Judicialization of access to medicines in four Latin American countries: a comparative qualitative analysis

Medicines are perceived as a health need once they are considered valuable goods. This valuation can vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations, economic and political interests [1]. Valuation differences materialize in the process of incorporation of certain technologies over others in the health system’s coverage, and lawsuits for access to medicines uncovered by the health systems. In this way, the judiciary as a guarantor of the right to health obtained an active role in the recognition of medicines as health needs and became a modulator of public policies for access to medicines. This phenomenon is known as Judicialization of access to medicines [2].

Judicialization is defined as a complex phenomenon that involves technical-scientific, legal and social aspects. In the literature two approaches to this phenomenon can be found: normative and social. Within the normative approach Judicialization is understood as the interference of the Judicial Power in the Executive Power, whereas within the social approach Judicialization is considered a form of citizen participation [3].

Judicialization of access to medicines has risen in the Latin American region, mainly in Colombia and Brazil [4, 5], and the magnitude of the phenomenon is growing in countries such as Argentina and Chile [6], despite the differences in the socio economic indicators, (Table 1), the legal recognition of the right to health (Table 2) and health system organization among these countries [2]. A brief description on how the health systems in these four countries functioned at the moment this study was carried out can be found in the Additional file 1.

In short, between 2000 and 2014 Argentina, Brazil, Colombia and Chile took measures aiming to extend the coverage of their health systems and access to medicines. However, the population coverage is fragmented and depends on the socioeconomic conditions of the individual, mainly related to their labour status, health status and ability to pay. Argentina has the highest level of fragmentation, with seven different pathways to access the health system, followed by Chile where the population is stratified according to the income in the public sector and according to their ability to pay and their health status in the private sector. In Brazil, although all citizens have access to public health services in the Unified Health System (SUS by the name in Portuguese), the presence of the private health insurance creates fragmentation as regards ability to pay and health status. In Colombia, access to the health system depends mainly on the income level and labour status within the General Social Security in Health System (SGSSS by the name in Spanish), and the income level and health status in the case of private health insurance [2].

The fragmentation in the population coverage results in the fragmentation of the health services and technology coverage, since the medicines included in the benefit plan which people have the right to depends on their relationship with the health system. During the mentioned period, Argentina, Colombia and Chile implemented reforms aimed to reduce the differences in quality and access to health care and medicines between different health systems’ subsectors. In Argentina, the country that has more diversity in the list of covered medicines among and within the health system’s subsectors, the Mandatory Medical Plan (PMO by its name in Spanish) statement was an attempt to achieve equalization of the benefits for all beneficiaries in the social insurance sector; nevertheless since this is a minimum coverage, and the financial capacity of the Obra Social (OS) depends on the level of income of their affiliates, the inequality in the access to medicines remains [7]. In Colombia, the benefit plans of the contributory and subsidised regimes were equalized and updated; and in Chile the Explicit Guarantees in Health for the public sector in the National Fund of Health (FONASA by the name in Spanish) and the private insurance companies (ISAPREs by the name in Spanish) were established. In the case of Brazil, a reorganization of the Specialized Component of the Pharmaceutical Assistance of the SUS (CEAF by its name in Portuguese) took place, in which the funding and the list of the medicines coverage was updated [2].

Another important aspect that varies among the countries is the scope of the Health Technologies Assessment (HTA) agencies. While the Brazilian agency (CONITEC) and the Colombian agency (IETS) assess and advise about inclusion of medicines to be supplied for the entire or almost the entire population in their countries, the Argentinian agency (SUR) has a restricted scope because its decisions only bind to the national OS. In Chile was not created a specific agency for HTA.

