First meeting of the WHO Strategic

and Technical Advisory Group working

group on access to safe, efficacious
and quality-assured health products
for neglected tropical diseases
Virtual meeting, 15–16 September 2022
First meeting of the WHO Strategic
and Technical Advisory Group working
group on access to safe, efficacious
and quality-assured health products
for neglected tropical diseases
Virtual meeting, 15–16 September 2022
First meeting of the WHO Strategic and Technical Advisory Group working group on access to safe, efficacious and
quality-assured health products for neglected tropical diseases: Virtual meeting, 15–16 September 2022

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Contents
Abbreviations and acronyms iv
1. Introduction 1
1.1 Opening remarks 1
1.2 Purpose of the meeting, expected outcomes and appointment of rapporteurs 1
2. Technical sessions and discussion 2
2.1 Evaluation of NTD diagnostics 2
2.2 GAP-f and paediatric drug optimization for NTDs 2
2.3 Gap assessment tool on access and logistics 3
2.4 Leishmaniasis procurement steering committee 3
3. Drug efficacy monitoring 4
4. Conclusions and recommendations 5
4.1 On coordination of procurement: establish a subgroup to support market shaping
and procurement coordination mechanisms, including supply and demand forecasting 5
4.2 On evaluation of NTD diagnostics: establish a subgroup to support this activity 5
4.3 On the GAT assessment tool on access and logistics: involve the Working Group
in any additional reviews to ensure that intended impact is achieved 5
4.4 On the GAP-f: share additional information on disease prioritization with
the Working Group 5
4.5 On drug efficacy monitoring: expand the scope of the initiative to include diseases
and medicines other than those currently monitored, and secure appropriate resources 6
5. Meeting closure 7
Annex 1. Agenda 8
Annex 2. List of participants 9

iii
Abbreviations and acronyms
GAP-f Global accelerator for paediatric formulations
GAT GAP assessment tool
NTD neglected tropical disease
PADO paediatric drug optimization
WHO World Health Organization

iv
1. Introduction
The WHO Department of Control of Neglected Tropical Diseases (WHO/NTD) manages a
diverse portfolio of 20 diseases and disease groups, each with its own unique epidemiology
and implementation challenges. These programmes aim to achieve set goals for disease
control, elimination as a public health problem, elimination of transmission, or eradication,
as determined through expert consultations in collaboration with countries. This requires
consistent emphasis on the availability, accessibility, acceptability and affordability of medicines
and other health products for NTDs.
The STAG Working Group on access to safe, efficacious and quality-assured health products
for NTDs (“the Working Group”) was established in 2021 to facilitate alignment of stakeholders
on strategies and best practices for improving access to medicines and other health products
for NTDs. Following its introductory meeting in January 2022, the Working Group held its first
technical meeting virtually on 15–16 September 2022. The agenda is reproduced in Annex 1
and the participants are listed in Annex 2.

1.1 Opening remarks

Dr Gautam Biswas, Director ad interim, WHO/NTD, welcomed participants to the meeting.
He mentioned that access to NTD health products had been impacted during the coronavirus
disease (COVID-19) pandemic and that measures were taken to adapt to challenges globally.
He summarized the key achievements made in 2021–2022 including the delivery of 1.9 billion
tablets of NTD medicines; the prequalification by WHO of four new medicines; the submission
of five new dossiers for prequalification; and the webinar on improving access to NTD health
products (7 December 2021). He recognized the critical role of a revitalized Working Group
in achieving the 2030 targets of the NTD road map for 2021–2030 (“the road map) and in
ensuring access to NTD health products in all populations in need. Finally, he wished the
participants a productive meeting.

