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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 Nine

Policy Options

The findings drawn from our survey of the status quo, as presented in Chapter 8, suggest that a number of serious concerns may accompany the present and future uses of reproductive and genetic biotechnologies, and that there are potential deficiencies in our national system of monitoring, oversight, and regulation. But shortcomings in the present arrangement do not, in and of themselves, mean that new policies are called for. Any new form of regulation would surely come with costs, and in assessing prospective policies it is important to weigh their potential costs as well as their benefits; we must be sure that changes to the present system are not worse than doing nothing.

The appeal of doing nothing in this arena is, frankly, rather great, not only because the costs of regulation may be high (and, in their full proportions, incalculable in advance) but also because the areas of assisted reproduction, new genomic knowledge, and embryo research are socially and politically quite sensitive. Some prospective policies might touch on highly private matters of procreation, family life, and infertility, and we Americans are loath to intrude in these areas, even if our aim is to help and to protect those involved. Some potential policies may also involve questions of the character and status of human embryos—a crucial but highly charged subject in our politics. Parties on all sides have strong convictions to defend that reach well beyond the uses of reproductive biotechnologies; the ongoing national debate and struggle over abortion are never far from the surface in any discussion of reproduction and responsibility. Anyone contemplating new regulation in this field must acknowledge that there is no easy avenue to clear-cut policies or comfortable compromises, and perhaps that is as it should be.

But if action, any action, in this field has its financial, social, and political costs, inaction could surely prove costly as well. The most obvious costs of leaving the status quo untouched are reflected in the findings that have emerged from our survey of the field. These problems are real, and they demand serious public deliberation if not also improved public monitoring, oversight, or regulation.

Moreover, recognizing these problems, and detailing them as we have, places a burden upon us. While much remains unknown about the present state of technologies affecting human reproduction, we can no longer claim to lack a sense of the circumstances surrounding their use. We have a good grasp of the various concerns that mightarise in these areas, and we have a sense of what sorts of benefits and difficulties will emerge as assisted reproductive technology (ART) becomes more integrated with the new genomic knowledge and technologies. We also have a reasonably well-developed understanding of what sorts of information we now lack. Having put together this picture of the status quo, we cannot now recommend that nothing further needs to be done without, in effect, declaring that the status quo is in all respects better than any realistic alternative.

The issues raised and the concerns described in our survey of the field make it difficult for us to make such a declaration; and it would be premature  to allow the difficulties that might accompany new policies to foreclose any further discussion of regulatory or institutional change. At the same time, we are in no position at this stage of our inquiry to offer any comprehensive suggestions regarding what, if anything, should be done regarding this field as a whole. Before any such suggestions could be made, extensive further investigation and consultation would be needed. Further testimony and advice would need to be sought from the various identifiable stakeholders—including research scientists and biotechnologists, ART practitioners and their professional societies, disease and disability organizations and advocates, religious organizations, bioethics and “watchdog” organizations, and the various governmental institutions already charged with some regulatory responsibility in this field—as well as from ordinary citizens. We would also need to carry out a thorough exploration of what could be done within the existing regulatory framework, limited though it may at present be. To offer suggestions that would be of genuine practical value, due attention would also have to be paid to the constraints imposed on any new policy by the special features of American political and economic life, medical and research practices, personal privacy protections, and the realities of public attitudes and domestic political struggles. To do this properly would take at least several years.

In the absence of such a thoroughgoing inquiry, we can however present in outline certain institutional options that might be considered for the field as a whole, indicating in general terms some of their strengths and weaknesses. And, more modestly, we can revisit some of the findings of our diagnostic assessment in order to consider certain specific policy options that might command some attention, even as people try to think through the desirability and feasibility of more thorough institutional changes. The remainder of this chapter takes up these matters in turn. In each case, we are merely laying out the alternatives. We are not here endorsing any one of them.

I. INSTITUTIONAL OPTIONS

What, then, might be done institutionally regarding this field as a whole? We begin by briefly offering a sense of what sorts of policy may be available to us. There is certainly something counter-intuitive about discussing institutional arrangements in the abstract without first articulating the substantive principles that should guide their design and operation. But it is nonetheless useful to approach the subject with a rough sense of the contents of our toolbox, so as to better organize our thinking about which particular substantive options are feasible. The actual design of oversight and regulatory mechanisms must of course begin from the substantive aims motivating the policy; but because such design is not our purpose at this stage, review of possibilities may usefully begin at the more general level of institutional forms.

