Legislation for Cord Blood Bank Network Reminiscent of Early Organ Transplant Days

Gwen Mayes, JD, MMSc

Disclosures

September 19, 2003

In labor and delivery rooms across the country, more is being birthed than babies.

Consider a multimillion-dollar booming industry for the collection and storage of cord blood from a new mother's once-discarded placenta and umbilical cord. Or how about the latest opportunity for the American public to donate blood for stem cell transplantation in such a way that politicos can circumvent the fetal tissue debate?

Traditionally, bone marrow and peripheral blood have been the primary sources of hematopoietic stem cell transplantation for the treatment of a variety of malignant and genetic disorders such as sickle cell anemia, Parkinson's disease, and leukemia. However, stem cells from cord blood -- the placenta and umbilical cord -- have proven to be superior to traditional bone marrow transplants in that they require a less perfect match than bone marrow transplants, thus making it more likely to find a suitable donor, especially for minority populations that are underrepresented in the banked donor pools. Stem cell transplants from cord blood provide a second advantage: They reduce the risk of graft vs host disease and its attending mortality and morbidity.[1]

As of December 2002, the National Marrow Donor Program (NMDP), based in Minneapolis, Minneapolis, includes 12 cord blood banks listing more than 25,000 umbilical cord blood units, the largest listing of cord blood units in the United States.[2] There are also many other cord blood banks not affiliated with NMDP.

The United States Food and Drug Administration (FDA) requires cord blood banks that "manufacture" hematopoietic stem cells derived from peripheral and cord blood (defined as any establishment involved in the "recovery, processing, storage, . . . distribution of any human cell or tissue . . .") to be registered under a new regulatory scheme that expands FDA's jurisdiction and regulatory abilities to cover various human cell and tissue products. The final rule, issued in January 2001, represents a composite of 3 separate proposed rules dealing with registration and product listing, donor suitability, and current good tissue practices.[3]

Federal legislation introduced earlier this summer would expand even further the federal government's role in regulating cord blood banks. Rep. Christopher Smith [R-NJ (4th district)], a Congressman more noted for his legislation involving veterans' affairs than biotechnology, introduced the Cord Blood Stem Cell Act of 2003 (H.R. 2852) in hopes of "significantly increasing the nation's supply of stem cells obtained from cord blood and its use in the treatment of blood and immune deficiency diseases."[4]

What is Smith's interest in cord blood banking? According to his office, stem cell transplantation is one of the only prompt treatments available to people exposed to radiation and chemical agents during a terrorist attack, an important factor for the people in Smith's district, who were hard hit by the Fall 2001 anthrax scare.

Reading through Smith's bill, one is hard pressed not to recognize its similarities to early legislative efforts to centralize solid organ donation and transplantation efforts in the 1980s. First, the bill calls for the establishment of a "Network" of blood banks that will contract with the Health Resources and Services Administration, an administrative agency within the U.S. Department for Health and Human Services, a system very much like the one operating for the solid organ transplant field. The cord blood Network is to establish and maintain at least 150,000 units of human cord blood. The bill also provides for the Network to establish protocols for tissue typing and storage of the blood and to make up to 10% of the cord blood inventory available for research annually. The Network is to "make cord blood . . . available to transplant centers," but the bill stops short of using the word "allocate," a requirement of the organ transplant field that has been so difficult to achieve.

Now, almost 20 years since the enactment of the National Organ Transplant Act (NOTA),[5] what lessons can the cord blood bank industry learn from the organ transplantation field should this legislation pass?

First, without an incentive -- carrot or stick -- for blood banks to contract with the federal government for inclusion in the Network, it is unlikely that regulators will be sufficiently convinced that the field is playing under a uniform system. Or, more importantly, that the public is benefitting from a single centralized system that enables them to maximize their donor search. By contrast, under the Omnibus Budget Reconciliation Act of 1986, organ transplant centers were required to be part of the National Organ Procurement and Transplantation Network created by NOTA and to abide by its rules and regulations as a condition for participation in Medicare and Medicaid.[6] Such an onerous requirement has been fraught with its own regulatory uncertainty; however, its intent to centralize the field of solid organ transplantation and ensure the American public that match runs would include all possible donated organs has been laudable.

Second, proponents of H.R. 2852 should be aware that even with extensive federal funding, public awareness campaigns, and mandatory participation by hospitals and related health establishments, donation rates have never reached the level originally envisioned or hoped for. In recent years, annual increases in organ donation rates have hovered around 5% (in 1988 there were a total of 5904 donors, in 2002 there were 12,796), while the waiting list of transplant candidates has increased from a few thousand to 82,500.[7] Although there are obvious differences between donating tissue that is normally discarded at birth and the complex circumstances of solid organ donation, it is still a daunting task to increase the nation's supply of cord blood units to 150,000, considering the ability to donate has existed for some time.

And finally, although NOTA expressly prohibits the buying and selling of organs for transplantation, the legal system has never consistently applied commercial law or property law for financial consideration to other body parts.[8] One could easily argue that the placenta and umbilical cord are reproductive tissues not dissimilar to eggs and sperm in that they can be replenished and are of commercial value to the donor. Such a view could severely jeopardize voluntary donations of cord blood for stem cell transplantation and research.

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