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ICAN: Infant, Child, & Adolescent Nutrition

Infants

Breast Milk Versus Formula Courts, Health Marketing, and Asymmetric Information Roger Lee Mendoza, PhD

Abstract: This study addresses the following research questions: How efficient is the judicial process in resolving health and nutrition policy conflicts that inevitably entail a cost-benefit calculus? What are its corresponding policy implications? The case method was used based on an illustrative, landmark decision of the Supreme Court of the Philippines concerning milk formula marketing. Comparative country experiences in implementing the International Code of Marketing of Breast-Milk Substitutes were surveyed for this study. The study underscores the vital initiatives taken by the Philippines as a model for other countries in promoting, protecting, and supporting breastfeeding. However, it finds that the institutional capacities of courts to gather, process, and evaluate healthrelated information are limited, even when courts adopt a posture of restraint. The adversarial structure of litigation, the assumptions and expectations of litigants and judges, and the normative orientation and methodology of adjudication breed reliance on information asymmetries, as depicted in mathematical equations developed in this study. The study contributes to current scholarship on the judicial process and health marketing by drawing attention to key information asymmetries in litigation and adjudication. It suggests that courts be viewed as

a last resort in health and nutrition policy conflicts and advocacy. Political and administrative processes should be revisited for possible accommodation following judicial settlement of policy disputes. Keywords: adjudication; advocacy; asymmetric information; breastfeeding; breast milk; cost-benefit analysis; economic asymmetries; health promotion; infant and young child nutrition; judicial review; litigation; milk formula/substitutes

claimed victory amid the confusion generated by what is arguably the most important Philippine health care ruling to date. This study seeks to determine the efficacy of the judicial process in resolving questions and conflicts raised by health and nutrition policies. PHAP v Duque is considered a policy watershed for 3 major reasons. First, the Philippine government’s experience in breastfeeding advocacy—that led to PHAP v Duque—offers valuable

“Notwithstanding the conflicting impact assessments, PHAP v Duque illustrates the limits of adjudicating claims and conflicts over nutrition policy and health marketing.”

O

n October 9, 2007, the Supreme Court of the Philippines delivered its much-awaited decision in Pharmaceutical and Healthcare Association of the Philippines (PHAP) v Health Secretary Francisco T. Duque III et al. (G.R. No. 173034, 2007). At issue was the validity of the implementation of the national Milk Code (E.O. 51, 1986), which promotes breastfeeding of infants and young children. Both sides in the protracted battle

lessons and insights to policy makers and pediatric practitioners seeking to implement the substantive intent and content of the International Code of Marketing of Breast-Milk Substitutes. The comparative experiences of other countries are especially noted in this study, as it explores the impetus behind the formulation of the Philippine Milk Code and the policy implementation issues that eventually arose.

DOI: 10.1177/1941406409358564. From Cherry Hill, New Jersey. Address correspondence to Roger Lee Mendoza, PhD, 205 Hadleigh Drive, Cherry Hill, NJ 08003; e-mail: [email protected]. For reprints and permissions queries, please visit SAGE’s Web site at http://www.sagepub.com/journalsPermissions.nav. Copyright © 2010 The Author(s)

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Second, PHAP v Duque was the first time worldwide that litigation was ever used to promote and protect breastfeeding. The Philippines serves as a model for other countries, including the United States, which continue to encounter various obstacles in enforcing international covenants on breast milk. The International Baby Food Action Network (IBFAN), for example, has regularly given the Philippines its highest rating in terms of compliance with international breastfeeding standards and protocols.1 TIME also featured in 2009 the leadership role assumed by the Philippines in global breast milk advocacy.2 This contrasts with many other countries. The United States, for one, has almost consistently ranked in the lowest IBFAN category because it “has taken no action to implement laws that would protect breastfeeding or restrict the marketing practices of the formula-milk companies.”2 Third, PHAP v Duque illuminates the impact of judicial decision making (or adjudication) and the institutional capacity of courts in democratic countries to perform policy analysis in addressing competing claims over health and nutrition policy. The viability of litigation as a health and nutrition promotion strategy is examined in this study because the Philippines thus far is the only country with a milk code/legislation that regulates milk formula marketing and advertising.3 Theoretical Underpinnings The separation of powers doctrine in a democracy prescribes that the interpretation of laws and policies enacted by a legislature and implemented by the executive rests with the courts. Judicial review refers to the power of courts to determine the constitutionality of legislative and executive action. In countries such as the United States, judicial review has evolved from constitutional interpretation to encompass judicial policy making,4 by which judges resolve questions “on the basis of their judgment that their decisions will produce socially desirable results.”5 Much of the literature on adjudication in the health care field considers the scope, process, and impact of judicial policy making with little attention devoted to the institutional capacity of 8

