2013 progress report un commission on life-saving … · iii. report of activities undertaken to...

UN Commission on Life-Saving Commodities: 2013 Progress Report

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2013 PROGRESS REPORT UN Commission on Life-Saving

Commodities

Prepared by the RMNCH Strategy and Coordination Team May 2014

This report documents the January 2013 to April 2014 progress against the recommendations outlined in the UN Commission on Life Saving Commodities report (Sept 2012).


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Contents

List of abbreviations ..................................................................................................................................... 3

I. Executive Summary .......................................................................................................................... 4

II. Background ....................................................................................................................................... 6

III. Report of activities undertaken to further UNCoLSC mandate (Jan 2013-Apr 2014) ................ 7

(1) Support for Technical Reference Teams and global partnerships .......................................... 8

(2) Development of a commodity tracking platform ................................................................. 10

(3) Direct Country Support: National plans to increase access to RMNCH commodities and

services ............................................................................................................................................... 12

IV. Progress against the UNCoLSC recommendations .................................................................... 13

Recommendation 1: Shaping Global Markets ................................................................................... 14

Recommendation 2: Shaping Local Delivery Markets ...................................................................... 16

Recommendation 3: Innovative Financing ........................................................................................ 18

Recommendation 4: Quality Strengthening ...................................................................................... 19

Recommendation 5: Regulatory Efficiency ....................................................................................... 20

Recommendation 6: Supply and Awareness ..................................................................................... 22

Recommendation 7: Demand and Utilization ................................................................................... 24

Recommendation 8: Reaching Women and Children (Financial Access) ......................................... 25

Recommendation 9: Performance and Accountability ..................................................................... 26

Recommendation 10: Product Innovation ........................................................................................ 28

Advocacy Working Group .................................................................................................................. 29

V. Summary: Challenges, lessons learned and next steps ................................................................ 30

(1) Re-organization of the TRTs ................................................................................................... 31

(2) Renewed country-level focus ................................................................................................. 31

(3) RMNCH Country Engagement Process .................................................................................. 33

Appendices ...................................................................................................................................... 34

Appendix 1: UNCoLSC List of Technical Resource Teams ................................................................ 34

Appendix 2: Interagency Supply Chain Vision Statement – DRAFT NOT FOR CIRCULATION ............. 35

Appendix 3: Commodity Tracking Platform- Data Sources, Partners and Assessment Levels ........... 36

Appendix 4: Monitoring Advisory Group ....................................................................................... 37


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List of abbreviations

API – Active Pharmaceutical Ingredient

BMGF – Bill and Melinda Gates Foundation

cGMP – Current Good Manufacturing Practice

CSO – Civil Society Organization

DT – Dispersible Tablet

EAC – East African Community

ECOWAS – Economic Community of West African States

EML – Essential Medicines List

ERP – Expert Review Panel

EWEC – Every Woman Every Child

HMIS – Health Management Information System

HRITF – Health Results Innovation Trust Fund

ICT – Information and Communication Technology

iERG – Independent Expert Review Group

IV – Intravenous

LMIS – Logistics Management Information System

LSC - Life-saving commodity

MDG – Millennium Development Goal

NMRA – National Medicines Regulatory Authority

NGO – Non-governmental Organization

ORS – Oral Rehydration Solution

OTC – Over the counter

PMRN – Pediatric Medicines Regulatory Network

RMNCH – Reproductive Maternal Newborn & Child Health

RBF – Results Based Financing

SADC – Southern African Development Community

SBCC – Social and Behavior Change Communication

TA – Technical Assistance

TRT - Technical Resource Team

SC – Supply Chain

SCT – Strategy & Coordination Team

UNCoLSC: United Nations Commission on Life Saving Commodities


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UN Commission on Life Saving Commodities – Progress Report

I. Executive Summary

This report profiles the global efforts between january2013 and April 2014 to further progress towards the recommendations made by the UN Commission on Life Saving Commodities (UNCoLSC) in its first report, launched in 2012. Three main activities were undertaken in the immediate follow-up to the launch of the report:

The establishment of a global network of Technical Resource Teams (TRTs) to enhance global partnerships and address the overarching barriers outlined in the UNCoLSC report

The development of a commodity tracking platform that draws together information from existing monitoring systems to better track the country-status of 13 life-saving commodities

The provision of catalytic support to national RMNCH plans that identify and address country-specific bottlenecks

In the UNCoLSC Report and Implementation Plan, a series time-bound activities with corresponding milestones were specified to chart progress against 10 recommendations to address commodity-related bottlenecks. Progress-to-date has been reviewed for each recommendation, with most milestones being achieved or nearing completion (Table 1). Perspectives on the ten commodities are integrated within reporting for these recommendations. As the scope of the recommendations were ambitious, early emphasis was placed on the achievement of global-level milestones. Key highlights include:

All 13 LSCs are now listed on the WHO EML, to guide procurement and financing. Corresponding treatment guidelines have been revised or are underway for most commodities

Major manufacturers for these commodities have been identified, including for newly listed commodities such as chlorhexidine and Amoxicillin DT, and procurement has begun.

A Nigerian manufacturer has recently achieved Current Good Manufacturing Practice (cGMP) certification to produce a range of products, the first in West Africa

Global price reductions of approximately 50% have been negotiated for implantable contraceptives with dramatic increases in global procurement and availability. Similar options for other products such as newborn resuscitation devices are being explored

Efforts to fast-track the national registration of LSCs are underway, alongside initiatives to harmonize and coordinate across multiple countries on a regional basis

Needs-based quantification algorithms have been developed for all LSCs to assist national forecasting and procurement efforts

A survey of the quality of LSCs across 10 countries has been conducted, with most products meeting acceptable standards and quality thresholds with the exception of oxytocin

Guidance materials that synthesize supply chain best-practice have been developed for a range of critical areas, and an initiative to further global and country-level cooperation around supply chain management has been initiated

A synthesis of available job-aids, check-lists and mHealth tools has taken place, with the generation of high-quality adaptable learning materials currently underway

Advocacy and Demand-generation tool-kits have been developed to improve levels of information and awareness as well as to increase utilization of LSCs

Despite this encouraging progress, a number of critical challenges remain. Foremost among them is translating global momentum into country-level responses in the face of pervasive remaining barriers.


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This report highlights first-phase learning and makes recommendations regarding next steps. Principal among them are finalizing efforts to address upstream bottlenecks; better coordinating the global response through the TRTs and other partners; implementing a dashboard to better track commodity-specific progress at the country-level from manufacturing through to coverage; adopting a cross-country and cross-commodity approach to disseminate the learning, resources, and technical support from this initial phase to the full range of EWEC countries, and finally; to better align partner resources against national RMNCH Plans to expand access to LSCs and accelerate progress towards MDGs 4 and 5. Table 1: Progress against UNCoLSC milestones

RECOMMENDATIONYEAR OF

COMPLETIONSPECIFIED MILESTONE Completed Partial

Not

commenced

2013

Aligning the market data collection efforts being undertaken by various groups (including CHA I,

USAID, WHO, and the commodity TRTs) and consolidating this data in a web-based portalx

2014x

2013

Working with the commodity TRTs and other groups engaged in generating demand forecasts to

consolidate this information at the global-levelx

2014

Develop toolkits for a portfolio of interventions to engage private sector suppliers

(manufacturers and distributors) to produce, distribute, and promotion appropriate productsx

2013

Identify appropriate supply interventions and begin implementing select supply side

interventions for relevant life-saving commodities in targeted countriesx

2014

Expand implementation of supply interventions and supply side communication to regional

initiatives. (such as pooled procurement and local manufacturer engagementx

2012Agree on the host of a result-based funding mechanism for life-saving commodities x

2013

At least 10 EWEC countries enter into an agreement with the funding mechanism to increase

access to the life-saving commodities x

2014

Guidance developed for countries to implement in-country RBF-approaches to strengthen access

to life-saving commodities at all levels x

2012ERP for dispersible amoxicillin x

2012Development of optimal quality assurance for zinc (e.g., market surveillance approach, ERP) x

2013ERP for chlorhexidine x

2013WHO-EML includes all 13 life-saving commodities x

2013Joint inspections or dossier reviews are implemented for at least 3 LSC x

2013

Regulators in pathfinder countries agree on a common pathway for at least 5 lifesaving

commoditiesx

2013

Quantification and forecasting guidance for all LSC available to countries(including harmonized

definitions of forecasting and quantification and forecasting algorithms) x

2013Toolkit for private sector engagement in supply chain functions available x

2014

Commodity-related functionality for an open source LMIS system (LMIS 1.0) developed, and pilot

integration with HMIS in at least one countryx

2013

Global demand generation Implementation Kit developed with adaptable communication

strategies for at least 9 priority commoditiesx

2014

Country-specific communication strategies developed in at least two pathfinder countries that

incorporate life-saving commodities from at least one health area (e.g. family planning) x

2013Eight EWEC countries have financial protection programmes with a commodity focus x

2014Evaluate the increase in use of (a sub-set of) life-saving commodities in concerned countries x

2014

The status of national availability and use of the 13 commodities and available guidelines

(including m-applications) in 8 pathfinder countries for their use have been analyzedx

2013Development of generic checklists for implants and safe birth, including use of MgSO4, has begun x

2014

Training and scalable strategies for checklist use including e- and m-learning have been

developed and deployed x

2014

Secure commitments including donor and private industry earmarks for innovation and research

and development x

x10 New Product

Innovation

5 Regulatory Efficiency

x

Form a coordinating group to lead reviews, prioritization and monitoring of product

improvements/ innovations

Prioritize four product improvement/ innovation areas2014

2014

x

8 Reaching Women and

Children

Feasibility assessments on the use of social audits to improve accountability have been carried

out in 10 countries

9 Performance and

Accountability

2014

Demand generation programs implemented in at least 4 pathfinder countries that incorporate

life-saving commodities from at least one health area (e.g. family planning)2014x

7 Demand and Utilization

Briefs/guidance and /or reference documents published on a range of supply chain topics

6 Supply and Awareness

2013x

2 Shaping Local Delivery

Markets

3 Inovative Financing

4 Quality Strengthening

Sign volume guarantee with at least one manufacturer of contraceptive implants, if appropriate

pricing and volume terms can be agreed upon

Evaluate the increase in availability and affordability of contraceptive implants

2014

1 Shaping Global Markets

x


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II. Background Millennium Development Goals (MDG) 4 and 5 underscore global commitments to reduce child mortality by two-thirds and maternal mortality by three-quarters between 1990 and 2015. Too often, high-impact interventions and the essential commodities they deliver fail to reach the women and children who need them most. While impressive global progress has been made in reducing child mortality with a 60% reduction in preventable child deaths since 1990, progress has been unequal. Mortality rates remain high in many areas of sub-Saharan Africa and South Asia, with many countries remaining off-track to achieve MDG 4.1 Significantly, newborns now comprise over 40% of child deaths. Progress towards MDG 5 has been slower still, with estimates suggesting a 45% reduction in maternal deaths has been achieved since 1990 relative to the target of three quarters. 2 A redoubling of efforts is clearly required. In response to these challenges and as part of the Every Woman Every Child (EWEC) movement, the UN Commission on Life Saving Commodities (UNCoLSC) was established with the overall goal of increasing access to life-saving commodities in 50 of the world’s poorest countries. The UNCoLSC identified 13 underutilized, low-cost and high-impact commodities that if implemented at scale, could make the greatest impact in reducing preventable maternal and child deaths (Figure 1). The Commission also identified a series of interrelated barriers that prevent access and utilization of these 13 commodities. These include severely under-resourced regulatory agencies leading to delayed registration of commodities; lack of oversight of product quality; market failures, where return on investment is too low to encourage manufacturers to enter the market or produce sufficient quantities; and user supply and demand challenges such as limited demand for the product by end-users, local delivery problems and incorrect prescription and use. Figure 1: UNCoLSC: 10 Recommendations and 13 Life-Saving Commodities

1. Shaping global market

2. Shaping delivery markets

3. Innovative Financing

4. Quality strengthening

5. Regulation efficiency

6. Supply and awareness

7. Demand and awareness

8. Reaching women and children

9. Performance and accountability

10. Product innovation

Reproductivehealth

Female Condoms

Implants

Emergency Contraception

Maternal Health

Oxytocin

Misoprostol

Magnesium sulfate

Newborn Health

Injectable antibiotics

Antenatal Corticosteroid (ANCS)Chlorhexidine

Resuscitation Equip.

