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Getting RUTF on the WHO list of Essential medicines - Call to sign a letter of support - repost

This question was posted the Management of wasting/acute malnutrition forum area and has 26 replies.

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Sonja Read

Nutrition Advocacy Officer / ACF-Fr

Normal user

2 Feb 2017, 12:56

Dear all,

As you may be aware, Action Contre la Faim (ACF) has recently conducted a study on whether RUTF should be added on the Essential Medicines list (EML) of WHO and of countries. We have concluded that having RUTF on the EML would be an important step to advance SAM treatment coverage globally.

We have thus submitted an application to the WHO Expert Committee on the Selection and Use of Essential Medicines for RUTF to be accepted to the EML as an item.

The committee accepts comments on and letters in support of our application from individuals, organizations or governments until the 24 February 2017. There are good chances that this application will go through but letters of support from the scientific community, NGOs as well as governments are likely to have an important impact.

By clicking the links you can see the application to the WHO Expert Committee on the Selection and Use of Essential Medicines and get more information on how to submit an online letter of support yourself.

We have already drafted three letters for different types of signatories (NGOs, researchers/academics, general) and centralize signatures for these. You can also use our draft to submit a separate letter for your organization.
You can view and edit the letters by clicking on the following links:
Researcher letter
NGO letter
General letter

Please sign one of the letters if you support the idea of adding RUTF on the EML. Contact us if you or your organization want to add your signature or would like more information on the arguments of putting RUTF on the EML:

Many thanks and have a nice day,

Michael B. Krawinkel


Normal user

4 Feb 2017, 09:23

ear friends,
RUTF is not an essential medicine ! - It is not even one product, but many locally produced RUTF based on peanuts, chickpea, and other foods are known: which one should go on the list ?
RUTF are extremely helpful for managing childhood malnutrition in emergencies. But in normal health care - even in community-based mnagement of malnutrition - it is not essential. Shall we distract families from using their local resources and preparing diets for their children which are nutritious and promote growth and health ? - There is no evidence for a sustained success of RUTF-administration when it comes to re-introduce family foods. Or has anybody data on outcomes one year after the last RUTF-administration ?
On the essential medicine list are lifesaving and essential medicines for disease management. And RUTF is not such a medicine.
Could those who propose putting RUTF on the ED-list provide a conflict of interest statement please. We can also not ignore the ‚commercialization of malnutrition‘-aspect.
Sorry for a frank statement, but the proposal is diverting our attention from managing childhood malnutrition with food instead of commercial dietary products.

Paul Mabany

Nutrition Project Officer ( UNIDO)

Normal user

4 Feb 2017, 11:21

I totally agree that RUTF can be added to WHO list of essential medicine

Sameh Al-Awlaqi

Public Health and Nutrition Consultant

Normal user

4 Feb 2017, 21:36

Dear Michael,

Thanks for sharing your concerns,

The contents of RUTF are standardised and it’s basically the same caloric and nutritious /vitamins/minerals values despite the different trade names.

RUTF is not a substitute for good nutrition for all family members at various growth periods; this is why we focus on Infant and Young Child Feeding and the first 1000-Days in health and nutrition services. RUTF is only indicated when a child fits admission criteria for severe acute malnutrition, a medical status that can lead to death if left untreated.

As a matter of life or death in any given context especially in developing countries, RUTF is lifesaving, please note that in many countries acute malnutrition is endemic and has specific seasonal pattern, it exist with spikes in specific months, it is not only happening in emergencies.

There are plenty of technical resources my colleagues can share on the RUTF revolution since early 1990 and its efficacy in the treatment of severe acute malnutrition. It saves millions of children every year, if you are familiar with the metabolic status of acute malnutrition, you can notice that food alone will not treat severely malnourished children, but they have to take this balanced medicine to gradually move them out of “severe” status.

No one can guarantee the commercialization aspect of RUTF, the same is applicable to drugs on the EM list, which have thousands of trade name and companies that we can’t control (but governments and UN agencies can). We do care about the medicine itself and its indication to save lives and treat patients.

