Reproduction and Responsibility:

The Regulation of New Biotechnologies

Table of Contents

The President's Council on Bioethics
Washington, D.C.
March 2004
www.bioethics.gov

Chapter Seven

Diagnostic Survey: Summary and Conclusion

I. Summary

Chapters 2 through 6 describe in some detail the current regulatory activities governing the uses of biotechnologies that touch on human reproduction; this diagnostic survey reveals that the present constellation of regulatory mechanisms is broad but not uniform or systematic in its objectives, scope, or enforcement.

The practice of assisted reproduction is subject to oversight by a host of sources, governmental and nongovernmental. Governmental regulation is motivated by concerns for consumer protection, quality assurance in laboratory procedures, safety and efficacy of products according to their intended use, and the delivery of medical care according to accepted standards of practice. Nongovernmental oversight is aimed primarily at ensuring the satisfaction and privacy of those who seek assisted reproductive technology (ART) services. These standards, while extensive, are hortatory rather than compulsory. What seem to be missing from both governmental and nongovernmental regulations, individually or in the aggregate, are meaningful, enforceable rules directly aimed at safeguarding the health and well-being of the children who come to be born via ART.ⁱ Moreover, there do not seem to be significant oversight activities or effective guidelines that address larger ethical concerns relating to the enhanced control over human procreation. Finally, the system of regulation currently in place does not reflect the concerns many people have about the use and destruction of human embryos attendant on the practice of assisted reproduction.

New capacities to screen and select for specific genetic traits and characteristics are not regulated as such through governmental institutions. Insofar as they are regulated, they are governed by state, local, or institution-based standards for the practice of medicine or the conduct of embryo research. There do not seem to be any governmental authorities or regulatory efforts to comprehensively monitor the uses, applications, or long-term health effects of preimplantation genetic diagnosis (PGD) on children born after its use. And there is no public oversight or public guidelines with respect to the broader social and ethical implications of enhancing control of the genetic characteristics of children. At the nongovernmental level, there are guidelines that "strongly discourage" the use of PGD for elective sex selection, but these guidelines are not binding and, in fact, are not (at least as of this writing) followed by all of the prominent practitioners of assisted reproduction. There are also no guidelines regarding the permissibility of crossing the boundary between using PGD for producing a disease-free child and using it for so-called enhancement purposes or to produce siblings for children needing transplant donors.

The ability to genetically modify gametes or human embryos, today a merely speculative reproductive possibility, would likely be regulated under the existing federal guidelines for gene-transfer research. Current regulations in this regard include stringent protections for human subjects and rigorous standards requiring practitioners to demonstrate and document the safety and efficacy of such gene-transfer procedures. Moreover, most (if not all) such research is subject to federal guidelines that require submission of prospective research protocols to a body that publicly discusses the ethical implications of projects raising novel or important issues. Officially, it is the safety of the participants in clinical trials such research that drives the federal regulation of genetic modification, but these regulations seem also to be informed by a regard for as-yet-unconceived future generations who may be affected (unintentionally) by such germ-line genetic modification. That being said, there is no positive authority that empowers the federal government to consider the safety of such future individuals. The absence of such authority might prove to be an obstacle to meaningful regulation of germ-line gene-transfer, should it ever be undertaken. At present, however, deliberate germ-line modification is not now being pursued in humans, due to concerns for safety and efficacy.

The use of in vitro human embryos for purposes of scientific research is not regulated by the federal government. The federal government neither promotes nor prohibits such research.ⁱⁱ Regulation in the individual states varies widely, ranging from active endorsement to silent permission to strict prohibition. There is thus no uniformity in governmental regulation of embryo research. The nongovernmental regulation of this practice takes the form of ethical opinions and practice guidelines issued by professional societies. Subject to certain limitations discussed in Chapter 5, these authorities, in the main, endorse and promote such research based on their view that the embryo's moral status permits its use and destruction for certain scientific ends.

Commerce in gametes, embryos, and assisted reproductive services is subject to only a small degree of regulation. There is very little controlling law respecting the sale of gametes or embryos. Professional societies provide detailed yet merely hortatory guidelines regarding financial incentives and donor protections. The practice of assisted reproduction itself is subject to external regulation for purposes of consumer protection, particularly with regard to truth in advertising and reporting the rates of success. Some states have laws concerning the provision of insurance coverage for assisted reproductive services, but the scope and substance of these laws vary widely. Professional societies offer some guidance as to how to structure compensation and some standards for truth in advertising. Regarding intellectual property protections, the recently enacted Weldon Amendment (along with the U.S. Patent and Trademark Office's policy) precludes the issuance of a patent directed to human organisms at any stage of development. The Weldon Amendment expires at the end of fiscal year 2004 and would have to be reauthorized if it is to have continuing effect.

II. Conclusion

Taken as a whole, the present system of regulation advances a number of goods and values. It allows for the robust and innovative practice of medicine, permitting physicians wide latitude to employ novel approaches in their efforts to help patients overcome infertility and experience the joys of parenthood. It promotes the safety and efficacy of products for their intended uses and provides an extensive system of protections for human subjects participating in clinical trials. Scientists are generally permitted (though not generally federally funded) to pursue most research relating to assisted reproduction or involving harm to human embryos. In many cases, scientists can secure patents to protect the fruits of their labors. The present system accords prospective parents a great deal of freedom to choose among a variety of approaches to assisted reproduction; it similarly confers upon them maximum freedom to make choices on behalf of their future children. Finally, present governance of commerce growing out of reproductive biotechnologies is largely left to the market, with all the attendant benefits of free enterprise and the freedom to contract.

The weaknesses of the present system in some ways grow out of its strengths. Practitioners and parents have such wide latitude to pursue the benefits of the new reproductive biotechnologies precisely because there are no governmental authorities or professional bodies formally charged with ensuring the well-being of children conceived and born with the aid of assisted reproduction. Tort liability for harm to children in this context is a crude (and, for the harmed children, necessarily after-the-fact) substitute for formal and effective guidelines. As with their treatment in other branches of medicine, protecting the interests of children is primarily the responsibility of parents. As we have seen, however, there are compelling reasons to believe that assisted reproduction-especially in light of new and emerging genetic technologies-raises unique ethical concerns and perhaps deserves more careful social oversight. No governmental bodies are today responsible for monitoring or assessing the broader ethical implications of the new reproductive biotechnologies, nor are there clear and accepted boundaries that would protect human procreation from possibly unwelcome innovations and degrading practices. Scientists in many states enjoy largely unlimited freedom regarding what they can and cannot do with human embryos in research because the current system of federal regulation is silent, neither promoting such research nor prohibiting it. Finally, as to commerce, the present regulatory system lacks a uniform approach to questions of access to reproductive services, and it sets no uniform, enforceable limits on the buying and selling of human gametes and embryos.

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Footnotes