Is the judicialization of health care bad for equity? A scoping review

Most studies on the judicialization of health care focus on Latin American countries like Colombia, Brazil, Costa Rica and Argentina, where litigation of health rights has sharply increased since the early 2000s [1]. According to the available data, in no other region of the world is the judicialization of health care more prevalent than in Latin America. For example, a comparative study found that the number of yearly health rights lawsuits per one million individuals was 3289 in Colombia, 206 in Brazil, 109 in Costa Rica, 29 in Argentina, and only 0.3 in South Africa and 0.2 in India [2].

The term “judicialization of health care” describes the use of rights-based litigation to demand access to pharmaceuticals and medical treatments. Medical malpractice lawsuits, a common subject in health law studies [3], falls within the purview of professional negligence and is usually excluded from the judicialization of health care literature. According to the extant literature, the judicialization of health care in the region has two defining features that set it apart from other comparable cases. Firstly, in highly litigious Latin American countries the judicialization of health care has been conducted in an individualized fashion by thousands of plaintiffs who, acting separately, routinely demand access to specific treatments and pharmaceuticals [4]. Contrastingly, in countries like South Africa the judicialization of health care was spearheaded by rights-advocacy organizations who, acting collectively, went to Court in order to demand structural judicial remedies that challenged the global and local arrangements of intellectual property rights limiting access to HIV/AIDS drugs [5]. It is likely, as some authors suggest, that one of the variables that may explain why the individualized, case-by-case judicialization of health care in South Africa has been limited is the fact that in common law countries the weight of judicial precedent is much higher than in civil law countries like Brazil and Colombia [6].

Secondly, the judicialization of health care in Latin America is highly pharmaceuticalized, since most public expenditure related to health rights litigation is invested in paying for costly medications [7]. In Brazil, for example, the costs of health rights litigation are concentrated on a group of expensive biotech drugs for the treatment of chronical medical conditions like cancer, arthritis and rare diseases [8]. Similarly, a study found that most rulings handed down by Costa Rica’s Supreme Court provided costly, experimental or low-priority pharmaceuticals with only negligible health effects for plaintiffs [9]. In Colombia, the pharmaceuticalization of health care litigation has been a recurring issue in the literature and in the public debate. For instance, in 2008 the Colombian government invested US$156 million—approximately 22% of the public pharmaceutical expenditure—in paying health insurance companies for only seven types of expensive biotech drugs demanded, among others, by litigants [10]. A different, yet related instance of the pharmaceuticalization of health rights litigation is the financial support offered by Big Pharma companies to patients’ organizations that provide, in countries like Colombia, Brazil and Costa Rica, pro bono litigation support to patients living with cancer, HIV, renal failure and rare diseases, among other medical conditions [11].

In the past years, the optimism of the early socioeconomic rights literature, which celebrated the pioneering judicial decisions that enforced the right to health as a basic social right [12], has been replaced by a more precautionary approach that is attentive to the unintended and unwanted effects of the increasing litigation of health rights in Latin America. According to this literature, the judicialization of health care in Latin America may also be characterized by its lack of transformative potential. More concretely, a growing number of studies argue that the judicialization of health care exploits—financially— the health system but is incapable of transforming it [13]. Other scholars suggest that the judicialization of health care in Latin America is not transformative since it follows a downstream approach to litigation incapable of addressing the institutional, regulatory, environmental, and social determinants of health that lie upstream [14].

Among the most serious charges waged against the judicialization of health care in Latin America is that it fosters inequity in the allocation of limited health resources. In general terms, equity in health can be defined as “the absence of systematic [and potentially remediable] differences in one or more aspects of health status across socially, demographically, or geographically defined populations and subgroups” [15]. In this sense, health inequity refers to differences in access to health care that result from institutional arrangements that are potentially avoidable or remediable [16]. Therefore, not all inequalities can be considered inequitable. Only those health inequalities that are avoidable, unnecessary or remediable can be deemed as inequitable.

