Reproduction and Responsibility:

The Regulation of New Biotechnologies

Table of Contents

Findings

In this chapter, we enumerate the key findings growing out of our survey and analysis of the current regulation of biotechnologies that touch on human reproduction. Clearly, many human goods are well served by the current regulatory arrangements. Yet other goods are unmonitored or unprotected and may require further attention. Each of the findings listed below has been identified by a significant number of Council members as a matter of concern or at any rate worthy of note. The listing of findings here is not intended to imply that anything in particular, or indeed anything at all, is required by way of public policy response.

I. DOMAIN OF INQUIRY

The fields of assisted reproduction, human genetics, and embryo research are increasingly converging with one another. The integration of genomic knowledge with the practices of assisted reproduction is no longer speculative. Techniques and practices such as preimplantation genetic diagnosis (PGD) are already enhancing our control over human procreation, making it possible to screen and select specific genetic characteristics of our offspring.

II. GENERAL CONCLUSIONS

There is no uniform, comprehensive, and enforceable system of data collection, monitoring, or oversight for the biotechnologies affecting human reproduction. The present system is a patchwork of federal, state, and professional self-regulation.

1. Institutional Governance.

a. Governmental oversight. There is minimal direct governmental regulation of the practice of assisted reproduction. The primary animating values of current federal regulation are (1) consumer protection and (2) safety and efficacy of products when employed for their intended use. In the main, assisted reproductive technologies (ARTs) are regulated as the practice of medicine-with licensure, certification, professional oversight, and malpractice litigation as the chief means of regulation. Under this system, the children who will be born with the aid of these technologies are not technically considered patients, and parents are left solely responsible for safeguarding the interests of their children (though of course ART practitioners aim to help parents conceive healthy children). On the federal level, the Centers for Disease Control (CDC), acting pursuant to the Fertility Clinic Success Rate and Certification Act, collects and publishes some data on the practice of assisted reproduction at clinics in the United States; most of this information relates to the clinics' per-cycle success rates of initiating pregnancies and achieving live births. The CDC also provides a model certification program for embryo laboratories, although to date no states have adopted it. The federal Food and Drug Administration (FDA) regulates some of the products used in the practice of assisted reproduction, although this oversight is limited to insuring the safety and efficacy of a product in its intended use. Several experimental ARTs (for example, ICSI [intracytoplasmic sperm injection] and PGD) have entered clinical practice with limited prior testing and limited monitoring of their effects on the children produced with their aid. At the same time, there is at least one instance of the FDA asserting its authority to stop an experimental new technique (ooplasm transfer), the safety of which, for the resulting child, had been called into question. But the legal justification for doing so was not the protection of the child, as such, since the FDA has no explicit legal authority to regulate on such grounds.

b. Professional oversight. There is extensive professional self-regulation of the practice of assisted reproduction, but compliance with the standards invoked is purely voluntary. The animating ethical values of current professional self-regulation are safety, efficacy, and privacy for the individuals seeking infertility services. The standards are merely advisory, with no meaningful enforcement mechanisms. The professional societies do address some broader ethical issues-such as the permissibility of elective sex selection and cloning-to- produce-children-and recommend limiting or not engaging in certain practices. But these recommendations are also merely advisory.

2. Substantive Areas of Concern.

a. The well-being of children, egg donors, and gestational mothers. There is no comprehensive, uniform, and enforceable mechanism for data collection, monitoring, or oversight of how the new reproductive biotechnologies affect the well-being of the children conceived with their aid, the egg donors, or the gestational mothers. There is no definitive understanding of how ART or its adjuncts affect the well-being of children born with their aid. Some studies suggest that most children are normal and healthy; others raise serious concerns. No longitudinal controlled study has yet been undertaken to follow the long-term health and development of children born with the aid of ART. Multifetal gestations are significantly more common in pregnancies initiated with the help of ARTs as currently practiced; such pregnancies are associated with a higher incidence of serious health problems for both mothers and children. Yet there are at present no requirements to publish adverse health effects from the use of ARTs or their adjuncts.

b. Access to services and consumer protection. There are no nationally uniform laws or policies relating to access to assisted reproduction. State law relating to insurance coverage of ART services varies greatly; fourteen states have laws speaking to the question, the rest do not.ⁱ The federal Fertility Clinic Success Rate and Certification Act does not require the reporting of the average price (to the patient) of a successful assisted pregnancy.

