Project Title

Closing the Gaps in Good Manufacturing Practices Compliance along the Blood Supply Chain in APEC Economies 

Project Year

2016   

Project Number

CTI 30 2016A 

Project Session

Session 2   

Project Type

Standard 

Project Status

Project in Implementation   
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Project No.

CTI 30 2016A 

Project Title

Closing the Gaps in Good Manufacturing Practices Compliance along the Blood Supply Chain in APEC Economies 

Project Status

Project in Implementation 

Publication (if any)

 

Fund Account

APEC Support Fund 

Sub-fund

ASF: Human Security 

Project Year

2016 

Project Session

Session 2 

APEC Funding

85,000 

Co-funding Amount

100,000 

Total Project Value

185,000 

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 

Co-Sponsoring Economies

Indonesia; Malaysia; Mexico; Peru; Viet Nam 

Expected Start Date

01/01/2017 

Expected Completion Date

31/12/2017 

Project Proponent Name 1

Dr Maureen M Goodenow 

Job Title 1

Senior Advisor 

Organization 1

Bureau of East Asian and Pacific Affairs, US Department of State and the University of Florida 

Postal Address 1

2201 C Street, NW, Washington, DC 20520, USA 

Telephone 1

1-352 3165138 

Fax 1

Not Applicable 

Email 1

goodenow@ufl.edu 

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

Dr Maureen M Goodenow 

Project Summary

The APEC Blood Supply Chain 2020 Roadmap, welcomed by APEC Ministers and Leaders in 2015, calls for capacity building in economies to integrate quality systems throughout the blood supply chain.  Implementing Good Manufacturing Practices (GMP) at all levels of the blood supply chain is critical for achieving consistent quality in the preparation of blood and blood products. GMP compliance varies widely across the APEC region; many APEC economies still struggle to implement GMP into their daily practice.  This project proposes to help APEC economies close remaining gaps in GMP compliance along the blood supply chain through a survey and 3-day policy dialogue.  The survey will allow APEC economies to assess current domestic practices in relation to international practice, identify gaps and priorities in GMP compliance.  The policy dialogue will allow APEC economies to review and discuss gaps identified in the survey and identify and exchange strategies for closing the gaps in international GMP compliance along the blood supply chain. The policy dialogue will also examine the economic benefits of GMP compliance, including the return on investment in attaining GMP, plasma fractionation opportunities, and improving access to innovative treatments for bleeding disorders and other rare diseases in APEC economies.

Relevance

The APEC Blood Supply Chain 2020 Roadmap, welcomed by APEC Ministers and Leaders in 2015, calls for capacity building in APEC Economies to improve technical competence and understanding of quality systems among stakeholders in the blood supply chain.  The blood supply chain is a multi-step process with risk of error in each step (from selecting qualified donors, collecting and processing donations, testing of donor and patient samples, issue of compatible blood, to transfusing the patient).  In 2010, the 63rd World Health Assembly recognized the importance of establishing reliable quality assurance systems covering the blood supply chain as a necessary measure to increase the global availability of blood and blood products that meet internationally recognized standards.  An effective quality system provides a framework for supply chain activities to be established, performed in a quality-focused way, and continuously monitored to improve outcomes. The risks associated in the blood supply chain can be significantly reduced by implementing Good Manufacturing Practices (GMP).  

According to the World Health Organization (WHO), compliance with GMP Guidelines at all levels of the blood supply chain is critical for achieving consistent quality in the preparation of blood and blood products.  A GMP approach to consistently manufacture safe blood components that meet predefined specifications and customer’s expectations provides a model that allows for a documented system of incorporating quality throughout the entire process of the blood supply chain.  Once GMP compliance is achieved, blood centers in the APEC region will be prepared to address opportunities for centralization and regionalization, advanced testing strategies, and manufacturing plasma.  At the present time, however, GMP compliance varies widely across the APEC region; many developing APEC economies still struggle to implement GMP into their daily practice. The quality and safety of locally-manufactured products can only be ensured if APEC Economies implement and enforce appropriate international GMP standards. 

