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Evaluation of the effects of a generic substitution policy implemented in Chile
  1. Cristián Mansilla1,
  2. Jorge Cárdenas1,
  3. Warren A. Kaplan2,
  4. Veronika J. Wirtz2,
  5. Lucy Kuhn-Barrientos1,
  6. Matías Ortíz de Zárate1,
  7. Tatiana Tobar1,
  8. Cristian A. Herrera3,4
  1. 1 Ministerio de Salud, Gobierno de Chile, Santiago, Chile
  2. 2 Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA
  3. 3 Health Division, OECD, Paris, Île-de-France, France
  4. 4 Department of Public Health, Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile
  1. Correspondence to Cristián Mansilla; camansil{at}gmail.com

Abstract

Introduction Chile implemented a generic substitution policy in 2014 to improve access to medicines. This study aims to measure if the generic substitution policy had an effect on the sales volume and prices of referent and the branded generic products with demonstrated bioequivalence (BEQ) in the private pharmaceutical market.

Methods The volume and total private sales of medicines sold at private sector retail outlets between November 2011 and October 2016 were considered in the analysis. We calculated the total number of daily defined doses (DDD) by adding up the number of DDDs of different presentations with the active pharmaceutical ingredient (API). We determined the ratio of the median prices of all BEQ per DDD presentations compared with the median price of the corresponding referent presentations per DDD in 2011 and 2016. Sixteen APIs representing 231 different conventional-release presentations were included in the analysis.

Results Overall, the volume of sales of the referent products decreased over time after the intervention. However, this reduction was not mirrored by an increase in the corresponding branded generic BEQ volumes overall. In all cases, the median price per DDD of the referent was higher than its BEQ counterpart in 2011 and 2016.

Conclusion Since referent products are more costly than branded BEQ generic products, reducing their consumption—and increasing the BEQ availability—should improve access to medicines in Chile. However, this must be accompanied by promotion of BEQ products to ensure savings for consumers in the long term. Future research should focus on identifying facilitating and inhibiting factors of generic substitution.

  • health policy
  • health services research
  • health systems
  • health systems evaluation
  • public health

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: http://creativecommons.org/licenses/by/4.0

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Footnotes

  • Handling editor Seye Abimbola

  • Contributors All authors have read and approved the submission of the manuscript.

  • Funding This study was funded by Alliance for Health Policy and Systems Research, WHO, Geneva, with support from the Norwegian Government Agency for Development Cooperation (Norad), the Swedish International Development Cooperation Agency (Sida) and the UK Department for International Development (DFID). Pharmaceutical sector market data were procured by the Ministry of Health of Chile to IQVIA in Chile.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

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