How the World's Governments Have Regulated Human Genome Editing
By Bio-IT World Staff
January 25, 2016 | Three members of McGill University’s Centre of Genomics and Policy—Rosario Isasi, Erika Kleiderman, and Centre Director Bartha Maria Knoppers—have published a global survey of restrictions on modifying the human genome. The article, which appears in Science and is free to access, comes in the midst of a simmering debate about CRISPR gene editing, a powerful technique for rewriting living genomes, which has already been used at least once in (nonviable) human embryos and inspired calls for a voluntary moratorium on editing human egg, sperm, and embryonic cells.
However, the authors pointedly avoid mention of CRISPR, and while their survey covers speculative technology like gene editing and human cloning, it also looks at established practices like tests for genetic disease in embryos during in vitro fertilization (IVF).
Governments and regulatory bodies have struggled to write useful policies around science that alters, or could alter, the human genome. On the one hand, potential abuses seem dire: from programs that empower the wealthy and privileged to choose the genetic makeup of their children, to mishaps causing damaging mutations that could be passed from generation to generation.
On the other hand, benefits to society from this brand of research are undeniable. Already, IVF is routinely paired with preimplantation genetic testing, which lets mothers avoid giving birth to children with serious diseases. The promise of other fields the authors explore, like gene therapy and embryonic stem cell research, is still more far-reaching.
The result, the authors conclude, has been a series of vague regulations and moving targets. Countries that have reached for blanket bans on the more menacing aspects of human genome modification―like France, which legislates against “crimes against the human species”―may find their laws unenforceable, or else so broad that they scare off useful medical innovations. Yet laws that hedge more carefully, making exceptions for medically accepted procedures or those needed to bring an embryo to term, can find themselves fading into insignificance as the standard of care changes. This can clearly be seen in the spread of genetic testing during IVF.
Sometimes, legal language is even unclear about which kinds of research it aims to regulate. “We believe that scientific understanding and precision in legal definitions of what constitutes a human embryo and/or its germ line are essential to developing coherent policies,” the authors write. While most countries do want some level of oversight in procedures that create living people with edited genomes, ambiguous laws can also end up restricting basic research, which may or may not be legislators’ intent.
What stands out in the article is the sheer variety of systems for regulating human genome modification around the world. Not only are some countries more permissive than others, the mechanisms of regulation and enforcement can also change across borders. Many countries prefer to write regulations into law, but in the United Kingdom and China, for instance, smaller licensing agencies may consider studies on a case-by-case basis, while both the United States and Mexico leave many regulations in the hands of professional groups outside of government.
None of these approaches is necessarily wrong. However, inconsistency in global regulations may have an erosive effect over time―so that a procedure accepted in one country slowly becomes the standard of care, smoothing the way for it to jump across borders. “Eventually,” the authors write, “as we move from research to the clinic, the collective sum of individual decisions could constitute a de facto policy.”
In the case of preimplantation genetic diagnosis, the authors feel this process has been a win for public health, leaving intact a few stringent rules while opening doorways for scientists to tend to the most pressing medical needs. But if society agrees that newer technologies―CRISPR not the least among them―need to be watched more closely, then existing models, with their baked-in tolerance of whatever becomes the standard of care, will likely fall short.