Countries Already Drafting Rulebooks for Ethically Editing Human Embryo DNA

Which country will be first to create a CRISPR baby?

The promise of genetic editing to extend human lifespans and limit the potential for disease is ground-breaking, but also raises huge ethical questions. If everyone can’t afford the latest in human embryo modification, then wouldn’t you get a two-tier society?

Fortunately, forward looking countries are already trying to hammer out some of these thornier issues. Most recently, the health and science ministries of Japan convened an expert panel which released draft guidelines permitting scientists to apply gene editing to human embryos on September 28. Although research on human embryos is already regulated by the Japanese government, bioethicist Tetsuya Ishii explained in the announcement that the proposal officially moves Japan’s public stance on specifically using gene editing on embryos from neutral to supportive.

It’s only a starting point. While the guidelines restrict the use of gene editing to conceive an actual human, for example, that wouldn’t be enforceable. But without clear boundaries, the allure of learning about early human development may overtake respect for the rules.

What is CRISPR?

CRISPR, the revolutionary technology that allows humanity to consider this level of gene manipulation, are essentially a Swiss Army knife for DNA. Simple, precise, and relatively cheap, CRISPR uses the enzyme Cas9, guided by a piece of RNA, to alter DNA by cutting out or attaching new pieces. CRISPR has experienced lots of success, reviving the ground cherry to identifying breast cancer mutations. When it comes to applying the technology to human embryos, the risks are much higher.

gRNA guides the enzyme Cas9 to the precise location where the DNA will be cut. 

Marius Walter

Using CRISPR to investigate infertility and potentially fix diseases is probably its most compelling use-case. A landmark study conducted by researchers at Sun Yat-sen University in 2015 used CRISPR to inject HBB gene to 86 embryos in an attempt to fight a blood disorder, beta thalassemia. But only 71 embryos survived, and the gene splice properly took in 28 embryos, a success rate far too low to consider for clinical use. The cost of getting it wrong, whether or not this splicing leads to a miraculous cure or a terrible mistake, the changes in DNA can still carry forward to future generations.

When Every Country Writes Its Own Rules

As usual, while technology surges forward, regulation plays catch-up. Although the National Academy of Sciences spearheaded an International Summit on Human Gene Editing in Washington D.C. in 2015, the global community lacks global guidelines that, even if not enforceable, would help countries shape their own laws. (The second International Summit of Human Genome Editing is only taking place this year, from November 27-29).

But the lack of cohesion means that, at least so far, policies on editing human embryos vary wildly.

On one side of the spectrum, Germany restricts research involving human embryos, enforcing the rules with the threat of criminal charges. The US, by contrast, is far more lax. Although the government doesn’t contribute federal funds to research modifying human embryos, private endeavors remain untouched, and the FDA allows germ-line research as long as it doesn’t fall under, “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.”

Without international guidelines, countries have taken to crafting their own rules. This 2014 chart analyzed 39 countries and their stance on germline gene modification.

Motoko Araki and Tetsuya Ishii

But countries like China, India and Japan are even more permissive, and hold the loosest regulations with general guidelines that aren’t enforced. This makes these countries the most likely contenders to one day cross the line to clinical trial.

“The truth is, we have guidelines but some people never follow them,” Qi Zhou, a developmental biologist at the Chinese Academy of Sciences Institute of Zoology in Beijing told Nature.

Japan’s status as the “superpower of fertility treatment” positions the country to be extra motivated to join the race of human embryonic research. With over 600 fertility clinics, 5 percent of all births rely on in vitro fertilization. With such low birth rates, it’s easy to see how CRISPR research could address such a salient issue for Japan’s citizens.

The proposal is available for public comment for a month and will then undergo review, setting up the guidelines to take effect as early as 2019.

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