It is worth emphasizing that we take a broad view of the meaning of the term “regulation.” In employing that term, we do not refer merely to restrictions or enforced prohibitions, but to a broad range of potential actions that might be undertaken to encourage, facilitate, protect, oversee, restrain, or restrict a given activity. A government’s regulatory stance may range from promoting (through funding), to permitting without restriction, to tolerating or permitting within enforceable limits, to discouraging (by withholding funding), to prohibiting. And particular regulatory policies may range from information-gathering and reporting, to monitoring, to oversight, to setting hortatory guidelines, to providing rules and regulations with penalties for violation, among others. An analogous range of regulatory stances and policy options (with some differences) is open also to professional societies and institutional ethics committees.

The array of national-level policy options that present themselves, and that have been examined by observers and critics in the past, may be divided roughly into five categories of potential institutional change: (1) a new regulatory agency; (2) new authority granted to existing regulatory agencies; (3) specific legislative action; (4) the use of government funding as a regulatory lever; and (5) increased oversight and self-regulation by the relevant professional societies. Let us briefly describe each of these in institutional terms, highlighting also what might be said for or against each alternative.

A. A New Regulatory Agency

One possibility, suggested by a number of observers and evident in the policies of several foreign countries, is the creation of a new administrative agency of the executive branch that would be authorized to monitor and administer the uses of biotechnologies discussed in this report. Such an agency would be charged by Congress with a number of specific tasks but would be also given some leeway in applying its mandate to particular circumstances that might arise. Its creation would therefore involve some delegation of regulatory authority. This, for instance, is the idea behind the Human Fertilization and Embryology Authority (HFEA) in Britain and the Assisted Human Reproduction Agency (AHRA) in Canada.

The logic of this approach is fairly straightforward: by creating a body whose business it is to oversee this arena of research and practice, we might ensure that the problems that worry us are at least noticed and at best addressed with appropriate policies. Many issues involved in assisted reproduction, genetic testing and screening, embryo research, and related fields are new and unprecedented, and they do not fall naturally into the purview of any existing government body or agency. Existing agencies, like the federal Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control (CDC), to name just the most prominent ones, were designed and have evolved to serve different purposes, and authorizing them to oversee this field might not adequately address the important concerns that have emerged from our review of the present state of affairs.

Such a new agency would be granted some degree of latitude in making judgments in particular cases, so that each controversy in this emerging field would not turn into a legislative question requiring prolonged congressional debate.i

A new agency dedicated exclusively to monitoring or regulating this arena might ensure that all the relevant concerns are addressed. But the costs of such an agency, financial and otherwise, could be quite high. It would be very difficult for an institution along the lines of the British HFEA to function in the American system, since our approaches to embryology and human genetics, the practice of medicine, the financing of health care, private enterprise, reproductive freedoms, government regulation, and scientific progress are different from those of the British.

The potential wisdom or utility of such an agency would have to be judged in light of the tasks it would need to carry out. In purely institutional terms, designing and establishing it would be a complex undertaking. It therefore marks the most ambitious of the potential institutional options before us.

B. Augmentation of Existing Agencies

Rather than establish a new agency, Congress might expand the scope and jurisdiction of one or more existing federal agencies to authorize them to exercise oversight over this field.

A number of potential candidates present themselves. The FDA, as discussed in our overview of the status quo, already exercises some limited oversight over certain elements of reproductive biotechnology, and its reach in this arena might reasonably be extended somewhat. In addition, the NIH, along with several of its subsidiary institutions (for example, the Recombinant DNA Advisory Committee, or RAC), might also be given some authority to monitor or even to regulate specific areas of research and, to a limited extent, of clinical applications. The CDC is already charged by statute with the task of gathering and publishing data on assisted reproductive technologies, and its authority in this regard, as well as other related ones, could be increased.