1.2 Purpose of the meeting, expected outcomes and appointment of

rapporteurs
Sarah Andersson, Chair of the Working Group, said that the purpose of the meeting was to
review and highlight the priority areas of work in improving access to NTD health products
and recommend the establishment of subgroups (if needed) or areas of active participation
to actively engage in the identified priority issues. Hye Lynn Choi, Technical Officer/WHO
Prequalification, and Perrer Tosso, Senior Manager, United States Pharmacopeia, were
appointed rapporteurs. Participants were then invited to introduce themselves and indicate
their areas of expertise and experience.

1
2. Technical sessions and discussion

2.1 NTD diagnostics evaluation

Camilla Ducker, Consultant, WHO/NTD, provided background on the critical need of NTD
diagnostics to support the achievement of the road map targets. The WHO Diagnostics
Technical Advisory Group for Neglected Tropical Diseases and its subgroup on manufacturing
and regulatory pathways had advised WHO to establish a regulatory pathway to evaluate
the quality, safety and performance of NTD diagnostics. Currently, there is no established
mechanism. WHO/NTD is discussing with WHO Prequalification options for evaluation,
particularly for diagnostics with lower risk (Class A and B) levels. NTD diagnostics are
unique, as those used for mass drug administration programmes, for instance, have a lower
risk classification (Class B); yet there is very little interest from manufacturers due to an
unprofitable market and the unknown or uncertain quality of many NTD diagnostics. An expert
review panel for diagnostics, an interim risk-assessment mechanism providing time-limited
recommendations, or similar process, will be established for NTD diagnostics to provide
reasonable assurance of product safety and effectiveness. Priorities could be for lymphatic
filariasis, onchocerciasis, schistosomiasis and yaws (pending regular updates). The ways in
which members of the Working Group can contribute to the evaluation process would be
discussed, pending a decision by WHO senior management on the appropriate mechanism
for the panel.

2.2 GAP-f and paediatric drug optimization for NTDs

Martina Penazzato, GAP-f lead, WHO Research for Health/Science Division, described the
GAP-f and its activities. Recognizing the challenges with limited availability of child-friendly
paediatric formulations for public health programmes, GAP-f, a WHO network, was created
to address the gap in paediatric treatment by coordinating a concerted response across the
product life cycle, from prioritization to evaluating, developing and delivering products. GAP-f
works on several diseases, including HIV, TB, hepatitis, antibiotics, childhood cancer and now
NTDs. She presented the GAP-f strategy to stimulate accelerated to access to paediatric
formulations together with its various partners.
Tiziana Masini, GAP-f prioritization consultant, WHO Research for Health/Science Division,
provided further details on the prioritization process, known as paediatric drug optimization
(PADO). Given the challenges in developing paediatric formulations, including lengthy and
expensive clinical research, small and fragmented market for medicines for children, and
uncoordinated research and development efforts, PADO seeks to identify priority medicines
and formulations to be investigated and developed. In addition, it aims to identify promising
candidates that require accelerated investigation plans, provide guidance to research and
development, define a clear research agenda and enable alignment among funders, procurers,
researchers, manufacturers and regulators.
The list of PADO priorities contains priority formulations to be investigated and developed
with a time horizon of 3–5 years, and a watch list of promising candidates for investigation and
development in children aged 5–10 years. The process will include background assessment,
review of gaps and opportunities and prioritization of research and development. PADO
for NTDs will require a disease-specific approach due to specific issues and involve diverse
groups of experts and networks. The proposed priority NTDs include schistosomiasis, visceral
leishmaniasis, human African trypanosomiasis, and strongyloidiasis, onchocerciasis and
scabies. The specific objectives for each disease were presented to the group. The first PADO
2
meeting (17 October 2022) would be on schistosomiasis, with other PADO meetings during
Q4 2022 and Q2 2023. Interested Working Group members can participate in each meeting to
provide their expertise and help with potential, next rounds of prioritization.

