Hostname: page-component-745bb68f8f-lrblm Total loading time: 0 Render date: 2025-01-14T20:32:34.689Z Has data issue: false hasContentIssue false
  • English
  • Français

Transferable Exclusivity Vouchers and Incentives for Antimicrobial Development in the European Union

Published online by Cambridge University Press:  25 May 2023

Victor L. Van de Wiele ,
Adam Raymakers ,
Aaron S. Kesselheim  and
Benjamin N. Rome
Victor L. Van de Wiele
Affiliation:
PORTAL, HARVARD MEDICAL SCHOOL, BOSTON, MA, USA
Adam Raymakers
Affiliation:
PORTAL, HARVARD MEDICAL SCHOOL, BOSTON, MA, USA
Aaron S. Kesselheim
Affiliation:
PORTAL, HARVARD MEDICAL SCHOOL, BOSTON, MA, USA
Benjamin N. Rome
Affiliation:
PORTAL, HARVARD MEDICAL SCHOOL, BOSTON, MA, USA
Get access Rights & Permissions [Opens in a new window]

Abstract

The European Commission’s proposal to address antimicrobial resistance using transferable exclusivity vouchers (TEVs) is fundamentally flawed. European policymakers and regulators should consider alternatives, such as better funding for basic and clinical research, use of advance market commitments funded by a pay-or-play tax, or enacting an EU Fund for Antibiotic Development.

Keywords

AntimicrobialsEuropean Unionantimicrobial resistancetransferable exclusivity vouchersmarket exclusivity
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue 1: The Evolving Fight Against Gun Violence , Spring 2023 , pp. 213 - 216
Copyright
© 2023 The Author(s)

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.)

Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at akesselheim@bwh.harvard.edu.

References

See <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
See <https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance#:~:text=Antimicrobial%20Resistance%20(AMR)%20occurs%20when,spread%2C%20severe%20illness%20and%20death> (last visited March 13, 2023); Mitra-Majumdar, M., Powers, J. P. III and Kesselheim, A., “Evidence at Time of Regulatory Approval and Cost of New Antibiotics, 2016-2019,” BMJ Medicine 1 (2022): e000227.CrossRefGoogle Scholar
EP3716992B1.Google Scholar
For example, Pfizer and Shionogi will receive £10 million per year from the NHS to fund production of cefiderocol. See A. Mullard, “Pull Incentives for Antibiotics Get Push from the UK,” Nature Reviews Drug Discovery 21 (2022): 406.CrossRefGoogle Scholar
EU Commission Public Assessment Report.Google Scholar
Id.Google Scholar
C. Martuscelli, “Document: Commission Mulls Changes to Rules for Rare Disease Drugs,” Politico Pro (October 18, 2022), available at <politicopro.com> (last visited April 17, 2023).+(last+visited+April+17,+2023).>Google Scholar
J. Shimkus, T. Cardenas, and A. Eshoo, H.R. 6294–Re-Valuing Anti-Microbial Products Act of 2018. US House of Representatives (2018).Google Scholar
Rome, B. N. and Kesselheim, A. S., “Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis,” Clinical Infectious Diseases 71, no. 7 (2020): 1671–1675.CrossRefGoogle ScholarPubMed
See <https://www.healtheuropa.com/europes-quest-for-new-antibiotics/118297/> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
See <https://pink.pharmaintelligence.informa.com/PS147398/EU-Countries-Slam-Transferable-Exclusivity-Voucher-Proposal> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
Mitra-Majumdar, M., Powers, J. H., and Brown, B. L., et al., “Evidence at Time of Regulatory Approval and Cost of New Antibiotics in 2016-19: Cohort Study of FDA Approved Drugs,” BMJ Medicine 1 (2022): e000227.CrossRefGoogle ScholarPubMed
Ardal, C. et al., “Financing Pull Mechanisms for Antibiotic-Related Innovation: Opportunities for Europe,” Clinical Infectious Diseases 71, no. 8 (2020): 1994–1999.CrossRefGoogle ScholarPubMed
Supra note 7, at 105.Google Scholar
See <https://eregister.ipoi.gov.ie/query/SPQuery.aspx> (last visited April 17, 2023).+(last+visited+April+17,+2023).>Google Scholar
See <https://www.cdc.gov/drugresistance/pdf/report-to-the-president-on-combating-antibiotic-resistance.pdf> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
Outterson, K. and McDonnell, A., “Funding Antibiotic Innovation Vouchers: Recommendations on How to Strengthen A Flawed Incentive Policy,” Health Affairs 35, no. 5 (2016): 784–790.CrossRefGoogle ScholarPubMed
P. Dubois et al., “The Economics of Transferable Patent Extensions,” Working Papers N.1377 (2022), available at <https://www.tse-fr.eu/publications/economics-transferable-patent-extensions> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
See <https://www.kff.org/coronavirus-covid-19/issue-brief/how-much-could-covid-19-vaccines-cost-the-u-s-after-commercialization/> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
See <https://www.gov.uk/government/collections/antimicrobial-resistance-amr-information-and-resources> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar
See <https://www.england.nhs.uk/patient-safety/fighting-antimicrobial-resistance/> (last visited March 13, 2023).+(last+visited+March+13,+2023).>Google Scholar