encourage education and research, recognize outstanding contributions to
knowledge, and increase public understanding in matters of science,
engineering, and medicine.”138 The NAM Report was written by a committee
of twenty-two experts (legal academics, bioethicists, biologists, and
bioengineering company leaders).139 It was reviewed by twelve excellent
academics and lawyers to ensure that review comments were considered.140
It is a first class document: it summarizes the science clearly, it outlines the
issues for human germline editing, and it makes specific recommendations.
It is a one-off document by a working group under the NAM/E/S auspices.141
The authors note that other studies are underway by the NAS and the NAM,
including agricultural uses, gene drive issues, animal genome modification,
and future biotechnology products.142
The report starts with a sanguine observation about the lack of need for
regulation of human genome editing: it notes that CRISPR research requires
high quality laboratories and medical facilities and this inevitably ensures
regulatory oversight.143 The report then observes that marketing of therapies
using human genome editing products will need regulatory review and
approvals. Such marketing will require regulatory bodies with the legal
authorship, commitment and political support to block marketing of
unapproved genome editing products.144
The Report takes the position that existing regulatory infrastructure and
processes are sufficient for evaluating gene therapy using genome editing.145
Uses should however be limited to treatment or prevention of disease or
disability.146 And the Report proposes public participation in some form
before CRISPR can be used beyond disease treatment or prevention.147
The use of inheritable germline editing is viewed as problematic at this
point.148 The Report notes the disquiet that surrounds this use that can affect
multiple generations and asks whether “enhancement” uses should be limited
or prohibited.149 Recommendation 6-1 proposes a moratorium on somatic or
germline editing, while Recommendation 6-2 wants public discussion and
138. Id. at iii.
139. See Id. at v.
140. Id. at vi.
141. Id. at 1.
142. Id. at 13–15.
143. Id. at 80.
144. Id. at 81.
145. Id. at 83 (See Recommendation 4-1).
146. Id. (See Recommendation 4-2).
147. Id. (See Recommendation 4-4).