Regarding the medicines funding, in the Argentinian context, as aforementioned, the SUR only covers national OS affiliates and covers only a list of medicines defined by the Health Superintendence, and in the public sector there are specific funds for high cost medicines, but they are fragmented and cover only some specific medications. In Chile, besides the fact that the Additional Coverage for Catastrophic Diseases (CAEC by its name in Spanish) does not have a specific coverage (but explicit exclusions), this fund covers only the open ISAPREs affiliates; and in the public sector there are other specific funds for high-cost medicines and health services which have limited economic capacity, and then, limited population coverage. It is expected that some of these problems might be resolved with the implementation of Law Ricarte Soto, which constitutes the first intent for reducing the financing fragmentation of the Chilean health system.

Finally, during the period 2000–2014, the focus of the public policies for access to medicines across the 4 studied countries changed from essential medicines to high-cost medicines, bringing potential regressive effects on the guarantee of the right to health especially for the most vulnerable people [2].

Access to medicines depends on complex and dynamic relationships among the health system’s stakeholders, and the health system’s organization and litigation for access to medicines are determined by social and political features [3]. Recently, a theoretical model was proposed to analyse how technical, political and social factors modulate the role of medicines as a health need and influence accessibility and access to medicines [1].

This model offers the opportunity to analyse the possible causes and consequences of litigation for access to medicines in these countries, from the stakeholders’ perspective, in order to better understand the phenomenon and collect information to work towards possible solutions to promote equitable access to medicines. Within this framework, this study aims to conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia and Chile from the perspective of medicines as health needs.

A cross-country study including Argentina, Brazil, Chile and Colombia was carried out. In-depth semi-structured interviews were conducted in order to explore the perceptions of stakeholders regarding the possible causes and consequences of judicialization of access to medicines in the studied countries. Semi-structured interviews were conducted with 50 key actors linked to the different stakeholders involved in the judicialization of access to medicines phenomenon (Table 3). A key actor was defined here as an individual involved in the judicialization of access to medicines, working for the stakeholder during at least 1 year, who was willing to offer his or her expertise, opinions and knowledge to the object of study. The interviews were conducted in Argentina (Buenos Aires, La Plata), Brazil (Rio de Janeiro, Porto Alegre, Brasilia, and Sao Paulo), Chile (Santiago) and Colombia (Bogota), between August and December 2014.

The researchers from each country, who were involved in the study, helped to identify key actors as potential participants. Additional respondents were identified through the snowball technique [8]. Respondents were invited to participate in the study by means of e-mail, telephone or personally. All the interviews were conducted as individual face-to-face interviews and, in almost all the cases, they happened at the participants’ workplace.

The interview script included two general questions: (a) “In your opinion, what are the possible causes of judicialization of access to medicines?” and (b) “In your opinion, what are the possible consequences of judicialization of access to medicines?” All the interviews lasted from 30 to 45 min and were conducted by the same interviewer in Spanish or Portuguese. The interviews were audio-recorded and transcribed verbatim. To guarantee the quality of the data, all the transcriptions were sent to each participant for checking and correction. In order to maintain the participants’ confidentiality, only the country name and the represented stakeholder were informed in the results. All participants signed informed consent before the interview.

Thematic analysis was applied to the verbatim using a framework approach, following the methodology proposed by Pope et al. [9]: familiarization with the data, identification of the thematic framework, indexation, charting and mapping and interpretation. The theoretical model for medicines as health need [1] was adopted as framework. The categories for the analysis were previously adopted, and correspond to the elements (stakeholders and policies) considered in the theoretical model (Fig. 1). Two researchers (CMVP and MRMR) conducted the analysis manually. In case of disagreement the reviewers discuss and if consensus was no reached, a third person made the decision (MRF) on the final code. The data from interviews were sorted by country and stakeholder in order to identify similarities and differences in their perceptions on the causes and consequences of judicialization of access to medicines. The verbatim of the selected segments of speech in the original language can be found in the Additional file 2.

Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries, while in Chile the respondents highlighted that most lawsuits related to the right to health were filed against the private insurers (ISAPREs) because of unjustified increases in the insurance premiums.

