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Israel: Germline / Embryonic

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Mostly Prohibited

Germline gene editing is prohibited, but can be permitted in limited cases with explicit approval from the Minister of Health.

Germline gene editing “for the purpose of creating humans” is banned and can be punishable with up to four years imprisonment or fines under the Prohibition of Genetic Intervention Law, passed in 1999 and since renewed multiple times by the Israeli Parliament. However, the Minister of Health may give permission for germline gene editing experiments, upon the recommendation of an advisory committee.

An amendment of the Prohibition of Genetic Intervention Law, passed in 2016 and in effect until 2020, upheld a ban on germline gene editing unless authorization for it is granted by the Minister of Health. Authorization must be based on the determination that the procedure would “not harm human dignity” and must be made with a recommendation of the Superior Helsinki Committee, an advisory committee for the approval of human research.

After a Chinese scientist altered the DNA of human embryos that were carried to term, reported in 2018, some Israeli researchers joined an international call in 2019 for a global moratorium on all clinical uses of germline editing.

Products/Research

None

Regulatory Timeline

2019: International group of researchers from seven countries (none from Israel) calls for a global moratorium on all clinical uses of germline editing after a Chinese scientist genetically edited embryos during fertility treatments, and at least two of those embryos were carried to term.

2016: Israel’s parliament passes Amendment No. 3 to the Prohibition on Genetic Intervention (Human Cloning and Genetic Change in Reproductive Cells), maintaining the ban on germline gene editing.

2000: Genetic Information Law passed, regulating genetic testing and research.

1999: Israeli parliament passes the Prohibition on Genetic Intervention (Human Cloning and Genetic Change in Reproductive Cells) banning germline gene editing.

NGO Reaction

Israel is by tradition more supportive of germline gene editing than many other countries because Talmudic tradition dictates that life begins 40 days after conception. In addition, there is a Jewish imperative to help humans in need of treatment, which promotes medical advances in human research. However, some Israeli bioethics experts say that Chinese scientist He Jiankiu’s experiments on the DNA of human embryos were “tantamount to changing the human race without its consent.”

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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
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: 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
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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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.