London/Austin, 22 Apr (Sangeeta Shashikant and Edward Hammond) – The World Health Organization (WHO), in an announcement in March, linked rapid sharing of SARS-CoV-2 virus materials and sequence information to fair and equitable benefit sharing. But how this linkage will be operationalized remains obscure.WHO’s blueprint for COVID-19 research and development titled “Coordinated Global Research Roadmap: 2019 Novel Coronavirus” published in March 2020 has identified access and benefit sharing as one of the immediate next steps to contribute to control the pandemic outbreak.
WHO said that an agreed action is: broadly and rapidly share virus materials, clinical samples and data for immediate public health purposes – It was agreed that virus materials, clinical samples and associated data should be rapidly shared for immediate public health purposes and that fair and equitable access to any medical products or innovations that are developed using the materials must be part of such sharing”.
Developing countries have responded positively to WHO’s call for broad and rapid sharing; and as of 21 April have generated and uploaded 855 complete SARS-CoV-2 sequences into the major international database used by researchers.
These sequences are critical to ongoing public and private efforts to develop COVID vaccines and therapeutic treatments.
Yet there is little progress in defining exactly how the blueprint’s parallel call, for fair and equitable access to medical products and innovations, will be realized.
The R&D Blueprint is the outcome of a discussion held on 11-12 February 2020 by WHO in collaboration with the Global Research Collaboration for Infectious Disease Preparedness and Response (GLOPID-R) which organized a Global Forum on research and innovation for COVID-19.
A fundamental guiding principle of the Blueprint is “Committing to fair and equitable access” and in that context an unambiguous commitment to global solidarity and equitable access to advances made”; “global effort to enable the scaling-up of any successful intervention”, and “coordinated effort to facilitate effective, fair and equitable access-based on public health needs”.
It also recognizes that “Access to the benefits of research is critical” and that the “scale up manufacturing of products (speed, access, cost)” is an important component of a successful implementation of the Roadmap.
It further calls on research funding grants to “include clauses that promote timely sharing of research data relevant to the outbreak response”.
The origins of access and benefit sharing may be traced back to the Convention on Biological Diversity (CBD), which came into force on 29 December 1993.
A key objective of the CBD is the “fair and equitable sharing of the benefits arising out of the utilization of genetic resources”.
Sharing of pathogen samples and digital sequence information is crucial for the rapid development of diagnostics, therapeutics and vaccines.
Notably, in January 2020, China rapidly shared with the Global Initiative of Sharing All Influenza Data (GISAID), sequences of viruses from early cases of COVID-19, kick-starting global R&D efforts.
Since then, sharing of COVID-19-related samples and digital sequence information has continued rapidly especially from developing countries.
SARS-CoV-2 is also mutating as it passes from person to person, just like other viruses. The potential significance of these mutations for drug and vaccine development remains unclear.
There are also a number of reports, as yet unconfirmed, of re-infection of COVID-19 victims, indicating that it is possible that infection with SARS-CoV-2 may not create full immunity.
The situation thus strongly suggests that there will be an ongoing need for global epidemiological genomic surveillance of the virus.
This means continuing sharing of SARS-CoV-2 samples and sequence data to allow tracking of mutations to determine if a particular vaccine or drug will remain effective or if, as in the case of influenza, there will be a need for treatments to change in line with the virus (mutations).
It is this “unhindered” sharing that is enabling rapid research and development of diagnostics, medicines and vaccines across the world.
However, a narrow focus on sharing of SARS-CoV-2 samples and data without addressing mechanisms for sharing of the research outcomes, technologies and medical products that have resulted from the use of samples and data, risks creating a situation of winners and losers.
( Sangeeta Shashikant is a lawyer and the coordinator of Third World Network’s Programme on Intellectual Property. Edward Hammond is a policy researcher on issues related to biodiversity, agricultural genetic resources, infectious diseases, laboratory biosafety, and intellectual property.)
