Genetic Exceptionalism and the Precautionary Principle

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Alan E. Dow, Vice President of Intellectual Property and Legal Affairs, Complete Genomics, Inc.

One important issue that must be addressed in the field of genomics and / or personalized medicine is “genetic exceptionalism.”

Genetic exceptionalism is the concept that genetic information is inherently unique and should be treated differently in law than other forms of personal or medical information.

There are several reasons for such special consideration: genetic information can predict disease occurrence in a person and their blood relatives; it uniquely identifies a person; and it can be used to discriminate and stigmatize individuals. While these issues deserve attention and steps should be taken to protect people, over-regulation could limit our ability to investigate how genetic information predicts disease and improve medical outcomes.

Some people appear to equate genetic information and personal identity. For such people, protecting an individual’s genetic information is tantamount to preserving their “respect… as an individual and as a member of the human species and recognizing the importance of ensuring the dignity of the human being” (Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997). Such a belief can translate into over-regulation.

Opponents of a new technology can fight its introduction by applying the “precautionary principle.” A strong form of the precautionary principle would require that, when “potential adverse affects [of an activity] are not fully understood, the activities should not proceed” (United Nations World Charter for Nature, 1982). The burden then shifts to proponents of the new technology to prove that it will not cause harm. A more nuanced version of the precautionary principle would require “cost-effective measures” in the face of threats of serious or irreversible damage, even where there is a lack of full scientific certainty regarding the threat (e.g., Principle 15 of the Rio Declaration, 1992). What is considered to be “serious damage” or a “cost-effective measure” can appear very different to legislators and those being regulated – as would be appreciated readily, for example, by companies that have sought to introduce genetically-modified crops into Europe since the 1980s.

It would be tragic if genetic exceptionalism led to regulation that denies the public the tremendous benefits of the genomics revolution as a result of misplaced concern for human respect and dignity.