Shortages of medicines are a global issue and a critical public health challenge that is at the top of the agenda of EU policymakers, regulators and healthcare providers. The World Health Organization (WHO) and various health authorities worldwide have acknowledged the growing problem of medicine shortages, which have been affecting high-income, middle-income, and low-income countries. Shortages can affect any medicine (prescription and non-prescription) with a significant impact on patient care. Shortages can lead to medicine rationing and delay of critical treatments and can require patients to use alternatives which may be less efficacious or may increase the risk of medication errors due to unfamiliarity with the new regimen. In some cases, an absence of alternatives can mean that patients cannot be treated, and their disease may progress or worsen.
Many factors contribute to shortages, including supply chain disruptions, due to manufacturing or quality issues, regulatory issues, natural disasters, geopolitical conflicts. Other factors leading to shortages include rising demand and economic factors or the withdrawal of a product from the market by the marketing authorization holder. Shortages are not unique to the pharmaceutical sector, they are also a concern in other industries such as the microchip industry, the construction industry, the automotive industry, and the energy trade (1). In the EU, policymakers, regulators and healthcare providers are working to develop effective strategies to prevent and manage medicines shortages, as a matter of priority. The EMA/HMA taskforce on availability of authorised medicines for human and veterinary use (TFAAM, the “taskforce”) was set up in 2016 for this purpose and has now reached the end of its mandate in facilitating the prevention, identification, management and communication of shortages. Its work is being integrated into EMA and HMA’s core activities, and we therefore take the opportunity to reflect on the work completed by the taskforce. This reflection highlights the challenges overcome through close collaboration and the strategies and regulatory approaches developed, which will shape future EU efforts in addressing medicine shortages and improving public health.
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https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1673681/full