Having RUTF on the EML is a great advocacy tool that will enable the government to prioritize acute malnutrition treatment and make it more integrated within the health services, the cost of SAM treatment has been reduced over the last two decades but it is still high, in many cases governments alone especially in developing countries can’t afford it, but when adding it to the list, donors and aid agencies will provide the support, and with time, new local companies can produce it locally with a cheaper price like any medicine which can cover the local need of each country. Developed countries may not need to produce it in large quantities, but when they have it on the list, they can spare some quantities to deal with sporadic cases that may occur among under 5 children.

Your point in promoting balanced family diet and food diversity is very valid at preventive stages as I mentioned before, or when the child reach to a cut-off points at risk ( WHZ or MUAC), but if the child reached to WHZ <-3 or <115 MUAC, RUTF is the treatment and it shouldn’t be delayed.




Normal user

5 Feb 2017, 06:01

Thank you Sameh for the explanation. RUTF Is a life saving commodity and should not only be included in the EML but should be one of the UN life saving commodities. When you are involved in the management of children with SAM, you would understand the value of RUTF in Saving lives of children under five.

In Nigeria, we have commenced the process of including it in the country's EML As well as inclusion of Inpatient Management of SAM In the Standard Treatment Guidelines

I support the inclusion of RUTF in the EML. I suggest that we start advocacy for the inclusion as one of the UN Life Saving Commodities. One in five U5 children with SAM will die if they are not treated. If contraceptives are on the list, then why not RUTF?


Emily Mates

Technical Director

Normal user

6 Feb 2017, 15:11

Dear Sonja

Thanks for your message and very good advocacy initiative to try and get RUTF onto an 'essential' list - I was just wondering why the essential medicines list has been chosen, rather than the essential supplies list?
The reason i'm asking is because when I was in Ethiopia for a number of years and intimately involved with RUTF supplies/local production, etc. we started talking to various people about the possibility of including RUTF onto the essential medicines list. We were very strongly advised to advocate for inclusion onto the essential supplies list instead, for two main reasons:
- If the product is considered a medicine, then it has to be produced under pharmaceutical conditions - this would considerably increase the price of any locally produced product (and possibly for imported also)
- If classified as a medicine, RUTF would have to be approved for usage by the relevant country authority (at the time it was the Drug Administration and Control Authority) which can take a number of years - a local version of ORS took over 5 years to be registered with DACA.

Perhaps in many countries these limitations would not be an issue - but in some they may. Are there contingency plans for countries with very strict rules and regulations around medicines?

Many thanks


Jessica Bourdaire

Normal user

6 Feb 2017, 16:35

Dear Michael,

It’s important to differentiate prevention of malnutrition (stunting, wasting, underweight, etc.) and treatment of Severe Acute Malnutrition (SAM) defined as a MUAC <115mm and/or WFH <-3 SD and/or nutritional oedema.

Based on the current available evidence, WHO recommends the use of RUTF for the community management of SAM children who don’t require inpatient care. Thus, it’s my understanding that RUTF is an essential lifesaving treatment for SAM children, which is not intended to be a sustainable solution for fighting malnutrition but a punctual treatment reserved to SAM children.

The WHO essential medicines list contains not only drugs but also compounds such as ORS, and products such as activated charcoal, condoms or water for injection, so I think RUTF can fit in WHO's list.


Michael B. Krawinkel


Normal user

6 Feb 2017, 17:18

Dear colleagues and friends,
thank you for the clarifications about the use of RUTF. On the WHO-list you don't even find F75 nor F100. What do you expect to be listed there ? - Just RUTF ? - If yes, which description / recipe ? - It cannot be just a brand name.
Kind regards.

Sameh Al-Awlaqi

Public Health and Nutrition Consultant

Normal user

6 Feb 2017, 18:31

Dear Michael,

Please refer to Sonja's post and its attachment. I am quoting the below from ACF's call to WHO( found on WHO website, please clink on the links on Sonja's post):

Anatomical Therapeutic Chemical (ATC) code of the medicine:

No ATC code for the product described. RUTF is intended to cover the special nutrient needs (macronutrient and micronutrients) of children with severe acute malnutrition.
5. Formulation(s) and strength(s) proposed for inclusion; including adult and paediatric (if appropriate).


RUTF is a lipid-based nutrient-rich product.
It consists of a lipid matrix with a complex of vitamins and minerals.
The lipid-based matrix is constituted of peanut paste (or chickpea paste), vegetable oil, sugar and milk powder and a complex of vitamins and minerals.

