TWN Info Service on Health Issues (Mar24/09)
20 March 2024
Third World Network

WHO: INB Revised Negotiating Text Serves Bio-surveillance Agenda of developed countries

20 March, Geneva (K M Gopakumar and Nithin Ramakrishnan) – Surveillance-related proposals in the Revised Draft Negotiating Text of the pandemic instrument serves the bio-surveillance agenda of the developed countries.

The three proposals are:

·         Article 4 on pandemic prevention and surveillance,

·         Article 5 on One Health Approach

·         Article 6 on the elements of preparedness, health system resilience and recovery

According to the International Health Regulations (IHR), surveillance means “the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary”.

The proposed obligations on surveillance are coupled with sharing of information generated through the surveillance with not only WHO but a range of other organisations. There are no corresponding obligations to share the benefits emanating from the processing of data except for the data related to pathogens.

Surveillance obligations under Articles 4 and 5 

Article 4 is titled “Pandemic prevention and surveillance”.

Paragraph 4.3(a) obligates Parties to undertake “coordinated multi sectoral surveillance” in eight areas.

According to paragraph 3(a) “coordinated multisectoral surveillance” means “(i) detect and conduct risk assessments of emerging or re-emerging pathogens, including pathogens in animal populations that may present significant risks of zoonotic spill-over, in accordance with the International Health Regulations (2005); and (ii) share the outputs of relevant surveillance and risk assessments within their territories with WHO and other relevant agencies”.

Though the surveillance is to be in accordance with IHR 2005 however, there is a major difference with regard to the scope of surveillance under IHR and the proposed Article 4.

First, the purpose of surveillance under IHR is to capture public health events and to make an assessment on whether the event has the potential to cause a public health emergency of international concern (PHEIC). Article 4.3 (a) obligates Parties to undertake pathogen-based surveillance, i.e. organisms including microbes and viruses should be kept under regular surveillance. Countries should track their emergence and re-emergence not only in human infections, but out there in natural hosts or environmental settings. In IHR 2005 the obligation is only event based, i.e. a manifestation of a disease or any other occurrence that creates potential for a disease.

Second, in IHR 2005, only when the national authorities are satisfied that an event might cause a public health emergency of international concern, by applying a decision instrument given under Annex II of IHR 2005, do they need to notify or inform WHO. There is no such risk assessment or decision instrument proposed under Article 4 of the revised draft. 

Third, the scope of surveillance is expanded to cover pathogens in animal populations that may present significant risks of zoonotic spill-over. This requires further investment in animal health surveillance and require law and policy intervention to facilitate such surveillance in most of the developing country settings.

Further, paragraph 3(e) requires Parties to identify settings and activities that present a risk of emergence and re-emergence of pathogens with pandemic potential at the human-animal-plant-environment interface. Article 4.3(e) states:

“… zoonotic spill-over and spill-back prevention: (i) identify settings and activities that create or increase the risk of disease emergence and re-emergence at the human–animal–plant–environment interface; (ii) take measures to reduce risks of zoonotic spill-over and spill-back associated with these settings and activities, including measures aimed at safe and responsible management of wildlife, farm and companion animals, in line with relevant international standards and guidelines”.

Although the proposal in paragraph 3(e) does not specify measures to prevent zoonotic spill over, there are many other valid sources such as the draft global action plan on biodiversity and health, which the quadripartite organisations ( FAO, WHO, WOAH and UNEP) can use to indicate that there could targeted surveillance of particular communities like hunters, farmers who have their farms closer to wildlife, their crops and produce. This may result in disproportionate interference in the livelihood of people, especially in resource-poor settings. There are no measures indicated to address the implications on people’s livelihoods. 

Additionally, community-based surveillance and vector-borne surveillance have also been pushed in under paragraph 3(b) of Article 4. Paragraph 3(g) proposes vector-borne diseases surveillance, which reads:

“… vector-borne disease surveillance and prevention: develop, strengthen and maintain capacity to conduct risk assessments of vector-borne diseases that may lead to pandemic situations”.

Another surveillance obligation is found in Article 4.3(h) on antimicrobial resistance (AMR), which asks Parties to take measures to address the pandemic-related spread of pathogens that are resistant to anti-microbial agents, including through the development of national antimicrobial resistance action plans, taking into account relevant international guidelines. AMR surveillance is one of the most important elements of these action plans.

