Personalizing Medicine from Birth: Are Countries Prepared for the Ethical, Legal, and Social Challenges?

Perry   W.   Payne; Shawneequa      Callier; Parker      Cunningham

Abstract

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 societies.

Keywords: Ethics, genome, international, law, newborn, personalized medicine, screening.

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