courts to perform policy analysis. Various studies, for example, find that health care decisions are wide-ranging in both developed and developing countries. These include mandating government provision of treatment for diverse health conditions, the inclusion of new groups of patients in existing schemes, and restructuring incentives and disincentives in service delivery. Outcomes vary. But they could run counter to legislative intent and equitable resource allocation and entrench inequalities (“economic asymmetries”), depending on who has the ability to litigate.6-10 Several country studies support those findings. A study of Colombia’s Constitutional Court underlines the growing trend in resource-poor countries toward judicial enforcement of health claims. It also points to the vast potential of adjudication in distorting priority setting and undermining the role of legislative and administrative agencies at the expense of public health promotion, when court decisions are directed at enforcing individual access.11 A study of South Africa’s AIDS epidemic indicates that courts can be producers of scientific knowledge when political consensus is lacking (eg, what constitutes good science and appropriate health and nutrition policy). This tends to shift health policy orientation from large-scale prevention to individual-oriented, rights-based access to treatment.12 The limits of a rights orientation are shown to derive from the methodological constraints to judicial policy making that encourage piecemeal, rather than coordinated, policy solutions in the United States and Canada.13-15 Case Setting The Philippines is a low-income Southeast Asian country with a 2009 population of approximately 93 million. Its constitution (containing a bill of rights), presidential form of government, and legal system are closely patterned after the United States, its former colonizer. Philippine judicial review in the health care field was practically nonexistent until the 2007 Supreme Court decision in PHAP v Duque. The high cost of litigation and undue delays in adjudication deter many Filipinos from availing of the judicial process for redress of individual rights-based grievances.

The Philippines’s Milk Code, as well as its original implementing rules, was enacted in 1986 based on an almost verbatim reproduction of the 1981 International Code of Marketing of Breast-Milk Substitutes16 adopted by the World Health Assembly (WHA). However, the Philippine Milk Code did not adopt the International Code’s absolute prohibition on advertising, marketing, and other promotional activities for milk formula/substitutes. Instead, health marketing was assigned to a Philippine interagency committee for approval and authorization. From 1982 to 2006, the WHA passed related resolutions urging governments to promote and protect breastfeeding and prohibit nutrition claims and advertising for breast milk substitutes. The Innocenti Declaration of 1990 called on all governments to implement the International Code of Marketing of BreastMilk Substitutes by 1995. The Philippine Milk Code’s basic provisions include (1) government promotion and protection of breastfeeding for infants, while recognizing that formula may be a proper substitute in certain instances; (2) mandatory approval by the Department of Health’s Inter-Agency Committee of any form of advertising, marketing, and distribution of breast milk substitutes/supplements and promotion materials; (3) product labeling requirements for breast milk substitutes that indicate the superiority of breastfeeding, their use only at the advice of health professionals, and any known product health hazards; (4) prohibition against the use of any health care facility to promote breast milk formula/substitutes and related products; and (5) public education about the proper use of breast milk substitutes/supplements. In 2005, Philippine President Gloria Arroyo further issued an order (A.O. 20050014, 2005) underscoring the primacy of breastfeeding for infants and young children as a matter of national health policy to strengthen the Milk Code. Comparative Country Experiences Over the course of a quarter century since the International Code of Marketing of Breast-Milk Substitutes was enacted, rampant violations were reported in both

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industrialized and developing countries.17 Very few of them had successfully passed supporting milk legislation/codes, despite persistent advocacy by the World Health Organization (WHO) and United Nations Children’s Fund (UNICEF). The WHO and UNICEF had also vigorously campaigned to encourage mothers worldwide to exclusively breastfeed infants for the first 6 months of life and thereafter offer them adequate complementary foods, in addition to continued breastfeeding until at least 2 years of age pursuant to the International Code of Marketing of Breast-Milk Substitutes.16,18 In affluent countries such as the United States, studies have found that visual messages indicating that bottle feeding is the norm abound through overt and sophisticated methods. Their direct impact is to force mothers to make a passive choice even if they are capable of breastfeeding.19,20 A study of West African countries found no significant difference in the degree and type of direct violations among countries with or without an implementing legislation or regulatory framework. It suggests that legislation/regulation be supported by systematic education, training, and compliance monitoring/reporting systems.21 In a country study of Hong Kong/ China, indirect violations included commercial materials distributed to clinics and hospitals that carry subtle messages undermining breastfeeding and the sponsorship by formula distributors of “mother-and-baby clubs” to distribute formula samples and information.22 A 4-country study (Poland, Bangladesh, Thailand, and South Africa) of pregnant women, mothers of infants, and health facility workers called for joint monitoring by the government and nongovernment organizations using a proposed survey methodology. The 4 countries’ experience confirmed that health facilities easily serve as conduits of milk formula companies and their distributors for trade promotion purposes.23 It found “little to suggest that the situation would be different in many other countries” because “the code is not enforced in its entirety under current legislation in the United Kingdom and Europe.”23(p1122)

