E-DRUG: Access to Medicine Foundation analysis of gaps in children's treatments
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Dear e-drug colleagues
I hope that you are all keeping safe and well,
Last week, the Access to Medicine Foundation published a new analysis
zooming in on the steps that the pharmaceutical companies assessed by the
2021 Access to Medicine Index are taking to develop and deploy treatments
for children under 12.
We think that this analysis effectively illustrates some of the gaps and
potential solutions needed to bring much-needed treatments to children in
low- and middle-income countries (LMICs). The findings show that the R&D
pipeline for paediatrics is worryingly slim, with less than 7% of the R&D
projects underway at leading pharmaceutical companies targeting children
below the age of 12. Furthermore, companies' R&D efforts are predominantly
focused on a handful of diseases: lower respiratory infections, cancer, and HIV.
Meanwhile, the amount of work underway for neonatal conditions
like sepsis is alarmingly low, with only five projects in development.
The study also identifies five treatments now entering the market that
could prove 'game-changers' for children in LMICs. However, not enough is
being done to ensure that these treatments are affordable and accessible to children in these countries, with nearly 45% of late-stage paediatric
treatments, including three of the five 'game-changers', not yet
supported by access plans.
You can download the report (PDF) from our website:
https://accesstomedicinefoundation.org/news/handful-of-new-childrens-meds-on-the-horizon-but-will-they-be-accessible-to-children-in-lmics
If you are interested in discussing this further, or in understanding how
you can practically apply some of the recommendations proposed by this
analysis to your work, please get in touch with me.
Warm Regards
Claudia Martinez
Research Programme Manager
Access to Medicine Foundation
Amsterdam
The Netherlands
www.accesstomedicinefoundation.org
Claudia Martinez <cmartinez@accesstomedicinefoundation.org>
E-DRUG: Analysis on WHO medicines prequalification
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https://extranet.who.int/pqweb/medicines/market-information?
In considering whether or not to submit a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API) to WHO for evaluation for prequalification, manufacturers will seek to understand and review the potential donor-funded market for the product concerned.
WHO does not generate its own information regarding markets for quality-assured APIs and FPPs. Rather, its role focuses on verifying the quality of urgently-needed APIs and FPPs, and, when needed, facilitating improvements to their quality.
However, market information is prepared and made publicly by several other organizations. It includes substantial "market landscape" reports that both review recent product procurement (within a specific therapeutic area), including pricing, and outline anticipated market trends. Additionally, some organizations make publicly available information regarding what FPPs have been procured, at what price, with their funds, and/or what they are currently procuring (including price range information).
Current bidding opportunities will also provide manufacturers with important information about procurement opportunities.
As well as submitting an API or FPP for evaluation for prequalification, applicants may consider submission of FPPs for assessment by the Expert Review Panel (ERP). WHO-prequalified or products approved by a stringent regulatory authority are not available on the market for all needed medicines, or may be in short supply. Procurers may therefore find themselves in the position of having to urgently procure products about which little is known in terms of quality risk. ERP was created to help procurers assess such risk. The results of ERP assessments enable procurers — such as the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria and UNFPA (United Nations Population Fund) — to make an informed decision regarding time-limited procurement of the products assessed. ERP assessment is therefore another route to markets.
Best wishes.
Jacqueline
Jacqueline Sawyer
Liaison Officer
Access to Medicines and Health Products
World Health Organization
Geneva, Switzerland
"SAWYER, Jacqueline K." <sawyerj@who.int>