by Jeremy Sugarman MD MPH,MA, Supriya Shivakumar PhD, Martha Rook PhD, Jeanne F. Loring PhD, Christoph Rehmann-Sutter PhD, Jochen Taupitz PhD, Jutta Reinhard-Rupp PhD, Steven Hildemann MD PhD

New genome editing technologies are playing an increased role in an array of advanced research and development efforts in the life sciences. In tandem, there has been broad recognition of the need to address the ethical issues associated with the use of these genome editing tools. Although many uses of genome editing technologies do not raise novel ethical concerns, some have rightly attracted considerable attention, especially regarding the possibility of manipulating the human germline (Baltimore et al. 2015; Lanphier et al. 2015). Such concerns have prompted a substantial body of scholarship and high-profile efforts to address these ethics and policy matters (Bonas 2017; German Ethics Council 2016; La Barbera 2014; National Academies of Sciences, Engineering and Medicine, Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations 2017; National Akademie der Wissenschenschaften Leopoldina 2015; Ormond et al. 2017; Reich et al. 2015). While the outcomes of these deliberations offer useful high-level advice, there has been little discussion of the critical ethical issues involved with the practical processes of manufacture, sale and distribution of genome editing technology products that enable this research. Here, we describe these issues and practices being developed and implemented to address them.

Our discussion builds upon the recent experience of Merck KGaA, Darmstadt Germany, a multinational corporation that operates as MilliporeSigma and EMD Serono in the United States and Canada, which is actively involved in discovering, developing, producing, selling and using genome editing tools and technologies.To develop approaches to anticipate and manage the ethical issues emerging in its work the company consulted with its existing Bioethics Advisory Panel (MBAP) that includes an international panel of external experts in bioethics and senior corporate leaders.

… continue reading ‘Ethical Considerations in the Manufacture, Sale, and Distribution of Genome Editing Technologies’

Image By National Human Genome Research Institute (NHGRI) from Bethesda, MD, USA – CRISPR-Cas9 Editing of the Genome, CC BY 2.0, https://commons.wikimedia.org/w/index.php?curid=52360100

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