These are the additional comments to the WHO Public Hearing on a possible WHO treaty or other instrument on pandemic preparedness and response (KEI also provided oral testimony at the hearing, and filed earlier comments here).
Luis Gil Abinader – Exceptions to Economic Sanctions
During the COVID-19 pandemic, several countries have been enforcing economic sanctions on other countries for a variety of reasons. These sanctions made it difficult for sanctioned countries to develop, manufacture and sell vaccines to other countries, and also to acquire COVID-19 countermeasures, because of both the real and the perceived effects of the economic sanctions imposed by other nations.
The Treaty should require that its members implement clear, workable exceptions to such sanctions, including plain language regarding permitted activities, web pages describing best practices, white-listed suppliers, and comfort letters to entities interacting with sanctioned countries.
Kathryn Ardizzone – Norms for Terms in Funding Contracts
COVID-19 has shown that the terms of contracts to fund the development of new countermeasures to address an emerging pandemic (“funding agreements”) largely determine what state actors can and cannot do to rapidly expand access. The pandemic has further confirmed countries’ tendencies toward nationalism, their willingness to expend unprecedented sums of money toward the development and procurement of countermeasures, and the impropriety of monopolies under these circumstances.
A treaty on pandemic preparedness and response should recognize this reality, and should commit governments to implement terms in future funding agreements that would guarantee the ability to perform a technology transfer of all of the inputs needed to enable generic manufacture of any useful countermeasures (a “deep technology transfer”). Such a deep technology transfer would authorize governments to issue third-party licenses to background and foreground patents, data, knowhow, cell lines, copyrights, regulatory filings and authorizations, and any other input needed to facilitate generic production. Such terms should be implemented at the outset of any pandemic, when governments award massive subsidies and bear the risk of failure, because it is not yet apparent which technology will be useful. There should be no qualifications for governments performing this deep technology transfer.
The treaty should further commit governments to full transparency of the funding agreements, by obligating them to post the agreements on a publicly accessible website with no or minimal redactions, and to share the contracts with a WHO hosted public repository.
James Packard Love – Independent Clinical Trials
In the current pandemic, much of the funding for the initial clinical trials came from governments, but the terms of the funding came with inadequate or no conditions on pricing, equitable access or technology transfer to scale manufacturing.
There have also been controversies over the trial designs.
Some vaccine hesitancy is related to the lack of trust in vaccine manufacturers as the source of data on safety and efficacy.
Many of the government-funded trials were controlled by the developers, and few featured useful head-to-head comparisons of safety and efficacy.
Public sector funding for trials of new vaccines declined after some vaccines received initial emergency use authorization (EUA), despite the public interest in evaluating new vaccines.
Clinical trials are expensive and important. Governments should collaborate to fund and set norms for transparent and independent clinical trials of vaccines and other countermeasures. Preferences should be given to funding trials that provide head-to-head comparisons of countermeasures, and include products that:
1. have strong technology transfer obligations,
2. provide concrete and credible plans to enable decentralized manufacturing including in developing countries,
3. can be manufactured and sold for lower prices, and
4. can be administered and are effective in resource-poor settings.