Over the last 10 years, the Nagoya Protocol and the underlying Access and Benefit-sharing (ABS) rules have had a negative impact on public health.  We identified that ABS laws have blocked or delayed access to pathogen samples of the following eight viruses: seasonal influenza, SARS-CoV-2, Zika, mpox, Japanese Encephalitis, Foot and Mouth Disease, Ebola, and African Swine Fever. There are at least 100 distinct ABS laws around the world. 

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; (iii) skewed and non-representative epidemiology in genomic surveillance. 

Many interviewees consider that applying the transactional model of the Nagoya Protocol to the Biodiversity Convention to pathogens is not logical, and that it has led to an increased “politicization” of pathogen sharing. As the Nagoya Protocol attaches value to the pathogens, but not to global health, countries are perversely incentivized to control pathogens to extract value, to the detriment of free and rapid pathogen-sharing for global public health.

Decoupling “access” from “benefit-sharing” could be a potential solution to ensure rapid and free sharing of pathogen samples and sequence data, while addressing equity concerns. However, this “decoupling” access from benefit-sharing will be hard to achieve without a comprehensive agreement involving all stakeholders on equity in global public health.

During the COVID-19 pandemic, non-surveillance platforms played an important role in the global sharing of pathogen genetic sequence data (GSD). We explored several platforms that were identified by stakeholders as being the leaders in that field. For all chosen data bases, we explore their governance, data access conditions and, where relevant, the obligation of users to acknowledge the original contributor of the data.

There is also a growing number of countries that have included GSD in the scope of their national ABS laws. Our interviewees have raised the concern that this practice takes scientific innovation and research as hostage in the bigger discussion for equitable benefit sharing. The EU has made a proposal for open, unhindered access to pathogen genomic data held by trusted databases - this could inform the Pandemic Accord.

Ensuring the unrestricted global flow of genetic sequence data is critical to global genomic surveillance as well as the development and evaluation of medical countermeasures.

The landscape of global, regional and national surveillance systems is extraordinarily fragmented. We looked at the largest four networks for influenza, polio, emerging and dangerous pathogens and anti-microbial resistance. There are two important lessons.

First, chronic underfunding and/or intermittent grant-based funding has highly detrimental effects on the ability of the network to carry out year-round, efficacious surveillance.

Second, 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.

Networks of biobanks are essential as they are uniquely prepared to respond to the early stages of an outbreak.  The networked approach means that material is held by the repositories of the individual members, with an online portal serving as a single point of access to all materials.  Examples of such networks that we explore in our Report include the European Virus Archive Global (EVA-G) and the American Type Culture Collection (ATCC). 

However, there are a number of legal difficulties due to unhelpful contract terms.  The International Health Regulations (IHR) require "legal preparedness" for an unknown pathogen that could cause a future outbreak. This includes agreeing now, between all parties, that samples can be used for the development of medical countermeasures.