Amsterdam: The EU pharma package took a major step on 28 September 2026, when the Council adopted it. The Commission proposed the reform in April 2023, and Council and Parliament reached a political agreement on 11 December 2025. The rules take effect only after Parliament gives final approval and the text is published in the Official Journal.

The core of the EU pharma package is a new balance of protection for new medicines. Regulatory data protection lasts 8 years, during which competitors cannot use the originator’s test data. Market protection starts at one year and can grow by up to two more years if the medicine meets conditions such as addressing an unmet medical need, comparative trials or a new therapeutic indication. The total is capped at 11 years, or 12 years with an exclusivity voucher.

Previously, market protection was a guaranteed two years regardless of company conduct, so the EU pharma package links reward to behaviour. Orphan medicines for rare diseases see their baseline exclusivity fall from 10 to 9 years, although products for conditions with no approved treatment can reach up to 11 years. EFPIA, the industry federation, criticised the reduction.

Antibiotics receive special treatment. Companies that develop priority antibiotics can earn an extra year of market protection on a product of their choice, and they can sell that voucher to other companies. The voucher cannot apply to products whose annual gross sales exceeded €490 million over the previous four years. The EU pharma package thus tries to reward work on drugs that commercial markets rarely pay for.

Generic and biosimilar makers gain from a wider Bolar exemption, which lets them prepare for launch during patent protection. The exemption now also covers health technology assessment applications, pricing and reimbursement approvals and public tenders. The EU pharma package also lets Member States require companies with regulatory protection to supply enough medicine to meet national needs, and a company that fails to comply within three years loses two years of market protection in that country.

The package also shortens regulatory clocks. The European Medicines Agency in Amsterdam will process marketing authorisation applications in 180 days instead of 210, and the Commission must decide within 46 days instead of 67. Malta was the only country to vote against the Council compromise, according to the think tank Tænketanken Europa.

Companies now wait for Parliament’s final vote. Until then, the EU pharma package is not law, and innovators, generic makers and health ministries will keep testing how its eight-year data window and tradeable antibiotic voucher change their plans.