2007 KEI Letter to WHO on the Essential Medicines List

March 2, 2007

Secretary of the Expert Committee on the
Selection and Use of Essential Medicines (2007)
Department of Medicines Policy and Standards (PSM)
Health Technology & Pharmaceuticals
World Health Organization
CH-1211 Geneva 27
Switzerland

Via e-mail:
emisecretariat@who.int

RE: Request for changes in the WHO Model EML

Knowledge Ecology International (KEI) asks the Expert Committee on the Selection and Use of Essential Medicines to create a new category in the 'WHO Model List of Essential Medicines' (EML) for products that would be essential “if available from competitive generic suppliers at generic prices.” Within this new category, we ask that the Expert Committee review evidence regarding the following products:

Disease Category	Generic Name	U.S. Proprietary Name	U.S. Patent Holder	Last year U.S. patent coverage	Indication
Asthma
	Montelukast sodium	Singulair	Merck	2012	Once daily tablet; leukotriene receptor antagonist for the management and treatment of asthma.
Bipolar Depression
	Fluoxetine hydrochloride + Olanzapine	Symbyax	Lilly	2017	Once-daily tablet; combination atypical antipsychotic and SSRI-class antidepressant medication used in the treatment of bipolar depression.
Cancers
	Bortezomib	Velcade	Millennium Pharms.	2012	IV-administered proteasome inhibitor for the treatment of multiple myeloma.
	Capecitabine	Xeloda	Roche	2013	Orally administered nucleoside for the treatment of metastatic breast and colorectal cancers.
	Gemcitabine	Gemzar	Lilly	2013	IV-administered nucleoside for the treatment of cancers including non-small cell lung cancer, pancreatic cancer, bladder cancer, and breast cancer.
	HPV Vaccine	Gardasil	Merck	2020	Vaccine against human papillomavirus types 6,11,16, and 18. Types 16 and 18 are thought to cause 70% of cases of cervical cancer.
	Imatinib mesylate	Gleevec	Novartis	2022	Orally administered tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
	Temozolomide	Temodar	Schering	2014	Orally administered alkylating agent for the treatment of anaplastic astrocytoma (brain cancer).
	Topotecan	Hycamtin	GSK	2010	IV-administered topoisomerase 1 inhibitor for the treatment of ovarian and lung cancer.
	Trastuzumab	Herceptin	Genentech	2018	IV-administered monoclonal antibody to treat and prevent recurrence of HER2-positive metastatic breast cancer.
Diabetes Mellitus
	Sitagliptin phosphate	Januvia	Merck	2022	Once daily tablet; the first dipeptidyl peptidase-4 inhibitor for the control of type II diabetes mellitus.
Eye Diseases
	Ranibizumab	Lucentis	Genentech	2026	Injected monoclonal antibody for the treatment of age related macular degeneration.
HIV/AIDS
	Emtricitabine	Emtriva	Gilead	2021	nucleoside reverse transcriptase inhibitor for treatment of HIV/AIDS.
	Tenofovir	Viread	Gilead	2021	nucleoside reverse transcriptase inhibitor for treatment of HIV/AIDS.
	Emtricitabine + tenofovir	Truvada	Gilead	2021	Once daily tablet; nucleoside reverse transcriptase inhibitor for treatment of HIV/AIDS.
	Emtricitabine + tenofovir +nevirapine	Atripla	Gilead	2021	Once a day fixed does combination for the treatment of HIV/AIDS.
Influenza
	Oseltamivir phosphate	Tamiflu	Roche	2016	Treatment and prophylaxis of influenza, including avian flu.
Ischemia
	Atorvastatin calcium	Lipitor	Pfizer	2018	Once daily tablet; Statin for the treatment of high cholesterol and triglycerides for the prevention of heart disease and stroke.
Psychotic Disorders
	Olanzapine	Zyprexa	Lilly	2011	Atypical/second-generation antipsychotic for the treatment of schizophrenia, acute mixed or manic episodes of bipolar I disorder and maintenance treatment of bipolar disorder.
	Quetiapine	Seroquel	AstraZeneca	2011	Atypical/second-generation antipsychotic for treatment of schizophrenia, acute manic episodes of bipolar I disorder, and as either monotherapy or adjunct therapy to lithium or divalproex.
Vascular Disease
	Clopidigrel	Plavix	Sanofi-Aventis	2019	Antiplatelet agent for the treatment of vascular and coronary artery disease and the prevention of heart attack, stroke, acute coronary syndrome, and thrombosis.

Theses medicines are each subject to patent protection in a number of developing countries. Where patent owners have exclusive rights and generic products are not available, prices are high.

In 2001, the WTO adopted the Doha Declaration on TRIPS and Public Health, which clarified the country obligations under the primary global norm for protection of patents and other intellectual property. This declaration said the WTO TRIPS agreement “should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.”

Following the 2001 Doha Declaration, a number of countries have used the flexibilities in the TRIPS agreement in a variety of ways, including by issuing non-voluntary authorizations to use patents (compulsory licenses, ex officio licenses, government use, crown use, etc.) in order to stimulate low-cost generic competition.

Today there are competitive generic markets for many of these products. For others, if sufficient numbers of countries obtain voluntary or non-voluntary licenses to patents, generic competition is feasible. Separately, we are asking the WHO to consider the creation of a patent pool for patents associated with vaccines for the human papillomaviruses (HPV). The HPV patent pool would include patents necessary for the manufacture of generic versions of Gardasil, as well as other vaccines now in development, and it would also permit the creation of new vaccines that combine different patented technologies that are not restrictively licensed.

Thank you for your consideration of this request.

Sincerely,

James Love
Director

Ben Krohmal
Coordinator – Project on Medical Innovation

Judit Rius
Legal Advisor

Malini Aisola
Research Associate

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