2015/SOM3/LSIF/SS/009 Agenda item: 6.8 APEC LSIF Blood Supply Chain Initiative Overview Purpose: Information Submitted by: LSIF PG Chair. Life Sciences Innovation Forum Special Session Cebu, Philippines 30 August 2015
August 2015 Overview of the APEC Blood Supply Chain Initiative Background The demand for human blood is increasing at a rapid rate throughout the Asia-Pacific region. Growth in demand is driven by rising incidence of disease, attention on maternal and child health, population growth, aging populations, a steadily growing middle-class population with greater access to medical care, as well as an increased government focus on improving healthcare infrastructure. Evidence-based strategies for blood safety and availability have been successfully implemented in most developed economies and in only some developing economies. Across the APEC region, wide disparities in the level of access to safe blood exist. As of 2013, only 13 of the 21 APEC economies report collecting 100% of their blood supplies from voluntary unpaid donors. Furthermore, the transfusion of infected blood contributes to an ever-widening pool of infection in the general population with far-reaching consequences. The WHO recommends that, at a minimum, blood is screened for HIV, hepatitis B, hepatitis C, and syphilis. The WHO estimates that the lack of effective screening results annually in up to 16 million new infections with hepatitis B, 5 million new infections with hepatitis C, and 160,000 cases of HIV infection. It is estimated that annually 5% and 10% of all HIV infections worldwide are the result of transfusions of contaminated blood and blood products. If the proper steps are taken, such infections can be easily prevented. An unsafe or inadequate blood supply is costly in both human and economic terms. According to the WHO, the health-related Millennium Development Goals (MDGs) of reducing child mortality, improving maternal health and combating HIV/AIDS, malaria and other acute or chronic diseases will be unachievable unless significant attention is focused on availability, safety and quality of blood products. Many challenges, such as governance alignment, appropriate resources (i.e., funding, infrastructure) and achievement of international safety/quality standards obstruct APEC economies efforts to improve the safety and sustainability of the blood supply chain. In spite of these challenges, there are clear opportunities for implementation of plans by APEC economies to achieve a well-organized, quality driven nationally-coordinated blood transfusion service. Following the WHO s 2013 decision to add blood and blood products to its List of Essential Medicines, the APEC Life Sciences Innovation Forum (LSIF) initiated action to develop a comprehensive and multisectoral approach to improve access to blood and blood products in the Asia-Pacific region. APEC recognized the need to leverage the collective strength of key stakeholders to help APEC economies, particularly developing economies, to build the capacity of their blood services, infrastructure, and governance and promote the achievement of international safety and quality standards. APEC Blood Supply Chain 2020 Roadmap In October 2014, APEC representatives convened in Manila, Philippines for the first policy dialogue to share experiences and develop a path forward for APEC to support blood safety. The meeting 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 key blood safety issues in the region and to discuss how APEC economies can work together to build the capacity of their 1
August 2015 blood services, infrastructure, and governance and promote the achievement of international safety and quality standards for the blood supply chain. APEC representatives subsequently adopted the APEC Blood Supply Chain 2020 Roadmap, launching a long-term multi-sectoral effort to address blood safety in the region that would support the translation of global blood safety policy recommendations and local economy blood safety plans into concrete, measurable results. Facilitating Policy Dialogue Facilitating high-level, multi-sectoral policy dialogue on blood safety challenges in the Asia-Pacific region is a key objective of the APEC Blood Supply Chain Initiative. The 2nd APEC High Level Blood Supply Chain Policy Forum: A Critical Time for Policy Action, Leadership, and Investment in Blood Safety will be held on Friday, 23 October 2015 in Anaheim, California, United States. The Policy Forum will convene senior blood safety leaders to develop and identify strategies to ensure the APEC Roadmap s successful implementation. The forum will focus in particular on securing political support in promoting policy implementation of quality systems as well as making high-impact investments, and how accreditation can be used to measure improvements. This meeting is open to representatives from APEC economies as well as invited guests from non-apec countries. Partnership Training Network (PTN) APEC representatives further agreed in Manila to establish an APEC LSIF Blood Supply Chain Partnership Training Network (PTN) to serve as a long-term sustainable mechanism to support capacity building activities to help APEC economies implement the APEC Roadmap s recommended actions. The PTN will develop and deliver an evolving curriculum that