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Rapporteurs Report


Matthew Doherty, Rapporteur


This report summarizes the proceedings, discussions and conclusions of the roundtable event Research for
Impact and the G20: How can global health innovation drive sustainable development? held on Friday 28th April
2017 at the Quadriga Forum in Berlin, Germany. The roundtable was organized by Sovereign Strategy and co-
hosted with the following organizations: the Global Alliance for TB Drug Development (TB Alliance), Medicines
for Malaria Venture (MMV), the Sabin Vaccine Institute, the Coalition for Epidemic Preparedness Innovations
(CEPI), PATH (Program for Appropriate Technology in Health), the Global Health Technologies Coalition (GHTC),
the Global Health Innovative Technology (GHIT) Fund, UNITAID and CARB-X.


The author wishes to thank the co-hosts, chairs, speakers and participants of the roundtable for their support
for this initiative and their valuable input at the event. Special thanks go to the Sovereign Strategy team; Alan
Donnelly, Executive Chairman of Sovereign Strategy and founder of the G20 Global Health Initiative; Hatice
Kk for her tireless efforts in helping to set up this initiative, managing the event and acting as a shadow
rapporteur to this report; and to the rest of the Sovereign team for the harmonious teamwork and delivery of
the project. Additional thanks go to the Quadriga Forum for their kind hospitality.

The report entirely represents the views and perceptions of the Rapporteur. Any amendment requests should
be sent to:

List of Acronyms ......................................................................................................................... 3

EXECUTIVE SUMMARY ............................................................................................................... 5

REPORT OF THE DISCUSSION .....................................................................................................7

Welcome Remarks ..................................................................................................................... 7

Opening Speeches...................................................................................................................... 8

Roundtable Session 1: Taking Stock: How global health partnerships changed the research and

development landscape for neglected diseases .......................................................................9

AMR and Pandemic Preparedness as G20 Priorities ............................................................... 16

The Work of the B20 in Health Innovations ............................................................................ 20

Roundtable Session 2: Looking Ahead: Improving Global Health Cooperation to meet the Sustainable

Development Goals ................................................................................................................ 21

Call to Action and Next Steps...................................................................................................29

Closing Speeches ...................................................................................................................... 30

ANNEX ......................................................................................................................................33
Participants list G20 Global Health Innovations Event ......................................................... 33
Call to Action ........................................................................................................................... 35

List of Acronyms

AMC Academic Medical Center

AMR Antimicrobial Resistance
ARV Antiretroviral
BARDA Biomedical Advanced Research and Development Authority
BMGF Bill and Melinda Gates Foundation
CDC Centre for Disease Control and Prevention
COHRED Council on Health Research for Development
CEPI Coalition for Epidemic Preparedness Innovations
CTA Call to Action
CWA Compact with Africa
DNDi Drugs for Neglected Diseases Initiative
EC European Commission
EDCTP European & Developing Countries Clinical Trials Partnership
EMA European Medicines Agency
FDA US Food and Drug Administration
FIND Foundation for Innovative and New Diagnostics
GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria
GHIT Global Health Innovative Technology Fund
GHTC Global Health Technologies Coalition
GNI Gross National Income
HCV Hepatitis C Vaccine
HOOKVAC The Human Hookworm Vaccine
HSS Health Systems Strengthening
IRC International Rescue Committee
ITNs Insecticide Treated bed-Nets
LMICs Low and Middle Income Countries
MdB Member of the German Bundestag
MDR / XDR TB Multidrug-resistant / extensively drug-resistant Tuberculosis
MERS Middle East Respiratory Syndrome
MMV Medicines for Malaria Venture
MOH Ministry of Health
MP Member of the U.K. Parliament
NCDs Non-Communicable Diseases
NTDs Neglected Tropical Diseases
PATH Program for Appropriate Technology in Health
PDP Product Development Partnership
PEPFAR The United States President's Emergency Plan for AIDS Relief
PHU Primary Health Units
PPE Personal Protective Equipment
PRND Poverty Related and Neglected Diseases
R&D Research and Development
RMNCH Reproductive, Maternal, Newborn and Child Health
SAC Scientific Advisory Committee
SDGs Sustainable Development Goals
SMEs Small and Medium Sized Enterprises

SOP Standard Operating Procedure
SSA Sub-Saharan Africa
TB Tuberculosis
TB Alliance Global Alliance for TB Drug Development
TDR the Special Programme for Research and Training in Tropical Diseases
TPPs Target Product Profiles
UHC Universal Health Coverage
USAID United States Agency for International Development
VFM Value for Money
WHA World Health Assembly
WHO World Health Organization

Sovereign Strategy created and designed an initiative to support the prioritization, under the German G20
Presidency, of global health in the context of the 2030 Agenda for Sustainable Development. Following active
mobilization of seed sponsorship and co-host organizations, the project was implemented over the course of a
number of months, supporting the Business20 consultative dialogue to the G20, maintaining a focus on
innovation in global health and planning an event to bring interested stakeholders together in Berlin to
participate in a roundtable: Research for Impact and the G20: How can global health innovation drive
sustainable development?

Media coverage of the event can be found at the following links:

1. DEVEX: 'Call to action' for G20 health ministers ahead of Berlin meeting
2. The Guardian: G20 must invest to deal with pandemics
3. Sabin Vaccine Institute: Sabin Leadership Discusses Global Health Innovation at G20 Summit
4. DEVEX: G20: Can the world's richest economies innovate for global health?
5. Yahoo Finance: Global Health Coalition Urges G20 Pledge on Pandemics and Neglected Diseases
6. Euractiv: African Union EU rep: Africa shouldnt just be a spectator to global decisions
7. GHTC: G20: Connecting the dots on global health innovation, sustainable development, and health

Photos of the event can be found here.

The one-day event involved opening and closing speeches, two sessions of moderated roundtable discussions,
presentations on the G20 priority foci of Antimicrobial Resistance (AMR) and pandemic preparedness, the B20
and its health initiative as well as the current project, its Call to Action (CTA) output document and discussions
on how to carry it forward. The stated objective was to create a platform for cooperation and policy advocacy
for an open and unique coalition of organizations leading up to and following the Berlin declaration of the G20
Health Ministers and the Hamburg Summit.

A number of cross-cutting aspects were highlighted throughout the day, such as concepts of partnership (both
in the abstract and with concrete impactful examples). The relevance of the G20 was consistently highlighted1
as were calls for the G20 to continue this priority focus, building on investments and current models in the
global health space. In addition to increased financial investments, coordination platforms for Research and
Development (R&D), data sharing or complimentary technologies were used as possible areas that could be
considered by the G20 going forward. The relevance of this dialogue to economic development and security2
gave additional credence to the G20 maintaining this focus particularly when framed in the context of the 2030
Agenda for Sustainable Development3 which is now an explicit driver of the G20 prioritization process.

Maintaining a focus on the political - in addition to the scientific - aspects of global health was emphasized with
the political figures present highlighting the need to embed government involvement in global health and

1 see for example, below sections 2, 3, 4, 9, 14, 17, 22, 25, 30, 33, 36, 39, 43, 45, 47, 48, 70, 71, 76-79
2 see for example 1, 25, 34, 40
3 2, 3, 5, 36

innovation into the domestic political discourse.4 Related to this were the exchanges and comments on
improving communication and significantly broadening the base of advocates (including global parliamentary
champions) outside of the traditional areas of operation, using smaller - but more regular - conduits of
information and facts on impact that are compelling and show value for money.5 These political and
communicative aspects, combined with the need to embrace long-term approaches6 were reflected in broad
support for the current dialogue and its continuation7 as a way of stimulating a broader multi-stakeholder
coalition of advocates and a platform for creating innovative partnerships.

The work of the PDPs was mostly covered during session one8 including examples of their strong capacities to
leverage expertise, funding and partnerships. Session two also included some forward-looking perspectives9
with innovation in financing and incentivization10 including models such as GHIT11 or UNITAID12 a regular part of
the discussion. The work of CEPI13 and CARB-X14 was showcased and contextualized within the agenda. There
were also regular calls to move away from siloes of pathogens and therapeutic verticals, particularly in relation
to funding.15

Another focal area was coordination16 often in the context of monitoring, evaluation and the importance of
data17 or Target Product Profiles (TPPs).18 Health Systems Strengthening (HSS) - including regulatory and
access - 19 and capacity building and local ownership / innovation 20 gave significant emphasis to the
developmental aspects of the dialogue. This was regularly intertwined with discussions focusing on Africa
continent as well as the G20 initiative on The Compact with Africa (CWA).21

4 2, 4, 25, 29, 64
5 4, 8, 29, 30, 46, 64, 66, 80-82
6 4, 11, 15, 43
7 7, 30, 34, 47, 48, 74, 75
8 10, 11, 12, 13, 14, 15, 16, 17, 23
9 60
10 6, 9, 17, 20, 34, 35, 36
11 17, 20, 22
12 57 - 58
13 37-42, 51, 52
14 43-45, 53
15 26, 34, 56
16 22, 30, 32, 34, 35, 38
17 2, 3, 22, 55, 62, 63, 64
18 23, 40, 73
19 14, 15, 16, 21, 23, 25, 27, 28, 30, 31, 38, 58, 72, 73
20 19, 22, 23, 24, 27, 28, 40, 54, 55
21 48, 49, 83, 84


Welcome Remarks

1. The event was opened by Mr. Alan Donnelly, who gave thanks to the co-hosts as well as some
background as to how the project came about. He outlined Sovereigns work in the areas of sustainable
development, health, and innovation and in building coalitions of like-minded organizations. Reference
was made to the inclusion of AMR in the Hangzhou Communiqu and the focus on global health under
the German G7 Presidency with noted presence of the BMBF - a strong supporter of innovation in
global health including through PDPs. Mr. Donnelly mentioned the Call to Action (CTA) as an output of
the roundtable and gave reference to elements of economic development and security in the context of
global health indicating that foreign ministries and finance ministries should also be recipients of the
CTA. He said that the objective of the roundtable is to directly influence the outputs of the G20 health
process by bringing together the expertise of a diverse and unique group of people and by working
closely with politicians and engagement groups such as the Business20 (B20). He added that any
positive output from the Berlin Declaration of the G20 Health Ministers should quickly be responded to
and converted into long-term action. Before introducing the Chair of the event Prof. Annelies Wilder-
Smith, Mr. Donnelly acknowledged the interesting range of participants and speakers and encouraged
those present to actively participate.

2. Chair of the event, Prof. Annelies Wilder-Smith, began by underlining the G20s commitment to
Agenda 2030. She reiterated Mr. Donnellys gratitude to the co-hosts and thanked Sovereign Strategy
for bringing the initiative to fruition with their support. She noted the range of participation and
mentioned the significance of Berlin and Germany to the global health dialogue, something
championed personally by the German Chancellor, including under the G20. Professor Wilder-Smith
indicated the involvement in the afternoon session of the B20 Sherpa and moved on to outline why
science, technology and innovation are critical to the global health dialogue while in parallel how the
roundtable was also focused on converging important political questions into what is often a
scientifically focused area. She emphasized the need to advocate for global health innovation to be
embedded into the G20 process before highlighting some formalities: The event is on the record,
welcome to press representatives, outcomes include CTA and formal report both of which will be
circulated to participants following event, participation is not a commitment to the CTA, social media
aspects and introduction of welcome speeches.

Opening Speeches

3. The speeches were opened by Mr. Jeremy Lefroy, Member of Parliament (MP) who began by
referencing a September 2016 event at the Bundestag on the Global Fund to Fight AIDS, Tuberculosis
and Malaria (GFATM) and that it was welcome news to see the EU, UK and Germany having increased
their contributions to GFATM since that time. Mr. Lefroy underlined that his determination to attend
the roundtable, despite a snap general election in the UK, was to show his appreciation to everyone in
the room as well as to the German government. Mr. Lefroy emphasized that it is vital that the G20
continues and builds on this work, framing his intervention in the context of the title of the event with
particular relevance to the Sustainable Development Goals (SDGs). With 17 goals and 169 targets it is a
very difficult question so often worth looking for levers of SDGs - Mr. Lefroy identified 5 including
global public goods such as health and highlighted why innovation in global health directly impacts on
SDG 1, 2, 3, 8, 9, 10 and 17 while indirectly impacting on 4, 5, 11 and 16.

