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Abstract

Precautionary reasoning has deep historical and wide cross-cultural roots in the ethics of health, health care, and medical research. As in general ethics, however, this side of bioethical thinking has not been the subject of focused critical analysis until recently. The emergence of the precautionary principle (PP) in general environmental and technology policy debate has, after an initial period of confusion, resulted in a range of possible ideas about the value of precaution and what sacriﬁces it may be worth. This has indicated some need for developments in ethical as well as decision theory. In bioethical debates, this process has left only vague traces, however. Although many issues exist where precautionary reasoning has a place, this is either often left unnoticed or arguments developed suffer from elementary ﬂaws. Environmental and general public health ethics, the ethics of evidence-based practice in research, as well as clinical decision-making, management of normative or factual uncertainty, and the nature of clinical ethical virtues are all areas where precautionary ideas seem to have a place. Such reasoning moreover has speciﬁc relevance for global approaches to bioethics and health policy issues in a number of ways.

Introduction

Precaution as a concept in ethics is about the moral reason for and value of taking extra care in the face of uncertain or unknown outcomes of decisions. Historically, this theme may be traced back to both eastern and western moral philosophy and religious ethics, such as the roles of courage, patience, and self-control in the ethical ideals of Aristotle, as well as similar notions in earlier Buddhist, Taoist, Hindu, and later Islamic traditions. Outside of this virtue ethical domain, related themes ﬁgure for instance, in David

Hume’s classic defence of private property, or the generic ideas of negligence and recklessness as forms of legal culpability in the philosophy of law. The more speciﬁc notion of a precautionary principle (PP) is more recent, however, and its wide impact has its roots in the U.N. Rio Declaration of 1992 and its mention of a “precautionary approach” to be applied in policy making on environmental and technological issues. This launched the notion of precaution as a central ethical theme, besides sustainability. As a consequence, there are now different policies in different countries and areas, mandating decision makers to take preventive action in the face of unknown, uncertain, or probable dangers.

The background motivation for PP is the experience of how seemingly valuable and promising practices may lead to seriously adverse results in spite of lack of solid evidence to that effect. Thus, PP emerged as a clearly global concept (with global historical roots), distinguishing it from many central notions in state-of-the-art bioethics, such as the “four principles”, with a distinct European or North American legacy. At the same time, the underlying value conveyed by PP, about being careful in the face of uncertainty and danger, is an age-old motif of health care institutions and the ethos of medical professions – visible whenever needs of garnering information to make responsible decisions are emphasised, such as in African rituals of divination and the Hippocratic dictum of “primo non nocere” – and provides a core rationale for medical research.

This entry ﬁrst presents the general philosophical ethical debates on PP and precaution. Second, it describes how issues of a precautionary nature and PP-type ideas and arguments occur in different strands of bioethics discourse. On this note, some weaknesses and theoretical gaps are pointed out. Third, some speciﬁcally global aspects of precautionary thinking in bioethics are set out. The concluding section summarizes the main points and sketches some suggested directions for future work.

General Ethics And Philosophy Debates

Within general ethics and philosophy, PP has been criticized on three main fronts: for lack of clarity, for lack of practicality, and for ethical implausibility. The discussion has shown that PP may be interpreted in a multitude of different ways, some of which convey ethical ideas that may accommodate much of common criticism (Munthe 2011). Building on a seminal analysis by Per Sandin (1999), followed by similar suggestions by Manson (2002) and Gardiner (2006), the generic idea of PP offers a variety of possible interpretations of interest to many ﬁelds of study. The most interesting aspect from an ethics standpoint is the suggestion that “in the face of an activity that may produce great harm, we (or society) have reason to ensure that the activity is not undertaken, unless it has been shown not to impose too serious risks” (Munthe 2013). This prescriptive or strong idea needs to be distinguished from what has been called the weak or argumentative idea behind PP (Gardiner 2006; Roeser et al. 2012) which merely says that acting on weak evidence may be acceptable when much seems to be at stake. Further sharpening the understanding of PP requires a basis for assessing

What determines whether an activity may produce great harm
What determines whether or not some risk is too serious
What is required to show that too serious risks are not imposed

It is far from clear that these issues can be satisfactorily attended to using ready-made standard models in decision theory, ethics, and/or political philosophy. In particular, the recurring idea of understanding PP as a formal decision rule, such as the maximin strategy, has proven highly problematic (Munthe 2013; Roeser et al. 2012).

