The European Commission’s proposal for a Critical Medicines Act marks a significant step toward securing the supply, availability, and accessibility of essential medicines across the EU. For patients with digestive cancers, who rely on a steady and timely supply of life-saving treatments, this proposal is both promising and concerning.

A Step in the Right Direction

The Act correctly highlights the need to reduce geopolitical dependencies on medicine supply chains and reinforce EU-based production. Digestive cancer patients, particularly those with rare cancers or advanced-stage diseases, are often vulnerable to supply chain disruptions. A stronger, more resilient system is necessary to prevent treatment delays that could negatively impact survival and quality of life.

We welcome the Act’s emphasis on joint procurement mechanisms and public procurement criteria beyond just pricing, which could help avoid medicine shortages and ensure more sustainable access to essential drugs. This is particularly relevant for chemotherapy, targeted therapies, and supportive care medicines, where shortages can have severe consequences.

Gaps That Must Be Addressed

While the proposal takes positive steps, there are critical gaps that must be filled to truly protect cancer patients:

1. Uncertain Financing Threatens Patient Care

The proposal suggests financing the initiative through existing EU funds such as EU4Health and Horizon Europe, both of which have already faced budget cuts. This raises concerns about the impact on other essential health and research projects. Without clear long-term funding, patient organisations and research groups could struggle to sustain vital programs, including those focused on early diagnosis and innovative treatment options for digestive cancers.

2. Lack of Patient Involvement in Decision-Making

Patient organisations must have a structured role in defining procurement criteria and monitoring medicine shortages. Digestive cancer patients have specific needs, including tailored chemotherapy regimens and access to precision medicines, that should be considered in policymaking. At present, patient representation in these discussions is unclear.

3. Transparency and Accountability Are Essential

Any public funding for pharmaceutical companies must come with strong obligations, including:

• Supply guarantees to prevent companies from prioritising more profitable markets.
• Transparency in medicine pricing and production locations.
• Clear penalties if companies fail to meet supply commitments.

Without these safeguards, there is a risk that funding will benefit industry stakeholders without delivering meaningful improvements for patients.

4. Better EU Coordination on Stockpiling Needed

Medicine shortages continue to be a major concern for digestive cancer patients, particularly when it comes to chemotherapy and pain management drugs. The Act must introduce a strong EU-level coordination mechanism for stockpiling to prevent duplication, ensure equitable distribution, and allow the reallocation of critical medicines between member states in times of crisis.

Next Steps: A Call for Action

While the Critical Medicines Act is a step in the right direction, it must be strengthened and clarified to ensure that digestive cancer patients are not left behind. DiCE urges policymakers to:

• Guarantee dedicated funding for cancer-related health programs and research.
• Establish formal patient representation in medicine procurement and supply discussions.
• Implement strict transparency and accountability measures for pharmaceutical companies receiving public support.
• Develop a centralised EU stockpiling system to avoid critical shortages.

Ensuring strong, sustainable, and equitable access to medicines is not just a matter of policy— it is a matter of survival. DiCE will continue working with EU institutions and partners to make sure the voices of digestive cancer patients are heard in this crucial legislative process.ke sure the voices of digestive cancer patients are heard in this crucial legislative process.

Author:

Ivan Ratkovic