Regulation on Critical Medicines to Reduce the EU’s Dependencies

The European Union is facing a severe shortage of medicines, with access to essential products such as antibiotics, insulin, painkillers, and others becoming increasingly difficult. China and India have emerged as the primary suppliers, creating vulnerabilities and contributing to supply shortages.

The concentration of manufacturing facilities outside the EU raises concerns about the security of supply within the Union, putting the health and well-being of citizens at risk.

The growing dominance of production of raw materials, intermediates, and active pharmaceutical ingredients (APIs) outside the EU, combined with the COVID-19 pandemic and the war in Ukraine, has already led to severe disruptions in supply chains.

Medicine shortages persist, and recent developments in the international order call for the European Union to take even stronger measures to ensure the strategic production of these essential medicines and secure the necessary financial instruments to support this effort.

The root causes of medicine shortages are multifaceted, with challenges identified throughout the entire pharmaceutical value chain, ranging from quality and manufacturing issues to the competitiveness of the industry.

EU Member States, the European Parliament, and other stakeholders have consistently called on the European Commission to address these vulnerabilities, particularly by strengthening the supply chains for these critical medicines.

In response to this situation, the European Commission will propose a Regulation on Critical Medicines aimed at reducing the EU’s dependency on third countries for the production of medicines and the necessary APIs. The proposal is expected to introduce a set of measures designed to address vulnerabilities in the supply chain for medicines and critical ingredients. In this context, the European Economic and Social Committee has already recommended that the EU adopt a series of measures to strengthen its pharmaceutical manufacturing capacity.

Key Measures Include:

• Establishing a new European mechanism to support the production of APIs and finished medicines in Europe.
• Encouraging the development of innovative manufacturing technologies.
• Promoting the use of APIs and finished medicines produced in Europe.
• Adopting fair pricing mechanisms.

Overall Objectives of the Proposal:

• Address supply chain vulnerabilities and reduce the EU’s dependencies to strengthen the supply of critical medicines.
• Increase the availability of other medicines of common interest.

This proposal will complement the broader reform of the pharmaceutical sector and will be based on the work of:

• The Executive Steering Group on Shortages and Safety of Medicinal Products.
• The Structured Dialogue on the Security of Medicine Supply.
• The Alliance for Critical Medicines.
• A support study.

Our team is at your disposal for further information.