KotaliK the PrinciPle of SubSidiarity for bioethicS

Jaro Kotalik

Examining the Suitability of the Principle of Subsidiarity for Bioethics

ABSTRACT. The political and social principle of subsidiarity can be useful as a general principle of bioethics. The principle states that only those decisions and tasks that cannot be effectively decided upon or performed by a supported or subsidized lower level authority ought to be relegated to a more central or higher authority. The concept of subsidiarity has been embedded tacitly in Western political thought for two millennia, but it has been articulated expressly only in the twentieth century. The principle has unique strengths: it is the only principle that addresses the issue of locus of decision making; it is strongly linked to human dignity, democracy, and solidarity; and it can assist in reaching agreements on the common good. There are also potential drawbacks that need to be taken into account when developing rules and guidelines for the principles application in bioethics. The principle is particularly helpful in public health ethics, but it is also of use in the ethics of personal care and human research ethics.

here is a significant omission in the whole endeavor of moral analysis as commonly used in bioethics. Whether the analysis is based on a set of moral principles grounded in common morality, on a deontological or a consequentialist theory, or on other considerations, the focus has been to assist moral agents in making ethically appropriate decisions. Little or no attention has been paid to the issue of who the appropriate moral agent or decision maker is in any given situation. Yet, how to make a decision and who should make that decision are equally important, albeit separate, issues. The principle of respect for autonomy, which favors self-determination of the patient or the surrogate, generally is invoked when considering a personal health intervention. But this principle operates only in situations when the decision involves one person in contact with a professional or an institution. Many health care decisions are not of this kind however. Important health care decisions are made
Kennedy Institute of Ethics Journal Vol. 20, No. 4, 371390 2011 by The Johns Hopkins University Press

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by groups, organizations, or governments, for not one, but many people. In those situations, omission of moral analysis of who the decision maker ought to be or at what societal level the decision should be made is a serious shortcoming. Such analysis and judgments are often not simple because there are numerous levels to choose from, such as an individual, family, hospital, care agency, neighborhood, municipality, region, province, state, federation, or global organization. At any of these levels, candidates for moral agency may be found among professional or business associations, expert groups, elected boards, committees, or branches of the government. Accepting any one of these organizational levels as the locus of moral agency for a particular issue has the potential to make a major morally significant difference in the decision-making process and outcome. For example, the lower the locus of agency is placed, the more people will be participating in that decision and the greater the diversity of the decisions about similar cases will be. Conversely, the higher the locus of the decision making is, the fewer the number of people involved will be, reducing the variety of decision outcomes. This deficiency of moral analysis in bioethics can be addressed by employing the sound and well-established political and social principle of subsidiarity. This principle states that each larger social and political group should help smaller or more local ones to accomplish their respective ends without arrogating those tasks to itself (Carozza 2003). A richer definition of the principle holds that larger and higher-ranking bodies should not exercise functions that could be efficiently carried out by smaller and lesser bodies; rather, the former should support the latter by aiding them in the coordination of their activities with those of the greater community (Mel 2005). In this paper, I briefly review experiences with the principle of subsidiarity in political and social spheres, point to some strengths and weaknesses of the principle, and outline recent attempts to specify it. Finally, I discuss the use of the principle in bioethics.
SUBSIDIARITY AS A POLITICAL AND SOCIAL PRINCIPLE

The idea of subsidiarity has a long history, which has been traced from Aristotle to the present time (Wilke and Wallace 1990; de Noriega 2001). Aristotle, in his Politics, describes a society in which each individual, each group, and each large social body has a particular task to be performed autonomously. An interference from other groups or individuals is permissible only in situations of absolute need. Thomas Aquinas expands [ 372 ]

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these ideas by stressing the role of intermediate groups and justifies such an organization of society by appeal to human dignity. According to him, human dignity requires that human beings should enjoy a sphere of freedom as long as such freedom does not conflict with the common good. All other societal groups, from the family to the state, must be at the service of the human person and be given freedom to do so without interference from higher levels of society (de Noriega 2002). Althusius and other seventeenth century German philosophers, while building their notion of the secular federal state around the idea of contract, also advance the idea of subsidiarity without using the term. Contemporary scholars identify an acceptance, or at least an echo, of the principle in the writings of such diverse philosophers and personalities as Montesquieu, Locke, von Humboldt, Mill, and Nietzsche. John Stuart Mill, for example, proposed the practical principle of the greatest dissemination of power consistent with efficiency and stated:
A government cannot have too much of the kind of activity which does not impede, but aids and stimulates individual exertion and development. The mischief begins when, instead of calling forth the activities and powers of individuals and bodies, it substitutes its own activity for theirs; when, instead of informing, advising, and upon occasion, denouncing, it makes them work in fetters, or bids them to stand aside and does their work instead of them. (Mill 1956, p. 140).