 This project proposes to help APEC economies close remaining gaps in GMP compliance along the blood supply chain through a survey and 3-day policy dialogue in 2017 and follow-up assessment in 2018.  APEC and self-funding funding will support the development and distribution of a survey in early 2017 and a report on the survey results by Q4 2017.  The survey will allow APEC economies to assess current domestic practices in relation to international practice (adequate infrastructures, indicators and criteria for inspection) and identify gaps and priorities in GMP compliance.  Information gathered during the December 2016 APEC Blood Supply Chain Policy Forum in Hanoi, Vietnam (existing project) will also inform the survey’s development. 

APEC and self-funding will also support a 3-day policy dialogue in late 2017 to review and discuss gaps identified in the survey and identify and exchange strategies for closing the gaps in international GMP compliance along the blood supply chain. The policy dialogue will also examine the economic benefits of GMP compliance, including the return on investment in attaining GMP, plasma fractionation opportunities, and improving access to innovative treatments for bleeding disorders and other rare diseases in APEC economies. Follow up assessments will be conducted in 2018.  This project will seek to leverage other APEC developed economies that have strong GMP compliance to support capacity building in APEC economies. The policy dialogue will include representatives from ministries of health, domestic regulatory authorities, and blood services leadership in APEC economies as well as representatives of the Pharmaceutical Inspection Cooperation Scheme (PICS), the World Health Organization, ASEAN; academia, private sector, civil society, and other GMP expert groups.

This project is aligned with 2016 funding criteria, specifically Rank 1 criteria of promoting regional economic integration through “standards, conformity assessment, technical regulations, regulatory cooperation, and regulatory coherence, including good regulatory practices”; “Building sustainable and resilient communities”; and, “emergency preparedness and disaster management, including activities relating to the efficient movement of capital, goods, services and people”.  Further, the project supports the APEC Regulatory Cooperation Plan endorsed by APEC Leaders and Ministers in 2010.  Finally, the program  advances Peru’s APEC 2016 host year theme “Quality Growth and Human Development” and priorities of “Investing in Human Capital Development” and “Advancing in the Regional Economic Integration and Growth Agenda”.

Objectives

·  To increase knowledge of international GMP compliance along the blood supply chain in APEC Economies by conducting a survey in early 2017 to assess current domestic practices in relation to international practice, identify gaps and priorities in GMP compliance.

·  To build capacity of APEC economies by holding a 3-day policy dialogue in late 2017 and assessments in 2018.  Both activities will allow APEC Economies to review and discuss gaps identified in the survey and identify and exchange strategies for policy-level action to support international GMP compliance along the blood supply chain.  This project will also increase knowledge of APEC Economies on the economic benefits of GMP compliance, including the return on investment in attaining GMP, plasma fractionation opportunities, and improving access to innovative treatments for bleeding disorders and other rare diseases.

Alignment

In May 2016 in Arequipa, Peru, APEC Ministers Responsible for Trade “welcome(d) the LSIF’s quality systems capacity building work in laboratories, hospitals and blood banks to promote use of international standards.”  In November 2015 in Manila, Philippines, APEC Economic Leaders “welcomed the training network established to ensure the safety of our region’s blood supply”.  The APEC 2015 Joint Ministerial Statement also “welcome(d) the development of the APEC Blood Supply Chain 2020 Roadmap, and the establishment of the Blood Supply Chain Partnership Training Network.” In August 2015 in Cebu, Philippines, Health Ministers participating in the 5th APEC High-Level Meeting on Health & Economy stated: “to ensure sustainable access to safe blood across the APEC region, we endorsed the APEC Blood Supply Chain 2020 Roadmap and welcomed the establishment of the Blood Supply Chain Partnership Training Network to support the Roadmap’s implementation. 

This project effectively promotes the goals of the 2004 LSIF Strategic Plan in the area of “Good Manufacturing Practices”.  The LSIF’s goals for advancing GMP adherence are: 1) work, individually and together, to ensure the adequate training of government personnel, including inspectors and industry personnel; 2) assess current domestic practices in relation to international practice (e.g., WHO guidance); 3) establish a regulatory framework that recognizes manufacturers with history of adhering to GMPs (a. performance based on international best practices; b. Pharmaceutical Inspection Cooperation Scheme (PICS) as a mechanism for training, documentation and information exchange across APEC Economies); 4) develop performance assessment criteria based on international best practices— adequate infrastructure, indicators and criteria for inspection. This project also addresses the LSIF Strategic Plan’s goals of promoting harmonization of regulatory standards and practices for life sciences products and services through collaboration with relevant international standards bodies.

