Germline gene editing, including for non-clinical research, is prohibited in Canada under the Assisted Human Reproduction Act of 2004 (AHRA) even if there is no intention of implanting the embryo. Health Canada is responsible for enforcing the Act. In 2017, Canadian scientists requested a review of the AHRA, arguing that potential human reproductive applications of […]
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The Prohibition of Human Cloning for Reproduction Act 2002 (PHCR) prohibits embryonic germline gene editing. It sets a 15-year jail term for anyone who alters the genome of a human cell in a way that is heritable when the researcher who made the alteration intended the alteration to be heritable. The Research Involving Human Embryos Act
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Germline gene editing is banned in the United States by acts of Congress although there is no federal legislation that dictates protocols or restrictions regarding human genetic engineering. Federal controls exist for allocating government funding of research projects, manipulating human embryos and running gene therapy clinical trials. There are no germline gene therapy products in
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Germline editing is banned in New Zealand under guidelines set by the Health Research Council of New Zealand. As part of the Research Ethics Guidelines, the agency concluded in 2018, “there is insufficient knowledge about the possible consequences, hazards and effects on future generations” of germline gene editing. Implanting genetically modified embryos is also banned
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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.