Project Title

Ensuring an Inclusive "Healthy Asia Pacific 2020" by Addressing Barriers to Healthcare Services for Populations Affected by Rare Diseases 

Project Year

2017   

Project Number

CTI 34 2017A 

Project Session

Session 2   

Project Type

Standard 

Project Status

Project in Implementation   
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Project No.

CTI 34 2017A 

Project Title

Ensuring an Inclusive "Healthy Asia Pacific 2020" by Addressing Barriers to Healthcare Services for Populations Affected by Rare Diseases 

Project Status

Project in Implementation 

Publication (if any)

 

Fund Account

APEC Support Fund 

Sub-fund

ASF: General Fund 

Project Year

2017 

Project Session

Session 2 

APEC Funding

45,000 

Co-funding Amount

100,000 

Total Project Value

145,000 

Sponsoring Forum

Life Sciences Innovation Forum (LSIF) 

Topics

Life Sciences 

Committee

Committee on Trade and Investment (CTI) 

Other Fora Involved

 

Other Non-APEC Stakeholders Involved

 

Proposing Economy(ies)

United States; Viet Nam 

Co-Sponsoring Economies

Australia; China; Indonesia; Malaysia; Chinese Taipei; Thailand 

Expected Start Date

31/12/2018 

Expected Completion Date

31/12/2018 

Project Proponent Name 1

Matthew Bellgard 

Job Title 1

Professor and Foundation Chair in Bioinformatics and Director, Centre for Comparative Genomics 

Organization 1

Murdoch University - Perth 

Postal Address 1

90 South Street, Murdoch WA 6250, Australia 

Telephone 1

61-8 93606088 

Fax 1

Not Applicable 

Email 1

mbellgard@ccgmurdoch.edu.au 

Project Proponent Name 2

Not Applicable 

Job Title 2

Not Applicable 

Organization 2

Not Applicable 

Postal Address 2

Not Applicable 

Telephone 2

Not Applicable 

Fax 2

Not Applicable 

Email 2

Not Applicable 

Declaration

Matthew Bellgard 

Project Summary

There is a vast population across all of the APEC economies that is being overlooked by the healthcare system due to the inability to either diagnose or manage rare diseases. Accordingly, no APEC Economy will be able to claim that is has successfully implemented the “Healthy Asia-Pacific 2020” initiative if it has not adequately and equitably met the needs of those with rare diseases.  This project seeks to help APEC developing economies adopt an inclusive approach to “Healthy Asia Pacific 2020” implementation by addressing barriers to healthcare services for populations with rare diseases.  With an estimated 200 million people in the APEC region living with one of the 7,000 known rare diseases, APEC Economies cannot afford not to improve access to screening, diagnosis, appropriate medical management and support to people with rare diseases. This project will establish a tripartite task force and convene a 2-day policy dialogue to facilitate the sharing of best practices, policies, standards, and guidelines for addressing rare diseases, drawing on the experiences of developed APEC economies.  Economies will then work together to develop an APEC Rare Disease Action Plan to facilitate greater alignment of domestic policies and implementation of best practices and to provide a framework for short-term and long-term multi-sectoral collaborations to advance progress in key areas. By addressing the barriers to healthcare services for rare diseases, APEC Economies will improve the economic and social inclusion of those affected by rare diseases, including caregivers, and ensure a more inclusive “Healthy Asia Pacific 2020”.

Relevance

Relevance - Region:  In November 2016, APEC Leaders recognized that “health is the foundation of economic prosperity and human development” and highlighted the importance of “promoting health systems towards the achievement of Universal Health Coverage (UHC), which are resilient, sustainable, accessible and responsive to current and future needs.”  The Healthy Asia Pacific 2020 Initiative, welcomed by APEC Leaders in 2014, also calls on APEC Economies to strengthen health systems to support UHC, and in doing so, to “collaborate with stakeholders and share experiences to provide the whole population, including the poor, vulnerable and marginalized groups, with access to safe, effective, high quality and affordable primary health care.” No APEC economy will be able to claim that is has achieved APEC Leaders’ vision for health, or successfully implemented “Healthy Asia-Pacific 2020”, if it has not adequately and equitably met the needs of those with rare diseases.

