Mexico: Germline / Embryonic

Prohibited

Research using embryos, including gene editing, is prohibited.

Germline gene editing is not explicitly regulated, but a law from 1997 prohibits the fertilization of human eggs for any purposes other than reproduction. This has been interpreted as prohibiting the use of embryos for research, including gene editing.

The Ministry for Health is responsible for regulating human gene editing research. The General Law on Health prohibits embryo research and violations can result in up to six years of imprisonment. The Office of Scientific and Technological Information for the Congress of the Union recommended changes to the country’s General Health Law in 2019, including suggesting that all clinical uses of CRISPR be regulated and supervised. No changes or updates have been made to the law yet.

In 2016, a baby whose parents were Jordanian was born in Mexico using a controversial technique called mitochondrial replacement (aka ‘three parent baby), which can help avoid certain mitochondrial genetic diseases. Researchers from the New Hope Fertility Center in the US performed the procedure in Mexico because mitochondrial replacement therapy is not specifically regulated or banned. The UK is the only country that has officially approved the procedure.

Products/Research

“Three-parent baby”: New Hope Fertility Center researchers used mitochondrial replacement therapy, popularly known as ‘three-parent IVF’, to protect an infant from a fatal genetic disease.

Regulatory Timeline

2019: Office of Scientific and Technological Information for the Congress of the Union recommends changes to the country’s General Health Law, including suggesting that all clinical uses of CRISPR be regulated and supervised.

2016: First ‘three-parent’ baby born produced by mitochondrial-replacement therapy.

1997: General Law on Health passed, which prohibits the fertilization of human eggs for any purposes other than reproduction, including gene editing research.

NGO Reaction

Researchers raised ethical concerns about the ambiguity of Mexico’s gene editing legislation after a baby developed through mitochondrial replacement therapy was born to a Jordanian couple in Mexico in 2016. The operation was performed by a US-based team, prompting widespread criticism for choosing to perform the operation in Mexico to dodge regulations, and prompted calls for clearer, tighter regulation.

Additional Resources

Genes and Science’s FAQ on gene editing
Library of Congress summary of Mexico gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

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

Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.

*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

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.

Rating by Country / Region
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Country / Region	Therapeutic	Germline	Human Rating
Japan	8	8	8
Brazil	4	0	2
Canada	4	0	2
Russia	10	5	7.5
Argentina	5	1	3
Israel	8	2	5
Australia	4	0	2
China	8	4	6
US	4	0	2
Chile	4	1	2.5
New Zealand	4	0	2
Ukraine	10	5	7.5
Central America	1	1	1
Paraguay	1	1	1
Uruguay	1	1	1
India	4	0	2
UK	4	4	4
Mexico	8	0	4
EU	4	0	2

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which gene drive products and processes are approved or in development and their regulatory status.

Gene Drive Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

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

Lightly Regulated: Gene drives regulated through existing biotechnology laws.

*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: 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.

Rating by Country / Region
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Country / Region	Gene Drives	Gene Drive Rating
Japan	1	1
Brazil	8	8
Canada	8	8
Russia	1	1
Argentina	1	1
Israel	1	1
Australia	4	4
China	1	1
US	4	4
Chile	1	1
New Zealand	4	4
Ukraine	1	1
Central America	1	1
Paraguay	1	1
Uruguay	1	1
India	1	1
UK	2	2
Mexico	1	1
EU	2	2

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

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

Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.

*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

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.

Rating by Country / Region
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Country / Region	Food / Crops	Animals	Ag Rating
Japan	8	8	8
Brazil	10	10	10
Canada	8	8	8
Russia	5	5	5
Argentina	10	10	10
Israel	10	5	7.5
Australia	8	8	8
China	5	5	5
US	10	4	7
Chile	10	1	5.5
New Zealand	4	4	4
Ukraine	1	1	1
Central America	6	6	6
Paraguay	10	10	10
Uruguay	6	6	6
India	6	6	6
UK	2	2	2
Mexico	1	1	1
EU	2	2	2
Colombia	10	1	5.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:

(1) Cartagena Protocol on Biosafety [https://bch.cbd.int/protocol/]

Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.

(2) Product v process

Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.

A Public Resource Compiled by the

Mexico: Germline / Embryonic

Prohibited

Research using embryos, including gene editing, is prohibited.

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing IndexCompare Regulatory Restrictions Country-to-Country

Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country