Sperm Bank Laws

Sperm, as a form of living tissue, is heavily regulated across the world. Every state and transnational body, such as the European Union, has strict laws on the storage and processing of human sperm. Sperm banks, organizations that store and sell human sperm to a third party for fertility, are not exempt from government regulation.
  1. The Food and Drug Administration

    • The Food and Drug Administration, or the FDA, regulates sperm donation and sperm banks in the United States. The federal government classifies sperm as "human cell, tissue, and cellular and tissue-based product" or HCT/Ps. HCT/Ps are under the jurisdiction of the FDA.

    FDA Laws

    • The FDA drafted three rules specifically for sperm banks and sperm donations. One law states that all sperm banks must be registered with the FDA. Any establishment that stores and distributes HCT/Ps must be registered with the FDA first. The second rule concerns the screening for any communicable disease. The FDA defines communicable disease as one that will negatively impact or harm the donor population. This includes AIDS, syphilis and other STDs. The third rule that sperm banks must follow is that if a sperm donor is flagged for having a communicable disease or if there is an error in the process of sperm storage, the sperm bank must report this data to the Center for Biologics Evaluation and Research and the Office of Compliance and Biologics Quality as soon as possible.

    Genetic Issues

    • A landmark ruling in 2009 showed that sperm banks can be brought to a court of law if they distribute defective sperm to a client. The case, known as Donovan v. Idant Laboratories, revolved around a mother who gave birth to a girl with mental retardation. The federal court ruled that because the sperm bank could screen for genetic defects such as mental retardation, the sperm bank sold a defective product to the mother. Although the case does not mandate genetic screening, the case shows that customers of sperm bank have the right as customers to sue a sperm bank over defective sperm.

    Specific Sperm Bank Guidelines

    • Sperm banks are given the liberty to screen donors in any discriminatory way. For example, a sperm bank located in Berkeley, California has certain donor guidelines. The sperm donor must be legally able to work in the United States, have a high school diploma, must be at least five feet and seven inches tall, and must be between the ages of 18 and 40. Many sperm banks are given the liberty to require a sperm donor to sign a commitment contract. In the contract, the sperm donor must be rigorously tested medically, consume appropriate nutrients and give weekly samples. Most sperm banks structure their guidelines from the medical advice of the American Society of Reproductive Medicine.

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