Hostname: page-component-78c5997874-mlc7c Total loading time: 0 Render date: 2024-11-19T00:15:28.661Z Has data issue: false hasContentIssue false

Stimulating Research and Development of New Antibiotics While Ensuring Sustainable Use and Access: Further Insights from the DRIVE-AB Project and Others

Published online by Cambridge University Press:  01 January 2021

Extract

Global discussions are ongoing on how to stimulate antibiotic research and development in order to provide patients with new antibiotics able to address the challenges of antimicrobial resistance. In this supplement, we present nine articles derived from the research performed as part of the Innovative Medicine Initiative-funded DRIVE-AB project and others. These publications provide new evidence and arguments in the debate around economic incentives to stimulate antibiotic innovation, including characteristics, implementation and governance.

Type
Symposium Articles: Introduction
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Tacconelli, E., Carrara, E., Savoldi, A., Harbarth, S., Mendel-son, M., Monnet, D. L., Pulcini, C., Kahlmeter, G., Kluytmans, J., Carmeli, Y., Ouellette, M., Outterson, K., Patel, J., Cavaleri, M., Cox, E. M., Houchens, C. R., Grayson, M. L., Hansen, P., Singh, N., Magrini, U. Theuretzbacher, and , N., WHO Pathogens Priority List Working Group, “Discovery, Research, and Development of New Antibiotics: The WHO Priority List of Antibiotic-Resistant Bacteria and Tuberculosis,” The Lancet Infectious Diseases 18, no. 3 (2018): 318327.Google Scholar
Silver, L. L., “Challenges of Antibacterial Discovery,” Clinical Microbiology Reviews 24, no. 1 (2011): 71109; Tomayko, J. F., Rex, J. H., Tenero, D.M., Goldberger, M., and Eisenstein, B. I., “The Challenge of Antimicrobial Resistance: New Regulatory Tools to Support Product Development,” Clinical Pharmacology & Therapeutics 96, no. 2 (2014): 166-168; Harbarth, S., Theuretzbacher, U., Hackett, J., and the DRIVE-AB Consortium, “Antibiotic Research and Development: Business as Usual?” Journal of Antimicrobial Chemotherapy 70, no. 6 (2015): 1604-1607.CrossRefGoogle Scholar
Innovative Medicine Initiative (IMI), available at <www.imi.europa.eu> (last visited February 7, 2018); Kostyanev, T., deWinter, R., Steel, H., Ross, S., O'Brien, S., François, B., Winterhalter, M., Stavenger, R., Karlén, A., Harbarth, S., Hackett, J., Jafri, H., Vuong, C., Witschi, A. MacGowan, , , A., Angyalosi, G., Elborn, S., Bonten, M., and Goossens, H. for the ND4BB Consortia, “The Innovative Medicines Initiative's New Drugs for Bad Bugs Programme – European Public-Private Partnerships for the Development of New Strategies to Tackle Antibiotic Resistance,” Journal of Antimicrobial Chemotherapy 71 (2016): 290295.Google Scholar
DRIVE-AB Final Report, “Revitalizing the Antibiotic Pipeline: Stimulating Innovation While Driving Sustainable Use and Global Access,” 2018, available at <http://www.imi.europa.eu/projects-results/project-factsheets/drive-ab> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
Savic, M. and Årdal, C., “A Grant Framework as a Push Incentive to Stimulate Research and Development of New Antibiotics,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 924Google Scholar
Baraldi, E., Lindahl, O., Savic, M., Findlay, D., and Årdal, C., “Antibiotic Pipeline Coordinators,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 2531.CrossRefGoogle Scholar
See DRIVE-AB Final Report, supra note 5.Google Scholar
Okhravi, C., Callegari, S., McKeever, S., Kronlid, C., Baraldi, E., Lindahl, O., and Ciabuschi, F., “Simulating Market Entry Rewards for Antibiotics Development,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 3242.Google Scholar
Årdal, C., Johnsen, J., and Johansen, K., “Designing a Delinked Incentive for Critical Antibiotics: Lessons from Norway,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 4349.CrossRefGoogle Scholar
Daniel, G. W., Schneider, M., Lopez, M. Hamilton, and McClellan, M. B., “Implementation of a Market Entry Reward within the United States,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 5058.CrossRefGoogle Scholar
Daniel, G. W., Schneider, M., and McClellan, M. B., “Addressing Antimicrobial Resistance and Stewardship: The Priority Antimicrobial Value and Entry (PAVE) Award,” JAMA 318, no. 2 (2017): 11031104.Google Scholar
Bhatti, T., Lum, K., Holland, S., Sassman, S., Findlay, D., and Outterson, K., “A Perspective on Incentives for Novel Inpatient Antibiotics: No One-Size-Fits-All,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 5965.Google Scholar
Lum, K., Bhatti, T., Holland, S., Guthrie, M., and Sassman, S., “Diagnosis Confirmation Model: A Value-Based Pricing Model for Inpatient Novel Antibiotics,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 6674.CrossRefGoogle Scholar
See DRIVE-AB Final Report, supra note 5, at 15.Google Scholar
Id., at 53-57.Google Scholar
Morel, C. M. and Edwards, S. E., “Encouraging Sustainable Use of Antibiotics within the DRIVE AB Selected Innovation Incentives,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 7580.Google Scholar
Storehagen, L., Aftab, F., Årdal, C., Savic, M., and Røttingen, J. A., “Should Antibiotics Be Controlled Medicines? Lessons from the Controlled Drug Regimen,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 8194.Google Scholar
Årdal, C., Outterson, K., Hoffman, S. J., Ghafur, A., Sharland, M., Ranganathan, N., Smith, R., Zorzet, A., Cohn, J., Pittet, D., Daulaire, N., Morel, C., Rizvi, Z., Balasegaram, M., Dar, O. A., Heymann, D. L., Holmes, A. H., Moore, L. S., Laxminarayan, R., Mendelson, M., and Røttingen, J. A., “International Cooperation to Improve Access to and Sustain Effectiveness of Antimicrobials,” The Lancet 387, no. 10015 (2016): 296307.CrossRefGoogle Scholar
World Health Organization (WHO), “Global Action Plan on Antimicrobial Resistance,” 2015, available at <http://www.who.int/antimicrobial-resistance/publications/global-action-plan/en/> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar