Anderson Michael, Panteli Dimitra, van Kessel Robin, Ljungqvist Gunnar, Colombo Francesca, Mossialos Elias
Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
European Observatory on Health Systems and Policies, Brussels, Belgium.
Lancet Reg Health Eur. 2023 Jul 26;33:100705. doi: 10.1016/j.lanepe.2023.100705. eCollection 2023 Oct.
Antimicrobial, and particularly antibiotic resistance are one of the world's biggest challenges today, and urgent action is needed to reinvigorate the antibiotic development pipeline. To inform policy discussions during and after the 2023 Swedish Presidency of the Council of the European Union, we critically appraise incentive options recently proposed by the European Commission, and member states, and consider what has been achieved over the last two decades in relation to antibiotic research and development. While several new antibiotics have achieved regulatory approval in recent years, almost none have innovative characteristics such as new chemical classes or novel mechanisms of action. We consider four incentive options to incentivise research and development of new antibiotics, including subscription payments, market entry rewards, transferable exclusivity extensions, and milestone payments. While each option has advantages and drawbacks, a combination of incentives may be required and continued investment is needed by the EU in push incentives, such as direct funding and grants, to incentivise drug discovery and preclinical stages of development. The EU must also coordinate with international initiatives and support access to new and pre-existing antibiotics in LMICs through platforms such as the WHO, and G7 and G20 group of countries.
抗菌耐药性，尤其是抗生素耐药性，是当今世界面临的最大挑战之一，需要采取紧急行动来重振抗生素研发渠道。为了为2023年瑞典担任欧盟理事会轮值主席国期间及之后的政策讨论提供参考，我们批判性地评估了欧盟委员会和成员国最近提出的激励措施选项，并考量了过去二十年在抗生素研发方面所取得的成果。尽管近年来有几种新抗生素获得了监管批准，但几乎没有一种具有新化学类别或新作用机制等创新特性。我们考量了四种激励新抗生素研发的选项，包括订阅付款、市场准入奖励、可转让的排他性延期以及里程碑付款。虽然每个选项都有优缺点，但可能需要多种激励措施相结合，而且欧盟需要继续投资于推动性激励措施，如直接资助和拨款，以激励药物发现和临床前研发阶段。欧盟还必须与国际倡议进行协调，并通过世界卫生组织、七国集团和二十国集团等平台，支持低收入和中等收入国家获取新的和现有的抗生素。
