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EU support for Global Health R&I

RECOMMENDATIONS FOR THE FUTURE FP9 IMPROVED HEALTH AND WELLBEING OF THE PEOPLE IS THE ULTIMATE GOAL OF RESEARCH the European Commissionâ€™s Scientific Panel for Health1

Today one billion people worldwide are affected by poverty-related and neglected diseases (PRNDs), including major diseases like HIV&AIDS, tuberculosis, and malaria, and a range of neglected infectious diseases. PRNDs impose an unacceptable moral and health burden on individuals and societies, costing lives and hampering human and economic development. Major product- and research-gaps persist, as there are limited market incentives for the private sector to invest in new or improved tools to fight PRNDs. Where treatments exist, many are losing their effectiveness as PRNDs are developing drug resistance, making infections harder and more costly to treat. Already today, globally, around one third of deaths caused by antimicrobial infections are due to drug-resistant tuberculosis.

1. â†˜ Impactfully

A DEDICATED PARTNERSHIP INSTRUMENT FOR PRND R&I

addressing PRNDs through FP9 will require a dedicated R&I partnership instrument building on the success of the European and Developing Countries Clinical Trials Partnership (EDCTP). EDCTP, as a mission-driven publicpublic partnership, is responding to societal challenges with a clearly needs-driven research agenda. The new instrument should have:

An ambitious budget not depending on matched funding from Participating States

A flexible funding approach including portfolio funding, and the possibility to invest strategically (without Call for Proposals) in exceptional cases

An inclusive and transparent governance, safeguarding the equal partnership nature with subSaharan African states while enhancing public accountability and transparency in decision-making

Coordination mechanisms to improve alignment with Participating States activities and ensure coherence and institutionalised dialogue with other EU programmes

1 Cf. A vision for health and biomedical research from the Scientific Panel for Health, available at: http://ec.europa.eu/programmes/horizon2020/sites/horizon2020/files/SPH_Vision_Paper_27052016.pdf

A flexible and simple mechanism to partner with third parties (public and private) to facilitate co-funding and co-designing PRND R&I activities

Relaxed restrictions on the geographic locations of applicants to facilitate the participation of the most relevant actors and attract international expertise

A GLOBAL MISSION FOR RESEARCH AND INNOVATION: END POVERTY-RELATED AND NEGLECTED DISEASES

Investing in PRND R&I saves lives, combats ongoing epidemics, can prevent future catastrophic outbreaks, delivers on the SDGs, and has a great economic return on investment for Europe, while creating quality jobs and driving scientific excellence. R&I missions under FP9 should address societal challenges, be needs-driven, and include indicators to monitor societal impact. The required technological development should attract research and innovation activities that otherwise would likely not be undertaken by private actors, providing the justification and legitimacy for public intervention2

↘ A major PRND R&I mission with substantial funding of at least €1 billion should support

all parts of the research and development chain, creating a new generation of candidates through basic research, supporting preclinical testing, clinical development, and other important elements of making new tools accessible to those in need.

END PRN

Licence a highly effective and safe malaria vaccine universally accepted by 2030

…

Malaria

Develop a preventive HIV vaccine by 2030

Develop self-initiated HIV prevention tools for women and adolescents and make them available by 2025

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HIV/AIDs

Develop an affordable six week treatment against all forms of TB within the next 10 years

Develop a safe, effective and affordable TB vaccine by 2025

…

Tuberculosis

Neglected tropical diseases

Licence a vaccine against hookworm by 2025

Licence a vaccine against schistosome parasites by 2025

Licence a vaccine against leishmaniasis by 2025

Licence a vaccine against onchocerciasis to eliminate river blindness by 2025

2 Cf. Mariana Mazzucato, 2018. Mission-Oriented Research & Innovation in the European Union, available at: https://ec.europa.eu/info/sites/info/files/mazzucato_report_2018.pdf

Develop a vaccine against Chagas disease by 2025

…

INCREASED AND IMPROVED SUPPORT TO GLOBAL HEALTH R&I UNDER FP9

↘ Increase annual funding for

PRND R&I and establish a track and monitoring system to report the share of funding dedicated to PRND R&I

↘ Develop a comprehensive vision and action plan for global health research and product development

• To coordinate European programmes with national priorities • To ensure that EU health research priority-setting is driven by global health needs • To ensure a greater focus on disease areas where industry interest is limited and R&I relies on public funding

↘ Ensure accessibility and affordability • Include clear and sustainable access, suitability and affordability conditions for health research projects • Support alternative biomedical innovation and financing models that de-link the costs of R&I from product prices where possible, e.g. innovation prizes, not-for-profit product development partnerships, patent pools, etc. • Guarantee open access to research results, and promote open access to research data, with strict criteria for derogations of open data requirements, to accelerate R&I and avoid duplication

↘ Support promising products throughout the entire pipeline, and ensure necessary mechanisms are in place to capitalise on successful previous R&I investments

↘ Adopt a multi-stakeholders participatory approach,

by actively and meaningfully engaging civil society organisations at all levels to maximise societal impact

RECOMMENDATIONS SUPPORTED BY:

