[Ip-health] WHO Essential Medicines Committee calls for licensing of key medicines to MPP to support affordable access in low- and middle-income countries

Sophie Thievenaz sthievenaz at medicinespatentpool.org
Fri Oct 1 08:09:19 PDT 2021

Dear colleagues,

The Medicines Patent Pool has just published a statement in reaction to the publication of the updated WHO Essential Medicines List published today. Please see below or on our website: https://medicinespatentpool.org/news-publications-post/who-essential-medicines-committee-2021/

We also published a joint statement with the International Diabetes Federation welcoming the inclusion of SGLT2 inhibitors to the WHO Essential Medicines List: https://medicinespatentpool.org/news-publications-post/sglt2-inhibitors-who-eml-inclusion-idf-mpp-statement/ (or below)

WHO Essential Medicines Committee calls for licensing of key medicines to MPP to support affordable access in low- and middle-income countries

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<https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists> 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<https://medicinespatentpool.org/who-we-are/business-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.

The International Diabetes Federation and the Medicines Patent Pool welcome the inclusion of SGLT2 inhibitors to the WHO Essential Medicines List

The two organisations commit to working together to improve affordable access to SGLT2 inhibitors in low- and middle-income countries (LMICs).

Geneva – The International Diabetes Federation (IDF)<https://idf.org/> and the Medicines Patent Pool (MPP)<https://medicinespatentpool.org/> welcome the inclusion of SGLT2 inhibitors – oral medications used to lower blood glucose levels – to the 2021 World Health Organization (WHO) Essential Medicines List (EML), namely empagliflozin with canagliflozin and dapagliflozin as therapeutic alternatives. The WHO Expert Committee called on originators to license their medicines to MPP to scale up access in LMICs.

Nearly half a billion people live with diabetes worldwide, with four out of five living in LMICs[1]<https://medicinespatentpool.org/news-publications-post/sglt2-inhibitors-who-eml-inclusion-idf-mpp-statement/#_ftn1>. At least 90 percent of all cases of diabetes are type 2, for which metformin represents the first-line therapy. SGLT2 inhibitors are a second-line treatment to add to metformin to improve glycaemic control. They have been shown to be particularly effective in reducing overall and cardiovascular mortality, non-fatal myocardial infarction, kidney failure and hospitalisations for heart failure in patients with, or at high risk of, cardiovascular disease and/or renal disease, for whom they represent a reference treatment.[2]<https://medicinespatentpool.org/news-publications-post/sglt2-inhibitors-who-eml-inclusion-idf-mpp-statement/#_ftn2>

“IDF submitted SGLT2 inhibitors for inclusion onto the EML list. We are delighted that our request has been accepted. 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,” said IDF President Professor Andrew Boulton. “As these are patented medicines, we will work further in partnership with MPP to make this treatment affordable and available to those in need.”

“At MPP, we have seen time and again that access to important treatments lags dramatically in LMICs,” said Charles Gore, Executive Director of MPP. “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 LMICs.”
More than 150 countries use the WHO EML<https://www.who.int/news/item/27-02-2020-who-launch-e-eml> to compile their own national essential medicines lists. Every two years, a WHO Expert Committee reviews the list. This year, the experts considered 88 applications, including 40 proposals to add 38 new medicines. The availability of the medicines included on the EML are regarded as minimum requirements for a functioning health system and should be available to all who need them. The addition of SGLT2 inhibitors in the 2021 EML increases the diabetes treatment options for countries and brings hope to the hundreds of millions of people who could benefit from these medicines.

Following the signing of a Memorandum of Understanding between IDF and MPP<https://medicinespatentpool.org/news-publications-post/mpp-and-international-diabetes-federation-join-forces-to-improve-access-to-diabetes-medicines/> in August 2020, both organisations have been actively collaborating to apply MPP’s model to bring affordable generic diabetes treatments to LMICs.

Access the Executive summary – Report of the 23rd WHO Expert Committee on the Selection and Use of Essential Medicines<https://apps.who.int/iris/bitstream/handle/10665/345554/WHO-MHP-HPS-EML-2021.01-eng.pdf>
Access the WHO news release<https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists>

Best regards

Sophie Thievenaz | Communications Manager | Medicines Patent Pool
Rue de Varembé 7, 1202 Geneva, Switzerland
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E-mail: sthievenaz at medicinespatentpool.org<mailto:sthievenaz at medicinespatentpool.org>
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