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可转让排他性优惠券与激励措施促进欧盟抗菌药物研发

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

机构信息

PORTAL, HARVARD MEDICAL SCHOOL, BOSTON, MA, USA.

出版信息

J Law Med Ethics. 2023;51(1):213-216. doi: 10.1017/jme.2023.58. Epub 2023 May 25.

DOI:10.1017/jme.2023.58
PMID:37226746
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.

摘要

欧盟委员会提出的利用可转让独占权凭证(TEVs)来解决抗微生物药物耐药性的建议存在根本性缺陷。欧洲政策制定者和监管机构应考虑其他替代方案,例如为基础和临床研究提供更好的资金、利用预付款制度的预付款市场承诺供资,或制定欧盟抗生素开发基金。

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引用本文的文献

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Transferable data exclusivity vouchers are not the solution to the antimicrobial drug development crisis: a commentary on the proposed EU pharma regulation.可转让数据独占性凭证并非解决抗菌药物研发危机的办法:对欧盟拟议药品法规的评论
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