The following is the nutrient content of 100g of the product (RUTF):

? Energy content is between 520-550 kcal/100 g
? Proteins content 10-12% total energy( equivalent to 12.8-16.2% by weight)
? Lipids content: 45-60% total energy (equivalent to 25.8-36.3% by weight)
? N-6 fatty acids represent 3 to 10% of total energy
? N-3 fatty acids represent 0.3 to 2.5% of total energy
? Trans-fatty acids represent less than 3% of total fat
? Fibres content is below 5%
? Vitamin A(retinol) between 0.8 and 1.2mg RE
? Vitamin D (Cholecalciferol)between 15 and 20 mcg
? Vitamin C (Ascorbic acid) 50 mg minimum
? Vitamin E (Tocopherol) 20 mg minimum
? Vitamin K (Phytonadione) between 15 and 30 mcg
? Vitamin B1 (thiamine) 0.5 mg minimum
? Vitaminb2 (riboflavin) 1.6 mg minimum
? Vitamin B6 Pyridoxine 0.6 mg minimum
? Vitamin B12 Cyanocobalamin 1.6 mcg minimum
? Vitamin B9 (folic acid) 200 mcg minimum
? Vitamin B3 (niacin) 5 mg minimum
? Vitamin B5 (pantotenic acid) 3 mg minimum
? Vitamin B7 (biotin) 60 mcg minimum
? Sodium below 290 mg
? Potassium between 1100 and 1400 mg
? Calcium between 300 and 600 mg
? Phosphorous between 300 and 600 mg
? Magnesium between 80 and 140 mg
? Iron between 10 and 14 mg
? Zinc between 11 and 14 mg
? Copper between 1.4 and 1.8 mg
? Selenium between 20 and 40 mcg
? Iodine between 70 and 140 mcg


The recommendation is 150 to 220 kcal/ kg body weight/ day of RUTF for young children from 6 months of age who have SAM without medical complications.

Hope that helps,



Action Against Hunger UK

Technical expert

6 Feb 2017, 19:00

Dear Sonja,
Thanks for the information. However I have a few concerns.

Firstly, I would like to express my personal point of view that this submission to place RUTF on the WHO essential medicine list needs to be viewed with caution. I fully support the concerns regarding the cost and procedural implications as already outline by Emily Mates above. I also agree that it might be good to have it listed as some sort of 'essential' product but I am unconvinced that listing it as a medicine is the best way forward.

On reading the submission to WHO, the document lists agencies with which 'consultations' were held and states (in a later section) that "Most of the consulted stakeholders expressed willingness to collaborate". However this is not transparent in terms of the level of support / objection raised in any discussions.

I also have several concerns regarding the technical information contained in the submission. Examples of this might be the "Strength" and "Therapeutic dose regimen and length of treatment" sections. The 'strength' noted is in fact a 'dosage' (150-220 kcal/kg/day). However this is not consistent in all protocols and some recent studies have achieved good results with varying doses of RUTF during treatment. Would listing this as a medicine necessitate restricting the 'dosage' to that recommended in this submission?

The length of treatment and protocols used to start and end treatment vary widely and it is not clear what the submission is suggesting as an appropriate length of treatment might be. I disagree wholeheartedly that the "recommended duration is 6-8 weeks". This is without reserve incorrect. The required length of treatment depends on the extent of malnutrition at admission and each child should be treated until cure or referral to another service when cure is not possible as an outpatient. As an example (using the MUAC admission / discharge protocols you advocate in the submission document), a study in Malawi indicated that a child admitted with a MUAC of 10 or less has a median LOS of approximately 15 weeks to recover to a MUAC of > 12.5cm. What I would agree with is that the median LOS for ALL cases is approximately 7 weeks but this also includes very sick / malnourished individuals who require much longer in treatment.

If this is listed as an "individual medicine" what are the knock on effects for similar formulations such as RUSF (and other LNS products) and formula milk powders? How does one account for variations in the formulations that do not use peanuts or chickpeas? These implications are not considered in the document.

