The Council and the European Parliament have reached an agreement on the “pharma package”, a set of legislative changes aimed at improving access to medicines and strengthening the competitiveness of the EU pharmaceutical sector.
The reform updates the EU’s pharmaceutical framework with measures intended to support fair access to safe and affordable medicines, reduce administrative barriers for industry, and improve the security of supply.
Sophie Løhde, Danish Minister for the Interior and for Health:
“I am pleased we have reached an agreement with the European Parliament on a new legislative framework for pharmaceuticals. The deal demonstrates the EU’s commitment to both innovation and to ensuring that patients in Europe have access to the medicines they need. We are strengthening incentives for priority antibiotics, reducing red tape for the life science industry, and safeguarding the availability of essential medicines. The package marks a crucial step towards making a more resilient and dynamic life science sector in Europe, and it shows that Europe is able to make the necessary decision to protect European interests.”
Regulatory protection
Under the agreement, companies introducing a new medicine will receive an eight-year data protection period and one year of market protection, with the option of an additional year for certain innovative products that meet two of three defined criteria.
Availability of medicines
The agreement maintains a Council proposal allowing member states to require an adequate supply of medicines covered by regulatory protection to meet patient needs. Additional safeguards have been added to clarify responsibilities for companies and national authorities and to prevent misuse of this provision for parallel trade.
The Bolar exemption
The package confirms an exemption that allows manufacturers to carry out the studies and trials needed to prepare generic medicines for launch immediately after patent expiry. The scope continues to include submissions for procurement tenders.
Antimicrobial resistance
A new transferable exclusivity voucher is introduced to encourage the development of priority antibiotics. The voucher grants one extra year of market protection for a product chosen by the company.
The Parliament has retained the “blockbuster clause”, which prevents use of the voucher for products with annual gross sales above €490 million in the previous four years.
Next steps
The provisional agreement will proceed to endorsement by both institutions before formal adoption and publication in the EU Official Journal.
11.12.2025.