Most studies consider that equity in health services can be achieved by giving equal or horizontal treatment to equivalent needs [17]. However, the predominant notion of horizontal equity, which commends the equal treatment of equals, tends to overlook vertical equity, which suggests that in many cases policymakers must offer unequal or enhanced health services to those who have greater needs [18].

How to offer fair or equitable treatment to different health needs remains a nagging question in the literature. According to Norman Daniels’ accountability for reasonableness approach, in order to meet health needs fairly we have to rely on procedural justice. In other words, policymakers need to fall back on a process that is (a) transparent or public; (b) based on relevant reasons; (c) revisable through an appeals procedure; (d) enforceable [19].

When it comes to the literature on the judicialization of health care, despite the fact that there is cross-country evidence suggesting that the existence of a constitutional right to health contributes significantly to the wellbeing of citizens [20], a growing number of authors consider that the judicialization of health care is at odds with equity. As Biehl et al. argue, in the extant academic literature, but also in the journalistic portrayals of the judicialization of health care in countries like Brazil and Colombia, there is a prevailing narrative according to which judicialization is driven by urban elites and private interests and is used to access high-cost drugs that are not part of government formularies. It is reported that the people who file lawsuits are well-off litigants who exploit the expansiveness of the country’s constitutional right to health [21].

For instance, a study points out that in Colombia most health rights plaintiffs are not poor patients, but middle or upper-middle class individuals who, thanks to litigation, obtain access to expensive medical treatments [22]. Authors like Ferraz argue that in Brazil health rights litigation “harms the poor” since it has been hijacked by affluent free riders that use litigation to obtain high-cost medical treatments from the underfinanced public health system [23]. Based on that type of findings, Ferraz argues that in countries like Brazil health rights litigation is regressive because it skews limited health resources away from the poorest citizens and in favor of the more affluent [24].

But although the scholarship on the impact of health litigation on equity is growing, there are no studies that collect the available evidence and analyze the methodological soundness and significance of the literature’s findings. This paper seeks to provide such assessment by answering the following question: what type of evidence and methodological designs have been deployed to evaluate the impact of the judicialization of health on equity?

We focus on the leading developments in the extant literature to provide a framework to assess, based on a scoping review of the literature, the main characteristics of the studies that seek to understand whether the growing judicialization of health care in Latin America is conducive to more or less equitable health systems.

The findings of this paper can contribute not only to the specialized scholarship, but also to public policy and judicial reform discussions. On the one hand, if it is true that the judicialization of health care “harms the poor”, then the theoretical assumptions regarding the right to health’s redistributive potential [25] could be called into question.

On the other hand, if there is enough evidence supporting the claim that the judicialization of health care fosters inequity, governments, policy makers and legislators could trigger a wave of constitutional and legislative reforms aimed at curtailing the right to health and rights-based judicial mechanisms such as Colombia’s Tutela, Costa Rica’s Amparo, and Brazil’s Mandado de Segurança. This is already happening in Brazil, where local governments, pressed by the mounting financial pressure exerted by right to health litigation, have argued before the Federal Supreme Court (Supremo Tribunal Federal or STF) that health rights litigation benefits a few patients, but harms the health system as a whole with unreasonable demands for medical treatments and pharmaceuticals [26]. Taking into account those arguments, on April 2018 the STF decided that Brazil’s health system is only obliged to provide to litigants medications excluded from the basic health plan— Sistema Único de Saúde or SUS—under three conditions: that the medication is approved by ANVISA, the government’s food and drugs’ agency; that the litigant demonstrates that she is unable to pay for the medication; that the prescribing doctor states that medications included in the SUS plan are ineffective to treat the litigant, and that an “excluded” drug is thus needed [27].

However, if the evidence suggesting that the judicialization of health care is still inconclusive, as this paper finds, then a more precautionary approach to judicial reforms that may curtail health rights litigation is necessary.

