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Abstract
Introduction Indonesia, the world’s fourth most populous nation, is close to achieving universal health coverage (UHC). A widely-publicised falsified vaccine case in 2016, coupled with a significant financial deficit in the national insurance system, has contributed to concern that the rapid scale-up of UHC might undermine medicine quality. We investigated the political and economic factors that drive production and trade of poor-quality medicines in Indonesia.
Methods We reviewed academic publications, government regulations, technical agency documents and news reports to develop a semi-structured questionnaire. We interviewed healthcare providers, policy-makers, medicine regulators, pharmaceutical manufacturers, patients and academics (n=31). We included those with in-depth knowledge about the falsified vaccine case or the pharmaceutical business, medicine regulation, prescribing practice and the implementation of UHC. We coded data using NVivo software and analysed by constant comparative method.
Results The scale-up of UHC has cut revenues for physicians and pharmaceutical manufacturers. In the vaccine case, free, quality-assured vaccines were available but some physicians, seeking extra revenue, promoted expensive alternatives. Taking advantage of poor governance in private hospitals, they purchased cut-price ‘vaccines’ from freelance salespeople.
A single-winner public procurement system which does not explicitly consider quality has slashed the price paid for covered medicines. Trade, industrial and religious policies simultaneously increased production costs, pressuring profit margins for manufacturers and distributors. They reacted by cutting costs (potentially threatening quality) or by market withdrawal (leading to shortages which provide a market for falsifiers). Shortages and physician-promoted irrational demand push patients to buy medicines in unregulated channels, increasing exposure to falsified medicines.
Conclusion Market factors, including political pressure to reduce medicine prices and healthcare provider incentives, can drive markets for substandard and falsified medicines. To protect progress towards UHC, policy-makers must consider the potential impact on medicine quality when formulating rules governing health financing, procurement, taxation and industry.
- public health
- health policy
- health systems
- health insurance
- qualitative study
Data availability statement
Data are available upon request. The interviews that underlie in this study discuss at times unethical behaviour. During our informed consent procedure, we assured participants of anonymity. We are unable to comply with that commitment if we make the interviews recordings available. We believe there is an unacceptable high risk of disclosure in sharing full transcripts, and do not have the resources to redact the interviews fully. However, we do provide our detailed coding structure (https://doi.org/10.7910/DVN/CVPSBB). Researchers are welcome to request specific coding queries by contacting the corresponding author. We will run the queries as requested, redact the results only to the extent necessary to ensure anonymity and pass the results on to fellow researchers. We also provide a downloadable bibliography of all references reviewed during this research, and a collection of full documentation of all court records from the falsified vaccine case.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Data availability statement
Data are available upon request. The interviews that underlie in this study discuss at times unethical behaviour. During our informed consent procedure, we assured participants of anonymity. We are unable to comply with that commitment if we make the interviews recordings available. We believe there is an unacceptable high risk of disclosure in sharing full transcripts, and do not have the resources to redact the interviews fully. However, we do provide our detailed coding structure (https://doi.org/10.7910/DVN/CVPSBB). Researchers are welcome to request specific coding queries by contacting the corresponding author. We will run the queries as requested, redact the results only to the extent necessary to ensure anonymity and pass the results on to fellow researchers. We also provide a downloadable bibliography of all references reviewed during this research, and a collection of full documentation of all court records from the falsified vaccine case.
Footnotes
Handling editor Seye Abimbola
Twitter @amaliahasnida, @elizabethpisani
Contributors All authors were closely involved throughout conceptualisation and review of the draft manuscript. In addition: EP designed and led the analysis of the larger four-countries study, led the conceptualisation of this paper. AH led the Indonesian case study data collection, conducted the data analysis and drafted the first manuscript. MK contributed to the study design and analytical methodology.
Funding This work was supported by the Wellcome Trust (grant holder: Elizabeth Pisani; grant number 209930) and Erasmus University (through a Research Excellence and Innovation grant).
Competing interests AH is a recipient of a 2-year research fellowship, supported by the United States Pharmacopeial Convention (USP) Quality Institute for subsequent research based on this submitted work.
Patient and public involvement We sought the views of patients, and parents of vaccinated children, as participants during the study, but they were not specifically involved in the design, conduct, reporting or dissemination of what is largely a policy-focussed investigation.
Provenance and peer review Not commissioned; externally peer reviewed.