Gap analysis for drug development policy-making: An attempt to close the gap between policy and its implementation

PLoS One. 2019 Aug 6;14(8):e0220605. doi: 10.1371/journal.pone.0220605. eCollection 2019.

Abstract

Introduction: Most drug development policies in developing countries are enacted without achieving the desired results. This study aims to determine the prioritization of drug development in Indonesia through the evidence-based policymaking process in order to close the distance between stated policy goals and the realization of planned goals.

Methods: A quantitative approach in the form of cross-sectional research using a structured survey was adopted and validated using a set of techniques involved in the calculation of a structural equation model. An independent samples t-test was used to test the significance of the differences between two views: pharmaceutical industries and the government of Indonesia.

Findings: The study reveals that pharmaceutical industries and governments were highly consistent in their perceived challenges in facing the drug development. It also reveals drivers and weaknesses of drug development, including market opportunities, push-pull-regulatory pull factors and regulation, as priorities for improvement.

Conclusions: Gap analysis based on a structural model was borne out to address gap challenges between policy and its implementation, with the use of evidence-based policymaking.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cross-Sectional Studies
  • Developing Countries
  • Drug Development*
  • Drug Industry / methods
  • Government
  • Health Plan Implementation*
  • Health Policy
  • Humans
  • Indonesia
  • Policy Making*

Grants and funding

The work was supported by Universitas Indonesia (PENG-1/UN2.R3.1/PPM.00/2019) to DA and by Badan POM to RCS scholarship. There was no additional external funding received for this study. The funder has no role in study design, data collection and analysis, decision to publish, or the preparation of the manuscript.