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
ATMF
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 2024. Completed:
The Access to Medicine Foundation completed the review of its Index methodology and consulted with over 100 stakeholders and technical experts. Gender parity was achieved with 50% of women consulted. It was published on the Access to Medicine's website in October 2023.
The 2024 Access to Medicine Index Methodology considers issues of sex and gender and explores ways to better include those who are pregnant and lactating in the next Access to Medicine Index through the indicators RD1a, RD1b, RD3a and RD3b. The Access to Medicine Foundation updated the indicator rationale for these pipeline indicators to highlight the importance of the non-exclusion of pregnant and breastfeeding women from clinical trials (when applicable).
The R&D team completed the assessment of inclusion/exclusion criteria of clinical trials within our internal database to analyse whether pregnant & breastfeeding women are excluded from clinical research. In the data collection tools for the access planning indicators (RD3a and RD3b) sent end of January 2024, companies have been given the opportunity to include details in their access plans on how or if they are including pregnant and breastfeeding women in clinical research. Finally, the data submission from companies is now done and the anaysis almost completed. The Access to Medicine Foundation is currently exploring ways this new data could be best highlighted in the next iteration of the Index, which will be published in Q4 2024.
June 2024. Completed: The Access to Medicine Foundation completed the review of its Index methodology and consulted with over 100 stakeholders and technical experts. Gender parity was achieved with 50% of woman consulted. It was published on the Access to Medicine's website in October 2023.
The 2024 Access to Medicine Index Methodology considers issues of sex and gender and explores ways to better include those who are pregnant and lactating in the next Access to Medicine Index through the indicators RD1a, RD1b, RD3a and RD3b. The Access to Medicine Foundation updated the indicator rationale for these pipeline indicators to highlight the importance of the non-exclusion of pregnant and breastfeeding women from clinical trials (when applicable).
The R&D team has already begun a preliminary assessment of inclusion/exclusion criteria of clinical trials within our internal database to analyse whether pregnant & breastfeeding women are excluded from clinical research. In the data collection tools for the access planning indicators (RD3a and RD3b) sent end of January 2024, companies have been given the opportunity to include details in their access plans on how or if they are including pregnant and breastfeeding women in clinical research. Finally,the data submission from companies is now done. The Access to Medicine Foundation is currently analysing it and exploring ways this new data could be best highlighted in the next iteration of the Index.
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 2024. Ongoing: 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 Access to Medicine Index Methodology, published in October 2023, also delves into issues linked to R&D for pregnant and lactating populations. The data collection for the 2024 Access to Medicine Index started in Autumn 2023 and ended on May 29th, 2024. New opportunities for companies will be published in Q4 2024. We anticipate that these opportunities will also feature targeted asks pertaining to clinical trial etiquette. The Patient Reach report, published in September 2024, highlights the need for more ambitious commitments towards maternal health, particularly addressing gaps in reproductive and newborn health. It emphasizes the importance of focusing on pregnant and lactating women, especially in low- and middle-income countries, while also encouraging transparency and collaboration to expand patient reach.
June 2024. Ongoing: 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 Access to Medicine Index Methodology,published in October 2023, also delves into issues linked to R&D for pregnant and lactating populations. The data collection for the 2024 Access to Medicine Index started in Autumn 2023 and ended on May 29th 2024. New opportunities for companies will be published in Q4 2024. We anticipate that these opportunities will also feature targeted asks pertaining toclinical trial etiquette.
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 2024. Completed: The Access to Medicine Foundation published in February 2023 the first-of-its-kind framework to assess how generic 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.
June 2024. Completed: The Access to Medicine Foundation published in February 2023 the first-of-its-kind framework to assess how generic 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.
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.
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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313. October 2024. Completed: The 2024 Access to Medicine Index Methodology was published in October 2023. The Access to Medicine Foundation consulted with over 100 stakeholders and technical experts, including paediatric experts. The 2024 Access to Medicine Index Methodology explores ways to better include paediatric populations in the next Access to Medicine Index through the indicators RD1a, RD1b, RD3a and RD3b, discussing the inclusion of children (<12 years) in clinical research. 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.
314. October 2024. Ongoing: The 2022 Index highlighted one paediatric opportunity on HIV for MSD, related to expanding access to raltegravir in countries with a high disease burden by expanding registration and applying equitable pricing. The data collection for the 2024 Access to Medicine Index started in Autumn 2023 and ended on May 29th, 2024. The Patient Reach report, published in September 2024, highlights the significant burden of paediatric HIV across low- and middle-income countries and underscores the need for pharmaceutical companies to enhance their patient reach efforts.
New opportunities for companies will be published in Q4 2024. We anticipate that some opportunities may feature targeted asks pertaining to the paediatric population.
315. October 2024. Completed: The generics & biosimilar manufacturers company profiles include 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. A follow-up report on paediatric diabetes will be published in Q1 2025, focusing on global access to insulin. This deep dive will provide nuanced analyses of inequities in diabetes diagnosis and treatment among children worldwide. Similar to the diabetes thematic report published in 2022 by the Access to Medicine Foundation, the upcoming study will include a comparable set of companies, examining their specific efforts regarding paediatric access. It will also highlight the unique challenges faced by children in administering diabetes treatments and emphasize the importance of improving access to diverse insulin delivery mechanisms, addressing the disparities and striving towards equitable solutions for this vulnerable cohort.
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.
-
360. October 2024. Completed: The Access to Medicine Foundation completed the review of its Index methodology and consulted with over 100 stakeholders and technical experts. Gender parity was achieved with 50% of women consulted. It was published on the Access to Medicine's website in October 2023. The 2024 Access to Medicine Index Methodology considers issues of age, sex and gender and explores ways to better include peadiatric populations as well as pregnant and lactating individuals in the next Access to Medicine Index through the indicators RD1a, RD1b, RD3a and RD3b. The Access to Medicine Foundation updated the indicator rationale for these pipeline indicators to highlight the importance of the non-exclusion of pregnant and breastfeeding women from clinical trials (when applicable). The R&D team has completed its assessment of inclusion/exclusion criteria of clinical trials within our internal database to analyse whether pregnant & breastfeeding women are excluded from clinical research. In the data collection tools for the access planning indicators (RD3a and RD3b) sent at the end of January 2024, companies have been given the opportunity to include details in their access plans on how or if they are including pregnant and breastfeeding women in clinical research. Finally, the Access to Medicine Foundation is currently exploring ways this new data could be best highlighted in the next iteration of the Index, which will be published in Q4 2024.
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 2024. Ongoing: The 2022 Index highlighted 6 sexual and reproductive health opportunities for 6 different companies. The data collection for the 2024 Access to Medicine Index started in Autumn 2023 and ended on May 29th, 2024. New opportunities for companies will be published in the 2024 Access to Medicine Index in Q4 2024. The Patient Reach report, published in September 2024, emphasizes the importance of expanding access to treatments for vulnerable populations, such as children, pregnant, and breastfeeding women, particularly in addressing TB. Through the example of Johnson & Johnson’s MDR-TB commitment, which aims to expand access to bedaquiline for underserved populations including paediatric and maternal groups, the report highlights how setting measurable and targeted initiatives can help ensure broader access to critical TB treatments.
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).