ICAN: Infant, Child, & Adolescent Nutrition

It was against this backdrop that the impugned Revised Implementing Rules and Regulations (RIRR; A.O. 2006-0012, 2006) of the Philippine Milk Code evolved 20 years after its enactment in 1986. In their aggressive promotion of breast milk substitutes/supplements, formula companies in the Philippines repeatedly violated the terms of media advertising, product labeling, and information dissemination. Pregnant and new mothers were offered “mothering classes,” participation in corporate-sponsored contests with big prizes at stake, and free samples and gifts/ donations often through (commission-paid) doctors and hospitals.17,24 False or dubious benefit claims, along with branding healthy, happy, and intelligent Filipino children (eg, as “Promil kids,” after Wyeth’s Promil formula), became serious concerns to government policy makers, health experts, and cause-oriented/advocacy groups. Hence, Philippine implementation of the Milk Code replicated many other countries’ experiences that were reviewed earlier. On top of ineffective regulation were growing nutrition studies about the serious health risks of infant formula and the detrimental effects of its advertising and marketing on breastfeeding. A 2003 survey found that only 16% of 2 million babies born in the Philippines annually were exclusively breastfed for at least 4 to 5 months—the lowest breastfeeding rate among 56 countries in a 10-year period. Joint studies by the UNICEF, WHO, and the Department of Health attributed as many as 16 000 Filipino infant mortalities per year to infections and diseases associated with using breast milk substitutes during an infant’s first 6 months of life. The UNICEF proposed an educational campaign for Filipino mothers to breastfeed exclusively for the first 6 months and continue breastfeeding for 2 years or more with complementary solid foods.3,25 Conflict and Controversy President Arroyo and her health officials responded to rapidly declining breastfeeding rates and the ensuing public uproar by expanding the Milk Code’s provisions with the issuance of the RIRR in 2006. The RIRR (1) specifically covered young children, in addition to

infants (0-12 months old); (2) prohibited any form of promotion, advertisement, and marketing of breast milk formula/ substitutes and supplements; (3) created additional labeling requirements to indicate that “there is no substitute for breast milk”; (4) prescribed tighter government regulations; (5) set additional marketing proscriptions of formula companies; and (6) granted the government/ Department of Health the authority to impose sanctions on violators. Their net effect was to suppress the market power of formula companies, anchored as it was on the free flow of asymmetric information (more or better information held by one transacting party) from producers to consumers. PHAP, the petitioner in the landmark decision under review, is a broad-based organization of companies producing and distributing pharmaceutical, medical, and nutritional products. Its members include the major multinational players in the breast milk substitute industry, including Abbott Laboratories, Wyeth, Mead Johnson, Astra-Zeneca Pharmaceuticals, Bayer, Gerber/Novartis, and GlaxoSmithKline. PHAP went to the Supreme Court to invalidate the newly approved RIRR. Named respondents were Department of Health officials led by Secretary Francisco Duque. The challenge for PHAP was to find in the health marketing restraints imposed by the RIRR some (potentially) transgressed authoritative norms that would allow its case to be (favorably) considered by the Supreme Court. Specifically, it needed to persuade the Court that the RIRR’s bottom-line objective of correcting information asymmetries—which prevented mothers from making a conscious and informed choice about the benefits of breastfeeding and the risks of formula/substitutes—was offset by a costlier transgression of constitutional rights. Litigation as Health Promotion At bottom lay the resolve of the contending parties to avail of litigation and adjudication to achieve their respective health promotion objectives after years of gridlock. PHAP and its allies 9

