Tackling medicine shortages during and after the COVID-19 pandemic: Compilation of governmental policy measures and developments in 38 countries

Countries all over the world, including high-income countries in Europe, have been experiencing increases in temporary and permanent non-availability of medicines, commonly referred to as shortages [1], [2], [3], [4], [5], [6], [7], [8], [9]. Already before the COVID-19 pandemic, the number of medicine shortages reported had reached unprecedented levels in several high-income countries in the last decade (e.g., Canada [10], Finland [11], France [12], Switzerland [13]). For 2019, a European Commission study surveyed more than 6,633 shortage notifications (relating to nearly 3,000 medicines) in Portugal and over 4,800 notifications (1,630 products) in the Netherlands [7]. In COVID-19 times, in particular in the early months of the pandemic, increases in shortages of medicines, including those needed to treat COVID-19 symptoms, were reported [14], [15], [16], [17], [18], [19], [20]. The extent of medicine shortages remained high in the course of the years: for instance, in the Northern hemisphere winter 2022/2023, several countries faced shortages of “basic medicines” for the treatment of respiratory tract infections, including paediatric formulations, over several months [21], [22], [23].

Data agree in documenting substantial increases in notified shortages over the last decade (however, with a decrease in 2021 compared to the previous year but resulting in another increase in 2022 at higher levels than in 2020) [24], [25], [26], [27], which may also be attributable to stricter reporting requirements [1,7,12,13]. However, the magnitude of shortages (and increases in shortages) cannot be compared across countries. This is due to a lack of a harmonised definition and counting methodology for reporting shortages (see Acosta et al. 2019 [28], a 2022 OECD study [1] and the annex in Vogler and Fischer 2020 [29] for an overview of national definitions for a medicine shortage).

In some cases, therapeutic alternatives might be identified for the medicine in short supply, so that a supply chain disruption does not compromise patient access to medicines. The German language provides for a distinction between a “Lieferengpass” (interruption in the normal volume of supply over a defined period of time) and a “Versorgungsengpass” (a treatment shortage resulting from a shortage in supply) [30]. Such treatment shortages pose risks which endanger patient health [31], [32], [33]. Adding to negative impacts on clinical health outcomes for patients, medicine shortages also have economic implications, since they were found to increase costs, due to the need to purchase more expensive alternatives or due to additional costs incurred for health professionals and the health system to manage medicine shortages [13,34,35]. Evidence shows that health care providers have been investing relevant parts of their working time to secure needed medications for patients, e.g., by identifying and procuring alternatives [2,36]. Most recent data of the annual survey of European community pharmacy association with responses from 29 countries indicated that in 2022 community pharmacy staff spent on average 6.68 hours per week on dealing with medicine shortages, and these figures had increased compared to previous years [37].

A variety of supply-side and demand-side related root causes, which may occur simultaneously, are responsible for the non-availability of medicines. They include quality problems in the production, global concentration of production sites for active pharmaceutical ingredients (API), disruptions in the transportation and business strategies by suppliers as well as increased demand due to higher incidence of some diseases as observed during the COVID-19 pandemic and in the winter season 2022/2023 when other infections had increased [1,7,13,32,38].

In light of the urgency for action, policy-makers, staff in public administration, health care providers and further experts are interested in learning about policies that other countries have been applying. Some studies provided cross-country overviews of policy measures to address medicine shortages [1,7,28,29,39]. However, these publications took stock of policies which were in place before or at the beginning of the COVID-19 pandemic. A systematic update on more recent measures is, to our best knowledge, not available.

Against this backdrop, this article maps governmental policy measures to manage and mitigate medicine shortages in mostly high-income countries in 2023. Additionally, it explores the developments and changes in national policy approaches during the years of the COVID-19 pandemic. The study investigates a larger number of countries, including those European countries which are less in the focus of public attention and less covered in scientific research (e.g., smaller and/or less resourced countries).

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