By May 2024, the 194 countries of the World Health Organization (“WHO”) aim to finalize negotiations on a new international treaty on pandemic prevention, preparedness and response (“Pandemic Accord”). At the center of the negotiations is the contentious issue of Pathogen Access and Benefit-Sharing (“P-ABS”). In this blog we explain how this will directly affect many companies developing medical countermeasures against infectious diseases. Of note, this is not only relevant to vaccines manufacturers, but equally for those entities working on (e.g., repurposed) therapeutics or medicines, diagnostics, and personal protective equipment.
As we approach the Sixth official round of negotiations on July 17-21, 2023, we have summarized the key issues underlying the P-ABS negotiations and highlighted what companies should look out for.
What is Pathogen Access and Benefit-Sharing (P-ABS) in Global Public Health?
“Access” refers to the rapid, systematic and timely sharing of biological materials with epidemic and pandemic potential, as well as related information. This kind of sharing is critical during an outbreak of an emerging disease: development of a diagnostic test, a vaccine, or a therapeutic, typically requires access to information and/or physical samples on the pathogen that it targets.
As we reported in January 2023, pathogen-sharing currently occurs through dozens of formal and informal networks, where timely access is not always guaranteed for everyone. Therefore, the Pandemic Accord aims to facilitate access through “laborator[ies] recognized or designated as part of an established WHO coordinated laboratory network.” The system is expected to apply to “all pathogens with pandemic potential, including their genomic sequences.” That means it will comprise both physical materials – e.g., a vial containing an isolated SARS-CoV-2 Omicron strain, as well as digital information – e.g., the sequence of an Omicron variant of SARS-CoV-2.
Turning now to “Benefit-Sharing”, this term refers to the timely, effective, global, predictable and equitable availability of pandemic related products – i.e., vaccines, therapeutics and diagnostics, as well as “monetary and non-monetary benefits” – e.g., profits from sales or know-how related to pandemic related products. During COVID-19, inequitable access to masks, reagents, and (updated) vaccines was a major flashpoint. For instance, South Africa criticized that it had no access to updated vaccines against the Omicron variant, even though South Africa’s researchers were among the first to identify and publish information on the new variant of SARS-CoV-2. The WHO negotiations seek to make amends for the “… catastrophic failure of the international community in showing solidarity and equity in response to the coronavirus disease (COVID-19) pandemic…”.
But how and why, is access to pathogens for R&D, linked to equitable access to countermeasures to save lives (benefit-sharing)?
Why the Link between Accessing Pathogens for R&D, and Sharing of Medical Countermeasures against those Pathogens?
The political linkage between Access to pathogens, and Sharing of pandemic-related products, goes back to 2005-2007. During the H5N1 avian influenza outbreak, Indonesia had shared pandemic influenza samples through the WHO’s global influenza laboratory network. However, Indonesia faced major difficulties in securing access to vaccines developed from “its” H5N1 influenza samples, due to Advanced Purchase Agreements negotiated by other countries. In response, Indonesia stopped sharing influenza samples.
From a legal perspective, Indonesia considered that it exercised its “sovereign right” to restrict access to its “genetic resources” under the Convention on Biological Diversity (“CBD”) (and later, its Nagoya Protocol). To continue sharing, Indonesia demanded that it will have fair access to “benefits” (e.g., vaccines) arising from R&D on the influenza samples materials it shared. This global incident led to the creation of the 2011 Pandemic Influenza Preparedness Framework (“PIP Framework”) and the notion that countries exercise sovereignty over “their” pathogens. Unfortunately, Covington’s research into the impact of exercising “viral sovereignty” has shown that delays or refusals for timely pathogen-sharing have led to: (i) sub-optimal vaccine composition, including lack of regional representativeness; (ii) diagnostics that were not tailored or tested against original or new variants of pathogens; and (iii) skewed and non-representative epidemiology in genomic surveillance.
Mirroring the aftermath of the avian influenza outbreak, the COVID-19 pandemic has also led to the reassessment of the global rules on pathogen sharing. The Pandemic Accord is quite simply history repeating itself, but applying the PIP Framework model much more broadly to “biological materials with epidemic and pandemic potential”. This is why many vaccine, therapeutic, and diagnostic companies, which were blissfully unaware of the PIP Framework, may be in scope of the Pandemic Accord. Here is how.
How will P-ABS under the Pandemic Accord affect Vaccine, Therapeutic and Diagnostic Companies?
To understand how P-ABS will impact companies, the comparison with the PIP Framework is helpful.
Advance Agreements between WHO and Companies, or Not?
The PIP Framework applies to “PIP Biological Material”, which means “H5N1 and other influenza viruses with human pandemic potential.” When a private company wishes to receive these materials from the WHO’s laboratory network, it must first conclude a Standard Material Transfer Agreement (“SMTA”) with the Secretariat of the WHO. This SMTA will enable the transfer of the physical influenza samples to the company. In return, the company must agree to provide to WHO specific items to respond to pandemic influenza. For instance, in the case of vaccine manufacturers, a company can opt to, e.g., “donate at least 10% of real time pandemic vaccine production to WHO”, or to “grant to manufacturers in developing countries licenses on mutually agreed terms that should be fair and reasonable including in respect of affordable royalties.”
