Equity is listed as a "guiding principle and approach" in the current proposed negotiating text for a new pandemic instrument.
"Equity is at the centre of pandemic prevention, preparedness and response, both at the national level within States, among and within countries or regions, and at the international level between States…” as per Article 3 of the negotiating text that elaborates on the principle of equity.
Similarly, EB decision 150(3), which spells out the scope of the amendment of the International Health Regulations 2005 (IHR) also mandates to address the issue of equity. It states: “Such amendments should be limited in scope and address specific and identified issues, challenges – including equity, technological or other developments – or gaps that could not effectively be addressed otherwise but are critical to supporting effective implementation and compliance of the International Health Regulations (2005)”.
Despite the loud and clear mandate to address equity within the international health emergency regime, the negotiations in both processes are moving towards the opposite direction that legitimizes inequity.
Inequitable International Health Emergency Regime: The Limitations of IHR (2005)
One of the glaring gaps in the international health emergency regime is the legal vacuum in providing predictable financial assistance for effective response during outbreaks of diseases. The IHR is the only legally binding instrument setting out the obligations for countries “to prevent, protect against, control and provide a public health response to the international spread of disease”.
It effectively obligates its 194 member states (who are State Parties to the IHR) countries to assess public health events and inform WHO within 24 hours if such public health events have the potential to become Public Health Emergency of International Concern (PHEIC). The Director General of WHO is to act upon this information and make a decision on whether to declare the outbreak as a PHEIC.
However, there is no explicit legally binding provision in IHR to facilitate availability and access to required health products to contain the international spread of diseases. Thus, IHR effectively operates as an instrument only to provide information about potential PHEICs without any corresponding obligations on State Parties or WHO to guarantee assistance in public health response.
Though the IHR recognises the need to assist its State Parties, it fails to effectively address the prevailing development divide. Provisions on technical assistance are framed without recognising the special needs of developing countries.
Articles 5 and 13 setting the obligations on surveillance and public health response obligates WHO to assist State Parties as a general obligation. For instance, Article 5 .5 states; “WHO shall assist States Parties, upon request, to develop, strengthen and maintain the capacities referred to in paragraph 1 of this Article.” The IHR refers to the special needs of developing countries only once.
Article 44(2)(c) obligates WHO to assist developing countries to the extent possible “in the mobilization of financial resources to in building, strengthening and maintaining core capacities mentioned in Annex 1.” There are no specific obligations on developed countries, who possess the technological capabilities in the pharmaceutical sector to assist in the response to a PHEIC, to help developing countries.
The lack of obligations on developed countries and for WHO, in assisting the implementation of the IHR and facilitating access to health products makes the IHR an inequitable regime. This is especially true in the light of the fact that these health products are developed from the information including from pathogens shared by developing countries.
The IHR amendment process
Developed countries are making all efforts to undermine the equity-related amendment proposals by putting forth an argument that the pandemic instrument is the best place to address equity and also stressing the need to preserve the current version of IHR. The WHO Secretariat is also toeing the same line and made several attempts to reject the amendment proposals contained in Article 13 A on equitable access to medical products and Article 44 A on the proposed financial mechanism for IHR implementation.
Shifting equity provisions from the IHR to the pandemic instrument would undermine the need for equity in health emergencies because the scope of the pandemic instrument is very limited i.e. pandemics and not PHEIC. Hence, preserving the status quo of IHR would create an equity vacuum in addressing PHEIC situations.
Marginalisation of Equity in INB
Common but Differentiated Responsibilities (CBDR):
Recognition of the development divide among WHO Member States is a prerequisite to addressing equity.
In this regard, the negotiation text brings back the principle of Common but Differentiated Responsibility (CBDR) as a guiding principle and approach in Article 3. It states: “Governments have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures. Given the unequal global development in the promotion of health and control of diseases, especially communicable diseases, which is a common danger, developed countries that hold more capacities and resources relevant to pandemics should bear a commensurate degree of differentiated responsibility regarding global pandemic prevention, preparedness, response and recovery through effective means of implementation, such as technology transfer and know-how as well as financial resources”.
However, none of the subsequent Articles propose specific obligations on developed countries to assist developing countries.
Equitable Access:
Proposed articles on equitable access from Articles 9 to 11 and 13 deal with R&D, production and distribution and are mostly stated as “best endeavour” language. For instance, Article 10’s Chapeau (sustainable production) reads: “..thereby reducing the potential gap between supply and demand, shall endeavour to". Similarly, the Article on technology transfer is qualified with terms including promoting, encouraging, etc. Technology transfer is proposed through mutually agreed terms. There is nothing in these articles, which offers predictable access through diversified production.
Existing Obligations on Cooperation:
The reluctance of developed countries to share technologies is a convenient ignorance on their obligations under the Biological Weapon Convention, which creates an obligation on State Parties to cooperate with other states or international organisations in the field of bacteriology for the prevention of disease or for other peaceful purposes. Article X(1) states: “ …Parties to the Convention in a position to do so shall also co-operate in contributing individually or together with other States or international organisations to the further development and application of scientific discoveries in the field of bacteriology (biology) for the prevention of disease, or for other peaceful purposes”.