A number of national constitutions of the seventeenth and eighteenth centuries, when regulating the relationship between the national and lower level governments, seem to rely on the concept of subsidiarity without actually articulating the concept. The Tenth Amendment of the United States Constitution declares: The powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the States respectively, or to the people. Similarly, one can say that the principle of subsidiarity was applied implicitly when the fathers of the Canadian Confederation in 1867 decided that health care should be the responsibility of provincial governments, although they identified the operation of marine hospitals and oversight of quarantine as those areas, which are best to put under federal jurisdiction (Department of Justice Canada 1867). However, it is only in the twentieth century that the principle of subsidiarity has been specifically named, defined, and explicitly applied. When, after World War I, fascism in the West and communism in the East gave [ 373 ]

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rise to totalitarian states, Catholic social thinkers were challenged to articulate the proper roles of individuals, states, and intermediate groups. They identified the ancient notion of subsidiarity as the best theoretical foundation for these deliberations. This is the origin of the 1931 encyclical, Qudragesimo Anno, in which Pope Pius XI used the term principle of subsidiary function, which commentators interpreted as the principle of subsidiarity (PS). Pius XI (1931, Sections 7080) referred to subsidiarity as a fundamental principle of social philosophy, unshaken and unchangeable. Subsidiarity can be found in the teachings of other religions as well. Within the protestant tradition, for example, a similar notion is called sphere sovereignty (Sirico 1997). This principle embodies and recognizes a reverence for institutions of civil society, the obligations of personal responsibility, and the demands of the common good (De Vous 2003, p. 1). In the last two decades, a number of U.S. political theorists have developed an interest in subsidiarity, compared this concept to the idea of federalism, and examined the differences between the application of both concepts in the United States and in Europe (Neuman 1996). However, knowledge about the subsidiarity principle increased during the last 20 years largely due to the major role it has played in organizing the European community. It is a fundamental concept in the European Charter for Self-Government endorsed by the Council of Europe in 1985, and it rapidly became the most often employed principle in all European treaties. In this way, it contributed to the successful integration of the European Union (EU). The principle acquired the power of law in the EU by its incorporation into the Treaty of Maastricht of 1992 and the Amsterdam Treaty of 1997 (Fllesdal 1998; Carozza 2003, p.50). It is also included in the 2002 Charter of Fundamental Rights and in the 2003 draft of the European Constitution. The principle has been further refined by rulings of the European Court of Justice (de Burca 1998). In some applications, including those involving health care, subsidiarity is to be balanced with the principle of solidarity, another political principle utilized by the EU (Saas 1992). A recent formulation of the principle of subsidiarity is contained in the Treaty of Nice:
In areas which do not fall within its exclusive competence, the Community shall take action, in accordance with the principle of subsidiarity, only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale

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or effects of the proposed action, be better achieved by the Community. (Official Journal of the European Union 2006, E 46)

