Dataset Information

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.

SUBMITTER: Vargas-Pelaez CM

PROVIDER: S-EPMC6545681 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Vargas-Pelaez Claudia Marcela CM Rover Marina Raijche Mattozo MRM Soares Luciano L Blatt Carine Raquel CR Mantel-Teeuwisse Aukje K AK Rossi Francisco Augusto FA Restrepo Luis Guillermo LG Latorre María Cristina MC López José Julián JJ Bürgin María Teresa MT Silva Consuelo C Leite Silvana Nair SN Farias Mareni Rocha MR

International journal for equity in health 20190603 1

<h4>Background</h4>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.<h4>Aim</h4>To conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia an ...[more]

PMID: 31154999

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Project description:BackgroundIn September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process.MethodsWe conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives.ResultsThe most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media.ConclusionsMedia framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.

Project description:BackgroundAlmost 100 novel cancer medicines have been approved in Europe over the last decade. Limited public health care resources in countries in Central and Eastern Europe (CEE) call for a prioritization of access to effective medicines. We investigated how both reimbursement status and waiting time to reimbursement correlate with the magnitude of clinical benefit provided by novel medicines in four selected countries (Czechia, Hungary, Poland, and Slovakia).Materials and methodsA total of 124 indications of 51 cancer medicines with marketing authorization by the European Medicines Agency in 2011-2020 were included and followed up until 2022. Data on reimbursement status and waiting time to reimbursement (i.e. time from marketing authorization to national reimbursement approval) were collected for each country. Data were analyzed in relation to clinical benefit status (i.e. substantial versus nonsubstantial clinical benefit) of indications according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).ResultsThe degree of reimbursement differed between countries with 64% of indications with reimbursement in Czechia, 40% in Hungary, 51% in Poland, and 19% in Slovakia. In all countries, a significantly greater proportion of indications with a substantial clinical benefit was reimbursed (P < 0.05). The median waiting time to reimbursement ranged from 27 months in Poland to 37 months in Hungary. No significant differences in waiting time in relation to clinical benefit were observed in any country (P = 0.25-0.84).ConclusionsCancer medicines with a substantial clinical benefit are more likely to be reimbursed in all four CEE countries. Waiting times to reimbursement are equally long for medicines with or without a substantial clinical benefit, indicating a lack of prioritization of fast access to medicines delivering a substantial benefit. Incorporation of the ESMO-MCBS in reimbursement assessments and decisions could aid in better utilization of limited resources to deliver more effective cancer care.

Project description:ObjectiveTo assess scientific publication and map research gaps on access to medicines (ATM) in Latin American and the Caribbean low-income and middle-income countries (LMIC).DesignScoping review. Two independent reviewers assessed studies for inclusion and extracted data from each study.Information sourcesSearch strategies were developed and the following databases were searched: MEDLINE, ISI, SCOPUS and Lilacs, from 2000 to 2010.Eligibility criteriaResearch articles and reviews published in English, Spanish and Portuguese were included. Studies including only high-income countries were excluded, as well as those carried out in very limited settings and discussion papers.ResultsThe 77 articles retained were categorised through consensus among the research team according to the level of the health system addressed, ATM domain and research issues covered. Publications on ATM have increased over time during the study period (r 0.93, p=0.00; R(2) 0.85). The top five countries covered were Brazil (68.8%), Mexico (15.6%), Colombia (11.7%), Argentina (10.4%) and Peru (10.4%). 'Health services delivery' and 'patients, household and communities' were the health system levels most frequently covered. The ATM domains 'leadership and governance', 'sustainable financing, affordability and price of medicines', 'medicines selection and use' and 'availability of medicines' were the top four explored. There are research gaps in important areas such as 'human resources for health', 'global policies and human rights', 'production of medicines' and 'traditional medicine'.ConclusionsThe upward trend on scientific publication reflects a growing research capacity in the region, which is concentrated on research teams in selected countries. The gaps on research capacity could be overcome through research collaboration among countries. It is important to strengthen these collaborations, assuring that interests and needs from the LMIC are addressed and local capacity building is promoted.

Dataset Information

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

Background

Aim

Methods

Findings

Conclusion

Publications

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

Similar Datasets

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