Parent’s Guide to Cord Blood, December 2022
Terri Tibbot & Gia Frazier
The short answer is no. The long answer is still no, but with more detail. Parents frequently ask questions about selling their placenta, and the purpose of this article is to explain that you can’t sell a placenta in the United States.
What is the legal status of a placenta?
From a strictly medical perspective, the placenta is an organ, and placenta donation is organ donation. But, unlike organs which can be transplanted to a recipient, you cannot transplant a whole donated placenta to save the life of a developing fetus. Current medical applications use pieces of the placenta, in the form of cells or tissues.
There is no single definition of the placenta under federal law1. The National Organ Transplantation Act (NOTA) says: “The term ‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus)”2. While this definition of human organs seems to indirectly include the placenta, the question of whether the placenta is legally an organ has never been adjudicated1,2. The common law tradition at hospitals is to treat the placenta like other tissues that are produced as a byproduct of surgery. The federal Occupational Safety and Health Act (OSHA) regards bodily parts and fluids collected in a healthcare facility in the course of diagnosis and treatment as human pathological waste3. This type of waste must be placed in biohazard containers. OSHA is primarily concerned with worker safety, and does not regulate the final disposal of the material in biohazard containers.
State laws control the removal and disposal of biohazardous medical waste4-6. Lacking a clear federal status for the placenta, most states in the US quote OSHA regulations and treat the placenta as biohazardous waste.
Can you leave a hospital with a placenta?
If you were going to sell your placenta, the first step is getting the hospital to release it to you. You can’t sell it if it’s not out the door. Only four states (Hawaii, Connecticut, Oregon, and Texas) have laws on the books which allow parents to repossess the placenta post delivery1. After completing infectious disease testing, and learning instructions for proper handling, parents then have to sign a release form agreeing to not sell or profit from obtaining the placenta. Several more states (Arkansas, Maryland, Massachusetts, New Jersey, New Mexico, New York) exempt placentas from medical waste requirements, and this enables parents to take the placenta home, subject to varying release requirements1. Across the United States, there is a patchwork of policies at different levels, down to individual hospitals and medical practices, which effectively constitute a “hidden form of placenta law”1. At the time your baby is delivered, whether or not you can repossess the placenta comes down to where you delivered the baby and who is the staff on duty that day.
Let’s assume you make it out the door with the placenta…
For there to be any way to use a placenta for medical applications, the tissue has to be processed in a laboratory. While there is no concrete definition of the placenta under federal law, the use of the placenta to develop human cell and tissue products (HCT/P) is subject to numerous federal regulations and industry standards7-9.
Any company looking to make a marketable product from placenta tissue must have a licensed medical laboratory and must track a whole host of information required for the approval of a placenta product. This means obtaining medical and social histories from birth mothers, conducting infectious disease testing, and implementing a system of identifiers that track the placenta from its source to its final disposition. The company trying to utilize the placenta will also have to verify that all proper handling requirements are followed. This includes monitoring the supplies used for collection of the placenta, that anyone handling the placenta is appropriately trained, that systems are in place for monitoring temperature, and that all transfer and shipping supplies are validated for use. The point here is, that no medical product developer is going to buy a placenta off an individual parent, because that placenta does not come with the pedigree of proper handling and a jacket of paperwork.
Is it legal to sell a placenta?
The answer is no. The NOTA regulations clearly prohibit the sale and purchase of organs10. The Uniform Anatomical Gift Act (UAGA) explicitly prohibits the sale or purchase of any body parts11. A few exceptions to the UAGA rules are spelled out to allow the sale of self-replicating body parts like hair and blood plasma12. If found guilty of violating UAGA law, perpetrators are looking at a felony conviction complete with a fine up to $50,000, up to 5 years of imprisonment – or both.
The founding principles of organ donation are based on altruism, the desire to give life. There has long been a debate among experts over whether some system of donor compensation would help alleviate the shortage of donated organs13,14. But there are very strong ethical concerns about making the human body a commodity. People in financial need should not be subject to coercive efforts to encourage consent to donation of any part of their body. So far, the basic altruistic system has not been changed.
It can be argued that since the placenta is not legally treated as an organ, it is not illegal to compensate placenta donors. The current system where hospitals categorize the placenta as waste is convenient for them, because it allows the hospitals to give or sell this waste to procurement organizations and medical product companies1,15,16. In theory, a procurement organization that has the proper licensing to operate inside hospitals could offer financial incentives to donors, but in practice this would increase their cost of doing business and make it difficult for them to compete against other procurement organizations. Also, any organization that started compensating birth parents for placentas would be operating in a gray area of US law, which is not the sort of thing an organization wants to do when they run a business in a highly regulated environment like tissue procurement.
Can you sell your baby’s placenta? No. Not only is it illegal to sell body parts in the United States, but there are multiple barriers in place which prevent compensating birth parents for placentas. In most states it is not even guaranteed that parents can get their placenta out the hospital door. Several regulatory standards exist which would prohibit the medical use of placentas purchased from birth parents due to lack of quality and safety controls. Many people believe that keeping money out of the equation is the most ethical way to honor donors and recipients. While there are advocates who present intriguing models for compensating donors, until the laws change, for now the answer is still no.
- Cohen, M. The Law of Placenta. Yale Journal of Law and Feminism, 2020; 31(2):337-409.
- National Organ Transplantation Act of 1984 (NOTA)
- United States Dept. of Labor. Occupational Safety and Health Administration (OSHA). OSHA’s Guidelines for Biohazard Waste Removal. Last updated 2021-05-12
- United States Environmental Protection Agency (EPA). Medical Waste. Last updated 2022-05-14
- Healthcare Environment Resource Center. State-by-State Regulated Medical Waste Resource Locator. Copyright 2015
- Harris J. SHARPS Compliance. How State Medical Waste Regulations Differ. Published 2017-04-05
- Code of Federal Regulations 21 CFR Section § 1271. Subpart D, Current Good Tissue Practice. Effective 2004-11-24, unless otherwise noted.
- Food and Drug Administration (FDA). Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use Guidance for Industry and Food and Drug Administration Staff. Last updated July 2020
- American Association of Tissue Banks (AATB). Standards for Tissue Banking (14th ed.) Published 2016
- National Organ Transplantation Act of 1984, 42 U.S. Code §274e Prohibition of organ purchases Last Revised or Amended 1988.
- Uniform Anatomical Gift Act (UAGA) of 1968, §16 (page 48) Sale or purchase of parts prohibited. Last Revised or Amended in 2009.
- Greenberg Z. What Is the Blood of a Poor Person Worth? NY Times. Published 2019-02-01
- US Dept. Health & Human Services. Health Resources and Services Administration (HRSA). Human Organ Procurement & Transplantation Network (OPTN). A Report of the Payment Subcommittee of the Ethics Committee. Financial Incentives for Organ Donation. Published June 1993.
- Williams KL, Finley M, Rohack JJ. Just say No to NOTA: Why the Prohibition of Compensation for Human Transplant Organs in NOTA Should Be Repealed and a Regulated Market for Cadaver Organs Instituted. American Journal of Law & Medicine 2014; 40(4):275-329.
- Yoshizawa RS, & Hird MJ. Schrödinger’s placenta: Determining placentas as not/waste. Environment and Planning E: Nature and Space 2020; 3(1):246-262.
- Verter F. It’s the morning before your C-section, and someone wants you to donate your placenta. Parent’s Guide to Cord Blood Foundation Newsletter Published January 2021
Source: Parent’s Guide to Cord Blood