The claim that PP is impractical holds out its prescriptions as impossible to satisfy. This is because it is either assumed that the standard regulating what it takes to show that some activity does not impose too serious risks is very demanding (McKinney and Hill 2000) or that PP generally bans (very) risky action, in effect forbidding us to do any of the things we can do, including the option of “doing nothing” (Harris and Holm 2002; Sunstein 2005). This argument connects to the idea that PP cannot take into account variations in probability, outcome value, and so-called opportunity costs of options and therefore violates basic tenets of standard risk-cost-beneﬁt analysis (RCBA). However, these arguments may instead be taken to show merely that a desideratum for a sound version of PP is that it avoids such extreme implications (Munthe 2011).

Claims that PP is generally ethically implausible have come in three forms. One assumes that PP arbitrarily exempts the option of preserving the status quo from scrutiny, thereby faulting its own rationale (McKinney and Hill 2000). Another assumes that taking precautionary action in the face of potentially risky activities cannot take into account the costs, risks, and uncertainties of this very action (McKinney and Hill 2000; Harris and Holm 2002; Sunstein 2005). The third objection conjectures that political implementation of PP would have to break with political values such as science-based policymaking or individual liberty (Sunstein 2005). Sunstein has insisted that the only alternative to PP is standard RCBA, essentially expressing the decision theoretical idea of maximizing expected utility and that PP therefore has to express deeply irrational sides of human nature. Such general attacks become less convincing in view of the many ways of interpreting PP, given by answering the questions (1–3) posed above. PP may be as applicable to the option of preserving status quo as to other options, and the answer to question (1) may include a threshold that restricts the choices or options to which PP is applicable, although the form and basis of such a threshold has been debated (Roeser et al. 2012; Munthe 2013). One idea is some variation of the classic de minimis risk notion from decision theory (where very small probabilities are excluded from a decision calculus); another is to restrict PP to options where some of the possible outcomes are especially sinister –often described in terms of catastrophe or irreversible damage– or when the evidential basis of decision-making is particularly weak. The answers to questions (2) and (3) may furthermore allow versions of PP that take opportunity costs and degrees of riskiness and uncertainty into account, without making it identical to standard RCBA (Munthe 2011, 2013; Roeser et al. 2012).

Within the frame of avoiding the criticism just described, there is plenty of room for arguments concerning which more precise PP may be ethically justiﬁed. This encompasses three distinct challenges (Munthe 2011):

(a) Supporting and clarifying the idea that lack of precaution has a moral price (i.e., that we have some reason not to impose or allow impositions of risks)

(b) Acknowledging that precaution also has such a price (since any measure to prevent or reduce a risk will bring costs and risks of its own)

(c) Balancing (a) and (b) in a way that provides reason for believing this version to prescribe an ethically acceptable price of precaution

The general idea of (a) goes well with common sense opinions in health-related policymaking (e.g., trafﬁc rules, safety assurance of pharmaceuticals, and communicable disease management), as well as in private life (inconsiderate, reckless, or negligent behavior imposing signiﬁcant risks to the well-being or liberty of others). Although modern ethics or moral philosophy have not until recently focused their attention on such phenomena (Asveld and Roeser 2009), they are an obvious part of human moral thinking, institutionally present within such spheres as law and constituting an essential part of medical ethical thinking. It is important to note that the balancing of (a) and (b) is not only about weighting predetermined risks and chances of predeﬁned options according to a predeﬁned decision rule (thus, not only actualizing standard RCBA thinking). Rather, it likewise involves the question of how to assess the ever present option of delaying decision-making to improve the basis of information or knowledge that underlies any risk assessment. This issue becomes especially complex in cases where the activity itself is pondered for precautionary or risk-reducing reasons; a common enough situation in the settings of health care, medical research, and public health.