enhances capacity and promotes the achievement of international standards in the blood supply chain. The PTN is not intended to be an actual bricks and mortar facility, but instead will build upon existing resources in the region to create a network of organizations with the capacity to conduct training in international best practices in maintaining safety and quality in the blood supply chain. The PTN will involve representatives of health ministries, national blood services organizations, regulatory agencies, international organizations, academia, the private sector, and other key stakeholders. The PTN will operate in accordance with a Terms of Reference approved by the LSIF. AABB, the internationally-recognized, independent professional body and standards organization for blood services, was appointed by the LSIF Executive Board as the Secretariat for the PTN in June 2015. Following the 1st Pilot Workshop, the PTN will operate entirely on a self-funded basis with in-kind support coming from partner institutions throughout the region and a coalition of relevant private sector entities managed by AABB. A PTN Advisory Board, comprised of up to 12 representatives from APEC governments, international organizations, medical associations (AABB, APBN), academic societies (ISBT), and the private sector, is currently being established and will provide strategic guidance and oversight over the PTN s activities. Working Towards Blood Safety Accreditation throughout the APEC Region 2
August 2015 Progress will be measured over the medium-term by assessing the ability of participating institutions to meet international accreditation standards through a tiered approach. Participating institutions (nominated by APEC economies) in the PTN training programs 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. Next Steps APEC funding has been approved to support two pilot programs - one in Lima, Peru in December 2015 and another in Southeast Asia in mid-2016. Following the successful completion of the pilot programs, the PTN will operate entirely on a self-funded basis with in-kind support coming from partner institutions throughout the region, government support, and private sector contributions managed by the PTN Secretariat. Who Should Be Involved in the APEC Blood Supply Chain Initiative? Governments. The 21 APEC Governments will facilitate the participation of experts from Ministries of Health and national regulatory agencies as appropriate in ongoing policy dialogue and in PTN activities. Through the APEC process, policy recommendations and reports on the PTN training activities will be reported to APEC Governments, including Ministers of Health, and APEC Ministers (Foreign) and Leaders as appropriate. National Blood Services. The PTN s training and capacity building activities are targeted at managers of National Blood Services organizations (both government and non-profit, independent organizations). Securing high-level support from these organizations is critical to the success of the APEC initiative. Regional and International Organizations. Regional and international organizations will provide strategic input and advice on training and capacity building programs and activities. Academia, Medical Associations, and Patient Groups. Academic and non-profit leaders in key areas of blood safety will be included in APEC s ongoing policy dialogues and PTN training activities as appropriate. Private sector. The Private sector will have input into policy dialogues and PTN Training Activities through the PTN Secretariat. The private sector s input will be provided in a transparent manner and without the perception of a conflict of interest. If you are interested in participating in the APEC Blood Supply Chain Initiative or to request more information, please contact Prof. Maureen Goodenow at apecbloodproject@outlook.com. 3
APEC LSIF Blood Supply Chain Initiative Maureen M. Goodenow, PhD. APEC SOM 3 Cebu, Philippines August, 2015 APEC LSIF Blood Supply Chain Initiative 3 GOAL Building the capacity of the blood supply chain in the Asia Pacific region 1
3 APEC: Building the capacity of the blood supply chain in the Asia Pacific region 2013 Blood and blood products added to WHO List of Essential Medicines Wide disparities in level of access to safe blood Only 13 of 21 APEC economies collect 100% of blood supply from voluntary unpaid donors. Where safe blood is available, supply chain and quality systems may fail to ensure timely access. Health-related MDGs and SDGs will be unachievable without significant attention to access to safe blood Economic value of safe blood to universal health care systems and to health of populations Accomplishments to Date 3 2013 June Initiative proposed at LSIF HAI Workshop in Medan, Indonesia August-December Applied and approved for APEC Project Funding 2014 January-August Established APEC Blood Supply Chain Task Force / Network of Economies; drafted Roadmap; worked with the Philippines Dept. of Health to prepare for Policy Dialogue/Workshop May-September Conducted pre-workshop survey September 30-October 1 1 st APEC Blood Supply Chain Policy Dialogue (Manila, Philippines), Developed APEC Blood Supply Chain 2020 Roadmap October-February 2015 Finalized 2020 Roadmap and initiated discussions to establish Partnership Training Network [PTN] 2
