Global Gene Editing Regulation Index
Despite the innovations already in place, and with a tsunami of discoveries coming every month, gene editing represents an immense public policy challenge. With new technologies come ideological opponents to innovation. Environmental groups suspicious of technology, court cases and regulations passed over the objections of the science community, particularly in Europe, are already maneuvering to stifle innovation. Our job as advocates for choice and science will continue to be making the case for the Innovation Principle—allowing scientists and scientific agencies to make determinations of efficacy and safety, and not being at the mercy of the theatre of our broken political process.
This index illustrates the existing differences in regulation for gene editing in plants, animals and humans and the frameworks for gene drives. The index was created to help journalists, regulators, and policy-makers understand how their actions can help or stifle innovation.
This index has been compiled by using the thorough and important analysis done by scientist Dr. Kayleen Schreiber with the Genetic Literacy Project in collaboration with the Consumer Choice Center.
We would like to thank Jon Entine, executive director of the GLP, for his work in promoting biotechnology education and for his support and encouragement for creating these invaluable tools.
REPORT
COLORS AND RATINGS GUIDE
| Regulation Status | Rating |
|---|---|
| Determined: No Unique Regulations* | 10 |
| Lightly Regulated | 8 |
| Proposed: No Unique Regulations** | 6 |
| Ongoing Research, Regulations In Development | 5 |
| Highly Regulated | 4 |
| Mostly Prohibited | 2 |
| Limited Research, No Clear Regulations | 1 |
| Prohibited | 0 |
AGRICULTURE
HUMAN
GENE DRIVES
AGRICULTURE
Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.
*Gene editing regulated under existing legislation with no unique restrictions, except Argentina, which passed new, flexible regulations. / **Decrees under consideration, but not yet passed, to regulate gene-edited crops or animals as conventional.
HUMAN
Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.
*Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions. / **Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.
GENE DRIVES
Gene Drives:
Genetic engineering technology used to transmit a characteristic throughout a wild population. For example, it can be used to develop mosquitoes that only have female offspring. If released into the wild, these mosquitoes would breed with wild malaria-carrying mosquitoes and over time would eliminate the population. Scientists are interested in using this technology to help eradicate disease-carrying insects and control invasive species, but questions about how gene drives will be directed and controlled are still being fleshed out.
*Gene drives not specifically regulated. / **Decrees under consideration that would flexibly regulate.
Human and Agricultural Gene Editing Regulations
Agriculture: Food & Crops
Agriculture: Animals
Human: Therapeutical
Human: Germline
Gene Drives
Agriculture: Food & Crops
| Country / Region | Food / Crops | Animals | Ag Rating |
|---|---|---|---|
| Japan | 10 | 10 | 10 |
| Brazil | 10 | 10 | 10 |
| Argentina | 10 | 10 | 10 |
| Canada | 8 | 8 | 8 |
| Australia | 8 | 8 | 8 |
| Israel | 10 | 5 | 7.5 |
| US | 10 | 4 | 7 |
| Russia | 6 | 6 | 6 |
| Central America | 6 | 6 | 6 |
| Paraguay | 6 | 6 | 6 |
| Uruguay | 6 | 6 | 6 |
| Chile | 10 | 1 | 5.5 |
| China | 5 | 5 | 5 |
| Africa | 5 | 5 | 5 |
| New Zealand | 4 | 4 | 4 |
| India | 4 | 4 | 4 |
| UK | 2 | 2 | 2 |
| EU | 2 | 2 | 2 |
| Ukraine | 1 | 1 | 1 |
| Mexico | 1 | 1 | 1 |
Agriculture: Animals
| Country / Region | Food / Crops | Animals | Ag Rating |
|---|---|---|---|
| Japan | 10 | 10 | 10 |
| Brazil | 10 | 10 | 10 |
| Argentina | 10 | 10 | 10 |
| Canada | 8 | 8 | 8 |
| Australia | 8 | 8 | 8 |
| Israel | 10 | 5 | 7.5 |
| US | 10 | 4 | 7 |
| Russia | 6 | 6 | 6 |
| Central America | 6 | 6 | 6 |
| Paraguay | 6 | 6 | 6 |
| Uruguay | 6 | 6 | 6 |
| Chile | 10 | 1 | 5.5 |
| China | 5 | 5 | 5 |
| Africa | 5 | 5 | 5 |
| New Zealand | 4 | 4 | 4 |
| India | 4 | 4 | 4 |
| UK | 2 | 2 | 2 |
| EU | 2 | 2 | 2 |
| Ukraine | 1 | 1 | 1 |
| Mexico | 1 | 1 | 1 |
Human: Therapeutical
| Country / Region | Therapeutic | Germline | Human Rating |
|---|---|---|---|
| Japan | 8 | 8 | 8 |
| Russia | 10 | 5 | 7.5 |
| Ukraine | 8 | 5 | 6.5 |
| China | 8 | 4 | 6 |
| Africa | 10 | 1 | 5.5 |
| Israel | 8 | 2 | 5 |
| UK | 4 | 4 | 4 |
| Mexico | 8 | 0 | 4 |
| Argentina | 5 | 1 | 3 |
| Chile | 4 | 1 | 2.5 |
| India | 4 | 0 | 2 |
| Brazil | 4 | 0 | 2 |
| Canada | 4 | 0 | 2 |
| Australia | 4 | 0 | 2 |
| US | 4 | 0 | 2 |
| New Zealand | 4 | 0 | 2 |
| EU | 4 | 0 | 2 |
| Central America | 1 | 1 | 1 |
| Paraguay | 1 | 1 | 1 |
| Uruguay | 1 | 1 | 1 |
Human: Germline
| Country / Region | Therapeutic | Germline | Human Rating |
|---|---|---|---|
| Japan | 8 | 8 | 8 |
| Russia | 10 | 5 | 7.5 |
| Ukraine | 8 | 5 | 6.5 |
| China | 8 | 4 | 6 |
| Africa | 10 | 1 | 5.5 |
| Israel | 8 | 2 | 5 |
| UK | 4 | 4 | 4 |
| Mexico | 8 | 0 | 4 |
| Argentina | 5 | 1 | 3 |
| Chile | 4 | 1 | 2.5 |
| India | 4 | 0 | 2 |
| Brazil | 4 | 0 | 2 |
| Canada | 4 | 0 | 2 |
| Australia | 4 | 0 | 2 |
| US | 4 | 0 | 2 |
| New Zealand | 4 | 0 | 2 |
| EU | 4 | 0 | 2 |
| Central America | 1 | 1 | 1 |
| Paraguay | 1 | 1 | 1 |
| Uruguay | 1 | 1 | 1 |
Gene Drives
| Country / Region | Gene Drives | Gene Drive Rating |
|---|---|---|
| Brazil | 8 | 8 |
| Canada | 8 | 8 |
| Australia | 4 | 4 |
| US | 4 | 4 |
| New Zealand | 4 | 4 |
| UK | 2 | 2 |
| EU | 2 | 2 |
| Japan | 1 | 1 |
| Russia | 1 | 1 |
| Argentina | 1 | 1 |
| Israel | 1 | 1 |
| China | 1 | 1 |
| Chile | 1 | 1 |
| Ukraine | 1 | 1 |
| Central America | 1 | 1 |
| Paraguay | 1 | 1 |
| Uruguay | 1 | 1 |
| India | 1 | 1 |
| Mexico | 1 | 1 |