It may in principle be possible to delegate all or nearly all of the regulatory and oversight authority deemed appropriate in this field to one of these (or other) federal agencies. Alternatively, such authority might be divided among several existing agencies.

There would be several advantages to delegating any new authority to existing institutions. For one thing, it would circumvent the need to create a new federal regulatory body—a difficult and costly undertaking, with uncertain prospects of success and potential unintended consequences if it were to be established. A delegation of authority to an existing agency could probably be put into effect more quickly, as the basic mechanisms for oversight and enforcement would likely already exist, and the institutional resources for action would not need to be created from scratch. In addition, the authority could be delegated by integrating the new areas of oversight and regulation into existing patterns of regulatory activity, rather than, again, by beginning with a blank slate.

On the other hand, the delegation of oversight authority over reproductive biotechnologies to an existing federal agency would mean that no institution would have this arena as its prime or exclusive portfolio, and hence that the questions and concerns we have raised would not be anyone’s principal business. In addition, the structure, authority, experience, and expertise of existing federal agencies might not be quite suitable for regulating in this area. Each existing federal agency was created, and has evolved, to oversee a particular sort of activity, and the issues that concern us may not be a good match with any of them. The questions before us do not, for the most part, involve food or drugs, the control of disease, or the funding of scientific research, for instance. While they touch on these subjects, these questions should not be understood primarily through lenses developed for viewing other problems. There is also the further difficulty, intrinsic to all attempts at regulation, that the regulators may be co-opted by the interests they seek to regulate.

If Congress deems it necessary to delegate some new regulatory authority over the technologies we have discussed, the choice between delegating such power to a new federal agency or to an existing agency or agencies should come down to the question of whether this arena of technology and activity raises (or is likely to raise) fundamentally new and different sorts of questions and challenges from those that have been dealt with by existing federal agencies in the past. This is a complex question that certainly cannot be answered in the abstract; rather, it must be considered with regard to each particular target of potential oversight and regulation.

C. Particular Legislative Action

The two previous options assume some degree of delegation of authority by Congress for the regulation of these technologies in particular instances. Congress, however, may also decide to address particular issues directly and specifically through legislation. Acts of Congress are necessarily broader and blunter instruments than the particular case-by-case decisions of a regulatory agency, but they can also speak with greater force and authority in the public eye.

Of course, the delegation of power to a regulatory agency would itself be an act of Congress, but what we have in mind in this category of potential institutional change is the passage of laws that lay down distinct and precise rules that do not require a great deal of complex regulation, or much case-by-case judgment to enforce them. The issues would be dealt with legislatively rather than administratively. Such policies could involve limitations or prohibitions, but they might also involve means of support for certain technologies and practices, or offers of funding that might be made available through existing funding agencies.ii

Several advantages may be gained by proceeding through acts of Congress, rather than delegating judgment to an administrative agency. Such a process would be more democratic and more directly answerable to public wishes and concerns.

However, proceeding by acts of Congress would also limit the potential flexibility of oversight and legislation in this arena. It would make cast-iron prohibitions more likely and case-by-case judgment more difficult. It would also, of course, be slow and arduous, as past and present efforts to legislate policy regarding human cloning, genetic discrimination, and embryo research have already demonstrated. It may well be the appropriate means to achieve some potentially desirable reforms, but its limitations are apparent.

D. Federal Funding as a Regulatory Lever

A fourth institutional means for regulation involves the use of federal funding to encourage desirable practices and (by withholding funding) to discourage troubling ones. Federal funding can also be used as a more nuanced regulatory mechanism, since Congress can attach requirements to funding and compel all recipients to abide by certain rules. Indeed, this is an important way in which scientific research is currently regulated by the federal government. Researchers who receive federal funds, or whose institutions do, are required to abide by certain basic guidelines regarding clinical standards, human subject protections, the need to obtain informed consent, and other issues. Many people, including some members of this Council,iii believe that the current paucity of oversight in this field is owed mainly to the absence of federal funding of in vitro fertilization (IVF) research, and that it is only through federal funding that the public can gain some control over this sensitive area of biotechnology.

