AMR Global Positioning Session · 2018-10-03 · 1 JPIAMR in the global AMR landscape –...

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1 Item Title of document Action 10 AMR Global Positioning Session Information and discussion AMR Global Positioning Session Purpose of the item Provide an overview of the current international landscape of international initiatives: by international organisations and by international funders. The aim is to clarify the landscape and the role that JPIAMR should play in it. Background In 2015, the WHO announced antimicrobial resistance as one of the greatest threats to public health. It endorsed a Global Action Plan to tackle AMR that underscores the “one health”. Since then, AMR has shot to the top of the global health agenda with various institutions weighing in: The Council of the European Union conclusions, the G7 communiqué, the G20 declaration, and the UN declaration on AMR. Several international organisations are getting more involved in AMR issues and new funding initiatives in the area of AMR drug development are appearing The Joint Programming Initiative on Antimicrobial Resistance, JPIAMR, stresses the importance of combating resistance as a key actor to identify and coordinate research priorities for funding. This paper describes JPIAMR’s approach to cooperation activities with key international AMR initiatives. Also a new MoU has been signed with international funders to develop a joint Educational Programme. Link to the supporting documents 1. JPIAMR in the global AMR landscape – International Coordination 2. Joint Educational Programme MoU Questions for the Management Board representatives What should be the JPIAMR positioning in the global landscape of international AMR activities? As platform of public research funders? In the early stage drug development? As One Health advocate/supporter? Main activity of JPIAMR should be the coordination of research programmes? The coordination of research funding? The bridge to get scientific evidence? Global Research prioritisation? Decision Sought Discussion on what should be the JPIAMR positioning/niche in the global landscape. Provide input for further international interactions. Document prepared by Laura Marin, JPIAMR Secretariat

Transcript of AMR Global Positioning Session · 2018-10-03 · 1 JPIAMR in the global AMR landscape –...

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Item Title of document Action

10 AMR Global Positioning Session Information and discussion

AMR Global Positioning Session

Purpose of the item

Provide an overview of the current international landscape of international initiatives: by

international organisations and by international funders. The aim is to clarify the landscape and the

role that JPIAMR should play in it.

Background

In 2015, the WHO announced antimicrobial resistance as one of the greatest threats to public health. It endorsed a Global Action Plan to tackle AMR that underscores the “one health”. Since then, AMR has shot to the top of the global health agenda with various institutions weighing in: The Council of the European Union conclusions, the G7 communiqué, the G20 declaration, and the UN declaration on AMR. Several international organisations are getting more involved in AMR issues and new funding initiatives in the area of AMR drug development are appearing

The Joint Programming Initiative on Antimicrobial Resistance, JPIAMR, stresses the importance of combating resistance as a key actor to identify and coordinate research priorities for funding.

This paper describes JPIAMR’s approach to cooperation activities with key international AMR initiatives. Also a new MoU has been signed with international funders to develop a joint Educational Programme.

Link to the supporting documents

1. JPIAMR in the global AMR landscape – International Coordination

2. Joint Educational Programme MoU

Questions for the Management Board representatives

What should be the JPIAMR positioning in the global landscape of international AMR activities?

As platform of public research funders?

In the early stage drug development?

As One Health advocate/supporter?

Main activity of JPIAMR should be the coordination of research programmes? The coordination of

research funding? The bridge to get scientific evidence? Global Research prioritisation?

Decision Sought

Discussion on what should be the JPIAMR positioning/niche in the global landscape. Provide input for

further international interactions.

Document prepared by Laura Marin, JPIAMR Secretariat

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JPIAMR in the global AMR landscape – International Coordination

JPIAMR’s approach to cooperation activities with key international agenda setting

funders, institutions and initiatives.

Internal JPIAMR document. Draft August 2018.

Disclaimer: this document has been developed with: Extracts from the “ERALearn2020 Good Practice Case

Study: JPIAMR’s Approach to Policy Coordination”1 (written by Anna Wang; based on interviews with

Laura Marin and Jonathan Pearce) and complemented with additional information by Laura Marin.

Contents

1 Background 2

2 JPIAMR’s Approach to international collaboration 3

2.1 Collaboration with the UN 3

2.2 Cooperation with the WHO 3

2.3 Collaboration with the G20 / G7 and the Global AMR R&D Hub 4

2.3 Partnership with the European Commission 4

2.4 Research funding coordination 5

2.5 Collaboration with the US 5

2.5 Countries beyond Europe 6

3 Future Plans 6

1 https://www.era-learn.eu/documents

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1 Background

1.1 The Challenge - Lives Are at Stake

Antibiotics have saved millions of lives throughout the many decades they have been in use as a common drug to

treat infection. However, antibiotic resistance is now a global health security challenge. When bacteria become

resistant to commonly used drugs, society needs to respond with concerted actions. Only together can we divert

from a trajectory leading to up to 10 million human lives being extinguished yearly because of antibiotic resistant

bacteria, this by 2050 if projections become reality.