Your posting indicates that ACF have concluded from a study that listing RUTF as a medicine would be an important step in advancing treatment coverage. However I see no evidence of this in the submission document. Even when RUTF is procured and supplied at country / district levels, it is the logistic systems (especially in non-NGO programmes) which are often a bottleneck for treatment. The submission needs to demonstrate the evidence for your argument.

There is a section on "cost effectiveness" which cites various work done on the cost effectiveness of RUTF, however there is no analysis regarding the potential cost increases and pipeline issues that may result from being listed as a medicine. Without such analysis I find it difficult to understand how any agency is able to conclude that the product will become more accessible as a result. It could be argued that the potential increases in production costs as a result of being labelled a pharmaceutical and the requirement to abide by national and international codes for medicines might actually reduce coverage.

In conclusion, I am not arguing for or against the case for RUTF being placed on the EML however I think the document as it stands does not offer a good case for supporting the submission. It is incumbent on ACF to explore the implications more fully and to be more transparent regarding the results of the analysis and various consultations.


Bindi Borg

IYCF researcher and practitioner

Normal user

6 Feb 2017, 19:04

Dear Sameh
Thank you for this clarification. By stipulating that the RUTF contain peanut or chickpea paste and milk powder, it excludes RUTFs that do not have those ingredients. Which brings us back to Michael's concerns about conflict of interest and commercialisation.
What does it mean that countries that are attempting to make RUTFs which is adapted to local tastes and available products?
Many thanks.

Suzanne Fuhrman

Project Manager, Micronutrient Forum

Normal user

6 Feb 2017, 19:45

Sonja, I think on an earlier version of your post you had a link to a guidance document ACF created with some of the potential benefits and drawbacks to inclusion of RUTF on the EML. Can you post a link to that document?

Sameh Al-Awlaqi

Public Health and Nutrition Consultant

Normal user

6 Feb 2017, 20:02

Dear colleagues,

Thanks for your useful comments. I agree with Paul on the issue of LOS, although many countries I know have standardized an average LOS 6-8 weeks treatment in the absence of SFP programme in their CMAM guidelines, but on the ground it is not common to achieve this recommended LOS.

I think the specification of RUTF as peanut/chickpeas paste-based in the call might carries a potential reference to commercial brands, but this is common and sometimes unavoidable with drugs and medical supplies (and vaccines) I believe.

ACF and the technical committee can respond to all these concerns in details, but the assumption (I think) is that RUTF that are based on chickpeas and peanut paste have been tested worldwide for decades and we all know and used them in our programmes.

Nutritionists, please let us think about the lifesaving aspect of that call, the additional millions of children that would benefit from that inclusion and how this step would affect the CMAM programme/ health/nutrition integration and SDGs. Technicalities are extremely important and I believe the WHO committee with our colleagues in ACF will have a very through discussion, tests, researches and will involve all agencies before reaching to a decision, so from that perspective, I totally support the call.

Kind regards,


Dr Charulatha Banerjee

Asia Regional Knowledge Management Specialist

Normal user

7 Feb 2017, 07:00

An important discussion with major implications.

A couple of points from the Asia perspective

RUTF is less accepted in Asia vs Africa - there is major resistance in India and Bangladesh - the debate is long standing and complex and is not the subject of the post.Asia has a considerable burden of SAM and needs to scale up CMAM urgently. There have been a few trials with products of the same energy density and with all micro nutrients as the prototype RUTF not using peanuts but 2 products 1.rice and lentil based and 2. chick pea based which have been successfully trialled in Bangladesh- results yet to published but have been shared in meetings publicly a couple of years ago. Taking from the point made by Paul Binns does this statement by ACF cover such products?

There is great sensitivity around calling RUTF "Food"- the adjective "therapeutic" gets lost - fear of RUTF displacing all local foods is often cited as the main opposition to the product itself. Perhaps introducing it within the medicine list is a wise option making it clear that this is a therapeutic product.

Having said this in the recent years when RUTF was being bought into Bangladesh by various agencies it was done through the Ministry of Food because the regulations around bringing it as a medication would have been extremely complicated.

RUTF in India is in all likelihood registered as a Nutriceutical and not as a food- there are local companies making them.

I hope more practitioners working on SAM using RUTF in different contexts in Asia are able to add to this important discussion.