2.3 Gap assessment tool on access and logistics

Ashley Souza, Associate Director of Programs, NTD Support Center, The Task Force for Global
Health, presented the background and status of the NTD GAP Assessment Tool (GAT). GAT
is a periodic, global-level assessment tool introduced in the road map. It analyses all 20 NTDs
against 11 dimensions to provide a systematic, collective understanding of gaps globally and
of bottlenecks in NTD programmes that are impeding progress towards achieving the road
map targets; it is a call for collective action to accelerate progress. One of four dimensions
prioritized is access and logistics. The working group on monitoring, evaluation and research
of the WHO Strategic and Technical Advisory Group for Neglected Tropical Diseases is
tasked with developing the GAT. The GAT defines the dimension assessment criteria for
access and logistics, separately. This dimension will be assessed at national and global levels.
Questionnaires for the national and global level assessments are now completed and expected
to be launched within the next month.
Pamela Mbabazi, WHO/NTD, clarified that the GAT will not be an annual exercise; rather, it will
be implemented three times by 2030. Responding to a question on specific issues at country
level, Dr Mbabazi indicated that those will not be highlighted in the global assessment but can
be addressed by required actions in the qualitative part of the exercise.
Members of the Working Group will have an opportunity to review the GAT and contribute
to its planned implementation. Xiaoxian Huang, WHO/NTD, highlighted the possibility of
developing an investment proposal for access and logistics and invited interested members of
the Working Group to participate and contribute to it.

2.4 Leishmaniasis procurement steering committee

Fabienne Jouberton, Médecins Sans Frontières International, and Chair of the steering
committee on leishmaniasis procurement, described the challenges to accessing leishmaniasis
products. These include the limited number of manufacturers with acceptable standards of
quality, high prices, the small and fragile market, uncoordinated procurement practices, lack
of visibility on demands and insufficient funding. For the five leishmaniasis products currently
used, potential solutions were discussed to address specific, identified issues. To facilitate
coordinated procurement, engagement with manufacturers and market shaping, WHO/NTD
established the procurement steering committee for leishmaniasis in 2020. The committee
developed an annual forecast for 2021 and 2022 and shared it with manufacturers. It also
coordinated with partners and manufacturers to ensure adequate production and supply for
miltefosine and diagnostics. A market shaping strategy is yet to be developed, and strong
and effective procurement coordination is required. The committee will continue to develop
forecasting models and scenarios, explore mechanisms and other initiatives to create a healthy
market, and advocate for more funding.
A member of the Working Group asked if technology transfer was being considered to expand
the manufacturer base and respond to the discontinuation of certain products. Fabienne
Jouberton replied by giving an example of technology transfer for IT-Leish (a diagnostic tool
for leishmaniasis) from Bio-Rad to Mologic. The group discussed whether this procurement
coordination mechanism should include other diseases.

3
3. Drug efficacy monitoring
Antonio Montresor, WHO/NTD, gave an overview of the need to monitor drug efficacy and
the role of the working group on drug efficacy. Monitoring of drug efficacy is required because
helminths can develop resistance under high drug pressure from use of single medicines. Soil-
transmitted helminthiases and schistosomiasis have long-term control programmes and no
new drugs are in the development pipeline. The working group on drug efficacy is responsible
for developing standard methods to assess anthelminthic drug efficacy, supporting endemic
countries to assess and test new medicines or combinations of medicines for use in second-
level treatment with preventive chemotherapy. Revision of the manual to estimate therapeutic
efficacy is planned in early 2023.
The Working Group suggested to continue testing combinations of already registered
medicines (for example, albendazole + ivermectin, pyrantel + oxantel, tribendimidine) as
second-line interventions. Responding to a question on the egg per gram level, Dr Montresor
mentioned that the new limit for re-intervention can be reflected in the revised manual. Dr
Mbabazi also addressed the need to expand drug efficacy monitoring beyond helminths. A
member of the Working Group suggested building on the increased capacity of countries to
conduct genome sequencing of organisms. Dr Montresor also pointed out that albendazole
and mebendazole are rarely absorbed; they act directly on worms in the intestine. Therefore,
dosing based on the pharmacokinetics study is ineffective in increasing efficacy. .

