- Email: [email protected]
New Partnerships to Advance Global Health Research for NCD
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New Partnerships to Advance Global Health Research for NCD George A. Mensah Bethesda, MD, USA
Strategic partnerships are crucial for advancing health and health research, especially in the global arena [1e3]. One form of these partnerships is the public-private partnership (PPP) that brings together researchers from the public and private sectors as well as stakeholders from civil society with complementary skills, resources, and a common mission to advance global health. However, it was not until the 1990s that public-private partnerships (PPP) in global health emerged [4]. Since that time, PPPs have proliferated [3] and so have their functions and goals. However, the vast majority of PPPs address product development or strategies to improve access to diagnostic, preventive, and therapeutic interventions for specific diseases [4]. Recently, PPPs between academic health center researchers and those in industry and public sector research have been emphasized as necessary to “kindle academic entrepreneurship” and help accelerate “the translation of promising new therapies” [5]. These partnerships are important, especially for fundamental discovery science and for reclaiming what is lost early in translation; however, by themselves, they are insufficient to lead to transformative changes needed to dramatically and sustainably advance the global health research agenda in the prevention, treatment, and control of noncommunicable diseases (NCD). In addition, old models of biomedical research assistance and partnerships based entirely within the health sector are unlikely to work well. New models of partnerships that transcend the health sector and also focus on building local level capacity and workforce for health research and research management will be needed. Here I examine examples of recent research partnerships and explore the 5 basic needs of the global health research system identified in the framework by Rudan and Sridhar [6] as necessary for ensuring efficient performance of the research enterprise. The article goes beyond the domains of this framework to articulate the need for placing the patient at the center of clinical and public health research enterprise and to recognize patients as important stakeholders worthy of engagement in strong partnerships. It also addresses the need for active community engagement and partnerships with community stakeholders as a crucial element that can help solve several critical challenges of sustaining the impact of health research. I discuss several currently available models that demonstrate elements of these new approaches in partnerships for advancing clinical and public health research.
GLOBAL HEART, VOL. 11, NO. 4, 2016 December 2016: 473-478
Finally, I address the importance of partnerships that lead to building needed research capacity and development of a diverse research workforce, especially in low- and middle-income countries.
THE ACCELERATING MEDICINES PARTNERSHIP EXAMPLE In February 2014, the National Institutes of Health, the Food and Drug Administration, several nonprofit organizations, and a group of biopharmaceutical companies from the United States, United Kingdom, France, and Japan (Fig. 1) launched the Accelerating Medicines Partnership (AMP) as a PPP to transform the way in which new diagnostics and therapeutics are developed in the fight against Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus [7]. The primary reason for forming this partnership was the realization that “the development and testing of new medications takes too long, costs too much, and fails too often” [8] and that such a partnership could leverage the expertise of the diverse partners to help optimize the process for identifying and validating clinically relevant disease targets for the development of novel drugs, devices, and diagnostics [7]. The anticipated impact of the AMP is to increase efficiency with which targets and biomarkers for complex diseases are discovered and validated by leveraging advances in molecular profiling technologies, big data analytics and open science principles. This is an example of a precompetitive PPP for product development in which a broad range of scientists from the public and private sectors and their partners from nonprofit organizations come together to address a common health challenge. In this PPP enterprise, government, industry and nonprofit partners combine resources and leverage each other’s expertise to create a new knowledge base for the discovery and validation of novel targets and biomarkers and to develop new big data infrastructure that will enable rapid and broad sharing of data and analytical results [8]. Consistency and clarity of purpose around a well-defined goal entirely addressable within the health sector was an important attribute of this PPP. A streamlined governance structure, comprising steering committees for each of the 3 disease areas with representation from all partners was put in place to monitor progress and milestones and is managed by the Foundation for the National Institutes of Health under the direction of an AMP Executive Committee.
The author reports no relationships that could be construed as a conflict of interest. The views expressed in this article are those of the author and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, National Institutes of Health, or the United States Department of Health and Human Services. From the Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA; and the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA. Correspondence: G. A. Mensah ([email protected]). GLOBAL HEART Published by Elsevier Ltd. on behalf of World Heart Federation (Geneva). VOL. 11, NO. 4, 2016 ISSN 2211-8160/$36.00. http://dx.doi.org/10.1016/ j.gheart.2016.10.022
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The Accelerang Medicines Partnership
Industry AbbVie (USA) Biogen Idec (USA) Bristol-Myers Squibb (USA) GlaxoSmithKline (UK) Johnson & Johnson (USA) Lilly (USA) Merck (USA) Pfizer (USA) Sanofi (France) Takeda (Japan)
PhRMA USAgainstAlzheimer’s
FIGURE 1. The Accelerating Medicines Partnership. Source: National Institutes of Health [7].
