The draft procedure released for public comments raises the standard of care in the field while balancing the demand and need for sperm donations with the rights of donors and the health of offspring.
Key changes include establishing minimum medical criteria for donors, including comprehensive genetic testing, and limiting the number of families that can receive donations from the same donor.
Today, the Ministry of Health is releasing for public comment an amendment to the procedure governing the management of sperm banks in Israel in order to regulate their operations. The procedure represents an improvement in the standard of care in this sensitive field, balancing the demand for sperm donations from both domestic and international sources with the protection of donor rights and the health of resulting children.
Recent years have seen several developments in sperm donation: increased demand, particularly among single women and same-sex couples, while the number of Israeli donors has not grown to meet this demand; rising costs of international sperm donations; and challenges in donor recruitment due to stricter requirements, resulting in only about 15% of applicants qualifying and significant price increases due to the need for extensive testing.
About two and a half years ago, the Ministry of Health established a Department of Fertility and Birth to regulate fertility treatments in Israel. Within this framework, procedures and ministry circulars were updated and oversight strengthened. Currently, 17 sperm banks operate in Israel under the 2007 Director General circular. Due to the many changes in the field, the ministry decided to update the relevant circular and procedures.
The updated circular outlines rules for the management and licensing of sperm banks, regulation of sperm bank laboratory activity, guidelines and restrictions for obtaining donations from Israeli donors, genetic and other testing of donors, acceptance of sperm donations from abroad and import mechanisms, allocation of donations to recipients, release of sperm from the bank, management of medical records, as well as sperm deposition for personal use, storage of minors’ sperm, collection from deceased donors, and rules for safety, confidentiality, and data protection.
Clear guidelines have also been established for medical and genetic testing of donors and minimum medical criteria for accepting a donation, including full access to the medical record, comprehensive genetic testing, and DNA storage for future testing, applicable to donors both in Israel and abroad.
Central procedures include the regulation of the donor database within the Ministry of Health to prevent a donor from contributing to more than one bank and to allow secure information sharing between banks about genetic and other findings in offspring, reducing the risk of children being born with genetic disorders. Donations from the same donor are limited to 12 families, with an additional allowance for up to five women seeking fertility preservation only. Given the responsibility of sperm bank managers in matching donors to recipients, recipients are required to undergo at least the genetic tests included in the national health basket to minimize the risk of genetic diseases.
There is also a reporting requirement to the relevant sperm bank manager and the Ministry of Health for any genetic or potentially genetic findings in offspring from sperm donation, to assess the continued use of the donation and prevent harm to future children. The circular specifies the minimum donor information to be provided to recipients, including declared religion and any additional halachic information if provided.
Additionally, donors may indicate in their consent form whether, if legally permissible in the future, they would consider a non-anonymous donation, subject to applicable law at that time. The circular continues to require obtaining consent from the recipient and, if applicable, her partner for the use of donor sperm, including acknowledgement that any resulting children will be legally considered theirs for purposes such as child support and inheritance. For clarity, the circular also recommends that couples prepare a will. To expand the donor pool, men up to age 38 may donate sperm. Married or partnered donors may also donate but must declare that their spouse or partner has been informed.