Blessing Mureverwi


Normal user

7 Feb 2017, 07:41

I would really be interested in finding out more about what prompted ACF to conduct the study on whether RUTF should be added to the EML. I would think that even if this was done and all agreed, it would not necessarily change the way RUTF is accepted or used by different countries.

Sonja Read

Nutrition Advocacy Officer / ACF-Fr

Normal user

7 Feb 2017, 15:10

Dear colleagues,

Many thanks for sharing your thoughts and concerns.

As stated in our initial post, ACF decided to conduct a study on whether RUTF should be added on the Essential Medicines List (EML) of WHO and of countries as it has been a long standing debate amongst actors so far.

These last years a lot of work has been done in identifying major barriers to SAM treatment that as some of you rightly stated remains shockingly low. One of the barriers listed relates to the product. The study therefore intended to assess whether or not having RUTF on the EML would be one of the steps to advance SAM treatment coverage globally.

Recently the CMAM forum developed a digest of the study ACF made and it responds to a lot of the concerns raised in this discussion. We would like to invite you to click on the link and read this short digest:

There is no conflict of interest for Action Contre la Faim to follow WHO’s recommendations to use RUTF as a solution for SAM treatment.

ACF is an independent international NGO. Our sole mission is to fight malnutrition worldwide and we believe in the right to food and in the right to nutrition. While we promote a multisectorial approach to treat malnutrition we strongly favor working on the nutritional status of the populations in need. We also tackle the underlying causes of malnutrition by aligning nutrition programs with Health programs, WASH interventions, Food Security and Livelihoods, and Mental Health and Care Practices initiatives.

We agree that food-based approaches are and will continue to be essential in promoting healthy diets and preventing malnutrition. RUTF does not replace these; it’s a therapeutic food specifically used to treat severe acute malnutrition, a disease that does not only occur in emergencies. And as stated by Sameh in his post, any country with an endemic and seasonal burden of children suffering from SAM should ensure that their health system is able to provide treatment to those that are affected, in the same way that patients should have the right to access treatment for any other condition.

To respond to Paul, the document submitted does not necessitate restricting the 'dosage' to that recommended in this submission. The composition as listed in the application is not binding. Indeed the duration of treatment is rather an average and is not binding either. As of today, we understand there is no international authority that binds the composition of RUTF. The codex is the only authority on the composition of RUTF.

The submission proposes to add RUTF on the list as a ‘miscellaneous item’, not as a medicine.

Placing RUTF on the WHO EML would not transform it into a medicine nor, would RUTF need to be a medicine prior to it being listed on the WHO EML. The WHO EML has a category for miscellaneous items such as sterilized water. RUTF is to fall into this category.

Countries are not bound by the WHO list and will choose to add it or not to its national EML. Therefore all countries can decide whether or not to apply the international recommendation and to find the right way to do it (in our study digest you can find a list of countries that have decided to list RUTF and the various ways possible to do so).

Adding it to the international EML is just a step to help countries to consider RUTF as an essential commodity.

As stated in the digest of the study published by the CMAM forum, there is no silver bullet for increasing access to SAM treatment but adding RUTF to the WHO EML can act as a catalytic initial step in this process. Global action could influence countries to integrate the product into national EMLs, ultimately leading to increased prioritisation of SAM treatment with RUTF, increased budget allocation and improved inclusion within the health system and supply chain. These are critical factors to increase the availability and access to SAM treatment. Given the potential implications, an application to adding RUTF to the WHO Essential Medicines List should be strongly considered.

We are very happy to engage in a further conversation.

ACF-F Nutrition & Health Team

Michael B. Krawinkel


Normal user

10 Feb 2017, 11:00

Dear friends and colleagues,
first, when you go for listing of RUTF on the EML I would like to suggest to list F75, F100, and F135 as well;
second, the nutrient description is almost in every nutrient the same as that for 'plumpynut'; that means that no RUTF could be considered except it has the required nutrient contents. But most of our colleagues working with locally made RUTF may not be able to provide such a detailed nutrient analysis of their stuff. Therefore, standardization is good - but it needs to be manageable. And it should not exclude all products except one for which the company can afford to get all nutrient analyses done.
Sorry, but we are to provide expert advice and not to advertise for one product.