TRADITIONAL PUBLICePRIVATE PARTNERSHIP Traditional PPPs, such as the one described previously, have memberships from at least 2 of 3 distinct categories: the public sector, the private sector, and civil society. Public sector partners include entities that are officially part of local, provincial, state, national, regional, or international governmental agencies or institutions with a primary responsibility of providing public goods or services. Private sector partners include manufacturers of drugs, devices, and other products and may or may not be for profit. The civil society partners include predominantly nongovernmental organizations and advocacy groups. Nishtar [9] identified 6 major functions that these PPPs typically serve: product development, improving access to healthcare, global coordination mechanisms, strengthening health services, public advocacy and education, and regulation and quality assurance. As Nishtar put it, the public sector’s “inability to provide public goods entirely on their own, in an efficient, effective and equitable manner because of lack of resources and management issues” is a primary reason for developing these partnerships. However, the advantages in terms of the efficiency and resources that the public sector leverages, especially from the private sector, must be viewed within the context of criticisms of real or perceived conflicts of interest that are introduced by these PPPs. In addition, the complexity of funding streams and related administrative and governance requirements can be challenging and often require management expertise that may not be readily available at the local level in the recipient country. For example, Figure 2A shows the complexity of global health funding flows from source to channel to health focus area in 2015 demonstrating the relatively very little funding toward NCD [10]. The corresponding funding flows of Development Assistance for Health for NCD from source to channel to program area are shown in Figure 2B [10]. Table 1 shows the annual health research expenditures of the 10 largest public and philanthropic
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funders of health research through official development assistance [11]. Regardless of the type of function that these partnerships are designed to undertake, the PPP has come to embrace specific challenges, especially in low- and middleincome countries and regions. In sub-Saharan Africa, for example, varying governance structures; misalignment of partnership interests with recipient country strategic plans and priorities; selective, vertical, disease-specific focus rather than patient-centered focus; multimorbidity approaches; lack of coordination of efforts across PPPs; inadequate emphasis on developing local capacity; and workforce continue to be important challenges [12]. Although some progress has been made in many of these areas [12], much remains to be done and there are additional challenges that compromise the usefulness and efficiency of these PPPs [6]. For example, Rudan and Sridhar [6] examined the structure of the global health research system within the context of its evolution under a decade of funding increases and proposed a framework of 5 basic needs to ensure efficient performance (Fig. 3). They identified 5 basic needs that include the need to: 1) coordinate funding among donors; 2) prioritize among many research ideas; 3) recognize successful research; 4) ensure broad and rapid accessibility to research results; and 5) evaluate returns on investment in research [6].
CRUCIAL ATTRIBUTES OF NEW PUBLIC-PRIVATE PARTNERSHIPS To meet the challenges addressed in the previous section, new PPP for advancing global health research need to go beyond the 5 basic needs of the framework by Rudan and Sridhar [6]. First, as noted in the global framework of the Addis Ababa Action Agenda [13], these multistakeholder partnerships should engage “the private sector, civil society, the scientific community, academia, philanthropy and foundations, parliaments, local authorities, volunteers
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FIGURE 2. (A) Complexity of global health funding flows from source to channel to health focus area in 2015. The relatively very little funding toward noncommunicable diseases is noted. Note: 2015 estimates are preliminary. (B) Complexity of funding flows of Development Assistance for Health for noncommunicable diseases from source to channel to program area, 2000 to 2015. BMGF, Bill and Melinda Gates Foundation; HSS, health sector support; NGOs, nongovernmental organizations; SWAps, sector-wide approaches. Reproduced with permission from Institute for Health Metrics and Evaluation [10] under the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 Unported License (http://creativecommons.org/licenses/by-nc-nd/4.0/). and other stakeholders.” In other words, a partnership based solely in the health sector is not ideal. Engaging all relevant sectors of government beyond health, such as finance, commerce, education, transportation, agriculture, or the parliament (as appropriate) is ideal, especially for PPPs that address the complexities of NCD research, healthcare delivery science, or health research systems strengthening [1,13]. Second, engaging civil society is
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crucial, especially beginning with patients and their families, patient advocacy groups, and community stakeholders [14,15]. Partnerships that place the patient at the center of clinical and public health research and address both biological as well as social, environmental, economic, and environmental determinants of NCD is preferable to the traditional single disease-focused biomedical approach. Third, ideal PPP also address local research capacity
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TABLE 1. Annual health research expenditures of key funders of Official Development Assistance Year for which funding data were collected
Expenditures on health research (in million 2013 U.S. $)
Specificity of the funding data*
Research area that the funding data refer to*
Reporting format of the funding data*
Funding organization
Country
United States Agency for International Development (USAID) UK Department for International Development (DFID) Grand Challenges Canada Dutch Directorate General of Development Cooperation German Federal Ministry for Economic Cooperation and Development (BMZ) Canadian Department of Foreign Affairs, Trade and Development (DFATD) Ministère des Affaires Etrangères et Européennes (MAEE) L’Agence Française de Développement (AFD)
USA
2012
186.4
II
A
1
GBR
2014
97.5
III
A
2
CAN NLD
2013 2012
46.3 11.7
I I
A A
1 1
DEU
2011
0.9
I
A
1
CAN
2011
0.8
I
A
1
FRA
2011
0.7
I
A
1
FRA
2013
0.0
—
—
—
For DFID, USAID, and Grand Challenges Canada, data on annual health research expenditures were publicly available. For AFD, data were acquired through a personal communication. For all other organizations, no data were available or could be provided. For these organizations, annual health research expenditures were approximated by extracting expenditure figures from G-FINDER, which is limited to health research focused on product development. *Funders report differently on their expenditures. Preferably, we collected information on the actual expenditures of a funder in the area of health research, excluding funders’ operational costs. However, this information was not always available. Therefore, we describe here the type of data that we collected, in terms of how funding organizations report annual health research expenditures (i.e., I, actual expenditures; II, commitments; or III, budgets), in terms of the research areas that their reported numbers pertain to (i.e., A, only health research; B, health and biological research; or C, life sciences research), and in terms of what the expenditures cover (i.e., 1, total expenditures on health research excluding operational costs; 2, total expenditures on health research including also operational costs; or 3, total overall turnover for the funder over a single fiscal year). Reproduced from Viergever and Hendriks [11] under the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/).