4. Mr. Lefroy mentioned several means of implementation including data, scale, partnership, long-term
engagement and parliamentary scrutiny. The latter two to mitigate budgetary and parliamentary cycles
and maintain parliaments and the electorate within the dialogue to debate legislation and address
sometimes-unpopular policies (such as the UKs international development commitment to 0.7% of
Gross National Income (GNI)). Mr. Lefroys reference to five political challenges addressed this directly:
(1) Long-term approaches with parliamentary champions, (2) close cooperation between governments,
(3) better communication as constituents want to hear good news as well as bad, (4) engagement with
youth and (5) embedding government involvement in global health and innovation into the domestic
political discourse.

5. Member of the German Bundestag (MdB) Ms. Kordula Schulz-Asche followed on by highlighting why
health remains core to Germany and its future and made reference to the importance of Reproductive,
Maternal, Newborn and Child Health (RMNCH). Once again framing in the context of the 2030 Agenda
for Sustainable Development, the emphasis on an action-oriented approach and why innovation, rather
than a race between companies, countries and regions should be a race against poverty and premature
death and towards shared prosperity. Ms Schulz-Asche called on all present to take on this subject
together using tools that were previously unavailable, by prioritizing research to ensure innovation and
affordability through international funding and with everyone playing their part.

6. Mr. Bernhard Schnittger made the third of the opening remarks by discussing the specific role of the
European Commission (EC) in global health research. Referencing the most recent G-Finder report,
which placed the EC as the second largest funder in this area, he outlined why this was seen as an
obligation by the EC at such a pivotal point-in-time. Challenging questions such as how to incentivize
development of next generation antibiotics when the intention is to use them as little as possible or
how to take medical products for infectious diseases from laboratory to market when the market is so
fragile formed the basis of Mr. Schnittger highlighting the diverse programs currently led by the EC such
as loans for infectious disease products like the InnofinID project, incentivization prizes, partnerships
that bring together funders to share data and respond to epidemics like GLOPID-R or 21st century
capacity building and governance models where European and African partners have equal say in
priority setting, such as The European & Developing Countries Clinical Trials Partnership (EDCTP).

7. Mr. Schnittger underlined the value of partnerships to solve the challenges of global health highlighting
the importance of the roundtable as a way of stimulating partnership. He then went on to recognize the
importance of CEPI to the future of the global health architecture, confirming the ECs commitment to
the initiative and referencing a 25 million pledge by EU Commissioner for Research, Science and
Innovation Carlos Moedas.

8. Concluding the opening speeches the chair, Prof. Wilder Smith emphasized the key element of positive
messaging and the importance of communication in getting the word out on the great work being done
in global health.

Roundtable Session 1: Taking Stock: How global health partnerships changed the
research and development landscape for neglected diseases

Introduction by Dr. Stephan Albani MdB chaired by Ms. Jamie Bay Nishi, Director Global Health Technologies
Coaltion (GHTC)

9. MdB Stephan Albani, reiterating the theme of partnership, captured ways in which the G20 provides a
unique opportunity for the worlds wealthiest countries to take the lead in global health innovation and
why it should present a platform to build on current models. Drawing attention to the fact that the G20
involves many processes, he referenced the Global TB Caucus and the outcome document which calls
on the G20 to establish a new mechanism of R&D to address drug resistant TB. Dr. Albani went on to
underscore that there is a clear need to join together these initiatives to call for investments in
innovation and global health R&D from the G20. Dr. Albani then introduced Ms. Nishi as the Chair of
the Session.

10. Ms. Nishi introduced the GHTC as a coalition of 27 non-profit organizations including PDPs working to
advance global health R&D and gave a brief statistic stating that out of the current 485 neglected
disease products under development, 58% were managed by PDPs. Ms. Nishi introduced the
representatives of four of the PDPs Mr. Ben Alsdurf from the Global Alliance for TB Drug
Development (TB Alliance), Ms. Silvia Ferazzi from the Medicines for Malaria Venture (MMV), Ms. Tara
Hayward from the Sabin Vaccine Institute and Ms. Claire Wingfield from PATH asking each of them to
give an example of a model or project from their portfolios.

11. Speaking about properly formulated pediatric TB regimens, Mr. Alsdurf cited that in 2010 the WHO
released new guidelines on what the appropriate formulation for TB medicines for children should be
and that no appropriately formulated medicines existed at the time. The TB Alliance, UNITAID, United
States Agency for International Development (USAID) and others worked to incentivize manufacturers
to develop those formulations. In 2015 the TB Alliance and its partners announced the availability of
child-friendly TB medicines in the correct doses with Kenya the first country to launch nationally in 2016
and with global partners helping the overall roll-out. Mr. Alsdurf specified that this was one specific
example and that development timeframes are often longer agreeing with Mr. Lefroys earlier point
that there is an overall need for long term vision.

12. Approaching the discussion through a lens of funding, Ms. Hayward referred to the Human Hookworm
Vaccine (HOOKVAC) consortium, led by the Academic Medical Center (AMC) at the University of
Amsterdam, which was awarded a grant of 6 million from the EC FP7 programme to expand Sabins
work to develop and test a vaccine for human hookworm, a disease that infects 600-700 million of the
worlds poorest people. To be eligible Sabin brokered new partnerships to build European and African
involvement with the consortium being led by a European institution, which allowed the research to
move forward that would otherwise not have been possible without the EC funding. This presented a
challenge to Sabin as a US institution and regulatory sponsor of the product under development, with
management of the project being handed over to a European partner. Ms. Hayward stressed that
geographic and institutional requirements of funders can actually drive the nature of scientific
collaborations and stressed the need for funding to remain as flexible as possible.

13. Pointing to the involvement of two dozen institutions from across four continents Ms. Wingfield spoke
of a meningitis A vaccine - MenAfriVac - the first time in history a vaccine has been specifically
designed for Africa with specific focus on its introduction in Africa. The vaccine was rolled out across
the 26 nations of Africas meningitis belt over the course of seven years with no vaccinated patients
contracting Meningitis A. Through the WHO, government ministries, communities and a manufacturing
partner (Serum Institute of India Ltd) PATH was able to establish the right product at a sustainable
price. Ms. Wingfield emphasized the unique role PDPs play as bridging agents and facilitators in
managing partnerships.

14. Reminding participants that it was recently World Malaria Day (25th April 2017) Ms. Ferazzi captured a
two-part story related to severe malaria. An estimated two million people develop severe malaria every
year, 90% being young children in Africa. Severe malaria causes both death and long-term cerebral
damage. Historically treated with injectable quinine, MMV with several partners including Guilin
pharmaceuticals was able to obtain World Health Organization (WHO) prequalification for injectable
artesunate in 2010, saving an estimated half a million additional lives under the new superior
treatment. The second element cited by Ms. Ferazzi was the need to treat severe malaria, particular in
children, in remote communities. MMV is collaborating with two pharmaceutical partners (Strides and
Cipla) to secure WHO prequalification of rectal artesunate as part of a UNITAID-funded project. In 2016
a GFATM Expert Review Panel gave temporary authorization to use it for international procurement for
one year in anticipation of WHO prequalification. As elements of success, Ms. Ferazzi cited broad
partnership (six partners from six G20 countries including emerging global health actors such as China
and India) synergy with other international partners (WHO, TDR, UNITAID, GFATM). She closed by
highlighting how PDPs can contribute to Health System Strengthening (HSS) when technologies are
customized to different parts of the health system in an integrated way.

15. Ms. Nishi picked up on this final point on how R&D / innovation up front is often separated out from the
health system, trying to understand the interplay and dynamics of how technologies are customized to
the health system and how uptake happens at the community level. Ms. Ferazzi said that access is
becoming increasingly important to MMV as is helping to strengthen the role of regulatory systems,
which are also part of health systems, in order to make sure that new technologies are registered and
available nationally. The second part is to make sure that health workers in the communities are aware
of the availability of the new medicines and can use them appropriately. Ms. Wingfield also
acknowledged the regulatory aspect citing it as an often-lost piece of the health system. When
conducting research, when getting a product registered and during implementation, PDPs spend a lot of
time interacting with different regulatory institutions. She also acknowledged Ms. Haywards point on

funding and went on to underline the importance of making sure that funding is available throughout
the process - from an idea, to a product, to market with access being a consideration from the very
beginning. This is another role that PDPs play as there is a need to leverage lots of different actors who
have strong expertise in one specific area.

16. Ms. Nishi asked Mr. Alsdurf to develop his contribution on development timeframes and maximizing
impact. Acknowledging that almost every R&D enterprise is a time-consuming endeavor, Mr. Alsdurf
suggested that PDPs have been advanced in terms of thinking of how to innovate around the
development process and with regulatory considerations in mind. He cited the TB Alliances strategic
decision to take multiple novel drugs and test them together at the same time thereby abolishing an
older model and using novel regimens as the unit of development, something other PDPs are doing in
their respective therapeutic areas. He suggested that because PDPs are operating at a nexus they may
have more flexibility to think through and innovate around the structure of the development process
than some other organizations.

17. Ms. Nishi asked Ms. Hayward to develop her contribution on the financing aspect and asked about
incentives for the public and private sector to come together and work in this space. Ms. Hayward cited
innovative financing models and open source initiatives like patent pools, drug libraries and sequencing
projects that are driving early stage innovation and encouraging investment. She mentioned newer
models like CEPI and Innovfin (both mentioned earlier by Mr. Schnittger) as well as country-specific
mechanisms like GHIT which all add a much-needed financial boost to the R&D funding landscape. She
advanced this into the context of the G20 where more models are needed supported by the G20 that
help galvanize efforts against emerging and infectious diseases that stimulate private and public sector
partnerships and investments. The G20, with a focus on economic development in the top 20
economies of the world, is well positioned to broaden this community of stakeholders.

18. Building on this forward-looking approach, Ms. Nishi asked Ms. Wingfield to speak about any
opportunities and models for the future. Ms. Wingfield began by emphasizing that PDPs should not be
viewed as homogenous, but rather sharing some key components, one of them being the business
approach to portfolio management and the leveraging of public/ private partnerships. Highlighting a
difference, she cited that PATH has over one hundred products in its portfolio and cuts across many
diseases and conditions compared to TB Alliance or Sabin who in many ways drive their specific
development fields.

19. Ms. Wingfield discussed how PATH is moving towards working with local innovators who have identified
the problems in their communities and is helping them get concepts to market using its substantial
experience in this area. For example with the South African Medical Research Council (SAMRC) PATH is
helping to support local innovators to move their projects forward and looking to expand partnerships
with manufacturers in Sub-Saharan Africa (SSA), something they are already doing in Asia, with local
manufacturers being able to manufacture for the global, not just local, markets.

20. Ms. Nishi moved on to discuss the larger ecosystem with other stakeholders in the global health
innovation ecosystem, including on the funding side, and referred to the Global Health Innovative
Technology (GHIT) Fund represented by Dr. Kei Katsuno. Established in 2013, Dr. Katsuno presented
GHIT as the first of its kind: a Japanese public-private partnership, focusing on infectious diseases that
are prevalent in developing countries, funded by the government, the Bill & Melinda Gates Foundation
(BMGF) and the pharmaceutical sector. The original partners to the Fund initially committed between
US$100 and US$120 million over five years with around half coming from the government and the rest

from BMGF and the pharmaceutical companies: Astellas, Chugai, Eisai, Daiichi Sankyo, Shionogi, and
Takeda. Over the initial four years, GHIT has funded over 80 projects totaling US$80 million. Referring
to eligibility, Dr. Katsuno stated that projects have to be a collaboration between Japanese entities
(research institutions, universities or pharmaceutical companies) and non-Japanese entities. He
indicated that all of the PDPs present, including the Foundation for Innovative and New Diagnostics
(FIND), have been a recipient of GHIT funding as well as others including Aeras and the Drugs for
Neglected Diseases Initiative (DNDi). He pointed to the pivotal announcement at the G7 Ise-Shima
Summit, where the Japanese government pledged another US$130 million for the next five years and
cited additional involvement from BMGF, the Wellcome Trust, and ten additional companies including
GSK, Merck and J&J. Dr. Katsuno finished by highlighting how the model could potentially be replicated
and was interested in discussing questions of applicability.