1.2 The JPIAMR – The key to turn the tide of AMR

In 2015, the WHO announced antimicrobial resistance, including antibiotic resistance, as one of the greatest

threats to public health. It endorsed a global action plan to tackle antimicrobial (AMR) that underscores the “one

health” approach involving coordination among numerous sectors and actors, including human and veterinary

medicine, agriculture, environment, and finance. Since then, AMR has shot to the top of the global health agenda

with various institutions weighing in: The Council of the European Union conclusion, the G7 communiqué, the

G20 declaration, and the UN declaration on AMR. There have been no new antibiotics since the 1950s and rising

resistance threatens the ability to treat infectious diseases and undermines many other advances in health and

medicine.

The Joint Programming Initiative on Antimicrobial Resistance, JPIAMR, stresses the importance of

combating resistance as a key actor to identify and coordinate research priorities for funding.

This paper describes JPIAMR’s approach to cooperation activities with key international AMR

initiatives.

JPIAMR was formed in 2011 by 15 European countries and now comprises 27 countries globally (including most

of G20 member states)2. It is a global collaborative platform that funds and coordinates national research funding

and supports collaborative basic and exploratory research on new antibiotics, stewardship of existing antibiotics,

and studies of the spread of antibiotic resistance between humans, animals, and the environment in a One Health

perspective. JPIAMR coordinates national research programs on AMR through its Strategic Research Agenda that

defines six priority topics through which actions will be translated into new prevention and intervention strategies

to improve public health.

Based on its 2015 mapping on AMR research funding, projects, centres, infrastructures, and industry alliances in

the period of 2007-2013, JPIAMR identified the need for increased and new investment across all member states.

So far, it has launched eight transnational calls for research proposals and supported over 50 projects with a total

budget of Eur70 million3. It is currently undertaking an update of the research investments mapping with the

development of a AMR funded projects database. JPIAMR also aims to support AMR research through activities

such as the JPIAMR Virtual Research Institute and actions to promote alignment of national and European

strategies with its SRA.

Due to the nature of AMR, the initiative assumes a global approach by actively engaging countries beyond Europe

as members, by cooperating with key international platforms (UN, WHO, G7, G20, TATFAR – Transatlantic US-

EU Task Force on AMR, etc.), and by establishing relationships with the pharmaceutical industry (the Innovative

Medicines Initiative, industry associations like EFPIA or BEAM alliance).

2 Members: Argentina, Belgium, Canada, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, India, Japan, Netherlands, Norway, Poland, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom 3 More information on call topics and selected projects: https://www.jpiamr.eu/supportedprojects/

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2 JPIAMR’s Approach to international AMR initiatives

JPIAMR’s focus is on identifying and defining research priority

areas and on subsequently coordinating national and

international funding efforts to ensure complementarity and

synergies in AMR and antibiotics research funding. The aim of its

coordination activities is contribute to the (scientific) evidence base

for what those AMR policy objectives should be and support

coordination between various stakeholder categories. JPIAMR

pursues a range of activities with a variety of counterparts/partners

that fall into the category of international coordination or that

contribute to it. The following sections detail JPIAMR’s activities

and approaches toward engaging and collaborating on one side with international AMR research funders

and on the other side with international institutions involved in AMR policy issues.

2.1 Collaboration with United Nations

On the September 2016, the UN General Assembly (UNGA) convened to discuss on antimicrobial resistance for

the first time. Representatives from 193 countries signed a declaration to “Act on AMR”4, which signals a

strong commitment to curb the global overuse of medicines to treat disease. Much of the content in the UN

Declaration, - under the leadership of JPIAMR member countries Sweden, UK Norway and the Netherlands-, is

consistent with the work already done by JPIAMR.

This declaration established a UN coordination body the ad-hoc UN ad-hoc Interagency Coordination Group on

Antimicrobial Resistance (IACG), to “provide practical guidance for approaches needed to ensure sustained

effective global action to address antimicrobial resistance’ while also providing recommendations “on options to

improve coordination”. It coordinates the activities of relevant UN agencies and other international

organisations.

JPIAMR cooperates with the UN through:

• “IACG on AMR subgroup Innovation, R&D and Access”. To develop recommendations for the UNGA

in 2020 regarding critical research needs.

