Purpose The purpose of this paper is to identify, analyze and describe the novel approaches that affect vaccine development in lower-middle income countries (LMICs). Design/methodology/approach The vaccine market in LMICs currently focuses on traditional Expanded Program for Immunization vaccines instead of new ones. Unlike the successful introduction of those traditional vaccines, the introduction of new vaccines appears to be very slow, mainly due to financial issues. This paper systematically reviews a set of published papers on vaccine development and analyzes them against a specific region-setting framework. Findings Public–private partnership alone could not ensure long-term vaccine sustainability. Several factors that encourage domestic vaccine development were identified. The findings demonstrate that the regulatory approach of hybrid collaboration and market opportunity strategies can be a major breakthrough for domestic vaccine development in LMICs. Research limitations/implications Further research is required to include qualitative and quantitative methods for policy analysis, as all of the discussion in this research focused on literature reviews. The authors did not discuss how strategic decisions are affected from a political perspective and this needs to be specified in future research. Think tanks, considerably and fundamentally, affect policy ideas and decisions. However, important breakthroughs continue to be made at the same time. Social implications The development of vaccines in LMICs is expected to be a mechanism to overcome the inadequate access to vaccines in those countries, as solving this problem requires tackling issues from both the supply and demand sides. Originality/value This is a literature review that creates recommendation and approaches for domestic vaccine development in LMICs. This review aims to encourage LMICs to produce their own vaccines for sustainability of the vaccine access through vaccine development lifecycle, instead of expecting donor that provides funding and vaccines (vaccine access) in certain period of time. Donor is not always the solution for the problem, since vaccine development requires finance to function infrastructure. There are many efforts in revoking this, including World Health Organization through several reports; however, this effort still has many doubts. Therefore, the article would like to try to see this as a viable solution from the policy perspectives, with several examples to make recommendations more practical.
Purpose The World Health Organization has pointed out that the majority of developing countries currently rely on imported drugs, in spite of the fact that there is potential for them to produce their own drugs. The purpose of this paper is to present a framework as an innovation policy model that can strategically predict the outcome of drug development investment in developing countries. Design/methodology/approach In order to explore a model relevant to the policy-making process, the literature was systematically reviewed with a focus on the impact of policy changes on drug development in developing countries. Findings An innovation policy model consists of the relational influences of contextual variables of pharma capabilities, innovation incentives and political factors affecting drug development in developing countries, derived from a dissenting policy-making perspective. This was built to test two hypotheses of a positive relationship between the above variables; and a perspectives gap between the pharmaceutical companies and the policymakers. These hypotheses address issues related to the lack of drug development in developing countries. Research limitations/implications This paper presents a conceptual framework for the evaluation and provides examples of its use, but it is currently at a relatively early stage of research. Further work is currently underway and will later be presented to the same journal. Social implications Domestic drug development in developing countries needs to be feasible in order to ensure drug security. This predictive policy model provides a comprehensive approach to health policy reforms to examine innovation strategies. Originality/value This model includes measures to explore whether pharma capabilities, innovation incentives and/or political factors have an effect on domestic drug development in developing countries. It bridges the policy implementation’s operational process between pharmaceutical companies and policymakers.
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.
PurposeThe pharmaceutical industry in Indonesia appears hesitant to make the transition from inventor to innovator and instead continues with the process of formulation and packaging. Evidence-based policy has been advocated for Indonesia and, in general, this is more likely to hold. This study aims to establish a model for a policy-making process that is strategically able to predict strategies that would encourage drug development in Indonesia.Design/methodology/approachA quantitative approach with the survey method was designed to obtain appropriate data from a population of pharmaceutical industries in Indonesia and relevant government institutions to assess the relationship of various factors capable of triggering domestic drug development, including pharma capability, political feasibility and innovation incentives. The construct was validated using a set of techniques pertaining to the calculation of structural equation modeling.FindingsThe model demonstrates how it matters when applied to the policy-making process. It proves that pharma capability, political feasibility, and innovation incentives correlated to pharma capability are major catalysts in the promotion of drug development. These are largely explained by market opportunity, pull factors, government power, and position. Although all of the elements were moderately to strongly related to the promotion of drug development, this study has revealed the predictive impact on drug development in Indonesia to be only 46%.Originality/valueThis study adds values to policy-makers as it attempts to predict strategies that would encourage a successful policy when being implemented. Encompassing both pharma industries and government institutions, this study captures a real situation and provides an empirical contribution to the concept of the integrated research of drug development in developing countries.
Educational design research (EDR) was applied to address the challenge of providing more public health professionals with opportunities to develop their knowledge and skills related to Good Clinical Practices (GCP) inspections. The conduct of clinical research in accordance with the principles of GCP is necessary to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. The safety and efficacy of pharmaceuticals, medical devices, and other healthcare products depend upon the application of GCP. The World Health Organization has been providing a global face-to-face GCP Inspection course in Indonesia for a decade, but budget constraints only allow this course to be offered once a year to 15 participants. This paper describes how the move from a face-to-face course to an online authentic learning environment was accomplished through EDR and concludes with a discussion of design principles derived from the research. The results of a beta test of the new online course with 12 participants are also described in the paper.
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