The question of funding is, however, quite complex and controversial. By offering funding for a practice, the government at least implicitly expresses a public endorsement, in effect pronouncing the practice worthy of a share of taxpayer money. This becomes a problem when the work in question is controversial, or when it is deemed unethical or otherwise unacceptable by some significant portion of the public. Those who oppose the practice neither want their own tax money used to support it nor wish to have their government express approval of it. It is largely for this reason that much of the work in the fields taken up in this report has never been supported with federal funds.iv

Of course, to refrain from offering funds is also a kind of policy decision, and certainly an act of Congress that expressly forbids federal funding of specific practices (as is the case with embryo research, for instance) is an explicit policy and a form of regulation.

Moreover, institutions that receive federal funds may sometimes be required to submit to government regulations even in their privately funded activities, so that the government can still reach and regulate those activities it does not fund directly. In such cases the costs of compliance to recipient institutions can be huge.

Federal funds, in one way or another, may therefore be used as a means of encouraging or opposing certain practices that are deemed to require government supervision. At the same time, there is no necessary relationship between regulation and direct funding: the government can and does regulate activities it does not fund.

E. Increased Oversight and Self-Regulation by Practitioners and Professional Societies

Finally, the status quo might be improved by augmenting and improving the mechanisms for self-regulation by practitioners and by the relevant professional societies. There is currently a fairly complex framework of self-regulation for the practice of assisted reproduction, administered by very well-organized and influential professional societies. These existing structures could be strengthened through increased oversight, enhanced penalties for noncompliance, and substantive changes to the content of the regulations themselves.

The potential benefits of this approach are manifold. First, because professional societies and practitioners have great institutional competence and expertise in the technical and practical aspects of their fields, they are uniquely situated to craft fitting and effective regulations and safeguards. Second, it would be symbolically very valuable to have the practitioners themselves draw boundaries and erect protective measures to defend against abuses and injuries to parents, to children, and to society at large. It would demonstrate that the mainstream community of practitioners is committed to preserving the human goods at stake and will not tolerate the transgression of ethical boundaries by irresponsible clinicians or scientists. Moreover, effective self-regulation could potentially insulate the mainstream community of clinicians and researchers from public criticism and from the possibly overbroad legislative response that might follow any disasters or tragedies flowing from the actions of renegade practitioners. Finally, it is likely (and reasonable) that practitioners would prefer to be regulated by their peers rather than by some external governmental body.

The possible drawbacks of self-regulation are fairly straightforward. There is the danger that some practitioners will not follow standards they regard as unduly burdensome, or that the professional societies will not enforce them.

II. SUBSTANTIVE OPTIONS

As we have already indicated, we are not now prepared to reach conclusions as to the best form of general regulation, not only because much remains unknown about the field, but also (and especially) because we must first decide what problems, if any, are sufficiently great to call for government action and, when they are, what sorts of action, if any, would be most beneficial. Nevertheless, the findings of our diagnostic inquiry identify several substantive areas of ethical and social concern that are of sufficient magnitude to warrant a consideration of the policy options currently available to address them. Once again, we describe these options, and their perceived strengths and weaknesses, without endorsing any of them.

The following, then, are some concerns that emerge from the diagnosis and findings laid out in Chapters 2 through 7, and some suggestions for possible ways of dealing with them. As will become apparent, in some instances we describe a variety of possible options, some of which may be mutually contradictory. In many cases, we do not yet have enough information to make a choice among the options (thus, the options include the gathering of such information). In other cases, there remain deep disagreements over matters of principle or between competing priorities. Our aim in presenting the following policy options is to map the landscape so that public discussion on these matters might proceed in a more informed manner, and to see whether some limited, specific, but perhaps much-needed action might be recommended by the Council.

A. Safety and Well-Being of Children Born Using ART

Among the ethical issues raised by the use of ARTs, the concern for the safety and well-being of children conceived through these technologies seems the one most in need of greater attention. Together with the safety of the women involved, it ought to be the first consideration (though surely not the only one) guiding the use of ART. But for various reasons described above, it appears to us that these concerns have not received sufficient attention.

