the report of the meeting adopted by the INB2:

“Regarding the identification of the provision of the WHO Constitution under which the instrument should be adopted, the INB agreed that the instrument should be legally binding and contain both legally binding as well as non-legally binding elements. In that regard, the INB identified that Article 19 of the WHO Constitution is the comprehensive provision under which the instrument should be adopted, without prejudice to also considering, as work progresses, the suitability of Article 21. This identification is made mindful that the decision will be made by the World Health Assembly.”

The decision now enables the INB to work towards a negotiating draft on the basis of Article 19 of the Constitution. It is open for the INB to later switch to Article 21, but the final determination will remain with the WHA.

The INB Bureau’s original proposal read as follows:

“Regarding the identification of the provision of the WHO Constitution under which the instrument should be adopted the INB expects the instrument to contain legally binding and non-legally binding provisions. In that regard, mindful of the scope of Article 19 of the WHO Constitution, which allows the Health Assembly to adopt conventions or agreements regarding any matter within the competence of WHO, the INB identified that Article 19 of the Constitution is the most comprehensive provision under which the instrument could be adopted, without prejudice to also considering as work progress the suitability of Article 21 and /or 23 as may be deemed appropriate by the INB. The identification is made mindful that the decision will be made by the World Health Assembly.”

Nevertheless, certain Member States pushed back against this move by attempting to delete “most” in the bold decision text which prejudges the scope of Article 21. Peru proposed to delete first the two sentences which carry unnecessary comments and to incorporate a simple text in the report of the INB2: “As to the provision of the WHO Constitution under which to adopt the WHO legally binding instrument, the INB identified Article 19, not excluding Article 21”.

Some Member States were of the view that to expressly state that the INB prefers a legally binding instrument which may or may not contain non-binding elements was unnecessary, and prejudices the new treaty negotiation. Further a decision to identify the provision under which a new instrument should be adopted need not include an interpretation of other provisions.

Countries such as the United States and Paraguay also supported Peru’s text and further proposed to delete the second sentence i.e. “In that regard, mindful of the scope of Article 19 of the WHO Constitution, which allows the Health Assembly to adopt conventions or agreements regarding any matter within the competence of WHO, the INB identified that Article 19 of the Constitution is the most comprehensive provisions under which the instrument could be adopted, without prejudice to also considering as work progress the suitability of Article 21 and /or 23 as may be deemed appropriate by the INB.”.

A few more Member States proposed amendments to the Bureau’s text. At this stage, the Co-Chairs informed that the Bureau would come up with a new text on 21 July taking into account the comments made by Member States and this text that was later accepted by all Member States. The word “most” was removed from the paragraph to avoid a relative assessment of the scope of an Article 21 instrument.  Earlier certain Member States such as New Zealand said that it would be premature to rule out the scope of Article 21 in the current stage.

The regional statements of Member States from the Eastern Mediterranean, South East Asia, and Africa Regions (EMR, SEAR, AFR respectively) did not specify Article 19 or 21 as the provisions under which the new pandemic instrument will be adopted.

Pakistan speaking on behalf of EMR States stated that the INB meeting had come in line with the decision of the 2nd Special Session of WHA, to identify the provision of the WHO Constitution under which the new instrument should be adopted.  In this regard, Pakistan recalled the main reasons which brought nations together. It emphasised that during the painful period of COVID-19 spread, countries of the EMR along with all other countries experienced difficulties at various levels in dealing with the pandemic for various reasons, including for example weak health systems, difficulties in accessing countermeasures, lack of funding and many other reasons.

Without signalling any WHO Constitution provision, Pakistan said: “This pandemic has also proven beyond any doubt that the existing regulations and measures responsible for organising the efforts of the international community are insufficient and lack equity. There is an urgent need to develop a new instrument on PPPR (pandemic prevention, preparedness and response) to enable countries around the globe to strengthen national, regional and global capacities and resilience to future pandemics. For that reason, EMR believes that new instruments should be drafted based on international solidarity, need for equity and clear commitment.”

India on behalf of SEAR Member States said that the identification of the provisions under the WHO Constitution will facilitate and focus the future work of the INB. The regional statement reiterated that the instrument should inter alia reinforce preparedness capacities of health systems particularly through progressively realisation of Universal Health Care, improve public health competency and availability of health workforces in low and middle income countries, address barriers to development and distribution of medical countermeasures, as well as issues of critical importance such as research and development capacity, intellectual property, technology transfer and scaling up local and regional production capacities prior to and during public health emergencies with a view to adopting such an instrument under Article 19 or under other provisions of WHO Constitution as may be deemed appropriate by the INB.

South Africa on behalf of AFR States quoted WHO Director-General Dr Tedros Adhanom Ghebreyesus’ call for a legally binding agreement on pandemic governance, and stated that the Africa region, being one of the regions that has been disproportionately affected by the ongoing COVID-19 pandemic, supports a legally binding instrument for pandemic prevention, preparedness and response.  “Such an instrument should ensure coherence, collaboration, accountability and transparency and be grounded on the principle of equity,” it stated.

Further, South Africa requested the WHO legal counsel to build on the WHO Secretariat’s presentation from the Working Group on strengthening WHO preparedness and response to health emergencies (WGPR) and explicitly state whether the scope of Article 21 can accommodate provisions on prevention as well as preparedness and response.  According to the region, this would be helpful since several Member States required more time to identify the WHO provision, particularly between Articles 19 and 21. “In our view, this would further assist deliberations including in the upcoming regional committee meetings,” said South Africa, suggesting that the discussions be taken to the regional level for better consensus.

These regional statements show that there is yet to be a definite determination of the provision under which the new pandemic instrument should be developed. However, South Africa, Kenya and few others from the Africa Region clearly conveyed their preference to adopt the new instrument under Article 19. Indonesia and India from the SEAR region also explicitly chose an instrument under Article 19.

