Genome sequencing technology is the basis of personalized genomic medicine and expansion of this
technology will likely lead to widespread personalized medicine. Innovation in the highly competitive biotechnology
industry is leading to a substantial decline in the price of whole genome sequencing, which will increase access to this
technology. Also, the US National Institutes of Health recently invested $25 million in newborn genome sequencing,
which will substantially increase the number of newborns and thereby parents with genome sequence data, albeit in
research studies. These concurrent events are likely to stimulate an era of personalized medicine that begins at birth. This
era has come faster than expected by scientists, policymakers, ethicists, and clinicians. In order for newborn genome
sequencing to proceed in a manner that maximizes its benefits, countries need to consider key ethical, social, and legal
implications of this technology, which are likely to affect its uptake and impact on their societies – namely patent
protection of DNA, reimbursement, genetic discrimination, and equitable distribution of the technology. In this article, the
authors review these challenges and assess whether countries are prepared to address them. With an adequate
understanding of these issues, policymakers worldwide—advised by experts and their citizenry—can develop welldesigned
policies that increase the societal benefits of newborn genome sequencing and limit any potential harm to their
Ethics, genome, international, law, newborn, personalized medicine, screening.
Department of Clinical Research and Leadership/ Department of Health Policy / Department of Integrative Systems Biology, 2100-W Pennsylvania Avenue, NW – Ste. 5054, Washington, DC 20037, USA.