It would of course be incorrect to say that no care at all is presently taken for the well-being of children later born, or to assume in any way that clinicians do not seek the well-being of the children who are to be conceived using ART. But institutional or public oversight in this area is limited, and those rules that have been set by professional societies tend to be vague and unenforced, although most clinicians are conscientious and try to follow them. And while most institutions, wary of malpractice suits, clearly try to avoid irresponsible or risky practices, we simply do not know how well they attend to the outcomes of interest here.

Several options for policy seem feasible in this arena:

1. Improved Annual Monitoring of ART Techniques and Outcomes.

The federal government could gather and compile more copious and specific data regarding the various techniques used and the outcomes related to such techniques in assisted reproduction procedures. The mechanism for collecting such information is already in place, through the CDC, and it could fairly easily be expanded or relocated as deemed necessary.v This information would provide more detailed data about what methods and materials are used in assisted reproduction procedures, with what effect on resulting outcomes.

2. Long-Term Longitudinal Studies.

The federal government might fund long-term longitudinal studies to track the health and well-being of children conceived using various ART techniques, as well as of mothers who undergo the procedures. Some information is currently available through relatively small-scale studies, mostly carried out abroad. More and better information is essential before further steps can be taken. Participation would of course be voluntary.

3. Improved/Expanded Decision-Making.

State and federal government or ART practitioners themselves might put in place an improved and expanded informed consent process for prospective parents seeking ART procedures. Such a process might provide more complete information about the safety and well-being of children born through ART, including any and all available data about frequency of birth defects and other problems, in comparison to children in the general population. It might also seek to develop uniform consent procedures regarding the disposition and fate of any unused embryos generated in the process.

4. Requirements for Higher Standards and More Substantial Animal Research before Moving Experimental Procedures into Clinical Practice.

Since ART practices are largely unregulated at present, techniques can move from the experimental stage to clinical use quite quickly. One prominent technique, ICSI (intracytoplasmic sperm injection), was introduced into regular clinical use with minimal animal experimentation and with no studies to follow up on anecdotal reports of hazards for the children produced. More rigorous standards may well be called for, and these might be developed and enforced by a government body, by the professional societies (such as the American Society for Reproductive Medicine [ASRM]), or by some combination.

5. Enforcement Mechanism if Studies Show That Certain Procedures Are Insufficiently Safe.

Should the data collected by any of the above methods, or others, demonstrate that a particular ART procedure is sufficiently unsafe to be restricted only to patients with particular characteristics or needs, or halted altogether pending further review, some means should be available to formulate that judgment and to enforce it. The institutional layout presented above may provide some sense of the possible place and character of such an enforcement authority, though the question of who should be given that authority would of course be a controversial one. At present, we do not have sufficient information about whether such an agency might be required, and what might be required of it, to proffer more specific suggestions.

6. Expanded/Publicly Funded Research with a View to Improving ART Procedures.

The safety, reliability, and efficacy of ART procedures would be improved and better understood if more studies were conducted to test various methods and techniques of assisted reproduction. More and better-funded research could help to improve the reliability and effectiveness of existing techniques and to more thoroughly assess new ones before they are brought into practice. Such funding would also facilitate greater public oversight of the research in question. The extent, character, and funding of such research would likely be controversial issues, even if the benefits would be substantial.

B. Equal and Improved Access to IVF/ART

Among the concerns we have described are not only problems of practice, but also problems of access. Assisted reproduction procedures can be quite expensive, and at this point access seems to be fairly limited. The present situation varies by state (with some mandating that insurance companies cover it to various degrees, while most are silent) and by insurance company and policy. Such a situation may of course be deemed acceptable, but if policymakers were to see a need for action, at the state or federal level, several related avenues of recourse may be available.

The most commonly discussed policy option would be to require insurance companies to treat infertility as a medical condition like any other and to offer coverage for all assisted reproductive procedures. In most cases to date, proposed policies mandate funding only under certain circumstances (for instance, only for married couples, or for women of specified ages) or couple the funding with guidelines for practice (mandates regarding efficiency of the procedure, number of embryos created and implanted, etc.). As noted earlier, studies have shown a connection between availability of insurance coverage and decreases in the number of embryos transferred per cycle.vi

C. Genetic Screening and Selection of Embryos for Non-Disease-Related Traits

The use of genetic screening and selection of embryos before implantation is, at the present time, unregulated and largely unmonitored. For the moment, to be sure, the options for such use are limited, since the technical capacity to select for particular traits is still relatively undeveloped. Today there are in general practice basically two uses for embryo selection outside the disease context: sex selection, and selection of embryos that could develop into genetically suitable organ or tissue donors. Both have already become quite controversial subjects, and as further techniques for selection are developed, new controversies are likely to emerge.