21. Referring to the pharmaceutical sector, R&D costs, and the alignment of industry, Ms. Nishi then
brought in Dr. Harald Nusser on the role of Novartis in this area. Citing its several partnerships with
MMV particular the one that helped to develop the pediatric formulation of artemether lumefantrine,
Dr. Nusser stated that the vision of Novartis is to develop new technologies on the one hand and to
make those medicines available to as many people as possible on the other hand, which means that
R&D or collaborations with PDPs are only valuable if the medication eventually gets to the patient. For
more than 15 years artemether lumefantrine has been on the market through Novartis and the WHO.
Although there are many competitors now involved, the segment of ACTs is not big enough with many
people on antimalarial treatments that are not effective or no longer effective due to resistance. Of
particular concern, continued Dr. Nusser, is that despite the investments and subsidies from Novartis
and several others into the development of the product, the pediatric formulation - while available - is
largely not used or procured (emphasizing that it wasnt a case of whether or not it was procured from
Novartis). He observed that because the adult formulation is procured because it is two or three cents
cheaper with children swallowing a bitter-tasting crushed medication that is not properly dosed,
resistance can easily develop. He concluded that, while the product is available thanks to the
partnership with MMV, it is not being utilized to the extent that is necessary, which needs to be taken
into consideration. It is not just the research and the money spent that is relevant, but the uptake into
the market, and several partners have to work together to optimize this.

22. Ms. Nishi then asked Mr. Robert Terry to bring in the perspective of the Special Programme for
Research and Training in Tropical Diseases (TDR) including the work on the Global Observatory on
Health R&D. Mr. Terry began by saying that TDR, which has existed since the 1970s has trained over
3000 scientists from the developing world. Citing the discussion on global solutions and framing it as a
real opportunity for the G20, Mr. Terry outlined a global mechanism under the governance
arrangements of the WHO, which would bring together three components of the areas being discussed.
One is the creation of a new global health R&D observatory, which is currently operational. Citing Mr.
Lefroy on the importance of data and stating that, not for lack of data, there are no current means to
know who funds what, where and how around the world, he said that the observatory would bring
together all of the pieces of information required to make global priorities and global decisions on
funding, publications and patents. The second component is the creation of a directory on product
profiles - a technical way of describing the priorities needed. The third is establishing a new committee
under WHO which will use the data to get a global overview of health R&D funding. Commending the
excellent examples given earlier, Mr. Terry stated that there are still gaps (including funding gaps). His
plea on this to the G20 countries, particularly those that are not currently active at the global level, is to
seize the fantastic opportunity to come together and work together to create pooled funding
mechanisms, citing the success of GHIT. He expanded on his definition of pooled funding referring to

the risks of R&D including lots of failure, where pooled funding shares the risk and benefits. The
mechanism put forward to WHO particularly applies to those within the G20 who can help low and
middle income countries become producers, not just consumers, of research and Mr. Terry mentioned
that this has been discussed a number of times at the WHA. He said the mechanism would fit ideally
with CTA that was shared at the beginning of the session.

23. Ms. Nishi, referring to global mechanisms, convening roles and information sharing referred to the
essential medicines list and the proposal for an essential diagnostics list, and brought into the
discussion Ms. Julie Archer from FIND - a PDP involved in diagnostics for a series of diseases like TB,
malaria, NTDs and more recently diseases with outbreak potential and AMR. Ms. Archer built on, and
referred back to, a number of the key challenges and opportunities already mentioned by other PDPs
giving specific reference to the Xpert MTB/RIF test, a cartridge-based TB molecular diagnostic test that
gives a result in 90 minutes. As one of FINDs earliest successes, this paved way to a next generation
diagnostic test that was launched recently - the Xpert MTB/RIF Ultra cartridge that is currently in field
evaluations and which does a better job of diagnosing TB in people living with HIV and also in children.
Ms. Archer then referred to the GeneXpert Omni, which is battery-operated, and can be brought to
remote populations where TB diagnosis isnt possible adding that all of this has been accomplished, and
could only have happened, through multi-stakeholder multi-sectorial partnership with the private
sector involved due to the fact that the PDP could provide trial sites and specimens and reduce the cost
of development by providing an enabling environment to get the test to market. Ms. Archer agreed on
the access challenges saying that lessons had been learned after 2010 in terms of the capacity needs to
build regulatory policy change, introduce practitioners to the existence of tests in countries, particularly
where private sector practitioners play a big role in diagnosing TB (if the public sector is using the best
and latest tests and the private sector is not but most people still go to the private sector there is still a
problem), and moving away from a build it and they will come approach. Finally she added that
Technical Product Profiles are very important and need to be developed with the countries where the
technology will be rolled out - development should take place with relevance to low-income settings
and costs in mind.

24. Ms. Nishi highlighted that diagnostics need to be developed hand-in-hand with drugs and vaccines and,
connecting the points on capacity issues, asked Mr. Abdullah Aldahmash from the King Saud University
to discuss his current capacity building focus. Mr. Aldahmash referred to the fact that Saudi Arabia is
surrounded by unsettled countries with often collapsed health systems and emerging disease threats
and that it has a responsibility to address many of these issues so as to not let them spin out of control.
For that reason, and as the country is mostly focused on treatment rather than prevention through
vaccines, his institution recently collaborated with the Sabin Vaccine Institute, to build capacity to
produce vaccines for those diseases that are relevant to the region. He went on to indicate that the
collaboration is at an early stage of a multiyear process, with the ultimate goal to get more interest
from the private sector and other collaborators in order to eventually be able to develop and
manufacture vaccines in-country in order to help make the region more resilient by preventing the
spread of diseases within and from the area. Currently focused on early-stage personnel and knowledge
growth, the collaboration will move on to a technology transfer stage hopefully involving industry and
academic partners.

25. Ms. Nishi grounded the discussion in the G20 process by citing the strong linkage between health,
security and economic drivers alluding to R&D processes that are helping to solve some of the issues in
these areas as well as job creation of the researchers linked to economic growth, support of resilient
health systems and healthy populations that then drive economic growth for other countries. She

emphasized the relevance of the discussion on pandemic threats and global health security as part of
the G20 agenda before opening up to comments on next steps. Ms. Wingfield pointed out that, to build
on the capacity and talent, additional financing was needed, as well as enabling policies to address the
regulatory gap between licensure and access. Referring back to both Dr. Nussers and Ms. Archers
points on access, she emphasized that policies and political will are needed to support timely uptake
and saturation with health impact as the ultimate goal.

26. Mr. Alsdurf added that there is a need for a policy debate that does not create siloes between global
health conditions and those more directly related to health security, citing the exclusion of TB from the
WHO Priority Pathogens under the AMR agenda. The G20 and the policy response is important to avoid
artificial distinctions on what an AMR pathogen is as, for a lot of the developing world - including in G20
countries - drug resistant malaria and drug resistant TB are the face of AMR, so including those in the
same policy framework is important.

27. Ms. Ferazzi echoed the earlier points on focusing on how to tap into R&D potential and maximize this
capacity to stimulate innovation in endemic countries through technology transfers and how to engage
communities in the process in order to ensure access. Citing Dr. Nussers earlier comments on
procurement Mr. Lefroy then made a comment on procurement related to Insecticide Treated bed-
Nets (ITNs) where there is resistance to Pyrethrin, but where there is often an issue in procuring the
dual-treated nets as they are slightly more expensive to procure. It is therefore important to avoid
doing a lot of innovative and expensive research to find that the procurement strategies are to get the
lowest possible cost regardless of effectiveness.

28. Professor Helen Rees mentioned the Vaccinology Centre of Excellence in Johannesburg at the
University of Witwatersrand, which is mapping research in the African region, and stated that African
leadership is very weak and that there are no self-sustaining leadership organizations doing research
without partnering with the more developed countries. If global health is to align with development
then this leadership needs to happen. Similarly with technology transfer, where examples such as the
Serum Institute in India have shown that first class institutions can grow in the developing world, the
African region has no examples. Professor Reess second point on rollout used the HPV vaccine as an
example as this is something that should be rolled out globally however the map of Africa is empty with
lots of pilots. The perception of health ministers, particular with Gavi being withdrawn from a number
of countries, is that they cannot afford the vaccine. Mechanisms of tiered pricing are necessary, as first
class technologies are currently not being rolled out. Her third point on alignment, framed R&D
investment as critical but cited the withdrawal of polio funds without adequate planning in the African
region. Therefore donors, while doing fantastic things with their funding are also not fully aligning. Prof.
Rees then spoke about regulatory issues where there has been great progress on harmonization but
she appealed for a change in attitude and equitable relationship - using the example that whereas
South Africa supports lots of research there is often too strong a focus of a dialogue with the European
Medicines Agency (EMA) and the US Food and Drug Administration (FDA) before South Africa knows
about it.

29. Mr. Donnelly then gave some thoughts on the communication aspect of the various points that were
under discussion. In addition to very strong advocates such as Dr Albani, who has a medical
background, and Mr. Lefroy, who has first hand personal experience, influencing the political dialogue
means understanding political siloes and working into budget committee and other groups across a
number of parliaments. He stressed the need to significantly broaden the base of advocates outside of

the traditional areas of operation, using smaller - but more regular - packets of information and facts on
impact that are compelling.

30. Ms. Nishi expressed full agreement with this using some statistics from forthcoming reports from the
GHTC as examples of the kind of information diverse public stakeholders would welcome.
Dr. Denis Broun, acknowledging the richness of the discussion so far and speaking on behalf of Indian
generics manufacturer Cipla, spoke of the issue of time mentioning that rectal artesunate, as
mentioned earlier by Ms. Ferazzi, was part of TDRs portfolio in 1998 and took 20 years to bring to
market. He said that PDPs have brought progress but that more can be done. The second issue creating
delays he said was regulatory, outlining how it takes a couple of years to get a product registered in a
country where it is desperately needed, where all dossiers are ready and where the product is already
registered elsewhere, which he described as is frustrating. He gave the example of a pediatric HIV
product that was given fast track registration due to its importance but that got registration five years
later. Dr. Broun continued by discussing how the creation of markets has helped access, with the
GFATM having played a crucial role. Conversely, he added, when the market is small innovation
experiences issues. As the only manufacturer of artesunate mefloquine - an antimalarial used in the
Mekong Region - Cipla hesitated to produce a second batch due to uncertainly around uptake when the
first batch was not procured sufficiently and 80% had to be destroyed when it expired. Mentioning his
involvement with the High Level Panel on Access to Medicines Dr. Broun said that it is important to get
the right licensing policies for products that come out of pubic sector research and that this requires
work from the G20, EU and others. He continued that this is not just access related to poor countries.
He finished by saying that voluntary licensing particularly in HIV is creating elements of solutions but
also cited controversies such as the pricing of the Hepatitis-C-Virus (HCV) drug in middle-income

31. Ms. Archer picked up the point on HCV indicating that a further obstacle to access is the lack of
appropriate diagnostics especially in Low and Middle Income Countries (LMICs) where fewer than 1% of
people living with HCV know that they have the disease and are therefore not attempting to be
diagnosed nor to get the very effective drugs that are available - the reverse situation to what was the
case with antiretroviral drugs (ARV) therapy in HIV where there were waiting lists of people who had
been diagnosed with HIV but did not have access to treatment. To this end, FIND is currently working
with UNITAID and other partners on a project in seven countries but cannot work fast enough to
evaluate the tests that exist and to build the markets for HCV testing (and therefore drugs) alongside
civil society.

32. Ms. Wilder-Smith drew attention to the fact that it is important to recognize the critical work of FIND as
diagnostics currently still have a particular status and that it is maybe time for a Decade of
Diagnostics to follow the Decade of Vaccines given that it is diagnostics that will help reduce AMR,
address pandemics and implement new vaccines and medicines. Using Zika as an example, where more
than 70 companies are racing towards developing new diagnostics but only a few will make it to the
end, money and time can be saved through alignment.

33. Ms. Archer agreed, saying that this is something that FIND and other partners are currently debating,
particularly related to outbreak preparedness where work follows two prongs - known pathogens and,
even more complicated, unknown pathogens or those that have not yet emerged. She indicated that
several groups are currently working with industry to identify promising technologies including FIND,
Medicines Sans Frontiers (MSF) and WHO. She continued that platforms could be used to pool the work
of many different companies so if one company has the most promising diagnostic for one disease and

another company for another disease, the platform would provide an area to bring this together. She
said that a priority list has been identified by the WHO for pathogens with outbreak potential with CEPI
playing the critical role for vaccines and FIND hoping to work with them on companion diagnostics. For
unknown pathogens the goal is to streamline everything - regulatory, funding, development - to have
everything as ready as possible which also involves an enormous amount of partnership in advance
which reflects the points being discussed today.

