Project Title

Incentives to Bring New Antibiotics to APEC Markets 

Project Year

2022   

Project Number

HWG 05 2022A 

Project Session

Session 2   

Project Type

Standard 

Project Status

Completed Project   
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Project No.

HWG 05 2022A 

Project Title

Incentives to Bring New Antibiotics to APEC Markets 

Project Status

Completed Project 

Publication (if any)

 

Fund Account

APEC Support Fund 

Sub-fund

ASF: Human Security 

Project Year

2022 

Project Session

Session 2 

APEC Funding

107,200 

Co-funding Amount

Total Project Value

107,200 

Sponsoring Forum

Health Working Group (HWG) 

Topics

Health 

Committee

SOM Steering Committee on Economic and Technical Cooperation (SCE) 

Other Fora Involved

 

Other Non-APEC Stakeholders Involved

 

Proposing Economy(ies)

United States 

Co-Sponsoring Economies

Canada; Malaysia; Thailand 

Expected Start Date

01/02/2023 

Expected Completion Date

31/01/2024 

Project Proponent Name 1

Miranda Smith 

Job Title 1

Senior Global Health Officer 

Organization 1

US Department of Health and Human Services 

Postal Address 1

Not Applicable 

Telephone 1

(1-240) 429 7846 

Fax 1

Not Applicable 

Email 1

Miranda.Smith@hhs.gov 

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

Miranda Smith 

Project Summary

Antimicrobial resistance (AMR) is a threat to global health, global health security, and strong health systems and economies. Key to combatting AMR is addressing economic incentives to developing new antimicrobials and preserving the efficacy of currently available products. Global efforts incentivizing the antimicrobial R&D pipeline have somewhat succeeded, with new drugs gaining approval and proving that revitalizing the development of antimicrobials works. However, maintaining responsible stewardship continues to be a challenge. APEC provides an opportunity to address these issues through an economic impact lens. This project would survey existing strategies and best practices for economic incentives relevant to APEC economies, including examining and addressing barriers to market entry for new drugs. APEC economies would identify and create practical regional and economy-wide economic incentive strategies to support AMR efforts, market entry and access, while ensuring stewardship efforts remain a key part of access.

Relevance

Issues: Economic barriers to antibiotic drug development cause large biopharmaceutical and pharmaceutical companies to withdraw from the R&D development space leaving only smaller companies in the space who do not have the resources to ensure global access. Various reasons, including the struggle to achieve the capital needed to commercialize, cause small companies to declare bankruptcy after EMA or FDA approval and before the drugs can reach the patients that need them. This disincentivizes large pharma from engaging in the R&D needed to develop new molecules. AMR poses significant challenges across APEC economies. Diseases with drug resistance do not respect borders, and severely strain hospital systems and economies. The Global Health Security Agenda notes that resistant pathogens and genes continue to spread globally, and new resistance mechanisms are emerging, which threaten our ability to treat common infectious diseases, resulting in prolonged illness, disability, and death.

According to recent publications from the World Bank, in the optimistic case of low AMR impacts, the simulations found that by 2050, annual global gross domestic product (GDP) would likely fall by 1.1 percent, relative to a base-case scenario with no AMR effects; the GDP shortfall would exceed $1 trillion annually after 2030. In the high AMR-impact scenario, the world will lose 3.8 percent of its annual GDP by 2050, with an annual shortfall of $3.4 trillion by 2030. It is critical that global economies and partners work to stabilize and incentivize market entry so these much-needed antibiotics are available on a sustainable scale. Due to the interconnectedness of 21 partner economies, APEC is a forum for which there is potential to harmonize several smaller economies to tackle the economic challenges brought by AMR.

Promoting and developing strategies to remove barriers to market entry for new antibiotics and providing incentives to companies to develop new life saving antibiotics helps advance the goals and mission of the SCE. This project will identify and compile existing strategies aimed at economic incentives for antibiotic development and address barriers to market entry, allowing for strengthened health systems for universal coverage and sustainable development. Following the assessment, it will convene a capacity building workshop to develop regional economic incentive strategies for AMR efforts.