Yara Sfeir

Action Against Hunger

Normal user

11 Feb 2017, 13:11

Dear Colleagues,

I am happy to see you speak your concerns and to see that we have the opportunity to discuss. My first point is just to say a big thank you for opening the debate. The other option-not having a debate- was not very helpful.

Today some 20 factories produce RUTF worldwide. This application to add RUTF on the EML as a miscellaneous item is not to profit to one of those factories or one brand or one group. It might even increase the demand and invite and engage more actors in the offer.

Getting RUTF on the Essential Medicine List as a miscellaneous item will not unlock on its own the barriers to treatment for the greatest caseload of SAM children-the one that do not need to be hospitalized. It might however be a step towards it.

We decided to prioritize unlocking some of the barriers to treatment for the greatest caseload first: SAM cases that do not need to be hospitalized. Does that mean that we cannot in parallel try to unlock the barriers for those that need hospitalization?
WHO accepts applications for what should be on the international Essential Medicine List. Dr. Krawinkel asked a very good question: why not include F75 and F100? We believe this should be done too.

There are so many barriers to treatment today and one action alone will not -unfortunately for all of us- mean that tomorrow a small SAM child will wake up suffering less from his condition. It might however be one of the many actions that will help address those barriers.

We are co-reponsible and co-actors of the options that are made available to remove some of those barriers to treatment. I would like to invite you all to engage in this subject as this concerns us all.

Kind regards,

Yara Sfeir
Senior Nutrition and Health Advisor
Action Contre la Faim Action Against Hunger France



Action Against Hunger UK

Technical expert

13 Feb 2017, 13:03

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.


Expert Nutrition

Normal user

14 Feb 2017, 17:48

Dear all,
I also totally agree that RUTF can be added to WHO list of essential medicine. There is no matter for adding it

Many Thanks
Nutritionniste et Diététicien
Skype: kalufenye.ngengele.emmanuel
Tel: +243997267477,

Sonja Read

Nutrition Advocacy Officer / ACF-Fr

Normal user

22 Feb 2017, 17:46

Dear colleagues,

Please find below answers and comments on the points raised previously, based on exchanges with some of our key informants.

On technical specifications and quality insurance :
RUTF should have a specific status on the WHO EML and if the application is accepted, it is likely that there would not be any pharmaceutical standard being developed for RUTF.
Here are the main reasons:
- The consequences of adding an item to the EML will be determined by its category.
- Comparing with the current content of the WHO EML, RUTF is a special case, it does not fall into the existing categories, because it is a group of products, which can be based on different ingredients. It would be very complicated to have a common pharmaceutical standard. To accommodate the special nature of RUTF, a new category might be created under the WHO EML.
- Technical specifications relating to pharmaceutical production are usually associated to medicines added to the EML. As some of you rightly highlighted, these specifications are not adequate for RUTF. RUTF cannot be listed traditionally as a medicine on the list, it needs a specific category to avoid the specifications.
- Based on our knowledge and exchanges with WHO, the only section on the WHO EML which does not require these technical specifications is the miscellaneous items section, which allows some flexibility.
- Pharmaceutical standards being applied to RUTF is not an option on the table. In short, RUTF could be added on the EML under the miscellaneous item section, or under a newly created section. Again, and in both cases, the objective is to avoid pharmaceutical standards being applied to RUTF. The WHO nutrition department is involved in the process and they are in touch with the EML secretariat to discuss solutions adapted to the special status of RUTF.
- Quality standards for RUTF are expected to be listed by the Codex guideline on RUTF.

Information being unclear or missing in the application:
The information required for submission of the application is designed to fit usual medicine description, and does not completely match what should be presented for a therapeutic food application. There was no dedicated space in the application to provide further information and the application had to be made in the given format. We agree that it is not the optimal format to present RUTF.
However, WHO nutrition department will write an official letter to the EML secretariat with additional information on the matter and not reflected in the application.
We are also writing a letter to the EML secretariat to clarify the points which we could not add onto the application and this includes the comments on avoiding pharmaceutical standards.
In addition, please note that although the application cannot be changed, the comments which are sent to the EML secretariat will also be used by the EML Expert Committee during the review of the application.