The requirements by this approach to ethically clarifying and justifying PP has been conjecture not to be met by standard solutions in decision theory or ethics (Asveld and Roeser 2009). The idea of modifying classic approaches in ethical theory to this effect has been assessed with skeptical results (Munthe 2011). Rightsand justice based ethical theories assume rather than provide reason for the claim that risks are ethically important in their own right. Consequentialism encounters problems in justifying how the imposition of risks and chances is to be balanced against the occurrence of actual harms and beneﬁts. Natural law theories struggle to ground an even elementary coherent notion of how risk impositions may be absolutely morally wrong as such. Justifying a speciﬁc PP may thus require some ethical theoretical innovation, observing the formerly mentioned desiderata implied by the criticism against PP. This generates difﬁcult problems for attempts to recreate absolutist ethical ideas in the form of an ethics of risk, as that of Hans Jonas (Jonas 1979). The need for having a version of PP that is practically useful provides further reason to the same effect. A virtue of precaution may have a place in an ethics of risk making sense of general precautionary reasoning (Sandin 2009), but personal qualities of decision-makers do not seem central to assessing policy decisions or regulatory frameworks of the sort primarily targeted by PP. An adequate theory thus needs to be gradualist rather than absolutist and primarily focus on decisions and risk impositions. Virtue ethical renderings of suitable elements of precaution to include in particular contexts may follow as a secondary outcome.

A central problem for any such theory relates to the basis upon which decision-making may or may not be halted in order to improve the quality of the information underlying a risk assessment (which itself is a decision to which PP applies). Making PP sensitive to the probability and outcome variations of options, as well as their opportunity costs –thereby creating compatibility with the basic form of an RCBA– requires that the combination of the beneﬁts and harms of possible outcomes and the likelihood of these outcomes are accounted for but not that these are the only factors that matter. Thus, it has been proposed that making a decision on the basis of information that could be improved is a moral downside in its own right (Munthe 2011). Moreover, an ethics of risk meeting these standards need not –as is the case in standard RCBA– observe risk neutrality. Risks and chances need not be evaluated on the assumption that harms and beneﬁts of equal magnitude balance each other out perfectly from an ethical point of view, independently of the surrounding context. Instead, an idea of an increased moral weight of evil may be applied: harms and beneﬁts of equal magnitude are assessed differently in terms of moral importance or seriousness, so that risks involving the possible occurrence of worse consequences become more difﬁcult to justify in terms of compensating beneﬁts in a way disproportionate to their comparative magnitudes. This idea has been defended on the ground that the choice between two lotteries, with equal probabilities for winning or losing but with radically different stakes (say, losing a modest amount of money or winning the same sum, as opposed to losing all your material possessions or doubling them), is not indifferent from an ethical point of view, although this would be implied by the idea of risk neutrality and RCBA (Munthe 2011). Another critical issue is if the underlying justifying basis of PP should take the form of a moral right not to have risks imposed by others (Asveld and Roeser 2009). This may be problematic, since many risks relevant from the perspective of PP are the results of many individual actions taken together, thus making the responsibility for securing a plausible price of precaution a collective matter and, ultimately, the value of precaution into a public good (Munthe 2011). To secure defensible precaution for all (e.g., in the management of a serious pandemic or in organizing a health care system providing equal access to a certain level of care relative to need), it may be necessary to expose single individuals to loss, harm, or risk that cannot be balanced by any contribution to the prevention of any such downside for a particular individual, albeit all people may share in the resulting increase of safety. This mirrors well-known tensions within bioethics and public health ethics between traditions and topics where more individualistic stances may seem apt and those where more collectivist or community oriented approaches are held out as primary.