Child Health Amoxicillin

Oral Rehydration Salts

Zinc

Accelerate achievement

of MDGs 4 & 5

1 Wang et al. Global, regional and national levels of neonatal, infant and under-5 mortality during 1990-2013: a systematic analysis of the Global Burden of Disease study 2013. Lancet 2014. 2 Trends in Maternal Mortality 1990-2013. WHO, UNICEF, The World Bank and the United Nations Population Division. WHO 2014.


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To address these barriers, the Commission put forth 10 time-bound recommendations. These focus on the need for improved global and local markets for life-saving commodities, innovative financing, quality strengthening, regulatory efficiency, improved supply chains, demand generation, reducing financial access barriers, improving health worker performance, and new product innovation. The UNCoLSC report was delivered to the UN Secretary General in September 2012, under the chairmanship of Nigerian President Goodluck Jonathan and Norwegian Prime Minister Jens Stoltenberg. This was followed-up by a country-level launch in Abuja co-hosted by the Government of Nigeria and UNFPA, with the participation of eight ‘pathfinder’ countries and key global partners. To take forward the UNCoLSC’s recommendations, an Interim Secretariat was rapidly established, with the RMNCH Strategy and Coordination Team (SCT) formalized in May 2013. The SCT is an interagency body comprising representatives of WHO, UNFPA and UNICEF. It acts as a coordinating mechanism to facilitate action on three levels. First, it works to fund and facilitate a network of Technical Resource Teams (TRTs) who identify and address the interrelated barriers outlined above. Second, it supports efforts to work with and through the H4+ and partners to track the status of commodities from manufacturing through to coverage in high burden countries. Finally, alongside other financing streams, the SCT administers a Trust Fund which provides catalytic investments to support national RMNCH plans to address critical gaps. This aim of this report is to review progress to date against the recommendations of the UNCoLSC. The first section will expand upon the range of global and country-level activities undertaken to further the UNCoLSC mandate. The report will then document progress against specific activities and milestones outlined in the UNCoLSC report and Implementation Plan3. The final section will go on to discuss challenges, lessons learned and next steps.

III. Report of activities undertaken to further UNCoLSC mandate

(Jan 2013-Apr 2014)

In early 2013, three main activities were undertaken to further progress against the recommendations of the UNCoLC:

The establishment of a global network of Technical Resource Teams to enhance global partnerships and address the overarching barriers outlined in the UNCoLSC report

The development of a commodity tracking platform that draws together information from existing systems to better assess critical variables along the pathway towards ensuring availability and access of the 13 commodities and corresponding bottlenecks

The provision of catalytic support to national RMNCH plans that identify and address country-specific bottlenecks

Each will be described in more detail below, with a timeline of core activities highlighted in Figure 2.

3 UN Commission on Life Saving Commodities Report and Implementation Plan, September 2012 http://www.everywomaneverychild.org/resources/un-commission-on-life-saving-commodities/reports

http://www.everywomaneverychild.org/resources/un-commission-on-life-saving-commodities/reports


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Figure 2: Activity time line since the UNCoLSC Report (Sept 2012)

(1) Support for Technical Reference Teams and global partnerships To carry forward the UNCoLSC recommendations at the global and national levels, a network of Technical Reference Teams (TRTs) was established. One group was formed for each of the 13 commodities and 10 recommendations, with an Advocacy Working Group dedicated to advancing cross-cutting goals (Appendix 1). The aim of establishing the TRTs was to consolidate global expertise in a particular subject area to support a more coordinated and catalytic response to improving availability and access to life saving commodities. Each TRT is a consortium of global experts, comprising UN agencies, NGOs, government partners and academic institutions. An inception meeting was held in Oslo in August 2012 where the TRTs were formed and focus areas refined – in particular to understand how the cross-cutting recommendations were relevant to the specific commodities and vice versa. The TRTs met again in late 2012 to finalize their workplans for the first year of implementation. The implementation of these workplans was financially supported by the RMNCH Trust Fund. During this first phase of the UNCoLSC process, TRTs focused primarily on global-level activities. Examples of early priorities included mapping commodity manufacturers; assessing alignment between global standards and national systems; reviewing and updating training materials; systematic assessments of best practice and; new product development. The activities of each TRT and progress against specific UNCoLSC milestones will be highlighted in the next section. The second component of TRT engagement was at the country-level. Additional resources to support technical assistance (TA) from the TRTs was built into the country submissions to the RMNCH Trust Fund (outlined below). To facilitate this process, TRTs reviewed country plans and identified areas where technical support could be offered to countries on a demand-driven basis. A final area of emphasis have been efforts by the SCT to optimize alignment with key global partners. Major investments are being made to further progress against the UNCoLSC recommendations by a range of stakeholders. Many are represented both on the RMNCH Steering Committee as well as in the


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TRTs. Principal among these have been robust collaborations with USAID (Case Study 1), the Bill and Melinda Gates Foundation (Case Study 2) as well as emerging efforts to foster global coordination around supply chain management through the Interagency Supply Chain Working Group (Appendix 2).

Case study 1: USAID’s efforts to accelerate progress towards MDG 4 and 5

USAID has been a key driver in accelerating progress towards MDGs 4 and 5. USAID is an active member on the RMNCH

Steering Committee, and play a convening role in UNCoLSC TRTs including Maternal Health, Newborn Health and Supply Chain

groups. In fiscal year 2013, USAID funded $1.9 Billion in direct support to ending child and maternal death, including its

partnership in the global movement to end preventable child deaths called A Promise Renewed or APR. USAID advanced and

supported voluntary family planning and reproductive health programs in more than 45 countries and is a core partner in the

Family Planning 2020 initiative, working with the global community to reach an additional 120 million women and girls with

family planning information, commodities and services by 2020. Support for activities to improve newborn health is also a

major component of USAID’s current work and USAID is participating in an extensive consultative process to develop a major

new global plan to improve newborn health. Through a Saving Lives at Birth Grand Challenge for Development grant, USAID has

supported numerous innovations in maternal, newborn and child health, including the scale up in Nepal of chlorhexidine, a very

low cost antiseptic used to prevent umbilical cord infections in newborns, a leading cause of newborn mortality.

Case Study 2: The Bill and Melinda Gates Foundation’s (BMGF) support for Life-Saving Commodities Through the UNCoLSC, the BMGF has been a convener of TRTs on antenatal steroids and contraceptive implants, as well as active members in a range of other TRTs including joint efforts to improve supply chain management. In January 2013 Bill Gates announced that the foundation was planning to increase its investments in support of the UN Commission on Life Saving Commodities by nearly $100m in order to help improve access to life-saving treatments for women and children. In 2013 the foundation’s investments in this area set about increasing commodity coverage by improving supply and demand as well as expanding up-take of life-saving treatments for children, including ORS, Zinc and amoxicillin. In addition to this, the foundation committed to continue to support the work of the maternal health commodities technical reference group through on-going investments to improve access to misoprostol, and magnesium sulfate. Specific examples of efforts to implement the UNCoLSC recommendations and expand access to life saving commodities include:

Improving the management of childhood illness in under-fives in Burkina Faso with Terre des homes by increasing adherence to management protocols by public, facility-based providers

Helping to scale up the successful trial of JSI’s supply chain management software cStock in Malawi.

Support work to ensure a regulatory change in India to enable zinc to be sold by providers without a specialist license;

Working with CHAI to launch a major new effort to scale up ORS and zinc treatment for diarrhea in India

Research on simplified community-level protocols for the use of magnesium sulfate for pre-eclampsia

With support from PATH’s oxytocin initiative, efforts have brought together new evidence to develop a comprehensive PPH prevention and management strategy in Ghana

Operational research in Uganda and Malawi to establish how best to accelerate the uptake of antenatal corticosteroids in high volume facility settings.

In 2014, with the support of its partners, the foundation will work towards country-wide scale up of ACS in Malawi – which currently has the highest burden of prematurity in the world

Support for the development of new training materials for ACS in the style of the successful “Helping Babies Breathe” program – deploying these in Malawi and Bangladesh in 2014. Plans are also being formulated for increasing ACS uptake efforts in the other 7 pathfinder countries as well as several additional Asian sites.

Collaborating with UNCoLSC TRTS to launch of CHX for cord care in 13+ countries, several of which will launch programs in 2014

Direct support for technology transfer to Ethiopia and technical assistance to Nigeria as well as Ethiopia to enable local chlorhexidine manufacturing in the countries, each of which will have products come online in 2014/15

Collaborating with the Newborn Antibiotics TRT, supporting the work of the Simplified Antibiotic Therapy Trial (SATT) and the AFRNIEST Trial. Both trials are now complete and the data collected are expected to lead to a revised WHO recommendation for the use of antibiotics, reducing the total number of injections required from 20 to 2 injections per course of treatment for newborns in outpatient / community settings.


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(2) Development of a commodity tracking platform

The use of commodities as tracers provides a practical and operational focus for identifying and addressing implementation challenges across the commodity-spectrum – from manufacturing and supply chain management to health worker performance and demand generation. This approach mirrors recent successful efforts to expand access to antiretrovirals for the prevention and management of HIV/AIDS, and malaria control efforts through improving access to bednets, rapid diagnostics and combination therapy. However, while barriers to availability and access are broadly understood, there is no robust platform to allow systematic tracking of country and commodity-specific bottlenecks.

Over the course of 2013, the RMNCH SCT has been working with and through the H4+, partner agencies and the TRTs to develop a commodity tracking platform. This has required drawing together a wide existing range of data from in-country sources (ie. policies, guidelines, essential medicines lists, training materials, etc), and refining existing assessment tools to include a focus on the 13 commodities. This has involved the addition of common questions to WHO, UNFPA and DHS facility-assessment instruments alongside a process of indicator harmonization between tools (Appendix 3). The intent of these coordinated efforts is to minimize duplication, ensure there is no additional assessment burden placed on countries, and make certain commodity-specific information is available across the full range of recommendations outlined in the UNCoLSC report. Initial efforts to introduce this approach have been successful in the original eight pathfinder countries, helping to inform priorities, national planning and budgeting alongside needs for technical assistance. A broadly representative Monitoring Advisory Group (Appendix 4) has been established as a peer-support mechanism to the SCT, to facilitate data sharing, and to optimize linkages with other ongoing harmonization efforts. Finally, efforts are ongoing to develop a simple dashboard and dedicated web-site for visualizing the information from the respective data sources to help track country progress and better target technical support from the TRTs (Figure 3). Figure 3: Commodity Tracking Dashboard


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Preliminary findings: A systematic assessment of the status of the commodities and recommendations was conducted across 6 pathfinder countries. Twelve national-level indicators and 12 commodity-specific indicators were identified to track key bottlenecks. Data was gathered from various sources (e.g. document review, facility assessments) to provide an ordinal categorization of progress for each indicator4. For comparisons across countries or indicator groups, a composite score was generated with a maximum score of 10.0 – with higher scores indicating better progress5. While all commodities require additional improvement, chlorhexidine, dispersible amoxicillin, and emergency contraceptives are displaying the lowest achievement across countries - lowest composite score (Figure 4). Since chlorhexidine is a new product, additional efforts were required to introduction and adaption of the product.