34. Dr. Nusser reiterated the importance of cross-sectorial partnerships stating that there is a tendency to
look at donor / therapeutic area verticals which thereby neglects the patient as, for example, when a
malaria patient may have hypertension or other diseases. He continued by citing that the additional
burden of Non-Communicable Diseases (NCDs) costs the LMIC economies around US$500 billion
annually with more patients prematurely dying of hypertension than of all infectious diseases together.
It is therefore essential that every dollar is spent and leveraged to the best extent possible which is why
he considers the WHO R&D observatory, and other initiatives to avoid donor waste, as very important.
He then built on this by giving a self-critical example of Novartis only recently realizing that a compound
in their portfolio - clofazimine which treats leprosy - works for Multidrug-Resistant TB (MDR-TB). On top
of its obligations as a private sector company, Dr. Nusser finished by stating that the group of partners
in the room needs to always speak and share what they know.

35. Following Ms. Nishis call for closing comments Mr. Alsdurf and Ms. Ferazzi reiterated the need for an
integrated response to health and security challenges like pandemics and AMR in its many forms
including TB and malaria. Ms. Hayward and Ms. Wingfield mentioned financing and incentives in order
to achieve health impact by engaging both public and private sector partners with Ms. Wingfield
emphasizing that funders should fund portfolios not specific projects which lets the science guide the
decision-making. Mr. Terry closed by stating that the G20 has an opportunity to operate together and
pool resources which is a better use of their funding than operating unilaterally.

AMR and Pandemic Preparedness as G20 Priorities

Introduction by Prof. Annelies Wilder-Smith and presentation by Dr. Richard Hatchett, CEO of CEPI & by Dr. Peter
Jackson, Executive Chairman, AMR Centre & Founding Member of CARB-X

36. Moving onto the next session Ms. Wilder-Smith stated that the two main focus areas of the German
G20 Presidency are pandemic preparedness and AMR and that these are areas that two recently
launched public private partnerships - CARB X and CEPI - focus on. After being introduced as the new
CEO of CEPI, Dr. Richard Hatchett began by thanking Sovereign Strategy for bringing everyone together
and gave a short introduction to CEPI, which was formally launched at Davos at the beginning of 2017.
Dr. Hatchett emphasized the fit of CEPIs mission with the SDGs giving particular mention to SDG 322. He
said that epidemic and pandemic diseases like Ebola that cause preventable death and economic
disruption can undermine the overall achievement of the SDGs and that CEPI is a form of global health
insurance that aims to address this. Dr. Hatchett emphasized that it was extremely positive that the

22 SDG3: Ensure healthy lives and promote well-being for all at all ages

German G20 Presidency is highlighting pandemic preparedness and that CEPI wanted to thank the
German government for the leadership it has shown, with Germany as a founding donor. He qualified
this by expressing that this is not an issue for a single G20 cycle and that pandemic preparedness should
be part of the ongoing dialogue.

37. Dr. Hatchett went on to highlight that behind the abstract and strategic points of his presentation, is the
human suffering that occurs from epidemic diseases that can be prevented. He showed how quickly
testing of Ebola vaccines occurred but indicated that the point of the epidemic at which the trial started
was unacceptable and stated that one of reasons behind CEPI is to move these timelines back. While a
signal of efficacy was possible during the epidemic, if the goal had been to test an intervention strategy
rather than test the efficacy of a vaccine it may have been possible to change the overall outcome of
the epidemic. Showing a number of after-action reports that looked at what needed to change, he said
that there was wide agreement and convergence on the need to make investments into epidemic
preparedness specifically in vaccine preparedness citing a prominent article on Establishing a
Global Vaccine-Development Fund, (Plotkin, Mahmoud and Farrar, 2015) from where the ideas
converged resulting in CEPI.

38. Underlining that CEPI is a coalition, and acknowledging an earlier point from Ms. Archer, Dr. Hatchett
said that he is acutely aware of the need for diagnostics and therapeutics and that CEPI would be
focusing on vaccines to show that this model can work while leaving it open-ended as to whether this
mandate might be expanded to take on other components of preparedness from a countermeasures
perspective. Separating its functions, Dr. Hatchett said that CEPI would be funding projects from late
preclinical through to Phase 2 and that a joint coordination group under the umbrella of the WHO R&D
Blueprint list of epidemic threats needing urgent R&D action had been established in order to better
coordinate the end-to-end efforts adding that CEPI cannot succeed in the area it occupies without
broader coordination and broader engagement with regulatory authorities and others. He said CEPI
would also focus investment to develop rapid response platforms as resources needed to address the
next emerging threat.

39. Moving back into the story of CEPI, Dr. Hatchett said that he had been humbled and honored to be
asked to lead CEPI into the next stage and that it is an astounding story in terms of how fast the process
evolved during 2015 to 2017. With US$540 Million in initial funding from Germany, Japan, Norway,
BMGF and the Wellcome Trust, as well as in-kind funding of US$250 Million from the EC under existing
mechanisms, CEPI has a substantial base to work from. Thanking Chancellor Merkel, who has
mentioned CEPI on several occasions including during the recent Science20 Summit, Dr. Hatchett said
that he is grateful for the boost that this attention gives.

40. Following Ms. Patricia Nicklins reference to the No More Epidemics campaign at Management
Sciences for Health, which focused on the global health security agenda of the Obama administration
and used advocacy to make sure that, at the country level, there was investment in health systems, Dr.
Hatchett stated that CEPI does have a mission to ensure capacity building. While CEPIs mission is to
take products into Phase 2a and have them ready for deployment in an investigational setting during an
outbreak, the capacity building element is critically important to make sure that there is a research
infrastructure capacity in the regions where these diseases are likely to emerge. CEPIs target
pathogens have geographical relevance to West and Central Africa, the Arabian Peninsula and
Southeast Asia and those areas have varying levels of preparedness. Ebola demonstrated the challenges
faced when there are outbreaks in places that have poor pubic health infrastructures and poor clinical
research capacity. As CEPIs mission advances they will be working closely with partner countries in

regions at risk. Citing his forthcoming visit to WEF Africa and meetings with African public health
leaders, Dr. Hatchett said that he would be inviting global participation in order to involve potential end
users in the process. He said that the TPPs will be important in order to maintain end-to-end
perspectives even during early stage investments - investments that are made at the front end can lead
down a certain pathway. To Ms. Nicklins point on the global health security agenda under the current
U.S. administration, Dr. Hatchett acknowledged that the previous administration had done a good job
of weaving in the idea of global health security with national security and that CEPI could be the tip of
the spear when addressing national security issues not just health issues.

41. Prof. Rees declared her role on the Expert Scientific Committee of CEPI and stated that Ebola has
changed the way the world is doing things, mentioning how the Emergency Committee regarding
yellow fever was very quickly convened and that fractional dosing was done which was novel. She went
on to say that the WHO Strategic Advisory Group of Experts (SAGE) committee recommendations about
the use of the vaccines means that Gavi can purchase / pre-purchase and comes back to Dr. Brouns
point about trying to create a market when the market is small. Prof. Rees appealed to the G20 to think
about innovative incentivizing of vaccines that are not going to have widespread use but will need to be
stockpiled. She said that the regulatory meeting that WHO is convening the following week is about
getting fast-track regulatory processes ready so that once Phase 2 is done it can be pushed out very
quickly. She finished by saying that all of these different pieces are coming together without doubt as a
result of Ebola.

42. Prof. Wilder-Smith asked Dr. Hatchett to end his session by commenting on - given that emerging
infectious diseases are always unpredictable - what criteria CEPI is using to select and prioritize the
initial vaccines. Dr. Hatchett responded by outlining the prioritization process. CEPI engaged its
Scientific Advisory Committee (SAC) and limited to the eleven diseases that WHO identified in the R&D
Blueprint as presenting a high risk. The three diseases that CEPI is targeting with the first round of Call
for Proposals are Lassa, Middle East Respiratory Syndrome (MERS) and Nipa Virus. CEPI has an
independent commitment to support, facilitate and complete the development of the Ebola vaccines
but this is not part of the first Call for Proposals. Dr. Hatchett stated that there is a little bit of
misunderstanding on the three pathogens: that these are the only diseases that CEPI will ever work on
and emphasized that these are being targeted for the first Call for Proposals given restrained resources
- a strategic decision to constrain the focus to allow for multiple candidates that CEPI could begin to
develop for those diseases in anticipation of attrition with hopefully a couple of candidates for each
disease to the stage of development that is being targeted (post-Phase 2 waiting for outbreaks). CEPI
asked the SAC to look at the following factors: the potential impact of an outbreak, what we know
about the diseases, what we know about the logical response to the diseases, what we know about the
current pipeline and what we know about whether it is feasible to immunize against those diseases. To
sum it up, Dr. Hatchett said that CEPI is not picking the lowest hanging fruit but the low fruit with the
highest impact and trying to be pragmatic and design programs to increase probability of success.

43. Dr. Peter Jackson introduced CARB-X as a public-private partnership established over the last nine
months with a focus on developing antibiotics to combat AMR. Dr. Jackson spoke of the magnitude of
the challenge including the scale of funding needed to rebuild the antibiotic pipeline (citing Mr. Lefroys
earlier comment on the importance of scale). He underlined that whatever actions are taken with
diagnostics, preventatives, prescribing, surveillance and stewardship of antibiotics, in the end there will
be a need for new drugs. Showing a 14-year timeline and the empirical success rates for antibiotics
obtained from pharmaceutical industry publications, he said that for one successful new antibiotic, at
least 64 new projects are needed in discovery with 5 entering clinical trials, which will cost at least

US$600 Million. He emphasized the need for more than one new drug. Reiterating the messages on
scale, Dr. Jackson spoke of the importance to get the message across to policy makers and decision-
makers at the G20 and beyond. He said in the US, Biomedical Advanced Research and Development
Authority (BARDA) have provided hundreds of millions of dollars to support products through the
clinical stage and new funding that is being made available through CARB-X/ AMR Centre in the UK is a
very specific intervention aimed around the translational space - to take things from mid-preclinical
development and get them into the clinic as quickly as possible.

44. He continued that this also fits with the needs of the companies that they are partnering with, which
are predominantly Small Medium Sized Enterprises (SMEs). The BEAM Alliance - a collection of biotech
organizations within the EU - have called for significant increases in funding to bridge their valley of
death - an area that is particularly difficult in the development of new anti-infective when the funders
in this area have also got oncology, immunology, cardio-vascular disease and aging diseases, which
have a clearer business model and potentially higher returns. So there is a very specific intervention by
CARB-X and the AMR Centre into this translational space. Adding more context about CARB-X Dr.
Jackson, described how the consortium was built over summer of 2016 and is headed by Dr. Kevin
Outterson who is based at Boston University. CARB-X was awarded US$250 Million from BARDA at the
end of July 2016 with further support of US$150 Million announced from the Wellcome Trust. This
US$400 Million over a 5 year period is substantially leveraged by additional matched funding from
other members of the consortium as well as from SMEs and companies that they are working with.
CARB-X will be making awards of around 40% of overall program costs so that when it is scaled up it will
be leveraging around a billion dollars of funding into the translational space for new anti-infectives. The
consortium brings together some of the pre-eminent biotechnology locations including Boston and
California. It involves the US government (through RTI International) as well as the AMR Centre and its
wider network across the UK. It was created as a response to the policy recommendations of the O
Neill Review which called for US$2 Billion of global R&D to combat the issue of AMR. Dr. Jackson
described CARB-X as a substantial down-payment on US$2 billion. Two rounds of Expressions of Interest
for funding have already closed and the first 11 programs were announced at the end of March with
US$24 Million of funding for immediate stages of development which, if they achieve milestones, will
receive an additional US$24 Million of follow-on funding. These amounts do not include the funds that
will be leveraged from the shareholders and investors in those particular companies.

45. Dr. Jackson emphasized that CARB-X is not just a transatlantic initiative and from the outset the
organization was designed for scalability. Its leadership team would welcome new funders, new
accelerators and new partners from around the world to build this into a truly global organization and
the funded programs have no geographic limitation. The AMR Centre is one of the founding members
of CARB-X and also provides dedicated capacity using US$500 Million worth of infrastructure at the
former Astra Zeneca state-of-the-art research site in the Northwest of England and leverages expertise
across the U.K. such as with Public Health England. It also involves the Northern Health Science Alliance
- the umbrella body for the U.K.s National Health Service research organizations across eight leading
hospitals in the North of England that are connected together to enable fast track access to clinical trial
capabilities. Co-funding with CARB-X, the AMR Centre is working towards announcing its first three
programs in May. Citing Mr. Lefroy on the importance of goals Dr. Jackson went on to outline what the
objectives of the initiative are - to develop, with SME partners, ten new antibiotics ready for clinical
trials by 2020 with five of those going into the clinic and achieving one clinical proof-of-concept. Going
on to summarize, he said scale, collaboration and capacity were key as are working with colleagues,
funders and experts from around the world to accelerate the great ideas coming out of research
initiatives, leverage expertise and mobilize hundreds of millions of dollars in funding. Dr. Jackson urged

the G20 to help coordinate action to build an unprecedented initiative at the right scale to make
meaningful impact on the global threat from AMR.

