2022 Rome Action Plan on Paediatric HIV & TB
Diagnostic manufacturers commit to:
76. Implement and adhere to global access pricing reflective of global demand volumes that ensures consistent reagent pricing across governments and partners within all 145 low- and middle-income countries and regions, and provide a transparent breakdown of pricing for the products and services sold.
77. Implement more consolidated and flexible all-inclusive bundled, or other novel, pricing models that incorporate the menu of any essential molecular tests critical to public health (ie. HIV, TB, HBV, HCV, HPV, MPXV, SARS-CoV-2, etc) instead of separate instrument, consumable, and service procurement models.
78. Reconsider current volume commitment numbers for transitioning to flexible all-inclusive bundled, or other novel, pricing models as current mechanisms are limiting country participation, access, and benefit to novel procurement approaches.
79. Improve oversight and transparency of authorized distributors/representatives under service level agreements that address poor service and lack of adherence to global access pricing schemes.
80. Offer payment terms that better reflect the capability and structures of buyers.
81. Introduce available and upcoming assays on all available proprietary devices, including obtaining the necessary regulatory approvals.
82. Implement a standardized template for service level agreements that clearly spell out minimum performance indicators, including target up-time and failure rate thresholds (with consideration for different causes), plus a mitigation plan when thresholds are exceeded, while committing to improve response times for maintenance and repair programs.
83. Ensure instruments, both laboratory-based and point-of-care, include data connectivity options or are compatible with and can be exported to standard dashboards or databases used in LMICs.
84. Rapidly communicate stock shortages with major buyers and work on joint mitigation strategies. During pandemics or other outbreaks, continue to produce and supply essential tests in order to ensure supply security for critical diseases, such as HIV and TB.
85. Include and standardize multi-lingual display interfaces.
86. Provide three-year advance warning of device discontinuation and transition plans to ensure smooth and cost-minimal transitions to new platforms, including end-of-life equipment removal.
Cepheid commits to:
91. Prioritize transparent global access price both directly and with our distribution partners across all molecular assays in the HBDC program, not limited to HIV and TB but also HPV, HCV, and HBV.
92. Create a transparent & open time bound application process for AccessCare service and maintenance to all 145 high-burden low- and middle-income countries.
93. Rapidly implement an indeterminate range for infant diagnosis, per WHO guidelines, within product software.
94. Consider free replacements of Xpert 6-colour modules with new 10-colour modules when systems are covered under a service agreement.
95. Commit to a rapid roll out of hybrid software to enable a 6C & 10C module to run side by side in the Gene Xpert system.
All partners commit to:
163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment.
164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care.
165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.
166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.
Diagnostic manufacturers commit to:
174. Generate data on new and existing WHO-recommended tests where evidence is lacking for children, including evidence on using alternative (non-sputum-based) sample types.
175. Develop quality-assured, affordable, less invasive alternative specimen processing methods or products (not based only on sputum) that can be used for the paediatric population at the primary health care level, such as urine, stool, tongue swabs or saliva.
176. Work with procurers to monitor stock levels and consumption rates to improve forecasting aimed at minimising the likelihood of stockouts, maintain sufficient regional buffer stock levels and have mitigation plans in place to ensure service continuity
177. Begin moving from a separate instrument, consumable, and service procurement towards more consolidated, all-inclusive pricing models that pool volumes across diseases (i.e. TB, HIV, HBV, HCV, HPV, MPXV, SARS-CoV-2, etc.) and that include service and maintenance.
178. Provide service level agreements to all countries that are monitored according to standardised key performance indicators for all technology types and their offered service plans
179. Ensure TB molecular products that are WHO recommended achieve WHO pre-qualification by 2024 and the required post-marketing surveillance is in place.
Cepheid commits to:
182. Reduce the price of Xpert MTB/XDR ($19.80) to promote access and support the implementation of decentralised drug-susceptibility testing.
183. Consider the creation of a new bundle deal with 10C instruments & XDR for 2023
184. Deliver the rollout of new hybrid software in 2023 that enables the running of 6C & 10C modules side by side on the Gene Xpert platform.
185. Evaluate the blood-based host response test for TB for potential use in children as either a diagnostic or screening test
186. Create a transparent Access Care application process & time bound inclusion roadmap to all 145 high-burden low- and middle-income countries
187. Evaluate the blood-based host response test for TB for potential use in children as either a diagnostic or screening test
188. Offer global access pricing to both NTP and non-NTP/private sector in high-burden TB countries via a public-private partnership mechanism and provide a transparent breakdown of pricing for the products and services sold.
 Abbott, Cepheid, Hologic, Molbio, Roche.