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wanted the RIRR’s implementation invalidated for creating economic barriers, which they argued before the Supreme Court were infringements on free speech and due process of law. The government saw in judicial review a viable opportunity to broaden its regulatory and police powers over private enterprise to promote its nutrition and breastfeeding program under the Milk Code. For either party, a favorable decision would have farreaching implications: it would set a legal precedent for future action. The incentive to litigate policy conflicts (variable C) is modeled below as notation (1): C = ac + bc (Y – T )

(1)

where a = inputs/claims in policy conflicts b = outputs/responses in policy conflicts Y = point of equilibrium (ie, where a and b meet/clash) T = political/administrative settlement of policy conflicts Health officials promulgated the RIRR (b in notation (1)) without directly going through the political process (ie, congressional investigation, deliberation, and amendment) (T) and following a failed administrative bargaining process with PHAP (T ). The RIRR appeared to be a calculated strategy to achieve swift and decisive action that would not deviate from how they deemed it necessary to make the Milk Code more effective. Health officials had also grown accustomed to the objections and dilatory tactics of formula companies (a) after 2 years of negotiations. Formula companies, on the other hand, found it difficult to seek accommodation in the RIRR’s formulation, particularly in light of accusations made against them by top Department of Health, WHO, and UNICEF officials (a). Political pressure on behalf of these companies was subsequently exerted on the Philippine government (T) but ultimately failed (Y – T). The US Chamber of Commerce of the Philippines wrote a scathing, carrot-and -stick letter to President Arroyo expressing its objections to the RIRR, offering assistance in rewriting it, and implying an exodus of key American invest10

ments from the Philippines if the RIRR were not withdrawn.26 The US Trade Representative’s Office then sent representatives to Manila to communicate the same message to health agencies.27 With a militant and unwavering leadership in the Department of Health, the stage was set for contestation, through judicial review, to resolve the impasse. The ensuing litigation of rival health marketing claims can be illustrated using a modified aggregate demand equation (2) that builds on (1). Yd in (2) can be taken as the sum of separate demand (or litigation choice) curves. Specifically, we depict Yd as a linear sum of 4 separable demand sources:

Yd = C + I + G + NX (X – M)

(2)

where C = incentive to litigate competing policy claim(s) = ac + bc (Y – T) I = investment in litigation-related information (symmetric/asymmetric) G = conflict resolution methods/ procedures in litigation NX = adversaries’ net expected results/ benefits from litigation • X = expected policy benefits • M = expected policy costs based on inputs/outputs = am + bm (Y – T) By availing of litigation, both parties, in effect, did away with the political process (T) in both notations (1) and (2). The political process relies on exchange, bargaining, and mediation to accommodate conflicting interests and seek compromise. It is characterized by flexibility, dynamism, and power. It had been successfully pursued relative to some equally controversial Philippine health policies, such as complementary/alternative medicine, by the government and private firms.28 In contrast, litigation resolves conflicts through the authoritative articulation and argumentation of norms29 (G). Litigation nonetheless could be an attractive approach in resolving difficult questions, such as milk formula marketing, because its image of impartiality (X) and finality (X) endows it with greater moral authority than the political process (NX). Litigation is also invulnerable to the give-and-take or paybacks (M) of political

processes, which could endure long after a consensual choice has been made (M). Another critical insight we can derive here is the tendency of litigation toward bipolarization of conflict (C in (1) and (2)) because offending and aggrieved parties—often to the exclusion of objective third parties— make a case prosper before the courts. The year and a half that followed the filing of the PHAP petition before the Supreme Court heightened acrimony between PHAP and health agencies, as well as their respective supporters. Litigationmotivated information supplied by the two sides (I) was contained in various Court motions, countless press statements and accusations, and demonstrations by their supporters, including one held before the Court by bare-breasted mothers. During that period, the Department of Health’s legal counsel in the case was assassinated; another legal representative deputized by the WHO and UNICEF for the case was nearly shot to death (in both instances, some connection to PHAP v Duque was suggested by several individuals).30 After lengthy oral arguments, the Court delivered in October 2007 its unanimous decision on what was dubbed the “consumer battle of the century.”30,31 Adjudication Results The PHAP v Duque decision offers no indication of conscious legislation or activism on the part of the Supreme Court, even if it were presented with some opportunities to do so. As a decision grounded on judicial restraint, it offers a veritable laboratory for the study of policy (cost-benefit) analysis by the courts to settle competing health claims. The Supreme Court upheld PHAP’s claim that the Philippine Milk Code’s promotion of breastfeeding could not automatically be equated with a total ban on marketing breast milk substitutes/supplements. The Milk Code, in fact, allows formula promotion, advertising, and marketing if approved by the Inter-Agency Committee. The Court struck down (1) the advertising/ marketing ban under the RIRR for exceeding the Department of Health’s existing power to control breast milk information and (2) the RIRR-created administrative sanctions, which are nonexistent under