Eligibility and Fund Priorities: This project supports capacity building for developing Asia Pacific economies and relevant to the Human Security sub-fund supports both 1) Health Security; and 2) Emergency Preparedness. Infectious diseases with pandemic potential have the capacity to affect everyone, everywhere. Cooperation on policy can contribute to timely and equitable access to safe and effective medical technology in the region and around the world. Fighting any pandemic requires collective and multisectoral action and APEC is uniquely positioned to take the initiative.

Capacity Building: This project meets the goals and objectives outlined in the Guidebook, by providing a workshop focused on building the capacity of APEC member economies in line with APEC’s long-term goals for structural reform.  The project is designed to benefit all APEC member economies, including developing economies, by conducting a gap analysis and resulting workshop with options/implementation strategies that will enable increased access to antimicrobials through economic incentives, better stewardship of existing antimicrobials and combatting AMR. These feed into greater global health security strengthening and pandemic prevention and preparedness. 

Objectives

The objective is to build the capacity of APEC member economies to combat antimicrobial resistance, increase access to new antimicrobials while maintaining effectiveness of current antimicrobials. This would include addressing barriers to market entry and new drug development, equitable access, and preserve current antimicrobials through stewardship efforts. This is in line with the Putrajaya Vision 2040 which seeks to ensure the Asia Pacific region is resilient to pandemics and other emergencies, and to foster quality growth that brings palpable benefits and greater health and wellbeing to all.

Alignment

Alignment to APEC: The APEC Health Working Group (HWG) workplan states that, the Putrajaya Vision 2040 set out the objective to “ensure the Asia-Pacific region is resilient to pandemics and other emergencies, foster quality growth that brings palpable benefits and greater health and wellbeing to all.” The implementation plan of Putrajaya Vision, Aotearoa Plan of Action, pledged to “enable quality and equitable health access and outcomes for all with a view to achieving universal health coverage, including by strengthening health systems, preventing, detecting, responding to, and recovering from, pandemics.”

Alignment to Forum: The HWG workplan notes that “Economic growth is multi-faceted and inter-sectoral, and the health of a population plays an important role in the health of an economy. The COVID-19 pandemic has demonstrated that a health threat anywhere is a threat everywhere. This year, the HWG will enhance its effort to address issues at the nexus of health and the economy. We will discuss the economic impact of global health security and explore the utilization of the BCG Economy Model to support sustainable economic growth and economic resilience, health-related innovation cooperation, and UHC to strengthen global health security.” AMR is a global health security threat, which to be addressed successfully relies on infection prevention and control and surveillance in the health sector, and on innovation and R&D in the private sector. Strong health systems and economies are essential to both the prevention of and response to antimicrobial resistance.

TILF/ASF Justification

Not Applicable.

Beneficiaries and Outputs

Outputs:  

1.  Gap Analysis on Barriers to Market Entry and Access in APEC Economies: There is limited information from the perspective of the Asia Pacific region on how they think their markets could be adapted to bring in old and new antibiotics and antifungals. Barriers fluctuate based on domestic regulatory and licensing requirements, payment systems, guidelines for use, lack of antimicrobial industry presence, stewardship requirements, barriers to safe and environmentally friendly manufacturing, etc. In this context, APEC economies and their global partners are ideally suited to examine these issues from a different perspective so that solutions can be adapted to regional and economy specific requirements and concerns. 

The gap analysis will be performed through a survey of APEC economies. It will be presented to APEC economies by email prior to SOM1 to allow sufficient time for economies to identify AMR experts who can accurately respond on the current status of the antimicrobial market in their economy. 

