15 October 2001

HAI comments on the paper, "Updating and disseminating the WHO Model List of Essential Drugs: the way forward"

   

Dear Dr. Hogerzeil:

On behalf of all of the HAI regional coordinating offices, I am pleased to submit our comments on this paper. Our submission reflects consultation with and inputs from key partners throughout our global network.

With best regards,

Beryl Leach
HAI Africa coordinator

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Health Action International

HAI Africa
PO Box 78360
Nairobi, Kenya
tel: (254) 2 441.090; fax: (254) 2 440.306
e-mail HAIAfrica@net2000ke.com

 

 

15 October 2001

________________________________________________________________________________________

Dear Dr. Hogerzeil:

Health Action International* appreciates having the opportunity to provide our comments on the document Updating and Disseminating the WHO Model List of Essential Drugs: the way forward (revised version 10 September 2001). Before offering our comments on the specific issues identified by WHO specifically for reaction, we would like to make the following overarching points:

• The WHO Model List of Essential Drugs (EDL) is an enormously valuable contribution to strengthening public health, in particular in resource-poor countries; the recommendations being made to the list will improve it and make it even more useful.
• The process for developing the model EDL is a technical and expert process and it must remain so in order to be an effective public health tool.
• The WHO secretariat should be supported in its efforts to strengthen and ensure the technical, expert and independent nature of the committee.

We commend WHO and members of the expert committee for all of the work that has gone into identifying ways to improve the model list. The proposed way forward is sound, feasible and it will address important information needs.

The model list is an essential public health care tool for the vast majority of countries, especially in those that are resource poor. It is vital that WHO keep it up-to-date, so we strongly urge WHO to have the expert committee meet in early 2002, as the last update was in 1999. We also fully endorse these current efforts to ensure ways are being found to make the model list an even better and more useful tool. We therefore strongly support a final version of this paper being submitted to the director general for discussion and decision at the 109th session of the WHO Executive Board in January 2002 so that these changes can start to be implemented, as much as feasibly possible, during the next updating process.

Below are our responses to the specific issues identified by WHO for comment.

Issue 1: Description of Essential Drugs (selection criteria and conditions for provision)

The World Health Assembly (WHA) in its resolutions (WHA 28.66 and WHA 31.32) endorsed the need to provide essential drugs at reasonable cost. The latest description of essential drugs, as defined by the expert committee, i.e., the competent technical body, in 1999, is clearly based on the language and intent of WHA resolutions, and therefore we support and endorse this description.

Issue 2: Categories of drugs on the Model List

2.1. We support the proposal of maintaining two categories, i.e., the core and complementary one, with any drugs that previously would have been labelled "reserve" being integrated into the complementary category if they qualify for inclusion on the list.
2.2. In considering the criteria for inclusion, the core category should represent the minimum range of drugs that any health care system, in any setting, should make available for priority diseases, regardless of cost or infrastructure issues. They need not be listed separately, and information about cost and infrastructure requirements should be made available to guide list developers at country level.
2.3. In supporting the proposal to limit the list to two categories, we do not support adding the category, "promising drugs under investigation," or any other. We do not support the committee taking on the role of reporting on such drugs, as it would seem to be expanding the role of the committee beyond the work it is mandated and expected to do: update the model EDL.
2.4. The format of the model list should be guided by the need for convenience and ease of use at country level, and decided by the committee and the secretariat

Issue 3: Structure of the Model List

3.1. We support any effort to revise the list to make it easier and more useful to use. Simplicity and consistency should be priority criteria in any systematic review.
3.2. Yes, we support postponement.

Issue 4: Steps for reviewing an application

4.1. We support the proposed process outlined for reviewing an application.
4.2. However, even though the posting on the WHO website provides the most democratic and equitable way for gathering comments, we ask WHO to recognise that potential commentators in government and civil society in resource-poor countries may not have reliable access to the internet or may not have adequate training in using the internet to be able to use this means successfully. Therefore deliberate steps should be taken to make internet-based approaches are easy to find, understand and use and that commentators are aware of the application via non-internet-based means and that they can present their comments by alternative means.

Issue 5: Presentation of the Committee's recommendations

We support the proposed approach to speed and increase access to the latest model list, the reasons for the recommendations, notes and other relevant information.

Issue 6: External participation to the review process by the Committee

The proposed procedure for updating the EDL provides the most equitable way for all interested parties to participate in the discussion during the review process. This also allows all parties to give their input openly and at the most opportune time. After all inputs have been considered, the technical body, i.e., the Committee, should be allowed to make its recommendations in a totally independent position. We therefore support the recommendation that representatives of the healthcare industry or patient advocacy groups will not be invited as observers.

We also propose that (a) a clear process for appeals be set and (b) there is full transparency of the criteria for membership in the Committee, e.g., minimum technical qualifications and credentials needed and full disclosure of competing interests. The final choice of members should ensure their competency and independence. The secretariat should take due care for equitable geographic representation and representation of women on the committee. Members should be listed in the EDL library of information, including a short summary of their qualifications.

Issue 7: Systematic review of evidence for drugs on the model list

We support a full systematic review, as proposed. Over time as more information becomes available via the internet, WHO should consider providing links to the major evidence sources.

Issue 8: Organizing the WHO Essential Drugs Library

The WHO list is considered one of the most important public health tools for many developing countries and health care service providers. For some it may be the only technical document available. We therefore strongly endorse the additional information and the creation of the essential drugs library. We also support cross referencing to other fields, e.g., the ATC and DDD be added. Linkages with some of the existing pricing databases would address some of the complexities that may arise in providing cost information.

Issue 9: The next meeting of the Committee

Keeping the model list updated should be seen as a priority public health task. The value of the list depends, in part, on the timeliness of the information. The committee should meet in early 2002. The updating work of the expert committee should not be linked in any way to the status of this paper and/or the recommendations made in it in WHO deliberations.

It is our hope that these comments are useful. We wish you every success in finalising the recommendations.

Sincerely yours,

K. Balasubramaniam, coordinator HAI Asia and the Pacific
Margaret Ewen, coordinator HAI Europe and North America

Beryl Leach, coordinator HAI Africa
Roberto Lopez Linares coordinator HAI Latin America (Asociation Accion International para la Salud)


* HAI is a non-profit, global network of more than 150 health, development, consumer and other public interest groups in more than 70 countries working for a more rational use of medicinal drugs. HAI represents the interests of consumers in drug policy and believes that all drugs marketed should be acceptably safe, effective, affordable and meet real medical needs. HAI also campaigns for better controls on drug promotion and the provision of balanced, independent information for prescribers and consumers.