New Report Shows that Politicization of Sharing Pathogens Undermines Global Health Security

BRUSSELS—An independent Report found that serious shortcomings of the international framework on accessing and sharing pathogens are putting severe strain on the global health community's ability to control future outbreaks. The widespread collaboration and sharing of information on pathogens and emerging variants during the COVID-19 pandemic, which led to millions of lives being saved thanks to largely unhindered access to pathogens and their sequence information that resulted in a fast development of vaccines, treatments and diagnostics, is not a guarantee under existing and future international rules on access and benefit-sharing (ABS).

The work presented in the Report was carried out independently by Covington upon request, and financed by, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The IFPMA (or any of its members) had no access to the interview data, survey data or desk research; had no role in analyzing, interpreting or writing the report. 

The Report, produced by Covington's Life Sciences team led by partner Bart Van Vooren, compiled with input from a wide sample of experts in global public health, points to an increased “politicization” of access to samples of pathogens, as well as access to sequence information on pathogens. This is due to countries' adoption of national ABS rules under the Nagoya Protocol  and potentially, the future draft Pandemic Accord. The Nagoya Protocol employs a transactional model.  It means that nearly one hundred countries require a permit each time a researcher wishes to access that nation's biodiversity for R&D. In return for the permit, benefit-sharing in the form of a payment on the result from R&D is usually required. This is meant to attach value to and protect biodiversity. While biodiversity needs to be protected, there is a broad consensus among stakeholders interviewed by Covington that the transactional model of the Nagoya Protocol applied to pathogens is not logical, and undermines global health security.

A possible solution would be for "access" to pathogens to be decoupled from "benefits" derived from such access, to ensure rapid and free sharing of pathogen samples and sequence data, while addressing equity concerns separately.

As COVID-19 evolves, and surveillance of other viruses requires continued vigilance, it is increasingly important to understand how the complex rules on pathogen sharing can have a negative impact on the ability of scientists and public health experts to respond. There are several fora where rules on better pandemic preparedness are being discussed, such as Nagoya Protocol, the Conference of the Parties to the UN Convention on Biological Diversity (COP15) and the World Health Organization’s Pandemic Accord.

The Report represents the first time such research has been conducted on a global scale, taking into account in-depth interviews with 82 stakeholders in global public health, including 12 innovative pharmaceutical companies in Europe, the Americas and Asia (44% of respondents), the World Health Organization (17%), over half a dozen public health institutions such as the US Center for Disease Control, US National Institute of Health, US National Institute of Allergy and Infectious Diseases, and their equivalents in the Americas, Europe, Africa, Asia and Oceania (23%), as well as biobanks (7%), academia (1%), NGOs (7%), and other stakeholders (1%).

Findings highlights include:

• Desk research has identified at least 100 distinct ABS laws around the world. This means that every individual researcher or institution must receive duplicate permits each time they wish to access a pathogen, and agree on "benefit-sharing" in order to progress their R&D.
• The Report provides documented examples of how ABS laws have blocked or delayed researchers' access to pathogen samples of the following viruses: seasonal influenza, SARS-CoV-2, Zika, mpox, Japanese Encephalitis, Foot and Mouth Disease, Ebola, and African Swine Fever.
• The Report shows that delays or refusals for 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;
  • (iii) skewed and non-representative epidemiology in genomic surveillance.
• The problem does not only affect physical samples, but also pathogen sequence data. The Report shows that 39 out of 100 ABS laws now include sequence data in the scope of their national ABS laws.
• To understand current pathogen and data-sharing practices, the Report also looked at the four largest global surveillance networks for (1) influenza, (2) polio, (3) emerging and dangerous pathogens and (4) anti-microbial resistance. Two important lessons have been learned:
  • Chronic underfunding and/or intermittent grant-based funding has highly detrimental effects on the ability of the surveillance network to carry out year-round, efficacious surveillance and pathogen-sharing.
  • The key driver for successful surveillance is technical and professional capacity at national and local levels, including in low- and middle-income countries. This can be best achieved by multi-pathogen networks that benefit from economies of scale and integrated year-round activities to support capacity and knowledge retention.

"Coming on the heels of the Covid-19 pandemic and as negotiations commence on the so-called Pandemic Accord led by the World Health Organization, our report demonstrates the need to secure free, rapid and unhindered access for scientists to pathogen samples and sequence data," said Bart Van Vooren, partner in the firm's life sciences practice who led the Covington team. "Currently, pathogens are being held hostage to deals on benefit-sharing through the Nagoya Protocol.  This represents a grave risk for humanity when the next pandemic hits", he added.

Thomas Cueni, Director General of IFPMA, said: “Investments in global health security, especially improved and expanded pathogen and disease surveillance, will not achieve the ultimate goal of protecting people and saving lives, if immediate and unfettered access to pathogens and their genetic information is constrained. The report points to a shared concern that the Nagoya Protocol attaches value to protecting the biodiversity of pathogens in nature, but not to global health. This does not make sense, since no one wants to preserve pathogen biodiversity. Therefore, the countries that exercise sovereignty over pathogens are incentivized against free and rapid sharing for global public health, for financial or political gain. For the sake of global public health, this must be remedied. When researchers are required by law to withhold or delay access to pathogens, this elevates the severity of an outbreak by obstructing research into developing diagnostics, vaccines and treatments.

The findings are split into four Reports covering the following topics:

1. The impact of the Nagoya Protocol on global pathogen-sharing;
2. Global sharing of pathogen genetic sequence data;
3. Pathogen-sharing through selected global disease surveillance networks; and
4. Global sharing of physical pathogen samples through non-surveillance networks and biobanks.