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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
would add roughly 0.56 percent to the cost of this ART service. This figure must be regarded as a rough estimate; it does not include the one-time costs to ART programs to implement the new record-keeping and reporting requirements, and it does not include the additional operating expenses ART programs would incur in complying with reporting and other regulatory requirements. On the other end, it is quite possible that a U.S. regulatory agency would be less costly to operate and could charge lower user fees. The new record-keeping requirements are likely to increase the operational costs of ART programs, though it is unclear by just how much. If we assume that ART programs depend on effective systems of record-keeping for their daily operations, and that in cooperation with SART and the CDC they have already adopted an IT-based reporting system, compliance with new reporting requirements is likely to cause only modest additional costs. 352
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Beyond Bioethics: A Proposal for Mo
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(ARTs) as well as laboratory resear
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issues raised by new biotechnologie
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human and animals cells, tissues, a
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(CLIA) of 1988 and, more importantl
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the activities of both private and
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themselves whether or not to eat fo
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5.5 Creating a New Regulatory Insti
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egarding reproductive biomedicine t
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to represent constituencies that ar
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“Deliberative panels,” the term
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participants may be able to engage
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outer limits of the right to privac
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About the Authors Francis Fukuyama
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1.1 THE CHALLENGE OF NEW BIOTECHNOL
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7.1 TRADITIONAL REPRODUCTIVE TECHNO
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Shortness as a Psychological and So
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1 Introduction This report presents
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them only on the basis of safety an
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esearch, and clinical and medical p
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Congress’ powers over scientific
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of newborns; destruction of an embr
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1.6 Bibliography Evans, John H. Pla
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endogenous growth hormone secretion
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slippery slope toward blanket uses
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proposed by Eli Lilly - a rather su
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Committee tended, predictably, to r
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coincidentally, she was also one of
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2.5 Bibliography American Academy o
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• Limits on the commercialization
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the sick and relieving the pain and
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give for opposing this practice var
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We recognize that for some people,
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3.6 Bibliography Baruch, Susannah,
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taxonomies are likely to exist. For
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that an investigator may not be abl
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ecome part of this complex transact
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These concerns are not unfounded, a
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cryopreservation a good example of
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A 2003 news story published in Popu
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episode. Reputational incentives ar
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Would you approve or disapprove if
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strong preference for a mixed famil
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controversial not because it provid
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esearch. On the other end are situa
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nucleus of a somatic cell, such as
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And we have to have some degree - a
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father. The experiment could also l
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The availability of oocytes in larg
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and the tail of serpent. In biology
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our view, that the scientific commu
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Bonnicksen, Andrea. "Innovative ART
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Kubawara, Y., T. Okai, S. Kozuma, N
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Shamblott, Michael J., Joyce Axelma
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116
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iotech companies or university clin
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As an infrastructure of quality ass
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toward implementing a comprehensive
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clinical research, 22 while the FDA
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principles of good governance as fe
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sustainable way. Examples include c
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cloning to register with the Depart
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kind of cloning or they limit the b
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The federal government has been rel
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includes ethicists, scientists, men
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Society for Assisted Reproductive T
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Reproductive Endocrinology Subspeci
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safety guidelines aimed at ranking
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elatively mundane. 67 For example,
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Fallon, Peter, and Zafiris Tzannato
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148
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6.1 Italy - from the “Wild West
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also prohibited. 13 The law activel
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selection technologies, but only fo
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eproductive technologies in section
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Neither the RIHEA nor its explanato
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inspect all licensees, or how often
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(principle (e)). 43 Canada affords
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traditional views of reproduction,
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y the Canadian authorities and the
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esearch on human embryos. It requir
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This argument is not likely to conv
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• Maintain a formal register of i
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The remaining three positions reser
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type of research. The HFEA is requi
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The relevance of the Code of Practi
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180
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182
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of saving the life of an older sibl
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procreative right, unlikely as it i
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assisted suicide, the Court has est
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or that there are an infinite numbe
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What is obvious is that the Court s
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generalizing from a strong but gene
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are not any societal traditions tha
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the First Amendment’s protection
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least preferable among all forms of
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Surrogacy 16 Donor egg 14 Donor spe
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To recap, the survey data shows a s
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Robertson, John A. Children of Choi
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media and from polling organization
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Before diving into the data, the me
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(126), and allowing parents to have
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esearch cloning. Two questions (150
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asked five times whether the public
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the creation of embryos solely for
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Our conclusions could be criticized
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about embryonic stem cells? The ans
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were essentially split (44 percent
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coincidence that U.S. scientists id
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assertion of jurisdiction in this c
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of the opposition to genetically mo
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More generally, it is shortsighted
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Process.” 19 According to their i
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another branch of medicine. ART pra
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242
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Navasky, Victor S., and Christopher
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to extract benefits for their membe
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entails. 3 CAMR, a very large and h
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of scientists in these debates woul
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elatively modest. Canada and Austra
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ighteous manner, justifying their c
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eaching out to the public, the agen
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ultimately benefits more the patien
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In many cases, these efforts are pe
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The rationale for including stakeho
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years away. Again, no scientific ba
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The view that deliberation can shar
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members and instructed to reach con
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Deliberation: This requirement has
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One may wonder why public hearings
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conference. Denmark is the clear le
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legislative and regulatory process.
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10.9.1 The National Environmental P
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considered in the process, identify
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vicinity of black residential areas
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it significantly constraints the ag
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286
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Dunkerley, David, and Peter Glasner
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———. "The Courts and the Ossi
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292
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agency’s ability to implement Con
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areas that were thought to require
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Small decision-making bodies such a
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