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the Milk Code and only Congress could allow through an amendment. A separate concurring opinion issued by the chief justice directly considered the free speech claim of PHAP in finding the absolute ban unduly restrictive, particularly of commercial speech, “which is not accorded the same level of protection as that given to other constitutionally guaranteed forms of expression but is nonetheless entitled to protection.”32 At the same time, the Court’s splitlevel decision favored the Department of Health with respect to all other RIRR provisions, including the extension of the RIRR’s scope to young children; additional product labeling requirements; exclusion of formula companies from involvement in policy-making, educational, research, training, and government health promotion programs; and prohibition against these companies from making any gifts/donations through the health care system. The Court found these proscriptions “in consonance with the objective, purpose and intent of the Milk Code, constituting reasonable regulation of an industry which affects public health and welfare and, as such . . . do not constitute illegal restraint of trade nor are they violative of the due process clause of the Constitution” (G.R. No. 173034, 2007), as PHAP had claimed. If the adversaries found in PHAP v Duque a test case, the Supreme Court decision was hardly the precedent that they expected. PHAP v Duque defied a zero-sum (winlose) outcome. Neither did it conform to what international media and advocacy groups portrayed as a regional precedent that adjudicates “developing-world publichealth concerns against developed-world corporate profits.”25 The decision proved controversial in its aftermath, as the rival sides claimed (greater) victory over the other, media offered conflicting interpretations, and health organizations (including the WHO and UNICEF) weighed its substantive impact. Limits of the Judicial Process Notwithstanding the conflicting impact assessments, PHAP v Duque illustrates the limits of adjudicating claims and conflicts

ICAN: Infant, Child, & Adolescent Nutrition

over nutrition policy and health marketing. We find that these constraints inherently derive from the nature as well as the collection, utilization, and evaluation of information before the courts more than a decision’s substantive merits and outcomes. We explain in this section (1) why and how asymmetric information is acquired, processed, and employed in adjudication and (2) the methodological constraints faced by the courts in policy analysis (ie, determining which of the various competing claims and alternative approaches will most likely achieve the goals of legislation or public policy). At the end of this section, the key points made below are summarily illustrated using a proposed equation: 1. Lawsuits are bipolar and tend to produce binary choices. Nutrition policies, such as breastfeeding and health marketing, are multidimensional. They also affect many interests. These interests transcend the economic concerns of aggrieved parties, such as PHAP, and regulatory objectives of implementing agencies, such as the Department of Health. Yet, the adversarial structure of litigation restricts comprehensive data gathering and relies on (asymmetric) information submitted to the courts by two diametrically opposed forces. The Supreme Court reached its split-level decision in PHAP v Duque on the basis of the application of various constitutional doctrines and “tests” proposed mainly by the litigants to delineate the authority of the Department of Health (eg, to incorporate into the RIRR the provisions of international covenants not otherwise specified in the Milk Code, impose sanctions, prohibit formula marketing). But the decision did so without having to go through any specific policy review steps to determine, for example, the policy inconsistency or inconsistencies of invalidating the advertising/ marketing ban while upholding the additional product labeling requirements on the grounds that “correct information as to infant feeding and nutrition is infused with public interest and welfare” (PHAP v Duque, G.R. No. 173034, 2007). By reducing the participants’ number and conflict to the questions they raise, litigation also gives rise to binary policy choices (eg, for or against the ban, regardless of its actual costs and bene-