TILF/ASF Justification

This project aims to improve the development of blood systems and build the capacity of health systems of APEC developing economies. All four of the project co-sponsors are APEC developing economies. Each of these economies will be engaged throughout the development and execution of this project through participation in the Partnership Training Network (PTN). The project will also take place in an APEC developing economy. 

Following the policy dialogue, support networks will be created that will provide participating institutions in APEC developing economies with the information and resources to drive change and make improvements to their GMP compliance within the blood supply chain.  The goal is to have institutions achieve an international accreditation of their quality system and certification of compliance with international standards in key operational areas.

Beneficiaries and Outputs

Outputs: The outputs of this project will be one (1) survey and report of GMP compliance within the blood supply chain in APEC developing economies and one (1) policy dialogue over 3 days focused on closing the gaps in GMP compliance. The outputs will be under the guidance on the LSIF Blood Supply Chain Partnership Training Network Advisory Board in support of further implementation of the APEC Blood Supply Chain 2020 Roadmap developed in late 2014 and endorsed by the LSIF in early 2015. 

The host of the policy dialogue will be selected from the APEC developing economies, which will be invited to put forward an “expression of interest” to host the dialogue.   The short proposals will be reviewed and selected by the Project Overseer and the PTN Advisory Board.  The ideal host would be able to provide a meeting venue in a safe and easily accessible location and demonstrate a commitment to the initiative.  Those economies that are not selected to host the program will be prioritized to host workshops and training programs in 2018. 

In order to produce the budget estimate for this project, Jakarta, Indonesia is identified as the destinations for the policy dialogue.  Please note that this economy has not been selected as the host of the policy dialogue, but is eligible to apply.  Following completion of the survey, report, and policy dialogue, the PTN Advisory Board will begin work with APEC economies and key stakeholders to develop GMP compliance assessments in 2018 to follow up on the progress made since the previous outputs of 2017. 

Outcomes: The success of the survey and policy dialogue will enable the participating economies involved to continue to commit resources towards this initiative over the medium-term (at least through 2020). This will allow for sustainable, self-funded improvements to continue in APEC developing economies for implementation of the 2020 Roadmap. 

The GMP Adherence Survey and Report of GMP compliance status within the blood supply chain of selected APEC developing economies are focused on clear benchmarking of progress and improvement needs according to international GMP standards. The report targets the main goal of closing the gaps in GMP compliance by first identifying precisely where improvement is needed. The survey and resulting report will provide the necessary background for the medium-term goal of implementing the 2020 Roadmap.  A direct result will be the ability to formulate an informed action plan towards GMP compliance that can be tailored to specific, individual economy’s needs. The content will also provide the strongest guidance for the second output of this project, which is the 3 day policy forum. 

The 3 day policy dialogue will focus on an agenda directly based on the GMP Adherence Survey Report in addition to the 3rd APEC Blood Supply Policy Dialogue (December 2016). The combination of these two sources of insight into GMP adherence will help maximize the relevance and resulting impact of the policy dialogue. The agenda for the dialogue will also include the economic payoff for investment in GMP, including improved efficiency and performance of blood establishments, plasma fractionation opportunities, and improved access to innovative treatments for bleeding disorders and other rare diseases in APEC economies, thereby expanding the reach of the project. 

Policy changes and eventual behavior changes regarding GMP compliance are the expected medium-term outcomes of this event. Such policy changes may include establishing a regulatory framework that recognizes manufacturers with histories of adhering to GMPs (a. performance based on international best practices; b. Pharmaceutical Inspection Cooperation Scheme (PICS) as a mechanism for training, documentation and information exchange across APEC Economies); developing a performance assessment criteria based on international best practices— adequate infrastructure, indicators and criteria for inspection; and promoting harmonization of regulatory standards and practices for life sciences products and services through collaboration with relevant international standards bodies. Additionally, this dialogue has the potential to increase discussion with finance officials and extend cross-fora collaboration due to the multi-sectoral nature of GMP compliance. 

