Viewpoint
Thailand in 2011 puts factories producing 43% of the world’s hard disk drives underwater, reducing produc- tion of personal computers for months and reducing global industrial output by 2.5%. 12 The ability to manufacture products is also threat- ened by shortages of inputs, whether of raw resources or component parts. Input shortages may result from tightly coupled production arrangements, which limit inventory or increase complexity. 13 The severity of a shortage depends on the input’s ‘criticality’, including its importance and the availability of potential substi- tutes or other mitigation strategies. 14 Production vulnerabilities during the COVID-19 pandemic partly reflect drastically elevated demand, such as for PPE. 3 But production vulnerabilities can arise even with normal demand, especially when production is geographically concentrated, as with medical gloves and generic drug manufacture in India. 15 Moreover, the lean nature of the medical products industry is likely to challenge the capacity to produce sufficient quantities of any therapeutics that are shown to be effective in treating the disease. 16 Other threats to local product availability Even when manufacture occurs normally, multiple vulnerabilities can reduce availability of the right product in the right place (table 2). Lengthy trans- portation routes can prove fragile in times of need. 17 Additional challenges arise where companies fail to comply with the regulatory requirements that aim to reduce the risk of flawed products (eg, from the US Food and Drugs Administration or European Medi- cines Agency). 18 Conversely, inadequate regulatory arrangements can mean that available products are unsafe or product shortages are unexpected. 8 Vulnerabilities affecting the availability of products during the COVID-19 pandemic have included move- ment limitations due to the reduction of international transportation capacity as well as the imposition of border controls and export restrictions, as countries prioritised the needs of their own citizens over those of international clients. 19 Further, those charged with sourcing products have been exposed as ill-prepared. Few had sourced supplies with a view to long-term resilience (eg, by favouring reusable products or domestic suppliers), managed PPE as a critical sector requiring vendor monitoring and risk management, or maintained supplies sufficient to avoid stockouts and shortages, including of goods such as generic drugs, for which demand has not been markedly elevated. 20 21 Reactive and proactive solutions for medical product shortage Shortages during the COVID-19 crisis have forced reactive adaptations. For clinicians, this has included shifts in normal standards of PPE use, such as extended use (eg, wearing the same PPE for encounters with different patients), reuse after sterilisation, alternative
products (eg, positive pressure airflow helmets rather than N95 respirators) and even non-use. 22 The health and safety risks such reactive changes have created remain unclear. But shifts in policy on PPE use have challenged healthcare professionals’ trust in system leaders and governments. 23 For healthcare adminis- trators, product shortages make sourcing efforts much more complex. Many have had to deal with unknown and sometimes fraudulent suppliers or compete with other care delivery organisations for needed supplies, with concerning implications for care quality and equi- table access. 24 Virtually all have faced increased costs as well as operational, legal or reputational risks. 25 To an important extent, reactive efforts by clini- cians and administrators have been made necessary by pandemic planning policy failures. Many health systems had not built or adequately sustained national or regional stockpiles. Many agencies tasked with coordinating national or regional joint procurement efforts lacked capacity. Much of the information infrastructure needed to fairly allocate supplies to users across countries or regions has proven insuf- ficient. 26 27 And the pandemic has again exposed the weakness of market access regulation with respect to manufacturers’ obligations to notify about, or provide assurances of, reliable and quality supply. 28 Yet while necessary, more effective pandemic plan- ning will not be a sufficient response. The underlying causes of supply chain vulnerability are not specific to the pandemic. They include the economic and regu- latory arbitrage that lead brand name manufacturers to restrict generic competition, generic manufacturers to discontinue (or underinvest in) less profitable product lines, product supply chains to metastasise into complex networks of global manufacture and transport, and healthcare buyers to undervalue resil- ient supply. Importantly, the pandemic has increased experimen- tation with proactive solutions, some of which take aim at these systemic challenges. The most promising, in our view, include increased interest in medical prod- ucts that can be reused or repurposed, alongside the free and open-source hardware principles that support distributed and locally responsive refurbishment and manufacturing. Such experimentation has been most notable for PPE, often driven by front-line clinicians. 29 For more complex medical products, such as therapeu- tics or vaccines, governments and international agen- cies have experimented with ways to ensure adequate manufacturing capacity. This includes coordinated global strategies, such as advance market commitments for novel vaccines, 30 and the turn to enhanced domestic manufacturing and reduced dependence on limited suppliers of critical inputs for pharmaceuticals. 31 Less prominent but not absent have been challenges to the intellectual property rights that protect companies’ monopoly control and high prices, through efforts to create global technology access pools and national
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Miller FA, et al . BMJ Qual Saf 2021; 30 :331–335. doi:10.1136/bmjqs-2020-012133
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