fits). Binary choices, in this sense, impoverish policy debates by limiting the policy options available and often making consensual decisions unavailable. 2. The judicial process is self-contained. Policy analysis in legislative and administrative institutions is more flexible and creative because it is based on interdisciplinary research design, implementation, and validation techniques and data. In contrast, the judicial process is “too principle-prone and principle-bound.”33 It has “its own devices for choosing problems, its own habits of analysis, its own criteria of the relevance of phenomena to issues, its own repertoire of solutions”34 that are generally unsuitable for health and nutrition promotion. To illustrate, the Supreme Court rejected the Department of Health’s argument—that the RIRR’s promotion/advertising ban exceeded the Milk Code’s mandate to implement the WHA resolutions—not because the ban was deemed unnecessary. Rather, the Court found that those resolutions do not yet constitute “customary international law that may be deemed part of the law of the land” (PHAP v Duque, G.R. No. 173034, 2007). The Court also disagreed with PHAP’s contention that regulation of breast milk formula/substitutes applies only where infants are involved. It disagreed not because of a demonstrated health need to cover young children as well but because the Milk Code “conspicuously lacks reference to any particular age-group of children” (PHAP v Duque, G.R. No. 173034, 2007). 3. Litigation is party initiated and party controlled. Courts are passive arbiters of policy claims and conflicts because they depend on bipolar forces to frame issues and gather evidentiary information. This motivates the adversaries and their support groups to conceive litigation strategies based on the information incentives and constraints they face, frequently neglecting those that affect health and nutrition objectives and their broader policy implications as well as other interests that are not otherwise parties to the lawsuit. By restating issues in narrow, legal terms, lawyers “minimize or even avoid complex evidentiary or policy questions.”35 On the other hand, courts focus 11

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on legal procedure because they are not empirically suited for substantive policy judgments. These were evident during the oral arguments in PHAP v Duque. In seeking further information to determine how the RIRR advertising ban could even be reconciled with the Milk Code, the justices repeatedly pressed the government counsel to declare whether the ban was, in fact, absolute. Instead of a categorical reply, the government counsel asked the Court to interpret the ban as part of the Inter-Agency Committee’s power to authorize/disallow any formula promotion, hoping that the justices could be persuaded that one more formality can only increase fairness: MADAM JUSTICE SANTIAGO: Don’t you think that the Department of Health overstepped its rule-making authority when it totally banned advertising and promotion under [RIRR] Section 11, prescribed the total effect rule as well as the content of materials under Sections 13 and 15 of the Rules and Regulations (RIRR)? SOLICITOR GENERAL DEVANADERA: Your Honor, please, first we would like to stress that there is no total/ absolute ban. Second, the InterAgency Committee is under the Department of Health, Your Honor. . . . MADAM JUSTICE NAZARIO: But, would you nevertheless agree that there is an absolute ban on advertising of breast milk substitutes intended for children two years old and younger [under the RIRR]? SOLICITOR-GENERAL DEVANADERA: It’s not an absolute ban, Your Honor, because we have the Inter-Agency Committee that can evaluate advertising and promotional materials, subject to the standards that we have stated earlier, which are—they should not undermine breastfeeding, Your Honor. . . . Section 11, while it is titled “Prohibition,” must be taken in relation to the other Sections, 12

particularly 12 and 13 and 15, Your Honor, because it is recognized that the Inter-Agency Committee has that power to evaluate promotional materials, Your Honor. MADAM JUSTICE NAZARIO: So, in short, will you please clarify if there’s an absolute ban on advertisement for milk substitutes regarding children two years and below? SOLICITOR-GENERAL DEVANADERA: We can proudly say that the general rule is that there is a prohibition. However, we take exceptions and standards have been set, one of which is that, the Inter-Agency Committee can allow it if the advertising and promotion will not undermine breast milk and breastfeeding, Your Honor. (PHAP v Duque, G.R. No. 173034, 2007) 4. Adjudication is retrospective. Adjudication is suited for determining historical and adjudicative information.34 These refer to discrete events that transpired in the past and caused the harm for which remedy is sought. The development, implementation, and evaluation of health and nutrition policies take into account social science and health information, which include “causal relationships, recurrent patterns of behavior and future impact of policy choices.”34 Even when social science and health information become available, the courts have a difficult time analyzing and using it. Judicial ability to predict the consequences of a nutrition-related issue, such as breastfeeding, is extremely limited. The Supreme Court, for example, rejected the Department of Health’s argument that it needed to impose administrative sanctions on violations as a result of the department’s historical lack of authority to do so under the Milk Code and other measures that were enacted in the distant past (1980s), regardless of whether they effectively respond to present-day realities. It was obviously not within the competence of a single institution, much more a court, to determine the contemporary relevance or efficacy of any sanctions.