4
4. Conclusions and recommendations to STAG

The Working Group deliberated on the various topics presented to its members. The
recommendations are based on the scope of the Working Group, recognizing that increasing
access requires more leadership, coordination, financial support and other mechanisms such
as volume guarantees or any other initiatives that need to be explored.
Recognizing that its members do not have the complete background on all the initiatives that
were presented, the Working Group concludes and recommends as follows:

4.1 On coordination of procurement: establish a subgroup to support

market shaping and procurement coordination mechanisms, including
supply and demand forecasting.
Given the experience of the leishmaniasis procurement steering committee, it will be critical
that this subgroup has strong leadership (a secretariat) and resources to ensure it meets
regularly and can be effective. An option would be to extend the scope of the existing steering
committee on leishmaniasis procurement to other diseases and medicines (as needed) by
reinforcing its governance and capacity to fulfill its objectives.

4.2 On evaluation of NTD diagnostics: establish a subgroup to support this

activity.
The Working Group is particularly interested in the classification of in vitro diagnostics and the
recommended review processes and recommends establishing a subgroup to support this
activity (as required, pending the decision on prequalification of medicines for NTDs).

4.3 On the GAT assessment tool on access and logistics: involve the
Working Group in any additional reviews to ensure that intended
impact is achieved.
The Working Group foresees that the GAT assessment tool is essential to provide a baseline
for the demand and supply issues for NTD diagnostics and medicines and will significantly
inform its work. Recognizing that the tool is at an advanced stage, the Working Group must
be involved in any additional reviews to ensure that it produces the intended impact and
welcomes being part of the review of the findings.

4.4 On the GAP-f: share additional information on disease prioritization

with the Working Group.
This is a technical area of interest to the Working Group that requires significant attention and
investment. Additional information on how medicines or diseases are prioritized would be
helpful. The Working Group understands that its members may be involved in this depending
on which medicines are being addressed at the time (or which expertise is needed).

5
4.5 On drug efficacy monitoring: expand the scope of the initiative to
include diseases and medicines other than those currently monitored,
and secure appropriate resources.
The Working Group considers this a priority. It is essential to closely monitor the development
of resistance to medicines across the NTD landscape and to expand this initiative to diseases
and medicines others than those currently monitored, especially in cases where only one
medicine is available to treat a particular disease. It will be helpful to know the decision
process in choosing the current medicines being studied and design a strategy to expand its
current scope. This is an area that requires resources (both financial and technical) to be able
to expand the scope.

6
5. Wrap-up and closure

In wrapping up the meeting, the Chair of the Working Group commended its members and
requested that they meet in a week’s time to discuss the topics further and formulate the
recommendations. The above recommendations were shared with the WHO secretariat after
that meeting. In closing, discussions around creating or reviving subgroups were held and it
was noted that they should be streamlined to avoid any duplication.
In his closing remarks, Afework Tekle, WHO/NTD, thanked everybody for their interesting and
candid discussions and participation. WHO remains committed to engaging with stakeholders
and moving to the next steps to ensure access to NTD health products. Finally, he said that if
the situation allowed the next meeting of the Working Group would be held in person in 2023..

7
Annex 1. Agenda

DAY 1 – 15 September 2022, Thursday

Time Topic Speaker
14h00–14h10 Welcoming and Opening Remarks WHO
14h10–14h20 Introduction Chair
14h20–14h40 NTD diagnostics evaluation Camilla Ducker
14h40–15h10 GAP-f and PADO for NTD Martina Penazzato
Tiziana Masini
15h10–15h30 GAT on Access and Logistics Ashley Souza
15h30–16h00 Discussion All

DAY 2 – 16 September 2022, Friday

Time Topic Speaker
14h00–14h20 Leishmaniasis procurement Fabienne Jouberton
coordination
14h20–14h40 Drug efficacy monitoring Antonio Montresor
14h40–15h00 Discussion All
15h00–15h50 Recommendations Chair
15h50–16h00 Closing WHO

