Relevant Legislation
Relevant Legislation
California’s Stem Cell Research and Cures Initiative, commonly known as Proposition 71, passed in November 2004. It created the world’s largest single source of stem cell funding, authorizing $3 billion in state bonds to be managed by a newly established stem cell agency and governed by the Independent Citizens’ Oversight Committee. This investment was protected by a constitutional “right to research” amendment, which requires a 70% legislative supermajority to amend. This political right to scientific inquiry provides a lens for analyzing the relationship between innovation and equity.
The initiative highlights the tension between scientific progress and social inequality. Social science research has consistently shown that advances in health technologies often disproportionately benefit those who already hold economic and social power. The debate surrounding germline gene editing raises the same question: will society prioritize equity and justice from the outset, or will we allow a future where health and longevity for some depend on the exclusion and disposability of others?
The Genetic Information Nondiscrimination Act (2008) is an act to prohibit discrimination on the basis of genetic information with respect to health insurance and employment.
Federal law prohibits the use of federal funds for research on human germline gene therapy. Regulations govern the allocation of government research funding, the manipulation of human embryos, and the oversight of gene therapy clinical trials. Under FDA regulations and NIH guidelines, there are currently no approved germline gene therapy products in the United States.
Privately funded laboratories may conduct non-clinical human gene therapy research. However, any therapy intended for sale in the United States must undergo FDA approval, which includes clinical trials and marketing authorization.
In 2019, an international group of researchers called for a global moratorium on all clinical applications of germline editing in embryos. This followed reports that Chinese scientists had edited embryos during fertility treatments, resulting in at least two births. The researchers involved were fined and sentenced to prison for practicing without medical licenses and for using CRISPR in assisted reproductive medicine, leading to heritable genetic changes in children.
The moratorium recommended a five-year international pause on the clinical use of germline editing. Later that year, the NIH director reaffirmed this position, describing germline gene editing as irresponsible and unethical, and endorsed the moratorium.
Not all scholars support a ban. Some scientists and ethicists argue that moratoriums often become de facto permanent restrictions, stifling research that could help determine whether germline editing might be safe and effective for certain conditions. Critics also warn that a ban could stigmatize children born with genetic modifications, whether in countries that do not impose restrictions or through illegal procedures. Instead of a blanket moratorium, these voices recommend the development of carefully designed regulations focused on safety and efficacy, similar to existing frameworks for other assisted reproductive technologies.
Benjamin, Ruha. (2016). Interrogating Equity: A Disability Justice Approach to Genetic Engineering. Issues in Science and Technology, 32, 51-54.
Liu, S. (2020). Legal reflections on the case of genome-edited babies. Global Health Research and Policy, 5(1), 24. https://doi.org/10.1186/s41256-020-00153-4
The genetic information nondiscrimination act of 2008. (n.d.). US EEOC. Retrieved May 1, 2022, from https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008
United States: Germline / Embryonic. (2019, July 23). Global Gene Editing Regulation Tracker. https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/united-states-embryonic-germline-gene-editing/