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This staff working paper was discussed at the Council's July 2003 meeting. It was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.


U.S. Public Policy and the Biotechnologies That Touch the Beginnings of Human Life: Findings

This document is an effort to enumerate the key findings growing out of the Council’s survey and analysis of the current regulation of the biotechnologies that touch the beginnings of human life. Each of these findings has been identified by a significant number of Members as of concern or 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, genetics, and human embryo research are increasingly converging. The fusion of genomic knowledge and assisted reproduction is no longer speculative. Techniques and practices, such as PGD, greatly enhance our control over human procreation and the character, fate, and future of our offspring.


II. GENERAL CONCLUSIONS

There is no uniform, comprehensive, enforceable system of data collection, monitor-ing, or oversight for the biotechnologies that touch the beginnings of human life. The present system is a patchwork of federal, state, and professional self-regulation.

A. Assisted Reproduction

a. Institutional Governance

i. Governmental Oversight

There is minimal governmental regulation of the practice of assisted reproduction. The primary animating values of current federal regulation are consumer protection, and safety and efficacy of products when employed for their intended use. In the main, ART is regulated as the practice of medicine—with licensure, certification, professional oversight, and malpractice litigation as chief means of regulation. Under this system, the child-to-be is not generally considered as a patient, and parents are left solely responsible for safeguarding the interests of their children.

ii. Professional Oversight

There is extensive professional self-regulation of the practice of assisted reproduction, but these standards are hortatory and unenforceable. The animating 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.

b. Substantive Areas of Concern

i. Well Being of Children, Egg Donors, and Gestational Mothers

There is no comprehensive, uniform, or enforceable mechanism for data collection, monitoring, or oversight of how the new biotechnologies that touch the beginnings of human life affect the well being of the children conceived with their aid, egg donors, or 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 such children are normal and healthy; others raise serious concerns. Multiple gestations are significantly more common in pregnancies initiated with the help of ARTs as cur-rently practiced; such pregnancies are associated with serious health problems for both mothers and children. There is presently no system for reporting adverse health effects from the use of ARTs or their adjuncts.

ii. Access to Services

There are no 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. The Fertility Clinic Success Rate and Certification Act does not require the reporting of the average cost of a successful preg-nancy.

iii. Movement of Techniques and Practices from Experimental to Clinical Use

Given the present framework of regulation, novel technologies and practices move from the experimental context to clinical practice with very little oversight or deliberation. Once in practice, these techniques are used at clinician’s discretion with little or no external oversight. Use becomes widespread rapidly. Two exam-ples: (1) ICSI was discovered by accident in 1992. Two years later it was in clinical practice. In 2000, ICSI was used in 47 percent of IVF treatment cycles. (2) PGD was developed in 1989. Since then, there have been 6,000 cases of PGD use, with an esti-mated 2,000 children born thereafter. 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 the risk-benefit ratio is acceptable before a given practice moves 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 reporting possible adverse effects.

iv. Public Discussion and Deliberation regarding Ethical Significance of New Technologies and Practices

There is no uniform system for public review and deliberation regarding the larger human or social significance of new technologies that touch the beginnings of human life. Practices fusing assisted reproduction and genomic knowledge have come into clinical usage with little or no deliberation about their human, social, or ethical significance. Such practices include PGD for nontherapeutic indications or for concep-tion of donor siblings, ooplasm transfer, and the like. There is presently no system for data collection on the uses and application of these or similar technologies.

B. Preimplantation Genetic Diagnosis

PGD is not regulated as such. 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. Nor is there mechanism for the collection of data regarding the frequency or specific applications of PGD (for example, screening for disease, for traits, or for the creation of donor siblings).

C. Gene Transfer Research

Gene transfer research is regulated robustly. The federal government regulates gene transfer research in terms of safety, efficacy, and protection of human subjects. More-over, there exists a long-standing system for public discussion regarding novel protocols (through the Recombinant DNA Advisory Committee of NIH).

D. Use and Disposition of Human Embryos in Research

There is no comprehensive, uniform, or enforceable mechanism for data collection, monitoring, or oversight relating to the use and disposition of human embryos in the context of clinical practice or research. A credible industry estimate suggests there are 400,000 embryos in cryopreservation in the United States. There are no limits on what one can do to or with an embryo, so long as one is privately funded. Meanwhile, no federal funds may be used for the destruction of human embryos. Many in the research community believe that the federal ban on funding of human embryo research creates a chilling effect on embryo research generally. Anecdotally, it seems that few researchers are currently engaged in research involving human embryos, although an increasing number of researchers are taking up research involving stem cell lines derived from human embryos.

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, in order to safeguard the health of women and the dignity of gamete donors, but these guidelines are unenforce-able. Regarding the sale of ART services generally, there are general federal guidelines relating to truth in advertising, and professional societies have propounded guidelines on this matter as well.

Patenting of human organisms is presently ambiguous. The only obstacle to patenting human embryos is a Patent and Trademark Organization policy (memorialized in the Patent Examiners’ manual) that is ambiguously worded. PTO has approved at least one patent on a process for cloning mammals that could be construed to include humans. PTO has called for congressional guidance to clarify the current ambiguity.


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