c. Movement of techniques and practices from experimental to clinical use. Given the present framework of regulation, novel technologies and practices that are successful move from the experimental context to clinical practice with relatively little oversight or deliberation. Once in practice, these techniques are used at clinicians' discretion, with little or no external oversight. Use of effective technologies becomes widespread rapidly. Two examples: (1) ICSI was discovered by accident in 1992. Two years later it was in clinical practice. In 2001, ICSI was used in 49 percent of in vitro fertilization (IVF) treatment cycles. (2) PGD was developed in 1989. Since then, an unknown number of children have been born after undergoing PGD (estimates range between less than 1,000 and 10,000). Yet there have been no longitudinal studies of the effects of PGD on these children. Current professional guidelines dictate only that there be two peer-reviewed papers showing an acceptable risk-benefit ratio before the status of a new practice is elevated from "experimental" to "clinically acceptable."  There is no system for reporting the reasons for using ICSI, PGD, and similar technologies. Nor is there any system for publishing and disseminating information regarding possible adverse effects.

d. Public discussion and deliberation regarding the ethical significance of new technologies and practices. In ART, as in other areas of medicine, there is no uniform system for public review and deliberation regarding the larger human or social significance of new reproductive technologies. Practices combining assisted reproduction with genomic knowledge have come into clinical usage with little or no deliberation about their human, social, or ethical implications. Such practices include using PGD to screen and select genetic traits unrelated to the health of the child who is to be born-such as elective sex selection or compatibility with an older sibling in need of tissue donation. As genomic knowledge increases, the range of non-disease-related genetic traits for which PGD is feasible will potentially expand. There is today no system for data collection on the uses and applications of these or similar technologies.

PGD is an unregulated practice. There is no system of data collection, monitoring, or oversight for preimplantation genetic diagnosis per se, and no system for reporting of possible adverse effects on children conceived following the use of PGD. Nor is there a mechanism for the collection of data regarding the frequency of specific applications of PGD (for example, screening for disease, for non-disease-related traits, or for the creation of compatible tissue donors).

Gene transfer research is regulated robustly. The federal government regulates gene-transfer research in regard to safety, efficacy, and protection of human subjects. Moreover, there exists a long-standing system for public discussion regarding novel protocols (through the Recombinant DNA Advisory Committee of the National Institutes of Health (NIH), commonly known as the RAC). But it is unclear whether this supervisory system would suffice to encompass safeguards for the health and well-being of children who might be conceived or born using gene-transfer techniques. This is, at present, a remote question, because the relevant techniques are for now entirely speculative.

There is no comprehensive, uniform, and enforceable mechanism for data collection, monitoring, or oversight regarding the use and disposition of in vitro human embryos in the context of clinical practice or research. A credible, recent estimate suggests that there are 400,000 embryos in cryopreservation in the United States. There are no federal limits or regulations governing what one can do to or with an ex vivo human embryo, so long as one is privately funded and so long as the embryos are acquired in a legal manner. There is no uniform guidance regarding the disposition of such frozen embryos, once their progenitors no longer want them. There are no federal limits on the creation of embryos solely for research, the creation of cloned or hybrid embryos, the implantation of human embryos into the bodies of animals, or the creation of embryos using fetal gametes or gametes derived from embryonic stem cells. Meanwhile, no federal funds may be used for research that involves the destruction of human embryos, but the law has been construed to permit federal funding of research on a limited number of human embryonic stem cell lines. Many in the research community believe that the current restrictions on funding of embryo-derived stem cell research create a chilling effect on embryo research generally.

E. Commerce

There is no comprehensive mechanism for regulation of commerce in gametes, embryos, and ART services. Professional guidelines exist that attempt to place limits on commerce in human reproductive tissue and human embryos, primarily in order to safeguard the health of women and the dignity of gamete donors, but these guidelines are unenforced. Regarding the sale of ART services generally, there are overall federal guidelines relating to truth in advertising, and professional societies have propounded guidelines on this matter as well.

Patenting of embryonic or fetal human organisms is prohibited for the fiscal year 2004. The Weldon Amendment to the Consolidated Appropriations Act of 2004 provides that no funds shall be made available "to issue patents on claims directed to or encompassing a human organism." Until October 1, 2004, no patents may be issued on human organisms at any stage of development. Congress may continue this policy, or not, as it sees fit. Additionally, it has for many years been the policy of the Patent and Trademark Office not to issue patents directed to or encompassing "human beings."

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Footnote

i. One published study concluded that in states where IVF is covered by insurance, there are associated "decreases in the number of embryos transferred per cycle, the percentages of cycles resulting in pregnancy, and the percentage of pregnancies with three or more fetuses." Jain, T., et al., "Insurance Coverage and Outcomes of In Vitro Fertilization," New England Journal of Medicine 347(9): 661 (August 29, 2002).

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