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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. Electronic supplementary material The online version of this article (10.1186/s12939-019-0960-z) contains supplementary material, which is available to authorized users.

Resumo: O Componente Especializado daAssistência Farmacêutica (CEAF) do Sistema Único de Saúde tem como objetivo garantir a integralidade do tratamento medicamentoso em nível ambulatorial. Visando analisar a percepção dos atores envolvidos sobre o Componente, foi realizada pesquisa qualitativa (grupo focal e entrevistas semiestruturadas). Observou-se que há forte dependência do CEAF em relação às outras ações estruturantes na política de saúde. Segundo os atores, a forma de organização e gestão dos serviços não propicia a continuidade da atenção, o que resulta em um cuidado fragmentado. Destacaram-se fatores como falta de articulação entre serviços e profissionais, problemas na organização dos fluxos e oferta insuficiente de serviços. Ainda o foco dos serviços farmacêuticos no medicamento, ou seja, visão minimalista da assistência farmacêutica, tem impactado de diferentes formas no cuidado ao usuário. É necessária a coordenação dos serviços adequados às necessidades em saúde, que deve se traduzir na percepção de continuidade dos cuidados na perspectiva do usuário. Desta forma, o entendimento é: o medicamento tem sido garantido, mas a integralidade do atendimento preconizada nas linhas de cuidado se vê comprometida. Palavras-chave: assistência farmacêutica; integralidade; serviços de saúde; integração de sistemas; avaliação de serviços de saúde.

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