Higher Standards on Regulations and its Potential Impact on Access:
There are proposals to push the pharmaceutical monopoly agenda through regulatory strengthening. For instance, proposed Article 14 on regulatory strengthening proposes strengthening WHO pre-qualification and compliance with ICH standards. For instance, Article 14.7 states: “Each Party shall consider adopting and implementing, when practicable and consistent with national law and procedures, guidance and technical documents concerning medical products developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum (IMDRF) or their successor organizations”.
Compliance costs: Most of ICH and IMDRF standards are beyond the reach for most of the developing country manufacturers. This mandatory consideration of ICH and IMDRF standards would threaten the demand for diversified production of pandemic-related health products. The following remark from the WHO Meeting Report of Regulatory Officers in 2001 is still relevant:
“Public health implications of the application of guidelines of greater technical complexity in developing countries may be far reaching…If these suppliers are unable to meet what may be unsubstantiated quality standards the adverse impact of the withdrawal of these drugs on the health of the population might well be far more dramatic than that of haptically risk posed by failing to achieve the ICH standards.”
Similarly, except Article 13, no mechanism at the international level is envisaged in either Article 10 or Article 11 to facilitate the technology transfer and sustainable production. The only reference in Article 11 is to “develop and strengthen multilateral mechanisms, as appropriate, that facilitate the transfer of technology and know-how for pandemic-related products on voluntary and mutually agreed terms;”.
This provision is a non-starter.
Access and Benefit Sharing:
Another important area where developed countries especially the EU are trying to undo the international obligations on access and benefit sharing as described under the convention of Biodiversity and the Nagoya protocol, is Article 12 on pandemic access and benefits sharing (PABS). The EU tabled a proposal that makes access to the pathogen a legal obligation and makes benefit sharing an option. The approach of EU is to serve the purposes of developed countries, who have already invested in the data harvest by establishing Bio-hub and the Hub for Pandemic and Epidemic Intelligence.
There is a concerted attempt to accommodate the EU proposal through a subgroup proposal by marginalising a comprehensive proposal from the Africa group and group of equity that treats access and benefit sharing with equal importance.
(See TWN: Attempts to side-line Africa and Equity Group proposal on the PABS System)
The Hesitation For Financing Commitments:
The lack of adequate finance is another important inequity existing in the context of IHR. Therefore it is important to address this glaring gap through the establishment of a financial mechanism including a fund. The negotiations in the WGIHR on financing have not made much progress.
Article 20 of the draft text of pandemic instrument proposes to establish a financial mechanism along with a pooled fund,. The pooled fund is “ to provide targeted, supplementary financing to support strengthen and expand capacities for pandemic prevention, preparedness and response, and as necessary for day zero surge response, in Cooperating Parties when other resources are not accessible through existing financing entities.”
Thus, the pooled fund is envisaged as a last resort to obtain financial assistance for the implementation of the pandemic instrument including prevention, preparedness, response and recovery. The financial mechanism is envisaged to “increase the effectiveness and efficiency of existing and future financial mechanisms, within or outside WHO, including by providing additional financial resources”.
However, it is obvious that the existing and future financial mechanisms are not under any legal obligations to follow the directions of the financial mechanism under the pandemic instrument. For the moment, there are no proposed obligation or even a nudge to developed countries to provide financial resources for the implementation of IHR or in the pandemic instrument. This will contribute to existing inequities in availing finance for PPR.
A Motivation for Data Extraction?
While the provisions on equity are proposed as “best endeavour”, the language in the negotiating text contains concrete obligations on surveillance and data transfer, in our view. The proposed obligations under Article 4.3 extends surveillance obligations not only to public health but also to zoonotic? diseases. Further, parties are to commit to taking measures to prevent zoonotic spillovers. Further, the negotiating text proposes obligations on Member States to comply with various international guidelines including guidelines on health and anti-microbial resistance. Some of these guidelines require an exchange of data such as the One Health Joint Plan of Action developed by WHO, FAO, OIE and UNEP, which would result in data sharing. Many of these guidelines or action plans promotes data transfer. Similarly, the inclusion of Anti-Microbial Resistance (AMR even expands the scope of the instrument and makes international guidelines like the Global Action Plan on Anti-Microbial Resistance (AMR) legally binding, which also then will impose surveillance obligations. Once surveillance is in place, data transfer is a logical conclusion.
Legitimizing Inequity?
The IHR and INB processes bear the danger of limiting the legal obligations on equity to “best endeavours” and at the same time expanding the obligations on surveillance and data transfer. A “managed” process which prevented the text-based negotiations since the publication of the Zero Draft in February 2023 is now shifting the gears. Member states are now reminded that they must conclude the negotiations prior to the World Health Assembly in May 2024. This means Member States will be under pressure to conclude the negotiations within three months (March-May). There is already speculation that during the 9th INB, where text-based negations are expected to begin, both the Bureau and the Secretariat would likely actively discourage Member States from proposing textual suggestions to the negotiating text. This unrealistic timeline and approach would be used for the reinforcement and the legitimisation of inequity through IHR amendments and a new pandemic instrument.
Gopakumar is a legal advisor to Third World Network, an organization that works with developing countries. He can be reached at kumargopakm@gmail.com