Medicines Patent Pool Welcomes WHO’s Updated Essential Medicines List
WHO Calls On Originators To License Their Medicines To MPP
Executive Summary
The World Health Organization’s updated essential medicines list includes four medicines already licensed to the Medicines Patent Pool, of which two were developed through MPP licensees. The WHO’s updated list includes SGLT2 inhibitors – oral medications used to lower blood glucose levels – for which the MPP and the International Diabetes Federation have committed to improve affordable access in low- and middle-income countries.
The World Health Organization has updated its essential medicines list, which now includes 20 additions to the adult list and 17 additions to the pediatric list. The list – which is updated every two years – now includes new medicines for diabetes and cancer, and pediatric versions of key HIV and hepatitis treatments.
The updated list was welcomed by the Medicines Patent Pool, an organization that arranges voluntary licensing deals to help improve access to effective and affordable medicines for people in low and middle income countries (LMICs). Furthermore, the MPP along with the International Diabetes Federation has commended in particular the inclusion of SGLT2 inhibitors – oral medications used to lower blood glucose levels – to the 2021 WHO essential medicines list, namely empagliflozin with canagliflozin and dapagliflozin as therapeutic alternatives.
More than 150 countries use the WHO essential medicines list as a reference for the procurement and supply of medicines, and for clinical decision-making.
Commenting on the addition of SGLT2 inhibitors to the list, Charles Gore, executive director of the MPP said: “We hope originators will be willing to sit down with us as soon as possible to discuss how our public health-oriented licensing mechanism could contribute to making SGLT2 inhibitors accessible to those who need them in low- and middle-income countries.”
Meanwhile IDF president Andrew Boulton said: “IDF submitted SGLT2 inhibitors for inclusion onto the essential medicines list. We are delighted that our request has been accepted.” He added: “We will now work with countries towards including these medicines onto their national lists, as a first and crucial step towards making them available in LMICs.”
In August 2020, the MPP and IDF agreed to actively collaborate to apply the MPP’s licensing model to bring affordable generic diabetes treatments to LMICs, signing a memorandum of understanding aimed at improving access.
“As these are patented medicines, we will work further in partnership with MPP to make this treatment affordable and available to those in need,” said Boulton.
The MPP said: “we have seen time and again that access to important treatments lags dramatically in LMICs.” But the organization observed that the addition of SGLT2 inhibitors in the 2021 essential medicines list increases diabetes treatment options for countries and “brings hope to the hundreds of millions of people who could benefit from these medicines.”
The association noted that SGLT2 inhibitors are indicated for reducing overall and cardiovascular mortality, non-fatal myocardial infarction, kidney failure and hospitalizations for heart failure in patients with, or at high risk of, cardiovascular disease and/or renal disease, for whom they represent a reference treatment.
WHO Calls On Originators To License Medicines To MPP
The MPP has also applauded the WHO expert committee’s call on originators to license their medicines to the MPP so that affordable generic versions can be scaled up in LMICs.
The WHO’s updated essential medicines list includes four medicines already licensed to the MPP, of which two were developed through MPP licensees for supply in LMICs, including dolutegravir 10mg for the treatment of pediatric HIV and the fixed-dose combination of sofosbuvir and daclatasvir for the 12-week curative treatment of hepatitis C.
Commenting on the WHO’s decision, Gore said: “the MPP already holds licences on 15 products on the WHO essential medicines list, 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.”
Patented products included on the 2021 list for which the WHO committee called on the MPP to explore the possibility of licensing include:
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SGLT2 inhibitors: dapagliflozin, canagliflozin, empagliflozin, included on the list as add-on treatment for adults with type 2 diabetes with or at high risk of cardiovascular disease and/or diabetic nephropathy;
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ibrutinib: included on the list for the treatment of relapsed/refractory chronic lymphocytic leukemia; and
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enzalutamide: included on the list for the treatment of metastatic castration-resistant prostate cancer.
“What is new this time is that the committee has not only asked MPP to license medicines already on the essential medicines list, but to also work on products that have potential for future inclusion,” added Gore. “This recognizes the importance of working on access as early as possible so that the essential medicines of tomorrow are rapidly available and affordable to all.”
Since some applications did not make the essential medicines list “partly due to cost-effectiveness concerns that could pose serious affordability challenges, especially in LMICs,” the WHO has asked the MPP to explore the application of its licensing model to medicines including:
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cyclin-dependent kinase (CDK) 4/6 inhibitors submitted for the treatment of patients with hormone receptor positive/HER2-negative advanced breast cancer;
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daratumumab: a monoclonal antibody submitted for the treatment of newly diagnosed and relapsed or refractory multiple myeloma patients;
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osimertinib, submitted for first-linereatment of EGFR mutated locally advanced or metastatic non-small cell lung cancer;
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zanubrutinib, submitted for the treatment of relapsed/refractory mantel cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma; and
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PD/PD-L1 immune checkpoint inhibitors, already in the list for the treatment of melanoma, and submitted for the treatment of locally advanced and metastatic non-small-cell-lung-cancer.