Ready-to-use therapeutic food and the WHO list of essential medicines

Location: Global

What we know: Critical barriers to expanding SAM treatment services are problems in resourcing, procurement, distribution and supply-chain management of RUTF within national health systems.

What this article adds: An analysis by ACF has examined the pros and cons of including RUTF on the WHO Essential Medicines List (EML) to overcome barriers in national RUTF supply. This involved literature review, country case studies (Nigeria and Zimbabwe) and key informant interviews. Arguments for EML inclusion include increasing profile and prioritisation of SAM treatment with greater health system ownership and accountability to ensure supplies, stimulation of local production, greater integration of nutrition within healthcare systems, and complementing global quality assurance efforts (Codex). Risks of inclusion include stringent pharmaceutical requirements hampering supply, risk of product promotion, overstretching capacities and budgets of high-burden country health systems even further, and fuelling private sector interests. ACF concludes that the benefits outweigh the risks and has submitted an application for the inclusion of RUTF on the WHO EML as a miscellaneous item.

Background

Severe acute malnutrition (SAM) affects more than 16.2 million children each year (Unicef, WHO, World Bank, 2014), yet only 3.2 million have access to treatment (Unicef, 2015 [2]). Scale-up of high-impact, proven treatments is needed to improve coverage and access across high-burden countries. One critical barrier to expanding SAM treatment services is the acceptance, accessibility and utilisation of ready-to-use therapeutic Foods (RUTF). In some countries and contexts, RUTF is still not fully accepted by community members, while other countries face problems with procurement, storage and supply chain management which impact on availability and use (Unicef, 2009).

One proposed method for improving RUTF access is including the product as a miscellaneous item on the Essential Medicines List (EML) of WHO and of high-burden countries. This is “a list of minimum medicine needs for a basic health-care system, listing the most efficacious, safe and cost-effective medicines for priority conditions” (Aitken, 2015). It provides a guide to countries on medicines to prioritise for national procurement; national health and nutrition decision-makers tend to rely on the EML as a guide for determining their own national medicine and commodity lists (Aitken, 2015). Thus, placing RUTF on the EML could potentially assist in prioritising the procurement of RUTF and alleviate some of the distribution and supply chain issues.

Discussions on whether RUTF should be placed on the WHO EML began in 2009 and at a conference on government experiences of CMAM scale-up in 2011, the question of adding RUTF to national EMLs was identified as critical (ENN, 2012). General consensus remained that placing RUTF on the WHO and national lists of essential medicines could be a positive step, but closer investigation was needed.

This prompted an analysis by Action Against Hunger (ACF) on the potential inclusion of RUTF on the WHO EML and national medicines lists. This involved a literature review, two country case studies (Zimbabwe and Nigeria), a stakeholder mapping exercise, and interviews with key informants.¹ This article summarises some of the arguments for and against adding RUTF to the EML and suggests next steps. Based on the findings of this study, Action Against Hunger has filed an application for RUTF to be added to the WHO EML².

What are the arguments for placing RUTF on the EML?

There is a substantial body of observational and programmatic data documenting the effectiveness of RUTF

The use of RUTF to treat uncomplicated cases of SAM in children aged 6-59 months is well established and has been the recommended treatment approach for more than a decade. The 2007 Joint Statement by WHO, WFP, UNICEF and the UNSCN endorsed the use of a community-based approach, using RUTF to treat SAM (Maleta & Amadi, 2014). Additionally, the 2013 WHO guideline update for the management of SAM recommended using an outpatient model to treat children diagnosed with SAM who have passed an appetite test and are clinically well (WHO, 2013). Much grey literature and programmatic evidence points to the effectiveness of RUTF. A review conducted in 2006 noted that RUTF is effective in supporting rapid weight gain and safe to use in a community setting; low mortality rates and rapid recovery rates were reported comparable or higher than those achieved in previous inpatient treatment models (Prudhon et al, 2000) .

Including RUTF on the EML would assist in prioritising SAM at a global and national level

The WHO EML is a critical tool to identify priority medicines of public health importance. The WHO EML is a guide, not a global standard. However, implicit in adding medicines and items to the list is the imperative that countries should make them available and affordable. In practice, the WHO EML is used as the foundation of many national essential medicine lists (Kaiser, 2006). In addition, high-burden countries often (but not systematically) allocate budgets by priority according to the drugs listed in their EML; thus the integration of RUTF on the list could create political drive to prioritise SAM treatment.

A report by UNICEF in 2015 noted that the inclusion of nutritional products on national EMLs is an important mechanism for fostering integration into supply chains and ensuring quality assurance, and recommended that UNICEF country offices should support governments to integrate all nutrition products for SAM treatment into National EMLs (UNICEF, 2015). Many interviewees assumed EML RUTF listing could help make the product more affordable and available; this has been demonstrated in the past where improved availability of TB drugs were a result of their inclusion in the 2015 amendments to the list (Saez, 2015). In addition, medicines on the EML are prioritised by donors during emergencies. Most key informants suggested it could impact on political decision-making at a national level as it would contribute to greater awareness and prioritisation of SAM treatment at health facility and community levels. This could lead to more resources being allocated to treatment.