The dialogue will include representatives from ministries of health, domestic regulatory authorities, and blood services leadership in APEC economies as well as representatives of the Pharmaceutical Inspection Cooperation Scheme (PICS), the World Health Organization, ASEAN; academia, private sector, civil society, and other GMP expert groups. The dialogue will continue to facilitate exchange of strategies between economies of varying development status and promote policy goals that can help address the current gaps within these economies and promote changes in the medium-term time frame. 

Beneficiaries: The beneficiaries of this project are populations within APEC economies who will have improved access to blood services. Building the capacity to provide safe blood will strengthen health systems across the APEC region and the services they provide to the populations of the entire region. 

Output #1 and #2: The first and second output of this project will be the GMP Compliance Survey and Report distributed to selected APEC developing economies. 

Output #1 and #2 Beneficiary: The target audience of the survey and report are blood services leadership and managers in addition to state regulatory officials (regional, local, etc. depending on the economy). The survey and report will engage individuals responsible for implementing GMP standards in local blood organizations in addition to regulatory officials who are responsible for greater blood supply security. The report will identify specific gaps in compliance for each responding blood center which can used to promote directed, efficient actions towards achieving GMP compliance. The survey and report will also enable higher level officials to gauge the greater status of GMP compliance within their region and therefore allow better informed policy discussion moving forward. In addition to the economy specific audience, this output targets the PTN Secretariat and PTN Advisory Board in that the information gathered will largely guide the agenda for the policy dialogue and future engagements. 

Output #3: The third output of this project will be the Policy Dialogue held in a selected APEC developing economy.  

Output #3 Beneficiary: The benefits of this output are primarily the audience of APEC economy regulatory officials engaged in policy discussion and decision making regarding blood products and services. The benefitting audience is not limited to this group, however, and will include all of the PTN participants, including health officials and blood safety leaders within APEC economies; members of the LSIF and RHSC, the HWG; representatives of the international organizations such as the WHO and the ISBT (International Society for Blood Transfusion), as well as academia, civil society, and the private sector, including healthcare providers. All participants will benefit from the dialogue on progress made and remaining gaps to be filled in cGMP compliance. One other notable target audience will be stakeholders (public and private) within the financial sector who will benefit from a greater understanding of the returns on investment of GMP compliance and the need for more inclusion of financial officials in health policy discussion. 

Additional organizations, such as Red Cross organizations, are being recruited within APEC Member Economies to join this initiative.  These organizations have direct oversight and access to a broad networks of blood banks and bankers.  The Asia-Pacific Blood Network (APBN), an organization comprised of domestic blood services organizations within the Asia-Pacific region, will serve as a key partner in the PTN and in recruiting organizations and individuals to participate in the survey and policy dialogue.

The policy dialogue will also enable the target audiences to develop a network of partners and resources from across the APEC region, from whom and from which they can draw upon as they work to strengthen their quality system and improve GMP compliance with conformance to international standards. 

Output #4: The fourth output will be a 2018 assessment of the updated status of GMP compliance in participating APEC economies. 

Output #4 Beneficiary: The evaluations will benefit the target audience (participating economies, blood services leadership and managers who implement the quality system in their blood organization) as the feedback provided will allow the PTN Secretariat and PTN Advisory Board to continue to develop programs and tools to help facilitate completion of the 2020 Roadmap.

Dissemination

The GMP Compliance Survey will be available to selected APEC developing economies electronically as well as in hard copy form. Mailing addresses will be attained through connections within the APEC network as well as coordination with Ministries of Health of selected economies.

The Report from the GMP compliance survey will be developed and made publicly available through the APEC website and the LSIF webpage.  The partner institutions involved in the PTN will also be invited to make the report available on their websites.  Regular updates on the PTN initiative will continue to be presented to conferences of the major organizations involved in the PTN, such as the AABB Annual Conference; the International Society of Blood Transfusion (ISBT) Annual Meetings; the Asia Pacific Blood Network (APBN) Board Meetings and Conferences; the Plasma Protein Therapeutics Association (PPTA) regular meetings and workshops in the Asia-Pacific region.  The PTN and PTN Advisory Board will seek additional opportunities to present updates and outcomes of the initiative through international organization meetings (WHO); meetings of the International Red Cross and Red Cross organizations in APEC Member Economies; and other industry and academic events and workshops as appropriate.

