Final Report (all chapters)

There is some evidence that the biotech industry does conduct research in this area, but just
how much research is unknown. A fairly recent survey conducted by the Department of
Commerce in cooperation with BIO, the leading biotech industry trade association, shows that of
776 surveyed firms, 41 percent did perform “culturing/manipulation of cells, tissues,,
embryos.” 41 However, the survey does not provide any information on the relative importance of
embryo research proper, or the significance of this research area in the industry research
portfolio.
For the purpose of this discussion, we assume that the newly created regulatory agency
would have to fund itself through user fees. (This is a worst-case scenario, as Congress is likely
to fund this agency at least in part.) The regulators, then, would have to adopt a fee system
similar to the one operated by the British HFEA. A simple way to assess the burden imposed on
the ART industry and patients by this fee system is to compare fee levels to the cost of ART
services to patients. Assessing the cost of ART services in the United Sates is no easy task.
Prices vary considerably depending on the type of service rendered and the clinic’s reputation
and location. ASRM does not provide reliable cost information, nor does the CDC gather this
kind of data. A rough estimate of the cost of various ART services can be gleaned from Web
resources offering information to prospective parents and from fertility clinics’ own published
information. For example, www.babycenter.com provides the following price estimates per
cycle:
• Artificial insemination: $300 to $700
• In vitro fertilization: $8,000 to $15,000
• Gamete intrafallopian transfer: $8,000 to $15,000
• Zygote intrafallopian transfer: $8,000 to $15,000
• Intracytoplasmic sperm injection: $10,000 to $17,000 42
Note that these categories are not mutually exclusive. An individual cycle may require
performing ICSI followed by traditional IVF. Other cycle-related services such as testing of
reproductive tissues are charged separately. In the United States, by far the most common
procedure remains IVF. According to the CDC, in 2001, 107,587 ART cycles were performed. 43
Assuming that the U.S. regulatory counterpart would charge the same fee as the British HFEA
(i.e. £36, or $64), 44 and given the average price of $12,000 per cycle, a U.S. regulatory system
41
42
43
44
U.S. Department of Commerce, "A Survey of the Use of Biotechnology in the U.S. Industry," (Washington,
D.C.: Technology Administration, Bureau of Industry and Security, 2003).
See http://www.babycenter.com/refcap/preconception/fertilityproblems/1228997.html, page visited on July 20,
2005.
Centers for Disease Control and Prevention, "2001 Assisted Reproductive Technology Success Rates: National
Summary and Fertility Clinic Reports," (Atlanta, GA: National Center for Chronic Disease Prevention and
Health Promotion, Division of Reproductive Health, 2003), p.6.
Exchange rate as of April 26, 2006.
351