EU Council and Parliament negotiators have reached a provisional "pharma package" deal to modernize medicine rules, speed patient access, and bolster competitiveness, the Council said on Thursday.
The agreement grants companies launching new medicines eight years of data protection for trial results and one year of market protection. Innovative products meeting specific criteria may extend this by a year.
Danish Health Minister Sophie Løhde said the framework balances innovation incentives with measures securing patient access to necessary medicines.
However, drugmaker Novo Nordisk said the deal improves on the 2023 draft but fails to boost EU competitiveness.
Novo said EU intellectual property protections lag behind those in the US, discouraging innovation. It urged the bloc to use upcoming Biotech and Innovation Acts to sharpen competitiveness and lead the next wave.
Accelerated access to lower-cost medicines
"The various conditionalities, especially with a shortened baseline market protection period, will still weaken the EU's global competitiveness in attracting life sciences investment," said trade group European Confederation of Pharmaceutical Entrepreneurs.
To strengthen supply security, the text retains Article 56a, which empowers countries to require manufacturers to supply sufficient quantities to meet patient needs.
The package clarifies an exemption that permits generic and biosimilar manufacturers to complete studies, filings, and tender bids before patents expire, ensuring immediate market entry.
Negotiators approved a transferable exclusivity voucher to spur priority antibiotic development. This grants developers an extra year of market protection for a product of their choice.
A clause bars the voucher's use on drugs with gross annual EU sales exceeding 490 million euros over the preceding four years.
The agreement will help accelerate access to lower-cost medicines and provide companies in the space with certainty, said Catherine Drew, a lawyer at the London-based law firm Pinsent Masons.
The EU Council and Parliament must formally endorse the deal, which becomes law following publication in the EU's Official Journal.