All survey and report materials will also be made available to all participating blood bank participants and those involved in the PTN.

Output

Dissemination Plans

Target Audience

GMP Compliance Survey

The PTN will work with the LSIF, the LSIF RHSC, and the HWG to identify target economies and essential points of contact for survey dissemination

Blood services leadership and managers who implement the quality system in their blood organization

GMP Compliance Survey Report

The final report will be disseminated to all participating economies’ regulatory officials, PTN Advisory Board, the LSIF, the APEC Secretariat, and individual participant blood banks

Health officials and government regulatory authorities overseeing blood products and services; academia; industry; civil society in addition to Blood services leadership and managers who implement the quality system in their blood organization

In person policy dialogue

The PTN will work with the LSIF, the LSIF RHSC, and the HWG to identify policy dialogue  participants

Health officials and government regulatory authorities overseeing blood products and services; academia; industry; civil society;

Follow up assessment of GMP compliance status

The PTN will work with the LSIF, the LSIF RHSC, and the HWG to re-connect with target economies and points of contact

The PTN and member economies as they move forward with safe blood supply projects and programs

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. It should be noted that the Project Overseer is a woman. Additionally, PTN Advisory Board, since its inception, has sought to ensure that half of its members are women.

Work Plan

September-December 2016: Upon BMC issuance of in-principle support, begin working with technical experts and key stakeholders to develop survey on international GMP compliance along the Blood Supply Chain in APEC Economies. 

January-May 2017: Upon BMC final approval of proposed project, issue survey to all APEC Economies to assess current domestic practices in relation to international practice; identify gaps and priorities in GMP compliance. Seek responses from at least 10 APEC Economies. Identify potential host economy for the policy dialogue and set dates.

June-August 2017: Develop a report on results obtained from 3rd APEC Blood Supply Chain Policy Forum (Dec 2016) and GMP Adherence survey (Jan-Jun 2017) to assess performance criteria based on international best practices—adequate infrastructures, indicators and criteria for inspection. 

August-November 2017: Share report on GMP Adherence with APEC Economies ahead of policy dialogue; work with APEC economies and key stakeholders to finalize policy dialogue agenda and issue invitations to speakers and participants. Policy dialogue held in APEC developing economy in November or December 2017 to include at least 50 representatives from at least 11 APEC Economies. 

January-August 2018: Work with APEC Economies and key stakeholders to conduct GMP compliance assessments in a total of 10 blood banks (minimum) in at least 6 APEC Economies. Communicate outcomes, learnings, and benefits to stakeholders in APEC Economies. This part of the project will be self-funded. 

The beneficiaries are patients in communities who will have improved access to safe and adequate blood services and blood products.  The target audience includes officials in ministries of health, regulatory authorities, and blood services leadership and managers in APEC economies who play key roles in GMP policy and compliance along the blood supply chain.

Risks

Risk

Management strategy

Inability to secure participation in GMP Compliance Survey

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 economies interested in hosting the dialogue. 

Lack of interest by target beneficiaries

Concept received widespread, enthusiastic support from LSIF and has 5 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 Project Task Force have already identified potential speakers 

Long Term Risk: lack of funding for the PTN training programs following completion of policy dialogue and assessments

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

Monitoring and Evaluation

An evaluation will be developed and used to assess the effectiveness of the policy dialogue and project. 

The PO, the PTN Secretariat, and the PTN Advisory Board will convene regular conference calls to ensure actions in the work plan are on track. The PO will develop the work plan and will update it as necessary. 

A key indicator of success, in the short term, will be the number of blood banks that participate in the GMP Compliance Survey. The surveys will be conducted and collected electronically through the resources of the PTN Advisory Board.  The report that is generated from this data will give insight into the success of this output of the project. 

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. 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. 