46. Dr. Hatchett made the first follow-up comment saying that he was glad that there was the focus on
scale in Dr. Jacksons presentation, which he described as a commonality between CARB-X and CEPI:
they were both designed to attract and invite new investors to leverage the funding beyond just the
dollar amount that the organizations are in immediate control of. He emphasized that success will
breed success. Prof. Richard Feiner, Columbia University, commented on the importance he gives to
teaching about cross-sectorial partnerships in the global health space and that he highlights both
CARB-X and CEPI in class as new financing mechanisms. He commented that the philanthropic focus
was missing from the conversation and said that some of Dr. Hatchetts earlier comments in particular
would have a strong philanthropic pull as there is a wealth of invested philanthropists and social impact
investors that would welcome entry into this space. Mr. Donnelly echoed aspects of this point and used
the example of Bloomberg Philanthropies, who are in many cases unaware of, rather than not
interested in, much of the work happening in this area.

The Work of the B20 in Health Innovations

Introduction by Prof. Annelies Wilder-Smith and presentation by Dr. Stormy-Annika Mildner, B20

47. Prof. Wilder-Smith welcomed everyone back to the afternoon session and introduced Dr. Stormy
Mildner, who explained why she had been very interested to attend this meeting particularly in the
lead up to G20 Health Ministers Meeting. Dr. Mildner said that health is a topic that belongs on the
G20 agenda and that she is happy to support what she views as an initiative that is going to push the
issue forward and make it a permanent G20 agenda point. She said that she appreciates the CTA and
that the B20 wholeheartedly supports everything that is on there and believes that the initiatives have
to work together on these issues. She continued that the motto of the German G20 Presidency is
Shaping an interconnecting world, with building Resilience, improving Sustainability and assuming
Responsibility as the three pillars which is timely given the current problems of the international
cooperation environment. While it is important to continue to talk about economic growth, financial
stability and the more traditional G20 agenda points that are important to development, it is also
timely that the G20 is broadening its agenda into areas like health, sustainable development, energy,
climate, resource efficiency and responsible business conduct. The B20 has also changed and its motto
is Resilience, Responsibility, Responsiveness Towards a Future-oriented, Sustainable World Economy
and has involved, over the last 10 months more than 700 representatives from companies and
associations. The B20 functions on a consensual basis towards actionable recommendations through its
policy papers which were to be handed over to Chancellor Merkel at the B20 summit the following

48. Moving on to discuss the B20 Health Initiative, Dr. Mildner said that when they consulted with the B20
community and G20 economic associations on priority areas in 2016, health was excluded, and so it
came onto the agenda of both the G20 and B20 a little later on. There are over 100 representatives on
the B20 Health Initiative Working Group with recommendations to be presented to the German
Minister of Health on May 18th 2017. The priority topics are innovation and health, AMR, NTDs,

pandemic preparedness and digital health all of which reflect the health dialogue within the G20 but
with innovation and digital health being added to the three core priority areas as they believed them to
be critical enabling environments. Dr. Mildner said that there are a lot of health issues relevant to
economic and social development in Africa and began to speak about the CWA, which Germany had
initiated. She said that it is demand-driven with countries to stimulate private investment in Africa by
improving the macroeconomic stability, business environment and overall inclusivity for economic
activities. There are five countries that have voiced interest: Cte d'Ivoire, Rwanda, Morocco Senegal
and Tunisia. The Compacts will be individualized and the negotiations facilitated through the World
Bank (WB) and the International Monetary Fund (IMF) who are in coordination committees with the
G20 alongside investor dialogues and roundtables. In the Joint African Development Bank (AfDB), IMF
and WB Group Report on the CWA, health is included but could feature more strongly. So, if we are
talking about health in the G20, we should also talk about the CWA. Dr. Mildner finished by highlighting
again the value of the global health innovation initiative because of its capacity to bring together the
public and private sectors in order to work on an enabling environment for investment. She invited all
participants of the roundtable to join to the B20 Health Initiative in order to find concrete
recommendations for the G20.

49. Ms. Wingfield asked if, when trying to attract more private sector investment in Africa via the CWA, it
was prioritized to the African private sector to which Dr. Mildner responded that it is international with
companies coming from the G20 and with the initiative eventually becoming broader. As it is not a
development assistance program but a demand-driven partnership of equals, it is not just about
investment conditions for foreign investors but also an enabler of domestic investors to invest more,
that builds on and is complimentary to the AU 2063 Agenda. The initiatives require that specific
governments commit themselves so that private money is being supplemented through public money.
The current focus on infrastructure related to transport, energy, schools, and digitalization is why the
inter-linkage with health issues becomes quickly apparent. Dr. Mildner acknowledged the presence of
the African Union (AU) ambassador and the relevance of the 2063 Agenda. Dr. Mildner mentioned that
there is a recommendation paper from the B20 to the G20 for CWA, which builds on the AU Agenda.

Roundtable Session 2: Looking Ahead: Improving Global Health Cooperation to meet

the Sustainable Development Goals

Introduction by Dr. Stormy-Annika Mildner, B20 and chaired by Prof. Helen Rees, Executive Director, Wits RHI,
University of Witwatersrand, South Africa, Chairperson South African Medicines Control Council, Chair WHO IHR
Emergency Committee on Polio

50. Dr. Mildner then introduced Professor Helen Rees as the moderator of the afternoon roundtable
session. Prof. Rees began by speaking of the post-Ebola experience and giving a country perspective on
AMR, which for South Africa is strongly focused on HIV and TB, with HIV drugs failing in the tens and
hundreds of thousands and with MDR/ XDR TB emerging. Also colistin resistance is relevant, related to
the widespread use in agriculture which brings in other issues. She underlined that AMR is the whole
remit of infectious diseases and that vaccines are important. Referring back to a New York Times photo
from Dr. Hatchetts presentation and the devastation related to Ebola, Prof Rees also indicted how
mortality went up also because of Measles, Mumps, and Rubella (MMR), how the stigma related to

Ebola continues and how the economic disruptions that occurred resulted in migration thereby
destabilizing development efforts. She added that, post-Ebola, the International Health Regulations
(IHR) review on core competencies showed that while lot was lacking, there were many encouraging
things with many countries asking for external independent reviews, raising the partnership issue and
the need to have the capacity to respond to such reviews. Referring to South Sudan Prof. Rees
underlined the importance of leapfrogging technologies to get to the heart of the problem - solar
fridges, drone deliveries, good diagnostics, use of cell phone technology, data and mapping. She said
that in the context of the G20 it is not just about the G20 giving money but that partnership is also
about ownership by countries.

51. Introducing the session on improving global health cooperation to meet the SDGs, Prof. Rees began by
asking Dr. Hatchett and Dr. Jackson to give their visions of where they wanted to be in ten years time,
and looking at how the world should start to plan for the related opportunities and threats.
Dr. Hatchett replied that he is still in listening mode, that CEPI is a coalition and that it is therefore
important to capture the views of stakeholders and see what it is that they have signed up for. An
important role as CEO is stakeholder engagement particularly with CEPI starting from scratch and, as
yet, with no portfolio. He said they will likely start with vaccines that are in the late preclinical phase
with the vaccine portfolio maturing over the coming years. He said that in ten years CEPI needs to
ensure longevity by demonstrating success with their platforms maturing, thinking now what it would
mean to respond rapidly in the future and organizing the community is key. He continued that to be
ready to respond rapidly, there is a need for financing mechanisms and accelerated access to capital
resources that would be required for investments using the example that it took the U.S. government
eight months before responding to Zika, which is no way to run a response to a rapidly emerging

52. Continuing, he said that CEPI needs to be able to move money very quickly if they can identify
candidates that are worthy of funding and they are in a circumstance where they can confidently say a
vaccine is required as part of the response. Related to that he spoke of the need for caution often a
vaccine - which is very expensive and requires years of commitment - is not required. If a disease can
be contained relatively easy with public health interventions then perhaps a vaccine is not part of the
necessary response. Continuing, he said he would like to see the coalition enlarge and be more
inclusive, would like to have partnerships with many countries from Africa or South America once again
emphasizing that CEPI needs to be a global coalition and using the example of building on partnerships
in India. Referring to the longer-term, he said he would like to see CEPI have a partnership with a global
network of manufacturing facilities that could respond globally to emerging infectious diseases with
these partnership models evolving over the course of the next decade. Thus, CEPI would start with
some fairly conventional funding models in the first round and explore new approaches to partnership.
He gave an example of borrowing from BARDA the portfolio partnerships model with companies that
have interesting platforms and might be working on multiple candidates simultaneously. Here the
partnership evolves around the portfolio rather than a single vaccine. He said there will remain a need
to be flexible as CEPI may need to evolve certain internal capabilities. He finished by saying that CEPI
has the opportunity to do what the U.S. government did not - draw on the national resources of donor
countries in particular. He cited a recent meeting with the German government having discussed how
to draw on the tremendous resources embedded in German institutions.

53. Dr. Jackson said that he would like CARB-X to have its five year funding settlement extended at the
appropriate time. He also said that it would be nice to not be needed in five years time but that there
are a number of things that need to be done to fix the broken business model rather than having to

continue to deploy this sort of funding - some of the things that will change include taking more risk on
technologies. Currently, there is the need to balance the urgent need for new therapeutics right now
(up to 2030) with more innovative technologies and platforms that might come to be deployed. He said
that there will be more risk taken in these latter technologies. Referring to how to fix the business
model, he indicated that de-linkage as a concept had not been mentioned very much so far today -
ways of rewarding companies for the innovations and investors for the their investments for products
that are effectively too valuable to use and will want to be retained to be used as a last line of defense
as appropriate. He said that if those incentives and mechanisms can be resolved that will be a massive
incentive for businesses and investors to return to the sector - that the types of intervention that
CARB-X represents hopefully will not be needed in the future.

54. The dialogue continued with Dr. Michelle Gayer giving an introduction to the International Rescue
Committee (IRC) which in 2016 served 26 million people in 36 countries, 19 of them in Africa. The IRC,
created in 1933 by Albert Einstein, works on health, water and sanitation, nutrition, education,
governance, economic recovery and livelihood and also gives technical advice to governments on the
resettlement of refugees and asylum seekers. In health, the focus in on conflict, diseases and infectious
threats with conflict being one of the major risk factors for disease transmission and emergence.
Referring to the discussion during the morning session, Dr. Gayer said that resurgence of disease is
something that the IRC has seen on many occasions and is well published. She referred to AMR and
delays in outbreak protection and containment. Having the right products is extremely important and
having global and national policies and guidelines as well as global coordination is also important
because at some point that product or policy has to work for the individual somewhere - they may not
know about the product or even if they have the disease. She cited the example of the polio vaccine
which vast swathes of people are not getting. She continued that the IRCs biggest challenge is to
operationalize all global policies, tools and products to get them to impact. In order to target these
situations there are three issues where agencies like the IRC complete the puzzle:
Adapting solutions at the operational level - during the Ebola outbreak the IRC was working at a
hospital in Southeastern Sierra Leone where MSF had set up the treatment unit which was full
of patients - many awaiting results, many with malaria or who were pregnant in the same room
as people who had Ebola. This meant that people in the community were just seeing people
dying so others were hiding cases and people with pneumonia or malaria did not come in (here
she referred back to Prof. Reess point on deaths not due to Ebola). With no textbook solution
the IRC architecturally designed a hospital with an isolation unit before patients got to the
treatment center - working to safely triage and allow people to get the right treatment without
Personal Protective Equipment (PPE), they triaged 24,000 people in the space of six months who
got full and proper care and the communities started to return to the unit. This stopped a
bottleneck and saved lives - of all people not just those with Ebola. It involved thinking through
elements beyond guidance. A second example of community case management, of malaria,
pneumonia and diarrhea was used where they have given almost eight million private
treatments in nine countries is SSA at community level. With operational research they were
able to show that they were treating children three times more correctly than before which has
a huge impact on drug resistance.
Local partnerships to achieve scale - Once again using the Ebola example - in August 2014 the
IRC was working in Liberia and took their model to Sierra Leone where 5 NGOs became 15
within 8 weeks. Working with their extended networks, Ministries of Health (MOH), Centre for
Disease Control and Prevention (CDC) and WHO to get guidance - and with a coalition of local
partners - the consortium scaled up and managed to raise stocks from 19% across all Primary
Health Units (PHUs) to 91% in one week, were able to increase the presence of screening

stations from 30% to 86% and the presence of isolation areas from 33% to 72% within a rapid
timeframe. This could not have been done without a massive network of local partners.
Integrating an approach and embedding it into communities to allow ownership - related to the
areas covered on resilience. There was one of the largest Lassa Fever outbreaks in Nigeria last
year which affected 23 states. In the one state where the IRC was working there were no cases.
Massive displaced populations were not working only on community messages but integrating
care and primary clinics, water and sanitation infrastructure, and food safety thereby
embedding it in the community so that they understood the problem and what the surroundings
of the problem were.