Precaution And PP In Bioethics Discourse

Within bioethics, Bibliography : to PP or the value of precaution occur primarily in four contexts. First, when more traditional bioethics topics pertaining to the use and conduct of health science are linked to broader policy concerns, for example, those that have far-reaching environmental and technological impact, such as environmental health management or primary public health policy and safety system infrastructure management (Resnik 2013). In this area, PP-inspired arguments from the environmental and technology policy areas apply to issues such as the use of pesticides to battle insect-borne diseases, the effects of engineering solutions to tackle the impact on health of climate change in coastal areas, global use of genetically modiﬁed crop to tackle undernourishment, and other public health challenges. Other scenarios include disseminating (what is hoped to be) human enhancement drugs into the drinking water, common foods, or the atmosphere. Controversies may here be predicted to be similar to those arising in general environmental and technology policy, and the importance of formulating a PP capable of accounting for varying opportunity costs and evidence levels as well as the point about precaution as primarily a public good is therefore salient. Although there are a few exceptions, just as the general area of environmental health ethics has not yet been in focus among bioethicists, this more general way of framing bioethical discussions as parts of more overarching policy projects actualizing precautionary concern needs development.

Second, the issues of when available information is sufﬁcient to make decisions, when one should delay decision-making and pursue more solid evidence, and how risks and chances should be balanced in view of the options and stakes present once the evidence is good enough often arise in clinical care, medical research, as well as the transition in between them. One example of this is the issue of so-called stopping criteria for clinical trials (Malmqvist et al. 2011), when apparent outcomes seem to affect the stakes and/or risks considerably, albeit the evidence base may still be weak. A classic example occurred when new treatments for AIDS were tested in the early 1990s and some centers wanted to discontinue (and give the new treatment to all patients) in view of apparent good results, although that would delay the time to the level of evidence for effectiveness targeted (and required by licensing authorities) considerably. A similar question arose more recently, due to the 2014 Ebola outbreak in parts of West Africa, as discussions around applying unproven drugs gave rise to debates, eventually shifting to the beneﬁt of prioritizing more proven clinical and public health strategies. Another example comes from high-tech biomedical research, where the general discussion of the idea of changing the human genome and recent plans to attempt so-called mitochondrial replacement involve debate on how to assess the long-term uncertainties implied by these and many other reproductive medical procedures. Similar discussions apply to other instances of emerging medical technological procedures with potentially wide impact coming out of areas such as nanotechnology and synthetic biology. In all such areas, one may predict debates on the proper “price of precaution”, as theoretically possible health gains are set against problems in reducing uncertainty and ignorance with regard to efﬁcacy and negative side effects (Munthe 2011). In such debates, the issue of how to assess “the weight of evil” in a precautionary argument will have critical importance. For instance, a position of increased “weight of evil” means that precaution is worth less of a price when affected parties have less to lose by taking risks to improve their situation (depending on the gravity of conditions as well as the nature of alternative procedures). This issue moreover appears regularly as part of the core ethical aspects of assessing treatments for orphan diseases, due to the difﬁculty of meeting standards of evidence in research that makes it very difﬁcult for these to have “been shown not to impose too serious risk” on similar conditions as other procedures (Vos et al. 2004). Likewise, critical discussions of how much evidence is needed in order to motivate public health measures in general have been highlighted lately (Attena 2014). A further research ethics area of interest from a precautionary standpoint relates to the so-called dual use problem of how to assess the development of technologies which may be used for bad as well as good purposes (Kuhlau et al. 2011). Finally, this issue seems to be what underlies current critical debates around research ethics regulation on the basis of its possibly doing more damage by forestalling or delaying medical advances than good by protecting patients against infringements (Wilson and Hunter 2010).

