EU seals pact to overhaul drug rules, speed patient access

Dec 11 (Reuters) - ‌EU Council and Parliament negotiators 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 one year.

Danish Health ⁠Minister Sophie Løhde said the framework balances innovation incentives with measures securing patient access to ​necessary medicines.

However, Denmark drugmaker Novo Nordisk said the deal ‌improves on the 2023 draft but ⁠fails to boost EU competitiveness.

Novo added that EU intellectual property protections trail the U.S., discouraging innovation. It urged the bloc to use upcoming ​Biotech and Innovation Acts to sharpen competitiveness and lead the next wave.

To shore up supply security, the text retains Article 56a, empowering countries to mandate that manufacturers supply sufficient quantities to meet patient needs.

The package ​clarifies an ‍exemption permitting generic and ​biosimilar makers 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 ($573.89 million) over the preceding four years.

The agreement will help accelerate access ​to lower-cost medicines, adding it will give companies in the space certainty, said Catherine Drew, a lawyer at London-based law firm Pinsent Masons.

Both institutions must formally endorse the deal, which becomes law ‌following publication in the EU's Official Journal.

($1 = 0.8538 euros)

(Reporting by Puyaan Singh in Bengaluru; Additional reporting by Maggie Fick in London; Editing by Tasim Zahid)