55. Dr. Gayer went on to say that the work of the IRC is based on three principles: (1) That all interventions
should be evidence driven or evidence generating, (2) that measurement is essential to achieve impact
at certain scale and (3) that sustainability and resilience are fundamental.

56. Asking for Dr. Nusser to bring his perspective Prof. Rees asked about the classification of chronic
diseases to which Dr. Nusser reiterated the need to move away from historical therapeutic verticals
because, the knowledge, for example, in supply chains in HIV could help identify ways to make
medicines available at the community level for hypertension, diabetes Type II, breast cancer and
respiratory illness - four disease areas that form part of the Novartis Access Initiative. The initiative was
launched a year and half ago offering a basket of 15 medicines at 1$ USD per treatment per month to
governments and NGOs. He stressed that the public sector is asked to change its understanding of the
procurement paradigm because it is a basket or sub-basket that plays a role in addressing NCDs which
now pose a dual disease burden on LMICs with a lot still to be done on the infectious disease front. He
said that he completely subscribed to everything that was said by Dr. Gayer and said that when we
speak about global health we should not speak about medicines because that would be global disease.
He said that speaking about global health should start at the community level otherwise scaling up is an
issue. He added that prevention is the best buy and gave an additional point on the partnerships aspect
- a partnership is more than a transactional relationship of product procurement or giving money to an
NGO - partnership is co-creation of multiple partners. The issues are so great that there needs to be
more including an NCD intervention and a diagnostic intervention including capacity building, education
of the people engaged in those settings. He closed by saying that co-creation with multiple partners
including from the humanitarian sector would be something which would be very welcome to him.

57. The discussion moved on to Ms. Sanne Fournier-Wendes who introduced UNITAID, which was created
in 2006 as an innovative financing mechanism and recognized the presence in the room of long-
standing partners including France and the UK. Catalyzing equitable access to innovative health
products UNITAID identifies cost-effective interventions that will have an impact on, traditionally,
Malaria, HIV/AIDS and TB. UNITAID recently approved a new strategy that takes an integrated approach
and Ms. Fournier-Wendes stated that the global community needs to move away from the siloed focus
on diseases although acknowledged that this approach was what was needed and made complete
sense previously. The need to move away from that and start thinking differently includes the funding
environment and, although the UNITAID focus is mainly still on the three diseases it has also increased
its mandate to look at RMNCH - specifically focusing on integration and how they can build on the
successes and interventions of the three diseases in order to go beyond that. Over 50% of UNITAIDs
investments today focus on resistance management - a large part of that linking directly to AMR - they
focus on prevention, diagnostics and medicines and some of the things they are investing in are drugs
for MDR-TB, diagnostics in HIV, new regimens of HIV drugs coming forward or new vector control tools

to combat insecticide resistance in malaria - so resistance is really at the core of what UNITAID does
both historically and in the future.

58. Ms. Fournier-Wendes said that there is a common understanding in the room that having products
available does not mean that they reach the people who need them and that this is important to keep
in mind. UNITAID does not exist to provide that access at scale and is much too small to do that but
plays a catalytic role by identifying what the bottlenecks are in achieving access and asking whether
there are products available that are better adapted to the populations who need them. For example
knowing how new HIV drugs that have been invented in the developed countries work on pregnant
women in LMICs or the pediatric TB medicine example given earlier by Mr. Alsdurf. She underlined
quality, affordable and sustainable supply with innovative delivery systems that can reach the
populations and said that demand and adoption is very important with countries integrating into
national guidelines and communities to create the demand for the products. UNITAID funds projects
that overcome such bottlenecks so that once time bound programs end national programs can take
them on and GFATM, The United States President's Emergency Plan for AIDS Relief (PEPFAR) or the
Presidents Malaria Initiative (PMI) can fund them and take them to scale - a measure of UNITAIDs
success is if other partners have scaled them up. If they have not the projects have failed.

59. Once again referring to the conversation on partnerships UNITAID is a small organization with 89 people
based in Geneva dispersing US$ 150-200 million a year and need to partner in everything that they do.
When they define areas for intervention and launch calls for proposal and provide funding they work
with partners to select and implement the projects. They do not want to do what other organizations
are doing, which is why they always ask where the gap is and what their role should be. They have a
wide range of partners - technical partners like WHO, The STOP TB Partnership and Roll Back Malaria,
or innovators in countries. Civil society is crucial to creating demand in country. They aim to maximize
the effectiveness of their resources and identifying innovative ideas which is best done in partnership.
The group in the room proves that partnerships are needed to move an agenda item but partnerships
are not always easy.

60. Circling back to the PDPs, Prof. Rees asked them to make comments on how they will innovate going
forward. Ms. Ferazzi highlighted how MMVs long-term vision is aligned with the SDGs and the WHO
Global Technical Strategy for Malaria. Key areas such as customization of medicines for the most
vulnerable groups, resistance to drugs, as well as special topics that need to be addressed such as
Plasmodium vivax and Seasonal Malaria Chemoprevention (SMC). On the prophylactic side,
transmission blocking is not just from parasite to human being but also human being to parasite and
they are also looking to what is possible for Mass drug Administration (MDA). Ms. Wingfield welcomed
that Ms. Fournier-Wendes mentioned RMNCH saying that it often gets lost. She said that as the
landscape evolves they are looking to bridge and catalyze commitments and bring partners together.
Those partners are also changing including SMEs and new geographies. She said that SSA countries are
moving R&D to product development and from basic science to address local issues. She also said that
PATH do not just work on technologies or facilitating access but also on creating the enabling
environment and added that PDPs do lots of advocacy for the overall field where GHTC creates a
platform for advocates. She also cited R&D advocacy coalitions in Africa and mentioned the less
tangible role of PDPs in helping to bring together new stakeholders and creative new partnerships
giving the example of PATH and the Tableau Foundation on data visualization for malaria outbreaks and
interventions. She said that PATH will continue to push for more country ownership and political
commitment referring back to Prof. Reess comment. Ms. Hayward continued on behalf of the PDP
community by saying that Sabins development portfolio has traditionally been more early stage and

that in 10 years it would be good to have some clinical candidates through proof-of-concept. She said
that the Sabin Vaccine Institute is slightly different as they have a separate line of advocacy for access
and uptake of existing vaccines and that they could tap into and leverage that expertise for one of their
own projects. Ms. Hayward said that the sustainable immunization financing work where they help
transition Gavi countries from donor support and generating evidence for policy decision making for
their own support for immunization programs would continue. Mr. Alsdurf said that he hoped to see a
lot of the PDPs shifting the balance from R&D to access and availability including scaling up local
partnerships, and heavier engagement on the regulatory front - a whole range of activities slightly
different from the product development that has been the core focus of activities. From the TB
pipeline, he said he would like to see a unified treatment - a completely novel regimen to treat all forms
of TB that would be oral and shorter than three months. He cited some existing impressive results in
ongoing clinical studies with extensively drug-resistant tuberculosis (XDR-TB) patients and said he
would like to see that bring benefits to the wider community of people with TB.

61. Prof. Rees asked for additional input from Dr. Broun from the generics point of view. He said that
generics companies do a lot research on new formulations and associations of products which is not
considered the noblest part of innovation (like discovering new products) but can really bring
improvements forward relatively rapidly - for example fixed dosed combinations for HIV came from the
generics industry. He said that generics can bring a lot of value and improvements and linked with AMR
because this is one area where several of the Indian generics companies are working and coming up
with new combinations of products. He said he was always very surprised that we have triple therapy
for viruses and monotherapy for bacteria and that no one found that abnormal.

62. Prof. Rees pointed out that in global health cooperation there is not just one model but several and if
the G20 is going to take this forward we need to look at what has not been tackled and insert into the
G20 dialogue. Citing Dr. Gayer, Dr. Nusser said that monitoring and evaluation - not just counting input
and output parameters or how many treatments have been shipped for example - but really defining
the Key Performance Indicators (KPIs) that determine impact and independently - and candidly - having
those measured. He used an example of the collaboration between Novartis and Boston University on
M&E - a collaboration that is completely transparent. It is possible to see everything about it including
the contract thereby creating a methodology that can be applied by other organizations, which can
make their data public. He said that the Boston University retains freedom to publish results whether or
not Novartis likes those results as this needs to be a public health product in the end.

63. Mr. Robert Terry said that he would like to see greater sharing of data and greater openness. TDR are
creating platforms to enable TB clinical trials to share their data and there was lots of data collected
during the Ebola crisis. He said that he and his team are currently trying to work out how to share the
data in an ethical way and to ensure maximum pubic health benefits. He stressed that for health we are
only at the beginning of where the Internet can get us and recognized that there are lots of governance
and access issues to get around. He said that there is always resistance to coordination and highlighted
that it is frustrating when new global challenges emerge, a new institution created with a new board
and fundraising mechanism as this continually slices the R&D. He made another plea for the global
health observatory stating that one of things it needs - at almost no cost to G20 members states - is the
release of their data. He stressed the challenges in working out who is funding what, where and how
saying that some work is already done - with more to be done - to reduce waste and try to get towards
some kind of coordinated response. TDR will create a directory for TPPs which will describe priorities in
a technical way. There is currently no set of standards to do horizontal or vertical analyses where
people can actually report their TPPs, which will enable for the first time a heat map and identification

of gaps. He said, he would like to see WHO find its place for convening, norms and standards, and try to
identify and articulate what the priorities are at a global level.

64. Prof. Rees asked if much thought had been given to transparency and data sharing at the G20 level and
Mr. Donnelly picked up on the point of robust data in a time of very tight public budgets and austerity
measures, where public criticism of many initiatives is largely because the public are misinformed, often
deliberately. Therefore, the focus on Value For Money (VFM) should be backed up from a position with
robust data and concrete information - the interesting discussion about bringing data together should
be continued as this is the case across a number of fields given the overall power of data.
Prof. Wilder-Smith added that under several programs, including Horizon2020, everything has to be
open access and data sharing. Mr. Lefroy said that he fully agreed with Mr. Donnelly saying that in the
U.K. the government has been getting data out as much as possible - for instance the government
publishes everything above 500 that it spends including in the field of international development,
which means that people are sometimes swamped in data and the trends are not apparent. The key, he
continued, is to integrate what is being discussed here in the political discourse so that it is not a
question of local versus international. Ebola had a significant impact in the U.K. to show that
international development and domestic interests are not separate. A year after, support for
international development was still quite strong and this applies across the G20. Citing Mr. Donnelly,
Mr. Lefroy added that people understand when they get the accurate information.

65. Following Prof. Reess request for additional comments, Ms. Katharina Kuss of the Spanish Foundation
for International Cooperation, Health and Social Affairs (FCSAI) - part of the CAAST-Net Plus consortium
of organizations from Europe and SSA that work together to support bi-regional cooperation in
research and innovation and advise the EC and AU Commission on bi-regional health research. Together
with the Council on Health Research for Development (COHRED) they are working on the Research
Fairness Initiative (RFI). Ms. Kuss outlined some of their published recommendations. She said that to
build on the capacity that has been achieved in recent times there is a need to use research capacity to
extend to Universal Health Coverage (UHC). The this end, the EU has requested a study to be done on
what the impact of Poverty Related and Neglected Diseases (PRND) research on UHC is - as this has
never been asked as an objective it is in the own interest of those in the field to review their own
objectives which comes back to the M&E point. Secondly, to build on experience and on observations,
partnerships and equality of partnerships are key elements of SDG 1723 and how to improve the
mechanisms of collaborations is critical. Ms. Kuss mentioned the RFI as a reporting tool and invited
collaborators to have a look. She said it is a voluntary tool that gives transparency on best practices,
benefits and commitments for research partnerships in LMICs. Prof. Rees asked her to continue and Ms.
Kuss described it as a tool that is applied at an institutional level and mainly promoted in Europe but
also elsewhere - gradually research institutions are committing to using the tool. It raises questions on
IP, benefits for partner countries, transparency, national priorities, engagement with research
communities, and involvement of national ethics committee. The idea behind it is that by replying to
these questions, every institution will have to consider its own Standard Operating Procedures (SOPs)
and guidelines, reflect on gaps and develop mechanisms.