This regime created by the PIP Framework is highly controversial. Amongst the many critiques, from a legal perspective, the negotiation between the WHO – a highly politicized international organization that relies on privileges and immunities under international law – and a private commercial entity, is burdensome and can take years to complete. Moreover, the private sector also pays millions USD in financial contributions to the PIP Framework, raising questions over accounting and transparency of how the monies are spent.
Whether companies will be expected to sign an SMTA under the Pandemic Accord, depends on where the negotiations land on “linking” access to benefit-sharing. If access to “biological materials with epidemic and pandemic potential, as well as related information” is considered to be “open”, then in principle there is no need for an advance SMTA. Countries could give their advance consent for any transfer and use of biological materials falling under the Pandemic Accord. To assure Benefit-Sharing, in return for the access, companies could register through a central platform at WHO that they are developing countermeasures. This would avoid burdensome negotiations as in the PIP Framework, while still enabling transparency for the WHO on which entities are developing what.
However, the prevailing mood in early July 2023, according to the journalists at Geneva Health Files, still seems to favor the PIP model whereby the “the recipient” of biological materials (in physical or digital form) will need to conclude an advance agreement.
Which Companies will be caught by the obligation to sign Advance Agreements?
Who then, are these “recipients” obliged to sign advance agreements? There lies the catch, since it will not be just those entities that physically have received “biological material with epidemic and pandemic potential.” The negotiations started 18 months ago, and there are multiple, competing drafts of the Pandemic Accord. But the wide definition of entities that would be within the scope of the P-ABS, and that would be expected to share benefits, has tellingly survived so far. P-ABS would apply to those entities “utilizing” biological materials within scope of the Accord, which is defined as follows:
… the production of pandemic vaccines or other pandemic-related products, irrespective of the technology, information or material used, implies the utilization of pathogens with pandemic potential, their genomic sequence, components and related information.
The reason for this fine example of legal drafting goes back to 2016. Under the PIP Framework, there have been concerns that modern vaccine platforms that only require a genetic sequence of the target pathogen could “evade” benefit-sharing with the WHO because they do not necessarily require receiving physical viral samples from a WHO lab. Without a transfer of physical viral samples, there would be nothing obliging the company to sign an advance material transfer agreement with a deal on benefit-sharing. Hence the definition creates a presumption that if a company produces vaccines, therapeutics or diagnostic, it must have somehow – however remotely – accessed pathogens. Because of this history, we consider that the definition is pretty much set in stone and will likely remain in the final version of the P-ABS.
What kind of benefit-sharing is being considered?
On benefit-sharing, two models have currently emerged:
- The first approach (i.e., modeled on the PIP Framework) would oblige the “manufacturers of pandemic-related products” to commit, e.g., “real-time access by WHO to a minimum of 20% of the production of safe, efficacious and effective pandemic-related products, in order to support their equitable distribution through the WHO allocation mechanism, in particular to developing countries.” Half of these pandemic-related products would be provided as a donation, and other half at “affordable prices to WHO.”
- The second approach would see benefit-sharing integrated into the purchase agreements between governments and manufacturers of pandemic-related products. The draft text of the Pandemic Accord envisages that the government-funded purchase agreements would envisage, e.g., “donation of products outside its territories,” “delivery swaps or other modifications to address supply gaps around the world,” or “incentivize the increased production capability… for example through subcontracting, licensing or technology transfer.”
The first approach would require advance agreements between the company and the WHO, as explained above. It also does not necessarily require the adoption of specific legislation by the countries signing up to the Pandemic Accord, and companies could therefore be confronted quite quickly with new obligations. The second approach would not require advance contract negotiations with the WHO, and instead would depend largely on the national laws and approaches of WHO governments.
The Future of P-ABS: Four Key Take-Aways
Moving forward, companies should keep in mind the following four key takeaways on Pathogen Access and Benefit-Sharing under the Pandemic Accord:
- May 2024 is the date to keep in mind. At that time, the next World Health Assembly in Geneva will make key decisions on the Pandemic Accord. There’s significant political pressure and momentum for a text by that date.
- There will not be a Pandemic Accord without a deal on ABS. In some form, P-ABS is here to stay.
- The scope of application of P-ABS will be as broad as possible. Any entity working on infectious diseases, and not just vaccine manufacturers, should be on alert.
- Access and Benefit-Sharing originated in the Biodiversity Convention and its later 2014 Nagoya Protocol that already apply to pathogens. The P-ABS may be a “lex specialis” to the general ABS regime. In any case, regulatory authorities are increasingly enforcing compliance by life sciences companies with ABS – e.g. in the UK (2022), Germany (2018 and 2022) and Switzerland (2023).