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A Proposal for Modernizing the Regulation of Human Biotechnologies

BY FRANCO FURGER AND FRANCIS FUKUYAMA

In 1995, according to the Centers for Disease Control, over 280 fertility programs operated in the United States. Ten years later, in 2004, this figure had grown to 411, a 47 percent increase over a ten-year period – although since these figures do not include nonreporting clinics, the actual numbers may be even higher. Should this trend continue, procreation by technological means is likely to become a serious option for a significant fraction of the public.

Should we care? Let’s begin with a prosaic but important question about the safety of assisted reproductive technologies (ARTs). Practitioners are quick to point out that the safety record of ARTs is excellent. The claim has more than a grain of truth, but on close examination some doubts emerge. Because the industry has never implemented a robust system of health monitoring, it is in no position to reliably assess the health of children born using ARTs. A recent and thorough review of the medical literature on this subject, conducted on behalf the American Society for Reproductive Medicine, found essentially no reason for concern, but the study has never been published – only brief summaries of its main findings have been offerered for public scrutiny. As long as “we don’t know what we don’t know,” categorical statements about the safety of ART procedures seem premature.

Still less confidence is possible about the questions raised by the innovative treatments sometimes pressed into service in the quest to satisfy parents’ desires. In 2001, for example, news broke that an ART clinic had experimented with ooplasm transfer, a reproductive procedure that relies on the reproductive tissues of three individuals – sperm from a man, nuclear genetic material from a woman, and the cytoplasm (including mitochondrial DNA) of a second, younger woman. Children born through this procedure have three parents, although the fraction of DNA inherited from the third parent is very small.

Other innovations in ART have the effect of expanding the scope of the field from basic assisted reproduction toward customized conception. For example, preimplantation genetic diagnosis, initially developed to prevent the transmission of dreadful diseases, is increasingly used to prevent minor birth defects and to choose the sex of a baby. ART doctors also rely on PGD to select children for tissue matching – that is, to select children that the parents intend to be tissue donors for older siblings affected by severely debilitating conditions. PGD does not permit literally customized conception, but it certainly gives prospective parents considerably more control over the procreative process.

Meanwhile, some lines of basic medical research could change the biological foundations of human reproduction. In the last few years a series of experiments has shown that it may be possible to create artificial eggs and sperm from stem cells, which would open up entirely new reproductive possibilities. Lesbian couples could have their own biological descendents, for example. So far, these experiments have been conducted only on animal models, but there is no reason to believe that scientific research will stop there.

Nor should we think that commercialism lags far behind. Already people have spotted lucrative new business opportunities. Last year, an entrepreneur in Texas began offering “made-to-order” human embryos. If the present trend continues, the trade in human eggs may become an important source of revenue, at least for low-income women and students. And the sale of sperm can almost be considered a staple of American cultural traditions.

Identifying Appropriate Societal Responses

Libertarians will probably claim that these examples do not justify regulation. In their view, government should intervene only when an activity can be definitively shown to cause harm, and “harm” should be narrowly construed to mean physical harm. To be sure, the excesses of the regulatory state offer many familiar cautionary tales. Nonetheless, the libertarian stance fails to take account of the fact that in reproductive matters, individuals are making decisions not just for themselves, but for others as well. We are all quite accustomed to taking precautions even when we have no definitive proof of an actual harm. We buy earthquake insurance, we exercise regularly, we avoid fatty foods or quit smoking, and we wear helmets while riding bicycles. Governments in all liberal democracies have been operating in a similar way for a long time. In many instances, the risk to an individual may be minimal, but its societal impact may be quite significant.

At least in general terms, it is quite clear where reproductive medicine and biomedical research are headed. Over time, more effective reproductive techniques and new cures will become available. Simultaneously, ART technologies will continue to evolve from techniques that merely help people have children into tools for customizing and enhancing their children. We will move toward “reproductive customization,” understood literally: couples and increasingly individuals will have at their disposal a range of reproductive techniques to make specific choices about a baby’s health and sex, and eventually about other attributes as well, physical or cognitive. As a 2005 report by the Genetics and Public Policy Center demonstrates, the technologies available today to perform human germline genetic modifications (which would be passed through the germ cells from one generation to another) are far from mature. Enhancing higher cognitive traits is certainly beyond our present capabilities, but that will not stop molecular biologists from developing better and faster techniques for modifying the human genome.

Against this background, we believe it would be misguided to take a wait-and-see attitude. It would also be illusory to assume that we can respond by resorting to the arsenal of existing laws and regulations. As we discussed in some detail in our report, Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies, the federal statutory system is patchy at best; it was designed only to address concerns about safety and efficacy, not to sort out unfamiliar and difficult ethical dilemmas. State-level laws for their part do not fare much better.