Regarding Paul’s question about transparency:
We carried out the study in order to gain qualitative feedback on adding RUTF on the EML before deciding whether or not to submit an application, and the study’s purpose was not to determine the black and white positioning of each interviewee. Indeed, often respondents’ answers were nuanced, nor do key informant views necessarily reflect the official positioning of their organizations. All major concerns that emerged are summarized in the arguments against putting RUTF on the EML in the study digest. Based on the interviews, we established that there was general support for adding RUTF to the EML, but it is not for Action against Hunger to determine who officially supports this initiative after we submitted our application. Those who support the application may express this through letters to the EML Secretariat.
We also concluded as the result of our study that there were sufficient positive arguments in favor of adding RUTF on EML and that it would have a positive impact on priorisation of SAM treatment and availability of RUTF (amongst other findings).

We hope this clarifies.

Best wishes,
ACF Nutrition and Health team

Dr. Roshan

Doctor in Nutrition - National Cancer Hospital

Normal user

24 Feb 2017, 00:07

Yes, It's an essential therapeutic food in management of Malnutrition. As it is not in the essential drug list, there are many practical problems in getting it into the clinical practice.
Also because of that, it's impossible to get it into the essential hospital drug list.
Further, it should be modified to the country needs and people's taste.

Anonymous 3944

Ghana Health services

Normal user

24 Feb 2017, 15:37

The addition of RUTF and EVEN f-100, F-75 ETC into the essential medicine list will be of great impact to saving lives.many under five children and immunocompromised individuals die poorly its non-existence.
their packages may also modify to ensure easy handling and preparation devoid of contamination.
i vehemently support the inclusion of these products into the EML with due respect to safe lives.
the hospital where i work as nutrition, technical officer, its shocking to find poor children die mercilessly.Thus the need to find appropriate placement for these RUTF.

Anonymous 4221

Normal user

24 Feb 2017, 17:24

I have been following the comments posted here. I would like to know if anyone has commented on the Patent and if this might better or hinder the process.


Expert Nutrition

Normal user

12 Mar 2017, 15:13

Hello all
Just ask yourself what would be the practical solution faced with this problem on the ground:
A week ago we discharged a 4 month old infant. Unfortunately its mother's milk has completely dried up to the point where, after discharge, the child no longer receives any nourishment/food, in a situation of advanced poverty for this woman living alone who doesn't even have the means to purchase formula milk.
Eventually she returned to the General Reference Hospital to see if we can help with F100 therapeutic milk so that her child can survive.
Thank you

Hafsat Mustafa


Normal user

16 Mar 2018, 14:18

Hello all,
Maybe this question is outdated, I also agree to adding RUTF to EML, however, how will this be funded in some countries, especially knowing that RUTF is expensive to procure. Will there be a need to start advocating for funding, release of funds and monitoring to ensure funds are not diverted as is common in some countries?
I ask because there are countless policies, agreements, decisions yet things remains unchanged without the support of development partners.

Philomina Nwobosi

Food Safety & Quality Programme/ Federal Ministry

Normal user

17 Oct 2018, 15:09

My thoughts on the issue is why push for RUTF to be listed in EML when it is uknown that it is not a medicine. I hope and believe that WHO, who is party to both pharmaceutical drugs standards and codex standards for food will always do the needful not to create friction in slotting food items into medicine list. Is there any harm of having Essential Food/Nutriceutical List for sake of harmonious professional health operations?

Food in the first instance is life saving. Getting it in the form that is therapeutic has not taken away its nature which recently Codex Committee on Food for Specially Dietary Uses is busy developing a guideline on RUTF. Let us limit the professional friction. Again where will the dice be cast: is it on pharmaceutical standard or food standard? Let's leave the technicality of its prescription to SAM management or treatment which is not the contentious issue because we all know RUTF's usefulness in the management of SAM cases. In this situation whose profession the dice fall on will be raised and this is what makes every profession come on board in the health care delivery.

So my humble submission will be instead of WHO Expert Committee longing/stressing /calling for conviction of why RUTF will be accepted into EML as an item, why not change EML to Essential Commodity List (ECL) to be all encompassing or simply establish/create Essential Food/Nutraceutical List (EFL or EF/NL) which will be equally useful in national food formulary for easy procurement and cost.

I wish my humble opinion will be considered. Thanks

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