There is a vast population across all of the APEC economies that is being overlooked by the healthcare system due to the inability to either diagnose or manage rare diseases. Persons with rare diseases are often trapped in a vicious cycle of vulnerability and poverty due to exclusion from health care and education systems, as well as job markets.  APEC economies cannot afford not to improve access to screening, diagnosis, appropriate medical management and support to people with rare diseases.

Rare diseases are one of the most scientifically complex health challenges of our time. There are currently 7,000 known rare diseases. According to the World Health Organization (WHO), rare diseases affect roughly one in fifteen people globally with a majority of these diseases affecting children.  An estimated 200 million people in the APEC region, and 400 million people worldwide, are living with a rare disease.  Rare diseases are often difficult to diagnose, and in many cases, few or no treatment options are available. Approximately 80% of rare diseases are caused by abnormalities in a person’s genes.

Rare disease management remains immensely challenging across the region, due to high costs, limited resources, lack of scientific knowledge, and financial incentives.  The APEC economies are at vastly different stages of progress in addressing rare diseases and there is no alignment of priorities. However, APEC developed economies maintain best practices and established approaches in rare disease management that can be shared and effectively implemented in APEC developing economies. Economies typically take a similar journey in addressing rare diseases and thus there is no need to reinvent the wheel.

The proposed project seeks to help APEC developing economies adopt an inclusive approach to “Healthy Asia Pacific 2020” implementation by addressing barriers to healthcare services for populations with rare diseases.  This project will first establish a tripartite (academic, government, industry) APEC LSIF Rare Disease Network to identify and collect information/data on those barriers in APEC economies.  The collected information will be synthesized and used to develop and design a 2-day policy dialogue in mid-2018.  The policy dialogue will facilitate the sharing of best practices, policies, standards, and guidelines for addressing rare diseases, drawing on the experiences of APEC developed economies.  Participating economies will then work together to develop an APEC Rare Disease Action Plan to facilitate greater alignment of domestic policies and best practices and to provide a framework for short-term and long-term regional, multi-sectoral collaborations to advance progress in key areas. By addressing the barriers to healthcare services for rare diseases, APEC economies will improve the economic and social inclusion of those affected by rare diseases including caregivers, and ensure a more inclusive “Healthy Asia Pacific 2020”. Participating APEC economies will discuss and determine an appropriate timeline for the Action Plan to be implemented.  The Project Overseer currently proposes the end of 2025 as the target date for implementation of the Action Plan.

Health Ministers and health officials recognized the importance of addressing rare diseases at the 7th APEC High-Level Meeting on Health & the Economy (HLM7) in August 2017 in Ho Chi Minh City, Viet Nam.  HLM7 “welcomed the launch of a new APEC initiative to address barriers to the diagnosis and treatment of rare diseases in the region” and “noted that such efforts will improve the economic and social inclusion of those affected by rare diseases, including caregivers, and ensure a more inclusive Healthy Asia Pacific 2020”. HLM7 also “welcomed the development of an action plan to facilitate greater alignment of domestic policies and best practices and to provide a framework for regional collaboration”.

Relevance – Rank:  The project falls under three Rank 1 APEC Funding Criteria: 1. Human development – This project supports implementation provisions of the APEC Strategic Plan on Capacity Building to Promote Trade and Investment, including integrated and multi-faceted capacity-building based on demonstrated needs and mobilizing external resources to facilitate human development. 2. Services trade – This project supports implementation of the APEC Services Cooperation Framework and the APEC Services Competition Roadmap (ASCR), including the utilization of ICT to promote the dissemination of healthcare services. 3. Trade and investment facilitation and liberalization, including PPPs – The project facilitates the development of mulit-sectoral partnerships designed to improve healthy populations as they are drivers of sustainable economic growth, particularly for APEC developing economies. Trade and investment facilitation efforts require the maintenance of sustainable economic growth and a productive workforce through healthy populations.  The project is also linked to six Rank 2 APEC Funding Criteria, touching key areas of inclusive, sustainable, secure, and innovative growth. These include issues related to economic disparities helping member economies participate in regional trade, activities related to addressing the social dimensions of globalization, building resilient and sustainable communities, expanded empowerment of women in member economies, health and health systems including Healthy Asia-Pacific 2020, and innovation policy and research cooperation. The project directly supports the APEC Strategy for Strengthening Quality Growth.