The principle has been used primarily to preserve the powers of individual states to govern themselves and to set limits on additional powers that can be acquired by the central authority. However, increasingly subsidiarity is being extensively promoted and used below the level of member states. The principle has been recognized as a pillar for a vision of a Europe of the regions. The Assembly of European Regions established in 1985 upholds the principle of subsidiarity, fighting for decisions to be taken as close to the citizens as possible (Assembly of European Regions 2006, p. 6). A movement known as Subsidiarity is a Word, launched in 2008 by the Assembly, is demanding inclusion of the word and its proper definition in every major dictionary worldwide. The movement is promoting public discussion of the principle by all means that will command public attention. Interestingly, an activist attempted to climb a 10-story building in the center of Brussels to wrap the building in a huge banner proclaiming: Subsidiarity is a word. Thanks to the internet, it is possible to watch video clips such as Subsidiarity Man jumps from bridge to set new world record on the video-sharing website, YouTube, and join the subsidiarity discussion group on the social networking website, Facebook. This development seems to be the culmination of the transition of the notion of subsidiarity, at least in Europe, from an important but poorly defined idea, to an obscure neologism, and finally to a word in common currency. Quite possibly, in the future, subsidiarity could play a large role outside of Europe. Paolo Carozza (2003) suggests that subsidiarity should be regarded as a structural principle of international human rights law. It provides a tool to address the inherent tension in international human rights law between affirming a universal substantive vision of human dignity and respecting the diversity and freedom of human cultures (Carozza 2003, p.38). Carlos Maldonado (1997) calls the principle of subsidiarity an essential organizational principle of civil society. Domnec Mel proposes that subsidiarity should be employed as a business ethic principle and used to determine appropriate organizational forms within businesses and corporations. This principle would mitigate the effect of bureaucracies in which individuals, with their dignity, freedom, diversity and capacity for undertaking business activities with entrepreneurial spirit, are often not appreciated (Mel 2005, p. 293). Mel presents a case study involving a non-profit mutual insurance company and [ 375 ]

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argues that a new organizational structure of the company created by applying the principle not only provides better service to customers and more satisfaction to employees but is also ethically superior to the old structure because it offers greater respect for freedom and human dignity.
STRENGTHS OF THE SUBSIDIARITY PRINCIPLE

Unique Function The most important reason why the subsidiarity principle needs to be seriously considered for relevance to bioethics is its uniqueness. It can be argued that there already is a glut of principles and that their usefulness is limited due to undefined domains and persistent clashes between them. But the subsidiarity principle is unlike any other. Although the principles of beneficence, nonmaleficence, justice, and the like provide direction on how an ethical decision ought to be made, subsidiarity implores one to question the appropriateness of any candidate for decision-making power and helps one to determine rationally who should make the decision. As such, this new principle is complementary to other bioethics principles and will not collide with them. Subsidiarity could best be used at the beginning of a deliberation to decide whether the decision-making privilege and responsibility concerning a particular issue should be left to each individual or moved to one of the many higher levels of society and, if so, which level this ought to be. Once this assignment, which can be difficult, is completed, the moral agent selected could employ other principles or moral approaches to determine the appropriate course of action. Affirmation of Human Dignity and Creativity In addition to its uniqueness, the principle of subsidiarity has other attractive features from a bioethics perspective. Importantly, it is intimately linked to respect for human dignity, which has been called indispensible in moral discourse (Pullman 2004). Respect for human dignity is a notion consistent with deontological, natural law, human rights, and other ethical theories. The subsidiarity principle supports and enhances human dignity because it embodies high regard for the freedom of individuals, families, groups, and communities. The principle also promotes human dignity because it respects the creativity of the human person, whether discharged individually or as a member of a group, and draws on this creativity when searching for the best solutions to particular situations [ 376 ]

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(Sirico 1997, p. 553). Subsidiarity implicitly recognizes that freedom, support, and nurturing (a subsidium) create an opportunity to develop a full personal and community potential. By favoring smaller and lower social units, the principle maximizes the number of people drawn into active participation in societal developments, and this sort of engagement promotes personal fulfillment (Lassance 1946). Link to Participatory Democracy Subsidiarity also fits well into the toolbox of contemporary bioethics because it shares much in common with democracy, particularly deliberative and participatory democracy. Andreas Fllesdal (2006, p. 64) observes that the principle of subsidiarity
. . . seems to reflect similar normative ideas to those of democratic rule in general: policies must be controlled by those affected, to ensure that institutions and laws reflect the interest of the individuals under conditions where all count as equals. Only when these considerations counsel joint action is central authority warranted.