Should some oversight or regulation of this area prove necessary, it could take some or all of the following forms:

1. Increased Monitoring.

Regulation might begin with increased monitoring, to develop a clearer sense of the uses to which genetic screening and selection are being put and the degree and frequency of use. Such basic information is for the moment difficult to come by, and we may not have the kind of understanding of the status quo that would be required to make further judgments regarding regulation.

2. Review Mechanisms.

Beyond monitoring, Congress may establish new or improved mechanisms for reviewing non-disease-related uses of genetic screening and selection, setting a higher than usual bar for such techniques to pass before they are made generally available for clinical use or before they may be used in individual cases. Since very little information is available on the effects of screening and selection on the well-being of the child that results from the process, there may be a powerful case for such increased standards of scrutiny and care.

3. Limits on Non-Disease Uses.

Finally, Congress might consider placing limits or a moratorium on non-disease-related uses of screening and selection, whether in general or in relation to specific uses, such as non-disease-related sex selection. This would of course be quite challenging to implement, since it would require a fairly clear delineation of what are and what are not disease characteristics. It might also have certain unintended consequences, such as increasing the use of abortions (rather than preimplantation genetic diagnosis [PGD]) for elective sex selection. But policymakers may deem it sufficiently important nonetheless.

The various options along this continuum are not mutually exclusive; however, given our fundamental lack of data regarding the volume and popularity of such practices, and given the fact that most such practices are projected rather than current, it may be wise to begin with monitoring and data collection, so as to inform further decision-making in the future.

D. Intentional Germ-Line Modification of Embryos or Gametes to Produce Children

At present, germ-line modification of embryos and gametes with the intent to produce modified children is proscribed in practice by a decision of the RAC not to consider proposals for such work. But the moratorium could be overturned by a simple decision of the RAC, and it is also not clear whether it would apply to all potential modifications. Should it become technically feasible to safely correct single mutant genes in embryos or gametes, the RAC might relax its current proscription.

Given the fairly broad agreement in the country and Congress that germ-line modification should not now be attempted, Congress might institute, by statute, a national moratorium on germ-line modification to produce children, potentially including the following specific activities: (1) ooplasm transfer; (2) insertion of human genetic material into gametes or embryos with a view to fertilization and transfer to produce children; (3) insertion of animal genes or genetic material into gametes or embryos with a view to fertilization and transfer to produce children; and (4) insertion of artificial chromosomes, genes, or genetic material with a view to fertilization and transfer to produce children. Advances in technology and assurances of their safe and effective use could lead to a lifting of such a moratorium.

E. New Reproductive Possibilities That Alter the Biological Relationships between Children and Parents

A range of potential new reproductive technologies could mark a significant departure in human procreation, fundamentally altering the biological relationships between parents and offspring. In the future, for example, it might be possible to conceive a child using gametes obtained from an aborted human fetus or derived from embryonic stem cells. It might be possible to fuse blastomeres from two or more embryos to conceive a child with more than two genetic progenitors. It might be possible to conceive a child by transferring the nucleus from a person’s somatic cell into an enucleated egg, producing a child who is virtually genetically identical to the somatic cell donor (“cloning-to-produce-children” or “reproductive cloning”). Or it might be possible to “activate” a human oocyte, producing a child whose genetic heritage is derived from a single progenitor (“parthenogenesis”). Under present law, these (and other) reproductive possibilities would be legal if they were technically feasible. All would mark a significant crossing of boundaries in human reproduction, either by denying children the natural connection to two human genetic parents or by giving children a fetal or embryonic progenitor. To secure for children born with the aid of assisted reproduction the same rights and attachments as children conceived in vivo, Congress could pass a ban or moratorium on attempts to conceive a child by any means other than the union of egg and sperm, attempts to conceive a child using gametes obtained from a human fetus or derived from embryonic stem cells, or attempts to conceive a child by fusing the blastomeres from two or more embryos.