Progress of the entire PTN blood initiative and completion status of the 2020 Roadmap will be measured in the 2018 assessments (self-funded) and over the medium-term by assessing participating institutions ability to meet international accreditation standards through a tiered approach. Participating institutions will be invited to conduct self-assessments and external peer reviews to assess progress made on strengthening their quality system and operational areas for compliance with international standards. Accreditation is recognized at both a domestic and international level. The Accreditation Program itself is accredited by AABB and the International Society for Quality (ISQua).

Linkages

Engagement: This project cuts across areas of interest to numerous APEC groups, including the Committee on Trade & Investment (CTI); the Sub-Committee on Standards and Conformance (SCSC); the LSIF Regulatory Harmonization Steering Committee (RHSC); and the Health Working Group (HWG).  Additionally, this project will engage multiple non-APEC stakeholders, including Pharmaceutical Inspection Co-operation Scheme (PICS); ASEAN; AABB; ISBT; WHO; academia, civil society, and the private sector. This project will build on the success of the previous project, “CTI 06 2015A - APEC LSIF Blood Supply Chain Partnership Training Network (PTN) – 2016 Pilots”. 

Previous work: The APEC-funded APEC LSIF Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain (CTI 26/2013A) was held September 30 to October 1, 2014 in Manila, Philippines.   The event convened representatives from 20 of the 21 APEC Economies, including senior leaders from government, academic institutions, the private sector, civil society, and international organizations to identify how APEC economies can work together to build the capacity of their blood services, infrastructure, and governance and promote the achievement of international safety and quality standards for the blood supply chain.  The outcome of the Policy Dialogue was the APEC Blood Supply Chain 2020 Roadmap (the Roadmap), a practical framework for APEC economies to apply at local, economy, and regional levels to improve the safety of the blood supply chain. APEC LSIF representatives further agreed in Manila to explore the establishment of an APEC LSIF Blood Supply Chain Partnership Training Network (PTN) to serve as a long-term sustainable model for capacity building activities to help APEC economies implement the Roadmap’s recommended actions and ultimately achieve the goals set forth in the Roadmap. In August 2015 in Cebu, Philippines, Health Ministers participating in the 5th APEC High-Level Meeting on Health & Economy APEC LSIF members and the LSIF Executive Board endorsed the establishment of the PTN. 

This project largely builds on the PTN’s work in 2016 which included the training program “Embracing Quality Management Systems”, in Lima, Peru on 23-24 June 2016 and the December 2016 training program on “Good Manufacturing Practices (GMP)” (Dec. 6-7) and “3rd APEC Blood Supply Chain Policy Forum” (Dec. 8-9) held in Hanoi, Vietnam. These events have and will set the stage for a focus on the importance of quality management systems and GMP compliance which will continue through the work of this project. 

The project also builds on the outcomes of the June 2013 HWG and LSIF Policy Dialogue on Building Capacity to Address Healthcare-Associated Infections, which included discussions on the potential returns on investment in blood safety in developing economies. The project also builds on the Sepetember 2013 APEC High Level Meeting on Health & the Economy and the recommendations of the April 2013 Health Working Group Recommendations on Getting to Zero on HIV and AIDS to Support Sustainable Growth in Asia Pacific Region. It was recommended that APEC Leaders reaffirm their commitment to accelerate progress in achieving the Millennium Development Goal 6 (MDG 6), which specifically refers to halting and reversing the spread of HIV and AIDS, and other related MDGs by 2015. APEC adds value by addressing the link between the public health and economic development aspects of the issue in line with APEC priorities, the Bogor Goals, and the Strategic Plans of the LSIF and the HWG. By focusing on economic aspects, the proposed APEC Workshop supports, but does not duplicate, ongoing international efforts to improve the supply of blood worldwide. 

APEC’s comparative advantage: APEC is uniquely positioned to help build the capacity of its economies to make safe blood available to its populations by supporting the translation of the WHO’s essential medicine recommendation as well as economy-wide plans into concrete, measureable results. This APEC project convenes key stakeholders to identify areas where governments, academia, non-governmental organizations, and the private sector can work together to improve the infrastructure, systems, and governance of blood and blood products through well-placed investments, improved coordination and information sharing, and the application and use of innovation. 

