HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
2022 Rome Action Plan on Paediatric HIV & TB
AMF
Access to Medicine Foundation commits to include appropriate metrics to capture alignment with the Call To Action[1]principles in their next access index for pharmaceutical companies, and specifically:
23. Complete a review of how pregnant and lactating women are represented in the 2023 Access to Medicine Index Methodology and make subsequent changes to the methodology, as required to continue to reflect their unique needs by Q4 2023.
24. Highlight key opportunities for the pharmaceutical companies within the scope of its research pertaining to pregnant and lactating women as an inclusion in its collaborative engagement work aimed at moving the pharmaceutical industry further and faster on key topics by Q4 2025.
25. Explore the unique needs of pregnant and lactating women in the consultation process and the subsequent development of new frameworks for evaluation, as part of its 5-year Strategic Direction.
[1] See Annex section Rome 6 - https://www.paediatrichivactionplan.org/high-level-dialogues
WHO and Research networks commit to:
61. Working together to collaboratively develop standards to strengthen systematic population data collection, registries, and master protocols to promote alignment and harmonization of studies in pregnant women across studies within the work of the WHO HIV, Hepatitis and STIs Pregnancy
and Breastfeeding Therapeutics Working Group (HHS PTWG) .
62. Ensure appropriate consultation and engagement of community members and communitybased organizations through the research cycle for new therapeutics.
23. October 2023:
On track for completion: The Access to Medicine Foundation completed the review of its Index methodology and consulted with over 100 stakeholders and technical experts. The Foundation aims to discuss how pregnant and lactating women can be better represented in the next Access to Medicine Index, and to increase the percentage of women consulted.The 2024 Index Methodology explores ways to better include those who are pregnant and lactating in the next Access to Medicine Index, which will be published at the end of 2024.
24. October 2023:
Not started: The latest Access to Medicine Index, released in November 2022, highlighted access issues for women and maternal populations in a special report on sexual and reproductive health and rights (SRHR). It also defined 6 key opportunities targeting SRHR products and initiatives for 6 companies. The 2024 ATM Index Methodology will also delve into issues linked to R&D for pregnant and lactating populations. It will be published in October 2023. The data collection for the 2024 Access to Medicine Index will start in Autumn 2023 and new opportunities will be published in Q4 2024.
25. October 2023:
Completed: The Access to Medicine Foundation published in February 2023 the first-of-its-kind framework to assess how generics manufacturers expand access to medicine. This framework’s disease scope includes 10 maternal and neonatal health conditions.
The generics & biosimilar manufacturers company profiles, published on September 26th, 2023 includes an analysis of adaptive R&D projects, which can include adding new indications and new target patient populations (e.g., infants/children, pregnant and lactating people). It also features opportunities for companies to make progress on access to medicine for pregnant patients.
Access to Medicine Foundation commits to:
313. Completing a review of how paediatric populations are represented in the 2023 Access to Medicine Index Methodology and to making subsequent changes to the methodology, as required to continue to reflect their unique needs by Q4 2023.
314. Highlighting key opportunities for the pharmaceutical companies within the scope of our research pertaining to paediatric populations as an inclusion in our collaborative engagement work aimed at moving the pharmaceutical industry further and faster on key topics by Q4 2025.
315. Exploring the unique needs of paediatric populations in the consultation process and the subsequent development of new frameworks for evaluation, as part of its 5-year Strategic Direction.
313. October 2023: On track for completion: The Access to Medicine Foundation finished reviewing its Index methodology and consulting with over 100 stakeholders and technical experts, including paediatric experts. The Index methodology review will be published in Q4 of 2023.
314. October 2023:
Not started: The 2022 Index highlighted 1 paediatric opportunity on HIV for a company.
The new key opportunities for the companies in scope of the Index will be published in Q4 2024.
315. October 2023:
Completed: The generics & biosimilar manufacturers company profiles includes 4 key opportunities for companies to make progress on access to medicine for paediatric populations and includes analysis on adaptive R&D to promote paediatric products. The fourth key finding, on R&D, takes a deep dive into such projects targeting paediatric populations and includes analysis of paediatric HIV medicines.
Access to Medicine Foundation commits to:
360. Complete a review of how paediatric populations and pregnant and lactating women are represented in the 2023 Access to Medicine Index Methodology and to making subsequent changes to the methodology, as required to continue to reflect their unique needs by Q4 2023.
361. Highlight key opportunities for the pharmaceutical companies within the scope of our research pertaining to paediatric populations and pregnant and lactating women as an inclusion in our collaborative engagement work aimed at moving the pharmaceutical industry further and faster on key topics by Q4 2025.
362. Explore the unique needs of paediatric populations as well as pregnant and lactating women in the consultation process and the subsequent development of new frameworks for evaluation, as part of its 5-year Strategic Direction.
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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.
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360. October 2023:
Completed: The Access to Medicine Foundation finished reviewing its Index methodology and consulting with over 100 stakeholders and technical experts. The Foundation has increased the percentage of women consulted, and the 2024 ATM Index Methodology will also delve into issues linked to R&D for pregnant and lactating populations. It will be published in Q4 2023.
361. October 2023:
Not started: The 2022 Index highlighted 6 sexual and reproductive health opportunities for 6 different companies.
The new key opportunities for the companies in scope of the Index will be published in Q4 2024.
362. October 2023:
Completed: As part of the development of the Generics and biosimilar research programme, the Foundation has included in its framework adaptive R&D paediatric targeting the most vulnerable such as paediatric populations. The G&BM Company profiles report from the Foundation’s generics and biosimilar manufacturers research programme was published on September 26th 2023. It featured 9 opportunities specifically targeting women’s health and sexual and reproductive products. The products targeted in these opportunities are, for maternal hemorrhage: Oxytocin (2 companies), for oncology: Cisplatin (3 companies) for HIV/AIDs: Dolutegravir (adult) (1 company), Dolutegravir (peadiatric) (2 companies).