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Mexico: Therapeutic / Stem Cell

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Lightly Regulated

Gene therapy permitted and can be approved through an accelerated system that requires minimal clinical trial data for safety and effectiveness.

Gene therapy is not explicitly regulated, but new biotechnology drugs are regulated by the General Health Law, which includes safety and efficacy assessments. Until more specific regulations are developed, gene therapy would be considered a new biotechnology drug, which is defined as any substance produced by molecular biotechnology that has a therapeutic effect.

Applicants for new drugs must meet with the New Molecules Committee (NMC), which defines the trials and information required for a drug to be approved. A subcommittee of the NMC, the Subcommittee of Biotechnological Products Evaluation (SBPE), assesses biotechnology drugs. The SBPE decides on a case-by-case basis what tests and information are required to receive approval for each gene therapy. Applicants must then initiate the new drug procedure through the Federal Commission for the Prevention of Health Risks (COFEPRIS), who oversees safety and efficacy assessments.

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.

Gene therapy treatments also fall under Mexican Industrial Property Law, which does not allow gene therapies to be patented. The law establishes that “surgical, therapeutic and diagnostic treatment methods for the treatment of the human body and those related to animals” are not considered inventions.

Overall, the unclear legal framework means that pharmaceutical and research companies are not encouraged to settle and invest in Mexico, while simultaneously creating a panorama of clinics and providers that perform experimental treatments with little or no evaluation of health risks by competent authorities.

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

None

Regulatory Timeline

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

2014: New Molecules Committee (NMC) develops a Subcommittee of Biotechnological Products Evaluation (SBPE) specifically to assess biotechnology drugs, defined as “any substance produced by molecular biotechnology that has a therapeutic effect.”

2009: New regulations on biotechnology drugs introduced, but they do not address gene 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 Response

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

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 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 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
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
Click each column header and arrow to sort the countries / regions

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Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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