Inclusion of RUTF on the EML would lead to improved integration of nutrition within health systems

The potential to support integration is one of the strongest arguments in favour of adding RUTF to the EML. Most key informants agreed that inclusion on the EML would lead to better integration of SAM treatment within health systems, avoid vertical, parallel programmes being created and empower more national authorities to ensure the product is available. Supply chains should not be separated within a health system, especially in light of a health system-strengthening approach. Government ownership and accountability is critical. This requires that RUTF be integrated within national distribution systems. Additionally, including RUTF on the essential medicines list (and/or commodities list; see below) allows easier integration into national supply systems (easier clearance of supplies at port, government storage at central medical stores, and government-led distribution and logistics). Some countries like Burkina Faso have common lists of essential medicines and commodities that include a broader range of items, such as gloves, syringes, etc.

RUTF on the EML would result in better management of SAM treatment programmes

EMLs can influence the provision of medicines and result in increased availability of essential medicines compared to non-essential medicines, particularly in low and middle-income countries (Yaser et al, 2014). Thus, placing RUTF on the EML could lead to fewer stock-outs as stock management and distribution improves. In Zimbabwe, it was noted that there was better integration of nutrition products into the national distribution system after adding the product to the national EML, as well as improved data availability of stocks and delivery. Distribution is now overseen by the National Pharmacy, although RUTF is stored separately from other medicines. RUTF is now included in the national forecasting and quantification exercise. This exercise allows the identification of requirements, funding gaps and supply forecasting. The current system provides supply-chain management data routinely, which was not the case prior to integration into the national supply chain. The routine data provides reports on stock status, stock-outs and delivery coverage. It helps to reduce the potential for RUTF stock-outs at a health-facility level.

Increased financial resources would be available for RUTF and potentially decrease overall cost

The addition of RUTF on EMLs opens doors for treatment, as governments would be required to allocate adequate budget for the purchase of RUTF. Most importantly, the inclusion of RUTF on a national supplies list would likely ensure there is dedicated national health budget for community programmes that use RUTF. It can also contribute to decreasing the cost of RUTF, which would then allow countries to buy more supplies with the same amount of money. This is based on assumptions that this commitment and demand would stimulate local production of RUTF and that harmonisation of standards could lead to a larger scale of production for bigger producers, decreasing unit costs. However, the cost of local production has been shown to be equivalent to, or higher than, international production standards. However, even if RUTF scale-up is stimulated, significant impact on the cost of RUTF is not clear due to the large fixed cost of raw materials (Nutriset). Thus, more evidence is required.

Inclusion on the EML would assist in changing perceptions around RUTF

In Zimbabwe, EML inclusion led to RUTF being seen more as a therapeutic product. Health workers interviewed reflected that it changed their perception and pushed them to handle RUTF as a treatment rather than merely food. It contributed to raising awareness of treatment, as well as of undernutrition in general, motivating staff. In Tanzania, with RUTF distribution through pharmacies, RUTF slowly started to be seen as a medicine, which helped to control its misuse. Again, its integration into the EML “protects” RUTF from being seen simply as food.

Adding RUTF to the EML is complementary to efforts to have it included on the Codex list

Today there is no official standard for RUTF, which leaves a large gap in the definition and framework of the product. Since 2014, UNICEF has been developing a guideline for placing RUTF on the Codex Alimentarius (Fleet, 2015) as a food for specific medicinal needs. The Codex aims to set regulatory standards to ensure safe and good foods for international trade (Fleet, 2015). It is felt that Codex classification will assist in ensuring the safety of the global supply of RUTF, improve importing and exporting procedures, and build regulatory capacity (Fleet, 2015). While including RUTF on the EML and Codex are independent processes, key informants felt that the processes were complementary. The Codex aims to set standards for quality production and countries have to adopt Codex standards. The WHO EML is a list of safe priority medicines; countries do not have to adopt the WHO EML products on their national EML. Ensuring that RUTF is placed on both the EML and the Codex will assist in improving safety, quality and supply.

What are the arguments against placing RUTF on the EML?

Classifying RUTF as a medicine can be problematic in some countries

Classification as a medicine could imply that the product is a medicine. The challenge is that the recognition of the product as a medicine requires it to go through stringent quality assurance measures which would likely dissuade local producers. Hence, considering RUTF as a ‘commodity’ may be more beneficial (ENN, 2012). RUTF should fall into the general/non-medical category of the WHO EML, labelled ‘miscellaneous items’, which also includes sterilised water. Another risk is that adding RUTF to the WHO EML could be seen as a way to promote a product based-approach to SAM, undermining or distracting from other preventive/mitigating interventions, such as the promotion of breastfeeding. However, treatment and prevention of SAM should be seen as two sides of the same coin.

