Legislative Analysis of the European Union's Response to Public Health Emergencies

ABSTRACT: Although the European Union has long faced the problem of shortages of medicines in recent years, both due to increased global demand and the COVID-19 pandemic, the problem has worsened exponentially. The shortage of medicines is a growing threat to public health, with a serious negative impact on health systems and on the right of every patient in the EU to have access to appropriate medical treatment. The COVID-19 pandemic has highlighted the importance of a smoothly functioning internal market and strong supply chains for medicines and medical equipment, as well as EU dependence on third countries in the health sector, given that 40% of finished medicines marketed in the EU come from third countries. Although Europe has a large production capacity, the supply chain still depends to a large extent on non-EU subcontractors for the production of active substances, where labor costs and environmental standards are often lower (60 to 80% of the active chemicals in medicines are produced outside the EU, mainly in China and India). In this context, this article aims to examine the legislative measures taken at the EU level to prepare for crisis situations in the field of medicines, mitigate shortages of medicinal products, and improve the security of supply.

KEYWORDS: EU legislation, shortages of medicinal products, public health emergencies, COVID-19 pandemic, medical devices