In this paper we used a scoping study methodology, as described by Arksey and O’Malley [28] and by Levac et al. [29] In order to reduce the universe of results, we specifically searched for articles that addressed the effects of the judicialization of health care on equity in Latin American countries, independently of the study’s methodological design (theoretical, descriptive, qualitative, quantitative, mixed methods, etc.). Our search comprised journal articles, books and edited volumes. In the case of edited volumes, we treated book chapters as independent studies. For journal articles we searched Google Scholar, PubMed, Scopus, and Scielo databases. We also went through the studies’ bibliographic references, and hand-searched key journals and authors.

Searches were conducted between February and April 2018. The initial search was circumscribed to studies written after 1990, when the pioneering judicial rulings on the right to health were handed down by higher Courts in Brazil, Colombia and Costa Rica. We combined search words such as “health rights litigation”, “judicialization of health care”, “right-to-health lawsuits”, “equity”, “fairness”, “impact”, and “consequences”, always in combination with “Latin America”, “Colombia”, “Brazil”, “Costa Rica”, “Argentina”, “right to health”, “amparo”, “tutela”, etc. More importantly, we included studies that used the word “equity”, “equality”, and “fairness”, irrespective of their different meanings in the literature (see Fig. 1 for all the search terms used) [30].

Of the initial 112 articles identified in the first search, 60 were selected based on the fact that they mentioned the issue of equity in their title and/or abstract. After reading the full text of those 60 studies, we found that only 35 actually addressed the equity consequences of the judicialization of health care (see Additional file 1: Annex 1 for a full list of these studies). In other words, in our initial sample of 112 pieces, only 35 studies dealt directly or indirectly with the question: is the judicialization of health care bad or good for equity? We then proceeded to characterize the 35 resulting articles using a set of more than 20 variables. The chosen variables seek to provide an overview of the general characteristics of these studies, what cases they choose, whether they are comparative, historic, interdisciplinary, and what type of methodologies, variables and data they use (see Table 1). Although not all variables analyzed here are directly related with the question of the impact of health care judicialization on equity, they help us understand who is concerned with this issue and where, why and how have the studies about it been conducted.

We then investigated how many of the 35 studies conducted original empirical work. More concretely, we asked the following question: how many of the studies from our sample collected their own qualitative and/or quantitative data, totally or partially? We only included studies that conducted ethnographic work, extensive interviewing of stakeholders—litigants, judges, policymakers, NGOs, etc.—, applied surveys, or constructed robust databases based on content analysis of lawsuits, judicial rulings, courts’ files, etc. Based on the rationale that original empirical research is grounded on independent data gathering, we decided to exclude studies that declared themselves to be empirical, but only commented or synthetized data gathered by a third party—the government, other researchers, etc.

We found that 20 (57%) of the initial 35 studies constituted original empirical research (Fig. 1). We then proceeded to analyze this set of empirical studies. More concretely, we analyzed the type of equity approach the studies take, as well as quality variables that touched upon methodological and data collection strategies (see Table 2). The equity approach refers to whether the study explicitly or implicitly understands that citizens should receive equal treatment for equivalent needs (horizontal) or that preferential treatment should be given to those with greater health needs (vertical). We also assessed whether studies are concerned in anyway with procedural justice when allocating health care resources. The studies’ quality was measured using two sets of variables: (i) methodological design; and (ii) data collection and analysis’ techniques. The first set of variables evaluates whether there is a clear methodology, whether there is a fit between the question posed by the study and the methodology used to answer the question, how generalizable are the findings, and whether there are other questions that may be missing from the study given the methodological design. The second set of variables assesses how reliable and representative is the study’s data, whether the data is available or open for researchers and whether the analysis used in the paper can be replicated or not.

In this section we present the most relevant results of our scoping exercise. We discuss the outcomes of our review of the initial set of 35 studies, including the 20 studies that we consider to be original empirical research. These findings allowed us to map out the general trends in the literature that addresses the impact of the judicialization of health care on equity (see Table 3 for a summary of the findings). Additionally, our results would allow us to assess the equity approach, and the methodological quality, scope, reliability, representability, and generalizability of the 20 empirical studies.

