Ready-to-use Therapeutic Food (RUTF) Scoping Study

This work was conducted by Emily Mates (ENN Technical Director) and Kate Sadler (ENN Consultant). We are grateful to the many individuals and agencies who not only generously gave their time for participation in the key informant interviews, but also commented on the draft report, providing valuable feedback. We also offer thanks to members of the ENN team who reviewed and improved the many drafts.

The authors would like to thank Irish Aid and the Eleanor Crook Foundation for generously funding this work.

For further information, contact: emily@ennonline.net

Recommended citation: Mates, E., and Sadler, K. Ready-to-use Therapeutic Food (RUTF) Scoping Study. ENN, June 2020.

Background

Globally, wasting affects 47 million (6.9%) children aged under five years of age. The cornerstone of dietary treatment in outpatient care for uncomplicated severe wasting is ready-to-use therapeutic food (RUTF). A wealth of evidence has existed for over a decade of its use as part of effective outpatient treatment of severe wasting when delivered from programme platforms such as community-based management of acute malnutrition (CMAM). However, in 2018 it was estimated that only 25% of the 16.4 million children who had severe wasting at any point in time were receiving appropriate treatment. The COVID-19 pandemic means that the scale-up of severe wasting treatment is even more urgent as numbers of malnourished children are expected to rise. Barriers to scale-up of treatment include issues around the cost, availability and regular supply of RUTF. At the same time, considerable change has been linked to the product and its supply over the last 15 years, including a diversification of producers, scale-up of production, cost-reduction, work on new formulations, problems with contaminants, changes to product standards and regulation of supply, and developments around combined/simplified approaches to treatment. Through Emergency Nutrition Network (ENN)’s extensive network of practitioners, we are party to many informative perspectives on these issues. Given this, ENN has captured a snapshot of perspectives to bring some transparency to the debates and help identify common ground and opportunities to move forward.

Methods

The work was conducted between September 2019 and May 2020. It comprises a non-systematic review of available literature and a series of 22 key informant interviews with 36 people. These represent a range of stakeholders , including programmers, academics, producers, donors, auditors and United Nations staff. Both the literature review and the interviews were guided by a terms of reference that included a list of key questions to be addressed, which was developed into a semi-structured questionnaire.

Results

Cost of RUTF: A cross-cutting issue

Stakeholders interviewed agreed that reducing the cost of RUTF remains essential for achieving universal coverage of treatment for severe wasting. The cost of standard, peanut-based RUTF has decreased by around 23% in the last 10 years. It is expected that further cost reductions could only come about through:
• Reducing the amount of product needed to treat wasting through reduced dosages.
• Reducing the costs of production through:
- local production, which has had little impact on the cost of product itself in most settings but has reduced other costs, especially those linked to transport and lead times;
- changing the approach to inspection;
- roll-out of new formulations; and
- improving financing and supply-chain efficiencies.

Regulation and setting of standards

Standards, specifications and guidance

Some stakeholders articulated the need for review of several of the current standards and specifications for RUTF. This process is now underway through the development of the RUTF guideline by Codex (see below). Issues being reviewed include source of protein and how much needs to come from dairy sources, acceptable limits of aflatoxin, and quality testing and verification procedures. Stakeholders expressed a need for greater clarity throughout the process, including more timely communication of changes and ensuring opportunities for expert stakeholders (including producers) to inform the process of standards setting.

RUTF in Codex standards

The supplies division of the United Nations Children’s Fund (UNICEF) is now working with the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to develop a guideline for RUTF. Enshrining RUTF within Codex guidance is generally felt to be a positive step as it will help governments safeguard the quality assurance of local production. As new formulations and products are developed, it will be critical to ensure that guidance allows for rapid approval and scale-up of new products that may provide considerable cost savings and other benefits.

Accreditation, validation and auditing of RUTF

While UNICEF is not a regulatory authority it does, in the absence of governments fulfilling this role, approve all RUTF product and suppliers for the product that it procures. It therefore has a dual role: accreditation of quality assurance and procurement of the majority of RUTF purchased globally. There are advantages and disadvantages of having one international agency fufil both roles. Many stakeholders (including UNICEF) agree that, ideally, national governments would be more involved in the accreditation and procurement of RUTF.

