Wells Nadya, Nguyen Vinh-Kim, Harbarth Stephan
Global Health Centre, Geneva Graduate Institute, Geneva, Switzerland.
Faculty of Medicine, University of Geneva, Geneva, Switzerland.
J Pharm Policy Pract. 2024 Dec 3;17(1):2430441. doi: 10.1080/20523211.2024.2430441. eCollection 2024.
An explosion in a Chinese factory in 2016 caused a global shortage of essential broad-spectrum antibiotic piperacillin-tazobactam. Hitherto, no detailed, policy-relevant analysis has been conducted on this major shortage event. Thus, we aimed to (1) investigate causes; (2) describe supply chain challenges; and (3) uncover policy gaps to support possible mitigation actions.
Applying an analytical framework for security of medical supply chains, we investigated the changing roles of Pfizer-led and Chinese API suppliers. We identified demand surge, capacity reduction and co-ordination failures. Triangulating between scientific literature, corporate, and regulatory documents, we analysed the impact of Western and Chinese policy contexts on supply chain resilience.
We uncovered 'red flags': geographically dispersed manufacturing failures due to complexity of sterile production; undetected supply chain concentration and interlinkages; and Chinese policy-led API supplier consolidation. We found these warning signals were ignored in the absence of a co-ordinated policy framework to identify and mitigate emerging global supply risks. Firstly, policy makers lacked visibility on growing 'volume dependency' in the chain. Secondly, national policy makers lacked a global view of supply risk. Thirdly, we show antibiotic API manufacturing economics were impacted by a number of non-pharmaceutical policy decisions (e.g. state aid, environmental standards, procurement rules) which contributed to supply chain vulnerability.
Our findings suggest possible policy gaps in governance of supply chain resilience. Firstly, disclosure of API suppliers including degree of dependency may better pre-empt bottlenecks, facilitating priority setting for public investments in re-shoring where global API supply currently relies on few, or single plants; secondly, a whole-of-government approach may counter the potential impact of non-pharmaceutical policies on supply chain resilience. Our findings confirm suggestions from previous studies that international data sharing would be beneficial considering the global shortage effects which can emerge from a single point of failure.
2016年中国一家工厂发生爆炸，导致广谱抗生素哌拉西林-他唑巴坦全球短缺。迄今为止，尚未针对这一重大短缺事件进行详细的、与政策相关的分析。因此，我们旨在：（1）调查原因；（2）描述供应链挑战；（3）找出政策差距，以支持可能的缓解措施。
应用医疗供应链安全分析框架，我们调查了辉瑞主导的供应商和中国原料药供应商角色的变化。我们确定了需求激增、产能下降和协调失败等问题。通过对科学文献、企业文件和监管文件进行三角互证，我们分析了西方和中国政策背景对供应链弹性的影响。
我们发现了“危险信号”：由于无菌生产的复杂性导致生产故障在地理上分散；未被发现的供应链集中化和相互联系；以及中国政策主导的原料药供应商整合。我们发现，在缺乏协调一致的政策框架来识别和缓解新出现的全球供应风险的情况下，这些警示信号被忽视了。首先，政策制定者对供应链中日益增长的“数量依赖”缺乏了解。其次，国家政策制定者缺乏对供应风险的全球视野。第三，我们表明抗生素原料药制造的经济性受到一些非制药政策决定（如国家援助、环境标准、采购规则）的影响，这些决定导致了供应链的脆弱性。
我们的研究结果表明，在供应链弹性治理方面可能存在政策差距。首先，披露原料药供应商，包括依赖程度，可能更好地预先防范瓶颈，便于确定公共投资于回迁生产的优先顺序，因为目前全球原料药供应依赖少数工厂或单一工厂；其次，政府整体应对方法可能抵消非制药政策对供应链弹性的潜在影响。我们的研究结果证实了先前研究的建议，即考虑到单点故障可能产生的全球短缺影响，国际数据共享将是有益的。
