European Parliament Medicinal Products Regulation

Framework for Critical Medicine Supply and Availability

January 20, 2026

Main Purpose

The European Union must protect public health by ensuring medicines are always available. This regulation creates rules to:

• Strengthen the supply of critical medicines
• Make sure medicines remain available across all EU countries
• Support medicine manufacturing in Europe

Key Problems Addressed

Medicine Shortages

• Recent years have seen more medicine shortages in the EU
• Shortages happen when supply chains break down
• This creates serious risks for patients' health and healthcare systems

Manufacturing Challenges

• Too much reliance on a few suppliers outside the EU
• Not enough investment in European manufacturing
• Lower costs and fewer regulations in other countries make European production less attractive
• Shortage of skilled workers in pharmaceutical manufacturing

Older Medicines Most Affected

• Generic and off-patent medicines face the most shortages
• Low profit margins reduce investment in reliable manufacturing
• Many producers have moved operations outside Europe
• Heavy dependence on limited suppliers, often in other countries

Solutions Proposed

Strategic Projects

• Support building or expanding medicine manufacturing in the EU
• Faster approval processes for important projects
• Financial support for investments
• Help with permits and administrative tasks
• Priority for small and medium-sized companies

Better Procurement (Buying)

• Public buyers must consider more than just price
• Look at supply security and reliability
• Prefer suppliers who manufacture significantly in the EU when supply depends too much on other countries
• Allow contracts with multiple suppliers
• Coordinate buying across countries when beneficial

Stock Management

• Countries must maintain emergency medicine stocks responsibly
• Avoid negative effects on other countries
• Share stock information with EU authorities
• Enable redistribution during shortages as last resort
• Common standards for managing stocks

Joint Purchasing

• EU can coordinate bulk buying for member countries
• Minimum 5 countries needed to request joint procurement
• Commission facilitates the process
• Applies to both critical medicines and other medicines of common interest

International Partnerships

• Build relationships with other countries to diversify medicine sources
• Reduce dependence on any single country
• Promote regulatory cooperation
• Include access to active ingredients and starting materials

Coordination Mechanism

Critical Medicines Coordination Group

• Representatives from member countries
• Includes patient organizations and healthcare professionals
• European Medicines Agency participates
• Commission provides secretariat support
• Meets regularly to coordinate implementation
• Monitors stock levels and availability
• Can recommend redistribution during shortages

Special Provisions

Contraceptives and Abortion Medicines

• Recognized as essential for health rights and gender equality
• Countries must ensure availability and affordability

Antimicrobials

• New antimicrobials need special support due to limited use and market challenges
• Important for fighting antibiotic resistance

Transparency and Confidentiality

• Companies must provide requested information
• Commercial secrets protected
• Information sharing between authorities to avoid duplication

Evaluation

• Commission reviews regulation every 5 years
• Assesses if objectives achieved
• Examines impact on markets, competition, and supply security
• Reports to Parliament, Council, and other EU bodies

Timeline and Implementation

• Countries designate authorities within 3 months
• National programs established within 6 months
• Regular monitoring and reporting required
• Stockpile information updated quarterly