The shortages of inexpensive essential medicines are a growing public health emergency that requires concerted and collaborative action at EU level.
While there is a clear impact of shortages on patient outcomes, their causes are complex and multifactorial and cannot be solved by any Member State alone.
The situation can be particularly devastating for cancer patients, as the medicines affected by shortages often have few or no proven effective alternatives, and shortages negatively impact both the health of European citizens and the sustainability of the healthcare systems.
In 2023, the European Commission has published the first ‘Union list of critical medicines’, together with the European Medicines Agency (EMA) and the Member States’ Heads of Medicines Agencies (HMA).
The current list is the outcome of the first phase, which comprised a review of 600 active substances, including all products listed as ‘essential’ by the World Health Organization (WHO), and combinations of active substances identified as critical in existing national lists of critical medicines (Finland, France, Germany, Portugal, Spain and Sweden). This first Union list of critical medicines contains more than 200 active substances used in human medicines, including 35 antineoplastic medicines, which are considered essential in the EU/EEA. Below is reported the timeline of the next steps.
Additionally, ESMO has joined the Critical Medicines Alliance, a consultative mechanism which brings together all relevant stakeholders, to identify priorities for action and propose solutions to strengthen the supply of critical medicines in the EU, to prevent and combat their shortages. This initiative is therefore important to complement ESMO’s efforts related to the identification and inclusion of cancer medicines that are currently missing on the first version of the EU’s Critical Medicines List. The ESMO representative in the Alliance is the Chair of the ESMO Cancer Medicines Committee.
To address the frequent lack of medicines, ESMO has produced several reports and a call to action.
- Cancer medicines shortages in Europe: Policy recommendations to prevent and manage shortages in 2017
- Call to Action in 2019, requesting the EU to make a political commitment to tackle inexpensive essential medicines shortages.