In December 2025 the EU institutions agreed to revamp the EU's Pharmaceutical Legislation. The deal will help EU consumers face fewer medicines shortages and benefit from improved access to generics. The legislation should become applicable in 2028 at the latest. 

Why it's important

Europe faces serious challenges when it comes to medicines: growing shortages, high prices, and innovation that does not fully match patients’ real needs. The EU pharmaceutical legislation's revision came alongside negotiations on the Critical Medicines Act, both shaping future access to safe, available, and affordable medicines.

The new rules update legislation that is over 20 years old and aim to balance two key objectives: promoting pharmaceutical innovation and improving patient access to affordable medicines across the EU, including by ensuring continued supply.  

What BEUC did

Thanks to BEUC's recommendations and input during the 2.5 years’ negotiations, the final deal will provide big improvement for EU consumers:  

• Stronger shortage prevention measures:  
  • An obligation for companies to have shortage prevention plans for prescription-only medicines, and other medicines if the European Commission decides to expand the scope.  
  • An obligation for companies to report foreseen shortages six months in advance. Earlier reporting can help preventing that the shortages materialise, thanks to regulatory action.
  • The European Medicines Agency will have a reinforced role in shortage prevention and management beyond health crisis situations (e.g., beyond pandemics).
• Modulated market protection rules (e.g. monopoly protection) that encourage the development of medicines of higher healthcare value (e.g. for unmet needs), without delaying competition compared to today’s situation. Modulating the length of protection, with a shorter baseline, will allow faster generics entry meaning cheaper medicines will be accessible sooner for consumers.
• Medicine packages will contain both the paper package leaflet and complementary electronic information (e.g.  QR-codes). The deal will prohibit the Commission from removing paper leaflets across the EU. If Member States wishes to do so, they will have to consult with patients' organisations and healthcare professionals. Where digital information is the only one available, consumers can request a free printed copy of the leaflet at the pharmacy granting access to easy information for everyone.  
• To promote patient access to novel antibiotics, the EU will set up a voluntary subscription model for joint procurement.  Interested Member States will be able to buy medicines together and pay pharmaceutical companies a fixed fee, independent of yearly antibiotic sales. Decoupling revenue from volumes will prevent overuse, limit antimicrobial resistance, and still ensure companies recover their investment.  
• More transparency: companies with a new marketing authorisation will have to disclose direct public funding received to support their research and development efforts; a measure that will empower pricing and reimbursement authorities in their negotiations with companies.
• New measures allowing generic companies to better prepare their market entry before patents expire, including by taking part in hospital tenders. Generics and biosimilars can be supplied immediately after patents expiry, delivering faster savings for health systems and patients.
• A possibility for Member States  to require companies to apply for pricing and reimbursement soon after marketing authorisation. If companies fail to make the product available within three years, they may lose one year of market protection in that country, allowing generics to enter that market a year earlier.

Timeline

   2001 – Adoption of the EU Directive on the Community code relating to medicinal products for human use

   2004 – Adoption of EU Regulation on the authorisation and supervision of medicinal products for human and veterinary use and creation of the European Medicines Agency

   2023 – Commission proposal to reform the EU Pharma Legislation  

   2025 – Provisional political agreement confirmed to modernise pharmaceutical rules  

   2026 – Adopted acts of the new pharmaceutical legislation enter into force

   2026-2028 – Transition phase

• EU Member States update their national laws to reflect the new rules
• European Commission adopts implementing and delegated acts to help implement the new rules
• European Medicines Agency and national competent authorities develop implementation guidance and adapt their procedures and IT systems

   2028 – New pharmaceutical legislation becomes applicable