However, TWN learned that there was an informal meeting following the morning session of 20 July, whereby the Friends of  the Pandemic Treaty managed to tweak the INB determination in a way that it primarily favours Article 19 and then also to consider Article 21, if found necessary or appropriate.  Towards this purpose developing country members of the Friends of the Pandemic Treaty solicited support for Article 19 citing the following two grounds which are surprising misconceptions:

Article 21 is limited in scope and therefore comprehensive response aspects of the pandemic cannot be addressed through an instrument under Article 21.

Access to health products including vaccines, diagnostics, therapeutics etc. along with supply chains cannot be included in an instrument under Article 21.

According to a person familiar with the INB2 discussions, Article 19 proponents have argued that the text “other procedures to prevent international spread of disease” cannot include measures to establish production or distribution capacities for adequate supply of medical products. They also reported to have misread of the clarification of the Legal Advisor of WHO regarding the scope of Article 21, as “limiting” rather than understanding it as “specialized”.

Such an understanding is clearly contradictory to the legal text of Article 21, and the historical evolution of its meaning. The International Health Regulations (IHR) 2005, an instrument adopted under Article 21 is a living example, which reasserts that “other procedures” include “capacities”. The entire IHR 2005 operates through binding obligations on capacity building and assistance.

Paragraph 6 of Annex 1 of the IHR 2005, which deals with public health response capacities indicates a capacity for logistical supply of equipment, supplies and transport. Paragraph 6 (b) of Annex 1 enlists a public health response capacity “to provide support through specialized staff, laboratory analysis of samples (domestically or through collaborating centres) and logistical assistance (e.g., equipment, supplies and transport)”. The WHO and its Member States are also by virtue of Article 44 read with Article 13 of IHR 2005 obligated to cooperate with each other in establishing these capacities.

The scope of these provisions including obligations of a coordinated public health response under Article 13 and collaboration and assistance under Article 44(1) was clarified during the negotiations of IHR. Paragraph 11 of a report on “Alert and Response operations” (A/IHR/IGWG/2/INF.DOC./1) prepared by the Secretariat in 2005 states as  follows with regard to the technical support: “In practical terms, the Secretariat may supply technical support in the form of advice, guidelines, materials, medicines and assistance in arranging for, or coordination of, international public health response”. This clearly shows the understanding that the public health response under IHR 2005 includes supply of medicines not only within the countries but also across international borders.

The legal advisor to WHO has reiterated that Article 21(a) can include “issues of prevention, protection, detection and response” related to international spread of disease.  “Response” as shown above includes capacities to provide adequate supply of medicines, and these capacities can include production or distribution capacities as well. WHO can certainly do “everything within its scope to prevent international spread of disease” under Article 21. This was, however, not properly conveyed by the WHO legal advisor, and neither were Member States cognizant of the nuances in the explanation provided by the former.

The legal advisor had further said that “it would not be legally available, in my view, to interpret procedures designed to prevent the international spread of disease to cover anything within the competence of WHO. And why do I say that is not legally available? … reason I say that is because if… Member States wished to interpret Article 21(a) to that extent, it would amount, in effect, to a de facto Amendment of the Constitution”.

This was said in response to questions which were asked on whether WHO can act under Article 21, beyond the five specific areas. This was later wrongly picked up by certain Member States to illustrate why Article 21 is limited.

Following this informal meeting, the INB Bureau Co-chair, Mr Roland Driece of the Netherlands, opened the afternoon session of 20 July which resulted in the compromise text. He put a question to the Member States, who have not yet determined between Article 19 and 21, citing an interesting example of “health literacy”. He asked whether issues like “health literacy” can be addressed through Article 21 effectively, and also stated that according to the Bureau issues like health literacy would require Article 19 of the WHO Constitution. He also said Member States that think Article 19 is the best do not need to speak up.

The approach of the INB Bureau and WHO Secretariat effectively covered one simple truth about the scope of Article 21, i.e., while general competence under Article 19 is not available under Article 21, WHO’s competence under Article 21 is not limited when it comes to addressing the specific issues covered under Article 21. For example, while “water sanitation” is a subject matter of Article 19 and may not be addressed through an Article 21 instrument per se, nevertheless “water sanitation for the prevention of an international spread of disease” is a subject matter well within the scope of Article 21(a).”

Bangladesh, on the other hand, asked a pertinent question: before the determination of the relevant provision of the WHO Constitution what is it that developing countries are going to get from the new pandemic instrument?  It called on the developed countries to explain what obligations they are willing to undertake.

Bangladesh queried the developed countries about their standing on a few issues (i) Common but Differentiated Responsibilities and Respective Capabilities (CBDR-RC); (ii), reciprocity between sharing of pathogen, genetic sequence information, and Access and Benefit Sharing (ABS); (iii) waiver of intellectual property rights during health emergencies; (iv) transfer of technology and know-how; (v) mutual support, assistance and cooperation among the Member States and international cooperation.

Clarity on the above would as such, be encouraging and at the same time, dispel apprehensions, towards identifying the relevant WHO Constitutional provision for developing countries, said Bangladesh.

The question, however, remained unanswered and this raises concerns as several developed country Member States proceeded to make statements without any remorse expressing their dissent to several of the ideas which the developing countries are promoting in the Working Draft (A/INB/2/3) which was discussed earlier in the INB.  These include provisions for ABS, local production, technology transfer, and CBDR-RC (see https://twn.my/title2/health.info/2022/hi220702.htm). Additionally, several developed countries were very enthusiastic to include the idea of “non-binding provisions” in the new legal binding pandemic instrument.

- Third World Network