With respects to the UNCoLSC Recommendations that highlight key cross-commodity bottlenecks, mis-alignment of WHO guidelines with National EMLs, treatment guidelines and product registration was common in all countries (Figure 5). Supply chain challenges remained an issue for a wide range of commodities. Finally, where coverage levels were assessed, they remained relatively low.

Figure 4: UNCoLSC Commodity Composite Score (6 countries)

4 Ordinal categories: 0 = minimal or no progress (poor); 1= partial progress (moderate); 2 = established or completed (good) 5 Composite score: Score = [Sum of ‘Progress’ points (0, 1, or 2 per indicator)] / [Sum of eligible points (2 per eligible indicator)]. Maximum Composite Score = 10.0. Score excludes indicators with ‘no data available’ or ‘not applicable’.


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Figure 5: UNCoLSC Recommendation Composite Score (6 countries)

(3) Direct Country Support: National plans to increase access to RMNCH commodities and

services In October 2012, eight pathfinder countries convened in Abuja and mutually agreed to implement the UNCoLSC recommendations. All were sub-Saharan African, representing a diverse range of implementation challenges in achieving MDGs 4 and 5. In each country, teams were formed by the Ministries, the H4+ agencies and key partners, and concept notes were generated to implement the UNCoLSC recommendations. These concept notes were presented at a meeting of the eight countries and TRTs that took place in Dakar in July 2013 where a process of dialogue, feedback and refinement of the plans was initiated. Submissions were finalized and presented to the RMNCH Steering Committee in September 2013. These final submissions included log frames for the first year of the national plans, which identified activities, budget lines, the H4+ channeling agencies (who would receive resources from the Trust Fund on behalf of the country team) as well as implementing partners for each core activity (the government, H4+, NGOs, etc). A total of US$39 million was approved and an initial disbursement of approximately US$30 was made to countries between October and December 2013. Implementation is now beginning and first progress reports will be due in the second quarter of 2014. Table 2 summarises the approved budgets and disbursed amounts to each country in 2013, excluding the 7% overhead for the Direct Fund Recipients (UNFPA, WHO and UNICEF) and 1% fee for the Trust Fund (UNFPA).


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Table 2: Pathfinder country budgets and disbursements 2013

Country Year 1 Budget (US$)

Initial disbursement (October 2013)

Second disbursement (anticipated in 2014)

DRC 3,267,667 2,450,750 816,917

Ethiopia 3,343,046 2,805,805 537,242

Malawi 3,696,500 2,847,375 849,125

Nigeria 9,594,064 7,195,548 2,398,516 Senegal 5,130,017 4,131,512 998,505 Sierra Leone 4,672,000 3,516,500 1,155,500

Tanzania-Mainland 3,077,000 2,367,750 709,250 Tanzania-Zanzibar 701,000 638,250 62,750 Uganda 3,623,700 2,717,775 905,925

Grand Total 37,104,995 28,671,265 8,433,729

The techncical content of country plans aimed to address key commodity-related bottlenecks and

implementation gaps. The main cost-drivers were training/efforts to improve health worker

performance, advocacy/demand generation and supply chain management, with 10% of resources going

to purchase commodities – largely in Ethiopia and Senegal. Nearly all plans included harmonization and

alignment of national EML, treatment guidelines and training materials with latest recommendations

(Figure 6).

Figure 6: Budget split among 8 pathfinder countries by UNCoLSC Recommendation

Finally, while the inital round of support to countries focused on eight pathfinder countries and was focused on implementing the recommendations of the UNCoLSC, subsequent disbursements will be linked to a broader RMNCH Country Engagement Process, which is highlighted in Section V .

IV. Progress against the UNCoLSC recommendations A set of proposed activities and time-bound milestones against each of the 10 UNCoLSC recommendations were outlined in the 2012 report and accompanying Implementation Plan. These were further refined by the TRTs based on feasibility and relevance as insights from global and country-level experience was gained. A final revised list was submitted to the iERG in December 2013 which will form the basis of the progress below.

Regulation 7%

Quality 1%

Innovative financing 2%

Local market shaping 2%


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The sources of data for these metrics are variable and correspond to the workplans outlined in the logical frameworks for each TRTWork done by the TRTs supporting the 13 commodities has been integrated into the reporting of cross-cutting recommendations below. Illustrative case studies will also be profiled. As most activities pertain to addressing global bottlenecks, most progress gains outlined below have wider application across the full range of EWEC countries. 6

Please note: While some of the TRTs’ deliverables were developed specifically for the UN Commission on

Life-Saving Commodities, others were building on, or expanding already ongoing work in order to avoid

duplication of tasks and to streamline the TRTs’ efforts. Not all deliverable are available on-line yet but

we are following-up with all TRTs to that effect.

Recommendation 1: Shaping Global Markets

By 2013, effective global mechanisms such as pooled procurement and aggregated demand are in place to increase the availability of quality, life-saving commodities at an optimal price and volume

Activities Milestones Status Identify priority commodities amenable to immediate, global market-shaping efforts and analyse markets to identify the most effective global market-shaping mechanism for the prioritized commodities

Apply proposed market-shaping mechanisms to selected commodities Establish mechanism for consolidating market data & forecasts at the global level across all 13 essential commodities

Negotiate price reduction with at least one manufacturer of contraceptive implants, if appropriate pricing and volume terms can be agreed upon (2014-2015).

Completed: Price reductions were negotiated with both SRA-approved/WHO-prequalified implant manufacturers (Bayer and MSD) for approximately 50%

Aligning the market data collection efforts being undertaken by various groups (including CHA I, USAID, WHO, and the commodity TRTs) and consolidating this data in a web-based portal

Completed: Market data collection, supplier mapping, and barrier-to-access assessments have been aligned and have informed the prioritization of products for forthcoming global market shaping interventions. Key priorities include: (1) aggregating demand for oxytocin and misoprostol to incentivize purchase of WHO-prequalified, SRA-approved, or ERP category 1/2 uterotonics; (2) assessing price reduction opportunities for resuscitation devices; (3) accelerating development of heat-stable, easier-to-administer oxytocin formulations. Additional market data collection will also be prioritized to determine if other global market shaping priorities exist within the RMNCH space and to refine demand forecasts to support potential interventions.

Evaluate the increase in availability and affordability of contraceptive implants (2014).

Completed Public and private sector partners worked together to halve the price of contraceptive implants, including Bayer’s Jadelle and MSD’s Implanon and Implanon NXT, over the next six years. Deals are expected to dramatically expand availability and affordability, generate substantial procurement savings, and contribute to reductions in infant and maternal deaths as well as unintended pregnancies. Monitoring efforts are underway.

Working with the commodity TRTs and other groups engaged in generating demand forecasts to consolidate this information at the global-level

Partial: Needs-based forecast algorithms have been developed for all commodities. Demand forecasts have been initiated for prioritized commodities with further refinement to occur, once additional market data has been collected and analysed.

6 Key deliverables completed can be accessed by following this link.

(https://drive.google.com/folderview?id=0BxajLIcWD1kKV2ZoTGp3TFBoWGs&usp=sharing)

https://drive.google.com/folderview?id=0BxajLIcWD1kKV2ZoTGp3TFBoWGs&usp=sharing


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Overview: Market inefficiencies often create barriers to access for health commodities in developing countries. Some key marketplace issues – such as high price/low volume traps, limited demand visibility, demand fragmentation, limited supply base, and suboptimal product design – can be mitigated by global market shaping interventions, if certain parameters are met. The Global Market Shaping TRT was convened to assess whether global market shaping interventions could reduce some of the key barriers to access for the life-saving commodities prioritized by the UN Commission. As certain market characteristics are required to facilitate global market shaping interventions and as these interventions are only able to address some barriers to access, not all products prioritized by the UN Commission are likely to benefit from global market shaping interventions in the near-term. Therefore, the TRT was intended to collect sufficient market data and information to prioritize those commodities for which global market shaping interventions could be feasible and productive in the near-term, and to subsequently structure appropriate interventions for the prioritized commodities. Deliverables completed:

50% price reduction agreements with two manufacturers for implantable contraceptives

Needs-based forecasting algorithms have been developed for all 13 life saving commodities.

[Please note that not all of them are available online yet.]

Case Study 3: Price reductions and procurement guarantees for implantable contraceptives

At the landmark London Summit on Family Planning in 2012, global leaders committed to provide an additional 120 million women and girls in the world’s poorest countries with access to modern contraceptives and family planning information and services by 2020. It is estimated this could result in 110 million fewer unintended pregnancies, 200,000 fewer women dying in pregnancy and childbirth, and nearly three million fewer babies dying in their first year of life. Traditionally, access to long-acting reversible contraceptive methods (LARCs), including implants, has been limited in developing countries, despite high demand – particularly among women in areas where access to health clinics is limited and stock outs are common. In fact, while only 1 to 2% of women using modern contraception in developing countries use implants, a significantly greater proportion would choose this method if it were consistently available and supported by counseling and clinical services. Recognizing this gap, a group of organizations worked together in 2013 to help make contraceptive implants accessible to women around the world. Through this program, both Bayer Health Care and MSD (known as Merck in the U.S.) agreed to reduce the price of their respective contraceptive implants – Jadelle (Bayer) and Implanon and Implanon NXT (MSD) – by approximately 50% over the next six years in the world’s poorest countries. The price reductions have helped dramatically increase the global availability and affordability of implants. In 2013, 7.3 million implants were delivered in the world’s poorest countries – approximately 50% increase from 2012. Procuring implants at a 50% price reduction led to more than $60 million in savings for donors and developing country governments. Additionally, suppliers were able to produce a greater supply of implants globally than would have been available prior to the pricing agreements. In 2013, the top 10 implant procuring countries were: Ethiopia, Kenya, Uganda, Tanzania, Bangladesh, Nigeria, Burkina Faso, Zimbabwe, Madagascar, and Malawi. To help ensure access, JHPIEGO has developed a standard curriculum on implants for inclusion in existing health worker training programs. They are also working to reduce supply chain disruptions, increase the quality of service delivery and improve demand forecasting at the national level. Beyond Bayer and MSD, the organizations involved in this multisectoral program include: Bill & Melinda Gates Foundation; the governments of the United States, United Kingdom, Norway and Sweden; the Clinton Health Access Initiative; the Children’s Investment Fund Foundation; the UN Population Fund; John Snow, Inc.; Jhpiego and EngenderHealth.