development as well as research training and career development. Increasingly, more and more PPPs are rising to this challenge.
ALLIANCE FOR ACCELERATING EXCELLENCE IN SCIENCE IN AFRICA The Alliance for Accelerating Excellence in Science in Africa (AESA) is a new PPP established by the African Academy of Sciences and the New Partnership for Africa’s Development with the full endorsement of the African Union Summit of Heads of State and Government held in Addis Ababa, Ethiopia in January 2015 [16]. Launched in September 2015, AESA’s African collaborators also include both state and nonstate partners while its core international partners include the Bill and Melinda Gates Foundation, the Wellcome Trust, and the UK’s Department for International Development [16]. AESA aims to foster the longterm sustainable funding and development of global health research leadership and scientific excellence in Africa with specific goals that include: 1) contributing to setting the agenda for health research and innovation in Africa; 2) providing competitive research grants to train highquality future generations of scientists whose research can inform health policy development and health innovation; 3) create the scientific environment to facilitate recruitment and retention of world class scientists in Africa; and 4) mobilize resources from multiple domestic and
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international partners to ensure sustainable support for Science Technology and Innovation programs. The first 2 programs under AESA include: 1) the Wellcome Trustefunded Developing Excellence in Leadership, Training and Science program, a US$70 million initiative that provides competitive grants to collaborative teams “to conduct health research, offer training and mentorship and improve research infrastructure” to support of the development of world class researchers in Africa; and 2) the Grand Challenges Africa, an initiative “that seeks to engage innovators from around the world to solve the most pressing challenges in global health and development” in Africa [16]. The Developing Excellence in Leadership, Training and Science program alone is expected fund 11 consortia and to train up to 2,000 African researchers over 5 years [17]. As recently pointed out by the Head of International Operations and Partnerships at Wellcome Trust in a letter to The Lancet, AESA is the “first and only pan-African funding platform whose sole aim is to strengthen research capacity” in Africa, and that the establishment of AESA signals “a real shift in the centre of gravity of leadership and eventually funding of African science to Africa” [17].
GLOBAL HEALTH INNOVATIVE TECHNOLOGY FUND Much like AESA, the Global Health Innovative Technology Fund (GHIT) is a novel PPP whose partners transcend the
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PUBLIC SECTOR DONORS GOVERNMENT RESEARCH COUNCILS / MINISTRIES
PRIVATE SECTOR DONORS
BILATERAL ORGANIZATIONS
BIG PHARMA COMPANIES
BIOTECH INDUSTRY
PRIVATE PHILANTHROPIES
RECIPIENTS - RESEARCH TEAMS GENERATING NEW KNOWLEDGE
PRIVATE RESEARCH INSTITUTES / INITIATIVES
PUBLIC UNIVERSITIES AND RESEARCH INSTITUTES
INTERNATIONAL / MULTILATERAL ORGANIZATIONS
BIOTECH, CONSULTANTS AND OTHER “SME”
RESEARCHERS AND FIELD WORKERS IN LMICs / NGOs
j
NEED TO CO-ORDINATE FUNDING AMONG DONORS
NEED TO PRIORITIZE AMONG MANY RESEARCH IDEAS
STAKEHOLDERS GOVERNING DISSEMINATION OF NEW KNOWLEDGE RESEARCH TEAM LEADERS / PRINCIPAL INVESTIGATORS
LEADERSHIP OF PROFESSIONAL SOCIETIES
JOURNAL EDITORS AND REVIEWERS
COMPANY MANAGEMENT / OWNERS
DONOR’S REPRESENTATIVES
DISSEMINATION OF NEW KNOWLEDGE POSTED ONLINE / RELEASED AS DATA / “GREY LITERATURE”
PRESENTED AT MEETINGS, CONFERENCES, SYMPOSIA, ETC.