The answers to the survey will inform the agenda of the Workshop, including to identify solutions to be discussed and best practices currently utilized. The survey will be an electronic questionnaire with both multiple-choice and free-answer questions. The content of the survey will investigate what economies are implementing pre-market incentives (research and development, production/maintenance, stewardship/data collection), pull incentives and/or reimbursements, and will request input for perceived barriers to market entry. The survey will encompass approximately 10 pages, including directions, definitions, and the questionnaire. The answers provided by economies will be shared at the Workshop but will be de-identified to the extent possible to ensure privacy and encourage economies to be candid in free-answers. 

2. 2-day In-Person Workshop: HWG members will be invited to participate in a two-day workshop on the margins of the SOM3. At the workshop, participants will have the opportunity to engage in discussion of the gap analysis, provide economy best practices, and discuss which proposed solutions (worked on intersessionally) should be included in the options paper.  The workshop will include some expert speakers and representatives from the global initiatives working on AMR, including CARB-X, GARDP, and SECURE, but will also rely on the contributions of representatives from APEC economy competition agencies (or other relevant government agencies). The workshop will be hosted in the US in August 2023 on the margins of SOM 3. The Workshop will include sessions addressing the themes or issues identified within the gap analysis survey. We expect topics to demonstrate how various financial incentives may enable or accelerate the production of antimicrobials. Potential capacity-building activities will include panel discussions and economy representatives presenting case studies or policy perspectives. Activities may also include breakout sessions to allow smaller groups of similar economies to discuss the proposed solutions and brainstorm recommendations. 

3. Options Paper on Barriers to Market Entry and Access for Antimicrobials: Following the workshop, an options paper will be finalized. Project Overseer will draft the Options Paper including discussions from the workshop, to be circulated to the HWG for comment, and published on the APEC website. In the publication of the Options Paper, the Project Overseer will make recommendations about possible areas of future work based on the lessons learned at the workshop. The report is expected to be approximately 20 pages, depending on the number of economy responses received. The structure will include an Introduction and Overview, Executive Summary, Selected Issues (identified from the gap analysis survey), a summary of key Workshop discussions/findings/presentations, and the solutions suggested and recommendations for APEC economies. 

Outcomes:  

1. Identified potential solutions for implementing improvements to antimicrobial market entry: This will assist APEC economies in identifying new actions they can take to combat antimicrobial resistance and will be measured by asking participants to list what initiatives or changes they are contemplating. We will track which solutions are proposed by economies within the Options Paper. 

2. Increased skills and knowledge among APEC-member economies: This will be measured by a pre- and post-workshop assessment of economies.  In addition to assessing the value of the workshop, the assessment will ascertain pre- and post-workshop economy plans. 

3. Increased market access for antimicrobials in APEC economies: This will be measured by a post- one-year assessment of what changes economies have made. This will further enable assessment of the workshop and verify sustainability of outcomes. 

Beneficiaries: The targeted beneficiaries of this project are health policymakers, officials and decisionmakers in APEC economies, government officials within Health Ministries, regulatory bodies, and Economic Ministries, and members of other relevant APEC partners in the private sector, academia, NGOs, and international organizations. Project participants will be engaged in an interactive in-person workshop with opportunities for discussion and exchange with fellow participants and expert speakers. The ideal participants will be experts on antimicrobial or AMR policy within their economies. 

We will seek to have engagement from all APEC economies in the workshop to reflect the diverse views and experiences across APEC and emphasize the importance of nominating gender-balanced delegations to attend and participate in the workshop. The project will survey existing strategies and best practices for economic incentives relevant to APEC economies, including examining and addressing barriers to market entry for new drugs. 

This project will provide the basis of future actions taken by public health authorities and policymakers in the APEC economies to identify and create practical regional and economy-wide economic incentive strategies to support AMR efforts, market entry, and access. This will benefit all people by reducing the economic loss and health care costs associated with AMR and improving regional health security. The workshop and subsequent options paper will engage different systems in administering financial incentive payments to manufacturing and pharmaceutical companies. Both the industry and governments will be engaged and therefore public-private partnerships (PPPs) will be enabled, strengthened, or developed from this project.

