How ownership rights over microorganisms affect infectious disease control and innovation: A root-cause analysis of barriers to data sharing as experienced by key stakeholders

Abstract

BackgroundGenetic information of pathogens is an essential input for infectious disease control, public health and for research. Efficiency in preventing and responding to global outbreaks relies on timely access to such information. Still, ownership barriers stand in the way of timely sharing of genetic data from pathogens, frustrating efficient public health responses and ultimately the potential use of such resources in innovations. Under a One Health approach, stakeholders, their interests and ownership issues are manifold and need to be investigated. We interviewed key actors from governmental and non-governmental bodies to identify overlapping and conflicting interests, and the overall challenges for sharing pathogen data, to provide essential inputs to the further development of political and practical strategies for improved data sharing practices.Methods & findingsTo identify and prioritize barriers, 52 Key Opinion Leaders were interviewed. A root-cause analysis was performed to identify causal relations between barriers. Finally, barriers were mapped to the innovation cycle reflecting how they affect the range of surveillance, innovation, and sharing activities. Four main barrier categories were found: compliance to regulations, negative consequences, self-interest, and insufficient incentives for compliance. When grouped in sectors (research institutes, public health organizations, supra-national organizations and industry) stakeholders appear to have similar interests, more than when grouped in domains (human, veterinary and food). Considering the innovation process, most of barriers could be mapped to the initial stages of the innovation cycle as sampling and sequencing phases. These are stages of primary importance to outbreak control and public health response. A minority of barriers applied to later stages in the innovation cycle, which are of more importance to product development.ConclusionOverall, barriers are complex and entangled, due to the diversity of causal factors and their crosscutting features. Therefore, barriers must be addressed in a comprehensive and integrated manner. Stakeholders have different interests highlighting the diversity in motivations for sharing pathogen data: prioritization of public health, basic research, economic welfare and/or innovative capacity. Broad inter-sectorial discussions should start with the alignment of these interests within sectors. The improved sharing of pathogen data, especially in upstream phases of the innovation process, will generate substantial public health benefits through increased availability of data to inform surveillance systems, as well as to allow the (re-)use of data for the development of medical countermeasures to control infectious diseases.

Perceived utility and feasibility of pathogen genomics for public health practice: a survey among public health professionals working in the field of infectious diseases, Belgium, 2019

“…Finally, 27% of participants considered the priority to publication as a major bottleneck for sharing pathogen sequence data. Publication priority is linked to the importance of guaranteeing reputational returns to research efforts [40,62]. The challenge here is to find a balanced arrangement that allows data sharing in real time and the acknowledgement of research work by giving to researchers who have been involved in data generation the possibility to use and publish their own results in priority.…”

“…The set of questions was compiled based on the literature, including several review articles [1-3, 5, 7, 24-26, 44, 45]. Existing items from previous survey questionnaires [27,[36][37][38][39][40][41][42]46]) were used and adapted when relevant. Most of the existing questionnaires from which some questions were adapted to be used for this survey were not validated, except for Chow-White et al 2017 as mentioned in the respective publication [37].…”

“…Previous surveys in the field of public health genomics focused on: human genomics [36][37][38]; specific aspects such as proficiency testing [39], the design of WGS clinical reports [39] or data sharing [40]; or specific target groups such as National Microbiology Focal Points [41] or food safety laboratories [42]. In this study, by organizing an online survey, we aimed to perform a wide landscape analysis of all potentially involved stakeholders in order to appraise the level of genomic literacy and to gather the opinions of public health experts and allied professionals working in the field of infectious diseases in Belgium concerning the implementation of NGS in routine public health activities, in terms of its utility, feasibility, implementation, and translation into actionable results for public health decision making.…”

Probiotics: a new or an old concept?

“…В мае 2018 года в журнале PLoS One опубликована статья под названием «Как права собственности на микроорганизмы влияют на борьбу с инфекционными заболеваниями и инновации: коренной анализ барьеров на пути обмена данными, которые испытывают ключевые заинтересованные стороны» [27]. Многочисленные (юридические) неопределенности, которые существуют в контексте обмена данными в области микробных генетических ресурсов (MGR), препятствуют и задерживают совместное использование данных, являющихся важными факторами для систем эпиднадзора и, следовательно, общественного здравоохранения.…”

Classification and Specific Primer Design for Accurate Detection of SARS-CoV-2 Using Deep Learning

“…Given the impact of the world-wide outbreak, international efforts have been made to simplify the access to viral genomic data and metadata through international repositories, such as the National Genomics Data Center (NGDC) repository 11 , the National Center for Biotechnology Information (NCBI) repository 27 and the Global Initiative on Sharing All Influenza Data (GISAID) repository 28 , expecting that the easiness to acquire information would make it possible to develop medical countermeasures to control the disease worldwide, as it happened in similar cases earlier [29][30][31] . Thus, taking advantage of the available information of international resources without any political and/or economic borders, we propose an innovative system based on viral gene sequencing.…”