Third, precautionary arguments are recurring in various debates where the issue of moral status takes center stage, such as abortion, embryo research, preimplantation genetic diagnosis, and animal studies. It is, for instance, a common argument of supporters of prolife positions with regard to practices involving the destruction or killing of fetuses or embryos, to argue that the mere possibility of these entities possessing a moral status that would ground a moral ban on destroying or killing them is reason enough to support bans or restrictions (Mahoney 1984; Ford 1990). Similar lines of reasoning have been proposed regarding the use of animals in research (Bradshaw 1998). Another variety of this type of precautionary reasoning, found across a large span of bioethics discussions, does not link to explicitly moral uncertainty but instead holds out expectations or a possibility of some outstandingly serious effect (good or bad) as silencing all other reasons –pro or contra– some procedure. A special case of this variant has recently occurred in discussions of so-called existential risks or “ultimate harms”, where the mere possibility of outcomes such as humanity being eradicated sometime in the future is held out as a reason in itself to, for instance, prioritize research on the prevention of such eventualities. All of these cases, however, exemplify uses of PP or precautionary reasoning which are vulnerable to the standard objections regarding impracticality and ethical implausibility earlier described. While a version of PP which avoids such criticism would certainly not disregard the possible outcomes mentioned (e.g., that destroying an embryo in an IVF lab is a morally banned act of murder), neither would it disregard all other normatively relevant possibilities, such as not acting according to the reproductive wants of IVF couples being a grave wrong, while embryos possess no moral status whatsoever. Just mentioning one possible downside or upside of an option –however sizable– will not settle the issue from a precautionary standpoint. Neither will it by itself determine what price of precaution in terms of risky actions and lost beneﬁts of alternative ventures is justiﬁed. Thus, developing precautionary arguments of this sort into a convincing form would require quite a bit of revision of currently existing versions to ﬁt underlying plausible theoretical models of PP.

Finally, while the notion of precaution is seldom explicitly mentioned in these contexts, precaution is a salient part of health professional virtues or ethoses. Traditional virtues, such as courage, temperance, conscientiousness, prudence, and beneﬁcence, can all be partly spelled out in terms of precaution in clinical decision-making. Precaution spelt out as a virtue of clinical decision-makers (doctors, nurses, pharmacists, and others) should be possible to design with all the nuance and sensitivity to varying likelihoods and outcome-values, quality of evidence, and opportunity costs required to avoid obvious implausibility (Sandin 2009). It is a general weakness, however, of virtue ethical discourse to usually avoid making concrete issues of balancing competing reasons in decision-making more precise, and this applies also to the medical ﬁeld, as virtue approaches to bioethics tend to take a rather abstract route, with unclear implications for clinical decision-making. This suggests the need to develop the analysis of what clinical virtues there are, what they imply concretely for practical clinical decision-making, and what role a nuanced idea of precaution may play in that context.

Precaution And PP: Specifically Global Aspects

As mentioned at the outset, the basic ethical concept of precaution has far-reaching historical roots across many cultural traditions. At the same time, as just mentioned, it remains to spell out how a theory of clinical virtue provides room for nuanced and defensible precautionary thinking. Working that out may plausibly start off in a practice-oriented approach where the starting point is studies of how decision-making is actually experienced, handled, and judged within different clinical professions across countries and cultures, for instance, with regard to the issue of what degree of ignorance is acceptable and when to delay decision-making to pursue further information. Similar studies with regard to the way in which clinical decisions are institutionalized in the form of formalized ethoses, clinical guidelines, or policies of responsible authorities may also be of interest in this respect. Such work may possibly build on and interact with existing literature on the psychology of decision-making and risk and may then be analyzed and critically scrutinized from the point of view of normative ideals of professional responsibility in clinical health care, illuminating the issue of the price of precaution. Due to the cross-cultural roots of the idea of precaution as a virtue, such efforts may hold some promise of transcending present conﬂicts around “principlism” versus various antitheory approaches, Western/Eastern/ Northern/Southern ethical imperialism, individualist versus collectivist framings of bioethical problems, and so on. All positions in these debates assume the presence of a solution to the issue of the proper price of precaution, which remains to be explained.

A further area of special interest regards the bioethical implications for debates on truly global environmental and health policy issues. This regards the bioethics of, for instance, climate change and related environmental policy, global trade regulation with regard to health-related goods (food, drugs, infrastructural materials, arms), the management of migration following violent conﬂict, environmental destruction, or poverty. It also extends to the aftermath of all of these: the intergenerational distribution of goods and capabilities, among these many related to health (Coggon and Gola 2014). Such inquiries connect bioethics directly to the very roots of PP and will address the politics of bioethics and public health ethics on its grandest scale. Although there are some recent attempts to deal with this angle on precaution from the starting point of political philosophy and theory, as well as environmental ethics (McKinnon 2011; Resnik 2013), much remains to be done to achieve a coherent view on the issue of to what extent general theories of global justice or environmental ethics would support some version of PP and what that would imply in bioethical terms.