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Recommendation 2: Shaping Local Delivery Markets

By 2014, local health providers and private sector actors in all EWEC countries are incentivized to increase production, distribution and appropriate promotion of the 13 commodities

Activities Milestones Status Create incentives for national and regional wholesalers and large distributors to actively promote commodities over sub-optimal alternative treatments and to accelerate distribution through private channels

Perform WHO-supported global or regional joint regulatory reviews of safety for national approval of low-level and OTC use

Develop toolkits for a portfolio of interventions to engage private sector suppliers (manufacturers and distributors) to produce, distribute, and promotion appropriate products. (early 2014)

Completed: Detailed assessments conducted across 4 countries (Nigeria, Kenya, Tanzania, Malawi) to identify local market gaps and strategies to address them Market Shaping Primer developed and near completion

Identify appropriate supply interventions and begin implementing select supply side interventions for relevant life-saving commodities in targeted countries (2013)

Completed: Developed a summary of (or high-level) local market shaping strategies for roll out of Chlorhexidine and Amoxicillin DT in Nigeria (signed Apr 2014 by MoH); The strategy document will be shaped in collaboration with the chlorhexidine commodity group. Discussions with Governments continue, with Newborn Resuscitation commodities promising

Expand implementation of supply interventions and supply side communication to regional initiatives. (such as pooled procurement and local manufacturer engagement (2014)

Completed: Engagement commenced with East African Community to design market shaping initiatives to strengthen the East African pharmaceutical industry’s competitive position and market share; Other Regions (ECOWAS, SADC) at an earlier stage of development.

Overview: The lack of consistent supplies of quality assured, WHO recommended formulations of RMNCH commodities has represented a major bottleneck to accelerating access. In many instances, the commodities that are procured are not the WHO recommended formulations and/or are not of internationally recognized quality. Where high-quality optimal commodities are available, they are often priced at levels which are uncompetitive compared to sub-standard products and manufactured by producers who have not invested in ensuring minimum quality standards. The Local Market Shaping TRT addresses these local market failures (or 'market trap') particularly in situations where the local private sector comes into play. It may only therefore be relevant for a subset of commodities. Deliverables completed:

Market Shaping Primer: Intended to provide actionable frameworks and a portfolio of private sector interventions designed to help stakeholders design and monitor market shaping interventions in global health markets and increase access to life saving commodities

Applications and Outcomes of the CHAI conducted RMNCH Assessments: Detailed in-country commodity assessments performed in Nigeria, Malawi, Tanzania and Kenya in order to identify specific local market bottlenecks, thus providing an initial framework and approach towards assessments in further countries and directly feeding into strategic planning at a country level

Summary of Nigeria’s Local Market Shaping Strategy for chlorhexidine gel

Summary of Nigeria’s Local Market Shaping Strategy for amoxicillin dispersible tablets

Increasing Commodity Access by Shaping Local Markets at Regional and National Levels:

Regional market shaping efforts conducted with the East African Community (EAC) designed to

https://drive.google.com/file/d/0BxPKPKVkccHwakNZalF1Ri0xZkk/edit?usp=sharing

https://drive.google.com/file/d/0BxPKPKVkccHwVWJVNWFLRDZzQkk/edit?usp=sharing

https://drive.google.com/file/d/0BxPKPKVkccHwVWJVNWFLRDZzQkk/edit?usp=sharing

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strengthen the EAC pharmaceutical industry’s competitive position and market share of the

health pharmaceutical market, while increasing access to high quality, affordable maternal and

child health commodities and essential medicines

Financing Diarrhea and Pneumonia Treatment Gaps: Summary of key financing opportunities for

implementing national scale-up plans for child essential medicines in 10 high burden countries,

prepared by country Lead Partners identified by the Child Health TRT who are responsible for

driving initial implementation, resource mobilization and partner coordination efforts.

Case Study 4: Shaping local markets for ORS and Zinc in Nigeria

Each year, diarrhea kills almost 100,000 children in Nigeria. Zinc and oral rehydration salts (ORS) represent one of the most cost-effective solutions for reducing child deaths; yet, less than 1% of children in the country are receiving the full recommended treatment. Treatment access is impeded by failures in the local market—low demand for the recommended treatment discourages local suppliers from investing in zinc and ORS promotion and production, leading to unaffordable products and limited availability.

In 2012, the Government of Nigeria launched the National Essential Childhood Medicines Scale-up Plan, which outlines a concrete plan for addressing these local market barriers. The plan aligns with the recommendations of the UN Commission on Life-Saving Commodities for Women and Children. If the plan’s scale-up target of 80% for zinc and ORS are achieved, there is potential to save over 200,000 lives over the next 4 years. To date, the Government and key partners have laid a strong foundation for scale-up:

Created an enabling environment for implementation: The National Primary Health Care Development Agency (NPHCDA) and FMOH established the National Essential Medicines Coordination Mechanism composed of over 15 implementing partners to coordinate implementation of scale-up activities. To date, over US $30 million in new funding has been mobilized for scale-up in the country, including support from the RMNCH Trust Fund (USD 10 million). Key regulatory barriers have also been addressed. In particular, the National Agency for Food and Drug Administration and Control confirmed zinc and ORS as over-the-counter (OTC) products allowing the products to be widely distributed to all retail outlets in the country. The Pharmacists’ Council of Nigeria also added zinc to the list of approved medications for Proprietary Patent Medicine Vendors. Developed a reliable supply base: With strong support from the Clinton Health Access Initiative, key partners engaged with local manufacturers through supplier forums and by providing market intelligence and assistance to expedite registration and introduction of new, affordable, and high-quality zinc and ORS products. There are now 3 zinc and 4 low-osmolarity ORS products available on Nigeria’s market -compared to none at the start of the program. By building a more competitive market for ORS and zinc, wholesale prices for the combined treatment has dropped by ~60%. Partners are now working with manufacturers to expand distribution into hard-to-reach markets and to ensure affordable pricing is maintained at the retail level.

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Recommendation 3: Innovative Financing

By the end of 2013, innovative, results-based financing is in place to rapidly increase access to the 13 commodities by those most in need and foster innovation

Activities Milestones Status Review the use of the results-based financing mechanism to improve access to the 13 commodities; solicit country interest and applications for results-based financing and enter into agreements with relevant countries Ensure linkages between the results-based financing mechanism and funding mechanisms identified for the procurement of commodities and work with the private sector Include commodities in various monitoring systems; develop and use simple scorecard on access; link to other accountability recommendations

Agree on the host of a result-based funding mechanism for life-saving commodities (2012).

Completed: In late 2012, it was agreed that UNFPA would host the RMNCH Trust Fund.

At least 10 EWEC countries enter into an agreement with the funding mechanism to increase access to the life-saving commodities (2013).

Partial: In September 2013, 8 countries submitted national plans to increase access to life-saving commodities and services. A total of US$38m was approved across these 8 countries for catalytic, one-year investments.

Guidance developed for countries to implement in-country RBF-approaches to strengthen access to life-saving commodities at all levels (2014)

Partial: An extensive amount of guidance has been developed by the World Bank as well as other partners (RBF Community of Practice) on implementing RBF approaches. These are most often aimed at primary and secondary health care services and RMNCH in particular and target increasing the coverage and quality of critical services, including commodities. Based on lessons learnt, work is on-going to develop more specific guidance on the commodity aspect within RBF approaches.

Overview: Health services in the public sector often struggle with poor supervision, the lack of use of data for decision making, and the absence of performance-based incentives. Results-Based Financing (RBF) is an approach that provides additional financing to frontline health workers and facilities on the basis of verifiable results. The approach has evolved over the past decade and several robust impact evaluations and a large amount of independently verified operational data show that RBF has strengthened accountability, empowered frontline providers, achieved remarkable results working in countries of greatest need, such as Rwanda, Nigeria, Zimbabwe, and Afghanistan. The primary source of funding for such programs is the Health Results Innovation Trust Fund (HRITF), which targets MDGs 4 & 5 specifically. While performance against documented improvements in maternal and child health services has been central, a number of programs specifically monitor stock-levels and delivery of the 13 life-saving commodities. Some 30 countries are currently implementing RBF approaches, mainly still as pilots. However, an increasing number of countries are now scaleing up – expanding geographies and/or scope. While most programs still target front-line facilities and providers, there are innovative efforts to reward more upstream results, such as the district health management teams or supply-chain intermediaries. Finally, the RMNCH Trust has provided catalytic support in complementary ways to the HRITF. As outlined above (Table 2) the Trust Fund has financed specific gaps and priorities to strengthen health systems and increase access to commodities. This allows RBF-schemes to be even more impactful. In addition, in both Tanzania and Sierra Leone Trust Fund support is being used in part to further expand the on-going RBF programs to ensure the commodity perspective is more explicitly taken into account.


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Deliverables completed:

Scaling-Up Results-Based Financing for Maternal and Child Health, World Bank, 2014, Draft for consultation

Impact Evaluation Toolkit: Measuring the Impact of Results-Based Financing on Maternal and Child Health, 2012

Recommendation 4: Quality Strengthening

By 2015, at least three manufacturers per commodity are manufacturing and marketing quality-certified and affordable products

Activities Milestones Status The risk and nature of quality gaps of 5 lifesaving commodities are quantified Quality testing includes updates to useable monographs where missing Technical assistance is provided to at least 3 manufacturers of life-saving commodities

ERP for dispersible amoxicillin (2012).

Completed: The finalized ERP facilitated procurement through UNICEF, which makes the product available for EWEC countries

Development of optimal quality assurance for zinc (e.g., market surveillance approach, ERP) (2012).

Completed: Substantial assistance was provided to manufacturers as a means of strengthening quality production of zinc, along with a number of other LSCs

ERP for chlorhexidine (2013). Achieved through alternate means: To avoid precedent for an unrealistic regulatory pathway, CHX was procured and distributed using a quality assurance approach more suitable for antiseptics.

Overview: The quality of pharmaceutical products unfortunately remains a serious issue in many settings. WHO prequalification is mechanism to ensure quality by evaluating the quality, safety and efficacy of products, based on information submitted by the manufacturers and inspection of the corresponding manufacturing and clinical sites. When medicines prequalified by WHO are not available, either because they are too new to the market (such as Dispersible Amoxicillin (Amoxicillin DT)) or because there is no available prequalified source, procurers will still need to find a way to provide needed medicines. The Expert Review Panel (ERP process) was developed as a rapid assesment for products pending prequalifcation to provide a means to evaluate quality of certain medicines in their procurement transactions on a case by case basis. The Quality Strengthening TRT is led by WHO. In the first year post UNCoLSC, an ERP process was developed for Amoxicillin DT and procurers invited manufacturers to submit product dossiers for consideration. A total of 25 dossiers were reviewed. This facilitated the procurement and introduction of Amoxicillin DT through procurement initiated by UNICEF, making the product available to all EWEC countries. In the case of Zinc, WHO provided technical assistance to manufacturers in Nigeria, Zimbabwe, and Kenya, which all supply product to Pathfinder countries. A similar process is underway for magnesium sulfate and oxytocin to ensure quality product. For misoprostol, technical assistance had been provided to five manufacturers to enhance API quality. In addition, a quality survey was undertaken to identify risks and real problems with the LSCs in 10 EWEC countries. This included product surveillance among central medical stores, NGO stores and distribution warehouses. Preliminary information that the quality of most LSCs was acceptable, with the exception of oxytocin, where the sufficiency of the active pharmaceutical ingredient (API) was below recommended levels. Finally, a survey of procurement agencies was conducted to document the regulatory and procurement status of the LSCs in EWEC countries, to better understand the country and principal manufacturers of LSCs. Preliminary findings demonstrate that while many of the LSCs showed registrations of between 10-


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20 different manufacturers across 22 responding countries, the antibiotic class included over 400 registered manufacturers. There were an encouraging numbers of manufacturers of Amoxicillin DT, but relatively few for chlorhexidine 4% and pediatric formulations of IV antibiotics. Deliverables completed:

A dossier of Essential Medicines Lists from 65 countries is being compiled. The Essential Medicines Lists from 11 countries are available here.