As the history of the regulatory state clearly demonstrates, adopting reactive, sweeping legislation would most likely be counterproductive, as drawing the kind of fine distinctions that many biomedical developments require would become impossible. Nor is self-regulation adequate for this field: conflicts over the use of novel reproductive techniques should be resolved by political institutions, not private entities. For these reasons we believe that a new regulatory architecture is needed. It must be flexible and dynamic, yet rooted in broadly acceptable ethical principles, and it must be protected from the political and administrative pitfalls into which regulation on controversial matters easily falls.

What we propose consists of a set of ethical guiding principles, a series of prohibited and regulated activities, and a new regulatory institution. In the enabling legislation, Congress would spell out the ethical principles it considers indispensable to inform the operation of the newly established regulatory agency, identify which activities should be taken off the table up front and which can be performed under suitable regulatory oversight, and establish in some detail the structure of the new regulatory institution. Finally, Congress would also adopt a number of procedures beyond the usual requirements of the Administrative Procedure Act that are designed to ensure agency independency and to prevent administrative drift.

The New Architecture

The ethical principles we have identified in our proposal touch upon several basic aspects of the human experience. They reflect what we believe are widely shared values, not only in the United States but also in many other Western democracies:

• Children’s well-being and health should be protected.

• Biomedical procedures on human embryos must respect their intermediate moral status.

• Infertile couples’ access to ARTs should be promoted.

• Women’s well-being and health should be protected.

• Those making use of ARTs must give free and informed consent.

• Therapeutic uses of biomedicine should be favored over enhancement uses.

• Limits on the commercialization of eggs, sperm, and embryos should be imposed.

Some of these principles, like protecting the health and well-being of women or requiring informed consent, are hardly controversial. Others, such as ensuring the health and well-being of children, should be considered uncontroversial but are likely to be regarded suspiciously by some. Still more controversial is requiring regulators to favor therapeutic over enhancing applications. We realize that this guiding principle is just that – an obligation to make what in reality may be arduous determinations fraught with ambiguities. But these determinations are no different from the choices that courts are called upon to make in this country on a daily basis. As a matter of practice, even uncontroversial ethical principles such as ensuring the effectiveness of a medical device can raise difficult interpretive questions. Yet the Federal Drug Administration makes such determinations all the time – without having analytical, unambiguous definitions at its disposal.

Finally, we decided to call for regulators to sort out ethical dilemmas based on a view of the embryo as neither a mere clump of cells, nor the moral equivalent of an adult individual. We do not believe an embryo deserves the same legal protection as someone already born. At the same time, it seems to us that an embryo is more than just biological material and deserves a measure of respect. This position – consistent with the view expressed in 1999 by the National Bioethics Advisory Commission in its report on stem cell research – won’t satisfy pro-life advocates, but it is defensible and creates a much-needed space for political compromises.

Among the activities we believe Congress should ban up front are reproductive cloning, germline genetic modifications, and certain forms of human-animal chimeras and hybrids. Among the activities to be permitted but regulated is research cloning – that is, somatic cell nuclear transfer for research purposes, preimplantation genetic diagnosis, and biomedical research involving early stage embryos, among other things. These suggestions are neither exhaustive nor definitive. One could easily imagine prohibiting research cloning, at least for a while, or permitting but strictly regulating certain forms of germline genetic modification, for that matter. Pondering whether elective sex selection should not at least be regulated may also be worthwhile. In our view, which legal and ethical stance Congress might take is ultimately less important than establishing a precedent for making legally binding distinctions between acceptable and unacceptable reproductive practices.

What would a regulatory agency charged with implementing congressional intent be like? It should operate according to several basic principles. First, all affected constituencies should perceive it as independent: that is, it should be able to generate regulatory choices regarded by all affected parties as not unduly influenced by polarized interest groups. In the current charged political environment, this requirement needs no further elaboration. A second basic requirement is accountability: regulators should not be able to make what in the legal jargon are known as “arbitrary and capricious” decisions. Third, the agency should be perceived by all interest groups and by the general public as authoritative: regulators should be not only technically competent but also morally credible. Scientific competence without moral authority would be just as inadequate as moral authority without scientific competence.

At first, efforts to reconcile independence and accountability may appear contradictory. It would seem that independence can be achieved only at the expense of accountability, and vice versa. On closer examination, the contradiction disappears. An independent commission affords its members a measure of autonomy, especially with regard to the Office of the President. It is also well suited to perform what amounts to a quasi-judicial function: its members are selected by the president but confirmed by the Senate. Their appointment is stacked, and the president can remove them from office only in special circumstances. Finally, an independent commission operates in a deliberative, consensual manner.

