Managing pharmaceutical shortages during the COVID pandemic: An exploratory analysis of European collective and national government responses.

Prior to the outbreak of the COVID pandemic, pharmaceutical shortages were already recognised as a major policy problem by most, if not all, European governments; and virtually all European national governments today publicise official shortage lists. Policy making in the area has been centred on the national government level, which meant that the understanding, definition, and response to shortages has remained highly heterogeneous. When the advent of the COVID pandemic exacerbated shortages, this situation continued against a background of a weak collective European response. As part of their responses to COVID-shortages, the medicines regulators of European countries expanded the range of products pharmacies could manufacture, process and distribute as well as their procedural authority in issuing, handling and processing prescriptions. While these measures were fairly common across Europe and alleviated some bottlenecks or improved medicine access for some patient groups, other responses were highly individualistic and included export bans of certain medications as well as efforts to draw on veterinary supplies. Our own data analysis of officially recorded shortage data during the first COVID wave (to October 2020) indicates that countries that had prepared for these types of crisis and maintained an active policy stance (e.g. Germany and Norway) were more likely to encounter fewer shortages than others. We also note that there is no direct correlation between officially recorded numbers of shortages and the ways in which national governments responded to these - which indicates that cultural expectations also might have been a significant policy driver.

How to address medicines shortages: Findings from a cross-sectional study of 24 countries.

Shortages of medicines have become a major public health challenge. The aim of this study was to survey national measures to manage and combat these shortages. A questionnaire survey was conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network. Reponses relating to measures as of March / April 2020 were received from 24 countries (22 European countries, Canada and Israel). In 20 countries, manufacturers are requested to notify - usually on an obligatory basis - upcoming and existing shortages, which are recorded in a register. Further measures include a regular dialogue with relevant stakeholders (18 countries), financial sanctions for manufacturers in cases of non-supply and/or non-compliance with reporting or stocking requirements (15 countries) and simplified regulatory procedures (20 countries). For defined medicines, supply reserves have been established (14 countries), and legal provisions allow the issuing of export bans (10 countries). Some measures have been introduced since the end of 2019 and countries are planning and discussing further action. While governments reacted by taking national measures, the COVID-19 crisis might serve as an opportunity to join forces in cross-country collaboration and develop joint (e.g. European) solutions to address the shortage issue in a sustainable manner. A practical first step could be to work on a harmonisation of the national registers.