Para 3(c) obligates States to strengthen efforts to ensure access to safe water, sanitation and hygiene, including in hard-to-reach settings, but when read with the chapeau, the provision also pushes surveillance relating to water, sanitation and hygiene.

Similarly, Article 5 on One Health Approach expands the scope of pandemic prevention and surveillance from human disease events to bio-sphere surveillance. Article 5.3 states:

“The Parties shall contribute to the further development and updating of international standards and guidelines to detect, reduce risks of, monitor and manage zoonotic spill-over and spill-back, in collaboration with WHO and relevant intergovernmental organizations”. Thus, the obligation is to lock in parties to cooperate in further development of various regional and international guidelines on one health by different organisations. The main aspects of the One Health agenda are bio-surveillance.  

The One Health High Level Expert Panel explains: “Prevention of pathogen spillover from animals to humans; shifting the infectious disease control paradigm from reactive to proactive (Primary prevention). Prevention includes addressing the drivers of disease emergence, namely ecological, meteorological and anthropogenic factors and activities that increase spillover risk, in order to reduce the risk of human infection. It is informed by, amongst other actions, biosurveillance in natural hosts, people and the environment, understanding pathogen infection dynamics and implementing intervention activities”.

Further, the joint action plan on One Health Action (track 2) is heavily focused on surveillance.

Information sharing

The multisectoral surveillance obligations are accompanied with information sharing about all outputs of surveillance and risk assessment. This information has to be shared not only with WHO, but also with other relevant agencies. Article 4.3(a) states: “Share the outputs of relevant surveillance and risk assessments within their territories with WHO and other relevant agencies”.

The term “relevant agencies” is very broad and need not be an intergovernmental entity. It could be even a fully private entity or agency. There is no qualification on the purposes of the use of data by these entities.

Moreover, there is no provision in the pandemic instrument which discusses when and how WHO will handle this information. In IHR 2005, there are limitations on WHO in sharing the information with other States Parties and other entities. There is no such limitation on WHO or other relevant agencies in the pandemic instrument.

Paragraph 2 of Article 4 obligates Parties to cooperate with global and regional initiatives that improve surveillance, early warning and risk assessment etc. Here again, these initiatives are not intergovernmental. There is about a five-paged Annex in the One Health Joint Plan of Action which lists out quadripartite initiatives, most of them not negotiated by the States. Thus several organisations, both governmental and non-governmental, can then demand cooperation from States, in particular from developing countries, as they quite often seek assistance from WHO or other entities.

The initiatives can also include the Hub for Pandemic and Epidemic Intelligence in Berlin, which received an initial investment of US$100 million from the Federal Republic of Germany. The hub is staffed not just by the WHO officials meaning by sharing data with the WHO Hub such shared data and information can be directed to various entities without adequate safeguards and respect for data sovereignty of the States concerned.

It must be noted that in 2022, the WHO Hub brought on board a government secondment from the Republic of Korea; it has co-location with Robert Koch Institute experts, and other secondment and pro bono arrangements for diverse collaborations. Thus, it is clear that by sharing data with WHO, there are several institutions that will receive this data and some might even work against the developing country's interests.

Apart from the Berlin Hub WHO also received an annual budget funding of 600,000 Swiss franc (US$626,000) for the first phase of the WHO Bio Hub situated in Switzerland. This hub could also be part of the initiatives mentioned above. Further, the broad surveillance mandate provides an opportunity to countries to go ahead with the virus hunting projects such as STRIDES.

Article 6 paragraph 4 obligates Parties to develop international data standards and interoperability to facilitate hassle free sharing of public health data. It reads:

“… the Parties shall identify and promote relevant international data standards and interoperability that enable timely sharing of public health data for preventing, detecting and responding to public health events”.

The proposal is that Parties shall apply some data standards to ensure interoperability so that rapid or real-time sharing of information can take place. It must be noted that the United Nations World Data Forum in their data interoperability guide clearly states that“it is important to keep in mind when thinking about interoperability is that maximum levels of interoperability are not always desirable and can in fact be harmful or even unlawful”.

The proposal on data interoperability enhances the speed of sharing of data between computers, but then it does not have any other corresponding provision in ensuring the safe use of this data.