The causes and consequences of judicialization of access to medicines mentioned by the stakeholders’ representatives were related to aspects from both perspectives considered in the theoretical model: health and market. Below, the possible causes and consequences mentioned are presented by level (international, national and local level) according to the categories considered in the theoretical model.

This study analyses factors that influence the occurrence and consequences of judicialization of access to medicines in Argentina, Brazil, Chile and Colombia from the perspective of the stakeholders involved in this phenomenon, using a previously developed framework. Since this theoretical model allows a broad view of the factors involved, it is useful to conduct a cross-country analysis of this phenomenon.

The comparative analysis showed that in Brazil, Colombia and Argentina, judicialization of access to medicines is more common than in Chile. This result coincides with the findings of previous analyses [5, 10‐12]. These differences can be explained by two factors: the recent change on the axis of the Chilean Constitutional Tribunal for interpreting the right to health [13] and the late establishment of an explicit (or positive) list of coverage of medicines in the health system.

In the first case, while the Judiciary from Argentina, Brazil and Colombia, was sensible to lawsuits of patients with HIV that claim access to antiretroviral medicines in the 1990s, the Chilean Courts did not concede access to these medicines. Indeed, the earliest successful court cases involving access to medicines and health services occurred only at the end of the 2000s in this country [14], when the Supreme tribunal moved from an “individualistic/contractual” interpretation of the right to health to a “social perspective” one, that conceptualizes health as a social right [13].

Similarly, in the case of the explicit medicines list, the Explicit Guarantees in Health (GES) were established in 2004 [15], which was much later in comparison with the other three countries, which established explicit lists in the 1990s [16‐18].

The analysis also showed that the aspects of the international level, recognition of the right to health in human rights treaties and the TRIPS agreement, are poorly recognized by the stakeholders, with the exception of some representatives from Colombia. The disregard of the aforementioned factors, especially TRIPS agreement implementation, neglects to a certain extent the effects that the crisis of the current innovation model has on the occurrence of judicialization of access to medicines.

At the national level it was observed that judicialization of access to medicines emerged in Argentina, Brazil, Chile and Colombia regardless of aspects such as the recognition of the right to health in the constitution or the proportion of population covered by the public and private sectors. Although all the countries have signed human rights treaties [19], only in Brazil health was explicitly considered a fundamental right during conduct of the interviews in this study [20]. In the second case, in both Chile and Brazil most of population depend on the public sector for accessing healthcare services.

In the four studied countries, common causes were identified such as the health systems’ limitations in guaranteeing universal, equitable and timely access to health services and medicines covered by the health systems. According to the representatives, these limitations are related to management inefficiencies, health services networks fragmentation, stakeholders’ corruption and weak state regulation capacity, which would result in loss of credibility in the health system.

The representatives’ responses showed that the measures to regularly update the lists are insufficient for controlling litigation for access to medicines. Notwithstanding, the combination of the health system’s lack of credibility and the expectations created by the pharmaceutical marketing about the medicine outcomes makes the discussion about the judicialization causes concentrate on the comprehensiveness of the list of covered medicines.

On the other hand, the role of the physicians’ prescription practices in the occurrence of judicialization of access to medicines was recognized in the four studied countries. Nevertheless, strategies to counter the pharmaceutical marketing or to make the relationship between the pharmaceutical industry and prescribers transparent were not cited by the respondents. These strategies could contribute to reduce the frequency of lawsuits claiming uncovered medicines [21].

Furthermore, the responses of the participants show that the question “why the new medicines are that expensive?” as well as the relationship among the public policies for guaranteeing access to medicines and the intellectual property protection and the science and technological development policies are aspects frequently neglected in the discussion of litigation of access to medicines.

The disregard of some sectors for these political economy features of the right to health, had been previously described in Colombia [22], and our result suggest a similar situation in Brazil, Argentina and Chile. In addition, this neglect compromises the ability of countries to create strategies at a national and a regional level aiming to defend their health sovereignty against the pharmaceutical industry’s abuses.

