The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914: 3. The new procedures for updating and disseminating the Model List: 3.2 Key features of the new procedures

The Selection and Use of Essential Medicines - WHO Technical Report Series, No. 914
(2003; 132 pages)

Table of Contents

WHO Expert Committee on the Selection and Use of Essential Medicines
1. Introduction
2. Open session
3. The new procedures for updating and disseminating the Model List
	3.1 Background
	3.2 Key features of the new procedures
	3.3 Review of the new procedures
		3.3.1 Applications for additions
		3.3.2 Applications for deletions
		3.3.3 Selection criteria
	3.4 The WHO model formulary
	3.5 The WHO Essential Medicines Library
4. Other outstanding technical issues
	4.1 Change of name of the Expert Committee
	4.2 Description of essential medicines
	4.3 Role of treatment costs in relation to the Model List
	4.4 Inclusion of additional items in the Model List
5. Format and presentation of the 12th Model List
	5.1 Section headings
	5.2 The core and complementary lists
	5.3 The “square box” symbol
6. Changes made in revising the Model List
	6.1 Applications for additions
		6.1.1 Antiretroviral medicines
		6.1.2 Artemether + lumefantrine (fixed-dose combination)
		6.1.3 α/β-Arteether
		6.1.4 Artemotil (β-arteether)
		6.1.5 Amodiaquine
		6.1.6 Insecticide-treated bednets
		6.1.7 Miconazole nitrate buccal tablets
	6.2 Applications for deletions
	6.3 Other changes
		6.3.1 Meglumine antimoniate
		6.3.2 Antineoplastic and immunosuppressive medicines
		6.3.3 Reserve list medicines
7. Future reviews of sections of the Model List
	7.1 Update on the review of medicines for the treatment of hypertension
	7.2 Review of the core and complementary lists
	7.3 Review of the use of the “square box” symbol
	7.4 Review of injectable medicines
	7.5 Priorities for further systematic reviews
8. Recommendations
	8.1 Procedures for updating and disseminating the Model List of Essential Medicines¹
	8.2 Description of essential medicines
	8.3 Presentation of the 12th Model List
	8.4 Additions and changes to the Model List
	8.5 Deferred applications
	8.6 Rejected applications
	8.7 Priorities for future reviews of sections of the Model List
	8.8 Change of name of the Expert Committee
	8.9 Other recommendations
Acknowledgements
References
Annex 1 The 12th WHO Model List of Essential Medicines
Annex 2 Additional notes on the medicines recommended for inclusion in the 12th WHO Model List of Essential Medicines
Annex 3 The Anatomical Therapeutic Chemical (ATC) classification system¹
Alphabetical list of essential medicinces (with ATC classification codes)

3.2 Key features of the new procedures

As a result of the above two-stage consultation process, new procedures for updating and disseminating the Model List have been drawn up. The main features of the new procedures are as follows:

- the use of the term “essential medicines” instead of “essential drugs” to reflect the common use of the term “medicines” to describe pharmaceutical preparations used in clinical health care practice;

- a more systematic approach to inviting and dealing with applications for medicines to be included in, or deleted from, the Model List;

- a more transparent process for selecting medicines for inclusion in the Model List, including a systematic analysis of the evidence that supports the medicines proposed for use in the care of different health conditions (e.g. comparative evidence of efficacy, safety and, where possible and appropriate, cost-effectiveness);

- opportunities for interested parties to comment on both the application and its review to the Expert Committee;

- full involvement of different WHO departments in the application and selection process, and in the linking of the process to clinical guidelines published and disseminated by WHO;

- development of a new WHO Essential Medicines Library which facilitates access to information about medicines on the Model List (see section 3.5);

- steps to ensure that the Expert Committee operates with full scientific independence as it makes its final recommendations (in line with current practice for decisions on regulatory approval, procurement and reimbursement of medicines within Member States).

The new procedures were presented in a report by the WHO Secretariat (6) at the 109th session of the WHO Executive Board in January 2002 and discussed. The Board noted the report, including the attached Annex that sets out the new procedures (7). The Director-General decided to organize the next meeting of the Expert Committee on the Use of Essential Drugs in April 2002, taking into account the above-mentioned discussions on the new procedures while recognizing the fact that, owing to the relatively short time frame involved, not all of the proposed improvements could be implemented immediately.