66. Citing Mr. Donnelly, Ms. Fournier-Wendes contributed to the VFM focus and agreed that data is an
important element. She said that UNITAID has a responsibility to prove how they are investing donor
funding and also what interventions countries need to invest in and for what reasons - understanding

23SDG 17: Strengthen the means of implementation and revitalize the global partnership for sustainable development

the impact on their health systems and putting economic value on that can be useful. UNITAID looks at
impact in terms of its own investments and beyond and tries to put figures on that. They have a VFM
framework that looks at what the public health impact is that they are looking for and what savings are
being generated. In other words, by bringing in more cost-effective products to the market, they want
to know the savings generated for the health systems and also for partners or other investors. Currently
their projects are generating a return on investment of 1:5-7 (some much higher than that) and they
think it is crucial to make sure they are investing correctly. On the AMR discussion, Ms. Fournier-
Wendes said there were interesting numbers in the ONeill report on the effect that this will have on
health systems and said that it is important to think about VFM to work out which interventions are the
most optimal.

67. Prof. Feiner said that VFM resonates with newer funding sources and private funders and that the
philanthropy horizon is so long in medical technology where VFM frameworks often look at short-term
gains. He said, it is important to look at questions of outcomes as none of this can be quantified via the
outputs that several traditional donors look for. Stressing the fact that this is a long-term commitment
where the G20 is supporting publically would send a reassuring message to the private philanthropy
community to also come on board.

68. Brazils G20 Sherpa representative, Mr. Alexandre Brasil said that VFM is the most important matter
and to this end it was essential to avoid duplication of efforts. The new role of the G20 in health should
not divert anything from WHO as its global norm-setting and coordination is essential. He also stressed
the importance of strengthening local health with resources dedicated to this at community level (citing
Ebola and Zika). He added that the development of technologies is very important but that cost should
always be considered.

69. Prof. Rees, depicting a continuum where the current discussion is focused on investing in a piece of a
large continuum - around the product development area - and asked where the HSS element will be
coordinated from. Referring to CEPI and CARB-X as two new initiatives with a niche - she asked if there
is, or should be, a dialogue that outlines who is going to pick up the other, implementation, part if the
G20 focuses more strongly on the innovation aspect.

70. Mr. Donnelly reminded everyone that G20 was set up as a response to the economic crisis with the
Financial Stability Board (FSB) created to prevent systemic collapse of the global financial systems. Now
that it is moving into new priority areas, it is still an early stage of development. Acknowledging the
arrival of the representative of the Argentinian embassy, he said that there needs to be a decision
taken on if and how to continue in subsequent presidencies. He emphasized that the current question
is how to maintain global health as a G20 priority area.

71. Dr. Milder added that it is important to keep in mind what the G20 is for and what it can do - an agenda
setter. Agreements are not legally binding and the G20 is not an implementation body. It is the sum of
its members but members need to implement what has previously been agreed upon with
implementation being taken care of via working groups and task forces. In no way is the intention to
replace international organizations but to get the G20 organizations and international organizations to
work on these issues together. Using the trade example she said that the G20 has repeatedly
committed against protectionism through its working group on trade on investment - which is not
something to replace WTO but to discuss issues and to bind (in a sense) the members of the G20 to
commit to something and implement it. As a forum to discuss new ideas and set agendas, health

represents an area where it is possible to streamline goals and bring together stakeholders, alongside
the WHO.

72. Ms. Nicklin, commenting on health systems said that the Medical School Hamburg (MSH) focuses on
building health systems in developing countries, mentioning that large donors like USAID or BMGF put
very little towards health systems. She said that individual governments and donors should continue to
look at their funding - not just by diseases but to look at how to coordinate that and build capacity at a
country level as investments in innovations will not scale without capacity at a country level.

73. In her summary comments Prof. Rees said that globally the demand for funding is huge against a
background of tighter budgets which is why public sentiment is critical and a very strong justification of
public funding - which means something to the taxpayer - is needed. She cited the comments from Mr.
Donnelly and Mr. Lefroy on this. As expenditures continue, there needs to be accountability -
expenditure is justified but transparent - where you can demonstrate VFM. Here she mentioned a
recent visit to her University by the PEPFAR ambassador during which she used clear data to show the
impact of their funding. In relation to accountability is open access, data sharing and the importance of
communication - messages should be kept very simple and targeted to specific audiences. On the
appeal for coordination she said that avoidance of duplication of efforts was needed. She continued
that the nature of short, medium and long term investments needs to be articulated to people, adding
that TPPs can be helpful and stressed the need for quality, affordability and fit-for-purpose innovations.
In addition to the concerns of resistance, having products does not mean they will reach people and
there has been less investment in HSS - therefore coordination downstream should be considered. The
partnership element brings together all of the diverse stakeholders to produce something that
resembles a compelling enough argument for this to be maintained as a priority area under the G20. A
longer-term project is key to this.

Call to Action and Next Steps

Presented by Alan Donnelly, Executive Chairman of Sovereign Strategy

74. Mr. Donnelly said that there is strong interest for the initiative to continue citing some recent meetings
at senior political level and the comments of those in the room. Citing Dr. Mildner, he stressed that the
dialogue is not about the G20 becoming a mechanism for implementation, but rather influencing the
direction of the agenda and again underlined that the disease burden in the G20 will partially drive that.
He said that the Call to Action (CTA) had been carefully crafted by sponsors and hosts and that a report
with a summary of the discussion would be formulated over the subsequent weeks. He said that he
found the conversation on M&E and data very important and that practitioners should recognize this as
a crucial point in the context of financing and VFM.

75. He signaled his gratitude to the B20 and its Health Initiative and the convergence, in several areas,
between this initiative and the B20. He said that as outputs are important, a roadmap was needed
following the Health Ministers Declaration and leading into the Presidency of Argentina in 2018 so that
the G20 could act as a catalyst and mechanism for coordination and an opportunity to change and
influence positions on certain issues. Finally, he encouraged those present to build on the momentum
that had been created with the G20 acting as a catalyst to strengthen political support.

Closing Speeches

76. Prof. Wilder-Smith introduced the first of the final three closing speeches. Prof. Peter Hotez began by
saying that the community is on the cusp of something very exciting related to new findings that show
the shifting landscape in global health that calls on an unprecedented role for the G20 countries. The
findings show that a number of aspects of the MDGs worked, such as the major impact of MDG 4
through organizations like Gavi and a 50-80% reduction in child mortality from vaccine-preventable
diseases, as well as impact on MDG624 - AIDS, malaria, HIV/AIDS, NTDs, - with 90m lives saved from HIV
AIDS, a 40% reduction in malaria cases and deaths and a 50% reduction in diseases in many NTDs like
river blindness and trachoma.

77. On the other hand, he explains how new problems have arisen - such as vector-borne NTDs like
leishmaniasis and Chagas disease, arbovirus diseases like Zika, Dengue, with southern Europe hit by
malaria, dengue and schistosomiasis. Dr. Hotez says that by taking either WHO data or Global Burden of
Disease (GBD) data the findings were that most of the worlds poverty-related neglected diseases are
actually present are in the G20 countries together with Nigeria (Nigeria has an economy greater than
the bottom four G20 countries) which reflects an age of globalization where the poor live among the
wealthy. For example - most cases of Chagas disease are found in Latin Americas three wealthiest
economies - Brazil, Argentina, and Mexico (all G20 countries) with 300,000 people in the US with
Chagas. Northeastern Brazil which is a region of poverty is where the western hemispheres
schistosomiasis leishmaniasis, Chagas disease and Zika is found. In Southwestern China - Guizhou,
Yunnan Sichuan provinces - there are also widespread neglected diseases.

78. As most people and decision makers are not aware of this there is a need to decide what to do to raise
awareness. There are also policy implications - if most of the worlds PRNDs are in the G20, resources
should be less of a question as it is more a call to action or advocacy to get the G20 countries to
redouble their commitments to their own populations. According to Dr. Hotez this can be done, first of
all, by expanding use of existing medicines - in Argentina, Brazil and Mexico 99% of those with Chagas
do not have access to diagnosis and treatment. The same applies to China and Indonesia where MDA is
not being applied nearly at the level it should be. Secondly, Dr. Hotez spoke of the R&D agenda where
G20 countries have enormous capabilities in terms of biotechnology - China has vast capabilities in
vaccine manufacturing but they are not turning attention to neglected disease vaccines - same with
India, Indonesia and Brazil.

79. Dr. Hotez argued that the reason this is important is that over the next few years the G7 countries could
lose their appetite for global health as the old paradigm of development assistance gives way to a world
where all economies are growing and leaving behind a bottom segment of society. These findings are a
new avenue with the Presidency of Argentina a good aspirational goal for the advocates in the room.

MDG6: combat HIV/AIDS, malaria and other diseases

80. Following a question from Prof. Wilder-Smith, Dr. Hotez indicates the surprising amount of malaria in
the G20 citing Nigeria, India, Brazil Indonesia - with 44% of the total burden in G20 countries which is
less dramatic than the TB numbers but still significant. Prof. Rees said that this is all excellent input to
the conversation and that Mr. Donnellys comments on communication should be heeded. The
information should be leveraged, disseminated and correctly packaged in order to create a real global
noise. She cited the advantage of the post-Ebola era and global health security saying that there needs
to be a communications strategy that partially uses this data.

81. Mr. Donnelly, referring to the work of Sovereign Strategy in TB, replied to this indicating that in addition
to the briefings for MEPs, embassies and the EC, it is important to talk about the types of information
provided. The G20 disease burden data should, for example, be part of a communications package for
committees dealing with business innovation and skills or the treasury committees across the G20,
which needs coordination and resources. He added that parliamentarians can also be great catalysts to
bring the private sector to the table.

82. Mr. Lefroy seconded this using the example of the 500 million a year U.K. budget to tackle malaria. He
said former chancellor George Osborne visited the Liverpool School of Tropical Medicine (LSTM) with Bill
Gates to announce the renewal of this funding which was done with a domestic as well as international
agenda. Similarly with NTDs it was commitments at the highest level - PM or treasury with support of
international development and others. One of things to do, he added, is show the link with research,
manufacturing and hi-tech domestic capacity. Dr. Hotez finished by saying that he recognized the
excellent work of Sovereign Strategy in TB as well as the crucial role the U.K. plays in international
development but that there needs to be a horizontal framework or mechanism across the wider G20
which would be more sustainable and powerful.

83. Prof. Wilder-Smith introduced H.E. Ajay Bramdeo, who thanked Mr. Donnelly and all of the co-hosts of
the meeting for the invitation. He said that for the African continent the interest in this initiative is high.
A lot of importance is placed on it as it coincides with the Agenda 2063 referred to earlier by Dr.
Mildner. He explained how the Agenda 2063 was drafted with wide consultation - not just
intergovernmental but also for example with civil society and academia. The comprehensive vision
places a lot of emphasis on the SDGs as Agenda 2063 is the common position used by the AU to
negotiate and implement the SDGs. Health is cross-cutting and central to Africas development agenda,
which is why he said he agreed with everything that was discussed today. He gave some additional
points from the AU mentioning the Pharmaceutical Manufacturing Plan for Africa (PMPA) which
proposes a package of essential solutions to achieve desired public health outcomes in Africa by
strengthening industry in addition to human capital as well as the need to produce quality assured
essential medicines on the continent and taking full advantage of flexibilities in WTO Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS). He also mentioned the African Union
Roadmap on Shared Responsibility and Global Solidarity for AIDS, TB and Malaria in Africa and the
African Medicines Agency that is expected to be launched in 2018.