It may lead to the promotion of other products

The addition of RUTF on the EML could open the door for the promotion of other products on the EML, such as ready-to-use supplementary food (RUSF). However, on examining the EML of countries that had added RUTF recently, none were found to have added RUSF. If RUTF is added to WHO EML and national EML, this risk should be flagged with emphasis that the recommendation only relates to RUTF.

Low capacity of national health systems and pharmacies would be further stretched

Countries which would likely benefit the most from RUTF inclusion on their national EML often experience humanitarian emergencies and have low capacity to implement such measures, as well as low-tech capacity of pharmacies. There is a concern that adding additional services would only serve to further weaken the pharmacies and the health systems in general; this highlights the need for capacity strengthening.

Risk of potential conflicts of interest

The demand for RUTF is expected to increase as more countries add RUTF to their EML. The private sector will benefit from a new ‘market’ and become interested in a matter that has been so far a niche market (Persistent Market Research, 2016). The future influence of the private sector will need to be carefully monitored by states and NGOs/CSOs.

Conclusion and way forward

ACF concludes that there is a strong value-add for RUTF inclusion on the EML as a therapeutic food, under the category “miscellaneous item”, and with quality assurance criteria of RUTF to be set by the Codex. There is overwhelming programmatic and observational evidence on the effectiveness of the product and its many positive benefits.

Adding RUTF to the WHO EML can act as an initial catalyst in scale-up. Global action could seek to influence countries to integrate the product into national EMLs, ultimately leading to increased prioritisation of SAM treatment with RUTF, increased budget allocation and improved integration within the health system and supply chain. These are critical factors to increase the availability and access to SAM treatment.

Given this, Action Against Hunger has submitted an application to add RUTF to the WHO EML and has sought support from individuals and organisations for the application. The WHO Expert Committee on the Selection and Use of Essential Medicines will meet from 27 to 31 March 2017.

For more information, contact Aurélie du Châtelet, email: aduchatelet@actioncontrelafaim.org

¹The following stakeholders were interviewed: Alison Fleet and Thomas Sorensen (UNICEF), Zita Weise and Hala Boukerdenna (WHO), Hanane Bouzambou and Charlotte Bienfait (formerly WFP), Steve Collins (Valid International), André Briend (independent, formerly IRD & WHO), Odile Caron (MSF), Jane Badham (HKI), Patti Rundall (IBFAN), Stefano Prato (SID), Thomas Couaillet (Nutriset), Anne-Dominique Israël, Rachel Lozano and Danka Pantchova (ACF)

²The full application report is available on the ACF website under the publications section.

References

Aitken M. Understanding the Role and Use of Essential Medicines Lists Introduction. 2015;(April).

Bazargani YT, Ewen M, de Boer A, Leufkens HGM. Mantel-Teeuwisse AK. Essential Medicines Are More Available than Other Medicines around the Globe. PLOS ONE February 12, 2014. dx.doi.org/10.1371/journal.pone.0087576

ENN. Conference on Government experiences of Community-based Management of Acute Malnutrition and Scaling Up Nutrition. 2012;(November 2011).

Fleet A. Codex Proposal for ready-to-use therapeutic foods –  International Regulation for foods used in CMAM contexts. UNICEF Supply Division, 1 July 2015.  

Kaiser BM. World Health Organization’s Essential Medicines List: From Idea to Implementation. Glob Heal Educ Consortium (GHEC). WHO Constitution Basic Documents 45th Ed 2006.

Maleta K, Amadi B. Community-based management of acute malnutrition (CMAM) in sub-Saharan Africa: Case studies from Ghana, Malawi, and Zambia. Food Nutr Bull. 2014;35(2):34-38. www.ingentaconnect.com/content/nsinf/fnb/2014/00000035/A00102s1/art00005.

Persistent Market Research. RUTF Market – Global Industry Analysis and Forecast: 2016- 2024. 2016.

Prudhon C, Briend A, Weise Prinzo Z, Daelmans B, Mason JB. WHO, UNICEF, and SCN. Informal Consultation on Community-Based Management of Severe Malnutrition in Children. Ann Med Interne (Paris). 2000;151(8):629-634. doi:10.1016/S0140-6736(07)60356-0.

Saez C. WHO Reviews Its Essential Medicines List; Some New Candidates Under Patent. Intellect Prop Watch. 2015. www.ip-watch.org/2015/04/21/who-reviews-its-essential-medicines-list- some-new-candidates-under-patent/Unicef, 2015. Nutritional Supply Chain Integration Study. Unicef  2015;2(October).

Unicef, WHO, World Bank. Levels and Trends in Child malnutrition. Midwifery. 2014:4. doi:10.1016/S0266-6138(96)90067-4.

Unicef, 2015 [2]. NutriDash: Global Report 2014. Unicef 2015:2014. www.unhcr.org/gr14/index.xml.

Unicef, 2009. A Supply Chain Analysis of Ready-to-use Therapeutic Foods for the Horn of Africa. Unicef Report 2009;(May):1-136.

WHO, 2013. World Health Organization. Guideline: Updates on the Management of Severe Acute Malnutrition in Infants and Children. WHO 2013:1-123. doi:10.1007/s13398-014-0173-7.2.