Children are one of the most vulnerable yet neglected population in terms of access to optimal medicines in adapted formulations. Consequently, paediatric therapies often remain limited and sub-optimal. To address this issue, MPP and partners are accelerating the development and uptake of child-friendly formulations.
Array ( [0] => Array ( [acf_fc_layout] => text_editor_block [text_editor] => Across most disease areas in which MPP has worked, access to medicines for children lags behind that for adults, and in many cases important medicines are not available in formulations that can be taken easily by young children. Since its inception, MPP has prioritised working with manufacturers on bringing needed paediatric formulations to market, including accelerating their development and facilitating uptake. This contribution has increasingly taken place in partnership with other key stakeholders in the paediatric field. For example, throughout its interactions with manufacturers, MPP highlights the demand for recommended and priority paediatric medicine formulations listed in WHO guidelines and PADO priority lists, while exploring with patent holders practical ways to further expand access to optimal formulations for paediatric populations across disease areas. In addition, and as committed at the Vatican in December 2022, MPP has expanded its quarterly reported information on the progress of priority paediatric HIV drug formulations, in particular dolutegravir (DTG) based medicines. This detailed country-by-country quarter-by-quarter information on regulatory filing plans, reviews, and approvals, as well as supplies of medicines is available here (with more context available further below on this webpage): Click Here to Access MPP’s Reporting on Paediatric DTG Products Moving forward, and as outlined in MPP’s strategy 2023-2025, MPP will continue to place particular focus on addressing the needs of children across all disease areas in which it operates. Its contribution in paediatrics will be framed in alignment with the Global Accelerator for Paediatric Formulations (GAP-f) WHO network, of which MPP is a founding member, to ensure that the most-needed, optimal paediatric formulations are prioritised, developed, and made available to children in an accelerated manner. MPP will also take a more prominent leadership role within GAP-f by acting as the Vice Chair of its Strategy and Coordination Committee for the period from mid-2023 until end of 2024. [text_editor_styles] => Array ( [alignment] => left [text_colour_font] => text-default [background_colour] => grey [background_image] => [background_image_style] => center / cover no-repeat [overlay_colour] => false ) ) [1] => Array ( [acf_fc_layout] => text_editor_block [text_editor] => MPP’s commitments in the paediatric HIV space As part of high-level dialogues convened by the Vatican to accelerate research, development, registration, introduction and uptake of HIV and TB diagnostics and medicines for children living with HIV and/or TB, as well as medicines for pregnant and lactating women, with the ultimate objective of reducing morbidity and mortality among these high vulnerable groups , MPP made the following commitments: Facilitate access to the best available medicines for children. Specifically, MPP will continue to work with patent holders to in-license paediatric drugs as prioritized by the WHO/PADO, and to sublicense to generic manufacturers to ensure that appropriate formulations are rapidly developed, registered and made available in as many developing countries as possible (2017 commitment) [4]. Inform all countries in the paediatric license group on the status of paediatric ARV patents (2018 commitment)[4]. Expand MPP’s quarterly reported information on the progress of priority paediatric drug formulations, sharing not only the list of countries with regulatory filings, regulatory approvals, and supplies of paediatric DTG (10 mg scored dispersible tablets), but also reporting for paediatric ALD (ABC/3TC/DTG 60/30/5 mg) as an important upcoming addition to the paediatric HIV treatment toolbox. In addition, this reporting includes anonymized regulatory filing plans and timelines, as well as quarterly country-by-country volumes of medicines supplied across all countries covered by the MPP-ViiV Healthcare licence for paediatric DTG (2022 commitment) [4]. This information is available here: Click Here to Access MPP’s Reporting on Paediatric DTG Products MPP licences and paediatric HIV In the HIV space, MPP has signed licenses for all the drugs already developed for paediatric use that are included in WHO guidelines. In addition, MPP licences exist for a number of drugs that are still being studied for use in children or that could potentially be important for the paediatric population. There are four royalty-free MPP licensing agreements specifically for paediatric HIV medicines. These licences allow generic supply in countries where the vast majority of children living with HIV in low- and middle-income countries reside: Paediatric licence for abacavir (with ViiV Healthcare) Paediatric licence for dolutegravir (with ViiV Healthcare) Paediatric licence for lopinavir/ritonavir (with AbbVie) Paediatric licence for raltegravir (with Merck, Sharp & Dohme, MSD) Other MPP licences in the HIV space allow sublicensees to manufacture treatments for paediatric use without any royalties on paediatric sales: Licence for atazanavir (with Bristol-Myers Squibb, BMS) Licence for bictegravir (with Gilead Sciences) Licence for cobicistat (with Gilead Sciences) Licence on elvitegravir (with Gilead Sciences) Licence on emtricitabine (with Gilead Sciences) Licence for lopinavir/ritonavir (with AbbVie) Licence for patents related to darunavir (with U.S. National Institutes of Health, NIH) Licence for solid drug nanoparticle technology (with University of Liverpool) Licence for tenofovir alafenamide (with Gilead Sciences) Licence for tenofovir disoproxil fumarate (with Gilead Sciences) MPP licences and paediatric TB In TB, MPP has signed a collaborative agreement with Otsuka with the goal of making delamanid more available to children infected with multidrug-resistant TB. In addition, MPP signed a memorandum of understanding with TB Alliance committing both parties to explore potential avenues of collaboration to ensure that appropriate and affordable TB drug formulations reach children in need. Moreover, MPP licences in the TB space are royalty-free (including for paediatrics): Licences for sutezolid (with Johns Hopkins University and Pfizer) MPP licences and paediatric hepatitis C MPP licences in the hepatitis C space are either royalty-free or allow sublicensees to manufacture treatments for paediatric use without any royalties on paediatric sales: Licence for daclatasvir (with Bristol-Myers Squibb, BMS) Licence for glecaprevir/pibrentasvir (with AbbVie) Licence for ravidasvir (with Pharco Pharmaceuticals) MPP work in paediatrics more broadly As part of MPP’s strategy 2023-2025, MPP will collaborate with GAP-f to ensure the identification of relevant drug formulation gaps for children and, where appropriate, contribute to supporting development of and/or affordable access to needed paediatric formulations. Access related publications and events [text_editor_styles] => Array ( [alignment] => left [text_colour_font] => text-default [background_colour] => false [background_image] => [background_image_style] => center / cover no-repeat [overlay_colour] => false ) ) [2] => Array ( [acf_fc_layout] => post_grid [show_latest_posts] => [post_grid_layout] => rectangular [background_colour] => bg-grey [posts_per_row] => 3 [posts_to_display_in_grid] => Array ( [0] => WP_Post Object ( [ID] => 20840 [post_author] => 21 [post_date] => 2025-09-07 16:46:43 [post_date_gmt] => 2025-09-07 14:46:43 [post_content] => Children are often left behind when it comes to introduction of new medicines or formulations for better clinical management and improved prognoses. Introduction of a new health product requires significant engagement and planning efforts as well as guideline development and training. The purpose