In the case of the Judiciary, the aforementioned aspects influence their decision-making. Although the judges’ desire is to promptly protect the patients’ right to health, they usually do not recognize that their decisions can have adverse effects, especially when uncovered medicines are granted. This comes from the fact that the health system manager has a short time to respond, and needs to use exceptional pathways for procurement, which are usually difficult to control, favouring diversion of resources and corruption.

Furthermore, the Judiciary’s representatives argued that it is ethically unacceptable to sacrifice the individual right to health in order to protect the collective right to health. This evidenced the conflict of this view with the Executive’ and health system managers’ perspective that consider that what is actually unethical is to sacrifice the collective right to health in order to protect the individual right to health. In addition, they argued that the exposure of the patient to unsafe or unnecessary medicines, indeed, constitutes a violation of the right to health.

As regards the consequences of judicialization of access to medicines, our results coincide with the impacts reported in other studies [3]. Particularly our study showed the impacts related to inequality induced by litigation in the distribution of the health system resources. In the present study, the respondents recognized that litigation is an unequal solution to access to medicines, because the lawsuits are individual, and access both to healthcare and justice services highly depend on the socioeconomic characteristics of the population. Moreover, it is possible to observe that those who get the access to medicines granted by the judge jump the queue and pass the people who follow official or predefined pathways of the health system.

Concerning the positive impacts of litigation, one of the most emphasized ones was the pressure that this phenomenon exerts over the health system managers to fulfil their responsibilities [7]. Nevertheless, the respondents also highlighted other impacts such as the health system’s governability loss, which can compromise the implementation of corrective measures to control litigation and to improve the health system’s performance.

Following the theoretical model, a remarkable finding of our study includes the fact that only in Brazil judicialization has had impacts over R&D policies, including measures as the establishment of public-private partnerships for technology transfer in order to locally produce the medicines considered a priority for the public health system (SUS) [23].

In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right, the development of policies for controlling medicines prices, and the creation of a specific commission of the Judiciary that supervises the measures taken by the Ministry of Health to meet the commitments established by ruling T-760/2008¹ [24].

This qualitative study does not aim to generalize its findings, but describe the perceptions of the stakeholders involved in judicialization of access to medicines. This is the reason why the variation in the number of the stakeholders’ representatives across the studied countries is not believed to have a considerable effect on the results. A limitation of this study includes the fact that most of the interviews were conducted only in the capital cities, with the exception of Brazil and Argentina. Therefore the view of stakeholders’ representatives located in places where there might be more barriers to access to the health system or the judiciary were not reached. Another limitation is the fact that pharmaceutical industry’s representatives did not accept to participate, thus the study does not consider their views.

The analysis of judicialization of access to medicines using the proposed theoretical model allowed a comprehensive view of the phenomenon. In this way, our analysis explored the influence of different factors from the health and market perspective at different levels (international, national and demand-side), which can influence the occurrence of judicialization as well as the feedback effects that the phenomenon can bring.

According to the results of this study, the causes of judicialization of access to medicines commonly described by the studied countries’ representatives were those related to the organization of the health system (‘software’ and ‘hardware’). They mentioned especially issues about the definition of the list of medicines covered by the health system and the non-social legitimacy of the Executive and health system managers. The influence of the international context and the national economic and social policies on judicialization were poorly known.

The visibility of the right to health as a relevant issue for policy and pressure on the government to implement positive structural reforms were the two main positive consequences pointed out. In all the countries studied, respondents stressed that litigation is an unequal solution to barriers to access to medicines, since the processes are individual in scope and access to health services and justice depends on the socioeconomic characteristics of the individual.

Our analysis shows some similarities in the causes and consequences of litigation for access to medicines in the studied countries, despite the differences in the contexts and the possible aspects that define the extension or occurrence of this phenomenon in a specific time frame. The result suggest that this kind of analysis, applying the theoretical model adopted, creates the possibility of identifying critical points that can guide the policy making at both national and international levels to improve the performance of the health systems and control the lawsuits for access to medicines.