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.
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
News & Press Releases » News