of this disease agnostic toolkit is to support countries when developing implementation plans to introduce new health products for children. It is meant to serve as a guide to be adapted to the specific health product, therapeutic area, and local contexts. The toolkit defines a series of 10 steps to be initiated concurrently or consecutively as felt appropriate by the country leadership. Step 1. Community and other Stakeholder Engagement Step 2. In Country Registration Step 3. Revision of National Guidelines Step 4. Planning and Budgeting Step 5. Quantification Step 6. Procurement and Supply Chain Step 7. Health care provider capacitation Step 8. Demand Creation Step 9. Pharmacovigilance Step 10. Tracking and Impact. Access the Report [post_title] => Agnostic toolkit for introduction of a new product for children [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => agnostic-toolkit-for-introduction-of-a-new-product-for-children [to_ping] => [pinged] => [post_modified] => 2025-09-08 16:39:11 [post_modified_gmt] => 2025-09-08 14:39:11 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=20840 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 20517 [post_author] => 21 [post_date] => 2025-07-10 08:27:27 [post_date_gmt] => 2025-07-10 06:27:27 [post_content] => [post_title] => Paediatric drug optimization for respiratory syncytial virus: meeting report, April 2025 [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => paediatric-drug-optimization-for-respiratory-syncytial-virus-meeting-report-april-2025 [to_ping] => [pinged] => [post_modified] => 2025-07-10 08:38:57 [post_modified_gmt] => 2025-07-10 06:38:57 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=20517 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 19954 [post_author] => 21 [post_date] => 2025-05-27 12:09:05 [post_date_gmt] => 2025-05-27 10:09:05 [post_content] => Overview This third phase of GAP-f’s strategy (2025-2030) focuses on strengthening the global ecosystem for paediatric medicines. With a streamlined approach and deeper collaboration across sectors, the strategy aims to accelerate the development, approval, and uptake of child-friendly formulations—prioritizing where the need is greatest. Anchored in equity and impact, GAP-f will work with countries, regulators, industry, civil society and communities, health care professionals and funders to ensure that no child is left behind. Read more [post_title] => [Publication] Transforming the paediatric medicines ecosystem: strategic roadmap 2025–2030 [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => publication-transforming-the-paediatric-medicines-ecosystem-strategic-roadmap-2025-2030 [to_ping] => [pinged] => [post_modified] => 2025-05-27 12:11:39 [post_modified_gmt] => 2025-05-27 10:11:39 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=19954 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 19947 [post_author] => 21 [post_date] => 2025-05-27 12:00:23 [post_date_gmt] => 2025-05-27 10:00:23 [post_content] => Overview This third phase of GAP-f’s strategy (2025-2030) focuses on strengthening the global ecosystem for paediatric medicines. Read more [post_title] => [Summary] Transforming the paediatric medicines ecosystem: strategic roadmap 2025–2030 [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => transforming-the-paediatric-medicines-ecosystem-strategic-roadmap-2025-2030 [to_ping] => [pinged] => [post_modified] => 2025-05-27 17:49:28 [post_modified_gmt] => 2025-05-27 15:49:28 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=19947 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 19742 [post_author] => 21 [post_date] => 2025-04-30 12:01:09 [post_date_gmt] => 2025-04-30 10:01:09 [post_content] => The peer-reviewed article "Accelerating access to paediatric medicines: lessons learned from the Global Accelerator for Paediatric Formulations, a WHO-hosted network”, published in The Lancet Child & Adolescent Health, reflects on the experience and lessons from GAP-f’s phase 2 strategy between 2022 and 2024, and how these can inform the work moving forward into GAP-f's phase 3 strategy for 2025-2030. Despite progress in reducing neonatal and child mortality, access to age-appropriate medicines remains inequitable, particularly in low-income and middle-income countries. The Global Accelerator for Paediatric Formulations (GAP-f), a WHO-hosted network established in 2020, addresses these gaps by uniting 33 partners to promote innovation and access to child-friendly formulations. Phase 2 (2022–24) of GAP-f's work focused on therapeutic areas where innovation and access efforts often did not have stakeholder alignment and coordination of designing and implementing innovative clinical trial methodology, engaging with regulators to address systemic barriers, identifying novel technologies for safe and effective delivery, and collaborating across stakeholders for product roll out. Learnings from GAP-f work include the need to adapt prioritisation processes to diverse therapeutic areas and focus on high-impact areas based on unmet needs. Platform trials emerged as a promising tool to accelerate evidence generation but require guidance from regulators, collaboration among pharmaceutical companies, and operational challenges and funding constraints to be overcome. Incentivising paediatric formulation development remains crucial for small volume paediatric markets, and efforts are also needed to more proactively enhance, accelerate, and effectively match innovations to deliver medicines to children more efficiently. Even when products are successfully developed, political will and community engagement are essential to creating demand, supporting roll out, and ensuring equitable access and appropriate use in children. Dedicated funding and targeted programmes are crucial to drive systemic and sustainable change. GAP-f implementation lessons discussed in this Personal View will inform the future of this needed initiative, accelerating progress towards improved medicines for children. Figure 1. Global Accelerator for Paediatric Formulations formalises collaborations across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children Access the article [post_title] => Accelerating access to paediatric medicines: lessons learned from the Global Accelerator for Paediatric Formulations, a WHO-hosted network [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => accelerating-access-to-paediatric-medicines-lessons-learned-from-the-global-accelerator-for-paediatric-formulations-a-who-hosted-network [to_ping] => [pinged] => [post_modified] => 2025-05-01 15:22:34 [post_modified_gmt] => 2025-05-01 13:22:34 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=19742 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [5] => WP_Post Object ( [ID] => 19350 [post_author] => 21 [post_date] => 2025-03-24 12:58:43 [post_date_gmt] => 2025-03-24 11:58:43 [post_content] => Access the article [post_title] => Simplifying medicine dosing for children by harmonising weight bands across therapeutic areas [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => simplifying-medicine-dosing-for-children-by-harmonising-weight-bands-across-therapeutic-areas [to_ping] => [pinged] => [post_modified] => 2025-03-24 12:58:43 [post_modified_gmt] => 2025-03-24 11:58:43 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=19350 [menu_order] => 61 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [6] => WP_Post Object ( [ID] => 19961 [post_author] => 21 [post_date] => 2025-03-27 13:36:54 [post_date_gmt] => 2025-03-27 12:36:54 [post_content] => [post_title] => Uniting for children: closing the gap in paediatric medicines [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => uniting-for-children-closing-the-gap-in-paediatric-medicines [to_ping] => [pinged] => [post_modified] => 2025-05-27 17:44:20 [post_modified_gmt] => 2025-05-27 15:44:20 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=19961 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [7] => WP_Post Object ( [ID] => 19965 [post_author] => 21 [post_date] => 2025-03-27 13:43:01 [post_date_gmt] => 2025-03-27 12:43:01 [post_content] => [post_title] => Developing