Will Kymlicka (2002) noted that the concept of deliberative democracy was developed to balance liberal individualism and communitarianism (see also, Baylis 2007). Subsidiarity could be considered a practical tool to achieve this same objective in the health care sphere. An individual person would be considered first as a potential decision maker, which would honor the value of liberal individualism. But if the decision making at this lowest level is unsatisfactory for the issue at hand, the locus would move to a community. Smaller, lower level communities, such as the family, would be considered first, but the decision-making authority would move progressively higher as needed, while not exceeding the highest level reasonably required. The subsidiarity principle would help communitarians to specify what exactly they mean by community and how the type and size of the community could be determined. A health care system guided by subsidiarity would educate, inform, and engage more citizens in decision making about a wider range of issues because higher societal levels would abdicate some of their previous responsibilities to lower levels. Applying the principle of subsidiarity to determine at what level a public policy decision should be made and then to encourage people at that level to make the decision is preferable to making a high level policy proposal and then relying on a nationwide public consultation process to obtain [ 377 ]

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input from citizens. Those responsible for implementing such consultation can easily present the outcome of it in a way that favors the advice of the prevailing experts, endorses the intention of policymakers, and marginalizes any dissenting voices. A consultation with scattered, independent participants can create an appearance of a democratic process and legitimacy while essentially endorsing an elitist policy (Baylis 2009). Link to Civic Republicanism The notion of subsidiarity is complementary to civic republicanism. A society organized according to this political thought would be noted for its promotion of active citizenship, diversity of political and commercial institutions, checks and balances, and nurturing of public space for the practice of civic virtues. Civic republicanism has been recently proposed as an alternative framework for public health ethics (Jennings 2007, p. 31). Theorists favoring such a direction likely will find the principle of subsidiarity helpful. A health care system informed by the principle of subsidiarity would be more compatible with civic republicanism because it would encourage a culture of civic service and responsibility at the grass roots level and because it would militate against arbitrary power and domination from any single authority. Conversely, striving for realization of civic republicanism would make the operation of the principle of subsidiarity more fruitful, because the cultivation of civic virtues would prepare citizens for the kind of work needed for decentralized, morally sound decision making. Link to Solidarity The concept of solidarity appears to be increasingly important to bioethics as the discipline strives to overcome its early individualistic bias. The subsidiarity principle resonates with relational solidarity, a concept advanced by Franoise Baylis, Nuala Kenny, and Susan Sherwin (2008, p. 203). In certain senses, subsidiarity can be understood as a procedural manifestation of relational solidarity (personal communication with Nuala P. Kenny, 18 May 2008). The principle moves the decision-making locus to a level of society where concrete needs and opportunities can be more accurately specified; where people know of each other; and where the obligations of individuals, groups, or institutions can be more cooperatively met (Cahill 2006, p. 214). As Yves Soudan (1998, p. 185) says,

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subsidiarity is a call to build an actual solidarity of proximity, of the face to face, which opens the horizon of meanings and becomes the corner stone of the political construction. In this actual level, we can escape from the unmediated universal community, so wide that it cannot be grasped by the citizens in their actions, and relegates the person to individual passivity.

Identification of the Common Good Subsidiarity offers to bioethics an escape from its current major difficulty, the deeply entrenched ideological disagreements and practical difficulties encountered when attempting to identify the common good. After decades of bioethics discussions, diametrically opposing positions remain on many critical issues, such as abortion, euthanasia, end-of-life care, and genetic enhancement. The opposing sides of these debates often talk at cross-purposes, while a common position, needed to underpin laws, regulations, and practice, remains elusive. Madison Powers (2005, p. 1) notes that bioethicists fail to appreciate the wide range of reasonable disagreement that will remain past the point of extended reflection and discussion. Tom Koch (2005) charges that contemporary bioethics has too narrow an ideological approach and does not accommodate divergent perspectives. It could be argued that one reason for these difficulties is that bioethics is seen as trying to offer a moral norm for society as a whole. The subsidiarity principle could be used to move the policy development for certain kinds of issues from the central, often national, level to lower, smaller, and possibly more homogenous social units. At that level, the voices of groups and individuals not able to make an impact at the national level could be heard. Diverse, imaginative solutions might be proposed, and a genuine consensus may emerge. In promoting subsidiarity, bioethics can foster appropriate discussions to determine the common good in health care and health research, at least if one understands the common good as compelling community interests that are essential for both survival and general well-being, such as health and safety, and to which the market, property, and individual liberty are subordinate (Baylis 2007).
CRITICISM OF THE SUBSIDIARITY PRINCIPLE

Disrespect for Expertise It could be argued that the subsidiarity principle, by favoring decision making on lower societal levels, will place the decision in the hands of less [ 379 ]

