Fostering a competitive environment through the Critical Medicines Act
News
10 Mar 2025
Healthcare
Fostering a competitive environment through the Critical Medicines Act

Securing robust and diversified life sciences supply chains is essential for Europe to maintain a continuous and stable provision of medical products, both domestically and globally, especially during crises. Today, the European Commission presented the Critical Medicines Act, which represents a vital opportunity to achieve this goal by: ensuring the continued functioning of open global supply chains to deliver timely patient access; promoting collaboration with international partners and all stakeholders to improve global supply chain flexibility, diversification and resilience; strengthening open trade in life sciences and avoiding restrictive or protectionist measures, which could negatively impact production, supply resilience and availability. 

The Critical Medicines Act addresses structural challenges including the competitiveness of medicine production and medicine shortages by focusing on the overall attractiveness of the market and framework conditions. It supports European-wide harmonisation efforts while enabling a diversified global network by removing trade barriers and promoting international collaboration.  

However, the American Chamber of Commerce to the EU (AmCham EU) is concerned about the restrictive localisation strategies included in the proposal, which risk undermining the resilience of Europe’s healthcare systems. Instead, regulatory action should reinforce globally diversified supply chains by bolstering competitiveness, leveraging the EU's track record in industrial policy and implementing systematic market reforms that encourage global partnerships.  

For sustainable access to critical medicines, policymakers must enhance global supply chain flexibility, avoid protectionism and create an attractive environment for life sciences innovation and manufacturing in Europe. Detailed recommendations can be found in AmCham EU's position paper, Ensuring resilient life sciences supply chains in Europe

Related items

News
20 May 2026

Healthcare, competitiveness, innovation and simplification

Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation. 

The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment. 

The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains. 

Healthcare
Simplification
Read more
Read more about Healthcare, competitiveness, innovation and simplification
Position Paper
19 May 2026

Strengthening EU competitiveness through an adaptive MDR/IVDR framework

Healthcare
Read more
Read more about Strengthening EU competitiveness through an adaptive MDR/IVDR framework
Position Paper
19 May 2026

A global approach to strengthening Europe’s biotechnology ecosystem

Healthcare
Read more
Read more about A global approach to strengthening Europe’s biotechnology ecosystem