medicines for children: challenges and innovations [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => developing-medicines-for-children-challenges-and-innovations [to_ping] => [pinged] => [post_modified] => 2025-05-27 17:43:19 [post_modified_gmt] => 2025-05-27 15:43:19 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=19965 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [8] => WP_Post Object ( [ID] => 17597 [post_author] => 6 [post_date] => 2024-07-31 11:09:22 [post_date_gmt] => 2024-07-31 09:09:22 [post_content] => The commentary “Access to highly effective long-acting RSV-monoclonal antibodies for children in LMICs—reducing global inequity” published in The Lancet Global Health, highlights the significant impact of Respiratory syncytial virus (RSV) on child health, especially in low-income and middle-income countries (LMICs). It emphasises the need for strategies to prevent severe RSV lower respiratory tract infections (LRTI) in infants, given the high disease burden, associated mortality, and limited healthcare access in these regions. The commentary underscores the urgent need to bridge the gap in healthcare equity. As we strive to advance child health, it is imperative that we ensure the availability of long-acting RSV-monoclonal antibodies to children in LMICs. By prioritising access, we can significantly reduce the burden of severe RSV lower respiratory tract infections and associated mortality. Access the commentary (full access) Manuele Piccolis explains: [post_title] => Advancing Child Health: Innovative RSV Prevention Strategies in LMICs - Insights from The Lancet Global Health [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => advancing-child-health-innovative-rsv-prevention-strategies-in-lmics-insights-from-the-lancet-global-health [to_ping] => [pinged] => [post_modified] => 2024-08-21 14:46:49 [post_modified_gmt] => 2024-08-21 12:46:49 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=17597 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [9] => WP_Post Object ( [ID] => 17848 [post_author] => 6 [post_date] => 2024-09-06 16:45:42 [post_date_gmt] => 2024-09-06 14:45:42 [post_content] => The latest advocacy brief "Accelerating innovation and access to better medicines for children" by the Global Accelerator for Paediatric Formulations Network (GAP-f) is available on the WHO website. The objective of this brief is to mobilise global advocacy efforts to access better – safer, more effective and quality-assured – medicines in optimal formulations suitable for children. It outlines some of the main challenges in accelerating the development of and access to better medicines for children and presents possible solutions to address those challenges. This brief can be used to support the alignment, messaging, mobilisation and advocacy of stakeholders at global, regional and national levels. The brief outlines the main challenges in accelerating the development and access to these medicines and presents 5 concrete solutions to address these challenges: 1️. Prioritise efforts: Focus on priority drugs and formulations in the pipeline through the Paediatric Drug Optimization (PADO) process. 2. Strengthen coordination: Improve coordination to align efforts, track needs, and ensure seamless funding streams for paediatric medicines. 3️. Incentivise action: Address regulatory challenges and facilitate market entry to boost R&D investments for paediatric medicines. 4️. Ensure accessibility: Accelerate the introduction and sustain access to better and affordable medicines for children by addressing policy updates, capacity building, and more. 5️. Invest more and smarter: Mobilise resources to accelerate R&D of better formulations for children, with an estimated $100M needed by 2030 to impact 16M children's lives. Access the brief [post_title] => Accelerating innovation and access to better medicines for children: advocacy brief [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => accelerating-innovation-and-access-to-better-medicines-for-children-advocacy-brief [to_ping] => [pinged] => [post_modified] => 2024-09-06 16:58:03 [post_modified_gmt] => 2024-09-06 14:58:03 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=17848 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [10] => WP_Post Object ( [ID] => 17862 [post_author] => 6 [post_date] => 2024-07-30 14:36:31 [post_date_gmt] => 2024-07-30 12:36:31 [post_content] => The Action Plan “Accelerating bnAbs for Peri- and Post-Natal HIV Prophylaxis” was published in July 2024. Developed by a Task Force of leading experts and stakeholders, including the Medicines Patent Pool, this comprehensive plan outlines a strategic approach to address the urgent need for innovative HIV prevention strategies for infants. In 2023 alone, approximately 120,000 infants acquired HIV, contributing to 9% of new global infections. This underscores the urgent need to intensify prevention efforts and reduce new infant infections. The document highlights the potential of broadly neutralising antibodies (bnAbs) as a promising strategy to address gaps in the prevention of peri- and post-natal HIV transmission. These antibodies have shown encouraging safety and efficacy profiles in early clinical trials, offering hope for long-term protection against HIV without the adherence challenges associated with daily oral prophylaxis. The Action Plan details a multi-faceted strategy encompassing enabling science, clinical development, community partnership, regulatory pathways, manufacturing, access, policy, and advocacy. It aims to accelerate the development and broad implementation of bnAbs, ensuring they are accessible to the populations most in need. Click here to download the Action Plan. [post_title] => Accelerating bnAbs for peri- and post-natal HIV prophylaxis: An Action Plan [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => accelerating-bnabs-for-peri-and-post-natal-hiv-prophylaxis-an-action-plan [to_ping] => [pinged] => [post_modified] => 2024-09-09 14:36:48 [post_modified_gmt] => 2024-09-09 12:36:48 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=17862 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [11] => WP_Post Object ( [ID] => 17386 [post_author] => 6 [post_date] => 2024-07-09 11:50:42 [post_date_gmt] => 2024-07-09 09:50:42 [post_content] => The Medicines Patent Pool participated in AIDS 2024, the 25th International AIDS Conference in Munich, Germany and virtually from 22-26 July, as well as the pre-conference on 20 and 21 July. MPP shared a booth (#904) with Unitaid in the exhibition area. AIDS 2024 convened thousands of people living with, affected by and working on HIV to share knowledge, best practices and lessons learnt from the HIV response over the past 40 years, as well as from the responses to COVID-19, mpox and other public health threats. AIDS 2024 in Munich, Germany, and virtually provided a powerful platform to strategically align around a unified and equitable response to the pandemic. It signaed to the world that the HIV response is united behind an evidence-based approach that puts people first. MPP colleagues actively participated in a number of sessions: Pre-Conference Saturday, 20 July, 8:00 – 9:00 | Room 14a / Channel 9 The PrEP product introduction landscape Pre-conference session (session 1) Esteban Burrone, Director, Policy, Strategy and Market Access, speaking as a panellist More information Conference Monday, 22 July, 11:30 - 12:30 | Room 14a/Channel 9 Lessons learned from the DTG story MPP/Unitaid satellite session Esteban Burrone, Director, Policy, Strategy and Market Access, providing closing remarks More information Tuesday, 23 July, 10:30 - 11:30 | Room 13b/Channel 7 The law, human rights and access to medicines Oral abstract session | Track F: Political science, laws, ethics, policies and human rights Mila Maistat, Senior Manager, Policy, Strategy and Market Access, providing introductory remarks More information Wednesday, 24 July, 18:00 - 19:30 | Hall B0a/Channel 4 An action plan to accelerate bNAbs for peri- and post-natal prophylaxis (PNP) IAS, IAVI, Desmond Tutu Health Foundation satellite