Dec. 3, 2015 - University of Houston Law Center Professor Barbara J. Evans spoke at the International Summit on Human Gene Editing on Wednesday in Washington D.C., focusing on national frameworks for regulating gene editing and whether international harmonization is in order.
She acknowledged there is fairly wide support for international harmonization, but added, “Not so fast!” Gene editing presents different issues and risks in different contexts, she said. Editing the human genome—and especially the heritable human germline—is a different proposition than editing microbial or plant genomes. One-size-fits-all regulatory approaches may not be suitable for all applications of this technology. Evans suggested a nuanced approach to regulatory harmonization.
"Harmonization is of course good for business," Evans said. "Transnational corporations love it. But if you are not dealing with catastrophic potential risks that need to be managed globally, there may be merit in allowing diversity in national regulations. Nations have different values, different cultures” and “different goals for their innovation policies.” As they implement different regulatory approaches, “We can learn from each other. So let's not be too quick to harmonize."
She began her presentation by noting that some regulations already on the books, such as FDA’s investigational device exemption regulation, already supply a good set of tools to manage some of the concerns that surround human germline gene editing. Because the technology is evolving so quickly, Evans said it will take skillful lawyering to get the most mileage out of the regulations we already have. This implies that legal policy analysts need to take a very detailed look at each nation’s laws. “Law is just like genetics," Evans said. "We don't talk about disease by talking about genes. We have to talk about specific gene variants. In the same way, regulatory frameworks need to be analyzed provision by provision.”