5. Rights and remedies are interdependent. The political process involves cost-benefit calculations of health and nutrition policy impact and alternatives. Conversely, the focus on rights and duties in judicial decision making restricts the alternatives available to courts and hinders cost-balancing approaches, in order for courts to be able to grant remedies to violated rights at any cost. Thus, the Supreme Court refused to grant PHAP the relief it sought from the RIRR proscription of formula companies’ involvement in any policy-making body; educational, research, and training programs; and charitable initiatives because PHAP failed to legally demonstrate how these could unreasonably hamper their right to trade. At the same time, one is left to wonder how the Court would have admitted and treated any social science evidence that indicated the oppressive trade effects of the proscribed activities given the constraints to testing or validation in judicial review. It may be asserted that courts could potentially have several remedial alternatives to dispense. However, they can only do so by reliance on enforcement agencies (the “carrots and sticks” favored by economists to influence behavior), over which they have little or no control.14 The Department of Health’s partnership with other government agencies and civil society groups to monitor compliance36 following the Supreme Court’s ruling in PHAP v Duque underscores what courts can neither guarantee nor offer. The manner and extent of compliance affect a ruling’s impact. It could mitigate or aggravate it in ways that a court decision cannot forecast or control, unlike a political or administrative institution. 6. Court decisions anticipate the bestcase or worst-case scenarios, rather than modal (typical) situations. With relief provision as the expected output of adjudication, litigants tend to anticipate the best or worst/exceptional cases, so that a decision’s breadth of application may encompass the harm in question. Such behavior encourages more asymmetric information to be funneled through the courts. PHAP, for example, initially clarified that it did not

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dispute the nutrition superiority of breast milk (information symmetry). But it claimed that the RIRR unfairly restricted information flow and choice for women who could not breastfeed37 (information asymmetry). Thus, the (commercial) speech rights claim of an exception group helped gain for PHAP the relief it sought from the advertising/ marketing ban. How formula promotion— which could easily capitalize on information asymmetries—affects the more representative case of women who can breastfeed but are persuaded to abandon it requires data and methodology for which adjudication is ill-suited. Similarly, the scholarly literature previously reviewed indicates the passive but detrimental effect of formula samples on modal cases of able women. The same findings become information liabilities in adjudication unless they can be recast as admissible evidence or converted into legal or constitutional questions. 7. Adjudication is less amenable to policy review than other advocacy approaches. Because of its reliance on legal procedure, historical information, and judicial precedent, adjudication is normative in orientation (ie, based on authoritative norms/ rules, argumentation, and logical persuasion, rather than positive or empirical scholarship). Adjudication cannot easily compare and evaluate the direct and indirect (or unintended) consequences of a policy decision. In addition, because courts are relatively immune from public scrutiny, feedback mechanisms are nonexistent or inefficient in revising or enhancing policy choices contained in, or resulting from, a ruling. In PHAP v Duque, the Supreme Court’s validation of the total ban on gifts and donations by formula companies could not anticipate whether and how it could be circumvented by their (unbanned) promotion, advertising, and marketing activities. These instances illustrate how rights-based adjudication breeds piecemeal, rather than coordinated, policy solutions.15,34 In sum, information asymmetries arise in judicial settlement of health and nutrition policies at 2 stages, as depicted in our proposed equation (3) below. In litigation, adversarial behavior and binary choices motivate each party (P and Q) to maximize expected benefits and

ICAN: Infant, Child, & Adolescent Nutrition

minimize expected losses by collecting, presenting, and analyzing sets (1 . . . n) of information (I) that is unequal to each other in terms of quality and quantity, {P1, P2, . . . , Pn} ≠ {Q1, Q2, . . . , Qn}. In adjudication, courts decide a case after selecting, validating, and interpreting admissible litigant information (I) based on methods (G) that are frequently unsuitable for policy cost balancing and forecasting. Political and administrative processes (T) are better suited for the different policy review steps because of the greater quality and quantity of information and methodologies available to them. The asymmetries in both phases of the judicial process interact and affect each other, as denoted by the fraction bar (vinculum) below. Under conditions of imbalanced information, the actual output (O), represented in this study by the PHAP v Duque decision, constrains the efficiency of judicial decision making:

O=

I ({ P1 , P2 ,  , Pn} ≠ { Q1 , Q2 ,  , Qn} ) G (G < T )

(3)

A court ruling could nonetheless “provide an effective focal point for social mobilization and give impetus to advocacy and policy processes, regardless of the outcome of a case.”10 It is interesting to note that barely 3 months following the Supreme Court decision, PHAP and health officials agreed to return to the “bargaining table.” They held dialogues and conferences instead of proceeding further with litigation and discarded their previously announced motions for reconsideration before the Court.38 At least 3 pending congressional bills to amend the Milk Code and accommodate several unresolved concerns of both parties finally indicate how the political process can indirectly undo or modify the impact of a judicial decision. Policy Insights and Implications This study yields important insights for nutrition policy makers, pediatric practitioners, and health promotion advocates. It also contains policy implications