A detailed mapping survey from national procurement agencies was conducted to assess country and manufacturer of origin for all LSCs

ERP completed for Amoxicillin DT; Dossier submitted for ERP and pre-qualification for Magnesium sulfate and oxytocin.

A manufacturer in Nigeria (Swipha), a producer of misoprostol with capacity to produce supplements such as zinc as well as anti-infective products, recently achieved cGMP certification, the first in West Africa. Three additional manufactures of LSCs that are expected to reach GMP certification by the end of 2014

Technical support for quality improvement has been provided to manufacturers in 5 countries (Zimbabwe, Nigeria, Kenya, Pakistan, Indonesia) who are major manufacturers of 4 LSCs including Oxytocin, ORS, Magnesium Sulfate and Amoxicillin DT

A 10 country quality survey of LSCs

Recommendation 5: Regulatory Efficiency

By 2015, all EWEC countries have standardized and streamlined their registration requirements and assessment processes for the 13 live-saving commodities with support from stringent regulatory authorities, the WHO and regional

collaboration

Activities Milestones Status Evidence is developed, submitted, and reviewed for the EML Expert Committee for missing lifesaving commodities Joint inspections or dossier reviews are implemented for at least 3 lifesaving commodities Regulators in pathfinder countries agree on a common pathway for at least 5 lifesaving commodities

WHO-EML includes all 13 life-saving commodities (2013).

Completed: All EWEC countries have access to the WHO EML and revised lists were disseminated to all country offices. This further facilitates the work of other actors in the RMNCH space to support countries implementing local policy change and promoting procurement and access to the commodities.

Joint inspections or dossier reviews are implemented for at least 3 LSC (2013).

Partial: Three joint dossier review have been held in the East African Community for misoprostol and levonorgestrel submissions. Additional products would have been included; however, the reviews are dependent on submissions. In addition, 2 joint inspections have been conducted. WHO scheduled 4 joint inspections in collaboration with countries and manufacturers; however, countries have rescheduled 2 of the inspections to later in 2014.

Regulators in pathfinder countries agree on a common pathway for at least 5 lifesaving commodities.

Completed: The PMRN meeting created consensus and a process for paediatric products including zinc, ORS, Chlorhexidine, and Amoxicillin DT. The fast track approach provides an option for all of the LSCs, with RH products already on country markets after using the process.

Overview: Regulatory systems are designed to ensure that products on national markets are safe, effective and of appropriate quality. In addition to regulation, the recommendation also notes a number of important policy activities that must work in concert with regulatory affairs to move a LSC onto a local market. Policy activities include inclusion on the WHO Model List of Essential Medicines (EML) as well as

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https://docs.google.com/document/d/1n2V_KOu_3Chy14YEM6BA6LweNX3GBsOY-fNfnVbiwnw/edit?usp=sharing

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in treatment guidelines. These policy recommendations have to be translated to the National EMLs. Ministries work with national professional bodies to update and ensure availability of treatment guidelines on the appropriate use of products. Commodities on the National EML are eligible for public procurement. To move into procurement and distribution, however, a manufacturer still needs to obtain market authorization from the National Medicines Regulatory Authority (NMRA) of the country. This process of registration and authorization is unique to each country, usually requiring manufacturers to submit multiple different product dossiers for each country market and accommodate inspections of their manufacturing facility. This process can be slow and expensive, posing a particular risk for the LSCs, which are mostly generic products with relatively low profit margins. Preliminary analysis from pathfinder countries suggests that in all countries, significant misalignment exists between the WHO EML, National EMLs, Treatment Guidelines, LSCs registered with the regulatory authority, and which products were availabile in the country through public or private procurement, those with import wavers, and donated commodities. Better alignment of these processes is a critical first step in ensuring availability of LSCs. Furthermore, measures to coordinate and harmonize processes between countries and accelerate procedures for LSCs can further reduce regulatory bottlenecks. In the first year of activities, the Regulatory Efficiency TRT which is led by WHO took a number of steps to address regulatory hurdles for LSCs. These included steps to ensure all LSCs were on the WHO EML – including chlorhexidine and antenatal steroids for prematurity. WHO also conducted workshops in Ghana to support updates to national EMLs, though more work needs to be done here. Multiple treatment guidelines including the management of pre-term children were updated and disseminated. The TRT also initiated a fast track approach that NMRAs can use to accelerate registration for products that have already been prequalified by the WHO. To date 15 countries in sub-Saharan Africa have signed agreements to participate in the collaborative registration program, including 4 Pathfinder countries: Ethiopia, Nigeria, Tanzania and Uganda. Two reproductive health products have been received local market authorization (along with 9 antiretrovirals). Finally, WHO hosted the Paediatric Medicine Regulators Network to review options for accelerating the registration of products that may not have WHO prequalification status. Agreement on development of common dossiers and expressions of interest, as well as strong agreement on accepting variations for over the counter status for Zinc and ORS were among the outcomes. Finally, WHO also finalized specifications of newborn resuscitation devices, including resuscitators. Deliverables completed:

All LSCs are now listed on the WHO EML, including cholrhexidine and antenatal corticosteroids : www.who.int/selection_medicines/committees/expert/19/en/ www.who.int/medicines/publications/essentialmedicines/en/

The Pocket Handbook on Hospital Care for Children

Fast track registration process for pre-qualified products

http://www.who.int/selection_medicines/committees/expert/19/en/

http://www.who.int/selection_medicines/committees/expert/19/en/

http://www.who.int/medicines/publications/essentialmedicines/en/

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Case Study 5: Revising the WHO Essential Medicines List (EML) The EML is the basis for guiding national reimbursement schemes, procurement, supply and other health systems. Not all of the life-saving commodities specified by the UN Commission, notably chlorhexidine and antenatal steroids, were included on the EML. Without this, countries lacked important leverage in promoting access to all of the life-saving commodities. To resolve this, WHO undertook an extensive and evidence-based expert review process for these medicines, which led to their full inclusion in the 2013 EML. This is being followed by support to countries to adapt National EMLs. While inclusion in the National EML can faciliate procurement and availabilty on local markets, there are important secondary effects. For example, when multiple countries adopt the WHO EML standards, this can help to consolidate demand around a particular specification. This does not lead to sole source situations, but rather, creates a situation where the market is less fragmented and costs of market entry are reduced.

Recommendation 6: Supply and Awareness

Conduct country assessments and landscaping activities to identify key barriers and challenges to effective supply chains

Activities Milestones Status

Gather and share Supply Chain Challenges, best practices and lessons learned across countries and partners Develop common tools, guidance and approaches that can be leveraged by countries in addressing their supply chain challenges including SC Design, ICT solutions and engagement of private sector Establish indicators to monitor regional, country level data around SC Management to improve SC performance

Briefs/guidance and /or reference documents published on the following topics: Supply chain barriers; country-led best and promising practices in end-to-end supply chain management; supply chain indicators; Use of SC ICT solutions, including LMIS/HMIS integration; Recommendations for inclusion of RMNCH supplies into the work of National Commodity Security Committees; and Integration of Vertical Supply Chains (2013)

Partial: Guidance documents are complete or in the final stages of editing, with a full description below.

Quantification and forecasting guidance for all LSC available to countries(including harmonized definitions of forecasting and quantification and forecasting algorithms) (2013)

Completed: Described below

Toolkit for private sector engagement in supply chain functions available (2013)


Commodity-related functionality for an open source LMIS system (LMIS 1.0) developed, and pilot integration with HMIS in at least one country (2014)


Overview: Despite substantial efforts and resources over the past decades, supply chain managment remains an intractable challenge in many low income countries, creating major barriers to accelerating access to live saving commodities. In this initial phase, the Supply Chain TRT brought together a wide consortium of experts to synthesize existing tools and lessons where relevant, provide clear needs based forecasting algorithms for 13 life saving commodities, develop and deploy novel innovations ICT applications to generate real-time metrics on facility stock levels. Deliverables completed:

Supply chain barriers guidance document: Drawing from the experience of eight pathfinder countries, this synthesis draws together experience of supply chain challenges and options for addressing them

Supply chain best practice systematic review: systematic review of existing “best practice” interventions with proven outcomes in improving health commodity supply chains in low and middle income countries, followed by an extensive review of relevant sources – including grey literature, project evaluations, interviews, case studies, and lessons learned.

Supply chain indicators: A list of recommended supply chain and related performance indicators

for monitoring and improving the availability of key RMNCH commodities, related to barriers to


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availability of these commodities. A detailed reference document includes the definition,

formula, purpose, data sources, and data requirements for each indicator.

Inventory of 46 ICT tools for supply chain management of the 13 essential commodities and a guide developed to assist countries in selecting appropriate ICT solutions from the range of options, based upon approaches that have been already implemented in different countries. A guidance document on HMIS and LMIS data based on the limited country-level experience has been produced and will be ready for dissemination in the second quarter of 2014.

Recommendations for inclusion of RMNCH supplies into the work of National Commodity

Security Committees: At the country level, supply coordination committees help maintain a

focus on product availability issues, strengthen coordination between a broad range of

stakeholders, and reduce duplication and inefficiencies between similar initiatives. A toolkit has

been developed that provides clear guidance on how to establish, effectively operationalize, or

expand existing commodity coordination mechanisms to address critical MNCH products. This

document is near completion.

Integration of Vertical Supply Chains: A guidance document on successful supply chain

integration and guidance on how to consider integration opportunities for UN Commission

commodities to help improve product availability. Case studies for Tanzania, Nigeria, and

Sudan, as well as a guidance document are in final editing stages.

Quantification and Forecasting Guidance Document: To improve the forecasting capacity of national level program managers for the 13 UNCOLSC products, a guidance document was developed to assist countries when consumption and services data are unavailable.

Private Sector Engagement (PSE) Toolkit: The guidance toolkit was developed and piloted in Nigeria, when the government began to scope the feasibility of using private sector warehousing for MNCH commodities to address the challenges around ensuring adequate quality storage for the increased volumes of commodities.

Information Communications Technology (ICT) systems: o Commodity-related functionality for an open source LMIS system (OpenLMIS 1.0): An

enhancement of the OpenLMIS system has been designed as a collaborative project to design, develop, and share software, tools and methodologies, from which state-of-the-art, internet-enabled electronic Logistic Managment Information Systems (LMIS) can be customized for local deployments across low-income countries. The produce, OpenLMIS V1.0 Global, is ready for customization and deployment at the country level. Deployments of these systems in Tanzania and Zambia has been very positive.

o Pilot integration with HMIS in at least one country: A “basic LMIS package” has been

develpoed for DHIS 2 (a widely used electronic Health Management Information System (HMIS)) to support stock management at the health facility level. The focus of this package is to make the data available, visible and easily accessible, to improve the data quality, and to inform decision-making on logistics management, especially commodity distribution. The LMIS extension in DHIS2 is being developed and piloted in Benue State, Nigeria, where nearly all facilities have been reporting monthly stock out data.

http://www.everywomaneverychild.org/images/ICT_Solutions_Inventory_FINAL_1.pdf

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Case Study 6: Strategies to Improve Quantification for Life saving commodities The success of key interventions for maternal and child, and reproductive health depends upon the continuous availability of essential medicines and medical supplies both at the health facility and community levels. One of the main barriers to availability that was identified is poor forecasting and supply planning, or quantification in large part to a lack of reliable data. Where routine information systems are weak, or non-existent, many countries simply base forecasting on previous procurements. The thirteen priority commodities of the UNCoLSC present additional data challenges. Some, such as chlorhexidine gel, are new products or new formulations that are in the process of being introduced at scale. Others, such as magnesium sulfate, are products that have been in use for many years but are under-used or often not available when needed. A quantification guidance package developed by the Supply Chain technical resource team, under USAID’s leadership, will allow country programs to gain a better understanding of the quantities of essential products needed in-country. The guidance package includes forecasting algorithms for each of the 13 commodities describing special considerations to take into account when undertaking quantification. At the national level, this information is also essential for budgeting, resource mobilization, and procurement planning. At the global level, this information can inform both donors’ plans for procurement and manufacturers’ plans for production.