Dissemination

The target audience for dissemination of the options paper will include:

a)  HWG member economies;

b) Government officials in charge of R&D, AMR stewardship, and/or policy; and

c)  Other relevant APEC fora members.

The form and content of the result of the project as well as a the final Options Paper is expected to be published by 30 November 2023. A limited number of hard copies (max. 120) will be made available in conjunction with the materials to the APEC website.

Gender

Sound competition policy is one of the building blocks for ensuring free and fair trade, including equal access to, and participation by, women in the economy.  Our workshop will aim to have equal representation of gender in both speakers and participants, ensuring diversity in the viewpoints expressed at the workshop and highlighting contributions of female leaders within APEC economies. The Project Overseer is committed to collecting sex-disaggregated data for all speakers and participants (not only those funded by APEC) at the project event. This data will be included when submitting a Completion Report to the Secretariat upon completion of the project, as well as providing guidance to future Project Overseers on their own gender parity targets.

Targets

Female Participants (%)

50%

Female Speakers/Experts (%)

50%

Referring to the Guide on Gender Criteria for APEC Project Proposals in the Guidebook on APEC Projects, please tick the pillar or pillars that this project supports, in promoting women’s economic empowerment:

5 Pillars (you may tick more than one)

1

Access to Capital and Assets

2

Access to Markets

X

3

Skills, Capacity Building, and Health

X

4

Leadership, Voice and Agency

X

5

Innovation and Technology

X


Work Plan

Timeline

Tasks

Deliverables

Feb 2023

Gap analysis survey tasks:

a)   Undertake research of studies on the effect of antimicrobial market incentives to inform survey

b)   Draft survey

c)    Disseminate survey by email

d)   Announce survey/workshop intent at SOM1

Completed/distributed gap analysis survey

Feb – Mar 2023

Draft Terms of Reference for STC and event management tasks

Draft contract following selection

Contracts signed

Mar 2023 

1.     

Solicit experts and other speakers

Confirmation of venue and logistics for workshop

Official invitations sent to member economies

Invitations

1 Apr 2023

Submit APEC Project Monitoring Report to the Secretariat

APEC Project Monitoring Report

Apr 2023

Receive responses to gap analysis survey and compile data

May 2023

Workshop planning tasks:

a)   Develop agenda for workshop based on survey responses

b)   Finalize workshop speakers/participant list

c)    Draft GIC to include agenda, speakers and bios, venue and logistics, participant profile and nomination form.

Workshop agenda

Final speaker/participant list

GIC

Jun 2023

Disseminate GIC

Workshop ex-ante survey

GIC circulated

Survey results

Jul 2023

Finalize workshop speaker/participant list

Complete the gap analysis and send final version to the meeting participants

Begin work on the Options Paper

Draft Options Paper

Aug 2023

Conduct a two-day Workshop (in-person with possible livestream option for registered participants) back-to-back with Annual HWG SOM3 Meeting

Workshop ex-post survey

Documentation of Workshop and participant outputs

Workshop presentations/handouts

Aug – Sep 2023

Circulate draft Options Paper to participants following the Workshop, for comment

Draft Options Paper

Oct – Nov 2023

Finalize Options Paper and submit to APEC Secretariat for review and approval for publication and endorsement by HWG

Final Options Paper report  (planned submission date 1 Oct for 30 Nov publication date)

31 Jan 2024

Project completion date

Mar 2024

Submit APEC Project Completion Report and supporting documents to Secretariat

APEC Project Completion Report

6 to 12 months upon project completion

Participate in Longer Term Evaluation of APEC Projects (LTEAP) annual survey



Risks

No.

Risks

How will it be managed?

