August 23, 2022 — Three years into the COVID-19 pandemic and in the month that marks the expiration of the 10-year Cepheid Xpert MTB/RIF buy-down, we are at a pivotal moment to take stock of lessons learned, ongoing and new challenges, and the enduring structural barriers that continue to prevent equitable access to molecular diagnostics for TB, HIV, viral hepatitis, HPV, other STIs, and COVID-19. We can continue with business as usual, or we can chart another course toward correcting the unhealthy market. Our future capacity to equitably meet testing needs for infectious diseases will depend on the actions we take today.
Treatment Action Group (TAG) and Médecins Sans Frontières (MSF) Access Campaign are pleased to launch the Principles for Access to Multi-disease Molecular Diagnostics. These 10 Access Principles are intended to help country governments, donors, and global health actors work together to navigate the complex process of improving global, regional, and national systems for the procurement and implementation of essential molecular diagnostic tests. The Access Principles recognize that all people at risk of infectious diseases have a right to quality health care and diagnostic testing in accordance with World Health Organization recommendations. The 10 Access Principles articulate approaches and standards that country governments, donors, and global health actors can collaboratively apply to promote competition, increase efficiency, reduce costs, improve the terms and provision of service and maintenance, and put in place measures to ensure that pricing of molecular diagnostics is transparent, fair, equitable, and evidence based.
These Access Principles were developed based on discussions held between country program representatives, donors, members of civil society, and global health actors at the Roundtable on Access to Multi-disease Molecular Diagnostics, hosted by TAG and MSF on June 2, 2022, and attended by over 100 participants. The Roundtable Meeting Report, presentation slides, and Access Principles are available for download here.
The Cepheid Xpert MTB/RIF buy-down accelerated the initial roll-out of molecular TB testing in low- and middle-income countries, but it also inadvertently created a decade-long monopoly with high prices, lack of transparency in pricing, and inadequate service and maintenance. To make the next 10 years of diagnostics development and access more effective and equitable, we expect country governments, donors, and global health actors to apply these Access Principles to help re-shape the market and establish the conditions necessary for it to deliver equitable access to testing for infectious diseases.
 USAID. The Cepheid Buy-Down Agreement: Evaluation and Implications for the Future. November 2020. https://www.usaid.gov/global-health/health-areas/tuberculosis/resources/publications/cepheid-buy-down-agreement.