Recommendation 7: Demand and Utilization

By 2014, all EWEC countries in conjunction with the private sector and civil society have developed plans to implement at scale appropriate interventions to increase demand for and utilization of health services and products, particularly among

under-served populations

Activities Milestones Status Review and collate evidence of supply- and commodity-related communications including those that combine social and behavioral change communication (SBCC) and commercialization, social networking, franchising and marketing Establish innovative PPPs to address SBCC needs and develop materials and messages for the 13 commodities to enhance consumer and provider demand through high-impact marketing and promotion, including private sector providers Support government agencies in EWEC countries to establish a sustainability roadmap and build capacity to develop, monitor and sustain SBCC and mass-media activities

Global demand generation Implementation Kit developed with adaptable communication strategies for at least 9 priority commodities (2013)


Country-specific communication strategies developed in at least two pathfinder countries that incorporate life-saving commodities from at least one health area (e.g. family planning) (2014)

Partial: Plans are underway to support Uganda’s country plan to develop a communication strategy for family planning based on the demand generation tools developed by the global TRT. An updated communication strategy for demand generation will also be developed in DRC in 2014.

Demand generation programs implemented in at least 4 pathfinder countries that incorporate life-saving commodities from at least one health area (e.g. family planning) (2014)

Partial: Pathfinder countries have begun to plan for demand generation programs in the roll-out of their activities. The global TRT is also planning support to 3-5 countries to design communication strategies and implement demand generation programs for a sub-set of priority commodities.

Overview: Demand generation, or the process of creating a need, or belief in the need for a health product or service among a particular target audience, is a persistent weakness across all priority commodities. Low demand among both providers and end-users is a significant factor in low utilization of the 13 commodities. However, few tools exist to guide demand generation efforts for these specific commodities. The Demand Generation TRT therefore created a comprehensive online Demand Generation Implementation Kit for Underutilized Commodities in RMNCH (I-Kit). The I-Kit includes an evidence review, communication strategies for 9 commodities, and cross-cutting tools in gender, ICTs and new media and

http://sbccimplementationkits.org/demandrmnch/



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public-private partnerships, all packaged with clear guidance and links to additional tools, resources and project examples. By using the I-Kit, country teams can fast-track implementation of demand generation interventions in order to accelerate progress towards MDGs 4 and 5. Deliverables completed:

Demand Generation Implementation Kit for Life-Saving Commodities (described above): The web-based I-Kit has been finalized, with supplementary materials completed, undergoing final editing and translation into French, as follows:

o Illustrative adaptable communication strategies for 8 priority commodities o Demand Generation for 13 Life-Saving Commodities: A Synthesis of Evidence o 10 "Spotlight" briefs summarizing the evidence review covering all 13 commodities o Evidence Frameworks for 13 Commodities o Conducting a national assessment on demand generation for under-utilized, life-saving

commodities: Guidance and Tools o Demand assessments & stakeholder workshop in 2-3 pathfinder countries (1 complete; 1

planned) o Addressing the Role of Gender in the Demand for RMNCH Commodities: A Programming

Guide o A Theory-Based Framework for Media Selection in Demand Generation Program o Utilizing ICT in Demand Generation for RMNCH: Three Case Studies and Recommendations

Healthcare provider resources for zinc and ORS, which are free to use and locally adaptable for

targeting skilled and frontline healthcare workers, community leaders, and caregivers. Materials

are available at www.zinc-ORS.org

Recommendation 8: Reaching Women and Children (Financial Access)

By 2014, all EWEC countries are addressing financial barriers to ensure the poorest members of society have access to the life-saving commodities

Activities Milestones Status Apply a commodity-lens to existing work on financial barriers and the WHO's work on universal access, and ensure that commodities are appropriately included in global and national financial protection mechanisms (e.g., conditional cash transfers) Assist EWEC countries in establishing financial mechanisms to ensure equitable access to commodities by the poorest segments of society

Eight EWEC countries have financial protection programmes with a commodity focus (2013)

Not commenced

Evaluate the increase in use of (a sub-set of) life-saving commodities in concerned countries (2014)

Not commenced

Overview: In many settings, despite RMNCH commodities and related services being available at the point-of-service, formal and informal financial barriers remain an obstacle that limits access to life-saving commodities when in need. Progress: In the first year of the UNCoLSC, the financial access TRT was slow to take shape. An initial workplan was not provided to the RMNCH SCT until September 2013 - just prior to a substantial re-organization and convergence of the TRTs that was underway. It was decided that a re-thinking of this TRT should take shape alongside the year 2 workplan process for the TRTs.


https://drive.google.com/folderview?id=0BxajLIcWD1kKTVNLZE1YSVBmcGs&usp=sharing

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https://drive.google.com/file/d/0BxajLIcWD1kKWHE2b0dNajI1ajg/edit?usp=sharing

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https://drive.google.com/folderview?id=0BxajLIcWD1kKLXlkVW1yeDB1a28&usp=sharing

https://drive.google.com/folderview?id=0BxajLIcWD1kKWTVUQnVELVJlUDA&usp=sharing

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https://drive.google.com/file/d/0BxajLIcWD1kKcWZfc3hHMjVmUkE/edit?usp=sharing

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https://drive.google.com/file/d/0BxajLIcWD1kKakRQZDRVb0lXdXM/edit?usp=sharing

https://drive.google.com/file/d/0BxajLIcWD1kKakRQZDRVb0lXdXM/edit?usp=sharing

https://drive.google.com/file/d/0BxajLIcWD1kKVVNTZ3k5eUEwWlU/edit?usp=sharing

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Initial discussions with a newly configured group have taken place, with a number of proposed work plan activities including:

A synthesis of global experience approaches, policies, and materials used by countries and organizations around the world to mitigate financial barriers

For select countries where there is interest in improving financial access to life-saving commodities, the application of this learning to inform country-specific strategies

Recommendation 9: Performance and Accountability

By end 2013, all EWEC countries have proven mechanisms such as checklists in place to ensure that health-care providers are knowledgeable about the latest national guidelines

Activities Milestones Status

Support EWEC countries to develop and adapt national clinical guidelines to reflect international guidance on the use of the 13 commodities Develop and use national checklists, job aids, training programs and supervision structures to promote and monitor the use of clinical guidelines by public and private providers Strengthen EWEC country accountability mechanisms to monitor scale-up and use of the 13 commodities, including improved regulation and oversight of the private sector and mechanisms for community-level monitoring and feedback around service provision, availability and affordability

The status of national availability and use of the 13 commodities and available guidelines (including m-applications) in 8 pathfinder countries for their use have been analyzed (by March 2014).

Completed

Development of generic checklists for implants and safe birth, including use of MgSO4, has begun (by December 2013).

Partial: Work on these is ongoing though consultation with the various professional associations and technical experts

Training and scalable strategies for checklist use including e- and m-learning have been developed and deployed (by March 2014).

Partial: M health global assessment and Tanzania case study completed

Feasibility assessments on the use of social audits to improve accountability have been carried out in 10 countries (by December 2014).

Not commenced: Priority for year 2 work plan

Overview: Effective utilization of the 13 life-saving commodities is hampered by several factors related to the health worker performance including not being up-to-date with the latest guidelines and protocols, the lack of training materials that reflect recent policy shifts, and absent job aids and check-lists to facilitate best-practice at the health facility level. In some cases health care workers are also faced with policies and guidelines restricting them from prescribing and administering life-saving commodities at the appropriate level of care. During the initial year, the Performance and Accountability TRT has carried out a review and synthesis of available guidelines and health worker support tools in 6 pathfinder countries (Uganda, Senegal, Tanzania, Ethiopia, Sierra Leone, Malawi) as well as generic tools developed by WHO, and a global inventory of e and m-Health applications that could be used to support health worker performance. Based on these findings, the development a kit of generic high-quality, adaptable guidelines, checklist and job aids for all 13 commodities has commenced. These will be completed in 2014 with dissemination to groups of EWEC countries using all opportunities and possible channels/organizations.


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Report of desk analysis on the availability, content, appropriateness, usability and gaps in the existing tools, guidelines and job aids for Health workers supporting use of the 13 Lifesaving Commodities in Malawi, Tanzania, Uganda, Ethiopia, Sierra Leone and Senegal.

Training module on emergency contraception for inclusion in the Training Resource Package for Family Planning,

Inventory of over 100 unique e- and mHealth support tools for health workers covering the 13 commodities and Review of promising practices

Systematic approach and process for adapting content for delivery via mobile- to be applied in Phase 2

Assessment of protocol standards and policy landscape for ICT use within the health sector in pathfinder countries

Infographic of the inventory of 100+ e- and mHealth support tools for health workers Mechanism in place for provision of country-level technical assistance in e and mHealth (m and

eHealth Expert Learning Program – mHELP) Global desk review of uses of mHealth for neonatal resuscitation Country-level assessment in Tanzania for uses of mHealth for neonatal resuscitation

Case Study 7: Integrated Community Case Management Scaling up Integrated Community Case Management (iCCM) of childhood illness has the potential to deliver life saving commodities and services at the ground-level to children who need them most. Field studies show that iCCM programs – which rely on community health workers (CHWs) to diagnose and treat malaria, pneumonia, and diarrhea - can yield mortality reductions of up to 40 percent.7 The Child Health TRT through the Diarrheoa and Pneumonia Working Group has played a leadership role in expanding the iCCM approach. UNICEF, WHO, the Global Fund, and bilateral donors such as USAID and Canada/DFATD have made contributed investments in iCCM over the past decade. More recently, the RMNCH Trust Fund has added additional support. Over 30 countries are now implementing some form of iCCM – utilizing this strategy to increase access to care for rural groups. A range of new opportunities for drawing together additional funding streams and technical support are underway. UNICEF and the Global Fund have signed a Memorandum of Understanding8 confirming their commitment to investment in iCCM. Through the New Funding Model, malaria commodities as well as some delivery costs are eligible for Global Fund support. UNICEF also has made clear that it will use its best efforts to support costs for diarrhea and pneumonia commodities. This alignment of funding streams is taking place through the iCCM Financing Task Team with the support of the RMNCH Country Engagement Process (outlined in section V(3) below). With this additional momentum over the past six months alone, ten new countries have requested technical assistance to support development of iCCM.