Objectives

Establish a tripartite (academic, government, industry) APEC LSIF Rare Disease Network to identify and collect information/data on barriers to healthcare services for populations with rare diseases in APEC economies;  the collected information will be synthesized and used to design and develop the 2-day policy dialogue; 2) Convene representatives from APEC economies for a 2-day policy dialogue to facilitate the sharing of best practices, policies, standards, and guidelines for addressing rare diseases, drawing on the experiences of APEC developed economies; 3) Develop an APEC Rare Disease Action Plan to facilitate greater alignment of domestic policies and best practices and to provide a framework for short-term and long-term regional, multi-sectoral collaborations to advance progress in key areas.

Alignment

Alignment - APEC:  This project advances Viet Nam’s APEC 2017 host year theme “Creating a New Dynamism, Fostering a Shared Future” and priorities of “fostering sustainable, innovative and inclusive growth” and “deepening regional economic integration”.  This project supports the APEC 2016 Leaders Declaration which emphasized that “health is the foundation of economic prosperity and human development” and highlighted the importance of “promoting health systems towards the achievement of Universal Health Coverage (UHC), which are resilient, sustainable, accessible and responsive to current and future needs.”  This project support the Healthy Asia Pacific 2020 Initiative, welcomed by APEC Leaders in 2014, which calls on APEC Economies to strengthen health systems to support UHC, and in doing so, to “collaborate with stakeholders and share experiences to provide the whole population, including the poor, vulnerable and marginalized groups, with access to safe, effective, high quality and affordable primary health care.” A key APEC priority this project aligns with is the pursuit of universal healthcare and the goals of 100% health coverage. At this point in time, there is a vast population across all of the APEC economies that is being overlooked by the healthcare system due to the inability to either diagnose or manage rare diseases. 

Alignment – Forum:  This project supports the 2004 LSIF Strategic Plan in the area of health services. These include:

A) creating an environment that supports social and economic goals related to life sciences innovation;

B) fostering an inclusive, integrated, and sustainable approach to policymaking and implementation;

C) monitoring the quality and performance of health systems to ensure appropriate use of innovations; and

D) advocating accessibility, affordability, sustainability, and value from innovation in health services.

TILF/ASF Justification

The proposed project seeks to help APEC developing economies adopt an inclusive approach to “Healthy Asia Pacific 2020” implementation by addressing barriers to healthcare services for populations with rare diseases. Rare disease management remains immensely challenging across the region, due to high costs, limited resources, lack of scientific knowledge, and financial incentives.  The APEC economies are at vastly different stages of progress in addressing rare diseases and there is no alignment of priorities. However, several APEC developed economies maintain best practices and established approaches in rare disease management that can be shared and effectively implemented in APEC developing economies. Economies typically take a similar journey in addressing rare diseases and thus there is no need to reinvent the wheel.

Beneficiaries and Outputs

Outputs: 

Output

Description

Timeline

Rare Disease Issue Paper

Beginning in December 2017, the PO will seek input from LSIF members to provide a brief summary on the status of rare disease policies, standards, and guidelines in their economies.  This information will be collected, synthesized, and developed into an issue paper. The issue paper and collected information will also inform the development and design of the 2-day policy dialogue in June 2018.

December 2017 – February 2018

Rare Disease Network

While seeking inputs from LSIF members, the PO will also request APEC economies to submit nominations of experts from academic, government, and the private sector to join the APEC LSIF Rare Disease Network.  The Network will play an important role in shaping the policy dialogue, its outputs, and continuing work after the policy dialogue.

December 2017 – December 2018

Policy Dialogue

One of the main outputs of this project will be the June 2018 Policy Dialogue.  The policy dialogue will facilitate the sharing of best practices, policies, standards, and guidelines for addressing rare diseases, drawing on the experiences of all APEC economies. 

June 2018

Action Plan

Participating economies will then work together to develop an APEC Rare Disease Action Plan to facilitate greater alignment of domestic policies and best practices and to provide a framework for short-term and long-term regional, multi-sectoral collaborations to advance progress in key areas.