PUBLISHED IN INDEXED SCIENCE JOURNALS
REPLICATION OF NEW FINDINGS
CONFIDENTIAL REPORTS FOR LIMITED USE / UNPUBLISHED
RESTRICTED ACCESS OR CHARGE
FREELY AVAILABLE TO ALL USERS TRANSLATION OF NEW KNOWLEDGE “SPIN OUT”
PATENTED WITH/OUT FURTHER PUBLICATION
SECONDARY & META-ANALYSIS
NEW RESEARCH IDEAS AND GRANT PROPOSALS
EVALUATION OF RESULTS AND IMPACT ANALYSIS
NEED TO RECOGNIZE SUCCESSFUL RESEARCH
NEED TO ENSURE BROAD AND RAPID ACCESSIBILITY
NEED TO EVALUATE RETURNS ON INVESTMENTS IN RESEARCH
FIGURE 3. The structure of the global health research system and the 5 basic needs to ensure its efficient performance. LMIC, low- and middle-income countries; NGOs, nongovernmental organizations; SME, small and medium enterprises. Reproduced with permission from Rudan and Sridhar [6] under the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/). health and biotechnology sectors and come from many disciplines. Founded in 2013, it is considered the first PPP to involve a national government (Japan) and its Ministry of Foreign Affairs and Ministry of Health, Labor and Welfare; 7 Japanese pharmaceutical and diagnostics companies; a United Nations Agency (the United Nations Development Program); the Wellcome Trust; and the Bill & Melinda Gates Foundation [18]. The initial focus of GHIT is to expedite the development of novel technologies and drugs for the prevention, detection, evaluation, and treatment of neglected tropical diseases, HIV/AIDS, malaria, tuberculosis, and other neglected tropical diseases [18]. Importantly, and where appropriate, GHIT plans to invest in capacity building and technology transfer while fostering international research collaborations to advance the “creation of new biomedical systems, methods, and products that are appropriate, effective, affordable, and easy-to-use” [18].
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CONCLUSIONS Strategic partnerships, such as PPPs, remain crucial for advancing global health and health research. Regardless of the type of function that these partnerships are designed to serve, PPPs have come to embrace important challenges, especially in low- and middle-income countries. These challenges include varying governance structures, misalignment of strategic priorities, lack of coordination of efforts across PPPs, and inadequate emphasis on developing local research capacity and workforce. To successfully and sustainably address the complexities of NCD research and advance global health, it is ideal for PPPs to engage all relevant sectors of government beyond ministries of health and actively seek the participation of patients, communities, and other civil society stakeholders. It is also crucial to invest in research capacity development, research training, and career development. Increasingly, more and more PPPs are rising to this
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challenge in tackling neglected diseases of poverty, HIV/ AIDS, tuberculosis, malaria, and other communicable diseases. Similarly novel and innovative PPPs will be required to advance global health and health research for noncommunicable diseases.
REFERENCES 1. National Academies of Sciences, Engineering, and Medicine. The Role of Public-Private Partnerships in Health Systems Strengthening: Workshop Summary. Washington, DC: The National Academies Press; 2016. 2. Mensah GA. Global Health Research. Glob Heart 2016;11:159–64. 3. Cohen J. Global health. Public-private partnerships proliferate. Science 2006;311:167. 4. Widdus R. Public-private partnerships: an overview. Trans R Soc Trop Med Hyg 2005;99(Suppl 1):S1–8. 5. Gehr S, Garner CC. Rescuing the lost in translation. Cell 2016;165: 765–70. 6. Rudan I, Sridhar D. Structure, function and five basic needs of the global health research system. J Glob Health 2016;6:010505. 7. National Institutes of Health. Accelerating Medicines Partnership (AMP). Available at: https://www.nih.gov/sites/default/files/research-training/ initiatives/amp/amp-factsheet_0.pdf. Accessed October 29, 2016. 8. Hodes RJ, Buckholtz N. Accelerating Medicines Partnership: Alzheimer’s Disease (AMP-AD) knowledge portal aids alzheimer’s drug discovery through open data sharing. Expert Opin Ther Targets 2016;20:389–91.
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9. Nishtar S. Public - private ’partnerships’ in health - a global call to action. Health Res Policy Syst 2004;2:5. 10. Institute for Health Metrics and Evaluation. Financing Global Health 2015: Development Assistance Steady on the Path to New Global Goals. Seattle, WA: IHME; 2016. 11. Viergever RF, Hendriks TC. The 10 largest public and philanthropic funders of health research in the world: what they fund and how they distribute their funds. Health Res Policy Syst 2016; 14:12. 12. Mwisongo A, Nabyonga-Orem J. Global health initiatives in Africa governance, priorities, harmonisation and alignment. BMC Health Serv Res 2016;16(Suppl 4):212. 13. United Nations. Addis Ababa Action Agenda of the Third International Conference on Financing for Development. New York, NY: UN; 2016. 14. Thacker N, Vashishtha VM, Awunyo-Akaba J, Mistry RF. Civil society organizations, the implementing partners of the Global Vaccine Action Plan. Vaccine 2013;31(Suppl 2):B97–102. 15. Simms B. World Bank: harnessing civil society expertise in undertaking and disseminating research findings. AIDS Care 2013; 25(Suppl 1):S1–3. 16. New Partnership for Africa’s Development. Alliance for Accelerating Excellence in Science in Africa (AESA). Available at: http://www. nepad.org/programme/alliance-accelerating-excellence-science-africaaesa?qt-programme_page¼1. Accessed October 29, 2016. 17. Kay S. Supporting research leadership in Africa. Lancet Diabetes Endocrinol 2016;4:563. 18. Slingsby BT, Kurokawa K. The Global Health Innovative Technology (GHIT) Fund: financing medical innovations for neglected populations. Lancet Glob Health 2013;1:e184–5.