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informed or lay people, which underestimates the need for expertise. This is wrong, the argument goes, because, (1) the highest possible level of expertise should be made available to bear on every significant decision, and (2) the higher the societal level empowered to make a decision, the greater level of expertise will be. If, for example, a new vaccine is offered by a manufacturer, it is necessary, some may argue, that the leading experts in the state decide how, for whom, and when it should be used. The central organizational and funding measures identified as the most efficient are then to be used to implement the vaccination program. In response to this assertion, I suggest that the role of expertise should not be exaggerated, and it should not be understood narrowly as a scientific and technological expertise. Although technical and scientific knowledge is valuable, alone it cannot adequately inform decision makers about the social, political, and moral ramifications of any health care decision. The information necessary for a good decision, affecting large segments of populations, is likely dispersed among individuals and various organic units of the society (Hayek 1972, p.71). To continue with the vaccine example, I would argue that benefits and burdens of a new vaccine will have a different significance in different regions and communities, depending on their economic, social, cultural, and religious characteristics. A top-down, state driven vaccination campaign may not be perceived as evidence of a caring central government, but rather as bureaucratic interference, assuming and misinterpreting the needs and wants of the community. This in turn could lead to poor compliance with the program. In contrast, an approach informed by subsidiarity would make the leading experts recommendations available to the appropriate lower social units, let those units make the decision as to whether and how a vaccination program should be carried out, and assist in its the programs implementation. Inefficiency Another objection to the principle of subsidiarity is that it would be a waste of human potential and material resources to have dozens of parallel societal units deliberating and deciding on a policy or an issue that could be competently decided by a single higher level social unit and then implemented by lower units. Further, it could be argued that some of the smaller units may not have forums for appropriate deliberations or structures readily capable for such decision making and that there is a high risk of improper decisions, even if expert recommendations are provided. [ 380 ]

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In rebuttal, I would point out that any decision has an instrumental value, meaning that it is necessary for action, and it also has a transformative value, in that it subtly transforms the agent who makes the decision. A lower social unit that makes its own decision will be much more ready and able to carry it out than if the same decision is parachuted for implementation from above. However, the ability of a social unit to effectively make a decision would have to be considered each time the locus of decision making is under discussion. Denial of Social Interdependency The principle of subsidiarity also may be criticized as insensitive to human interdependency in general and to changes of health care affected by globalization of world affairs in particular. It could be said that no social unit is totally isolated and that local or regional decisions always affect others, sometimes in unforeseen ways. Current globalization of economic life, the argument would go, calls for an even greater uniformity and homogeneity of policies between regions and statesjust the opposite of what the subsidiarity principle would promote. This is a serious charge and not easily dismissed. However, in response, I would assert that the reaction favored in the above argument is not necessarily ethically desirable. Centralization of health care decision making and homogenization of health programs are neither the only nor the best responses to the globalization of human affairs. Experience in several sectors indicates that voluntary cooperation, approximation, and, where possible, harmonization are superior approaches and are much more respectful of communities aspirations. Particularly, harmonization, the process through which diverse elements are adapted to each other or merged so as to form a coherent whole while retaining their individuality is an ethically promising approach, complementary to subsidiarity. Lately, the concept of harmonization attracted attention both at the level of theory and practice (Vermeulen 2004). Insensitivity to the Principle of Justice Possibly, the most serious charge that can be made against subsidiarity is that it is insensitive to or even entirely contrary to the demands of justice. If the principle creates a situation in which multiple small units write policies to govern health care, it likely will result in a multiplicity of arrangements. As a result, people in geographically adjacent areas, [ 381 ]

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even if they are citizens of the same province or state, may have different access to services, unequal economic burden, and different opportunities for personal choices. To continue with the vaccination example, a child in one community may be unable to obtain the vaccination, or may receive it at cost, while in a neighboring town, under a different health authority, a child in the same situation would be able to receive the vaccination free. This, some people may complain, is unfair. The response to this charge is complex and has to involve specification and actualization of the principle in practice. However, the most fundamental response holds that if these different arrangements for the same health intervention result from inclusive, informed, and transparent deliberations involving the people affected, each arrangement could be judged to be fair. Especially, if a societal unit makes a decision about treating its members in a certain way, with knowledge that other units are making different decisions on the same matter, then the charge of injustice is hardly valid. Clearly, the practical application of this principle in bioethics will not be easy or morally simple. It is desirable to specify the principle for various circumstances and balance it against other principles in a way that utilizes the strength of the principle and compensates for its weaknesses.
APPLICATION OF THE PRINCIPLE OF SUBSIDIARITY