APEC holds a comparative advantage as host of the PTN and this project because of its unique focus on capacity building through the sharing of international best practices and standards, enhancing regulatory convergence, improving health and health security, and fostering public-private partnerships. These objectives will be incorporated into the activities throughout the duration of this project.  APEC ensures equity, by providing a vehicle for all economies to participate and take ownership of the project. Furthermore, APEC’s voluntary non-binding structure and focus on capacity building are key advantages, as this project seeks to foster an environment for sharing and developing best practices for blood services.

Sustainability

Upon completion of this project and APEC funding, the GMP compliance survey and report as well as the policy dialogue will have established essential groundwork for further implementation of the APEC Blood Supply Chain 2020 Roadmap. Additionally, the APEC LSIF Blood Supply Chain Partnership Training Network (PTN) has been formally established as a sustainable, self-funded initiative. The PTN’s goal will be to continue support of the strategies that are developed from the survey and policy dialogue for implementation of the Roadmap in APEC developing economies. With AABB, the internationally-recognized professional body and standards organization for blood services, as the Secretariat for the PTN and a PTN Advisory Board, 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 the strategies established towards closing the gaps of GMP compliance.

Following the completion of the survey, issuing of the report, and gathering for the policy dialogue, a self-funded follow up assessment will take place in 2018 that will, again, map the progress of these blood banks towards achieving GMP compliance. This assessment will be a coordinated effort between the APEC PTN and the participating economies. This follow-up will further build on the target goals of the greater project by clearly expressing the importance of action beyond diagnostics (survey/report) and discussing solutions (policy dialogue) towards implementation. The intention of the follow up is to continue to promote active and continued surveillance as well as another further expression of the importance for achieving the Roadmap. This part of the project will be self-funded.

Through the survey process and policy dialogue, support networks will be created that will provide participating institutions in APEC developing economies with the information and resources to drive change and make improvements to GMP compliance.  Progress will be measured over the medium-term by assessing participating institutions ability to meet international accreditation standards through a tiered approach. Participating institutions in the survey and policy dialogue will be invited to conduct self-assessments and external peer reviews to assess progress made on strengthening their quality system and operational areas for compliance with international standards. Accreditation is recognized at both a domestic and international level. The Accreditation Program itself is accredited by AABB and the International Society for Quality (ISQua).

Project Overseers

Dr. Maureen Goodenow is the Director of the Office of AIDS Research (OAR). She also holds the title of NIH Associate Director for AIDS Research. She received her Ph.D. in molecular genetics from the Albert Einstein College of Medicine in New York. Following a postdoctoral fellowship in molecular oncology at the Sloan Kettering Institute in New York, she was a visiting scientist at the Pasteur Institute in Paris, where she began her studies of HIV. 

Previously, Dr. Goodenow served as professor of pathology, immunology, and laboratory medicine at the University of Florida, Gainesville. From 2004 until her departure from the University, she held the Stephany W. Holloway University Endowed Chair for AIDS Research. She also was the Director of the Center for Research in Pediatric Immune Deficiency. She led a research program in molecular epidemiology, pathogenesis, and vaccines for HIV-1 and related viruses, including viruses that cause cancer. Dr. Goodenow has published over 100 articles and book chapters, and trained more than 25 doctoral and postdoctoral fellows. 

Dr. Goodenow has served NIH on multiple NIH advisory committees, including the AIDS Research Advisory Committee for the Division of AIDS at the National Institute of Allergy and Infectious Diseases, and an OAR planning committee for the Trans-NIH Plan for HIV-Related Research. She also advised a joint program between NIH and the U.S. Department of State to enhance research between U.S. and Russian scientists, and advised the Fogarty International Center on programs in India and Kazakhstan. 

Recently, Dr. Goodenow has played an important role in international AIDS efforts as the Acting Director of the Office for Research and Science within the U.S. Department of State, Office of the U.S. Global AIDS Coordinator and Office of Global Health Diplomacy. There she oversaw combination prevention trials funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). She also served from 2012-2013 as a senior science advisor and Jefferson Science Fellow in the Department of State Bureau of East Asian and Pacific Affairs, Office of Economic Policy.

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Not Applicable.

Waivers

 

Are there any supporting document attached?

No 
Attachments
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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

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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

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Originating Sub-Forum

Approval Status
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