– Two tiers needed to keep all on board and to optimise fight against pandemics threatening the existence of humankind

The World Health Organisation (WHO) is currently developing a “WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. The Regulatory Institute has read the June 2 2023 draft of the Bureau and is pleased to provide suggestions around enhancing effectiveness by using specific regulatory techniques, regulatory techniques being the field of specialisation of the Regulatory Institute. The development of a pandemics convention or instrument is of utmost importance and provides a one-off chance to reduce the risk of human extinction by pathogens.

The June 2 2023 draft of the convention or instrument has the right content to regulate pandemic prevention, preparedness and response. Noting the difficulty of drafting international conventions, where negotiating parties have different levels of ambition, interests and degrees of openness towards internationalisation of policies, understandably there are trade-offs in “keeping all negotiating parties on board”.

In view of these difficulties and trade-offs, we recommend investigating a two tier approach. Once the readiness of all negotiating parties to follow an ambitious line has been tested for its limits, some additional protocols should be drafted to permit the more ambitious parties to go one or two steps further, namely in view of pandemics potentially threatening the existence of humans.

In an earlier, attached letter on this matter, we recommended three types of additional measures that could be cast into such protocols: (RI Letter WHO CA+)

• Contracting parties empowering each other to adopt sanctions in case of non-fulfilment of obligations where there is a pandemic threatening the existence of humankind;
• Contracting parties taking joint measures against other states not participating in measures against a pandemic threatening the existence of humankind;
• A model law transposing the main obligations of the future convention or instrument into the national legal order, facilitating and inspiring strong measures in legislation.

These three measures still seem very important. However, after reviewing the June 2 2023 draft of the convention or instrument, we think that some more elements need to be taken considered:

1. Quality management system approach for the Universal Health Preparedness

Quality systems have the advantage of assessing and improving capabilities in a systematic way. Policies pursued by means of quality systems become more effective. Once a quality management system for the Universal Health Preparedness has been developed, e.g. with the help of ISO or some other international standardisation body, there will be a common, undisputed benchmark for the peer review or any other assessment of contracting parties by themselves or others.

In the absence of a quality management system, at least a clear benchmark for the assessment of preparedness is needed to ensure comparable results and clear guidance to the contracting parties. 

The Implementation and Compliance Committee should be empowered to develop such a benchmark for example: “The Implementation and Compliance Committee shall develop a quality standard like method for increasing the preparedness of Parties and a method for assessing the preparedness of Parties which shall contain an assessment grid.”

2. External auditing as a replacement or in addition to peer review of preparedness

Once a quality management system or another clear benchmark for assessment of preparedness has been developed, external auditing would be extremely helpful to achieve a fair and good comparison of contracting parties. Peer review alone will not lead to the same degree of comparability. Pure peer review of and by states leads to biased results because states avoid blaming each other, either in fear of retaliation or because they wish to maintain a diplomatic relationship. It is simply not in the interest of a state to criticise a peer for the peer’s poor performance.

External auditing can also be blended into the peer review by providing a peer review in presence of an external auditor. The external auditor should always come from the same private or public body (e.g. international auditing companies) or from WHO. Limiting the range of auditors and requesting them to be employed by the same body or institution  ensures methodological consistency and comparability of results. 

3. Addressing research and development risks on pathogens potentially threatening the existence of humankind

Nobody doubts that research is necessary. However, research is also a source of risk. The same applies to industrial product development and certain proper production of products, e.g. of vaccines. The draft text is largely oblivious in this regard. Article 9(5) refers to the application of international standards for biorisk management. However, this provision is insufficient to reach the goal of research, development and production safety because it does not:

• define which standardisation bodies are suitable to develop such standards and which standards are referred to. Thus a group of non-ambitious parties can easily develop “their own international standard”, making the provision void of effectiveness;
• refer to the latest versions of the standards, leaving leeway to apply more lenient, outdated versions;
• seem to include private (industrial) research and development, as it is embedded into provisions that are more or exclusively applicable to state research;
• provide for control, peer review or auditing mechanism, which leaves the fulfilment of the standards to the liberty and discretion of laboratories, which is particularly problematic where the existence of humankind might be at risk.

In view of the above, we suggest the following alternative wording of Article 9(5), unless a separate article or even section is inserted (see below):

“Each Party shall ensure that both public and private research, development, and production facilities implement and apply the latest version of ISO standard 35001 “Biorisk management of laboratories and other related organisations”. They shall [at least for facilities dealing with pathogens potentially threatening the existence of mankind] monitor the application of the standard by an independent, qualified, sufficiently staffed and equipped public or entrusted private [conformity assessment] body. That monitoring body and its supervising authority shall take part in international peer reviews, in presence of officials of WHO. These peer reviews shall include joint auditing of research, development and production facilities. Those peer reviews shall be organised by the WHO. Parties that are not able to effectively control facilities, shall either ban research [with pathogens potentially threatening the existence of mankind] or seek the assistance of a competent other party via WHO.”

We regard the lack of appropriate provisions addressing the risk of research, development and production facilities to be a substantive weakness. Encouraging research, as done in the draft text, without addressing appropriately the risks of research, development and production might at the end of the day, increases the overall risk for humankind. We therefore recommend this important aspect be covered in an entire article, if not an entire section.

If more provisions were to be developed, we recommend consulting our model law on research and technology risks. See also our articles on research and technology risks listed here.