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2022 Rome Action Plan on Paediatric HIV & TB

Hologic

HIV DIAGNOSTICS

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.

Hologic commits to:

96. Remain committed to providing all-inclusive, transparent pricing, based on eligibility criteria and volume tiers, that is available in many low- and middle-income countries (published under Hologic’s Global Access Initiative (GAI)), is inclusive of reagents, consumables, instrument charges, maintenance, and freight, and available for the following list of assays, which continues to grow as needs arise: HIV-1 plasma, DBS, and EID, HCV, HBV, HPV & GT, SARS-CoV-2.

97. Continue to report quarterly Key Performance Indicators that monitor the quality and timeliness of our product delivery and service and support of our instrument fleet.

98. Submit for WHO prequalification for HCV in 2023.

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.

Updates

76. Feb. 2024: COMPLETED

77. Feb. 2024COMPLETED

78. Feb. 2024: COMPLETED

79. Feb. 2024COMPLETED

80. Feb. 2024: COMPLETED

81. Feb. 2024: ONGOING. Hologic submitting for WHO PQ for HPV/GT assay in 2022 and HCV assay in 2024.

82. Feb 2024: COMPLETED

83. Feb. 2024: ONGOING. Hologic data connectivity pilots began in February 2024. 

84. Feb. 2024: NO LONGER RELEVANT

86. Feb 2024: NO LONGER RELEVANT

96. Feb 2024: COMPLETED

98. Feb 2024: DELAYED. Dossier is expected to be submitted in the first half of 2024.

99. Feb 2024: WHO re-engaged with Hologic in April 2023, dossier review is complete, and project is currently setting up Performance Evaluation Stage. 

81. June 2024: ONGOING. Hologic submitting for WHO PQ for HPV/GT assay in 2022 and HCV assay in 2024.

83. June 2024: ONGOING. Hologic data connectivity pilots began in February 2024. Commercial roll-out to begin in June 2024.

96. June 2024: ONGOING

97. June 2024: ONGOING

98. June 2024: DELAYED. Dossier is expected to be submitted in the first half of 2024.

99. June 2024: ONGOING. WHO re-engaged with Hologic in April 2023: dossier review is complete, and project is currently in Performance Evaluation Stage.

TB DIAGNOSTICS

Diagnostic manufacturers[1] 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.

 

Hologic commits to:

189. Continue development of a TB diagnostic and resistance assay on Panther

 

[1] Abbott, Cepheid, Hologic, Molbio, Roche.

Updates

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