This Position Paper might be of interest to some of you.
The recent application of tools — such as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats; Cas9 nuclease), to edit the human genome with the intention of treating or preventing disease and the gaps in our scientific understanding, in addition to some of the proposed applications of human genome editing — raise ethical issues that highlight the need for robust oversight in this area. The COVID-19 pandemic has clearly demonstrated the importance of using new tools and methods to combat serious diseases and highlighted the potential benefits of human genome editing research; it also reminds us of the need to develop technology carefully, with robust testing and quality assurance measures in place to maximize benefit and minimize harm. The balance between benefit and harm, safety and speed, and innovation and access is relevant to all of human genome editing.
In December 2018, the World Health Organization (WHO) established a global, multidisciplinary expert advisory committee (the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, hereafter called The Committee) to examine the scientific, ethical, social and legal challenges associated with human genome editing (somatic, germline and heritable).
The Committee was tasked to advise and make recommendations on appropriate institutional, national,regional and global governance mechanisms for human genome editing. Its remit did not include a review of matters to do with safety and efficacy. Committee members were drawn from each of the WHO regions — Africa, the Americas, South-East Asia, Europe, Eastern Mediterranean and Western Pacific.
The 18 members of The Committee worked for two years and developed several products and new initiatives. The governance framework on human genome editing, along with the recommendations of The Committee, form a set of two publications that provide advice and recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing. A position paper on human genome editing provides a summary of these two publications.
During its work, The Committee reviewed the current literature on human genome editing research and its applications, considered existing proposals for governance and relevant ongoing initiatives, and gathered information on a range of topics relating to the different uses of this technology. The Committee consulted widely with individuals and representatives of organizations including, but not limited to, United Nations (UN) and other international agencies; academies of science and medicine as well as other national or professional bodies; patient groups and civil society organizations.
The governance framework and the recommendations on human genome editing form a pair of reports that have been developed by the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. This position paper provides a summary of these two publications.