session Sébastien Morin, Senior Manager, Policy, Strategy and Market Access, speaking as a panellist More information Friday, 26 July, 10:30 - 11:30 | Room 1/Channel 2 No retreat! No surrender! The urgency of aligning investments where they are needed the most in the global HIV response Symposium | Track E: Implementation science, economics, systems and synergies Lobna Gaayeb, Head of Scientific and Medical Affairs, moderating the session More information Friday, 26 July, 12:00 - 13:00 | Room 13b/Channel 7 Taking Action on Long-Acting Injectable PrEP: Towards access and implementation Symposium | Track E: Implementation science, economics, systems and synergies Esteban Burrone, Director, Policy, Strategy and Market, moderating the session More information Activities at the Booth, Exhibition Area and Global Village MPP shared a booth (#904) with Unitaid in the exhibition area. Tuesday, 23 July, 11:30 - 12:00 | AVAC’s Research Literacy Zone at the Global Village (booth HT0401) Process and considerations for generics licensing with MPP Session organised by AVAC in collaboration with CS Caucus of LA PrEP Coalition Sébastien Morin, Senior Manager, Policy, Strategy and Market Access, presenting Tuesday, 23 July, 14:00 - 14:50 | PLHIV Networking Zone at the Global Village #BetterMeds4Kids – Children's Access to Life-Saving HIV Treatment Session organised by GNP+ and PATA Sébastien Morin, Senior Manager, Policy, Strategy and Market Access, presenting Wednesday, 24 July, 9:45 - 10:45 | Booth of France in the Exhibition Area (#804) Accès équitable aux traitements et innovations contre le VIH : regards croisés sur les leçons apprises et défis à venir Session organised by France, moderated by Anne-Claire Amprou, French Ambassador for Global Health Esteban Burrone, Director, Policy, Strategy and Market, speaking Wednesday, 24 July, 11:30 - 12:30 | Booth of MPP and Unitaid in the Exhibition Area (#904) Direct from the Source: The DTG Film Story Session organised by MPP - download flyer > Step behind the lens and experience the making of the "I am part of the DTG story" film. Meet and converse with the community heroes who shared their powerful stories during the cinema premiere at the World Health Assembly. Join us at the MPP booth for this enlightening session Watch the recording: YouTube live Wednesday, 24 July, 13:15 - 14:00 | Booth of MPP and Unitaid in the Exhibition Area (#904) #BetterMeds4Kids: Accelerating access to better HIV medicines for children Session organised by MPP and partners of the Global Accelerator for Paediatric Formulations (GAP-f) WHO network - download flyer > Children are one of the most vulnerable yet neglected populations in terms of access to optimal medicines in adapted formulations. Consequently, paediatric therapies often remain limited and sub-optimal. Hear from partners of the Global Accelerator for Paediatric Formulations (GAP-f) WHO network, of which MPP is a founding member, as they share their experiences in addressing innovation and access challenges in developing and improving access to HIV medicines for children. Watch the recording: YouTube live Thursday, 25 July, 11:00 - 12:00 | Booth of MPP and Unitaid in the Exhibition Area (#904) NAVIGATING LONG-ACTING THERAPEUTICS: LAPaL, a database at the Intersection of Innovation and Access Session organised by MPP - download flyer > LAPaL is the only online open access tool dedicated to supporting access to long-acting therapeutics. It not only provides patent and licensing information about key long-acting technologies and compounds, but also captures clinical development, regulatory filing information of selected treatment and prevention medicines. LAPaL aim is to provide reliable information and support innovation in the long-acting therapeutics while fostering access. Join this hands-on session to discover it! If possible, come with your computer/tablet to get the full experience! [post_title] => MPP @ AIDS 2024 [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => mpp-aids-2024 [to_ping] => [pinged] => [post_modified] => 2024-09-06 17:07:25 [post_modified_gmt] => 2024-09-06 15:07:25 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=17386 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) [12] => WP_Post Object ( [ID] => 14923 [post_author] => 20 [post_date] => 2023-05-24 15:28:14 [post_date_gmt] => 2023-05-24 13:28:14 [post_content] => The GAP-f pDTG task team has developed a brief outlining product introduction and rollout considerations for national programmes when introducing the fixed-dose combination (FDC) of paediatric abacavir/lamivudine/ dolutegravir (pALD). Specifically, this brief aims to inform the transition from pDTG + pABC/3TC to pALD. Click here to access the brief. [post_title] => GAP-f pALD Introduction and Rollout Planning Considerations for National Programme [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => gap-f-pald-introduction-and-rollout-planning-considerations-for-national-programme [to_ping] => [pinged] => [post_modified] => 2023-10-09 11:15:13 [post_modified_gmt] => 2023-10-09 09:15:13 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=news-publications&p=14923 [menu_order] => 0 [post_type] => news-publications [post_mime_type] => [comment_count] => 0 [filter] => raw ) ) [number_of_posts_to_show] => -1 [post_type] => news-publications [disease_styles] => [news_publication_type] => [people_type] => [company_type] => [story_type] => [include_filters] => [show_images] => 1 [show_events_from_date] => all ) [3] => Array ( [acf_fc_layout] => text_editor_block [text_editor] => Read our stories [text_editor_styles] => Array ( [alignment] => left [text_colour_font] => text-default [background_colour] => false [background_image] => [background_image_style] => center / cover no-repeat [overlay_colour] => false ) ) [4] => Array ( [acf_fc_layout] => post_grid [show_latest_posts] => [post_grid_layout] => rectangular [background_colour] => bg-grey [posts_per_row] => 2 [posts_to_display_in_grid] => Array ( [0] => WP_Post Object ( [ID] => 13030 [post_author] => 20 [post_date] => 2023-01-25 11:36:09 [post_date_gmt] => 2023-01-25 10:36:09 [post_content] => [lgc_column grid="30" tablet_grid="50" mobile_grid="100" last="false"] Nadia Adingra is the director at ICW - International Community Women living with HIV, Côte d’Ivoire. She is a founding member of COF+CI (Coalition des Organisations de Femmes vivant avec le VIH Côte d’Ivoire) and represents AfroCAB. Nadia found out about her HIV positive status when pregnant with her daughter who is now 17 years old. Approximately 380,000 people are currently living with HIV in Côte d'Ivoire, including 18,000 children (0-14 years), of whom just 54% are on antiretroviral treatment[1]. Click on the map to view the licences in Cote d'Ivoire. [/lgc_column] [lgc_column grid="70" tablet_grid="50" mobile_grid="100" last="false"] – Nadia Adingra, Director at ICW - International Community Women living with HIV, Côte d’Ivoire. The introduction of dolutegravir 10 mg For many years, children living with HIV in low- and middle-income countries such as Côte d'Ivoire have only had access to sub-optimal antiretroviral drugs, that are difficult to swallow because of their bad taste or because of their unsuitable formulation (large, hard-to-swallow tablets). In 2021, the World Health Organization (WHO) published their Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. These guidelines recommend dolutegravir (DTG)-based regimens as the preferred first- and second-line treatment option in children for age and weight groups with approved DTG dosing, from four weeks of age and three kilogramms. A licensing agreement between MPP and ViiV Healthcare, the originator company, was signed in 2014, which allows generic manufacturers to produce low-cost versions of DTG for paediatric use in 123 countries. Paediatric DTG, a 10 milligram scored dispersible tablet, offers many advantages: it is more effective, better tolerated, easier to administer thanks to its possible dissolution into a liquid, and better accepted by children due to its strawberry taste. In November 2020, the US Food and Drug