Is the judicialization of health care bad for equity? According to this review we are far from reaching a consensus on this issue. Half of the studies analyzed here find that judicialization has a negative impact on equity, but the other half finds that evidence is inconclusive or that the judicialization of health care has a positive effect on equity.

Although the equity approaches vary across studies, there seems to be a consensus that judicialization interferes with the regular allocation of health care resources; whether this is a good or a bad thing is where the whole debate lies. However, when measuring the impacts of the judicialization of health care on equity studies privilege the vertical approach to equity focusing on whether litigation benefits those who need it the most. Only some studies try to assess the procedural impacts of the judicialization of health addressing the fiscal, organizational and opportunity costs associated with litigation.

Moreover, the evidence and the methodologies used by the extant literature to assess the impact of health care judicialization on equity are, in most cases, weak. Three main issues regarding evidence arise from the analysis provided here. Firstly, comprehensive and reliable data is a problematic issue. Secondly, the majority of the studies that collect their own data rely on limited samples that are sometimes not representative and mostly not generalizable. Thirdly, there are several indicators that remain unexplored by the current literature but that could shed light on the impact of judicialization on equity. For example, on the litigants’ side, whether there are repeated claims by the same litigants, like orphan diseases patient’s associations and networks, could mean greater resources and higher rates of success in courts for patients with those conditions than for patients with more prevalent diseases that litigate only once (the repeat player hypothesis [35]). This, in turn, can provide new insights on the equity effects, vertical, horizontal and procedural, of the judicialization of healthcare. On the claims’ side, we still lack reliable accounts about public expenditure on expensive and ineffective treatments vis-a-vis cost-effective treatments that were first litigated and then included in health benefit packages—thanks, in great part, to the pressure exerted by litigation on policymakers. For example, a recently published paper suggests that in the case of Brazil, the changes brought about by individual litigation have potential to contribute to efficiency and fairness in the health care system through the improvement of the Health Technology Assessment (HTA) decision-making processes and health care governance [36]. Finally, the literature has not explored whether there are significant changes in the content of lawsuits across time that may reflect the emergence of different health needs within a given population.

Regarding the methodological strategies we find several gaps in the extant literature. Firstly, only few studies conduct systematic comparative analysis of different cross-country or within-country cases. Secondly, methodological approaches are focused only on the demographics of litigants and the availability, price and cost-effectiveness of treatments claimed, but tend to disregard symbolic and public policy impacts. For example, there are no empirically grounded analysis of the impact of judicialization on public policies such as cost-containment regulation, transparency of the relationship between pharmaceutical companies, physicians and patients, or on public debates about the limits of public health expenditure that could improve the allocation of healthcare resources. If, as Borges suggests, health litigation leads to better public policies that improve efficiency, these types of effects have to be factored in before one could argue for or against the judicialization of healthcare. Thirdly, none of the studies reviewed here aim to establish causation between judicialization and health outcomes (for instance, did the litigant’s health improve after the lawsuit?) that could give us a clearer view about the impact of the judicialization of health care on equity. Lastly, interdisciplinarity is limited and there is little methodological innovation.

Moreover, the literature tends to be categorical and ideological when it touches upon the issue of equity and litigation. An emblematic example is the divide that exists in Brazil between a pro-litigation camp that attributes to judicialization a positive role in guaranteeing the equitable right to health, and an anti-litigation camp, which argues that judicialization deepens health inequalities.

In conclusion, the findings of this article suggest that we still lack conclusive evidence about the regressive effect of health rights litigation in Latin America. In order to prove or disprove that the judicialization of health care is a foe for equity we first need to overcome the methodological and research-design problems that we identified in the studies analyzed here. There is ample space for innovation both in variables and in methods. Issues like changes in regulation, state capacity, the behavior of litigants, prescribers and judges, and the economic interests of big-pharma, are variables that could prove useful if they are incorporated into a rigorous empirical literature capable of assessing the regressive or progressive effect of health rights’ litigation.