On WHO’s essential medicines process and transparencyBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5637 (Published 17 September 2014) Cite this as: BMJ 2014;349:g5637
- Nicola Magrini, scientist1,
- Jane Robertson, technical officer1,
- Kees de Joncheere, director1,
- Lisa Bero, professor and chair of WHO expert committees on the selection and use of essential medicines in 2011 and 20132
- 1Essential Medicines List Secretariat, Essential Medicines and Health Products Department, World Health Organization, 1211 Geneva 27, Switzerland
- 2Medicines Use and Health Outcomes, Faculty of Pharmacy and Charles Perkins Centre, University of Sydney, Sydney, Australia
Barbui and Purgato have critiqued the processes used to select WHO’s list of essential medicines and provided suggestions on how it could be improved.1
As mentioned, reforms in 2001 substantially changed the way that the expert committee reviews submissions, introducing systematic evidence synthesis and appraisal as a requirement, along with an assessment of comparative cost and cost effectiveness. In addition, WHO made the processes transparent, with all submitted data and reviews publicly available, and introduced opportunities for public comment.
The authors raise three major issues regarding these processes: the quality of the evidence in the submissions and the recommendation on the use of GRADE; the transparency of the decision making process and the criteria used in making the judgments; and discord between expert committee decisions and the recommendations of WHO departments.
We disagree that the use of GRADE is new to the decision processes; a 2009 application used GRADE assessments,2 and since then it has been requested that “where appropriate evidence of comparative effectiveness and safety should be presented in tabular form using GRADE tables.” This has been done to a variable extent and may not always be appropriate or necessary.
Barbui and Purgato argue for strengthening evidentiary requirements; others have complained the “lengthy, exhaustive process for applying for a listing can be discouraging [because] each component requires a separate detailed, complex application.”3
WHO rules for expert committees require that the decision making of the expert committee is reported in the Technical Report Series. WHO has been discussing ways of improving the quality of this reporting, and the proposed approach of a more structured template has merit.
Consistency between decisions on the essential medicines list and WHO clinical guidelines issued by other WHO departments is highly desirable. Where available, high quality evidence generated for guideline development has been used for essential medicines applications.
WHO is working to improve these processes by supporting greater interaction between the secretariat and applicants to ensure that minimum standards for applications are met and that guideline development and expert committee considerations are better harmonised. Assessment of cost effectiveness at a global level is challenging and under discussion with the expert committee, taking into account broad public health priority setting.
Although the selection processes for essential medicines are not perfect, the concept is a key achievement in WHO’s history and an important contribution to promoting access to medicines globally.4 The current process is largely transparent and tries to strike a balance between methodological rigour, timeliness, public health relevance, and equity of access.
Cite this as: BMJ 2014;349:g5637
Competing interests: None declared.
Full response at: www.bmj.com/content/349/bmj.g4798/rr/762816.