Accomplishments to Date 3 2015 February - Presented Roadmap and updates at SOM1 LSIF meeting; secured support for establishing PTN (Clark, Philippines) February - July Applied and approved for APEC Project Funding for PTN Pilot Workshops June - AABB selected to serve as PTN Secretariat by LSIF Executive Board; PTN Terms of Reference developed August - Endorsement at SOM3 of final APEC Blood Supply Chain 2020 Roadmap and PTN Terms of Reference (Cebu, Philippines) APEC LSIF Blood Supply Chain 2020 Roadmap The Roadmap calls for: Step 1: Assessment (2014) - Blood safety gaps and capacity building priorities in APEC developing economies (Country level assessments). Step 2: Training (2015-2016) - Provide training on quality systems and leadership in blood safety. Step 3: Assessment of Training (2017) Step 4: Training to reach the 2020 goal (2017 2020) and further recommendations for blood safety improvements 6 3
APEC Policy Dialogue Attaining A Safe and Sustainable Blood Supply Chain September 30 October 1, 2014 Step 1: Assessment (2014) - Blood safety gaps and priorities in APEC developing economies - High Level Multi-country Assessment VENUE: Asian Institute of Management, Macati, Manila Co CHAIRS: Dr. Kenneth Hartigan Go and Dr. Maureen Goodenow LSIF Secretariat: Michael Schmitz 7 APEC Policy Dialogue Attaining A Safe and Sustainable Blood Supply Chain PARTICIPANTS 20 APEC member economies WHO & other regional/international health organizations Professional associations Private sector Academia TOPICS overview of the status of blood systems in the Asia Pacific region challenges to developing safe and sustainable blood systems within their economies, including an analysis of aggregated data and information collected from the pre workshop surveys. key elements of quality blood systems, shared strategies and best practices explore models for centralizing or regionalizing blood processing and testing facilities 8 4
APEC Policy Dialogue Attaining A Safe and Sustainable Blood Supply Chain September 30 October 1, 2014 Manila, Philippines 9 APEC Blood Supply Chain 2020 Roadmap Championed by the United States, the goal for the Blood Supply Chain Roadmap is: to improve the safety and sustainability of the blood supply in APEC economies through cross-sectoral, multi-disciplinary, coordinated & collaborative approaches. 10 5
APEC Blood Supply Chain 2020 Roadmap APEC Blood Supply Chain 2020 Roadmap Goals 1. Enhance cross sectorial political commitment and national level government leadership for improving the safety and sustainability of the blood supply for the advancement of public health 2. Strengthen quality systems as an essential foundational element for creating a viable National Blood System or Service that requires full government commitment for longterm success 3. Increase government awareness that economies of scale are best achieved through centralization and regionalization to provide quality services at the local level 4. Incorporate models such as public private partnerships and partnerships with nonprofit organizations to access resources and expertise and identify advocates for advancing blood safety 5. Provide to decision makers evidence on the economic value of blood safety policies that facilitate data driven decisions for public health 11 APEC LSIF Blood Supply Chain 2020 Roadmap The Roadmap calls for: Step 1: Assessment (2014) - Blood safety gaps and capacity building priorities in APEC developing economies (Country level assessments). Step 2: Training (2015-2016) - Provide training on quality systems and leadership in blood safety. Step 3: Assessment of Training (2017) Step 4: Training to reach the 2020 goal (2017 2020) and further recommendations for blood safety improvements 12 6
APEC LSIF Blood Supply Chain Partnership Training Network (PTN) Step 2: Training (2015-2016) - Training will be conducted through the Partnership Training Network (PTN). - The PTN will develop and conduct in-person and online training programs. - Training programs will be held at APEC sub-regional levels (i.e. Southeast Asia, Latin America) to maximize resources and impact. - The PTN Advisory Board in cooperation with the APEC sub-regions will identify specific training priorities. - Activities will be organized by the PTN Secretariat in cooperation with the sub-regional partner institutions. - The PTN Advisory Board will convene monthly or bi-monthly to provide strategic guidance, report updates on training programs, discuss priorities, and progress with Roadmap implementation. 13 APEC LSIF Blood Supply Chain Partnership Training Network (PTN) APEC Ministers and Leaders APEC Life Sciences Innovation Forum Blood Supply Chain Partnership Training Network Network of APEC Economies PTN Advisory Board PTN Secretariat (AABB) APEC Blood Safety Industry Coalition 14 7
