3 results on '"Outterson K"'
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2. Implementing an EU pull incentive for antimicrobial innovation and access: blueprint for action.
- Author
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Anderson M, Towse A, Outterson K, and Mossialos E
- Subjects
- Humans, Anti-Infective Agents, Motivation, International Cooperation legislation & jurisprudence, European Union
- Abstract
In June, 2023, the Council of the EU published a recommendation that the European Commission should contribute to the design and governance of an EU cross-country pull incentive to stimulate antimicrobial innovation and access. In this Personal View, we discuss six key considerations to support the implementation of the new pull incentive-ie, the size of the potential pull incentive and possible contributions of the member states, design of the incentive model, interplay of the new pull incentive with the proposed revisions of the EU pharmaceutical legislation, roles and responsibilities of both the EU and member states, balance between pull and push incentives, and global cooperation and responsibility. As the involvement of the member states with the EU pull incentive will be voluntary, member states should have confidence that the processes used to identify eligible antimicrobials, negotiate terms and conditions, and oversee access agreements are transparent, inclusive, and methodologically robust., Competing Interests: Declaration of interests MA declares consultancy fees from the European Observatory on Health Systems and Policies. AT declares consultancy fees from the Centre for Global Development. KO is the principal investigator and executive director of Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and also declares honoraria for academic lectures at Tufts University, Memorial Sloan Kettering, and the Sanger Institute. EM declares no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
3. Expanding antibiotic, vaccine, and diagnostics development and access to tackle antimicrobial resistance.
- Author
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Laxminarayan R, Impalli I, Rangarajan R, Cohn J, Ramjeet K, Trainor BW, Strathdee S, Sumpradit N, Berman D, Wertheim H, Outterson K, Srikantiah P, and Theuretzbacher U
- Subjects
- Humans, Bacterial Infections prevention & control, Bacterial Infections drug therapy, Bacterial Infections diagnosis, COVID-19 prevention & control, Drug Resistance, Bacterial, Health Services Accessibility, Pandemics, Anti-Bacterial Agents therapeutic use, Drug Development
- Abstract
The increasing number of bacterial infections globally that do not respond to any available antibiotics indicates a need to invest in-and ensure access to-new antibiotics, vaccines, and diagnostics. The traditional model of drug development, which depends on substantial revenues to motivate investment, is no longer economically viable without push and pull incentives. Moreover, drugs developed through these mechanisms are unlikely to be affordable for all patients in need, particularly in low-income and middle-income countries. New, publicly funded models based on public-private partnerships could support investment in antibiotics and novel alternatives, and lower patients' out-of-pocket costs, making drugs more accessible. Cost reductions can be achieved with public goods, such as clinical trial networks and platform-based quality assurance, manufacturing, and product development support. Preserving antibiotic effectiveness relies on accurate and timely diagnosis; however scaling up diagnostics faces technological, economic, and behavioural challenges. New technologies appeared during the COVID-19 pandemic, but there is a need for a deeper understanding of market, physician, and consumer behaviour to improve the use of diagnostics in patient management. Ensuring sustainable access to antibiotics also requires infection prevention. Vaccines offer the potential to prevent infections from drug-resistant pathogens, but funding for vaccine development has been scarce in this context. The High-Level Meeting of the UN General Assembly in 2024 offers an opportunity to rethink how research and development can be reoriented to serve disease management, prevention, patient access, and antibiotic stewardship., Competing Interests: Declaration of interests A meeting held to coordinate this Series paper was supported by the Bill & Melinda Gates Foundation (INV-055356 to RL) and the Africa Centres for Disease Control and Prevention (to all authors). Neither funder had any role in the design, writing, or decision to submit this paper for publication. RL has received grant funding from the National Science Foundation (CCF1918628). HW has received grant funding from Pfizer, the Wellcome Trust, ZonMW, the International Society of Antimicrobial Chemotherapy, and the International Centre for Antimicrobial Resistance Solutions; has received travel support from the European Society of Clinical Microbiology and Infectious Diseases to attend the European Congress of Clinical Microbiology and Infectious Diseases; has participated on the data safety monitoring board for the BCG PRIME trial; and has received research materials from Cepheid. PS is an employee of the Gates Foundation but authored this Series paper in her capacity as an individual expert on vaccines. KR received funding for the antimicrobial resistance landscape work in this Series paper from CARB-X and is currently employed by FIND. The views reflected in this Series paper are those of the authors and do not necessarily reflect those of the organisations with which they are affiliated. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved including those for text and data mining, AI training, and similar technologies.)
- Published
- 2024
- Full Text
- View/download PDF
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