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New Partnerships to Advance Global Health Research for NCD George A. Mensah Bethesda, MD, USA
Strategic partnerships are crucial for advancing health and health research, especially in the global arena [1e3]. One form of these partnerships is the public-private partnership (PPP) that brings together researchers from the public and private sectors as well as stakeholders from civil society with complementary skills, resources, and a common mission to advance global health. However, it was not until the 1990s that public-private partnerships (PPP) in global health emerged [4]. Since that time, PPPs have proliferated [3] and so have their functions and goals. However, the vast majority of PPPs address product development or strategies to improve access to diagnostic, preventive, and therapeutic interventions for specific diseases [4]. Recently, PPPs between academic health center researchers and those in industry and public sector research have been emphasized as necessary to “kindle academic entrepreneurship” and help accelerate “the translation of promising new therapies” [5]. These partnerships are important, especially for fundamental discovery science and for reclaiming what is lost early in translation; however, by themselves, they are insufficient to lead to transformative changes needed to dramatically and sustainably advance the global health research agenda in the prevention, treatment, and control of noncommunicable diseases (NCD). In addition, old models of biomedical research assistance and partnerships based entirely within the health sector are unlikely to work well. New models of partnerships that transcend the health sector and also focus on building local level capacity and workforce for health research and research management will be needed. Here I examine examples of recent research partnerships and explore the 5 basic needs of the global health research system identified in the framework by Rudan and Sridhar [6] as necessary for ensuring efficient performance of the research enterprise. The article goes beyond the domains of this framework to articulate the need for placing the patient at the center of clinical and public health research enterprise and to recognize patients as important stakeholders worthy of engagement in strong partnerships. It also addresses the need for active community engagement and partnerships with community stakeholders as a crucial element that can help solve several critical challenges of sustaining the impact of health research. I discuss several currently available models that demonstrate elements of these new approaches in partnerships for advancing clinical and public health research.
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Finally, I address the importance of partnerships that lead to building needed research capacity and development of a diverse research workforce, especially in low- and middle-income countries.
THE ACCELERATING MEDICINES PARTNERSHIP EXAMPLE In February 2014, the National Institutes of Health, the Food and Drug Administration, several nonprofit organizations, and a group of biopharmaceutical companies from the United States, United Kingdom, France, and Japan (Fig. 1) launched the Accelerating Medicines Partnership (AMP) as a PPP to transform the way in which new diagnostics and therapeutics are developed in the fight against Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus [7]. The primary reason for forming this partnership was the realization that “the development and testing of new medications takes too long, costs too much, and fails too often” [8] and that such a partnership could leverage the expertise of the diverse partners to help optimize the process for identifying and validating clinically relevant disease targets for the development of novel drugs, devices, and diagnostics [7]. The anticipated impact of the AMP is to increase efficiency with which targets and biomarkers for complex diseases are discovered and validated by leveraging advances in molecular profiling technologies, big data analytics and open science principles. This is an example of a precompetitive PPP for product development in which a broad range of scientists from the public and private sectors and their partners from nonprofit organizations come together to address a common health challenge. In this PPP enterprise, government, industry and nonprofit partners combine resources and leverage each other’s expertise to create a new knowledge base for the discovery and validation of novel targets and biomarkers and to develop new big data infrastructure that will enable rapid and broad sharing of data and analytical results [8]. Consistency and clarity of purpose around a well-defined goal entirely addressable within the health sector was an important attribute of this PPP. A streamlined governance structure, comprising steering committees for each of the 3 disease areas with representation from all partners was put in place to monitor progress and milestones and is managed by the Foundation for the National Institutes of Health under the direction of an AMP Executive Committee.
The author reports no relationships that could be construed as a conflict of interest. The views expressed in this article are those of the author and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, National Institutes of Health, or the United States Department of Health and Human Services. From the Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA; and the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA. Correspondence: G. A. Mensah ([email protected]). GLOBAL HEART Published by Elsevier Ltd. on behalf of World Heart Federation (Geneva). VOL. 11, NO. 4, 2016 ISSN 2211-8160/$36.00. http://dx.doi.org/10.1016/ j.gheart.2016.10.022
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The Accelerang Medicines Partnership
Industry AbbVie (USA) Biogen Idec (USA) Bristol-Myers Squibb (USA) GlaxoSmithKline (UK) Johnson & Johnson (USA) Lilly (USA) Merck (USA) Pfizer (USA) Sanofi (France) Takeda (Japan)
PhRMA USAgainstAlzheimer’s
FIGURE 1. The Accelerating Medicines Partnership. Source: National Institutes of Health [7].
