Gene therapy is permitted, but must be approved by Health Canada’s Biologics and Genetic Therapies Directorate (BGTD), which is responsible for overseeing all clinical trials. The BGTD applies the Food and Drugs Act, which includes the Food and Drug Regulations and the Medical Devices Regulations. The BGTD requires more detailed chemistry and manufacturing information for […]
Canada: Therapeutic / Stem Cell Read More »
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
Canada: Germline / Embryonic Read More »
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
Australia: Germline / Embryonic Read More »
Gene therapy is permitted but must comply with clinical trial regulations. Amended regulations implemented in 2019 make it quicker and easier for medical researchers to get approval for gene therapy research and to progress to clinical trials with patients. Gene editing techniques that pose no different risks, and cannot be distinguished from conventional methods, do
Australia: Therapeutic / Stem Cell Read More »
Gene therapy is permitted but must be approved by the Department of Health and Human Services (DHHS), which is responsible for overseeing clinical trials. The Food and Drug Administration (FDA), a DHHS agency, considers any use of CRISPR in humans to be a form of gene therapy. Germline gene therapy—editing of embryos that changes the
United States: Therapeutic / Stem Cell Read More »
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
United States: Germline / Embryonic Read More »
Gene therapy permitted for diseases when the cause is a defect in a single pair of genes or in cancers, and when there is clear evidence that therapy may improve clinical outcomes. Gene therapy regulated under the Medicines Act and every gene therapy must be approved by the Gene Technology Advisory Committee (GTAC). Products/Research Parkinson’s
New Zealand: Therapeutic / Stem Cell Read More »
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.