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United States: Germline / Embryonic

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Prohibited

Federal law prohibits the use of federal funds for research on human germline gene therapy.

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 the US. The Food and Drug Administration’s position on gene editing, according to the government website:

The idea of germline gene therapy is controversial. While it could spare future generations in a family from having a particular genetic disorder, it might affect the development of a fetus in unexpected ways or have long-term side effects that are not yet known. Because people who would be affected by germline gene therapy are not yet born, they can’t choose whether to have the treatment. Because of these ethical concerns, the U.S. Government does not allow federal funds to be used for research on germline gene therapy in people.

There is no law or regulation that bans germline gene editing conducted through private funding. In theory, you could operate a privately funded lab and conduct non-clinical, human gene therapy research. However, if someone wanted to sell that therapy in the US, they would need FDA approval for clinical studies and marketing. No proposals have been submitted.

After a Chinese scientist altered the DNA of human embryos that were carried to term, multiple American researchers joined an international call in 2019 for a global moratorium on all clinical uses of germline editing. Separately, over 60 scientists, ethicists, and biotechnology leaders sent a letter supporting a moratorium to the Secretary of the Department of Health and Human Services (DHHS). However, other scientists and ethicists object to a moratorium, arguing that it might impede research on or use of germline gene editing indefinitely because moratoriums and temporary bans tend to be difficult to change. It may impede funding for research that could help scientists understand whether germline gene editing could be safe and effective for certain conditions. In addition, a moratorium could stigmatize children that are born with genetic modifications, either illegally or in countries that choose not to ban germline gene editing. Instead, they suggest germline gene editing be tightly regulated for safety and efficacy, like other assisted reproductive technologies.

In 2019, US Senators introduced a bipartisan resolution encouraging international standards for germline gene editing to “prevent unethical researchers from moving to whichever country has the loosest regulations.”

Products/Research

  • Embryos without a gene that causes blindness: Researchers at Columbia University used CRISPR to eliminate the gene for retinitis pigmentosa, an inherited form of blindness in embryos, for research purposes only. The embryos are not being carried to term.
  • Embryos without a fatal heart mutation: Researchers at the Oregon Health & Science University used CRISPR to eliminate a gene that causes cardiomyopathy, a potentially fatal heart condition, for research purposes only.

Regulatory Timeline

2019: NIH director states that germline gene editing experiments are irresponsible and unethical and that the NIH supports the moratorium proposed in 2019 by leading scientists from seven countries, who called for a five-year international moratorium on the use of gene editing to modify the human germline for clinical purposes.

2019: Patient advocates and scientists launch push to lift ban on mitochondrial replacement therapy, popularly known as ‘three-parent IVF’, with recommendations to loosen restrictions on some forms of human germline therapy.

2019: US Senators introduce resolution condemning the Chinese experiments resulting in gene edited embryos that were carried to term, encouraging international standards for germline gene editing.

2019: International group of researchers calls for a global moratorium on all clinical uses of germline editing of embryos after a Chinese scientist genetically edited embryos during fertility treatments and at least two were carried to term.

2018: Associated Press poll finds 7 in 10 Americans support gene-editing technology to prevent a child from inheriting an incurable or fatal disease.

2017: The National Academy of Sciences releases report on guidelines for editing the human genome to treat diseases and other applications, concluding that clinical trials could be appropriate under the right conditions, including the need to avert a serious disease or condition, lack of reasonable alternatives, and strict oversight.

2015: In riders attached to the funding of the FDA, Congress passes the first of yearly bans altering the genome of human embryos intended for pregnancies.

2015: National Institutes of Health (NIH) announces it would “not fund any use of gene-editing techniques in human embryos,” citing the Dickey-Wicker Amendment.

2015: Group of scientists and bioethicists call for examination of the benefits and risks of germline gene editing.

1996: Dickey-Wicker Amendment passes, which prevents federal funding of research involving the creation or destruction of human embryos.

1964: Declaration of Helsinki, a non-binding codification of various ethical standpoints on human experimentation, is formed, but it is only operative when cited in national regulations. US observed it until 2006 when FDA eliminated all references in national regulations.

NGO Reaction

Most US faith groups and advocacy organizations, such as the Council for Responsible Genetics, argue that germline gene editing is an unethical practice, potentially dangerous and could lead to a new era of eugenics. Other organizations and an increasing number of scientists support allowing some forms of somatic gene editing, including mitochondrial replacement therapy.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

Hotspots Background

European Union

Brazil

New Zealand

United States

Australia

Canada

China

United Kingdom

Israel

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Central America

Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
*Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine856.5
Central America111
Paraguay111
Uruguay111
India804
UK444
Mexico804
EU402

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.

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