TRADITIONAL PUBLICePRIVATE PARTNERSHIP Traditional PPPs, such as the one described previously, have memberships from at least 2 of 3 distinct categories: the public sector, the private sector, and civil society. Public sector partners include entities that are officially part of local, provincial, state, national, regional, or international governmental agencies or institutions with a primary responsibility of providing public goods or services. Private sector partners include manufacturers of drugs, devices, and other products and may or may not be for profit. The civil society partners include predominantly nongovernmental organizations and advocacy groups. Nishtar [9] identified 6 major functions that these PPPs typically serve: product development, improving access to healthcare, global coordination mechanisms, strengthening health services, public advocacy and education, and regulation and quality assurance. As Nishtar put it, the public sector’s “inability to provide public goods entirely on their own, in an efficient, effective and equitable manner because of lack of resources and management issues” is a primary reason for developing these partnerships. However, the advantages in terms of the efficiency and resources that the public sector leverages, especially from the private sector, must be viewed within the context of criticisms of real or perceived conflicts of interest that are introduced by these PPPs. In addition, the complexity of funding streams and related administrative and governance requirements can be challenging and often require management expertise that may not be readily available at the local level in the recipient country. For example, Figure 2A shows the complexity of global health funding flows from source to channel to health focus area in 2015 demonstrating the relatively very little funding toward NCD [10]. The corresponding funding flows of Development Assistance for Health for NCD from source to channel to program area are shown in Figure 2B [10]. Table 1 shows the annual health research expenditures of the 10 largest public and philanthropic
474
funders of health research through official development assistance [11]. Regardless of the type of function that these partnerships are designed to undertake, the PPP has come to embrace specific challenges, especially in low- and middleincome countries and regions. In sub-Saharan Africa, for example, varying governance structures; misalignment of partnership interests with recipient country strategic plans and priorities; selective, vertical, disease-specific focus rather than patient-centered focus; multimorbidity approaches; lack of coordination of efforts across PPPs; inadequate emphasis on developing local capacity; and workforce continue to be important challenges [12]. Although some progress has been made in many of these areas [12], much remains to be done and there are additional challenges that compromise the usefulness and efficiency of these PPPs [6]. For example, Rudan and Sridhar [6] examined the structure of the global health research system within the context of its evolution under a decade of funding increases and proposed a framework of 5 basic needs to ensure efficient performance (Fig. 3). They identified 5 basic needs that include the need to: 1) coordinate funding among donors; 2) prioritize among many research ideas; 3) recognize successful research; 4) ensure broad and rapid accessibility to research results; and 5) evaluate returns on investment in research [6].
CRUCIAL ATTRIBUTES OF NEW PUBLIC-PRIVATE PARTNERSHIPS To meet the challenges addressed in the previous section, new PPP for advancing global health research need to go beyond the 5 basic needs of the framework by Rudan and Sridhar [6]. First, as noted in the global framework of the Addis Ababa Action Agenda [13], these multistakeholder partnerships should engage “the private sector, civil society, the scientific community, academia, philanthropy and foundations, parliaments, local authorities, volunteers
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FIGURE 2. (A) Complexity of global health funding flows from source to channel to health focus area in 2015. The relatively very little funding toward noncommunicable diseases is noted. Note: 2015 estimates are preliminary. (B) Complexity of funding flows of Development Assistance for Health for noncommunicable diseases from source to channel to program area, 2000 to 2015. BMGF, Bill and Melinda Gates Foundation; HSS, health sector support; NGOs, nongovernmental organizations; SWAps, sector-wide approaches. Reproduced with permission from Institute for Health Metrics and Evaluation [10] under the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 Unported License (http://creativecommons.org/licenses/by-nc-nd/4.0/). and other stakeholders.” In other words, a partnership based solely in the health sector is not ideal. Engaging all relevant sectors of government beyond health, such as finance, commerce, education, transportation, agriculture, or the parliament (as appropriate) is ideal, especially for PPPs that address the complexities of NCD research, healthcare delivery science, or health research systems strengthening [1,13]. Second, engaging civil society is
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crucial, especially beginning with patients and their families, patient advocacy groups, and community stakeholders [14,15]. Partnerships that place the patient at the center of clinical and public health research and address both biological as well as social, environmental, economic, and environmental determinants of NCD is preferable to the traditional single disease-focused biomedical approach. Third, ideal PPP also address local research capacity
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TABLE 1. Annual health research expenditures of key funders of Official Development Assistance Year for which funding data were collected
Expenditures on health research (in million 2013 U.S. $)
Specificity of the funding data*
Research area that the funding data refer to*
Reporting format of the funding data*
Funding organization
Country
United States Agency for International Development (USAID) UK Department for International Development (DFID) Grand Challenges Canada Dutch Directorate General of Development Cooperation German Federal Ministry for Economic Cooperation and Development (BMZ) Canadian Department of Foreign Affairs, Trade and Development (DFATD) Ministère des Affaires Etrangères et Européennes (MAEE) L’Agence Française de Développement (AFD)
USA
2012
186.4
II
A
1
GBR
2014
97.5
III
A
2
CAN NLD
2013 2012
46.3 11.7
I I
A A
1 1
DEU
2011
0.9
I
A
1
CAN
2011
0.8
I
A
1
FRA
2011
0.7
I
A
1
FRA
2013
0.0
—
—
—
For DFID, USAID, and Grand Challenges Canada, data on annual health research expenditures were publicly available. For AFD, data were acquired through a personal communication. For all other organizations, no data were available or could be provided. For these organizations, annual health research expenditures were approximated by extracting expenditure figures from G-FINDER, which is limited to health research focused on product development. *Funders report differently on their expenditures. Preferably, we collected information on the actual expenditures of a funder in the area of health research, excluding funders’ operational costs. However, this information was not always available. Therefore, we describe here the type of data that we collected, in terms of how funding organizations report annual health research expenditures (i.e., I, actual expenditures; II, commitments; or III, budgets), in terms of the research areas that their reported numbers pertain to (i.e., A, only health research; B, health and biological research; or C, life sciences research), and in terms of what the expenditures cover (i.e., 1, total expenditures on health research excluding operational costs; 2, total expenditures on health research including also operational costs; or 3, total overall turnover for the funder over a single fiscal year). Reproduced from Viergever and Hendriks [11] under the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/).
