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. 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. 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. 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. Gene therapy treatments also fall under Mexican Industrial Property Law, which does not allow gene therapies to be patented. No changes or updates have been made to the law yet.
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. 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 SBPE decides on a case-by-case basis what tests and information are required to receive approval for each gene therapy. A subcommittee of the NMC, the Subcommittee of Biotechnological Products Evaluation (SBPE), assesses biotechnology drugs. 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.Īpplicants for new drugs must meet with the New Molecules Committee (NMC), which defines the trials and information required for a drug to be approved. Gene therapy is not explicitly regulated, but new biotechnology drugs are regulated by the General Health Law, which includes safety and efficacy assessments.
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