June – December 2018

Website

An APEC satellite website will be established to provide information on the project and the policy dialogue as well as contact information for the project overseer.  The website will eventually provide a list of contacts for members of the Rare Disease Network, serve as a platform for collaboration for the Network, and eventually house the Action Plan and issue paper and future tools and documents to support the Action Plan’s implementation. Self-funding will be used to support the maintenance of the website after the conclusion of this project.

June – December 2018

Outcomes:  The Action Plan that is developed following the policy dialogue will provide a framework for addressing barriers to healthcare services for populations with rare diseases.  The Action Plan will recommend specific policy actions to facilitate greater alignment of domestic policies and best practices over the short-term, medium-term, and long-term.  The Action Plan will also identify specific ways that regional and multi-sectoral collaborations can support implementation of the policy actions. 

Over the medium-term, the expectation is that the LSIF Rare Disease Network will continue to provide a platform for APEC economies to share best practices, policies, standards, and guidelines for addressing rare diseases.  This will allow for sustainable, self-funded improvements to continue in APEC economies to support implementation of the Action Plan.

Beneficiaries:   Scoping key stakeholders will be a key first objective of this project.  The Project Overseer will request APEC economies to submit nominations of experts from academic, government, and the private sector to join the APEC LSIF Rare Disease Network.  The likely beneficiaries from this project will include organizations seeking to share best practices as well as those seeking to implement these best practices – these include governments (ministries of health, ministries of science and technology, domestic drug regulatory authorities), academic institutions (universities conducting research on rare diseases), patient organizations (such as Rare Disease International), industry groups (such as the biopharmaceutical industry sector), and other non-profit and civil society entities. 

The rare disease community, including the aforementioned stakeholders, lacks the resources and means to gather together frequently (unlike those communities addressing more common conditions with higher public profiles and financial support).  This lack of connectivity leads to isolation and through that potential duplication of efforts (research etc.) due to lack of knowledge of what others are doing.  The isolation and lack of financial support also undermines ability to collaborate.  This project provides a unique forum to foster collaboration and deal with the isolation of rare diseases. The stakeholders who will benefit will gain exponential benefit because of this structure.

Dissemination

Output

Dissemination Plans

Target Audience

Rare Disease Issue Paper

The draft issue paper will be circulated to LSIF members for comment. Once finalized, it will be made available through the APEC website and through an APEC satellite website for the APEC LSIF Rare Disease Network. 

Health officials and other government authorities overseeing rare disease policy in APEC economies

Policy Dialogue information

All information related to the policy dialogue, including the draft agenda and registration information, will be circulated to LSIF members at least 3-4 months in advance. 

Health officials and other government authorities overseeing rare disease policy in APEC economies; experts from academia; industry; and civil society; patient groups;

Rare Disease Action Plan

Once the Action Plan is drafted following the policy dialogue, the draft document will be circulated to LSIF members for comment.  After the Action Plan is endorsed by LSIF members it will then be made electronically available through the APEC website and through an APEC satellite website for the APEC LSIF Rare Disease Network.

Health officials and other government authorities overseeing rare disease policy in APEC economies; experts from academia; industry; and civil society; patient groups;

Website

An APEC satellite website will be established to provide information on the project and the policy dialogue as well as contact information for the project overseer.  The website will eventually provide a list of contacts for members of the Rare Disease Network, serve as a platform for collaboration for the Network, and eventually house the Action Plan and issue paper and future tools and documents to support the Action Plan’s implementation. Self-funding will be used to support the maintenance of the website after the conclusion of this project.

Health officials and other government authorities overseeing rare disease policy in APEC economies; experts from academia; industry; and civil society; patient groups; general public

Gender

According to the WHO, women comprise over 75% of the healthcare workforce in most economies in the world.  As indispensable contributors to the delivery of health care services, women’s involvement in this project will be crucial to its success. We will seek robust participation by women in all activities including both participation and speaking positions during the policy dialogue. 

As part of the information collected for the issue paper, we will seek data that pertain to the impact of rare diseases on women.  We will also plan to hold a session during the Policy Dialogue that explores any gender-related aspects of rare diseases.  We will also seek a target female participation rate of 40% (including both speakers and participants) in the policy dialogue.