• Partnership with the “UN AMR Call for Action” events and mapping of international AMR initiatives

(Berlin 2017 and Ghana 2018)

2.2 Cooperation with the WHO

In May 2015, the World Health Assembly, the WHO’s decision-making body, endorsed a global action plan to

tackle antimicrobial resistance. This step reflects its recognition of AMR as posing a profound threat to human

health. Since then, the WHO has been working on the development of a Global Action Plan on AMR. Due to

JPIAMR’s leadership position and early establishment as an initiative working in the AMR research field, its work

and especially its SRA are used as a basis and model for the ongoing WHO development of a global strategic

research agenda. Specifically, JPIAMR’s SRA is referred to in the global action plan as being a possible initial

framework for the further development of a similar document applicable globally5 to avoid overlaps and doubling

efforts. The JPI is directly involved in the development of the global action plan and global research agenda and

contributed scientific comments, gave feedback on the plans’ strengths and weaknesses, and suggested specific

4 https://digitallibrary.un.org/record/842813/ 5 WHO (2015), Global Action Plan on Antimicrobial Resistance, 9 http://www.who.int/antimicrobial-resistance/global-action-

plan/en/ .

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projects that could possibly be implemented. Some JPIAMR members have also participated as expert members

on specific committees dedicated to the development of the global research agenda.

The coordination with the WHO also involves JPIAMR research funding topics and priorities that were identified

in the WHO action plan.

Moreover, JPIAMR cooperates closely with the WHO, and by extension the UN, on various other activities. As

an initiative that brings together the AMR research community and provides them with a common voice, it has

extensive knowledge and contacts in the scientific community. By using this advantage, it managed to refer

scientific contacts to the WHO and provide scientific input on the AMR drug development pipeline analysis for

the report on antibacterial agents in clinical development. JPIAMR will also be involved in next year WHO next

pre-clinical pipeline analysis.

JPIAMR also involved key international stakeholders like the WHO early by inviting them to comment and give

feedback on early drafts of the SRA. This was a decision taken to ensure a high-quality SRA but had the

unforeseen side effect of establishing trust and starting a good working relationship, which then allowed JPIAMR

to play a role in global antimicrobial research policy coordination. Regular correspondence and meetings with

the Geneva WHO AMR office and the Europe WHO office are established.

2.3 Collaboration with the G20 / G7 and the Global AMR R&D Hub

In the preparation phase of both G7 and G20 resolutions of 2017, JPIAMR was represented by several member

states in the discussions leading up to the final resolutions. As a result, JPIAMR was highlighted as a key

initiative to combat AMR by both G7 and G20 resolutions. Member states of the G7 and G20 are usually

represented by their respective health departments, i.e., policymakers, JPIAMR is positioning itself as a bridge to

research, and research funder communities. The JPI is now working on establishing its connections with the G20,

particularly in matters related to the planned Global AMR R&D Hub announced during the German G20

presidency in 2017. The goal of this cooperation is to coordinate with the Hub to ensure complementarity and

avoid duplications of the work done by the two initiatives. The current focus of its coordination efforts with the

Hub is on the JPIAMR global research investments mapping exercise in order that the existing work can be

used and avoid duplication with the Hub dashboard activities.

2.4 European Union, partnership with the European Commission

JPIAMR works very closely with the European Commission (EC). The EC is a non-voting member of JPIAMR

through representatives of DG Research and Innovation that attend the Management Board meetings. There is

fluent dialogue in coordination of activities and calls. Every year there is also several bilateral meetings.

AMR is a priority policy area for the European Union. In the official documents of the EU JPIAMR is mention

as a reference and as a key initiative.

“The European One Health Action Plan against AMR” (June 2017)6

The new European Union Action Plan on AMR outlines JPIAMR as a key mechanism for global collaboration,

coordinating calls and for aligning a global research agenda to tackle AMR. In this new plan the European

Commission states that they will support JPIAMR to establish a Virtual Research Institute.

EU Council conclusions (June 2016): “EU Council conclusions on the next steps under a One Health

approach to combat antimicrobial resistance”.

6 http://europa.eu/rapid/press-release_IP-17-1762_en.htm

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In this official statement the Minsters of Health of the EU acknowledges the work of JPIAMR and calls all the

Member States to “join or strengthen their commitment to the existing Joint Programming Initiative on AMR”.

JPIAMR also joins forces with the European Commission in the AMR European Awareness campaign:

“Antibiotic Awareness Day” of each 18 November.

Furthermore, JPIAMR is engaged in coordination activities with various other European players such as the JTI

Innovative Medicines Initiative (IMI) and EFPIA, the European Federation of Pharmaceutical Industries and

Associations. These activities focus on the coordination of priorities and the better connection of the academic

researcher community to industry. For example, JPIAMR is member of IMI Strategic Group on Infectious

Diseases where they discuss regarding their allocation of funding to topics. Particular attention is paid to the

triangulation of dialogue between JPIAMR, IMI, and the SME community (through BEAM Alliance) to reduce

the number and complexity of coordination discussions. JPIAMR’s advantage is that by engaging JPIAMR one

is able to engage multiple partners, research funders, in one conversation.