development as well as research training and career development. Increasingly, more and more PPPs are rising to this challenge.
ALLIANCE FOR ACCELERATING EXCELLENCE IN SCIENCE IN AFRICA The Alliance for Accelerating Excellence in Science in Africa (AESA) is a new PPP established by the African Academy of Sciences and the New Partnership for Africa’s Development with the full endorsement of the African Union Summit of Heads of State and Government held in Addis Ababa, Ethiopia in January 2015 [16]. Launched in September 2015, AESA’s African collaborators also include both state and nonstate partners while its core international partners include the Bill and Melinda Gates Foundation, the Wellcome Trust, and the UK’s Department for International Development [16]. AESA aims to foster the longterm sustainable funding and development of global health research leadership and scientific excellence in Africa with specific goals that include: 1) contributing to setting the agenda for health research and innovation in Africa; 2) providing competitive research grants to train highquality future generations of scientists whose research can inform health policy development and health innovation; 3) create the scientific environment to facilitate recruitment and retention of world class scientists in Africa; and 4) mobilize resources from multiple domestic and
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international partners to ensure sustainable support for Science Technology and Innovation programs. The first 2 programs under AESA include: 1) the Wellcome Trustefunded Developing Excellence in Leadership, Training and Science program, a US$70 million initiative that provides competitive grants to collaborative teams “to conduct health research, offer training and mentorship and improve research infrastructure” to support of the development of world class researchers in Africa; and 2) the Grand Challenges Africa, an initiative “that seeks to engage innovators from around the world to solve the most pressing challenges in global health and development” in Africa [16]. The Developing Excellence in Leadership, Training and Science program alone is expected fund 11 consortia and to train up to 2,000 African researchers over 5 years [17]. As recently pointed out by the Head of International Operations and Partnerships at Wellcome Trust in a letter to The Lancet, AESA is the “first and only pan-African funding platform whose sole aim is to strengthen research capacity” in Africa, and that the establishment of AESA signals “a real shift in the centre of gravity of leadership and eventually funding of African science to Africa” [17].
GLOBAL HEALTH INNOVATIVE TECHNOLOGY FUND Much like AESA, the Global Health Innovative Technology Fund (GHIT) is a novel PPP whose partners transcend the
GLOBAL HEART, VOL. 11, NO. 4, 2016 December 2016: 473-478
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PUBLIC SECTOR DONORS GOVERNMENT RESEARCH COUNCILS / MINISTRIES
PRIVATE SECTOR DONORS
BILATERAL ORGANIZATIONS
BIG PHARMA COMPANIES
BIOTECH INDUSTRY
PRIVATE PHILANTHROPIES
RECIPIENTS - RESEARCH TEAMS GENERATING NEW KNOWLEDGE
PRIVATE RESEARCH INSTITUTES / INITIATIVES
PUBLIC UNIVERSITIES AND RESEARCH INSTITUTES
INTERNATIONAL / MULTILATERAL ORGANIZATIONS
BIOTECH, CONSULTANTS AND OTHER “SME”
RESEARCHERS AND FIELD WORKERS IN LMICs / NGOs
j
NEED TO CO-ORDINATE FUNDING AMONG DONORS
NEED TO PRIORITIZE AMONG MANY RESEARCH IDEAS
STAKEHOLDERS GOVERNING DISSEMINATION OF NEW KNOWLEDGE RESEARCH TEAM LEADERS / PRINCIPAL INVESTIGATORS
LEADERSHIP OF PROFESSIONAL SOCIETIES
JOURNAL EDITORS AND REVIEWERS
COMPANY MANAGEMENT / OWNERS
DONOR’S REPRESENTATIVES
DISSEMINATION OF NEW KNOWLEDGE POSTED ONLINE / RELEASED AS DATA / “GREY LITERATURE”
PRESENTED AT MEETINGS, CONFERENCES, SYMPOSIA, ETC.
