Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential Medicines (EML) and the Model List of Essential Medicine for Children (EMLc)....
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials... to treat serious bacterial and fungal infections.
The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.
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Building laboratory testing capacity
In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical products. Delegates developed the short Oxford Statement..., calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.
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This statement aims to provide guidance and recommendation to African Union Member States in responding to the following questions:
What should countries do when announcing identification of a herbal remedy or medicine?
What are the implications for the rest of the continent?
Soil-transmitted helminths are a group of intestinal worms that include Ascaris lumbricoides (giant roundworm), Trichuris trichiura (whipworm), and Ancylostoma spp. (A. duodenale, A. ceylanicum) and Necator americanus (hookworms). Despite the clear biological differences among the different species,... their transmission is characterized by the same sequence of events: (i) infected individuals excrete worm eggs through their stool in soil; (ii) under optimal conditions of moisture and temperature the excreted eggs develop into infectious stages; and (iii) finally, infection occurs through oral uptake (Ascaris, Ancylostoma and Trichuris) or skin penetration (Ancylostoma and Necator) of these infectious stages (embryonated eggs and third stage larvae) that reside in the soil and/or in the environment (referring to their common name).
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
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In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive... predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.
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The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG) was form...ed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
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