1

Some economies may not attend APEC HWG

APEC funds will pay for travel for speakers; we will also endeavor to provide a livestream of the program though due to budgetary limitations will not be able to provide full virtual participation.

2

Economies will not send the appropriate representatives

Project Overseers will do direct outreach to fellow APEC members to ensure participants are from relevant technical agencies or other relevant government officials. 


Monitoring and Evaluation

Evaluation Focus

Indicators

Target Goals

Evaluation Method

Reporting Method

Outputs

1.   Gap Analysis Survey

1.      No. of pages

10

Certification by PO

Email to the Secretariat

2.      No. of solutions identified

5-10

Gap analysis survey responses

Options Paper

3.      No. of economies surveyed

21

Gap analysis survey responses

Options Paper

4.      No. of developing economies surveyed

9

Gap analysis survey responses

Options Paper

5.      No. of responses received

10

Gap analysis survey responses

Options Paper

2. Options Paper

1.      No. of pages

20

Certification by PO

Email to the Secretariat

2.      Submission to the Secretariat and EC

1 Dec 2023

Submission to the Secretariat and PD

Email to the Secretariat and EC

3.      Content developed and deployed

30 September 2023

Certification by PO

Completion Report

4.      No. of solutions identified

5

Gap analysis survey responses

Workshop and Completion Report

3.      Workshop

1.      No. of participants (excl. speakers/experts)

40

Event Attendance List

Completion Report

2.      % of participating men/women (excl. speakers/experts)

50/50

Event Attendance List

Completion Report

3.      No. of speakers/experts engaged

6

Event Attendance List

Completion Report

4.      % of speakers/experts (men/women)

50/50

Event Attendance List

Completion Report

5.      No. of attending economies

15

Event Attendance List

Completion Report

6.      No. of travel eligible economies

7

Event Attendance List

Completion Report

7.      Content developed and deployed

30 Aug 2023

Certification by PO

Contract

Out-comes

1.    Increase in participant’s knowledge and skills relating to AMR

1.     % of participants report substantial knowledge increase

75%

Ex-ante and ex-post evaluations

Completion Report

2.     Developing APEC economies report substantial knowledge increase

75%

Ex-ante and ex-post evaluations

Completion Report

2.    Identification of Solutions

1.      Recommendations in Options Paper

50% of economies will identify solutions to increase market access

Evaluation form from workshop (including input from HWG members) and Options paper

Completion Report

3.    Increased Market Access

1.      APEC economies report implementation of or progress toward implementation of market incentives

50% of responding economies will identify implementation of solutions or current in-progress implementation

Project-overseer administered post-one-year survey of changes implemented within economies

Completion Report and Post-One-Year Follow-up Report


Linkages

Within APEC, HWG is the sub-fora of SCE with responsibility for health and health security issues including pandemic prevention and response.  Other sub-fora within APEC who will also benefit: the APEC Business Advisory Council, Market Access Group and Public Policy Partnership in Science, Technology, and Innovation (PPSTI). 

This project will build upon existing HWG action plans including the APEC Action Plan on Vaccination Across the Life-Course (2021); the APEC Roadmap to Promote Global Medical Product Quality and Supply Chain Security (2018); the APEC-Global Health Security Agenda (GHSA) Framework on Infection Control Infrastructure (2015); the APEC Guideline to Tackle AMR in the Asia-Pacific Region (2014); and the Medan Principles for Public-Private Partnerships in Infection Prevention & Control (2013).

To date previous work on AMR in APEC has not addressed the development of strategies to remove barriers to market entry for new antibiotics and provide incentives to companies to develop new life saving antibiotics.

Sustainability

The workshop is designed for participants from APEC member economies to develop knowledge on the barriers and options involved in ensuring market entry and availability of antibiotics and antifungals, look for areas of coordination with other APEC economies and global partners, and commit to consider implementing changes proposed by the workshop. The results of the work will be uploaded to the APEC webpage. The report on the program will include recommendations on future work to be done within the HWG.  At the annual meeting following the publication of the final project report, the project will ask the Convenor of the HWG meeting to collect anecdotal evidence of longer-term indicators of success.