7 For example: Chinbua et al (2012), Community Management of Fever 8 http://www.unicef.org/media/media_73153.html

https://drive.google.com/file/d/0BxajLIcWD1kKTHdCVHNiLUJrWHM/edit?usp=sharing

http://www.mhealthalliance.org/images/content/publications/1822-Inventory-and-Landscape-Report-v6-JH-screen-spreads.pdf

http://www.mhealthalliance.org/images/content/publications/1822-Inventory-and-Landscape-Report-v6-JH-screen-spreads.pdf

https://drive.google.com/file/d/0B7TRvy3Na5u-LTZUUzBsU1Ftams/edit?usp=sharing

https://drive.google.com/file/d/0B7TRvy3Na5u-LTZUUzBsU1Ftams/edit?usp=sharing

http://www.mhealthalliance.org/images/content/publications/mHA_neonatal_v3-5.pdf

http://www.mhealthalliance.org/images/content/publications/mHA_neonatal_v3-5.pdf

http://www.mhealthalliance.org/images/content/publications/mHealthNNRTanzania_FINAL.pdf

http://www.mhealthalliance.org/images/content/publications/mHealthNNRTanzania_FINAL.pdf

http://www.unicef.org/media/media_73153.html


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Recommendation 10: Product Innovation

By 2014, research and development for improved life-saving commodities has been prioritized, funded and commenced

Activities Milestones Status Establish incentives for further commodity research and product innovation Invest in product innovation, including translational research, formulation development, new technological product development, stability studies and bioequivalence Use the public health need for new formulations, packaging or technological update of the 13 commodities as a practical example and justification in the global discussion on financing research and development Facilitate technology and knowledge transfer, together with financial incentives, to reinforce national and regional efforts in research, development, regulation and manufacturing of life-saving commodities

Form a coordinating group to lead reviews, prioritization and monitoring of product improvements/ innovations (2014)

Completed

Prioritize four product improvement/ innovation areas (2014)

Partial: Innovations in packaging and educations materials for Misoprostol and dispersible amoxicillin; Oxytocin time-temperature sensor; thermostable inhaled preparations of oxytocin; MgSO4 bundling with injection equipment; an upright resuscitator for newborn resuscitation is developed and undergoing testing

Secure commitments including donor and private industry earmarks for innovation and research and development (2014).

Partial: Co-financing for development of inhaled oxytocin has been identified

Overview: Product innovation involves modifications to the formulations of the existing group of life-

saving commodities, or alternatively changes in the packaging, delivery mechanism, or other product-

specific dimension that will increase effective utilization.


A range of product innovations are completed or underway to address critical bottlenecks:

Misoprostol: Uptake of misoprostol in the community was hindered by unavailability of appropriate

packaging and education materials. Efforts have been made in Malawi to assure that an appropriate

product (quality and presentation) will be available.

Dispersible Amoxicillin: To address similar bottlenecks for community treatment of pneumonia we

have initiated a similar activity and support to the amoxicillin DT group (TRT).

Oxytocin: As a ‘biological product’, the quality of oxytocin is compromised by heat/time exposure.

Women can thus receive oxytocin that has less than the recommended 10 IU – which leads to post-

partum haemorrhage despite appropriate use by providers. A working group to include oxytocin in

the cold vaccine cold chain has been established with WHO and UNICEF to improve the

management (storage, use of “older/exposed” products first) of oxytocin and minimize use of sub-

standard (due to exposure) products.

o A time-temperature sensor has been developed for oxytocin, to be included in the

packaging for each batch to assess whether products are likely to be viable and effective at

the point of administration.


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o To make oxytocin available for community use (self-administration) efforts to advance the

manufacture of ‘inhaled oxytocin’ have been initiated, which obviates the need for

syringes/injections and cold storage - both bottlenecks to increasing the use of this drug.

Magnesium Sulphate (MgSO4): Rapid administration of MgSO4 is in many cased delayed because

health workers’ need to gather several products and devices before they can administer the right

treatment. Bundling MgSO4 with these devices/products will improve the quality of treatment for

pre-eclampsia/eclampsia.

Advocacy Working Group

To improve global advocacy and awareness of the UNCoLSC mandate and activities, and better align the range of advocacy initiatives across the RMNCH space

Activities Milestones Status Develop Advocacy Working Group steering committee that includes representatives of the EWEC-related initiatives (e.g. APR, GNAP, GAPP-D, FP2020) Develop integrated advocacy messaging framework that spans the 13 commodities, promotes linkages with related initiatives (e.g. APR, GNAP, FP2020, GAPP-D) and highlights the importance of commodities within broader RMNCH initiatives/strategies. Develop advocacy toolkit for primary use in EWEC countries. Increase visibility of the Commission at global, regional and national levels and coordinate activities across EWEC related initiatives.

Formation of advocacy steering committee (2013)

Completed : Steering committee has been formed and is meeting on a monthly basis to coordinate and align advocacy related activities across the UNCoLSC

Development of messaging framework in the lead up to UNGA (2013-2014)

Completed: Two frameworks were developed a Backgrounder document on the Commission and a Messaging Framework. Integration of commodities messaging/objectives into related platforms like EWEC Messaging Framework

Development and launch of an Advocacy Toolkit (2013)

Completed: Scaling up Life-Saving Commodities for Women, Children and Newborns -Toolkit features an overview of gaps & barriers related to each commodity and advocacy related asks and activities that can be undertaken to advance at agenda at a country level

Increased visibility of the UNCoLSC at key global events(2013)

Completed The Messaging Framework developed were used in the lead up to UNGA 2013 to ensure that messages on the UNCoLSC were incorporated into events focused on maternal and child health. A side event on the Commission was hosted at the International Family Planning Conference. The side event was co-hosted by the AWG and Rec 7 WG. The side event was entitled: Advancing RMNCH Commodities and the Continuum of Care

Overview: A new TRT on global Advocacy was formed in 2013 to increase the awareness of the UNCoLSC mandate and activities and better align the range of advocacy initiatives across the RMNCH space. The Advocacy Working Group (AWG) is convened by PATH as a board alternate and representative of the Partnership for Maternal, Newborn, and Child Health. The AWG—a diverse group of approximately 100 partners from more than ten countries—works across the RMNCH spectrum to promote joint planning and advocacy to amplify a unified voice among the Commodities Commission’s stakeholders. The AWG seeks to ensure that stakeholders from different sectors and various EWEC initiatives are involved in the Commodities Commission’s advocacy activities to improve access to and availability of lifesaving maternal, newborn, and child health commodities, programs, and services. To engage and support country partners in leading commodity-related advocacy, the AWG is holding advocacy strategy development workshops in four target countries: Malawi, Senegal, Sierra Leone, and Uganda. During these four-day workshops, participants from local organizations will use the toolkit to


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create a unified strategy that identifies gaps in their country’s RMNCH policies and develop policy change solutions. The workshops will provide a platform for advocates to create linkages among colleagues to ensure a coordinated advocacy approach to advance RMNCH issues, the UNCoLSC, and other EWEC initiatives. Workshops are scheduled for the week of April 28 in Senegal and Uganda, and the week of May 5 in Malawi and Sierra Leone. Deliverables completed:

Advocacy Tool Kit: This toolkit provides information about the UNCoLSC, its 13 priority commodities, and examples of how its ten recommendations to improve access and availability are being applied globally and within countries. It also provides advocacy resources for utilizing the Commodities Commission platform to raise awareness and engage stakeholders in addressing commodity-related gaps in global and national plans, policies and initiatives, as well as providing strategic input to advance implementation of the recommendations

V. Summary: Challenges, lessons learned and next steps

This report has reviewed progress over first 18 months of efforts to implement the recommendations outlined by the UN Commission on Life Saving Commodities. At the global-level, most of the milestones highlighted in the UNCoLSC report and Implementation Plan for 2013-2014 have been achieved or are nearing completion. Some of the key highlights include:

All 13 LSCs are now listed on the WHO EML, with corresponding revisions to treatment guidelines for most commodities

Major manufacturers for these commodities have been identified, including for newly listed commodities such as chlorhexidine and Amoxicillin DT

Global price reductions have been negotiated for implantable contraceptives with dramatic increases in global procurement and availability. Similar options for other products are being explored

Efforts to fast-track the national registration of LSCs are underway, alongside initiatives to harmonize and coordinate across multiple countries on a regional basis

Needs-based quantification algorithms have been developed for all LSCs to assist national forecasting and procurement efforts

A survey of the quality of LSCs across 10 countries has been conducted, with few products falling below acceptable standards with the exception of oxytocin

Guidance materials that synthesize supply chain best-practice have been developed for a range of critical areas, and an initiative to further global and country-level cooperation around supply chain management has been initiated

Based on a global review of the evidence, a demand-generation tool-kit has been developed to inform country strategies to enhance utilization of LSCs

An assessment of available job-aids, check-lists and mHealth tools has taken place across a range of countries, and the generation of high-quality adaptable learning materials is currently underway

An advocacy tool-kit was developed, to provide strategic input to advance the implementation of the recommendations

Despite this encouraging progress, a number of critical challenges remain. Foremost among them is translating global learning into country responses. Initial findings from pathfinder countries suggest that in all contexts there is fundamental misalignment between WHO recommendations, the status of

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national EMLs, corresponding treatment guidelines, and LSCs registered by regulators. Providers are often not mandated to administer commodities at the level of care where the greatest gains can be achieved. Supply chain bottlenecks remain commonplace, with a complex and fragmented supply chain architecture and frequent facility stock-outs of LSCs. Health workers on the ground are not yet up-to-date with the latest treatment protocols, and lack basic supportive materials such as job-aids and check-lists. Finally, where levels of coverage with LSCs have been assessed, they remain disconcertingly low. A number of strategies have been put in place to address these challenges, and form the basis for the SCT and TRT activities for the 2014-2015 period.

(1) Re-organization of the TRTs A review of the global TRT mechanism was conducted in November 2013. A reconfiguration was adopted as a strategy to improve inter-TRT communication, facilitate TRT administration/coordination by the RMNCH SCT, and to better package global expertise to Ministries. This reconfigured TRT network has emerged as follows:

Four Commodity TRTs were thematically grouped by RMNC domain - with new product innovation contributing to each.

Three Recommendation TRTs: o A ‘Global Markets, Regulation and Quality TRT was created to support upstream

challenges with global manufacturing, commodity availability and price, import and regulatory hurdles, post-market surveillance and pharmacovigilance

o A ‘Local Markets and Supply Chain’ TRT was created to address national procurement and distribution bottlenecks in the public and private sectors.

o A ‘Demand, Access and Performance’ TRT addresses challenges at the interface between facilities, health workers and communities.

(2) Renewed country-level focus While a number global-level technical barriers remain, the primary focus for the next phase (July 2014 – Dec 2015) of the SCT’s efforts and TRT process is to further country-level progress in implementing the UNCoLSC’s recommendations. The main objectives are as follows:

To continue progress towards addressing global bottlenecks and commodity-focused technical

gaps in knowledge, guidelines, tools and standards where relevant

To define the most effective and efficient strategies for packaging and disseminating the global

learning and work products at the regional and country levels

Working through established in-country partners, to identify and address country-specific

bottlenecks that limit the availability and access to RMNCH commodities and related services

While workplans for this next phase are still in being finalized, a mechanism for coordinating the efforts

of the TRTs is outlined below (Figure 7). Briefly, Commodity TRTs will maintain a technical focus on

compiling research and evidence; advising on product specification; exploring opportunities new

product innovation; refining of treatment guidelines; mapping the manufacturing landscape, and;

technical input into the design of job-aids, check-lists and training materials.


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Figure 7: UNCoLSC revised organization and workplan structure

The Recommendation TRTs will act as the interface to translate and disseminate the work of the

UNCoLSC to the country-level. The most efficient strategy to engage the full range of EWEC countries

will be to adopt an implementation strategy that addresses multiple countries and multiple commodities

simultaneously. By nature, these groups are cross-cutting and will facilitate dissemination of global

learning to countries as follows:

Global Markets, Regulation and Quality: will address market and regulatory barriers through

working with regional bodies (EAC, ECOWAS, SADC) to bring together implementers across

multiple countries to address the following bottlenecks across the 13 life-saving commodities:

updating the EML and treatment guidelines, securing OTC status where relevant, defining

procurement standards and linking procurement agencies to WHO pre-qualified manufacturers,

ensuring products are registered in countries, assisting with post-market surveillance through

regional laboratories.