If the principle of subsidiarity is to be more than a nebulous concept or a slogan useful to justify a personal or institutional preference, it must come with criteria or rules that permit a certain precision and consistency in allocating decision-making authority to a particular societal unit. There are a number of proposals in this regard. One simple rule says that the decision-making power should move up to a larger unit if it can be demonstrated that a specific function cannot be adequately provided by the lower unit, even if the lower unit were to be provided with all reasonable help. An adequate provision test could be based on a number of factors, but most likely would rest on comparing institutional effectiveness at each level and moving up to a larger unit until the acceptable level of effectiveness is reached (Slaughter 2004). In this case, subsidiarity is used as a procedural principle. A contrasting proposal asserts that decision making should be located in the unit in which people are significantly and legitimately affected by a decision (Pogge and Menko 2002). In this case the principle would be used more like a substantive principle.

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Another theorist criticizes both suggestions as too limiting and suggests that an account of subsidiarity must mix procedural and substantive criteria for selecting an appropriate locus of decision making (Kolers 2006). So far, the most comprehensive approach to determining the proper societal level was proposed by David Held (2004, pp. 1012) and consists of three tests:
(1) The test of extensity, which assesses the range of people within and across borders whose life expectancy and life chances are significantly affected by the policy under consideration. This test detects any impact whatsoever. (2) The test of intensity, which examines the degree to which the policy issues impinge on a group of people. Three degrees of intensity are proposed to categorize the impact of a policy decision: Strong impact means fundamental consequences for vital needs or interests. Moderate impact affects secondary needs that is peoples ability to participate in the community and overall quality of life changes. Weak impact means impact on particular lifestyle needs or the range of available consumption choices. (3) The test of comparative efficiency, which compares efficiency across the unit, moving outward, until it reaches a unit for which an agreed minimum threshold of efficiency is reached.

To respect the spirit of the principle, this last rule could be supplemented by a provision requiring that the decisive efficiency of a unit is the one that incorporates an adequate assistance from higher units. Even if these rules would permit a decision in most cases, what should happen in situations where the outcome of such deliberation is equivocal or uncertain? Most commentators envision an inward default, that is, the allocation to a smaller or lower unit if there is not sufficient evidence that a larger or higher unit is more appropriate. The European Union also adopted inward default.
SUBSIDIARITY PRINCIPLE IN BIOETHICS

The principle of subsidiarity was introduced into bioethics discussions in Europe by Hans-Martin Sass. In a short, but seminal paper, Sass (1995) surveys the ethical foundations of most European health care systems and observes that they are governed by the notion of solidarity. He suggests that because of many scientific, technological, social, and political changes, the health care system needs to be based on a new triad: responsibility, solidarity, and subsidiarity. With respect to subsidiarity, Sass sees its benefits in identifying those health care needs that otherwise would go unnoticed [ 383 ]

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or underfunded and in providing health care with more flexibility, while mediating between conflicting principles of autonomy and solidarity. In this paper, Sass also draws a distinction between positive and negative subsidiarity. He notes that positive subsidiarity recognizes individual personal commitment and goals in life to serve others, while negative subsidiarity limits excessive bureaucratic activity (Sass 1995, p. 591). In 2001 article, Sass characterizes European bioethics as being on a rocky road. He notes that a European Union study group in the so called Barcelona Declaration proposed a set of basic ethical principles, consisting of autonomy, dignity, integrity, and vulnerability and expresses concern that these principles were arbitrarily chosen and are confusing. Sass (2001) observes that the notions of subsidiarity, solidarity, and tolerance are missing from the list. Subsidiarity is important to him because of its conflict-reducing feature. Sass (1998; 2004) also proposes a subsidiaritybased public policy in a paper discussing allocation of advanced medical technologies and in a paper contrasting Asian and Western bioethics. I have recommended that subsidiarity be considered as an ethical principle that can inform the Canadian Pandemic Influenza Plan (Kotalik 2003) and with Susan Tamblyn have included subsidiarity among eight ethical principles relevant to public health programs (Tamblyn and Kotalik 2003). In what follows, I touch on the possible applications of subsidiarity in three health care domains. My intention is not to provide an in-depth analysis, but rather to see if the principle can raise new questions and enrich bioethical analysis. Ethics of Research with Human Participants Research ethics is an area in which ethical standards and practice already are conforming substantially to the principle of subsidiarity. In most countries, there is a high-level general framework provided by federal and state laws, regulations, and policy statements. Still, decisions about the ethical acceptability of individual research projects, whether they are local, national, or international are made at the local and institutional levels by institutional review boards. Subsidiarity endorses this arrangement, which removes the need for a large bureaucratic apparatus at the central level, but also encourages decision makers to ask what support higher authorities should provide to local research ethics boards. Using the subsidiarity principle, one could argue that the central level, having an overall responsibility for the protection of research subjects, ought to [ 384 ]