PUBLISHED IN INDEXED SCIENCE JOURNALS
REPLICATION OF NEW FINDINGS
CONFIDENTIAL REPORTS FOR LIMITED USE / UNPUBLISHED
RESTRICTED ACCESS OR CHARGE
FREELY AVAILABLE TO ALL USERS TRANSLATION OF NEW KNOWLEDGE “SPIN OUT”
PATENTED WITH/OUT FURTHER PUBLICATION
SECONDARY & META-ANALYSIS
NEW RESEARCH IDEAS AND GRANT PROPOSALS
EVALUATION OF RESULTS AND IMPACT ANALYSIS
NEED TO RECOGNIZE SUCCESSFUL RESEARCH
NEED TO ENSURE BROAD AND RAPID ACCESSIBILITY
NEED TO EVALUATE RETURNS ON INVESTMENTS IN RESEARCH
FIGURE 3. The structure of the global health research system and the 5 basic needs to ensure its efficient performance. LMIC, low- and middle-income countries; NGOs, nongovernmental organizations; SME, small and medium enterprises. Reproduced with permission from Rudan and Sridhar [6] under the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/). health and biotechnology sectors and come from many disciplines. Founded in 2013, it is considered the first PPP to involve a national government (Japan) and its Ministry of Foreign Affairs and Ministry of Health, Labor and Welfare; 7 Japanese pharmaceutical and diagnostics companies; a United Nations Agency (the United Nations Development Program); the Wellcome Trust; and the Bill & Melinda Gates Foundation [18]. The initial focus of GHIT is to expedite the development of novel technologies and drugs for the prevention, detection, evaluation, and treatment of neglected tropical diseases, HIV/AIDS, malaria, tuberculosis, and other neglected tropical diseases [18]. Importantly, and where appropriate, GHIT plans to invest in capacity building and technology transfer while fostering international research collaborations to advance the “creation of new biomedical systems, methods, and products that are appropriate, effective, affordable, and easy-to-use” [18].
GLOBAL HEART, VOL. 11, NO. 4, 2016 December 2016: 473-478
CONCLUSIONS Strategic partnerships, such as PPPs, remain crucial for advancing global health and health research. Regardless of the type of function that these partnerships are designed to serve, PPPs have come to embrace important challenges, especially in low- and middle-income countries. These challenges include varying governance structures, misalignment of strategic priorities, lack of coordination of efforts across PPPs, and inadequate emphasis on developing local research capacity and workforce. To successfully and sustainably address the complexities of NCD research and advance global health, it is ideal for PPPs to engage all relevant sectors of government beyond ministries of health and actively seek the participation of patients, communities, and other civil society stakeholders. It is also crucial to invest in research capacity development, research training, and career development. Increasingly, more and more PPPs are rising to this
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challenge in tackling neglected diseases of poverty, HIV/ AIDS, tuberculosis, malaria, and other communicable diseases. Similarly novel and innovative PPPs will be required to advance global health and health research for noncommunicable diseases.
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9. Nishtar S. Public - private ’partnerships’ in health - a global call to action. Health Res Policy Syst 2004;2:5. 10. Institute for Health Metrics and Evaluation. Financing Global Health 2015: Development Assistance Steady on the Path to New Global Goals. Seattle, WA: IHME; 2016. 11. Viergever RF, Hendriks TC. The 10 largest public and philanthropic funders of health research in the world: what they fund and how they distribute their funds. Health Res Policy Syst 2016; 14:12. 12. Mwisongo A, Nabyonga-Orem J. Global health initiatives in Africa governance, priorities, harmonisation and alignment. BMC Health Serv Res 2016;16(Suppl 4):212. 13. United Nations. Addis Ababa Action Agenda of the Third International Conference on Financing for Development. New York, NY: UN; 2016. 14. Thacker N, Vashishtha VM, Awunyo-Akaba J, Mistry RF. Civil society organizations, the implementing partners of the Global Vaccine Action Plan. Vaccine 2013;31(Suppl 2):B97–102. 15. Simms B. World Bank: harnessing civil society expertise in undertaking and disseminating research findings. AIDS Care 2013; 25(Suppl 1):S1–3. 16. New Partnership for Africa’s Development. Alliance for Accelerating Excellence in Science in Africa (AESA). Available at: http://www. nepad.org/programme/alliance-accelerating-excellence-science-africaaesa?qt-programme_page¼1. Accessed October 29, 2016. 17. Kay S. Supporting research leadership in Africa. Lancet Diabetes Endocrinol 2016;4:563. 18. Slingsby BT, Kurokawa K. The Global Health Innovative Technology (GHIT) Fund: financing medical innovations for neglected populations. Lancet Glob Health 2013;1:e184–5.
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