The EC and JPIAMR work active together in the international policy arena representing Europeans views and

collaborating with third countries.

The EC provides funding to JPIAMR through one ERAnet Cofund and two CSAs.

2.5 Research funding coordination

The central element of JPIAMR activities is to

coordinate public research funding efforts among its

members. It identifies research priorities for funding

and coordinates calls among its members to ensure

the optimal allocation of funds. Beyond this core

function, JPIAMR is part of the Global AMR

Funder Forum which meets regularly to discuss

priority areas and how to coordinate funding on a

global scale, i.e., what can be funded nationally,

what needs to be funded internationally? The major

international funders are part of this forum, such as

US NIH, US BARDA, CARB-X, Wellcome, Gates

Foundation, etc. This is especially important

considering the political attention paid to the AMR threat recently, which caused a flood of new policies but also

increased funding available. Many countries have doubled the national budgets allocated to AMR research,

making coordination of policies, priorities, and funding essential. JPIAMR plays a central role in this process by

coordinating the activities of a number of countries and thus being able to represent them as a single contact point

in these discussions.

2.6 US collaboration

JPIAMR collaborates closely with TATFAR, the Transatlantic Taskforce on Antimicrobial Resistance, which

was created to improve cooperation between the US and EU to reduce the threat of AMR. Its members comprise

government agencies relevant to the field from the US, EU, Canada and Norway, and is co-chaired by DG Sante

and the US Department of Health and Human Services. JPIAMR participates in activities regarding research

bringing its perspectives and priorities into the transatlantic dialogue and to facilitate the compatibility of the US

and European agendas. It also co-organizes workshops, panels, and other events with transatlantic partners such

as the US National Institute of Health and the US National Institute of Allergy and Infectious Diseases that aim

to facilitate the transatlantic dialogue in the field of AMR and encourage transatlantic scientific collaboration with

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2 specific joint workshops in 2016. There is also current collaboration discussions with other US agencies such

as CDC and NIFA.

JPIAMR also acts as a sort of neutral platform between parties that might not be in frequent contact. It regularly

invites various external stakeholders to its workshops and meetings to exchange information and discuss possible

cooperation and coordination activities. Such meetings include ones that may bring together representatives from

the pharmaceutical industry and regulators from Europe, the US, and other countries. Opening up the dialogue

between these two groups is an important contribution to improving coordination, and ultimately, new and better

antibiotics.

2.7 Countries beyond Europe

JPIAMR is very successful in attracting countries beyond Europe as members. It now has 27 member states,

including almost all G20 countries, and the number is growing. These countries are mostly attracted to JPIAMR

by the opportunity to work and learn from a range of countries at once instead of having to engage in multiple

bilateral relationships. JPIAMR has members in the different continents such as Argentina, Canada, Egypt,

Sotuh Africa, India, South Korea or Japan. Since AMR is a global threat, particularly in countries outside Europe,

JPIAMR is now trying to strategically attract new countries with research capacity to become members. Its

Strategic Working Group 3, led by Germany, is dedicated to extending membership to key countries on other

continents. Considerations include the benefits that JPIAMR can offer to its members, but also on how to manage

expectations of candidate countries. Starting in 2018, JPIAMR has placed a greater focus on actively approaching

countries where membership could mutually benefit both sides, such as countries in Eastern Europe, Asia, and

Latin America. One of the approaches is through it workshops and events dedicated to establishing the JPIAMR

Virtual Research Institute, where the JPI strategically invites key countries of interest and key players into the

discussion.

In 2019 a new joint call with developing agencies would be able to include more research partners of lower

income countries in Africa and Asia in JPIAMR research activities.

3 Future plans

Antimicrobial resistance shot to the top of the global health agenda after the WHO resolution in 2015 following

UN Resolution in 2017. Since then, many other international organizations, governmental forums, politicians, and

private actors have intensified their attention and efforts on solutions for AMR. As a result, countries have

introduced a multitude of new policies and increased their budgets dedicated to AMR research. Thus, coordination

among this large and varied group of actors is more important than ever to ensure synergies and complementarity,

enhance efficiency and effectiveness, and avoid duplicating each other’s work. JPIAMR plays a key role in AMR

policy and funding coordination, not only among its 27 members, but more importantly, on a global scale. Its

cooperation with key international policymakers such as the WHO, G7, and G20 is a key contribution to better

and more effective coordination of global activities. Major lessons learned from JPIAMR’s experience, such as

the importance of building trust with key partners early on, the benefits of positioning oneself as a key information

hub, and highlighting the value added of coordination and cooperation with the JPI to relevant (potential) partners

are applicable to other JPIs, and the P2P community at large, that want to engage in policy coordination.

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