A third, and ﬁnal, global aspect of precaution from a bioethical standpoint is revealed by recent theoretical research on the practical implications of a PP –or precautionary policy– for global distributional issues (Munthe 2011). That is, rather than having a concrete regulative PP or some precautionary policy be supported by bioethical arguments or general theories from ethics or political theory already assuming particular views on global justice, the ethics of risk underlying a speciﬁc version of PP may by itself provide support for speciﬁc conclusion on global bioethical distributional issues. The opening for this comes out of the possibility of having a PP avoid the standard criticism and be compatible with basic RCBA tenets while at the same time applying additional requirements on the evaluation of options in view of risks, uncertainties, quality of evidence, and involved stakes. In particular, the idea of an increased moral weight of evil may favor the idea of a reduced price of precaution for parties with bad stakes and an increase in such price for parties who are already better off and thus have much to lose. In effect, the latter have lesser reasons for spending resources on additional (risky) improvements, while the former have much more reason to embark on such ventures– implying that the resources controlled by the latter should rather be spent on improving the conditions of the former. The additional risks thus created are simply less of a problem in view of the value of the additional chances of beneﬁts thus attained for those worse off. This in contrast to privileged societies, where more than decent conditions may in most cases be upheld without new measures which could be applied if resources are so allocated and the risks that would bring. In terms of opportunity costs, the latter will simply be a waste of resources compared to investing in improving the conditions of those worse off, where there is less reason for caution in view of the prospects of improvement of health or other life conditions. In essence, this type of reasoning seems to link well to standard lines of thought around so-called compassionate use of unproven procedures, where a distinctly precarious situation of a patient and lack of alternatives is thought to be able to motivate procedures otherwise ruled out due to lack of evidence. However, even if this or the foregoing notion is denied, there are attendant consequences for the distributional outcome of applying PP at a global level. How PP is speciﬁcally designed in this respect will thus form a necessary point of focus for critical assessment.

Conclusion

The precautionary principle engages the moral reasons for and value of taking extra care in the face of uncertain or unknown outcomes of decisions and has deep historical and wide cross-cultural roots in the area of the ethics of health, health care, and medical research. As in general ethics, however, this side of bioethical thinking has not been the subject of focused critical analysis until recently, and in particular, the central underlying issue of what price it is justiﬁed to pay for precautionary measures has been left unprobed. A sound PP needs to avoid absolutism and allow considerations of the quality of evidence, likelihoods, and outcome value of options, and must further imply a sound answer to the underlying ethical issue of what is the proper “price of precaution.” Further speciﬁcation of a PP requires an ethical theoretical defence, which may necessitate innovation and revision of standard ideas in moral philosophy and decision theory and serve to complement existing theoretical models in bioethics.

Nevertheless, precautionary reasoning is abundant in bioethics, albeit sometimes positions defended are about too much of precaution being applied or about precautionary measures having too high a price –as in recent criticism against clinical research regulation. Four general areas have been explored in this entry, as well as a wide variety of examples. Likewise, the idea of a PP and precautionary reasoning offers some speciﬁcally global aspects in relation to bioethical issues –from cross-cultural aspects of the further analysis of health professional virtues to overarching policy issues of the global distribution of goods and capabilities related to human health and well-being.

The under-researched nature of the relevance of precautionary thinking in bioethics offers ample opportunities to work on issues with greater latitude than usual for developing fresh ideas and solutions, including the development of sounder theoretical starting points than those applied in previous attempts. Thematic topics for such work include (but do not exhaust)

The transitional area between research ethics and clinical ethics, in particular with regard to the issue of how much evidence is sufﬁcient for defensible application of a procedure
Ditto with regard to public health measures and policies
Virtues of clinical decision-makers and professionals: the handling of uncertainty, risk, and possibility of improving evidence
Policies, institutions, and regulations for the

introduction of emerging medical technologies with potentially far-reaching impact

Cross-cultural mapping and analysis of precautionary thinking in clinical situations, health policy, and medical research
The role of bioethical values and norms in precautionary reasoning connected to largescale global policy issues with regard to the environment, violence, migration, poverty, and similar topics

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