TWN Info Service on Health Issues (May24/14)
23 May 2024
Third World Network

WHO: Proposed legal nature of pandemic instrument risks health emergency regime fragmentation

Geneva 23 May (K M Gopakumar) – The pandemic instrument as a treaty under Article 19 of the WHO Constitution raises concerns on the fragmentation of the health emergency regime, which the Intergovernmental Negotiating Body (INB) has not taken up for discussion.

The draft negotiating text and the draft resolution for its adoption proposes that the pandemic instrument would be adopted under Article 19 of the WHO Constitution as a treaty. Further, some Member States are moving towards the notion of a protocol for the Pathogen Access and Benefit Sharing (PABS) system and for the proposed instrument on One Health Approach.

Since treaty obligations would apply only after ratification, which is a sovereign decision, the result is that Member States could decide not to be part of the treaty or accompanying protocol. This would result in fragmented membership in various instruments and WHO Member States with different sets of obligations on health emergencies.

Legal instruments under the WHO Constitution

The WHO Constitution envisages two types of legal instruments. First, there are conventions or agreements also known as treaties. To date there have only been two instruments concluded under Article 19, i.e. the Framework Convention on Tobacco Control and the Protocol on Illegal Trade in Tobacco Products.  Secondly, there are legal instruments that can be adopted under Article 21 and this was the pathway for the International Health Regulations 2005 (IHR 2005). The nature of legal obligations under both pathways is the same, i.e. instruments under Article 19 and 21 are legally binding.

Articles 19 and 20 of the WHO Constitution set the rules for treaty adoption and joining of a treaty respectively. Article 19 states: “The Health Assembly shall have authority to adopt conventions or agreements with respect to any matter within the competence of the Organization. A two-thirds vote of the Health Assembly shall be required for the adoption of such conventions or agreements, which shall come into force for each Member when accepted by it in accordance with its constitutional processes”.

Article 20 sets out the ratification process of a treaty: “Each Member undertakes that it will, within eighteen months after the adoption by the Health Assembly of a convention or agreement, take action relative to the acceptance of such convention or agreement. Each Member shall notify the Director-General of the action taken, and if it does not accept such convention or agreement within the time limit, it will furnish a statement of the reasons for non-acceptance. In case of acceptance, each Member agrees to make an annual report to the Director-General in accordance with Chapter XI”.

Thus, obligations of an Article 19 instrument would be applicable to WHO Member States only after ratification.

In contrast, the obligations of an instrument adopted under Article 21 automatically apply without any need for ratification. Member States who do not want to be a party under an Article 21 instruments will need to notify the WHO Director-General, and this is provided in Article 22: “Regulations adopted pursuant to Article 21 shall come into force for all Members after due notice has been given of their adoption by the Health Assembly except for such Members as may notify the Director-General of rejection or reservations within the period stated in the notice”.

Thus, obligations under an Article 21 instrument are applicable to all WHO Member States in the absence of an explicit communication to the Director-General to opt out.

Article 21 allows the World Health Assembly to adopt resolutions in the following areas:

a) sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease;

(b) nomenclatures with respect to diseases, causes of death and public health practices;

(c) standards with respect to diagnostic procedures for international use;

(d) standards with respect to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce;

(e) advertising and labelling of biological, pharmaceutical and similar products moving in international commerce.

The pandemic instrument is now conceived as an Article 19 instrument. Article 34 of the draft negotiating text states: “The WHO Pandemic Agreement and any protocol thereto shall be subject to ratification, acceptance, approval or accession by [all States] and to formal confirmation or accession by regional economic integration organizations. This Agreement and any protocol thereto shall be open for accession from the day after the date on which the Agreement is closed for signature. Instruments of ratification, acceptance, approval, formal confirmation or accession shall be deposited with the Depositary.”

This means IHR 2005 and the pandemic instrument may not have the same number of memberships. As per the draft negotiating text, unlike the IHR, the pandemic instrument will have its own budget. These two elements may lead to fragmentation of norms and finance.

Normative Fragmentation: Since ratification is required many Member States may not join the treaty due to various reasons including domestic political reasons. Ratification in many WHO Member States including the United States require the approval of national legislatures and is guided by domestic political compulsions. Considering the historical reluctance of the US to ratify treaties Article 34 of the draft negotiating text uses words such as “acceptance”, “approval” and “accession” to bypass the normal ratification process in countries like the US.

In the absence of universal membership WHO Member States will have different legal obligations with regard to pandemic prevention, preparedness and response. The proposed instruments like the PABS system or One Health Approach if they emerge as a protocol would further fragment the health emergency regime.

Fragmentation of Finance: Though there is no consensus on the financial rules and budget the proposed text in Article 21.6 reads: “The Conference of the Parties shall apply the Financial Regulations and Rules of the World Health Organization by consensus adopt financial rules for itself, as well as governing the funding of any subsidiary bodies it may establish and the functioning of the Secretariat At each ordinary session, it shall adopt by consensus] a budget for the financial period until the next ordinary session”.

If separate financial rules and budget are created that would lead to the fragmentation of financial resources among WHO’s health emergency program, IHR 2005 and the pandemic instrument. In the absence of a fund for the implementation of the pandemic instrument, the fragmented finance would seriously affect the implementation of the instrument.

The resumed INB agreed not to establish a separate Secretariat for the implementation of the instrument, as originally sought by some Member States. Article 24.1 states: “The WHO Secretariat shall function as the Secretariat of the WHO Pandemic Agreement and shall perform the functions assigned to it under this Agreement and such other functions as may be determined by the Conference of the Parties. In performing these functions, the WHO Secretariat shall, under the guidance of the Conference of the Parties, ensure the necessary coordination, as appropriate, with the competent international and regional inter-governmental organizations and other relevant [international] bodies”.

This could provide much more effective implementation using WHO’s three-level (national, regional and headquarters) organisational infrastructure.  This is a departure from the Framework Convention on Tobacco Control (FCTC), which established a separate Secretariat, which is currently working from WHO.  Article 24 of the FCTC states:

“1 The Conference of the Parties shall designate a permanent secretariat and make arrangements for its functioning. The Conference of the Parties shall endeavour to do so at its first session.

 2. Until such time as a permanent secretariat is designated and established, secretariat functions under this Convention shall be provided by the World Health Organization.”

Since most of the WHO activities in health emergencies fall outside IHR 2005 and the proposed pandemic instrument there is no mechanism to facilitate coherence, accountability and transparency. The draft resolution circulated by the INB Bureau proposes the creation of a new committee of the World Health Assembly, called Committee E to discuss predominantly matters related to health emergencies. However, many developing country delegates expressed doubts about the efficiency of such a committee because many Member States send small delegations to the Assembly due to resource constraints and already struggle to attend multiple meetings.

The resolution is expected to be negotiated on 24 May after the completion of negotiatons on the pandemic instrument in the ongoing resumed 9^th session of the INB (20-24 May).   Considering the lack of consensus even after the last three days of negotiations, work on the resolution is likely to be delayed.