Work Plan

Dates

Actions

December 2017  – February 2018

PO will seek nominations of government, academic, and other stakeholders interested in joining the APEC Rare Disease Network. 

December 2017 - April 2018

·   Circulate survey to APEC economies and key stakeholders to identify barriers to healthcare services for rare diseases

·   Review and synthesize input of APEC economies and key stakeholders (governments, clinicians, academia, industry, patient groups)

·   Draft paper and circulate to interested APEC economies and key stakeholders for review and input

·   Coordinate any additional input on the paper

·   Submit final paper to all policy dialogue participants and LSIF members before the policy dialogue 

January – June 2018

Organize policy dialogue.

·   Seek and secure APEC economy to host policy dialogue

·   Identify and seek participation of key government officials, KOLs, patient groups, and other stakeholders from APEC economies

·   Identify and secure dates and meeting venue

·   Issue save-the-dates

·   Develop policy dialogue agenda

·   Identify and secure speakers, moderators, facilitators, and emcee

·   Issue and manage invitations

·   Develop and issue speaker guidance, coordinate speakers as needed

·   Manage presentations

·   Coordinate and manage arrangements for APEC-funded speakers and participants

·   Identify accommodations venue and coordinate transportation to/from meeting venue

·   Manage other meeting logistics

·   Hold two-day policy dialogue. 

April-August 2018

·   Develop draft of the APEC Rare Disease Action Plan

·   Coordinate input of network members and key stakeholders (governments, clinicians, academia, industry, patient groups)

·   Circulate draft Action Plan to policy dialogue speakers and participants in advance of policy dialogue

·   Coordinate input of policy dialogue speakers and participants during and after the policy dialogue

·  Revised draft Action Plan with input from policy dialogue

·   Submit Action Plan to LSIF for consideration.

Risks

Risk

Management strategy

Inability to secure participation in policy dialogue

Will contact ministries of health in all target economies and send program information to potential sites as early as possible so as to ensure our numbers 

Inability to secure project co-sponsoring economy to host the policy dialogue

The Project Overseer has already conducted outreach to some of the co-sponsoring economies to identify a potential venue for the policy dialogue. 

Not having enough/suitable takers in establishing the APEC Rare Disease Network

The PO will begin outreach as early as possible to recruit participants for the Network.  Most of the project co-sponsors (Australia, China, Indonesia, Malaysia, Chinese Taipei, Thailand) have already expressed an interest in nominating officials/key stakeholders to participate in the network.  The project can proceed even if economies are unable to nominate participants to join the network. 

Lack of interest by target beneficiaries

Concept received widespread, enthusiastic support from LSIF and has 7 co-sponsors 

Too few or too many interested members; members without appropriate expertise

Seek balanced representation from across APEC economies and among academia / industry / medical professionals / government; develop a list of back-up participants 

Difficulty identifying date when all members can participate 

Send dates as early as possible 

Not enough attendees able to attend

Request confirmations early so back-up members can be invited to participate 

Inability to secure quality speakers

The Project Overseer and Rare Disease Network will work together to identify potential speakers at least 4-5 months in advance of the meeting. 

Long Term Risk: lack of interest in implementing the Action Plan  

The Rare Disease Network is being established so that resources can be pooled by the various organizations to fund future programs.  Organizations are being recruited based on their long-term interest and commitment to the success of the initiative. 

Monitoring and Evaluation

Indicators to measure the project’s success will include:

1) the number of partners recruited to join the APEC LSIF Rare Disease Network – the target is 12;

2) the number of APEC Economies that contribute information/data on barriers to healthcare services for rare diseases – the target is 12;

3) the number of participants in the two-day policy dialogue in mid-2018 – the target is 75;

4) the number of new collaborations launched in support of the APEC Rare Disease Action Plan – the target by end of 2018 is 1 collaboration.  In addition, an evaluation will be developed and used to assess the effectiveness of the policy dialogue.  We will seek the active participation of women in all activities.

