Gene Editing’s Ethical and Regulatory Issues Take Center Stage

Experts discussed the future of CRISPR technology and its applications during a press briefing at the AAAS Annual Meeting on 16 February. | Courtesy of the McGovern Institute for Brain Research at MIT

BOSTON – A day after a critical patent ruling on the gene-editing technology called CRISPR, researchers gathered at the 2017 AAAS Annual Meeting to discuss the technology’s future ethical and regulatory concerns surrounding its broader use.

Although CRISPR technology has existed for only a relatively short time its development and applications have stirred much controversy. An administrative body addressed one particularly divisive aspect of its development on 15 February, when the federal Patent and Trademark Office decided that the Broad Institute in Cambridge, Massachusetts may retain more than a dozen patents related to the technology.

The decision dealt a high-profile blow to the University of California, which had been working to overturn the Broad patents.

During a AAAS press briefing on the technology, George Church, a key developer of CRISPR who is affiliated with the Broad Institute, fielded a question about whether the patent ruling would slow CRISPR-related advances particularly in the area of clinical therapies.

“I don’t think it would put a bottleneck on academic research,” said Church.

Even with select patent issues now addressed, many questions remain about the applications of such a technology. On 16 February Church joined several other experts in Boston to discuss the ethical issues that the use of CRISPR and other powerful gene-editing techniques raise.

Church outlined two significant ways that CRISPR could be used in humans: to eradicate diseases and enhance certain genetic or biological capabilities.

George Church, a professor of genetics at Harvard Medical School, discussed issues surrounding CRISPR during a press briefing at the Annual Meeting on 16 February. | Ashley Gilleland/AAAS

The “red line” that marks where people generally think the limits of gene editing should be set is shifting, said Church.

“Many diseases we are interested in [correcting] are human-specific,” he added. “If we can eliminate them for even a brief moment, they become extinct, as smallpox and polio did. So that’s a big decision, an ethical decision.” It is also one that could save many millions of lives, he noted.

Richard Hynes of the Massachusetts Institute of Technology discussed a National Academy of Sciences report on gene editing released on 14 February. While the report supports embryo, egg and sperm editing to eradicate disease under certain circumstances, enhancement editing, specifically, should be deferred until a broader society-wide discussion has been held, concluded the report.

“With enhancement,” said Hynes, “the benefit is more debatable.”

How gene editing may affect nonhuman animals and ecosystems is another concern, one where regulation may be lacking. Jennifer Kuzma of North Carolina State University addressed this, focusing on recent attempts to genetically modify the disease-spreading mosquito Aedes aegypti. When released into the wild, modified versions of this mosquito can mate with wild mosquitos and spread genes that will cause the latter’s offspring to die.

While such an approach is promising, regulation and evaluation of this type of endeavor has proved challenging. For example, the Food and Drug Administration was responsible for the final approval stage of plans to implement this technique in Florida. However, the FDA reported it did not have the means to conduct a related environmental assessment.

“My conclusion is that as we look to the future of gene drives and gene editing in nonhuman animals,”said Kuzma. “We are going to really need to bolster this process, because there are so many uncertainties when you put something out into the environment.”

A major problem, Kuzma added, is that it is almost impossible to collect enough data to conduct a preemptive risk analysis of such acts. She emphasized the need to engage experts to scope out solutions and to consider the impacts on animals and people.

Setting international standards for studying gene editing and its uses is another area in which more investment is needed. “The problem is that law is more constrained and narrower in scope than science,” said Gary Marchant of Arizona State University College of Law. “Laws are by country, but science is global.”

While the use of gene editing holds many beneficial promises, panel participants agreed, advancing this technique internationally and effectively will require much collaboration and careful consideration.