Local Markets and Supply Chain: will act as a hands-on resource to coordinate private sector

local market activities across those group of RMNCH commodities where they are relevant

(Chlorhexidine, Emergency Contraception, Female Condoms, ORS, Zinc); to address remaining

supply chain barriers by using in-country partners to conduct rapid diagnostics with links to

technical support as needed, and; facilitating coordinated efforts amongst supply chain partners

at the global and country level via the emerging Interagency Supply Chain Group.

Demand, Access and Performance: Both demand generation and health worker performance

teams will play crucial roles in working with in-country focal points to disseminate the breadth

of learning and work products from this initial phase of UNCoLSC activities.

Rec

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o Demand generation: dissemination efforts will involve work through NGOs, CSOs and

the media and could be undertaken for multiple countries simultaneously.

o Health worker performance: will work with professional bodies, training organizations,

and colleges to facilitate task-shifting around LSCs, to train on revised guidelines and

introduce and locally adaptable job-aids, check-lists, and training materials.

These efforts will be supported by a commodity tracking platform that will monitor commodity-specific

progress across the continuum on a country-by-country basis.

(3) RMNCH Country Engagement Process

A final strategy to accelerate implementation of the UNCoLSC mandate will be through expanding the

RMNCH Country Engagement strategy. Building on the principles of IHP+, the this process responds to a

country’s expressed interest to engage in support of national efforts to ‘bend the curve’ towards

achieving MDGs 4 & 5a and b. The goal is to align and coordinate funding streams to improve coverage

with critical interventions to accelerate the reduction of preventable deaths. Led by the Ministry of

Health, in order to sharpen existing plans and commitments, and to achieve immediate progress that

can also be sustained beyond 2015, this process includes:

A joint, rapid multi-stakeholder synthesis of the RMNCH landscape that brings together the

various RMNCH-related plans, sub-plans, initiatives, etc. relevant within the country context

Prioritization, based on the landscape review, the burden of disease and of programmatic and

financial gaps across the entire RMNCH continuum of care particularly for the most deprived

Commitment of development partners to support implementation of prioritized interventions,

under the leadership of the relevant Ministry. The prioritized actions will build off other major

planning processes in-country such as an RBF expansion through HRITF funds, the New Funding

Model of the Global Fund, or other processes as decided by the country in consultation with key

stakeholders, including civil society.

Working in conjunction with key partners such as the H4+ and the UN Special Envoy’s Office for

Financing the Health MDGs, the RMNCH SCT actively facilitates the RMNCH Country Engagement

process. Throughout this process, the ‘commodity-focus’ of the UNCoLSC remains a central planning

tool to help identify, prioritize and track progress against key bottlenecks. The RMNCH Country

Engagement process launched in late 2013, with seventeen countries have already been actively

engaged with five in advanced stages of discussion. For more information please refer to the

supplementary Report to the iERG on the Progress of the RMNCH Steering Committee (May 2014).

In summary, while the 13 life-saving commodities provide a focal point to concentrate global

momentum, many of the interventions to improve availability and access are by nature ‘systems-

strengthening’. They have the capacity to act interdependently to improve the quality and demand for

services more broadly, creating synergies that accelerate progress towards achieving the MDGs,

reducing health inequalities, and contributing towards universal health coverage.


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Appendices

Appendix 1: UNCoLSC List of Technical Resource Teams

COMMODITY TRT Conveners Partners RECOMMENDATION TRT Conveners Partners

OXYTOCIN USAID, UNFPA Mgt Sciences for Health, MCHIP/JHPIEGO, JSI

SHAPING GLOBAL MARKETS

DFID, CHAI

BMGF, CIFF, NORAD, Part for SCM, RHSC, Res for Dev, UNICEF, UNF, USAID, UNFPA

MAGNESIUM SULFATE USAID, UNFPA Mgt Sciences for Health, MCHIP/JHPIEGO, JSI

SHAPING LOCAL MARKETS

CHAI, MOH Nigeria

USAID, NORAD, PATH

MISOPROSTIL USAID, UNFPA Mgt Sciences for Health, MCHIP/JHPIEGO, JSI

INNOVATIVE FINANCING World Bank, Norad

CHLORHEXIDINE DIGLUCONATE

PATH

BMGF, BU, GSK, JHPIEGO, JHU, JSI, MCHIP, USP, PSI, SCF/SNL, Mgt Sci for Health, USAID, UNICEF, Venture strategies innovations, WHO

QUALITY STRENGTHENING

WHO, NAFDAC

Concept foundation, Eur Med Agency, PATH, PmRN, UNFPA, UNICEF, USAID, WB

NEONATAL RESUSCITATION

DEVICES USAID

AAP, MCHIP, mHealth Alliance, NIH, PATH, SCF/SNL, Mgt Sci Health, UNICEF, UNFPA, URC, WHO

REGULATION EFFICIENCY WHO, NAFDAC

Concept foundation, Eur Med Agency, PATH, PmRN, UNFPA, UNICEF, USAID, WB

ANTENATAL CORTICOSTEROIDS

SCF, BMGF

Am Coll Nurse Midwives, Cincnnati child Hosp, Global Alliance, MCHIP, USAID, NIH, WHO

SUPPLY AND AWARENESS

USAID, UNFPA

JSI, MSH, VillageReach

ZINC/ORS CHAI

DPWG: Abt, BMGF, FHI, icddr, JSI, McCAnn Health, MCHIP, Micrnut initiative, USAID, PSI, PATH, MDG Health, DFID, WHO, World Vision

DEMAND AND AWARENESS

USAID HC3 at JHU

AMOXICILLIN UNICEF

DPWG: Abt, BMGF, FHI, icddr, JSI, McCAnn Health, MCHIP, Micrnut initiative, USAID, PSI, PATH, MDG Health, DFID, WHO, World Vision

REACHING WOMEN AND CHILDREN

Not yet formed

Discussion with SCT still on-going with regards to the workplan

INJECTABLE ANTIBIOTICS

SCF/SNL USAID, CHAI, PATH, MSH, UNICEF

PERFORMANCE AND ACCOUNTABILITY

AMREF, mHealth Allicance

UNFPA, WHO, Innovation Working Group, Government of Norway, USAID, CIFF, SCF

FEMALE CONDOMS UNFPA

Centre for helath and gender equity, Condom Project, Cupid, FHI, HHL Lifecare, MSH, MAtCH, PATH, Safehaven, SUPPORT, WHO, Univ access to FC

PRODUCT INNOVATION PATH

ARK, BMGF, CIFF, JHBIEGO, MSH, Merch, MONASH, DFID, USAID, WHO

CONTRACEPTIVE IMPLANTS

DFID, BMGF, RHSC

Contraceptive Implant TRT - 66 members

GLOBAL ADVOCACY PATH

EMERGENCY CONTRACEPTION

WHO International Consortium for EC


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Appendix 2: Interagency Supply Chain Vision Statement – DRAFT NOT FOR CIRCULATION

Supply Chain Inter-Agency Group

Joint Vision Statement

Supply chain for health commodities and products is a core health system building block across all health areas. It

is an area that has continuously faced enormous challenges despite significant investments and efforts over the

past decades. No doubt, progress has been made in some countries and within certain health areas and prevention

programmes, most notably immunization, reproductive health, HIV and malaria. But this has been uneven and

sometimes at a price of fragmentation, the establishment of parallel systems and the general lack of sustainability.

Recognizing this, over the past year, global health development partners including the Global Fund, USAID, the

World Bank, GAVI, UNICEF, UNFPA, WHO, Gates Foundation and others have increased their interactions to find

ways to better coordinate supply-chain strengthening efforts.

The purpose of the joint vision statement is to articulate the shared vision towards which this group of interested

development partners and donors are working towards.

Overall Vision

The global development partners will collaborate in support of countries’ efforts to have sustainable access to

quality essential health commodities and supplies at the right time, in the right place and at lowest possible cost

for those who need them, through cost-effective and efficient procurement and supply systems.

This does not mean a one-size-fits all approach across countries or across commodities. It does mean looking at

ways to harmonize supply chains and supply activities where appropriate, optimize synergies across supply chains

and focus efforts towards building sustainable national systems.

In order to help advance this vision, we, development partners and donors, commit to:

Working collaboratively to analyse and address supply chain challenges with a view to aligning resources,

efforts and activities, including committing to a more coordinated approach towards governments in-

country and the use of public and private (for profit and not-for-profit) sector supply-chain capacity.

Better sharing information related to our respective Supply Chain strengthening efforts such as existing

assessments, best practices, lessons learnt as well as forthcoming planning, assessment or evaluation

exercises.

Ensuring appropriate incentives are built into our respective strategies, policies, agreements, grants or

financing mechanisms in order to encourage and support collaborative efforts at the global, regional and

country level.

Agreeing on a common set of performance metrics (building on already available data) to regularly assess

progress and agreeing to work against evidence-based, established and best practice industry standards in

supply-chain management.

Supporting the development or strengthening of national Supply Chain Strengthening Strategic Plans and

associated gap analyses; and moving towards a situation that would allow for alignment of investments or

joint financing of supply chain strengthening efforts against these plans.

Working together to translate recommendations on supply-chain strengthening efforts in a set of key

priority countries for our respective agencies, to be defined.

Strengthening communication within our respective agencies (global to country level) and with our

implementing partners and government counterparts in relation to this joint commitment whilst building

on ongoing coordination efforts.


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Appendix 3: Commodity Tracking Platform- Data Sources, Partners and Assessment Levels

Data Source Partner Global National Facility Population

Demographic and Health Surveys (DHS) USAID

Multiple Indicator Cluster Surveys (MICS) UNICEF

Health Management Information Systems (HMIS) National Government

[P]

Logistics Management Information Systems (LMIS) National Government*

RMNCH Scorecard ALMA

Service Delivery Point (SDP) survey UNFPA

Service Availability and Readiness Assessment (SARA) WHO

Service Provision Assessment (SPA) USAID (DHS)

Landscape Synthesis / Document Review SCT

Country Engagement Process: administrative records SCT

RMNCH Trust Fund: administrative records SCT

Technical Reference Teams: administrative records SCT / TRTs

Notes: * In-country partners may also operate LMIS. [P] Potential reporting based on operator implementation.


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Appendix 4: Monitoring Advisory Group

Name Organization Email

Mark Grabowsky MDG Health Alliance [email protected]

Katherine Rockwell MDG Health Alliance [email protected]

Maria Muniz UNICEF [email protected]

Desmond Koroma UNFPA [email protected]

Troy Jacobs USAID [email protected]

John Quinley UNICEF [email protected]

Mary Fan Mei ALMA [email protected]

Melinda Munos Johns Hopkins [email protected]

Meghan Reidy PSI [email protected]

Suzy Sacher JSI [email protected]

Antoinette Bhattacharya CHAI [email protected]

Felix Lam CHAI [email protected]

Agbessi Amouzou UNICEF [email protected]

Suman Jain Global Fund [email protected]

Elizabeth Katwan RMNCH SCT [email protected]

Blerta Maliqi RMNCH SCT [email protected]

Ben Nemser UN Special Envoy’s

Office

[email protected]

Paul Pronyk RMNCH SCT [email protected]

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