For the Policy Dialogue, the first indicator of success will be the number and type of participants that attend. The registration procedure will ensure that the organizations and roles of all participants are recorded. We will also seek to have women make up at least 40% of the total number of speakers and participants.  To evaluate the overall success of the policy program, participants will be asked to evaluate the content of the agenda and their satisfaction with the discussion following each day of programming. The feedback will be collated and distributed to the entire LSIF.

Linkages

This project cuts across areas of interest to numerous APEC groups, including the Committee on Trade & Investment (CTI); the LSIF Regulatory Harmonization Steering Committee (RHSC); and the Health Working Group (HWG).  Additionally, this project will engage multiple non-APEC stakeholders, including the academia, patient groups, civil society, and the private sector.  While there are a few international research groups focused on rare diseases, there is currently no initiative that brings together scientists, policymakers, healthcare practitioners and patients from APEC economies.  This project will leverage upon international initiatives such as the European Union Framework 7 Project RD Connect: An integrated platform connecting databases, registries, biobanks and clinical bioinformatics for rare disease research. The Project Overseer is co-lead of the Australian Consortium to RD Connect. We will not reinvent the wheel - this project will also leverage as much as possible global knowledge in this space, including international best practices and lessons learned.

Sustainability

Upon completion of this project, the policy dialogue and the Rare Disease Action Plan will have established essential groundwork for further action to address barriers to healthcare services for populations with rare diseases.  Additionally, the Rare Disease Network will have been established.  We will seek the support of an academic institution or center of excellence to provide support for the network to ensure its sustainability over the long term. The network and the self-funded satellite website will provide platforms for APEC economies to continue collaborative work on implementation of the Action Plan. With the RDN comprised of representatives from APEC governments, international organizations, medical associations, patient groups, and the private sector, the work begun through this project will continue well beyond the end of APEC funding and enable all beneficiaries to carry forward work towards removing the barriers to healthcare services for populations with rare diseases.

Project Overseers

Professor Matthew Bellgard is the inaugural Director of the Centre for Comparative Genomics (CCG) and the Professor and Foundation Chair of Bioinformatics, based at Murdoch University. The CCG, a Western Australian State Government Centre for Excellence, undertakes research in the biomedical and agricultural sciences on themes as diverse as human health, personalised medicine, animal and plant genomics and pathogens and viruses. As CCG Director, he was responsible for the expansion of the Centre into the fields of rare disease and molecular therapy. Pioneering research on innovative rare disease registries development and novel therapies for muscular dystrophy. Under his leadership, he has led the Centre into exponential growth. 

Professor Bellgard has a particular interest in rare diseases. He is co-leader of the Australian consortium in the European Union FP7 €12 million RD Connect program that focuses on providing an integrated platform connecting registries, biobanks and clinical bioinformatics for rare disease research. Under his leadership the CCG has deployed secure ICT solutions to: private hospitals; Department of Health - Western Australia; global and international rare disease patient advocacy communities and industry. These solutions address policy, privacy and consent issues across jurisdictions and require diverse, ongoing stakeholder engagement. His scientific work has resulted in developments in both the areas of pairwise sequence alignment and artificial intelligence, human genomics, bacterial bioinformatics, whole genome analysis and annotation for a range of species, as well as eResearch within a range of disciplines. 

Professor Bellgard’s is currently co-leading development of digital infrastructure for funded collaborative research in adaptive platform trials that are of particular relevance for rapidly evaluating new therapies for rare disease. This activity critically relies on quality health data linkage, patient engagement and reliable secure digital platforms that can operate across jurisdictions and health stakeholder business units. 

Viet Nam as the APEC 2017 host economy and co-proposing economy of this project will steer the direction of this project and contribute to the network, the policy dialogue, and potentially other collaborations.  The United States is the global leader in rare diseases and orphan drugs and is the other co-proposing economy of this project. The US will be a key resource for knowledge, experience, and best practices in rare diseases that can be shared with the other APEC economies.  The support of Viet Nam, the US, Australia, and the other co-sponsoring economies shows the tremendous interest in this project as well as the importance of regional/global collaboration to address the barriers to care for rare diseases.

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Not Applicable.

Waivers

Not Applicable.

Are there any supporting document attached?

No 
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Topics

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Gender

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