Administration (FDA) gave their green light for the use of DTG 10 mg in children. In December 2020, Unitaid announced that the price of this new treatment would be USD 36 per year per child (compared to approximately USD 400 for the previous available treatement), following an agreement between the Clinton Health Access Initiative (CHAI) and generic manufacturers, MPP sublicensees Viatris and Macleods. As part of this work, CHAI, with funding from Unitaid and in partnership with ViiV Healthcare, implemented a novel development incentive program and innovative regulatory strategy to accelerate the development and regulatory approval of a generic pediatric DTG product, which included technical support to these generic manufacturers to support the development of this unique formulation for children that did not exist. A partnership approach for access to paediatric dolutegravir 10 mg in Côte d'Ivoire In 2020, Unitaid and CHAI approached the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) to partner under the CHAI-Unitaid Optimal project, which includes a focus on accelerating access to optimal pediatric treatment regimens. This collaboration would build on EGPAF’s pediatric work previously funded by Unitaid under the SPAAN project (Securing Pediatric ARV Access Now). Côte d'Ivoire was a focal country under the SPAAN project and joined as one of the focal countries of the Optimal project in 2020. A key objective of the project was to support the uptake and roll-out of optimal antiretroviral products for children and to generate demand among the populations that need them most by working in partnership with AfroCAB through the Optimal Community Advisory Board. The project was supported by the government of Côte d'Ivoire. Nadia's role has been to explain the benefits of DTG 10 mg to mothers and the government: "We had to show that the product could make a real difference to the lives of children whose viral load was not being suppressed. At that time, only lopinavir/ritonavir in the form of granules or syrup were available for treating HIV in children. It was an effective treatment, but difficult to administer to young children because of its bitter taste. Children could not be looked after by a guardian because the product had to be measured precisely. The arrival of DTG 10 mg has made it easier to administer as it is a scored tablet that is dissolved in water.” There are multiple intervention strategies in the Optimal project, including involvement of communities in the implementation of the project through information meetings at community level; training of "mentor mothers" on DTG 10 mg; developing materials in various didactic ways that community members could use and targeted media campaigns (especially radio and videos - example here) to raise awareness on the use of DTG 10 mg; advocacy with health and political authorities; and finaly the evaluation of services offered through discussions with focus groups. “We organised focus groups across all of Côte d'Ivoire. The important feedback that came out of these meetings were that mothers are relieved because the medicine is easier to take for their infants: it is taken once a day and it allows for some flexiblilty as to the best time to take it. The tablet is scored so it can be broken in half and dissolved into water. It tastes like strawberry cream. The great thing about it is that children now ask for their medicine.” DTG 10 mg access and results in Côte d'Ivoire Côte d'Ivoire was one of the first 10 countries, along with Benin, the Democratic Republic of Congo, Haiti, Kenya, Malawi, Nigeria, Uganda, Zambia and Zimbabwe, to order and receive DTG 10 mg boxes (boxes of 90 tablets each) from in early 2021. Initially only newly diagnosed children between 3 and 20 kg were put on DTG 10 mg, due to limited stocks of the product. Then, from December 2021, the government transferred all children between 3 and 20 kg to DTG 10 mg. A total of more than 45 000 boxes of 90 tablets had been received by the end of December 2021, followed by more than 30 000 by August 2022. "Thanks to this new drug,the viral suppression in children on DTG 10 mg in Côte d’Ivoire is now at 84%, where it was just 25% before with the previous treatment (based on lopinavir/ritonavir, LPV/r)." Some key points: DTG 10mg was added to the Cote d’Ivoire ARV procurement plan in December 2020 DTG 10 mg has been included in Côte d’Ivoire’s national guidelines since June 2021 An estimated 2,952 (83%) of 3,566 eligible children less than 20kg are benefitting from DTG 10 mg in the framework of the Optimal project in Côte d'Ivoire (source EGPAF, December 2022). There are now differentiated care models for children under 5 years of age Stockouts are very rare or non-existent. "Let's not slacken our efforts!" Access to DTG 10mg now needs to be extended to the whole of Côte d'Ivoire and the African continent, and the latest data from sublicensed generic manufacturers of MPP (as of September 2022) shows that 45 of the continent's 54 countries have already begun the process of transitionning to DTG 10mg. "HIV infections are still very real in our societies, but we don't talk about it as much as we used to. We must not stop raising awareness, especially among the younger generations, about the ways HIV is transmitted and offer them a range of choices to protect themselves, tests and adapted treatments.” In addition to supporting the transition to DTG 10mg, AfroCAB continues to advocate for the availability of long-acting cabotegravir for PrEP (pre-exposure prophylaxis): MPP recently signed a licensing agreement with ViiV Healthcare for this product, and is working within an international consortium to accelerate access. Approaches at the international level To ensure a safe and effective transition to paediatric DTG for all children, the GAP-f (Global Accelerator for Paediatric Formulations) Paediatric DTG Task Team has developed a circular for national HIV programmes, implementing partners and service providers. These considerations are available online here. GAP-f is a WHO network dedicated to closing the paediatric treatment gap. GAP-f offers a viable mechanism to develop better tolerated, safer, more effective and sustainable paediatric formulations and make them available to children at an accelerated rate across different diseases, based on the vast experience from paediatric HIV as discussed in this article. [1]2021 data from UNAIDS > https://www.unaids.org/en/regionscountries/countries/ctedivoire [/lgc_column] [post_title] => Bringing dolutegravir 10 mg to children living with HIV in Côte d’Ivoire [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => bringing-dolutegravir-10-mg-to-children-living-with-hiv-in-cote-divoire [to_ping] => [pinged] => [post_modified] => 2023-01-25 14:09:52 [post_modified_gmt] => 2023-01-25 13:09:52 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=stories&p=13030 [menu_order] => 0 [post_type] => stories [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 7333 [post_author] => 14 [post_date] => 2020-09-03 13:00:51 [post_date_gmt] => 2020-09-03 12:00:51 [post_content] => [lgc_column grid="30" tablet_grid="50" mobile_grid="100" last="false"] "EGPAF is proud of its collaboration with MPP, an organization that will continue working until every child and young person has the quality medicine they need to live a happy, healthy life. MPP understands that innovation is vital to achieving this goal." [/lgc_column] [lgc_column grid="70" tablet_grid="50" mobile_grid="100" last="false"] – By Chip Lyons, EGPAF CEO & President At the Elizabeth Glaser Pediatric AIDS Foundation, we’re driven to create a world where every child can live a healthy life into adulthood. In the early years of the epidemic, little was known about the virus, and particularly its impact on children. Elizabeth Glaser watched her own daughter’s health decline as she waited for medicines suitable for children to become available. She advocated to make children a priority in the US and global HIV and AIDS response — and her legacy lives on. Today, we continue Elizabeth’s work to see a world where no other mother, child, or