WHO Essential Medicines Committee calls for licensing of key medicines to MPP to support affordable access in low- and middle-income countries
1 October 2021
The Committee updated the WHO Essential Medicines List and included four medicines already licensed to MPP, of which two were developed through MPP licensees.
Geneva – The Medicines Patent Pool (MPP) welcomes the updated WHO Essential Medicines List published today and the Committee’s call for licensing of the listed patented medicines to MPP. Twenty medicines were added to the adult list (EML) and 17 to the paediatric list (EMLc), including medicines for diabetes and cancer and paediatric versions of key HIV and hepatitis treatments.
The WHO EML and EMLc are updated every two years and contribute to informing national essential medicine lists, procurement and supply of medicines, and clinical decision-making. Over 150 countries use the list as a reference to develop their own country’s EML.
The Committee reviewed 88 applications and noted a growing concern for the increase in price of new medicines, particularly in certain areas such as cancer. Some applications did not make the EML partly due to cost-effectiveness concerns that could pose serious affordability challenges, especially in low- and middle-income countries (LMICs). The Committee has called on MPP to explore using its voluntary licensing model to make affordable generic versions of these medicines in LMICs.
“What is new this time is that the Committee has not only asked MPP to license medicines already on the EML, but to also work on products that have potential for future inclusion. This recognises the importance of working on access as early as possible so that the essential medicines of tomorrow are rapidly available and affordable to all,” said Charles Gore, Executive Director, MPP. “MPP already holds licences on 15 products on the WHO EML, and I am excited that MPP has been asked to work with industry and other stakeholders to facilitate affordable access to the medicines recommended by the Committee.”
The Committee also added four new medicines for which MPP already has licences. Two specific formulations, DTG 10 mg for the treatment of paediatric HIV and the fixed-dose combination (FDC) of sofosbuvir + daclatasvir for the 12-week curative treatment of hepatitis C were developed specifically through MPP licensees for supply in LMICs. Since November 2020, when DTG 10 mg was first approved, 18 countries have already received the HIV paediatric treatment. Ten countries have received the FDC hepatitis C treatment through MPP licence.
Listed below are the drugs for which Expert Committee called for MPP to use its licensing model to make available and affordable generic versions for LMICs. MPP is committed through its work to support access to quality essential medicines on the EML in LMICs.
Patented products included on the 2021 EML for which the Committee is calling on MPP to explore the possibility of licensing:
- SGLT2 inhibitors: dapagliflozin, canagliflozin, empagliflozin, included on the EML as add on treatment for adults with type 2 diabetes with or at high risk of cardiovascular disease and/or diabetic nephropathy.
- Ibrutinib: included on the EML for the treatment of relapsed/refractory chronic lymphocytic leukaemia
- Enzalutamide: included on the EML for the treatment of metastatic castration-resistant prostate cancer
The Executive Committee considered that several medicines had potential for future inclusion and recommended that MPP explores the application of its licensing model to:
- Cyclin-dependent kinase (CDK) 4/6 inhibitors submitted for the treatment of patients with hormone receptor positive/ HER2-negative advanced breast cancer
- Daratumumab: monoclonal antibody submitted for the treatment of newly diagnosed and relapsed or refractory multiple myeloma patients
- Osimertinib, submitted for the 1st Line Treatment of EGFR mutated locally advanced or metastatic non-small cell lung cancer
- Zanubrutinib, submitted for the treatment of relapsed/refractory mantel cell lymphoma and chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL)
- PD/PD-L1 immune checkpoint inhibitors, already in the EML for the treatment of melanoma, and submitted for the treatment of locally advanced and metastatic non-small-cell-lung-cancer.