Ensuring accountability – making sure that organized interest groups do not exercise undue influence (what is generally known as regulatory capture) – requires some ingenuity. According to the Administrative Procedure Act, regulatory agencies must publish a proposed new rule in the Federal Register and solicit comments from all interested parties before finalizing a new rule. This provision, known as “notice-and-comment,” was intended to ensure a measure of accountability: agencies are required to respond to every substantive comment and to take it into consideration. The courts have repeatedly underlined the need for regulatory agencies to provide extensive and detailed justifications for their regulatory interventions.

These judicial decisions, known as the hard look doctrine, have had several unintended consequences. One is that regulators must consult extensively with those organized groups most likely to challenge a new rule in court. In the context of reproductive medicine and biomedical research, consultation with organized interest groups is likely to produce political gridlock. This outcome would be particularly problematic in light of the fact that (as we show in Beyond Bioethics) the general public is far more centrist on many controversial issues than either the proscience or the pro-life camp. Deadlock in such a scenario should not be accepted as an unfortunate yet normal outcome of a functioning political system. Rather, it indicates a special kind of political failure: the failure of our administrative system to ensure that all societal perspectives, not just those of organized interest groups, are heard.

To prevent regulatory deadlock, we propose to complement notice-and-comment with a robust procedure of public consultation. One can envision different ways to implement a consultative process, but the following requirements should always be met: the consulted sample of the public should be representative of the population at large, the consultation should be deliberative – that is, based on two-way communication – and the outcome should reflect informed opinions. In addition, the process should be designed so as to avoid polarization: it should promote reciprocal understanding among participants rather than reinforce the prejudices the participants held before the consultative process began. Public consultation is not meant to produce a consensus, but it is certainly intended to promote consensual views.

The results of a consultative process are in no way binding. Regulators would be free to propose a new rule that departs significantly from the recommendations emerging in a public consultation. If they do, though, they would be required to provide a detailed rationale for ignoring informed public opinion. This gives regulators a strong incentive not to favor a special interest group over a clear consultative outcome. The agency would have to consider the possibility that the judiciary will review whatever rules it proposes – a possibility that, given the history of the regulatory state, seems quite real for any rule bearing on matters of reproduction. Furthermore, in particularly controversial cases a blatant abuse of administrative authority would likely attract wide public attention and eventually trigger intense congressional scrutiny. Most of the time, the combined risk of judicial review and public scrutiny should deter the agency from catering to special interests. In sum, a process of public consultation would ensure that a formally independent regulatory agency would be held accountable and that “arbitrary and capricious” decisions would be reduced.

Failure to ensure that all societal perspectives are heard is a problem not limited to reproductive medicine or biomedical research; it is quite common across the regulatory state. Regulatory agencies from the Environmental Protection Agency to the Department of Energy and the Occupation, Safety and Health Administration have a long history of producing regulatory decisions driven by the most influential interest groups, to the detriment of the public at large. Commentators and practitioners have long ignored this phenomenon, however, for two main reasons. With the arrival of the theory of public choice in the 1960s, scholars of the administrative state largely abandoned the thought that regulatory and political action was based on the notion of public interest; they held instead that nothing more than the aggregation of self-interested motives explained what went on in government.

Some find this analysis of politics excessively cynical, but it has been tremendously successful in illuminating many administrative and political phenomena. On the other hand, it has prevented scholars and practitioners alike from focusing on serious shortcomings of our regulatory system, such as capture by special interests. If the concept of public interest is held to be vacuous, then politics is nothing but a war between different special interests, and the only possible way of explaining a political outcome is to identify which interests won out. Our discussion suggests that, conceptual difficulties notwithstanding, it is easy to point to cases in which the public interest is being systematically ignored.

A second important reason for ignoring the failure to look beyond special interests is that there seemed to be no practicable way to correct the problem. Until recently, no viable options were available to mobilize a large, unorganized political constituency. Information technologies are now changing all this. For the first time in the history of modern liberal democracies, it is becoming possible for the public to take on an active role in politics outside regular elections and referenda. This possibility should be taken seriously and put to use. Internet telephony, combined with e-collaboration solutions, makes bringing together a large number of citizens fairly easy.

In this way, we can move decisions about reproductive ethics into the political realm, where they can be debated by the broader community. These decisions concern the future of mankind. They should not be left simply to individuals and the market.

In the commentaries:

• James Fossett argues that regulation is likelier – and would be better – at the state level

• Leonard Fleck calls for more robust public involvement

• John Robertson recommends sticking with the status quo

• Josephine Johnston examines Furger and Fukuyama’s suggestion that children have a right to a traditional genetic parentage

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Last Updated 6 November 2007