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

Abstract

Background: The valuation of medicines as health needs vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations. These factors modulate the role of medicines as a health need and influence access to medicines, and could be useful to explain the rising of Judicialization of access to medicines.

Aim: 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.

Methods: A qualitative, cross-country study was carried out in these 4 countries. Semi-structured interviews were conducted with 50 representatives of the different stakeholders involved in the judicialization of access to medicines, including Executive branch, Judiciary, health system managers, patient organizations. The interviews were audio-recorded and transcribed verbatim. Thematic analysis used a framework approach based on the theoretical model for medicines as health needs.

Findings: Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries. Meanwhile in Chile, the respondents highlighted that most lawsuits related to the right to health were filed against private insurers because of unjustified increases in the insurance premiums. The comparative analysis showed that judicialization of access to medicines emerged in the four countries regardless of the constitutional protection or the health system population coverage. Among the causes were mentioned difficulties in guaranteeing access to covered medicines and the influence of pharmaceutical marketing on needs assessment and prescription behaviours. The interviewees highlighted the pressure to health system managers to fulfil their responsibilities as a positive impact of litigation. In contrast, the funding of medicines without evidence of efficacy or safety was considered a negative impact. Only in Brazil, judicialization has had impact on R&D policies. In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right and the development of policies for controlling medicines prices.

Conclusion: The results suggest that applying the adopted theoretical model creates the possibility of identifying critical points to guide policy makers to improve the health systems performances and to control lawsuits for access to medicines.

Keywords: Access to medicines; Argentina; Brazil; Chile; Colombia; Essential medicines; Lawsuits; Right to health.

Fig. 1

Theoretical model for medicines as health needs. The theoretical model comprises stakeholders, policies and practices that modulate the perception of medicines as a health need from two perspectives - health and market - at three levels: international, national and local levels. The different perceptions created of medicines as a health need (according to Brashaw’s categories) do not always coincide, and as a result of this “conflict” the patients do not get access to the medicines they perceive as a need. The health system scheme ('software' and 'hardware') was adapted from Sheikh et al. (2011). Pharmaceutical policy is represented as a square behind the stakeholders and policies considered at the national level, since pharmaceutical policies could adopt different forms according to the context: (a) a unique document considering all the aspects defining them; or (b) a policy that guides the development of the other policies. Source: Vargas-Peláez, et al., 2017 [1] with permission of the Journal Social Science and Medicine