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examine systematically and periodically how best to assist ethics review and approval at local levels. Such subsidy might, for example, include resources for the training and continuing education of volunteer members of institutional review boards. Ethics of Personal Health Care Personal health care takes place at the micro level of the societal structure, between individual patients and health care professionals and between families and health care teams. At first glance, it may appear that the principle of autonomy determines what competent patients or their agents decide about care to be given and there would be no place for the subsidiarity principle. However, these micro level decisions increasingly are shaped and sometimes even strictly defined by multiple policies and decisions made by governments, corporations, and associations at various higher levels of society. The impact of each of these numerous higher level decisions on an individual persons care is rarely investigated. It is therefore difficult to analyze the very significant moral responsibility for these decisions. As a result, accountability and transparency, values declared important, cannot be honored. Consider an example: A physician is in charge of an intensive care unit (ICU) where there is one empty bed and receives two new patient referrals, both with an urgent need for that bed. Typically, the bioethics discussion of such a case would focus on assisting physicians to make the best ethically justifiable decision under the circumstances. The shortage of a resource, in this case an ICU bed, is treated as a given, as a fact of nature outside of human control. In this type of case, utilization of the principle of subsidiarity would be valuable because it would stimulate those involved to ask new questions, such as: What decisions at which organizational levels led to the fact that this ICU has a limited number of beds? What is the appropriate organizational level at which the decision about the number of ICU beds in a community hospital could and should be made? What assistance, direction, and professional and public input would people at that level need in order to make such a decision competently, and be held morally responsible for it? In this case, the employment of the principle would not help to decide which of the two patients should be given the remaining ICU bed, but it may help to prevent such situations from recurring. And, if shortages of a life saving resource were to occur in a society where the principle has been applied to ethical decision making in health care, patients and physicians likely would be aware that the community can change the situation. Attempts [ 385 ]

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to answer questions about personal care that have been generated by the principle of subsidiarity would provide a fresh approach to these old, seemingly intractable rationing problems. Ethics of Public Health Public health is an area of bioethics that may benefit most from the introduction of the principle of subsidiarity. The major ethical concerns in public health revolve around frequent conflicts between personal interests and community interests. Currently, in Western societies personal choice and personal freedom are highly regarded. At the same time, the population also has heightened expectations that governments and public institutions will minimize health risks and create a reasonably healthy environment. The expectation is, for example, that serious infectious outbreaks will be prevented or at least rapidly brought under control. This creates a most difficult task of balancing individual liberty with the public interest in every public health intervention. An additional factor that complicates the ethics of public health interventions is the need for justice. Everyone agrees that public powers ought to be used justly, but the content of justice in general and its specific cases is disputable. Even within a single profession like medicine, it is problematic to recommend which approach to justice is preferable. The World Medical Association Ethics Manual lists libertarian, utilitarian, egalitarian, and restorative approaches to justice as alternatives and notes that the choice of a particular version of justice will depend on the social-political environment in which a physician is practicing (Williams 2005). Given this complexity, working with the principle of subsidiarity in developing ethical perspectives for public health interventions would make sense. Instead of attempting to determine the right balance between public interests, personal liberties, justice, and efficiency for a state or an undefined populationas generally is the caseone first should determine the lowest societal level at which certain policy, program, or intervention decisions could be efficiently made if appropriate support to this level is provided. For example, when a new vaccine becomes available, instead of starting by asking how best to design a federal or state/provincial program, application of the principle of subsidiarity may indicate that national or global policy may be warranted, if for example, an opportunity exists to eradicate a biological agent from the human population. In other types of vaccination, the chief or only benefit may be the protection of an individual person, in which case, even if vaccination for the many would seem highly [ 386 ]

