The Selection and Use of Essential Medicines
WHO Technical Report Series
Report of the WHO Expert Committee, 2015
(including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List of Essential Medicines for Children)
Executive summary
The 20th meeting of the WHO Expert Committee on the Selection and Use of Essential medicines took place in Geneva, Switzerland, from 20 to 24 April 2015. The goal of the meeting was to review and update the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc).
In accordance with approved procedures,1 the Expert Committee evaluated the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines. Both lists went through major revisions this year, as the Committee considered 77 applications, including 29 treatment regimens for cancer, and innovative hepatitis C and tuberculosis (TB) medicines.
The Expert Committee –
:: recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list); and
:: recommended the addition of 16 new medicines to the EMLc (four to the core list and 12 to the complementary list).

Section 19: Immunologicals [p. 313]
19.3: Vaccines (review) – EML and EMLc
The EML Secretariat, with input from the WHO Immunization, Vaccines and Biologicals Department, proposed a slightly revised approach to the listing of vaccines on the EML and EMLc for consideration by the Expert Committee.

The revised approach involves the full alignment of vaccines on the Model Lists with current WHO immunization policy recommendations as published in vaccine position papers on the basis of recommendations made by the Strategic Advisory Group of Experts on Immunization (SAGE).

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development to delivery of immunization and its linkages with other health interventions in accordance with its mandate to provide guidance to Member States on health policy matters (http://www.who.int/immunization/policy/sage/en). SAGE consists of 15 internationally renowned independent experts in the field of immunization and is concerned not just with childhood vaccines and immunization but with all vaccine-preventable diseases. SAGE meets twice a year, generally in April and October. Working groups are established for detailed review of specific topics in advance of discussion by SAGE. Members of working groups review the evidence and prepare options for recommendations for discussion by the full SAGE group in an open forum. In developing recommendations, SAGE follows an evidence-based review process and applies GRADE. Processes follow the critical elements required by WHO’s Guideline Review Committee in the development of WHO guidelines.

SAGE may decide to recommend specific vaccines to be used universally or to be used conditionally or to not use specific vaccines at a given point in time. These recommendations translate into WHO policy recommendations. WHO publishes its global vaccine policy recommendations as vaccine position papers within the Weekly Epidemiological Record, available on the WHO website at http://www.who.int/immunization/documents/positionpapers/en/index.html. The position papers summarize essential background information on diseases and vaccines, and conclude with the current WHO position concerning vaccine use in the global context. The papers are designed for use by national public health officials and immunization programme managers. They may also be of interest to international funding agencies, the vaccine manufacturing industry, the medical community, and the scientific media.

WHO position papers undergo a formal review process both internally and externally before publication. Processes for managing potential conflicts of interest and ensuring careful and critical appraisal of the best scientific evidence have become more rigorous in recent years. The need for updating vaccine position papers is reviewed periodically and depends primarily on the availability of new scientific evidence and public health priorities. A brief update concerning a specific recommendation in a paper is released when warranted.

The Expert Committee agreed that the EML and EMLc should include those vaccines for which a WHO position paper exists (as at a specific publication date), with reference to the WHO immunization website for up-to-date recommendations at any point in time. The Committee also agreed that the EML and EMLc should specify whether vaccines are recommended for universal or conditional use (e.g. only in certain regions, populations, or in other specified circumstances), with reference to relevant WHO vaccine position papers for detail.