Network of APEC Economies Australia Australian Red Cross National Blood Authority, Australia Canada Health Canada Chile Ministry of Health China National Health and Family Planning Commission Institute of Blood Transfusion at Chinese Academy of Medical Sciences Hong Kong, China Hong Kong Red Cross Indonesia Ministry of Health Indonesia National Agency of Drug and Food Control Japan Ministry of Health, Labour, and Welfare Japanese Red Cross Society Korea Korean Red Cross Blood Services Malaysia National Blood Centre, Ministry of Health Mexico National Center of Blood Transfusion, Ministry of Health New Zealand New Zealand Blood Service Papua New Guinea PNG National Blood Transfusion Services Peru Ministry of Health Philippines Department of Health Philippine Food and Drug Administration Philippine Red Cross Russia Russian Federal Institute for Pediatric Hematology, Oncology and Immunology Singapore Health Sciences Authority Chinese Taipei Food & Drug Administration, Ministry of Health and Welfare Taiwan Blood Services Foundation Thailand Ministry of Public Health Thai Red Cross Society United States State Department FDA Centers for Disease Control and Prevention AABB Viet Nam National Institute of Hematology and Blood Transfusion, Ministry of Health 15 Establishing the Partnership Training Network (PTN) Advisory Board AABB (Co Chair) United States (Co Chair and Project Overseer) Asia Pacific Blood Network (APBN) World Health Organization Pan American Health Organization (PAHO) International Society of Blood Transfusion (ISBT) Industry Coalition Representative Industry Coalition Representative Miriam Markowitz, Chief Executive Officer, AABB Maureen M. Goodenow, Ph.D., Senior Advisor, Bureau of East Asian and Pacific Affairs, US Department of State, Professor & Stephany W. Holloway Endowed Chair for HIV/AIDS Research, University of Florida Dr. Kenji Tadokoro, Chair, Asia Pacific Blood Network TBD María Dolores Pérez Rosales, MD, MPH, Regional Advisor Blood Services and Organ Transplants (INVITED) Dr. Celso Bianco, MD, President, ISBT Dr. Jerry Holmberg, Director, Scientific Business Development, Grifols Diagnostic Solutions Inc. TBD 16 8
Establishing the Partnership Training Network (PTN) Advisory Board (Continued) Expert from an APEC Economy (Government or Academia) Expert from an APEC Economy (Government or Academia) Expert from an APEC Economy (Government or Academia) Expert from an APEC Economy (Government or Academia) Expert from an APEC Economy (Government or Academia) Expert from an APEC Economy (Government or Academia) Dr. Yuyun SM Soedarmono, PhD, Directorate of Basic Health Care, Ministry of Health, Republic of Indonesia Dr Noryati Abu Amin, Director, National Blood Centre, Ministry of Health, Malaysia (INVITED) Dra. Ina Noelia Perez Huaynalaya, Comité Directivo, GCIAMT Regional Director Southern Americas, ISBT, Clinica Delgado, Peru (INVITED) Dr. Pham Tuan Duong, Deputy Director, National Institute of Hematology and Blood Transfusion, Viet Nam (INVITED) Dr. Maria Victoria Abesamis, OIC Executive Director, Philippine Blood Disease and Transfusion Center, Department of Health Philippines (INVITED) Prof. Dr. Liu Zhong, Vice President, Institute of Blood Transfusion, CAMS, Vice Director, Department of Blood Transfusion, PUMC, Editor in Chief, Chinese Journal of Blood Transfusion, People s Republic of China 17 Scope Scope of of the the Accreditation Accreditation System System Citizens Healthy Population (potential donors) Patients Health Care Organizations Donor Recruitment Donor Awareness Blood Center & Transfusion Service Hospitals & Clinics and Physicians Transfusion Committee Unit for Transfusion 1. Organization 2. Resources 3. Equipment 4. Supplier & Customer Issues Technical Standards 5. Process Control Collection & Production of Components Transfusion Service Activities 6. Documents & Records 7. Deviations 8. Assessments 9. Process Improvement 10. Facilities & Safety Quality Management Systems Foundation 18 9
Scope of the Technical Standards and Feedback Loop Donor Vein Recruitment VNRBDs Donor Screening Donor Questionnaire Whole Blood Collection Sample Collection Donor Reactions Traceability (Donor, Paper, Blood Bag, Test Tube) Donor Counseling Donor Sample Product Laboratory TTI Testing Grouping & Compatibility Testing Test Results Traceability (Test Tube to Results) Sample Test Results Patient Vein Sterile Component Storage (Cold Chain Mgt) Traceability (Test Results to Product) Product labeling Issuing of Product Blood Administration (Traceability of Product to Patient) Transfusion Reactions Hemovigilance Product Patient 19 Next Steps and Milestones DATE ACTIVITY August APEC SOM3 LSIF Meetings Cebu, Philippines August October APEC Blood Safety PTN Membership and Advisory Board Recruitment October 23 2 nd APEC Blood Supply Chain Policy Forum Anaheim, California, USA December 2 3 1 st PTN Pilot Workshop Lima, Peru February 2016 APEC SOM1 LSIF Meetings Peru Mid 2016 2 nd PTN Pilot Workshop TBD(Southeast Asia) Late 2016 PTN Workshop location TBD 2017 2020 2 or more workshops each year 20 10
YOU RE INVITED 2 nd APEC Blood Supply Chain Policy Forum October 23, 2015 Anaheim, California, USA Program Topics Making a Commitment to Quality and Safety Panel Discussion: Achieving Sustainable Blood Safety Programs Securing Political and Financial Support for Blood Safety Using Accreditation as an Indicator of Progress Quality Systems for Blood Safety (Breakout Groups) Looking Ahead APEC AABB Dinner Other PTN Advisory Board 1 st Meeting Please fill out and return the enclosed RSVP Form by 1 October 2015 to Michael Schmitz at mschmitz@crowell.com. 21 SAVE THE DATE 1 st APEC Blood Supply Chain PTN Pilot Workshop December 2 3, 2015 Lima, Peru If interested in attending, please contact Michael Schmitz at mschmitz@crowell.com. 22 11