Hi Sonja and others,
Many thanks for your response. I wish to reiterate that I am not advocating either one position or the other on this subject. I am sure that almost anyone involved in the treatment of SAM (and other forms of malnutrition) would like to see improved access for products required to treat it where these are deemed necessary. However I do wish to seek clarification on some points.
The submission requests RUTF to be listed on;
"Essential Medicines List for Children (Section 26.”Solutions Correcting Water,
Electrolyte and Acid-based Disturbances”, under 26.3 Miscellaneous)" Section 6 further identifies that the listing should be "an individual medicine". Other posts suggest that other formulae should be included (F75, F100 etc.)
My questions are:
1. Does RUTF (and other products) require a new section on the EML to be listed appropriately?
The function of RUTF (and other nutrition products) is not only the correction of electrolyte and acid-base disturbances. It is not a solution as it contains no water.
2. While it is listed as under a subsection titled "miscellaneous", section 6 of the application requests the listing to be as "an individual medicine". While there is no ATC code what then is the consequence of labelling RUTF as a "medicine"?
Will the listing as "an individual medicine" have a consequence in terms of the manufacturing process? Has there been any official indication from the WHO or other organisations that there will be no change in the manufacturing requirements? Neither the report nor the submission indicate this. The report states in its conclusions that:
"While there is limited evidence for the implications of adding RUTF to the WHO EML, ACF-F concluded through their research that there is a strong value-add for RUTF being added to the EML as a therapeutic food."
If, as it is intended, this listing has an effect globally, then it is important to understand the implications fully and to be supported by more than the conclusion of one organisation. If the standards for manufacture change as a result of the listing then this may have consequences in increasing the difficulty and cost of production and potentially creating a barrier to access rather than the intended removal of a barrier. These potential difficulties would likely be felt most of all at local production facilities outside of USA and Europe. Neither the report or the submission document adequately addresses this issue.
This brings me to my final point regarding the process. The application lists organisations "consulted and / or supporting the application". The names of several organisations are listed. The submission continues...
"Most of the consulted stakeholders expressed willingness to collaborate."
This is not a transparent process. Can you confirm that the organisations were willing co-signatories and/or that the submission document was discussed with them prior to submission? Surely a move of such global importance with the reported widespread support would benefit from this support being given openly. Are there organisations on the list who did not agree with the suggested inclusion on the EML and why was this?
We are further invited to write individual letters of support and prewritten letters are provided on this forum. I think ACF deserve much credit for bringing the subject to debate but there are better process of engagement available that enables the considered opinion of a wider group of stakeholders to be heard at the most senior levels.
Debate on this forum is of great value because anyone can contribute. I think there are many (myself included) who might support this process as a 'good idea' without understanding the implications of such a move and, as such, popular support through this forum is not an indication of it being an advisable move to make.