Live Blogging #GeneEditSummit Day 2 Post #1: Governance of human gene editing

Barbara J. Evans
Barbara J. Evans

Now we have an interesting panel starting on questions of governance on human gene editing. This will focus on institutional and national levels of governance. Pilar N. Ossorio, University of Wisconsin, Madison, and Morgridge Institute for Research, is introducing the panel. Key question: how should emerging technologies being governed?

Jonathan Kimmelman, from McGill, was the first speaker. How do we evaluate risk versus benefit with human genetic modification? Particularly how to answer this question in the context of clinical trials? Benefit should be defined as benefits to subjects and society. Benefit is based on predicted promise/efficacy. How do we do that with gene editing? There are threats to validity in preclinical studies. “The main issue is safety rather than efficacy as we can be confident on efficacy.” (Comment from Paul: I disagree. Both are key). “We want to steward research in a way such that it is sustainable.”

Barbara Evans, University of Houston Law Center, spoke next. She said she appreciates the FDA research regulations on gene editing. Gene editing could be defined as drug or device. What difference would that definition work practically? Regulating it as a device would likely make things smoother for gene editing. There’s great uncertainty about risks from human gene editing. What are the chances of a weird effect? What are the chances of getting a 9-foot tall daughter from a designer baby attempt? The cost of clothes would be extreme (she gets laughs from audience). She seems to be arguing for a balanced, middle ground in terms of possible moratorium on human gene editing. “How do we define a gene editing catastrophe?” She feels there is higher risk from plant gene editing than from human gene editing. “Research subjects are smarter than corn. We could reason w/gene edited research subjects, but not w/corn.” Finally, she seems to be arguing against the assumption that international harmonization is a good thing.

Zhihong Xu, Peking University, spoke next on the governance in China. He discussed regs on stem cells as an example to compare to gene editing. “We would like to work with international community…as so far we do not have specific regulations on human gene editing”. But it seems germline modification is technically not allowed in China. I’m not sure, however, in practice how strong that would be as a deterrent.

Jennifer Merchant, Université Paris II, spoke on human consultation. “Bringing the people back in” was the title of her talk. She discusses past examples of public engagement in policy in France. She also mentioned the case of public consultation related to 3-person IVF/mitochondrial transfer in the UK. A wide range of citizen views. Criticisms of UK public engagement on 3-person IVF suggested that the period was too short and that the final policy did not link well to public comments.