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desirable, the decision about application could be justifiably made at a very low societal level, such as the local community or within a family. Another example of the usefulness of subsidiarity is the fluoridation of drinking water. This public health intervention has been a source of controversy throughout the past 50 years. Even if the prevailing scientific opinion is that fluoridation significantly reduces dental caries in children and creates no health problems, many people remain concerned about possible risks. Some countries or regions mandate water fluoridation based on administrative decision or referendum, others do not favor it, and reversal of these decisions has been common. What would subsidiarity say about the societal level at which such a decision is to be made? If one applies, even very crudely, Helds test of extensity, one will observe that only people who could be affected will be those whose homes are connected to a fluoridated water supply system. Because no one else would be impacted, the test of intensity is not required. Applying the test of comparative efficiency, one will determine that an individual or family cannot efficiently control the administration of additives to piped water. The threshold of efficiency of fluoridation is likely reached at the municipal level because the public water system is usually operated by municipalities. There would be no increase in efficiency if two, three, or more municipalities carry out the same policy because actual fluoridation of water has to be done by each municipal water plant. Therefore, subsidiarity favors a decision made by the population in each municipality sharing the same water supply system. Fluoridation imposed on municipalities by a decision at the provincial, state, or federal level would be contrary to the principle of subsidiarity.
CONCLUSION

An examination of the principle of subsidiarity, its roots and theory, its strengths and weaknesses, and finally its potential applications to health care, suggests that this political and social principle is suitable for adoption or perhaps appropriation (Baker and McCullough 2007) to bioethics. This principle could fill a current gap in the methodology of bioethics, a discipline that has articulated a number of principles and values aimed at how to make a decision, yet lacks tools to address the issue of who should make that decision. The principle of subsidiarity could complement other bioethics principles, but it does not commit its users to the adoption of any other principles or the whole system of principlism. The principle of subsidiarity has some drawbacks and weaknesses in its application that [ 387 ]

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need to be considered. In order to make PS operational in bioethics, it will need a great deal of specification, overall refinement, and development of rules for allocation of the decision making into the appropriate social units. However, discussions among theorists and practitioners and debates about the principle of subsidiarity in the public arena could bring rich dividends and refresh the whole discipline of bioethics.
I thank Laena Maunula for her assistance in background research for this article. Special thanks to my wife, Louisa Pedri, for many discussions of this topic and her editorial assistance. This work has been supported in part by a grant from the Canadian Institutes of Health Research for the project Pandemic Planning and Foundational Questions of Justice, Common Good and the Public Interests. Investigators and collaborator were N. Kenny (Principal Investigator), F. Baylis, J. Downie, R. Melnychuk, S. Sherwin, J. Luc, S. Halperin, N. MacDonald, L. Edwards, L. Bedford, E. Gibson, B. Appleby, E. Wasylenko, A. Nathoo, and B. Koenig. I am grateful for their critique and comments. An earlier version of this paper was presented at the Annual Conference of Canadian Bioethics Society, St. Johns, Newfoundland, 20 June 2008. REFERENCES

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Contributors
Emily Abdoler, B.S., is a student at the University of Michigan Medical School. She formerly served as a Fellow, Department of Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD. Jaro Kotalik, M.D., M.A., F.R.C.P.C., is Director, Centre for Health Care Ethics; Professor, Northern Ontario School of Medicine; and Adjunct Professor, Department of Philosophy, Lakehead University, Thunder Bay, Ontario. Lainie Friedman Ross, M.D., Ph.D., is Carolyn and Matthew Bucksbaum Professor of Clinical Ethics; Professor, Departments of Pediatrics, Medicine, and Surgery; and Associate Director, MacLean Center for Clinical Medical Ethics, University of Chicago. G. Owen Schaefer, A.B., is a graduate student in the Faculty of Philosophy, St. Cross College, University of Oxford, UK. He formerly served as a Fellow, Department of Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD. David Wendler, Ph.D., is Head of the Unit on Vulnerable Populations, Department of Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD. Alan Wertheimer, Ph.D., is a Senior Research Scholar, Department of Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD.

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