family is devastated by this disease. Ten years ago, the founding of Medicines Patent Pool (MPP) sparked new action towards closing the vast treatment gap between children and adults in the HIV treatment landscape. Over that time, we’ve been inspired by the progress that’s been made in shrinking that disparity, but we know our work is not done. EGPAF is proud of its collaboration with MPP, an organization that will continue working until every child and young person has the quality medicine they need to live a happy, healthy life. MPP understands that innovation is vital to achieving this goal. Improved formulations bring hope to families who thought they might never find the solutions they need to not just survive, but thrive. Furthermore, MPP knows that these innovations are only as powerful as they are accessible. Lives are only saved when medicines and tools make it into the hands of those who need them most. Each stage of life — from infancy to adulthood — brings new and different challenges in the fight to end this epidemic. Time after time in the global response to HIV, we see that our greatest achievements happen when organizations with shared goals come together to take action. The future looks bright with partnerships like the Global Accelerator for Paediatric Formulations (GAP-f) keeping children at the forefront. As an organization founded on a mother’s determination over thirty years ago, looking back at how far we’ve come as a global community allows us to imagine what it will take to overcome the challenges that still lie ahead. Thanks to MPP and others, we have more tools at our disposal than ever before. We see how we have driven effective innovation and provided access to vulnerable populations including children and young people around the world. Now, with those lessons in mind, we keep pushing forward together. [/lgc_column] [post_title] => Keeping children at the forefront of the Global AIDS Response [post_excerpt] => By Chip Lyons, EGPAF CEO & President - "EGPAF is proud of its collaboration with MPP, an organization that will continue working until every child and young person has the quality medicine they need to live a happy, healthy life. MPP understands that innovation is vital to achieving this goal." [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => keeping-children-at-the-forefront-of-the-global-aids-response [to_ping] => [pinged] => [post_modified] => 2020-12-08 12:47:39 [post_modified_gmt] => 2020-12-08 12:47:39 [post_content_filtered] => [post_parent] => 0 [guid] => https://medicinespatentpool.org/?post_type=stories&p=7333 [menu_order] => 0 [post_type] => stories [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 6863 [post_author] => 14 [post_date] => 2019-12-01 14:00:15 [post_date_gmt] => 2019-12-01 14:00:15 [post_content] => [lgc_column grid="30" tablet_grid="50" mobile_grid="100" last="false"] By Dr. Martina Penazzato, the paediatric HIV technical lead in the HIV, Hepatitis and STI department in WHO Headquarters, Geneva. In her role she leads the work of WHO on paediatric HIV treatment and care, contributes to a number of global initiatives to scale up HIV services for children living with HIV. She has led the setup of GAP-f in WHO and contributed to the work that WHO is undertaking to accelerate access to better medicines for children more broadly. [/lgc_column] [lgc_column grid="70" tablet_grid="50" mobile_grid="100" last="false"] For the HIV community, World AIDS Day is an important opportunity to reflect on progress made and the work that remains to be done. When 150,000 additional children are infected with HIV every year and only half of the 1.7 million children living with HIV receive antiretroviral therapy, with alarmingly low virological suppression, something needs be done, and urgently. We, at the World Health Organization (WHO), want this message to come across loud and clear at this World AIDS Day, and we will continue to call for action at the International Conference on AIDS and STIs in Africa (ICASA) taking place in Kigali, Rwanda this week as well as in the preparation of the thematic segment on “Reducing the impact of AIDS on children and youth” at the upcoming UNAIDS Programme Coordinating Board 45th meeting. Despite progress in identifying children living with HIV and starting them on antiretroviral therapy, particularly in Eastern and Southern Africa, the current situation is still not satisfying for children living with HIV. While tackling the paediatric HIV epidemic certainly requires a multifaceted approach that equally focuses on the tools (medicines and diagnostics) as well as on service delivery, one striking gap remains the lack of optimal drug regimens in child-friendly formulations to treat HIV and HIV-associated infections. In my role as WHO’s Paediatric HIV Technical Lead this is something I have been grappling with and considered a key priority for our WHO work. Over the last year I had the privilege to work closely with several country programmes and explore current practice and persisting issues in ARV drug optimization. The situation is very consistent throughout Sub-Saharan Africa: the majority of children are still on suboptimal, legacy regimens and despite updated policies, transition to more recent optimal formulations continues to be challenged and delayed due to limited availability as well as supply insecurity for some of the newest formulations. We know that the development of paediatric medicines lags unacceptably behind that of adults by nearly a decade. Investigating new drugs is typically delayed until later stages of mandatory clinical development plans, and often studies are not designed to efficiently generate the evidence we need to approve and safely use these drugs in resource-limited settings. Young children cannot swallow tablets or capsules; liquid formulations are bulky; and acceptable palatability is difficult to achieve. Drug doses need to be tailored to a child’s drug metabolism and weight, requiring dose adjustments and formulation changes as the child grows. Together, these elements complicate drug development and further fragment already small markets for paediatric drugs that prevent or treat infectious diseases such as HIV, tuberculosis (TB) and viral hepatitis. Following a resolution at the 69th World Health Assembly in 2016 “Promoting innovation and access to quality, safe, efficacious and affordable medicines for children”, WHO and partners have increased their efforts to deliver on this global commitment and have scaled up activities to ensure that better medicines become available for children. As a result, the Global Accelerator for Paediatric Formulations (GAP-f) was created as a WHO initiative with the support of the Clinton Health Access Initiative (CHAI), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Medicines Patent Pool (MPP), and Penta Child Health Research as well as initial contributions from other stakeholders like the Drugs for Neglected Diseases initiative (DNDi), the International AIDS Society, Unitaid and PEPFAR. GAP-f provides a sustainable mechanism dedicated to ensuring that the most needed optimal paediatric formulations across various diseases, including HIV, are developed against the highest standards of safety and efficacy and made available in appropriate formulations to children in a timely manner. GAP-f is the testimony of WHO’s broader commitment to provide better medicines for children. This initiative, which relies on a close collaboration among multiple technical departments of WHO, is now formally hosted by the Research Department in the newly formed Science Division led by WHO’s Chief Scientist, Dr Soumya Swaminathan, a paediatrician from India and a globally recognized researcher on tuberculosis and HIV. GAP-f works across the life cycle of drug development, bringing efficiency through enhanced coordination between stakeholders to:
Across most disease areas in which MPP has worked, access to medicines for children lags behind that for adults, and in many cases important medicines are not available in formulations that can be taken easily by young children.