It must be noted that the scope of information sharing obligations under Article 12’s Pathogen Access and Benefit Sharing mechanism related to pathogens of pandemic potential is not qualified with any risk assessments by Parties. As a result, there might be interpretation to share all pathogens detected during the surveillance mentioned under Article 4 and 5 irrespective of whether such pathogens pose significant risk of pandemic potential or not.

 Implications of unregulated data sharing: Biosecurity and Cyberbiosecurity concerns

Sharing of data, especially pathogen information and samples, poses significant biosecurity risks unless it is circumscribed by the proper monitoring and governance of the use of such shared resources. Even uploading the genetic sequence data (GSD) of pathogens with pandemic potential in the public domain could raise biosecurity concerns.

For instance, the Bulletin of Atomic Scientists argues that “by uploading to the web … the genetic makeup of new viruses, the government could inadvertently offer up the recipes for potential bioweapons to terrorists or other bad actors”.

Last year, Washington Post reported growing concerns among scientists about the dangers of prospecting for unknown viruses and conducting other high-stakes work with pathogens. It reported that “Governments and private researchers continue building high-containment laboratories to work with the most menacing pathogens, despite a lack of safety standards or regulatory authorities in some countries, science and policy experts said. Meanwhile, U.S. agencies continue to funnel millions of dollars annually into overseas research, such as virus hunting, that some scientists say exposes local populations to risks while offering few tangible benefits.”

It is clear that very little, in fact zero considerations have been made by the INB on the governing of the data or information shared by the Parties with WHO. There are no limitations whatsoever on when and with whom WHO can share this data. There are also no limitations placed on the purposes for which the data can be processed.

Even in the case of sharing GSD of pathogens, there has been no concrete proposal which ensures accountability and transparency of databases that will host these data. Scholars  have warned about cyberbiosecurity challenges or attacks of such databases compromising data confidentiality, integrity, and availability. They argue that:

“One unique concern for pathogen genome databases is that the knowledge of pathogen sequences may lead to malicious use. Such ill-intended use of genomic data and technology is a major biosecurity concern. Currently, many genomes of animal and plant pathogens are freely accessible to any user through pathogen genome databases. A study in early 2000s had concluded that open access to pathogen genomes should be promoted (Committee on Genomics Databases for Bioterrorism Threat Agents et al., 2004). However, situations have changed due to the reduced cost of synthetic DNA technology and advancement in synthetic biology (Hughes and Ellington, 2017). Even the genome sequence of such a high-risk pathogen as the smallpox virus, Variola major, can be easily accessed at NCBI by any anonymous user.”

Pressure to divert investments from public health priorities   

All the obligations in providing financial and technological assistance to developing countries are couched in a multi-channel delivery format. These channels, like the World Bank, are not accountable to the Parties to the proposed pandemic instrument and are wedded to donor interests.

Thus, even when developing countries lack primary health care facilities or access to health care products or other public (human) health systems, they might be forced to undertake investments in non-human health such as wildlife or one health surveillance. For instance, the Pandemic Fund administered by the World Bank did not even fund a single application which did not apply a one health approach to its application at the last funding cycle.

A group of academics had already warned the international community that “investments in research and development on topics like machine learning or animal virus genomics must not come at the expense of other essential kinds of modelling work (e.g. work focused on virus transmission and spread, or identifying the most consequential surveillance gaps), or more importantly, at the expense of non-technological investments in health systems strengthening, including attainment of universal health coverage, and similar aspects of pandemic preparedness.”

It is also doubtful whether surveillance and prediction can give accurate information and whether it will be practical to prevent pandemics with all these investments.

Apart from the above mentioned implications, the unregulated sharing of data and lack of restrictions on WHO or other entities who obtain the data through the pandemic instrument also have implications on trade and the economy. The above group of academics warns:

“It seems plausible that these technologies might mostly benefit from the research effort and data sharing occurring in tropical countries, where zoonotic viral diversity is believed to be highest. However, their development might mostly further the careers of researchers in high-income countries in North America and Europe, particularly if developed by experts who are unattuned to power dynamics in global health. Equally concerning, we identify a possibility that these tools will largely be developed as proprietary ‘risk assessment algorithms' by corporate ‘data science for impact’ programmes, for-profit global health firms and non-profit organizations, just as they have been for the development of pandemic insurance programmes or similar analytics. In these circumstances, and without appropriate governance, the countries with the highest burden of zoonotic emergence might find their own data (repackaged in an analytic format) sold back to them at a premium by scientists and corporations from high-income countries”.