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Editorial: It's time to take a hard look at regulating human genome editing

Interest is rising in genome editing as the next generation of the technology begins to make a serious impact. Scientists have been able to edit DNA strands for a while now, replacing sections of code. The newest techniques, however, are far more accurate, far more efficient and far cheaper than anything that has come before.

This has implications not just for the genetic engineering of laboratory animals and the alteration of agricultural plants and livestock. It has also made it quite likely that we will see the pace of development of human applications speed up. Which means we need to start asking some important questions, such as, "Can we allow genetic edits to fertilized eggs or reproductive cells that will then be passed down to a person's descendants, whatever the purpose may be?"

Genetic manipulation of fertilized eggs is prohibited in Japan and the West. However, the newest gene editing technology has much greater potential than its predecessors. The international community needs to reconsider world-wide regulation of human genetic engineering, and Japan cannot be late to the table.

Intense debate on the ethics of human genome editing was reignited in spring last year after the release of one particular research paper by a team in China. The team attempted to replace genes that coded for a blood disease with a normal section of DNA, and they performed the experiment using fertilized eggs. The team had no intention of creating a baby, but the experiment set off shockwaves nonetheless.

There are people that see big things for the treatment of genetic diseases and other illnesses using this kind of genetic editing. But the danger that the technology will be used to create "designer babies" -- choosing eye or skin color, or inserting genes for athletic ability, and so on -- cannot be denied.

Moreover, altering the genes of a fertilized egg means changing the genetic code for not just the person it grows into, but for their descendants as well, and all without them being able to give their permission. It may be possible that we will alter the human genome sometime in the future. There also remains the risk that the genetic editing process will alter DNA sections other than the one targeted, which means we have very real worries over the safety of genome editing.

The final statement at the International Summit on Human Gene Editing held in December by the British Royal Society, the U.S. National Academy of Sciences, and the Chinese Academy of Sciences, stated, "It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application." The statement did, however, approve of basic research into human gene editing, "subject to appropriate legal and ethical rules and oversight."

In Japan, there is no legal ban against developing clinical applications for editing the genes of fertilized eggs included in the administrative guidelines governing genetic therapies. There are also no clear-cut rules on basic research into the field. If this state of affairs continues, the state of the art may quickly outpace regulation, leaving the government to play catch-up. The country needs to quickly sort out the possibilities and ethical challenges of this new technology, and consider developing rules -- including legal measures -- to govern it.

It is extremely important to coordinate discussions on human gene editing among academic societies, the Science Council of Japan, and the government's own expert committee on bioethics. Moreover, we must regularly rethink the legal framework for reproductive assistance treatments that are closely linked to human gene engineering.

Practical research into genetic editing for crops and farm animals is also ongoing but, from a safety perspective, is there any difference between the plants and animals altered with the new techniques versus those already in use? We need to consider this question carefully and repeatedly.

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