Since its inception, MPP has prioritised working with manufacturers on bringing needed paediatric formulations to market, including accelerating their development and facilitating uptake. This contribution has increasingly taken place in partnership with other key stakeholders in the paediatric field.
For example, throughout its interactions with manufacturers, MPP highlights the demand for recommended and priority paediatric medicine formulations listed in WHO guidelines and PADO priority lists, while exploring with patent holders practical ways to further expand access to optimal formulations for paediatric populations across disease areas.
In addition, and as committed at the Vatican in December 2022, MPP has expanded its quarterly reported information on the progress of priority paediatric HIV drug formulations, in particular dolutegravir (DTG) based medicines. This detailed country-by-country quarter-by-quarter information on regulatory filing plans, reviews, and approvals, as well as supplies of medicines is available here (with more context available further below on this webpage):
Click Here to Access MPP’s Reporting on Paediatric DTG Products
Moving forward, and as outlined in MPP’s strategy 2023-2025, MPP will continue to place particular focus on addressing the needs of children across all disease areas in which it operates. Its contribution in paediatrics will be framed in alignment with the Global Accelerator for Paediatric Formulations (GAP-f) WHO network, of which MPP is a founding member, to ensure that the most-needed, optimal paediatric formulations are prioritised, developed, and made available to children in an accelerated manner. MPP will also take a more prominent leadership role within GAP-f by acting as the Vice Chair of its Strategy and Coordination Committee for the period from mid-2023 until end of 2024.
As part of high-level dialogues convened by the Vatican to accelerate research, development, registration, introduction and uptake of HIV and TB diagnostics and medicines for children living with HIV and/or TB, as well as medicines for pregnant and lactating women, with the ultimate objective of reducing morbidity and mortality among these high vulnerable groups , MPP made the following commitments:
In the HIV space, MPP has signed licenses for all the drugs already developed for paediatric use that are included in WHO guidelines. In addition, MPP licences exist for a number of drugs that are still being studied for use in children or that could potentially be important for the paediatric population.
There are four royalty-free MPP licensing agreements specifically for paediatric HIV medicines. These licences allow generic supply in countries where the vast majority of children living with HIV in low- and middle-income countries reside:
Other MPP licences in the HIV space allow sublicensees to manufacture treatments for paediatric use without any royalties on paediatric sales:
In TB, MPP has signed a collaborative agreement with Otsuka with the goal of making delamanid more available to children infected with multidrug-resistant TB. In addition, MPP signed a memorandum of understanding with TB Alliance committing both parties to explore potential avenues of collaboration to ensure that appropriate and affordable TB drug formulations reach children in need. Moreover, MPP licences in the TB space are royalty-free (including for paediatrics):
MPP licences in the hepatitis C space are either royalty-free or allow sublicensees to manufacture treatments for paediatric use without any royalties on paediatric sales:
As part of MPP’s strategy 2023-2025, MPP will collaborate with GAP-f to ensure the identification of relevant drug formulation gaps for children and, where appropriate, contribute to supporting development of and/or affordable access to needed paediatric formulations.
Children are often left behind when it comes to introduction of new medicines or formulations for better clinical management and improved prognoses. Introduction of a new health product requires significant engagement and planning efforts as well as guideline development and training.
The purpose of this disease agnostic toolkit is to support countries when developing implementation plans to introduce new health products for children. It is meant to serve as a guide to be adapted to the specific health product, therapeutic area, and local contexts.
The toolkit defines a series of 10 steps to be initiated concurrently or consecutively as felt appropriate by the country leadership.
Step 1. Community and other Stakeholder Engagement Step 2. In Country Registration Step 3. Revision of National Guidelines Step 4. Planning and Budgeting Step 5. Quantification Step 6. Procurement and Supply Chain Step 7. Health care provider capacitation Step 8. Demand Creation Step 9. Pharmacovigilance Step 10. Tracking and Impact.
The GAP-f pDTG task team has developed a brief outlining product introduction and rollout considerations for national programmes when introducing the fixed-dose combination (FDC) of paediatric abacavir/lamivudine/ dolutegravir (pALD). Specifically, this brief aims to inform the transition from pDTG + pABC/3TC to pALD.
Click here to access the brief.
In the early years of the epidemic, little was known about the virus, and particularly its impact on children. Elizabeth Glaser watched her own daughter’s health decline as she waited for medicines suitable for children to become available. She advocated to make children a priority in the US and global HIV and AIDS response — and her legacy lives on. Today, we continue Elizabeth’s work to see a world where no other mother, child, or family is devastated by this disease.
Ten years ago, the founding of Medicines Patent Pool (MPP) sparked new action towards closing the vast treatment gap between children and adults in the HIV treatment landscape. Over that time, we’ve been inspired by the progress that’s been made in shrinking that disparity, but we know our work is not done.
EGPAF is proud of its collaboration with MPP, an organization that will continue working until every child and young person has the quality medicine they need to live a happy, healthy life.
MPP understands that innovation is vital to achieving this goal. Improved formulations bring hope to families who thought they might never find the solutions they need to not just survive, but thrive. Furthermore, MPP knows that these innovations are only as powerful as they are accessible. Lives are only saved when medicines and tools make it into the hands of those who need them most.
Each stage of life — from infancy to adulthood — brings new and different challenges in the fight to end this epidemic. Time after time in the global response to HIV, we see that our greatest achievements happen when organizations with shared goals come together to take action. The future looks bright with partnerships like the Global Accelerator for Paediatric Formulations (GAP-f) keeping children at the forefront.
As an organization founded on a mother’s determination over thirty years ago, looking back at how far we’ve come as a global community allows us to imagine what it will take to overcome the challenges that still lie ahead. Thanks to MPP and others, we have more tools at our disposal than ever before. We see how we have driven effective innovation and provided access to vulnerable populations including children and young people around the world. Now, with those lessons in mind, we keep pushing forward together.
By Dr. Martina Penazzato, the paediatric HIV technical lead in the HIV, Hepatitis and STI department in WHO Headquarters, Geneva. In her role she leads the work of WHO on paediatric HIV treatment and care, contributes to a number of global initiatives to scale up HIV services for children living with HIV. She has led the setup of GAP-f in WHO and contributed to the work that WHO is undertaking to accelerate access to better medicines for children more broadly.
For the HIV community, World AIDS Day is an important opportunity to reflect on progress made and the work that remains to be done. When 150,000 additional children are infected with HIV every year and only half of the 1.7 million children living with HIV receive antiretroviral therapy, with alarmingly low virological suppression, something needs be done, and urgently. We, at the World Health Organization (WHO), want this message to come across loud and clear at this World AIDS Day, and we will continue to call for action at the International Conference on AIDS and STIs in Africa (ICASA) taking place in Kigali, Rwanda this week as well as in the preparation of the thematic segment on “Reducing the impact of AIDS on children and youth” at the upcoming UNAIDS Programme Coordinating Board 45th meeting.