Project Overseers

Miranda.Smith@hhs.gov

Dr. Miranda Smith is the Senior Global Health Officer on OGA’s Asia and the Pacific regional team and has background in AMR and global health security. Dr. Smith is a certified antimicrobial stewardship pharmacist and has authored multiple hospital and outpatient stewardship protocols; she is also a certified Project Management Professional. Dr. Smith will oversee the project, coordinate with the AMR team on policy development, and provide subject matter expertise to complete the work proposed.

Lynn Filpi, Senior Advisor and Team Lead for One Health and AMR, Pandemic Emerging Threats, HHS Office of Global Affairs lynn.filpi@hhs.gov

Dr. Filpi leads the OGA AMR team that will handle the coordination, policy, and provide subject matter expertise to complete the work proposed. In addition to Team lead responsibility, Dr. Filpi tri-chairs the international arm of the CARB Taskforce with State and USDA which will ensure appropriate experts from across the USG interagency are involved. Dr. Filpi is the USG coordinator for TATFAR, the USG Board Member for the Global AMR R&D Hub, represents OGA on the CARB Economic Incentives working group, and is the HHS SME for work on incentives with the G7 enabling her to bring in the appropriate global contacts and experts to complete this work while ensuring it is not duplicative of work in other forums.

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Event Management: The Event Manager is responsible for overseeing various tasks related to the event planning process and working with the Workshop organizers to ensure the completion of a successful event.

Specific Duties:

  • Meeting with workshop organizers to discuss the event and what they’re looking for
  • Creating an event proposal and budget that fits the organizers’ requirements
  • Liaise with vendor(s) and stakeholder(s) during the event planning process to ensure everything is in order.
  • Manage all event set-up, tear down, and follow-up processes.
  • Maintain event invoices for budget tracking.
  • Coordinate event services such as rooms, transportation, and food
  • Monitor event activities to ensure that the client and the attendees are satisfied
  • Conduct final inspections on the day of the event to ensure everything adheres to the client’s standards.
  • Ensure ongoing communication with the client to keep them up to date on any changes
  • Serving as the main contact point for any and all problems that arise at the event

Waivers

Not Applicable.

Are there any supporting document attached?

No 
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Version HistoryVersion History

Project No.

Project Title

Project Status

Publication (if any)

Fund Account

Sub-fund

Project Year

Project Session

APEC Funding

Co-funding Amount

Total Project Value

Sponsoring Forum

Topics

Committee

Other Fora Involved

Other Non-APEC Stakeholders Involved

Proposing Economy(ies)

Co-Sponsoring Economies

Expected Start Date

Expected Completion Date

Project Proponent Name 1

Job Title 1

Organization 1

Postal Address 1

Telephone 1

Fax 1

Email 1

Project Proponent Name 2

Job Title 2

Organization 2

Postal Address 2

Telephone 2

Fax 2

Email 2

Declaration

Project Summary

Relevance

Objectives

Alignment

TILF/ASF Justification

Beneficiaries and Outputs

Dissemination

Gender

Work Plan

Risks

Monitoring and Evaluation

Linkages

Sustainability

Project Overseers

Cost Efficiency

Drawdown Timetable

Direct Labour

Waivers

Are there any supporting document attached?

hdFldAdmin

Project Number

Previous Fora

Secretariat Comments

Reprogramming Notes

Consolidated QAF

Endorsement By Fora

PD Sign Off

Batch

Forum Priority

Committee Ranking Category

Committee Priority

PDM Priority

Priority Within Funding Category

Monitoring Report Received

Completion Report Received

PMU Field 1

PMU Field 2

PMU Field 3

On Behalf Of

Proposal Status

Originating Sub-Forum

Approval Status
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