[Ip-health] HAI Report - EU Leadership Crucial for Affordable & Responsible Antibiotic R&D
bobbi at haiweb.org
Tue May 23 03:55:33 PDT 2017
Dear IP Health subscribers,
As discussions regarding antimicrobial resistance (AMR) occur this week at the 70th World Health Assembly, Health Action International issued a new report calling on the European Union (EU) and its member states to use their influential positions and shape antibiotic R&D initiatives in a way that ensures equitable access in Europe and globally, and safeguards appropriate use to limit resistance.
In the report, Health Action International urges the EU and its member states to address the following four key challenges:
1. The global antibiotic R&D landscape is crowded. This seems like a good thing, but the lack of coordination and information sharing between these initiatives is worrying. It leads to research duplication (including duplication of clinical trials) and inefficient use of public spending.
2. There is a shortage of coordinated priority setting on antibiotic R&D spending. The current pipeline demonstrates a lack of truly valuable new antibiotics, vaccines and diagnostics. Moreover, most publicly funded R&D initiatives in this area target the basic research phase, and much less funding is available for later stages of antibiotic development.
3. Current publicly funded antibiotic R&D initiatives, including those by the EU and its Member States, lack effective conditions that steer antibiotic innovation towards priority areas and manage results (including intellectual property [IP]) to ensure affordable access and conservation of funded products. In addition, the EU and its Member States are not doing enough to explore alternative R&D mechanisms that use delinkage as a pathway to stimulate R&D in priority areas and meeting the dual goal of access without excess. The EU and Member States should also do more to explore how an R&D model based on delinkage can be implemented with (global) measures to control the number and quality of global producers of any resulting new antibiotic-and to control the sales and distribution routes through pooled procurement and reimbursement policies. This is unacceptable given the urgency of the threat of AMR.
4. The EU and its Member States bear a global responsibility and self-interest in ensuring global access, conservation and priority setting in low- and middle-income countries (LMICs). It is imperative that a social justice perspective is inserted into new innovation models for antibiotic R&D. This will ensure that resulting valuable new antibiotics are also available and suitable for people living in LMICs. Moreover, conservation efforts of new antibiotics are only effective if implemented globally. The EU and Member States should take the lead in supporting both politically and financially new and ongoing initiatives to promote global coordination in this area, including the World Health Organization's (WHO) Global Action Plan on AMR, and a meaningful follow-up of the United Nations' (UN) Political Declaration on AMR.
To address these challenges, Health Action International recommends that the EU and its member states:
- Support a robust and inclusive mechanism for global priority setting and coordination of antibiotic R&D which: improves EU coordination of existing and new antibiotic R&D initiatives, including clinical trials; and supports new and ongoing initiatives to promote global coordination of antibiotic R&D, including the WHO's Global Action Plan on AMR, and a meaningful follow-up of the UN's Political Declaration on AMR.
- Ensure R&D investments support global priorities by developing target prospective product profiles (TPPs) to guide priority setting in (global) antibiotic R&D investments. This includes using the WHO's list of global R&D priorities for resistant pathogens.
- Attach conditions to publicly funded R&D for antibiotics that help ensure global access and conservation. These conditions include: making resulting data and reports publicly available at defined points in time to facilitate follow-on research and early identification of potential targets; requiring pro-public health management of research results, including IP; and including a clawback mechanism when the funding recipient does not meet specified conditions.
- Explore how an R&D model based on delinkage can be coupled with (global) measures to ensure conservation and stewardship by controlling the number and quality of global producers of any resulting new antibiotic and the sales and distribution routes through pooled procurement and reimbursement policies.
- Lead in exploring and implementing alternative incentive models for antibiotic R&D that embrace delinkage as a pathway to needs-driven priority setting and global access and conservation using a mix of direct conditional grants (push) and prizes/market entry rewards (pull).
- Consider the use of (European) tax policies as a mechanism to ensure sustainable funding of antibiotic R&D.
- Insert a social justice perspective when developing new innovation models for antibiotic R&D so new and valuable antibiotics are also available and suitable for people living in LMICs. In particular: public R&D grants should include additional revenue streams for conservation and access in low-income populations; and the EU and Member States should commit to mobilising the means to implement technology and capacity building in LMICs to support development and implementation of their individual national action plans to combat AMR.
For further information about the content of the report, please contact Health Action International's senior research manager, Gemma Buckland-Merrett at gemma at haiweb.org<mailto:gemma at haiweb.org>.
Health Action International
bobbi at haiweb.org
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