Despite progress in identifying children living with HIV and starting them on antiretroviral therapy, particularly in Eastern and Southern Africa, the current situation is still not satisfying for children living with HIV. While tackling the paediatric HIV epidemic certainly requires a multifaceted approach that equally focuses on the tools (medicines and diagnostics) as well as on service delivery, one striking gap remains the lack of optimal drug regimens in child-friendly formulations to treat HIV and HIV-associated infections.
In my role as WHO’s Paediatric HIV Technical Lead this is something I have been grappling with and considered a key priority for our WHO work. Over the last year I had the privilege to work closely with several country programmes and explore current practice and persisting issues in ARV drug optimization. The situation is very consistent throughout Sub-Saharan Africa: the majority of children are still on suboptimal, legacy regimens and despite updated policies, transition to more recent optimal formulations continues to be challenged and delayed due to limited availability as well as supply insecurity for some of the newest formulations.
We know that the development of paediatric medicines lags unacceptably behind that of adults by nearly a decade. Investigating new drugs is typically delayed until later stages of mandatory clinical development plans, and often studies are not designed to efficiently generate the evidence we need to approve and safely use these drugs in resource-limited settings. Young children cannot swallow tablets or capsules; liquid formulations are bulky; and acceptable palatability is difficult to achieve. Drug doses need to be tailored to a child’s drug metabolism and weight, requiring dose adjustments and formulation changes as the child grows. Together, these elements complicate drug development and further fragment already small markets for paediatric drugs that prevent or treat infectious diseases such as HIV, tuberculosis (TB) and viral hepatitis.
Following a resolution at the 69th World Health Assembly in 2016 “Promoting innovation and access to quality, safe, efficacious and affordable medicines for children”, WHO and partners have increased their efforts to deliver on this global commitment and have scaled up activities to ensure that better medicines become available for children. As a result, the Global Accelerator for Paediatric Formulations (GAP-f) was created as a WHO initiative with the support of the Clinton Health Access Initiative (CHAI), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Medicines Patent Pool (MPP), and Penta Child Health Research as well as initial contributions from other stakeholders like the Drugs for Neglected Diseases initiative (DNDi), the International AIDS Society, Unitaid and PEPFAR. GAP-f provides a sustainable mechanism dedicated to ensuring that the most needed optimal paediatric formulations across various diseases, including HIV, are developed against the highest standards of safety and efficacy and made available in appropriate formulations to children in a timely manner.
GAP-f is the testimony of WHO’s broader commitment to provide better medicines for children. This initiative, which relies on a close collaboration among multiple technical departments of WHO, is now formally hosted by the Research Department in the newly formed Science Division led by WHO’s Chief Scientist, Dr Soumya Swaminathan, a paediatrician from India and a globally recognized researcher on tuberculosis and HIV.
GAP-f works across the life cycle of drug development, bringing efficiency through enhanced coordination between stakeholders to:
The global call to leave no one behind enshrined in the United Nations Sustainable Development Goals (SDGs) puts the world’s most vulnerable and marginalised people – including children – at the top of the agenda. GAP-f is an example of how experience from years of work across a multitude of stakeholders and best practices from the global paediatric HIV community can be brought together, and remaining gaps identified for coordinated actions to take place. (www.gap-f.org)
[/lgc_column]
This time last year, global agencies, including the World Health Organization (WHO), Elizabeth Glaser Pediatric AIDS Foundation and UNAIDS, joined key stakeholders for a High-Level Dialogue on Scaling Up Early Diagnosis and Treatment of Children and Adolescents, convened by the Vatican. The meeting discussed reducing mortality among children living with HIV and, through the resulting action plan, committed to prioritising the development of child-friendly formulations of antiretroviral drugs (ARVs).
The Medicines Patent Pool (MPP) will be participating in the follow-up meeting – also at the Vatican - on 5-6 December 2019. HIV in children remains one of the world’s urgent public health crises. Latest data show that there are an unacceptable 1.8 million children under the age of 15 years of age living with HIV. Three hundred children die of the virus every day.[1] Although approximately 936,000 children were on antiretroviral therapy in 2017, there were still 180,000 new infections in the same year, despite the success of prevention of mother to child transmission programmes.[2] But this is not just a disease of numbers. Each statistic represents personal stories of the impact on families and their communities – and a devastating waste of life.
Treatment options for HIV-positive children are insufficient. More investment and efforts to develop effective child-friendly versions are needed. Current versions are difficult to administer, especially in younger children, and can have toxic side effects, seriously undermining treatment initiation and attempts to suppress the virus. Better paediatric formulations would save hundreds of lives every day. And yet…the world lags behind in developing them.
The action plan from the meeting in Rome acknowledges this reality and states “an improved first-line therapy for children under three years of age would be safe, easy to administer, well-tolerated and palatable, heat-stable, readily dispersible, and dosed once daily or less.”
In that same plan, the MPP committed to continue facilitating access to the best available medicines for children through intellectual property and knowledge sharing, and through its work with the pharmaceutical industry and public health stakeholders. In the short-term, this commitment translates in our work with licensees to deliver paediatric formulations identified by WHO. To date, we have licensed 13 ARVs, four of them for children. In the longer-term, the MPP will continue reaching the necessary agreements to ensure newer priority products are made available as quickly as possible.
In 2019, new paediatric formulations from the pharmaceutical industry, some of them developed by MPP sub-licensees, will be submitted for regulatory approval or will be entering the market. For example, new formulations of lopinavir/ritonavir, including a ‘four in one’ combination with abacavir and lamivudine; the fixed dose combination composed of abacavir/lamivudine/efavirenz; and the first dispersible tablets of dolutegravir. These products should contribute to better implementation of the WHO treatment guidelines, simplifying the regimens in some cases or providing formulations that are better adapted for children.
However, new products mean new challenges regarding how the transition to updated treatments is made. For example, how to ensure that countries adapt their treatment guidelines; that treatment providers become familiar with the new therapies and are trained in dispensing them; that parents and families support the transition; and that HIV programmes are able to absorb and deliver the changes. Traditional barriers to access in low- and middle-income countries (LMICs) must also be factored in: chronic poverty, weak healthcare infrastructure, stigma and discrimination.
On 5-6 December, I will be joining a follow-up meeting convened once more by the Vatican where our partners will be addressing why children continue to be an after-thought in the HIV response and to follow through on the commitments made last year. This meeting is a critical opportunity to prioritise children in an accelerated HIV response. It’s an opportunity that must not be missed.
[1] UNAIDS 2021. Children living with HIV lagging behind adults in access to treatment [2] WHO Global TB Report 2018. [3] WHO Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection 2018. [4] Rome Action Plan on Paediatric HIV, Online tracker.
Strategy, Policy and Market Access
Agreements with Innovators
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.