Transferable data exclusivity vouchers are not the solution to the antimicrobial drug development crisis: A commentary on the proposed EU pharma regulation

Berner-Rodoreda, Astrid and Cobelens, Frank and Vandamme, Anne-Mieke and Froeschi, Gunter and Skordis, Jolene and Elil, Renganathan * and t'Hoen, Ellen and Raviglione, Mario and Jahn, Albrecht and Barnighausen, Till (2024) Transferable data exclusivity vouchers are not the solution to the antimicrobial drug development crisis: A commentary on the proposed EU pharma regulation. BMJ Global Health, 9. ISSN 2059-7908

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Official URL: https://doi.org/10.1136/bmjgh-2023-014605

Abstract

Access to pharmaceutical products worsened during the COVID-19 pandemic when key developers of active pharmaceutical ingredients and medicinal products prioritised their national markets. These challenges led to a stronger commitment by the European Union (EU) to become more autonomous in developing and providing access to pharmaceutical products for its population.1 In April 2023, the European Commission (EC) proposed a reform of the EU pharma regulation to improve patient-centredness, strengthen the European pharmaceutical industry and incentivise pharmaceutical innovation.1 This reform needs to be approved by the European Parliament. In its present form, it includes the introduction of Transferable Data Exclusivity Vouchers (TDEVs) to address the crisis in antimicrobial innovation. In this commentary, we assess the use of TDEVs as an important element of the EC’s proposed pharma strategy on antimicrobial resistance (AMR).

Item Type: Article
Uncontrolled Keywords: antimicrobial; AMR; transferable data exclusivity vouchers; TDEVs;
Subjects: R Medicine > RM Therapeutics. Pharmacology
R Medicine > RS Pharmacy and materia medica
Divisions: Others > Non Sunway Academics
Sunway University > School of Medical and Life Sciences [formerly School of Healthcare and Medical Sciences until 2020]
Depositing User: Ms Yong Yee Chan
Related URLs:
Date Deposited: 15 May 2024 07:44
Last Modified: 11 Jul 2024 00:05
URI: http://eprints.sunway.edu.my/id/eprint/2608

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