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Policy to encourage the development of antimicrobials

机译：鼓励发展抗菌素的政策

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Purpose - Antimicrobial resistance is a public health threat even in countries exercising aggressive antimicrobial stewardship. A market failure is also causing lackluster innovation in antimicrobial medicines development. At the heart of the issue are antimicrobial stewardship guidelines that, rightfully, reserve innovative antimicrobials for emergency situations that arise due to multidrug-resistant organisms. This suppresses revenues and research and development (R&D) investment incentives of manufacturers. The public policy makers and researchers have taken aim at the problem. The researchers have published strategies to encourage the production of innovative antimicrobials, while policy makers have taken legislative steps to address the issue. Most notably, the USA enacted the Generating Antibiotic Incentives Now (GAIN) act in 2012 and the EU created a commission to formally study possible policy solutions. The paper aims to discuss these issues. Design/methodology/approach - In this paper, the authors describe incentives that drive pharmaceutical R&D and review the impact of a number of R&D stimulus policies in other pharmaceutical markets. The authors also discuss which policy levers are useful to boost R&D of new antimicrobials. Findings - The authors find that a policy focused on extending intellectual property rights, as implemented in the GAIN act, are unlikely to be impactful. Instead, the authors see a need for the revision of the procurement policy to move away from paying per prescription and toward licenses and advanced market commitment models. Further, the authors note that the importance of steadfast public investment in basic biomedical research as it has been repeatedly shown to boost innovation. Originality/value - The authors hope that the work can support the refinement of the GAIN act and the EU efforts.
机译：目的-即使在行使积极抗菌管理的国家中，抗菌素耐药性仍然是公共卫生威胁。市场失灵也导致抗微生物药物开发方面的创新乏善可陈。问题的核心是抗菌素管理准则，该准则理应为因多药耐药性生物体引起的紧急情况保留创新的抗菌素。这抑制了制造商的收入和研发（R＆D）投资激励。公共政策制定者和研究人员已针对该问题。研究人员发表了鼓励生产创新型抗菌剂的策略，而政策制定者已采取立法措施解决了这一问题。最值得注意的是，美国于2012年颁布了《立即生成抗生素激励措施》（GAIN）法案，欧盟成立了一个委员会来正式研究可能的政策解决方案。本文旨在讨论这些问题。设计/方法/方法-在本文中，作者描述了推动药品研发的激励措施，并回顾了许多研发刺激政策对其他药品市场的影响。作者还讨论了哪些政策杠杆可用于促进新抗菌素的研发。调查结果-作者发现，按照GAIN法案实施的，旨在扩展知识产权的政策不太可能产生影响。相反，作者认为有必要修改采购政策，以从按处方付费转变为许可证和高级市场承诺模型。此外，作者还指出，在基础生物医学研究中坚持不懈地进行公共投资的重要性已得到反复证明，以促进创新。原创性/价值-作者希望该工作能够支持GAIN法案的完善和欧盟的努力。

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