F. Commercialization of Elements of Human Reproduction

The commercialization of various elements of human reproduction is, for some, a further cause for concern and an additional potential target for regulation. At present, the buying and selling of gametes is essentially unrestricted in most states, as is, in principle, the buying and selling of embryos, though there is no evidence to suggest the existence of any market in embryos. The potential patenting of human embryos is also a source of concern: the U.S. Patent and Trademark Office has traditionally refused to grant such patents as a matter of institutional policy, and an amendment to a recently passed appropriations bill prevents (through fiscal year 2004) the issuance of patents on human organisms at any stage of development.

Possible policies in this arena include:

1. Limits or Restrictions on the Buying and Selling of Gametes.

If the buying and selling of human gametes is deemed troubling, Congress, or state governments, could set certain limits, potentially including a ceiling on the price of eggs or sperm, limits on advertising for or by gamete donors, or perhaps even a restriction on the selling of gametes altogether.

2. Limits or Restrictions on the Buying and Selling of Human Embryos.

Similarly, Congress, or state governments, might set limits on the buying and selling of human embryos, whether for research or for implantation.

3. Prohibition on the Patenting of Human Embryos or Gametes.

In addition, Congress could permanently amend the patent laws to specifically forbid the patenting of human embryos, or of human organisms at any stage of development. It could also enact restrictions on the patenting of human gametes.

G. Biomedical Research Involving Early-Stage Human Embryos/Blastocysts

Embryo research is certainly among the most controversial and politically sensitive of the practices we have discussed, and therefore difficult to regulate. Those who believe it should be altogether prohibited often oppose regulating it, fearing that by doing so the government might implicitly sanction the practice and assure its continuation. Others see no need to regulate such research at all and fear that new regulations will only slow down or hinder new research. Still others worry that regulations founded in concerns about embryonic human life would set a precedent that might have implications for abortion law or scientific freedom in general.

The result has been essentially no regulation and almost no federal funding of embryo research, but rather an official policy of silently allowing such research in the private sector without public endorsement or support. All embryo research (including research on embryos left over from IVF procedures undertaken initially for reproductive purposes, embryos created by IVF solely for research, and cloned embryos produced solely for research) remains legal in the private sector. If it is regulated at all, it is regulated only by institutional review boards (IRBs), which generally do not have special rules for research involving human embryos used for research purposes, and whose oversight almost never takes into account the moral questions relating explicitly to the destruction of developing human life. We have only very limited knowledge of the numbers, uses, and commercial applications of embryo research in the private sector.

In the public sector, funding of research that involves the destruction of human embryos is prohibited by law, though current policy allows for the funding of research using certain embryonic stem cell lines that meet a series of qualifications: they must have been derived from human embryos originally created solely for reproductive purposes, with the informed consent of the donors, and without any financial inducements to the donors, and they must have been derived on or before August 9, 2001.vii These funding guidelines, combined with the broader restriction on all other federal funding of embryo research, are essentially the only federal regulations on the subject at present. Some individual states have crafted their own policies, ranging from sharp restrictions on embryo research to encouragement and even funding of such work. But most states have no explicit policy of any kind.

Should a national policy be deemed necessary, several options seem plausible, at least in theory:

1. Expanded Restrictions.

Congress might choose to impose new restrictions on embryo research, including restrictions on privately funded embryo research. For example: It might restrict embryo research exclusively to left-over IVF embryos. It might ban or pass a moratorium on the production of embryos solely for research purposes. It might ban or pass a moratorium on the creation of cloned embryos solely for research. It might ban or pass a moratorium on the creation of other “unnatural” embryos, such as man-animal hybrid embryos or embryos formed using fetal gametes or gametes derived from embryonic stem cells. It might allow research only on existing stem cell lines, and ban all future embryo destruction for biomedical research. Or it might set an upper limit on the age to which an embryo used in research may be grown or used for research purposes.

