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Prioritising Medicines for Licensing

The first step in MPP’s work on licensing is to select candidate medicines for in-licensing that could have the greatest public health impact in low-resource settings.

The Medicines Patent Pool (MPP) works to improve access to treatments for HIV, hepatitis C, tuberculosis and other patented essential medicines with high medical and public health value, in low- and middle-income countries.

Since our creation in 2010, we have published a list of priority treatments for our licensing programme. This started in HIV and was subsequently expanded to include hepatitis C and tuberculosis.

In 2018, following an extensive feasibility study, our mandate was expanded to include key medicines in other diseases areas that were on the WHO Model List of Essential Medicines (EML) or had strong potential for future inclusion, such as those for treating cancer, diabetes or cardiovascular diseases.  In 2019, MPP started exploring the opportunity to apply its model to long-acting formulations and technologies that could be important in LMICs, at various levels of development.

The focus so far has been on small molecules. In 2021, the MPP Board expanded its mandate to include biotherapeutics that are on the WHO EML or have strong potential for future inclusion, which will be included in subsequent prioritisation reports.

By expanding access to essential medicines, MPP is committed to supporting Universal Health Coverage.

Our method for prioritising treatments, developed with the support of a broad range of experts, is based on addressing three sequential questions:

  1. How important is a given medicine in LMICs?
  2. Are there access challenges with respect to that medicine in LMICs?
  3. Is the medicine patented in LMICs?

The 2022 Prioritisation Report includes:

  1. A PRIORITY LIST: patented medicines for which expanded access could provide significant health benefits over standards of care, and where voluntary licensing through MPP would lead to substantial public health impact
  2. A WATCHLIST: patented medicines for which expanded access could provide significant health benefits but for which supporting data are lacking and/or key challenges need to be addressed for expanded access through MPP licensing to provide significant benefits and lead to substantial public health impact

MPP has prioritised two HIV and one TB compound, as well as one long-acting technology for malaria vector control. A further three compounds are on the watch-list for HIV, and six are on the watchlist for tuberculosis.

The report also includes essential medicines for non-communicable diseases and conditions that were identified by the WHO Expert Committee on the Selection and Use of Essential Medicines as treatments for which MPP should explore obtaining licences. This includes nine medicines/classes of cancer medicines, one class of diabetes medicines and one compound for maternal health. A further nine cancer medicines, and one medicine for haematology are included in the watchlist for non-communicable diseases and conditions.

The current target products for licensing are:

Priorities in HIV:

  • Cabotegravir long-acting injectable
  • Lenacapavir

Priorities in TB:

  • Bedaquiline

Long-acting Technologies:

Lung Cancer:

  • Osimertinib

Breast Cancer:

  • Ribociclib
  • Abemaciclib
  • Palbociclib

 Leukemias:

  • Ibrutinib
  • Zanubrutinib
  • Nilotinib

Prostate Cancer:

  • Enzalutamide

Multiple cancer indications:

Immune checkpoint inhibitors

Diabetes:

  • Empagliflozin
  • Dapagliflozin
  • Canagliflozin

Maternal health:

  • Heat Stable Carbetocin

Access the 2022 Prioritisation Report

Access previous reports (archives)

Comments are welcome and encouraged. Please send an email to science@medicinespatentpool.org with the subject line “Comments on the 2022 Prioritisation Report”.

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