美国抗生素研发激励政策及启示

Study on American incentive policies for antibiotic research and development and the inspirations

近年来全球抗生素研发趋势减缓,但因抗生素滥用严重,细菌耐药性正以惊人的速度发展,抗生素抗菌效力不断降低,世界逐步进入"后抗生素时代"。因研发新型抗生素有望从根本上缓解全球抗生素耐药和抗生素药物不足的危机,一些国家已采取积极的引导政策激励抗生素研发。本文介绍了美国的GAIN法案及抗生素相关的研发激励政策,评价其激励效果,总结经验与启示。我国应抓住抗生素产业转型升级的机遇,鼓励抗生素创新研发,为完善我国抗生素研发激励政策提出建议。

Recently,research and development（ RD） of antibiotics all over the world is slowing down.However,bacterial resistance is increasing at an alarming rate due to overuse and inappropriate utilization which contributes to the decline of antibacterial efficacy. The world is heading towards a post-antibiotic era. Recognizing that RD of antibiotics can ease the crisis of bacterial resistance and relieve the shortage of effective antibiotics radically,some countries have published positive policies. This article introduced Generating Antibiotic Incentives Now（ GAIN） Act and other policies which aim to stimulate RD of antibiotics in the United State,evaluated their effects,and summarized the experience and inspirations. Finally,it is recommended that we should seize the opportunity of industry transformation and upgrading and encourage antibiotic innovation. Suggestions are also provided for perfecting the incentive policies of RD in antibiotic domain.