for other governments seeking to enforce the International Code of Marketing of Breast-Milk Substitutes in their respective countries. Based on the many pioneering initiatives undertaken by the Philippines to promote, protect, and support breastfeeding of infants and young children, one key insight from this study concerns the multifaceted issues that nutrition policy often raises. It also draws attention to the interdisciplinary approaches that are required to address them. A national legislation, like the Milk Code, serves as a viable instrument for defining basic principles and standards, creating a regulatory framework, and specifying stakeholder rights and responsibilities, whether or not the judicial process is the best avenue for interpreting them or settling conflicts. Policy makers and pediatric practitioners, however, can expect the health marketing rights (advertising, product distribution, information dissemination) of formula/supplement companies to be the centerpiece of any ensuing claim or controversy over such vital national legislation. PHAP v Duque illustrates how adjudication could become an attractive health promotion and advocacy technique because of its potential to resolve complex policy disputes with impartiality, authority, and finality. This is particularly the case when accommodation between the parties in conflict does not appear to be feasible at least in the short run, as exemplified by the deadlock over the RIRR’s formulation between 2004 and 2006. Even if one were to assert that submitting the conflict for resolution by political and administrative agencies raises the prospect of the process being controlled by powerful vested interests, PHAP v Duque reminds us that (bipolar) litigation is not necessarily a more objective and efficient and less burdensome option. The judicial process is not immune from economic asymmetries, particularly when prospective litigants have unequal power and resources. Information asymmetries, on the other hand, arise and abound in litigation and adjudication because of the rules and structure of contestation and the methodological constraints faced by courts (eg, types of data they can accept and process, delimited data sources and collection

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procedures, and methods/tools available to determine policy costs, benefits, and implications). Information asymmetries could, in turn, profoundly affect the quality and impact of health and nutrition policies, such as breastfeeding. They could also affect the breadth and depth of the government’s regulatory effectiveness. Because tension inevitably exists between the attributes of judicial decision making and the demands of health and nutrition policy and strategy, the resolution of multiple policy-based questions by the courts—even if they do not consciously make law and policy—can strain their institutional capacity. Litigation should be employed only as a last resort after political and administrative processes have been exhausted. However, should contending parties opt for litigation, care should be taken to ensure that as many interests and policy implications as possible are taken into account by the courts. Expert testimonies (eg, invitation by the courts of amici curiae, such as social and policy scientists, pediatric practitioners, etc) should be considered routinely. Finally, because part-by-part adjudication of policy conflicts rarely provides for clear winners or losers, as PHAP v Duque aptly demonstrates, rival parties should consider giving political and administrative processes another chance following a court decision. Political renegotiation, binding arbitration, and restructuring of policy decision-making processes, among others, could effectively mitigate costly judicial outcomes. The conscious decision of PHAP and health officials to backtrack from previously announced motions for reconsideration, return to the bargaining table, and work with Congress to amend/clarify the Milk Code is particularly insightful. A judicial decision’s impact depends on enforcement and compliance by policy actors for which courts have little or no control.

to health systems and policies.”10 We also need to discover how effectively courts gather, process, evaluate, and review (asymmetric) information in policy disputes. PHAP v Duque provides a useful illustration of the institutional efficacy of courts to conduct policy analysis and resolve nutrition policy-related questions of national concern. However, we find that the courts’ normative orientation and methodological constraints are further restricted by the concerns of the individuals or groups involved in specific cases. The broader implications and overall objectives of public health are therefore seldom efficiently addressed through the judicial process. We conclude that litigation and adjudication are not necessarily superior or equal to the political/administrative process, despite the latter’s own shortcomings. Fortunately, reliance on them by supporters and opponents of milk formula/substitutes worldwide constitutes the exception rather than the rule. Acknowledgments The author is intellectually indebted to his former professors at McGill University, Dr James R. Mallory (deceased) and Dr Christopher P. Manfredi, in writing this paper. The author also thanks the 3 anonymous peer reviewers for their helpful comments and suggestions; Linda Heller, of this journal, for her invaluable advice concerning format revision; Stephanie Brientnall, of Rutgers University, for reviewing the final draft of the manuscript; and Kay Felicano, of Sage Publications, for her patience and skill in making the necessary final editorial changes. References 1.

Conclusions To objectively assess the potential of litigation and adjudication for nutrition policy and advocacy, we need to know not only “to what extent [court] judgments are accepted and implemented and under what circumstances [they] bring changes 14

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ICAN: Infant, Child, & Adolescent Nutrition

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