Deutsche Stiftung Weltbevölkerung (DSW) is a global development organisation that focuses on the needs and potential of the largest youth generation in history. We are committed to creating demand for and access to health information, services, supplies, and economic empowerment for youth. We achieve this by engaging in advocacy, capacity development, and reproductive health initiatives, so that young people are empowered to lead healthy and self-determined lives. With our headquarters in Hannover, Germany, DSW operates two liaison offices in Berlin and Brussels, as well as maintaining a strong presence in Ethiopia, Kenya, Tanzania, and Uganda. Avenue des Arts 43, 1040 Brussels, Belgium • Tel: +32 (0) 504 90 60 • brussels@dsw.org • www.dsw.org facebook.com/DSWDeutscheStiftungWeltbevoelkerung/ •

@dsw_intl •

CALL FOR A DEDICATED R&I INSTRUMENT FOR DISEASES OF POVERTY UNDER FP9: BUILDING ON THE SUCCESS OF EDCTP

One billion people worldwide are affected by poverty-related and neglected diseases (PRNDs), including major diseases like HIV&AIDS, tuberculosis, and malaria, and a range of neglected infectious diseases1. PRNDs impose an unacceptable moral and health burden on individuals and societies, costing lives, and hampering human and economic development2. Major product- and research-gaps persist, as there are limited market incentives for the private sector to invest in new or improved tools to fight PRNDs. Where treatments exist, many are losing their effectiveness as the pathogens causing PRNDs are developing drug resistance, making infections harder and more costly to treat. Already today, globally, around one third of deaths caused by antimicrobial infections are due to drug- resistant tuberculosis3. Investing in PRND R&I saves lives, combats ongoing epidemics, can prevent future outbreaks, delivers on the SDGs, and has a great return on investment for Europe, creating high-quality jobs, boosting our economies and driving scientific excellence. The European Union and the African Union have committed to strengthening preparedness to detect, prevent and respond to disease outbreaks, and to increase efforts in research and innovation (R&I) for sustainable development4. Ensuring an impact of FP9 in addressing PRNDs will require a dedicated R&I partnership instrument building on the success of the European and Developing Countries Clinical Trials Partnership (EDCTP).

EDCTP HAS DEMONSTRATED IMPACT From its inception in 2003, EDCTP has significantly contributed to • Advancing tools against PRNDs through the research pipeline by funding more than 150 clinical trials of new or improved drugs, vaccines, and diagnostics; • Building health resilience in Africa by strengthening clinical research capacity across sub-Saharan Africa; • Enhancing the quality and safety of health products in Africa by improving regulatory environments, strengthening ethics review and national regulatory capacities in many sub-Saharan African countries.

The EDCTP2 interim evaluation conducted by independent experts found that • EDCTP is a highly relevant programme: it aligns with the EU’s aim of strengthening ties with Africa, and it delivers on its development cooperation objectives by addressing poverty, improving health and education, and fostering partnerships. • EDCTP’s mission is directly linked with the Sustainable Development Goals, which are high priorities for the EU.

1 CF WHO definition and list of NTDs, available at: http://www.who.int/neglected_diseases/diseases/en/ 2 For more information, please see: http://www.dsw.org/en/wp-content/uploads/2017/06/DSW-PRND-Infographic-WEB.pdf 3 Cf. The review of AMR, chaired by Jim O’Neill, available at: https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf 4 Cf. AU-EU Summit 2017 declaration, available at: http://www.consilium.europa.eu/media/31991/33454-pr-final_declaration_au_eu_summit.pdf

THE FUTURE PRND R&I PARTNERSHIP INSTRUMENT SHOULD CONTINUE EDCTP’S PROGRAMME AND MISSION THROUGH: An ambitious budget to capitalise on past EU investments • 700 million EUR contribution from the EC, not dependent on matched funding • European participating states should increase their contributions in cash. • Greater investment from sub-Saharan African participating states should be encouraged through stronger governance and funding incentives

A flexible funding approach to better deal with contingency and opportunity • Including a portfolio approach to development to help mitigate risks of failure and to focus on the most promising products within the portfolio as needed • Providing the possibility to invest strategically (without Call for Proposals), once approved by an independent external review committee, e.g. if there is only one viable candidate that can be progressed through the next phase of development • Offering a flexible and simple mechanism to partner with third parties (public and private) to facilitate co-funding and co-designing PRND R&I activities • With fewer restrictions on geographic locations of applicants to attract global expertise

An inclusive governance to enhance efficiency and accountability • Safeguarding the equal partnership nature with sub-Saharan African countries as it contributes to closer collaboration, network strengthening and capacity building • Including a high-level, strategic advisory board, separate from the scientific advisory committee and the board, to ensure more long term strategic planning • Promoting high standards of transparency at all levels, including by providing more detailed feedback within proposal evaluations

Strong mechanisms for improved alignment and coherence • of EU funded PRND R&I and Participating States activities, including a strategy that identifies synergies, gaps and overlaps • with other EU programmes, e.g. activities under the development and international cooperation instruments, for instance by including support to harmonisation efforts in the field of health regulation which fosters long-term sustainability of PRND R&I activities

Clear conditions on access, suitability and affordability • Guarantee open access to research results, and promote open access to research data, with strict criteria for derogations of open data requirements • Require proposals to include measures for ensuring accessibility and affordability of potential end products

Avenue des Arts 43, 1040 Brussels, Belgium • Tel: +32 (0) 504 90 60 • brussels@dsw.org • www.dsw.org facebook.com/DSWDeutscheStiftungWeltbevoelkerung/ •

@dsw_intl •