Can Law Keep Pace with Gene Editing Science?
In 2018, the scientific world was rocked by a startling announcement: Chinese scientist He Jiankui claimed to have created the world's first gene-edited babies. Using CRISPR technology, he modified embryos in an attempt to confer HIV resistance, producing twin girls named Lulu and Nana. 1
The global scientific community responded with unanimous condemnation, criticizing the experiment as premature and ethically indefensible. This event triggered urgent questions that continue to resonate today: How can society harness the tremendous potential of gene editing while protecting against its profound risks? 1
| Technology | Mechanism | Advantages | Limitations |
|---|---|---|---|
| ZFNs | Protein-based DNA recognition with FokI nuclease | First programmable nucleases; longer history of use | Difficult to design; high cost; lower specificity |
| TALENs | Protein-based DNA recognition with FokI nuclease | Higher specificity; modular design | Technically challenging to construct; larger size |
| CRISPR-Cas9 | RNA-guided DNA recognition with Cas9 nuclease | Easy to program; highly efficient; low cost | Off-target effects; requires PAM sequence |
Limited restrictions with ongoing monitoring
Extensive restrictions regardless of cost
Balanced consideration of risks and benefits
Germline interventions could allow couples to have genetically related children without passing on serious genetic diseases, reduce the frequency of recessive genetic mutations in populations, and potentially endow children with protective genes. 1
Off-target mutations could cause unintended changes that might not appear until later in life and could be passed to descendants. Limited knowledge of human genetics means intended edits might cause unanticipated harms. 1
Interactive map showing different regulatory frameworks worldwide
| Region/Country | Regulatory Approach | Key Characteristics |
|---|---|---|
| European Union | Process-based | Generally treats gene-edited organisms as GMOs |
| United States | Product-based | USDA exempts many gene-edited crops from regulation |
| China | Case-by-case with labeling | Shortened approval times (1-2 years) |
| Argentina, Brazil, Chile | Product-based | Focus on final product characteristics |
In a landmark 2025 study, researchers demonstrated how artificial intelligence can generate completely novel CRISPR systems that never existed in nature. 8
| Characteristic | Natural Cas9 (SpCas9) | OpenCRISPR-1 | Significance |
|---|---|---|---|
| Sequence Origin | Naturally occurring | AI-generated, not found in nature | First highly functional designed editor |
| Editing Efficiency | High | Comparable or improved | Performs well despite sequence divergence |
| Specificity | Moderate | Improved specificity | Potentially safer therapeutic profile |
The tension between gene editing innovation and the precautionary principle represents a fundamental challenge for modern society. The emergence of AI-designed gene editors suggests that scientific progress will continue to accelerate, likely at an increasing pace. 8
On the other hand, the potential risks—particularly regarding heritable human genetic modifications—demand careful oversight and thoughtful regulation. 1 7