84. He cited some Access and Delivery priorities and added that capacity development is needed in legal
and policy frameworks, optimizing technologies and monitoring safety, pricing supply and delivery
systems. Bridging gaps between R&D and access requires innovative new partnerships including main
actors in national health systems, UN agencies, PDPs, NGOs, private sector and academia. He finished
by outlining the establishment of the African Centre for Disease Control (ACDC) and its operational

85. Prof. Wilder-Smith lastly introduced Mr. Emanuel Sotelo, representative from the Argentinian Embassy
who thanked Mr. Donnelly and all of the co-hosts of the meeting for the invitation. Mr. Sotelo thanked
the German G20 Presidency for emphasizing the importance of global health in the G20. He said that
international cooperation is crucial and welcomed that Argentina will co-chair the health working group
in May 2017. He stressed that it is a great honor for Argentina to host the next G20 Presidency in 2018
and said the impact of global health on international politics has become increasingly visible, which is
why the international community has to confront this problem. He said that Zika and Ebola showed that
infectious diseases can affect global political and economic stability and, more importantly, progress in
sustainable development. He appealed for a better consensus regarding investing in human resources
as a precondition of human development which is also valid for health. Mr. Sotelo highlighted that
strengthening health systems in public health should be the first line of defense against international
health emergencies. Moreover, he emphasized that Argentina fully understands the importance of
AMR. He added that Argentina has supported the recommendations of the WHO High-Level
Commission on Health Employment and Economic Growth in 2016. In his closing remarks, Mr. Sotelo
said that he is convinced that the recommendations from the United Nations 2016 report should be
taken into G20 Health Ministers meeting in May 2017.


Participants list G20 Global Health Innovations Event

1. Abby Young-Powell (Correspondent, DEVEX)

2. Abdullah M. Aldahmash (General Director, Prince Naif Bin Abdulaziz Health Research Center, King-Saud
3. Alan Donnelly (Executive Chairman, Sovereign Strategy)
4. Alexandre Brasil (Counsellor, Brazils G20 Sherpa Representative)
5. Ama Lorenz (Correspondent, Euractiv)
6. Ben Alsdurf (External Affairs Manager, TB Alliance)
7. Bernhard Schnittger (Deputy Head, Representation of the European Commission in Germany)
8. Bjrg Nilsson (Communications Team Lead, Coalition for Epidemic Preparedness Innovations - CEPI)
9. Cdric Braquetti (Counsellor, Embassy of Monaco in Berlin)
10. Christina do Pao (External Relations Officer, Medicines for Malaria Venture (MMV))
11. Christine Jacob (Social Affairs Advisors, Embassy of France in Berlin)
12. Claire Wingfield (Senior Product Development Policy Officer, Advocacy and Public Policy PATH)
13. Clemens Staub (Health Attach, Embassy of Switzerland in Berlin)
14. Councillor Julie Donoghue (Rushcliffe Borough Council, UK and member of the All Party Parliamentary
Group (APPG) for Malaria and Neglected Tropical Diseases)
15. Delia Roling (Social Affairs Advisors, Embassy of France in Berlin)
16. Dr. Denis Broun (Director of Government and Public Affairs, CIPLA limited)
17. Dr. Detlef Boecking (Project Manager, Deutsches Zentrum fr Luft- und Raumfahrt e. V. (DLR) German
Aerospace Center: Project Management Agency, Health, Clinical Research)
18. Dr. Harald Nusser (Global Head Novartis Access, Novartis)
19. Dr. Jean-Jacques Pierrat (Scientific Advisor, Embassy of France in Berlin)
20. Dr. Kei Katsuno (Director, Investment Strategy and Development at Global Health Innovative Technology
(GHIT) Fund)
21. Dr. Laura de la Cruz (Scientific Officer, Deutsches Zentrum fr Luft- und Raumfahrt e. V. (DLR) German
Aerospace Center: Project Management Agency, Health, Clinical Research)
22. Dr. Michelle Gayer (Acting Senior Director, Health Unit Director, Emergency Health, International Rescue
23. Dr. Peter Jackson (Founding Member & Executive Chairman AMR Centre, CARB-X)
24. Dr. Richard Hatchett (CEO, Coalition for Epidemic Preparedness Innovations - CEPI)
25. Dr. Stormy-Annika Mildner (B20 Sherpa, Germany)
26. Emanuel Federico Sotelo (Political Department, Embassy of Argentina in Berlin)
27. H.E. Ajay Bramdeo (African Union Permanent Representative to the European Union)
28. Hatice Kk (Account Manager, Sovereign Strategy)
29. Isaac Bile-Hamilton (Attach, Economy and Technology)

30. Jamie Bay Nishi (Director, the Global Health Technologies Coalition (GHTC))
31. Julie Archer (Senior Communications Officer, FIND)
32. Katharina Klohe (Project Coordinator, Center for Global Health at the Institut fr Medizinische
Mikrobiologie, Immunologie und Hygiene Technische Universitt Mnchen (TUM), Centre for Global Health
at the University of Oslo)
33. Katharina Kuss (Advisor, Spanish Foundation for International Cooperation, Health and Social Affairs
34. Laura Voisin (Scientific Officer, Embassy of France in Berlin)
35. Leke Bataili (Office of Kordula Schulz-Asche, Member of the Bundestag)
36. Madeleine Heyward (Health Counsellor, Australian Permanent Mission to the UN, Geneva)
37. Marius Olivier Kahili Tien (First Secretary)
38. Matthew Doherty (Senior Counsel, Sovereign Strategy)
39. Dr. Maryse Nsangou Njikam (Cultural Counsellor)
40. MdB Charles Huber (Member of the German Bundestag)
41. MdB Kordula Schulz-Asche (Member of the German Bundestag)
42. MdB Stephan Albani (Member of the German Bundestag)
43. Molly Anders (Correspondent, DEVEX)
44. MP Jeremy Lefroy (UK Member of Parliament, Chair of the Parliamentary Network on the World Bank and
International Monetary Fund)
45. Ms Claudia Diebold (Executive Officer, UNITAID)
46. Neva Brahmbatt (London Office Manager, Sovereign Strategy)
47. Nigel Clarke (First Secretary (EU Affairs and German Foreign & Security Policy, Embassy of Ireland in Berlin)
48. Patricia Nicklin (EVP and Head, Corporate Partnerships, Reingold, Inc.)
49. Prisca Merz (Economic and Social Policy Officer, Embassy of the United Kingdom in Berlin)
50. Professor Annelies Wilder-Smith (Global Health Centre, Graduate Institute, Geneva, Chian School of
Medicine, ZikaPLAN Scientific Director, WHO Temporary Advisor, Senior Fellow, Global Health Centre)
51. Professor Helen Rees (Executive Director, Wits RHI, University of Witwatersrand, South Africa, Chairperson
of South African Medicines Control Council, Chair of WHOs IHR Emergency Committee on Polio)
52. Professor Peter Hotez (Dean for the National School of Tropical Medicine, U.S. and
53. Director of Texas Childrens Hospitals Center for Vaccine Development)
54. Rebecca Root (Correspondent, DEVEX)
55. Richard Feiner (Adjunct Professor, Columbia University)
56. Robert Terry (Special Programme for Research and Training in Tropical Diseases, WHO)
57. Roman Scherbakov (Attach, Departement of Education, Science and Technology, Embassy of Russia in
58. Sanne Fournier-Wendes (Advisor to the Executive Director, UNITAID)
59. Silvia Ferazzi (External Relations Officer, Medicines for Malaria Venture (MMV))
60. Susheel Kumar (Embassy Official, Embassy of India in Berlin)
61. Tara Hayward (Vice President, Resource Development & Policy, Sabin Vaccine Institute)
62. Viviana Gicela Usme Lozano (Office of Kordula Schulz-Asche, Member of the Bundestag)

Call to Action25

Berlin, 28 April 2017

This Call to Action strongly urges the G20 to commit investment in research, innovation and
development of innovative health technologies to counter threats posed by Antimicrobial Resistance
(AMR), Poverty-Related and Neglected Diseases (PRNDs) and pandemics.
We call on the G20 to agree to take the following actions:

1. Provide political support to address the inter-related issues of AMR, pandemic preparedness/
response and PRNDs.
Include a commitment to research and development (R&D) of products and interventions for
global health in the outcome document of the Meeting of the G20 Ministers of Health, in the G20
Communiqu and in all relevant G20 agendas, with a focus on addressing the threat of a broad
spectrum of emerging antimicrobial resistance from a variety of bacteria, parasites, viruses and
fungi, as well as emerging infectious diseases.

2. Increase financial support and its co-ordination across the G20 and partner countries to ensure
sustainable, long-term funding for global health innovation, with a focus on AMR, pandemic
preparedness/ response and PRNDs.
Coordinate funding between G20 countries to ensure inefficiencies and duplication of efforts are
avoided, and that the significant costs of product development are shared among nations.

3. Encourage business, philanthropic organizations and other financing institutions from the G20 to
increase investment in global health innovation, in the interrelated areas of AMR, pandemic
preparedness / response and PRNDs.
Promote financial support to the work of multinational partnership mechanisms such as Product
Development Partnerships (PDPs) and other public-private collaborations to expand global health

4. Mobilize G20 public health and scientific expertise to address antimicrobial resistance (AMR) in both
neglected and major poverty diseases by:
Supporting global efforts to develop new tools, interventions and approaches to address AMR.
Assisting low and middle-income G20 partner countries in building up their research and product
development capacity for the fight against AMR.
Promoting open data sharing in R&D to help technology transfers and strengthening of research
capacity in G20 and partner countries to address AMR.

Online Access to the Call to Action:

We invite all those who share this vision to sign and support this Call to Action
In advance of the 2017 Hamburg Summit we would like to commend G20 leaders, and especially the German
Presidency, for putting the 2030 Agenda for Sustainable Development and global health at the top of the G20
agenda. We represent a group of like-minded advocates and experts from public and private sector
organizations calling on the G20 to commit political and financial resources as well as expertise to science,
technology and innovation (STI) in global health.

We support the view of Chancellor Merkel that health is an issue that belongs on the G20 agenda and her
belief that addressing the worlds health challenges should become a permanent agenda item. Medical
innovation and the policy changes needed to transform global health take years to develop and take effect, and
require long-term political and economic commitment.1

Antimicrobial Resistance (AMR)

Growing antimicrobial resistance (AMR) by a variety of pathogens including bacteria, parasites, viruses and
fungi is an increasingly serious threat to economic development and global public health, and requires
urgent and coordinated action from governments, the private sector, academia, and civil society. Although
the world is broadly on track to achieving the target of less than 3% of people living in extreme poverty by
2030, the World Bank has recently found that AMR is putting this target out of reach.2

Pandemic preparedness/ response

The Ebola outbreak in West Africa and the recent outbreak of the Zika virus in the Americas underscored
the fact that the world remains woefully underprepared for pandemics. The Ebola epidemic in western
Africa accounted for more than 11.000 deaths and cost Guinea, Sierra Leone, and Liberia an estimated
US$2.2 billion in lost economic output.3

Poverty-Related and Neglected Diseases (PRNDs)

HIV/AIDS, TB, Malaria, and other diseases such as pneumonia and typhoid still cause high levels of mortality
and morbidity across the globe, including in several G20 countries.4 These are diseases of poverty, with
94.8% of cases found in low-income countries and among poor and marginalised populations in middle-
income countries. They also fuel the cycle of poverty, exacting a heavy economic toll on affected families,
which imposes a significant growth penalty on entire regions.

Looking ahead, the risk of resistance and emerging infectious diseases, combined with increased
transnational mobility, poses a major challenge for the global health community. Innovative
technologies for the protection of new vulnerable groups, such as migrant populations, are essential
components of control, elimination and eradication strategies moving forward.

The World Bank has estimated that by 2050, these issues will push an additional 28.3 million people
into poverty, increase global healthcare costs by $1.2 trillion and cause low income countries to lose
more than 5% GDP. G20 leadership in combatting neglected diseases could lead to significant
reductions in the global disease burden, lifting millions out of poverty and averting billions of dollars
of economic and social costs.

This Call to Action was initiated by the following organisations:

1. Sovereign Strategy

2. Coalition for Epidemic Preparedness Innovations (CEPI)

3. The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X)

4. Global Health Technologies Coalition (GHTC)

5. The Global Alliance for TB Drug Development (TB Alliance)

6. Global Health Innovative Technology (GHIT)

7. Medicines for Malaria Venture (MMV)

8. Sabin Vaccine Institute


10. PATH

B20 Health Initiative Policy Paper Stepping Up Global Health: Towards Resilient, Responsible, and Responsive
Health Systems
World Bank Group, Drug resistant infections: A Threat to Our Economic Future, accessed 20 April 2017,
Ebola Response Fact Sheet (April 6, 2016), accessed February 8, 2017,
World Bank Group, Drug resistant infections: A Threat to Our Economic Future, accessed 20 April 2017,