Examining the distribution of the TB diagnostic tool, GeneXpert: A Case Study Público

Gile, Emma (Spring 2023)

Permanent URL: https://etd.library.emory.edu/concern/etds/v979v445x?locale=es
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Abstract

In this case study, I describe some of the determinants of GeneXpert distribution including price and cost, intellectual property protections, and other determinants including supply delays, COVID-19, and health system weaknesses. While some broad conclusions can be made about GeneXpert distribution including that GeneXpert are not widely available in all high-burden countries and in recent years, there has been an increase in the presence of GeneXpert in public sectors globally, the specifics of global distribution of GeneXpert is unknown. A key takeaway from this case study is the elusiveness of the data related to GeneXpert procurement and distribution. The global distribution of GeneXpert is unavailable but there is data on the use of rapid molecular tests more broadly. However, data on rapid molecular tests still allow for discussions of equity. The distribution of GeneXpert has many inequitable aspects, which calls into question the obligations of justice to address this inequity. Despite concessional pricing agreements, price is still prohibitive for GeneXpert distribution in high TB burden countries. Price, however, is not easily fixable. One aspect of pricing that is highly complicated are intellectual property protections. For diagnostic tools in particular, little is understood about the specific impacts of IP on diagnostic access. Lastly, determinants beyond price include supply delays, COVID-19, and the need for health systems strengthening. Many countries have GeneXpert machines installed within a health system but cannot continue to afford the cartridges needed for diagnosis, especially through domestic funding alone. Additionally, many health systems still require strengthening to continue to use GeneXpert. Given the murkiness of GeneXpert distribution, we need to think about manufacturing differently. Rethinking manufacturing includes efforts to finance and strengthen health systems adequately beyond just the installment of a GeneXpert machine and rethinking how we think about diagnostic tools as potentially more of a global good than a private commodity.GeneXpert distribution and access is a component of the greater global health challenge of access to public health products. 

Table of Contents

Table of Contents

Chapter I. Introduction..........................................................................................................1

Purpose: ............................................................................................................................1

Introduction........................................................................................................................1

Brief Overview of TB Disease ..............................................................................................2

TB Diagnostic Practices and Policies....................................................................................4

Current Distribution of Diagnostic Tools...............................................................................5

Background and Significance .................................................................................................7

Chapter II. Methods ............................................................................................................ .....10

Chapter III. Findings ................................................................................................................ 13

The Global Distribution of GeneXpert.....................................................................................13

Price: GeneXpert is still not widely affordable.........................................................................14

Intellectual Property.............................................................................................................18

Determinants Beyond Price: Supply delays, COVID-19, weak health systems............................20

Chapter IV: Discussion ..............................................................................................................21

The Distribution of GeneXpert: An issue of equity .....................................................................21

Power, Pricing, and Intellectual Property ..................................................................................24

Do we need to think about manufacturing diagnostics differently?.............................................26

Chapter V. Limitations .................................................................................................................28

Chapter VI. Conclusion.................................................................................................................29

Works Cited..................................................................................................................................32

Appendix A ..................................................................................................................................37 

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