Theuretzbacher Ursula, Årdal Christine, Harbarth Stephan
Center for Anti-Infective Agents, Vienna, Austria.
Norwegian Institute of Public Health, Oslo, Norway.
Infect Dis Rep. 2017 Mar 30;9(1):6836. doi: 10.4081/idr.2017.6836.
There is now global recognition that antibiotic resistance is an emerging public health threat. Policy initiatives are underway to provide concrete suggestions for overcoming important obstacles in the fight against antibiotic resistance, like the alarming current paucity of antibacterial innovation. New economic models are needed as incentives for the discovery and development of novel antibacterial therapies especially for infections with too few patients today to justify private sector research and development (R&D) investments. These economic models should focus on rewarding the innovation, not the consumption of the antibiotic since sustainable use policies will reduce selection pressure and slow the emergence of resistance. To effectively stimulate greater innovation, the size of the reward must be commensurate with revenues from other therapeutic areas, estimated at about a billion dollar total pay-out. Otherwise R&D investment will continue to move away from antibiotics to areas where returns are more attractive. A potential sizeable public investment, if implemented, must be protected to ensure that the resulting antibiotics have a lengthy and positive impact on human health. Therefore, public investments in innovation should be bound to sustainable use policies, , policies targeted at a range of actors to ensure the preservation of the novel antibiotics. These policies would be targeted not only at the innovating pharmaceutical companies in exchange for the reward payments, but also at governments in countries which receive the novel antibiotics at reasonable prices due to the reward payment. This article provides some suggestions of sustainable use policies in order to initiate the discussions. These are built on planned policies in the US, EU, WHO and have been expanded to address and environmental aspects to form approaches. While further discussion and analyses are needed, it is likely that strong sustainable use policies will help to protect the sizeable public health investments.
现在全球都认识到抗生素耐药性是一个新出现的公共卫生威胁。正在采取政策举措，为克服抗击抗生素耐药性方面的重大障碍提供具体建议，比如当前令人担忧的抗菌创新匮乏问题。需要新的经济模式来激励新型抗菌疗法的发现和开发，特别是针对目前患者数量过少以至于私营部门研发投资无利可图的感染。这些经济模式应侧重于奖励创新，而非抗生素的使用，因为可持续使用政策将减少选择压力并减缓耐药性的出现。为了有效刺激更多创新，奖励规模必须与其他治疗领域的收入相称，估计总支出约为十亿美元。否则，研发投资将继续从抗生素领域转向回报更具吸引力的领域。如果实施，潜在的大量公共投资必须得到保护，以确保由此产生的抗生素对人类健康产生长期积极影响。因此，对创新的公共投资应与可持续使用政策挂钩，即针对一系列行为体的政策，以确保新型抗生素得到保存。这些政策不仅应针对创新制药公司以换取奖励支付，还应针对那些因奖励支付而能够以合理价格获得新型抗生素的国家政府。本文提供了一些可持续使用政策的建议，以引发讨论。这些建议基于美国、欧盟、世界卫生组织的计划政策，并已扩展到涵盖环境方面，形成综合方法。虽然还需要进一步讨论和分析，但强有力的可持续使用政策很可能有助于保护大量的公共卫生投资。
