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 StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations**6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
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.
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:
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

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
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
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
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
 

Country / RegionGene DrivesGene Drive Rating
Brazil88
Canada88
Australia44
US44
New Zealand44
UK22
EU22
Japan11
Russia11
Argentina11
Israel11
China11
Chile11
Ukraine11
Central America11
Paraguay11
Uruguay11
India11
Mexico11

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