Potential inclusion on the World Health Organization’s Essential Medicines List There

are different views on whether inclusion of RUTF on the Essential Medicines List (EML) of the World Health Organization (WHO) would help or hinder greater access by national governments and other stakeholders to regular and affordable supplies of RUTF. How it is included may affect consequences of its inclusion. Adding RUTFs to national essential medicines lists and the WHO EML could leverage domestic resources, improve procurement and distribution (and therefore availability of RUTF), reduce costs, and mobilise political commitment. In terms of potential unintended consequences of inclusion, it could increase the administrative and regulatory burden in some countries.

Patents

Many stakeholders have expressed concern that patent protection of Plumpy’Nut® has limited global RUTF supply and restricted RUTF innovation and price reductions. Stakeholder opinions in interviews for this review were divided over the advantages and disadvantages of patenting products for the treatment of wasting. It is crucial that discussions concerning lessons from the complex issues of patenting new products are held regarding any future alternative formulations, so that companies can protect their investments in innovation while ensuring that cheaper and potentially more effective products can be taken to scale rapidly.

Operational issues

Local production

In attempts to drive prices down, develop local industry, strengthen pipelines and reduce transport costs, a great deal of effort has been made by several suppliers, including Nutriset, to produce RUTF in countries where demand is high. UNICEF now procures RUTF from 21 different suppliers, of which 17 are located in countries with high levels of wasting. Eight of these are part of Nutriset’s ‘PlumpyField®’ franchise. While estimating cost of locally produced RUTF is complex, there was broad agreement from stakeholders on other advantages of local production, linked to incentivising domestic resource mobilisation and supporting more sustainable access to supplies for the treatment of wasting.

Supply breaks and leakage

Agencies involved in the treatment of severe wasting have highlighted significant shortfalls in RUTF supply. Factors contributing to these shortfalls include limited availability of supplies, weak supply-chain management at multiple levels, poor communication between suppliers and facilities, lack of access due to insecurity, and inadequate reporting. There is broad stakeholder consensus that better reporting and analysis of pipeline breaks and stockouts are essential. RUTF is largely financed via short-term humanitarian funding mechanisms, which adds complexity to ensuring continuous supplies. Over the past few years, UNICEF has employed a strategy of ‘bridge funding’, which has minimised gaps in funding and avoided potential stockouts.

Research and future direction

Alternative formulations

Consensus is building among stakeholders that, due to the cost of producing the original RUTF recipe and the challenges in procuring some of the ingredients locally, there is a need for alternative formulations that could make it easier to scale up treatment and therefore improve coverage. A number of non-peanut ‘alternative formulations’ are now in development, which may or may not include milk powder. For a small number of these new formulations, study leads claim non-inferior treatment outcomes and even added advantages (e.g., lowering anaemia) over standard, peanut-based RUTF. Others feel such conclusions are premature and that further research is needed. There is currently no consensus on the best way forward to build the evidence base to inform specifications and guidance. Stakeholders interviewed for this work agreed that there is an urgent need for decisions on clear benchmarks around evidence; i.e., what is ‘good enough’ and what is important in terms of demonstrating product effectiveness.

Combined/simplified protocols for wasting treatment

There is a growing consensus that a unified protocol with one product (a ‘uni-product’) delivered from the same programme platform to treat both severe and moderate wasting could support improved treatment coverage for some children, improve efficiencies at scale, and simplify delivery mechanisms. Production of a uni-product and the supply chain to deliver it would require considerable expansion if these protocols were to be scaled up, in any context. Analysis is required to establish the extent of increased needs in different contexts, how these needs could be met operationally, and the additional cost.

Conclusion

This review explores issues linked to the formulation, production and supply of RUTF, which each contribute to the current bottlenecks limiting treatment coverage of severe wasting and which were highlighted as research priorities in the recent Global Action Plan (GAP) framework for action on child wasting. Based on the information gathered from this community of stakeholders, we found differing opinions but also much common ground, with practical actions emerging to address some of the current issues that are detailed in the recommendations. Specifically, actions linked to reducing costs and increasing access to RUTF include those that could support adoption and use of alternative formulations, increase capacity of local production, and improve efficiencies around product financing, dosage, treatment protocols and supply chain. Actions linked to improving standards and smarter regulation of RUTF include those that support improved opportunities for expert opinion to feed into the process of guidance development on standards; review of the process of RUTF accreditation and the most appropriate sustainable mechanism for its implementation; and an analysis of the complex issues linked to patenting new products to ensure that cheaper and potentially more effective products can be rapidly taken to scale. We hope that the direction of travel identified by this committed community of stakeholders can help pinpoint urgent next steps to improve RUTF supply management in order to support greater coverage of treatment and make better progress towards meeting Sustainable Development Goals for reducing wasting, saving lives and safeguarding futures.