In March 2025, the European Commission proposed new legislation called the Critical Medicines Act (CMA). Its main goals are straightforward: to strengthen the availability and security of supply of critical medicines in the EU, and to ensure fair access to vital medicines through coordinated action at EU and national levels.

For people with CF, medicine shortages can be life-threatening or generate irreversible health damage. The CMA is the EU’s answer to the growing problem of supply disruptions and shortages.

Why Is the Critical Medicines Act Needed?

Europe has faced an increasing number of shortages of medicines, including life-saving drugs. These shortages are caused by:

  • Heavy dependence on a small number of suppliers outside the EU
  • Global supply-chain disruptions
  • Limited European production of active substances and raw materials

The COVID-19 pandemic exposed how fragile medicine supply chains can be. The CMA is designed to make Europe better prepared, more independent, and more resilient.

What Will Actually Change

The CMA introduces the following key instruments to address Europe’s vulnerability and dependency:

Strategic Manufacturing Projects in Europe

The CMA supports industrial projects that build or modernize factories in the EU to produce critical medicines and ingredients. These projects can benefit from faster regulatory procedures, financial incentives, and access to EU funding. This aims at keeping production closer to patients.

Financial Incentives for Supply Security

Member States will be encouraged to prioritize funding for projects that reduce medicine shortages, guided by a new EU coordination body.

Smarter Public Procurement

Public authorities will no longer choose suppliers only based on price, but they also must consider supply security, sustainability, and reliability. They may even favor EU-based producers if supply risks are high. Countries must also ensure transparent emergency stockpiles.

Joint EU-Level Procurement

The European Commission will be able to organize joint purchasing of medicines between countries, building on the successful vaccine purchases during COVID-19. This can help reduce inequalities in access between countries.

A New EU Coordination Body

A Critical Medicines Coordination Group will bring together the European Commission and national authorities to:

  • Monitor supply vulnerabilities
  • Coordinate procurement strategies
  • Advise on priority manufacturing investments

International Cooperation

The EU will also seek strategic partnerships with non-EU countries to diversify supply chains and avoid new dependencies.

Next Steps

On December 2, 2025, the Council adopted its position on the CMA. Key elements of the Council’s position include:

  • A stronger requirement for transparency of contingency stockpiling and supply-chain information
  • Public procurement rules that prioritize resilience over price, meaning tendering should consider supply security and sustainability, not just cost
  • Easier collaborative procurement: the minimum number of Member States needed to start a joint procurement was lowered from nine to six, making collaborative procurement more feasible
  • Clarity on “Strategic Projects” and support mechanisms for boosting EU manufacturing capacity for critical medicines or ingredients

The next step is for the European Parliament to adopt its own position. Once both the Council and Parliament have defined their positions, inter-institutional negotiations will begin to agree on the final text of the regulation. At that point, the CMA may start being implemented. The anticipated first implementations could begin as early as 2026–2027.

What Does This Mean for People with CF?

For the CF community, and depending on its implementation, the CMA could become a major step forward as it strengthens protection against shortages of medicines, supports fairer access across all EU countries, and helps ensure that patients are not left without treatments due to global supply disruptions.

The CMA also represents a strong political commitment to protect patients across Europe and opens new opportunities for CF Europe and its members to advocate for CF medicines to be considered “critical,” including antibiotics, mucolytics, pancreatic enzymes, and CFTR modulators. The CF community could officially call on the EU and national decision-makers to ensure that the needs of people with CF are fully reflected in the implementation of the CMA and call for formal recognition of CF medicines as “critical medicines.”

How Does This Relate to the WHO Essential Medicines List?

It’s worth noting that CF Europe has also advocated for CFTR modulators to be added to the WHO Essential Medicines List, which occurred recently. While both initiatives aim to improve medicine access, they operate at different levels. The WHO Essential Medicines List provides global guidance on which medicines should be prioritized in health systems worldwide, while the CMA is an EU regulatory framework focused specifically on preventing and managing shortages within Europe. The two initiatives are complementary: WHO recognition helps establish the importance of these medicines globally, while the CMA provides concrete mechanisms to protect their supply within the EU.

CF Europe will closely follow the development of this legislation and work to ensure that people with CF are protected from future shortages.