2. Expanded Funding.

Conversely, Congress might choose to relax existing restrictions and offer increased federal funding for embryo research. For example: The federal government might choose to fund all promising embryo research without restriction, including the creation of IVF or cloned embryos solely for research purposes. It might fund embryo research on left-over embryos that were originally created for reproductive purposes. Or it might fund research on all existing stem cell lines, including those lines produced since August 9, 2001.

3. Expanded Regulation/Public Licensure under Certain Guidelines.

Congress might also explicitly permit or endorse embryo research within the framework of a regulatory system. This policy might involve requiring all embryo researchers to be licensed or registered; requiring embryo experiments to be approved case-by-case on the basis of whether they are deemed “scientifically compelling” by a panel of experts; or requiring each embryo used for research to be registered and the purpose of its use described and recorded. This regulatory option might be combined with new restrictions, new funding, or some combination of both. For example, the federal government might fund research on all existing embryonic stem cell lines while prohibiting future embryo destruction for research. Or it might fund research on both IVF and cloned embryos with extensive regulation, licensing, and approval requirements.viii

H. Implantation of Human Embryos into Human or Non-Human Uteri for Biomedical Research

At present, there are no federal laws or rules restricting or prohibiting the transfer of a human embryo into a human or non-human uterus for the purpose of developing it solely for research.

If this is deemed sufficiently troubling to require action, two general options present themselves:

1. Restrictions on Embryo Transfer for Research.

Congress might put into effect a ban or moratorium on the transfer of human embryos to a woman’s uterus purely for research purposes. The law could also be more narrowly tailored, if desired, to restrict specifically the transfer of embryos into animals, human uterine material outside the body, (prospective) artificial wombs, or any combination of these, with the intent to keep such embryos alive purely for purposes of research.

2. Time Limit on Embryo Use.

Concerns on this score might also be addressed by prohibiting research on embryos beyond a certain age or stage of development.

III. CONCLUSION

At present, given the limited availability of data, we are not in a position either to recommend or to reject most of the options described in these pages, be they general institutional reforms or specific substantive policies. Some options may be deemed unacceptable on the basis of moral, ethical, or practical considerations independent of any information that might be gathered; others may turn out to be unwarranted or unwise as the nation learns more about the field; while yet others may prove to be desirable and sensible in light of new data still to be collected. No overarching policy direction in this arena can or should be set before substantially more and better information is gathered and before all interested parties are thoroughly consulted as potential policy options emerge.

There may, however, be some interim steps that would be advisable while the process of contemplating potential policies progresses. These involve both essential information gathering and some modest interim legislative action or policy reforms that may be deemed appropriate on the basis of the information we already possess and the findings of our preliminary inquiry. We offer some recommendations along these lines in the next (and final) chapter.

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Footnotes

i. Erik Parens and Lori P. Knowles advocate the creation of a standing federal entity to “facilitate reasoned and systematic public and policy deliberation about the purposes of reprogenetic research and practice.” This board would “resemble Britain’s Human Fertilization and Embryology Authority.” (Parens, E., et al., “Reprogenetics and Public Policy: Reflections and Recommendations,” Hastings Center Report, July-August: S1-S24 [2003].)

ii. Regulatory possibilities tied to the awarding of federal funding are discussed in the next section of this chapter.

iii. See, generally, the comments of Dr. Janet Rowley during session 2 of the January 15, 2004, meeting of the Council, available at www.bioethics.gov.

iv. This “failure to fund” was the issue that triggered public debate about embryonic stem cell research, a matter we have reviewed at length in our report on Monitoring Stem Cell Research.

v.Indeed, the CDC already collects some relevant data that it does not now publish; a simple requirement to publish the data in hand could be most helpful here.

vi. For instance, see Jain, T., et al., “Insurance Coverage and Outcomes of In Vitro Fertilization,” New England Journal of Medicine 347(9): 661 (August 29, 2002).

vii. For a discussion of the federal policy regarding the funding of human embryonic stem cell research, see the Council’s report, Monitoring Stem Cell Research, especially Chapter 2.

viii. To repeat, there is no necessary connection between public regulation and public funding. The government often regulates activities that it does not fund—as is the case with workplace safety regulations, and rules governing air travel, telecommunication, broadcasting, banking, and numerous other industries.

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