In a bid to tackle the persistent issue of medicine shortages amplified by the COVID-19 pandemic and supply chain disruptions, the European Commission has introduced a series of short-term measures. These measures aim to ensure a continuous supply of pharmaceuticals during the upcoming winter months while the EU works on an extensive reform of pharmaceutical regulations and a more integrated health union.
The COVID-19 pandemic laid bare significant vulnerabilities in the European Union’s pharmaceutical supply chain. Countries across the EU encountered shortages of critical medications as the virus spread, emphasizing the need for a more resilient system. To address this, the European Commission proposed its first major overhaul of pharmaceutical regulations in April, with the goal of creating a health union capable of effectively handling such crises.
A significant short-term measure is the introduction of a voluntary mechanism designed to facilitate cooperation between member states in mitigating medicine shortages across the European Union. Under this scheme, member states can communicate their urgent requirements for medicines currently facing critical shortages. This information is then shared with other member states, allowing them to indicate the availability of surplus stock that can be redistributed to address the shortage. This system ensures that essential medicines reach those in need promptly.
This initiative directly tackles the issue of uneven medication distribution within the EU, where some nations may have surplus medications while others face shortages. The voluntary mechanism promotes cooperation and equity, enabling a more balanced distribution of vital pharmaceuticals. Furthermore, it fosters solidarity among EU member states, reinforcing the notion of a united health union.
Anticipating the challenges of the upcoming winter season in 2024-2025, the European Commission is considering the implementation of a joint buying scheme for antibiotics and medicines used to treat specific respiratory illnesses. The winter months typically exert additional pressure on healthcare systems due to the higher incidence of flu and respiratory infections, making it essential to have an adequate supply of relevant medications.
The collaborative approach sought through the joint buying scheme aims to reduce the risk of shortages in these crucial categories of drugs, offering a preventive solution to potential crises. It allows member states to pool resources and collectively procure these medications, ensuring a stable and sufficient supply during the winter months when demand typically surges.
The European Medicines Agency (EMA), in collaboration with member states, is in the final stages of compiling a list of critical medicines. Several EU member states, including Belgium, France, Spain, and Germany, have called for this list to improve the security of supply. The list is expected to be finalized by the year-end, marking a significant step in identifying and prioritizing medicines of the highest public health importance.
Upon the completion of this list, each medication will undergo a vulnerability assessment to determine the specific measures needed to ensure a continuous and reliable supply of these critical medicines. Subsequently, the European Commission will engage in discussions with the pharmaceutical industry to boost production and enhance the EU’s resilience against potential shortages.
Over recent decades, the European Union has become heavily reliant on India and China for generic medicines and essential pharmaceutical ingredients. This dependency developed due to concerns about high pollution levels within the EU, which led to the offshoring of production. In response to these vulnerabilities, the EU is planning to establish a Critical Medicines Alliance in early 2024, acting as a precursor to a comprehensive Critical Medicines Act.
The Critical Medicines Alliance will concentrate on reshoring pharmaceutical production within the EU, diversifying sources of key ingredients, coordinating stockpiling efforts, and establishing pre-reserved production capacity for emergencies, such as the COVID-19 pandemic. This multifaceted approach aims to secure the EU’s pharmaceutical supply chain and protect public health by reducing the risk of future medicine shortages.