Gene therapy is permitted, but must be approved by a human research advisory committee and a dedicated advisory committee (made up of physicians, scientists, regulators and ethics experts) and must follow regulations outlined in the Genetic Information Law. The creation of embryos specifically for stem-cell research is banned, but researchers can use embryos left over from in vitro fertilization.
The 2000 Genetic Information Law regulates genetic testing and has been applied to cover gene therapy. Among other guidelines, the law stipulates that genetic tests must be done in facilities accredited by the Israeli Ministry of Health. Tests done outside of the country must receive special authorization. Clinical trials must be conducted in accordance with the Clinical Trials Procedure, which requires that an application be submitted to the Helsinki Committee (human research advisory committee) of the institution where the clinical trial will take place.
Some Israeli clinics do offer mitochondrial replacement therapy (MRT), a controversial procedure that has been used to correct genetic defects and boost success in pregnancies.
- Neuropathic pain: In 2019, Stem Cell Medicine received funding from the Israeli Ministry of Economy for a gene therapy facility in Jerusalem. Gene editing to treat neuropathic pain was among the first products in development.
- Muscular dystrophy: PTC Therapeutics, a US pharmaceutical company, developed a gene therapy to treat a specific type of Duchenne muscular dystrophy, a severe, progressive muscle disease. Approved in Israel as well as the EU, Iceland, Liechtenstein, Norway and South Korea.
- Cancer: The Israeli-founded company Kite Pharma has developed a CAR T-cell therapy for lymphoma that has been approved in the US. VBL Therapeutics has completed clinical trials for stem cell therapy for ovarian cancer.
- Age-related blindness: Cell Cure Neurosciences, based in Jerusalem, developed a stem cell treatment for age-related macular degeneration that causes blindness.
- ALS: Researchers are recruiting patients in Israel for a stem cell clinical trial to treat patients with amyotrophic lateral sclerosis (ALS), a progressive neurological disorder.
- CRISPR research: MilliporeSigma, a Merck company, approved to begin using CRISPR and other gene editing techniques for gene therapy in Israel.
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.
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of Israel gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- Israeli Ministry of Health, Department of Clinical Experimentation
- Israeli Ministry of Health, procedure for human medical experiments