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.
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.
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.
- Genetic Literacy Project’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
- Mitochondrial replacement techniques and Mexico’s rule of law: on the legality of the first maternal spindle transfer case