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Annex 2. List of participants

Members Hye Lynn Choi

Technical Officer, Prequalification Unit/
Sarah Andersson (Chair)
Neglected Tropical Diseases, WHO
Program Manager, World Scabies Program,
Regulation and Prequalification, Access to
Murdoch Children’s Research Institute,
Medicines and Health Products Division,
Parkville, Australia
Geneva, Switzerland
Olawale Ajose
Daniel Argaw Dagne
Partner, Market Access Africa, Geneva,
Unit Head, Prevention, Treatment and Care,
Switzerland
WHO Department of Control of Neglected
Vinay Garg Tropical Diseases, Geneva, Switzerland
NTD focal point, National Centre for
Camilla Ducker
Disease Control, New Delhi, India
Consultant, WHO Department of Control
Direk Limmathurotsakul of Neglected Tropical Diseases, Geneva,
Professor, Mahidol-Oxford Tropical Medicine Switzerland
Research Unit, Bangkok, Thailand
Dmitry Esin
Fabienne Jouberton Procurement Officer, Strategic Operations,
TB and NTD referent pharmacist, MSF WHO Department of Control of Neglected
International, Geneva, Switzerland Tropical Diseases, Geneva, Switzerland
Alison Mhazo Xiaoxian Huang
Supply Chain Technical Advisor, Health Economist, Strategic Information
United States Agency for International and Analytics, WHO Department of Control
Development Sustaining Technical and of Neglected Tropical Diseases, Geneva,
Analytic Resources, Malawi Switzerland
Brian Sekayombya Noha Iessa
Principal Regulatory Officer-Medicines, Technical Officer, Pharmacovigilance, WHO
National Drug Authority, Kampala, Uganda Regulation and Prequalification, Access to
Thiago Souza Medicines and Health Products Division,
Researcher, National Institute for Science Geneva, Switzerland
and Technology on Innovation on Neglected Dr Anh Tuan Le
Diseases, Brazil Technical Officer, Strategic Operations,
Perrer Tosso WHO Department of Control of Neglected
Senior Manager, United States Tropical Diseases, Geneva, Switzerland
Pharmacopeia, Frederick, United States of Tiziana Masini
America Technical Officer, TB Vulnerable Populations,
Communities & Comorbidities, WHO
Global Tuberculosis Programme, Geneva,
WHO Secretariat Switzerland
Gautam Biswas Pamela Mbabazi
Director ad interim; Unit Head, Strategic Medical Epidemiologist, Strategic
Information and Analytics, WHO Information and Analytics, WHO
Department of Control of Neglected Department of Control of Neglected
Tropical Diseases, Geneva, Switzerland Tropical Diseases, Geneva, Switzerland

9
Antonio Montresor Invited speaker
Scientist, Prevention, Treatment and Care,
Ashley Souza
WHO Department of Control of Neglected
Ashley Souza, Associate Director of
Tropical Diseases, Geneva, Switzerland
Programs, The Task Force for Global Health,
Martina Penazzato Decatur, United States of America
Medical Officer, Treatment, Care and Service
Delivery, WHO Health Systems and Services
Division, Geneva, Switzerland
Mariana Roldao Santos
Technical Officer, Facilitated Product
Information, WHO Regulation and
Prequalification, Access to Medicines
and Health Products Division, Geneva,
Switzerland
Anthony Solomon
Medical Officer, Office of the Director, WHO
Department of Control of Neglected Tropical
Diseases, Geneva, Switzerland
Afework Tekle
Unit Head, Strategic Operations, WHO
Department of Control of Neglected Tropical
Diseases, Geneva, Switzerland
Raman Velayudhan
Unit Head, Veterinary Public Health, Vector
Control and Environment, WHO Department
of Control of Neglected Tropical Diseases,
Geneva, Switzerland

10