EU states adopt pharma package that reshapes drug data protection

EU member states have formally adopted the biggest overhaul of the bloc's medicines rules in two decades. On 28 September 2026, the Council of the EU adopted its position on the pharmaceutical package, a new directive and regulation that change how long new medicines are protected from generic competition, how orphan drugs are rewarded, and how fast the European Medicines Agency (EMA) assesses applications.

According to Regulatory Affairs Professionals Society (RAPS) reporting, 26 member states voted in favour and one abstained, according to NAVLIN Daily, which reported the vote as 26 to 0 with one abstention. The texts now go to the European Parliament for its final vote before publication in the Official Journal of the EU.

The European Commission first proposed the package on 26 April 2023. The Parliament and Council reached a provisional deal on 11 December 2025, and member state ambassadors endorsed the compromise text on 6 March 2026. The reform replaces Directive 2001/83/EC and Regulation (EC) No 726/2004, along with the separate rules on medicines for children and rare diseases.

What the package is

The package has two parts:

• a directive, which member states must write into national law, covering marketing authorisation rules, regulatory protection periods and generic entry
• a regulation, which applies directly, covering the EMA's procedures, orphan medicines and incentives for new antimicrobials

Once adopted and published, the directive must be transposed into national law within two years, according to law firm Matheson's analysis.

Shorter baseline protection, with ways to earn more

Today, a new medicine in the EU gets eight years of regulatory data protection, during which generic and biosimilar companies cannot rely on the originator's trial data, plus two years of market protection, during which generics cannot be sold. That is often summarised as "8 plus 2".

Under the new rules, the baseline becomes eight years of data protection and one year of market protection. Companies can earn extra market protection by meeting set conditions, according to summaries by RAPS, Matheson and LISAH:

• One additional year of market protection if a medicine meets two of three criteria: comparative clinical trials, filing in the EU early, and running trials in several member states. Where comparative trials are not possible, the multi-state trial and early filing criteria can be combined.
• One further year for a medicine that addresses an unmet medical need.

Total regulatory protection is capped at 11 years, according to the summaries.

For clinical trial sponsors, the multi-state trial criterion is the most direct link to research. It gives companies a financial reason to run trials across more EU countries, which could mean more trial sites for patients in smaller member states.

A voucher for new antibiotics

To tackle antimicrobial resistance, the regulation creates a transferable data exclusivity voucher. A company that develops a qualifying priority antimicrobial gets a voucher worth an extra year of protection, which it can use on another product or sell to another company.

The voucher has limits. According to RAPS, it cannot be used on a product whose annual EU sales exceeded €490 million (about $556 million) in any of the previous four years. The Council says total protection for a product cannot exceed 11 years, or 12 years where a voucher is used.

The voucher aims to fix a long-running problem. New antibiotics are often held back for use only when older drugs fail, which keeps their sales low and gives companies little reason to develop them.

Changes to orphan drugs

Orphan medicines, for rare diseases, currently get ten years of market exclusivity in the EU. Under the package:

• Standard orphan exclusivity falls to nine years.
• "Breakthrough" orphan medicines get 11 years. These are medicines for conditions with no authorised treatment in the EU that deliver a clinically relevant reduction in illness or death.
• Orphan medicines based on well-established use get four years.
• The current two-year extension for orphan medicines that complete paediatric studies is replaced by a six-month extension of the supplementary protection certificate (SPC).

The changes reflect a long debate about whether orphan incentives reward medicines that make the most difference to patients, or reward any medicine that qualifies on prevalence.

Faster EMA assessment

The regulation cuts the EMA's standard assessment time for a marketing authorisation application from 210 days to 180 days. Accelerated assessment, used for medicines of major public health interest, is set at 150 days.

These clocks cover the scientific assessment. The final legal decision is taken by the European Commission afterwards. Clock stops, when the company answers questions, are not counted.

Earlier generic entry

The package widens the Bolar exemption, which lets generic and biosimilar makers carry out studies and trials during the protection period so that they are ready to launch on day one. Under the new rules, the exemption also covers work needed for health technology assessment, pricing and reimbursement, and public procurement tenders.

In practice, this should help cheaper versions reach patients faster once protection ends, because the paperwork for pricing and tenders can be done in advance.

Supply obligations

According to Matheson, member states will be able to require companies to supply medicines to their markets, linked to the protection periods. Supply gaps between EU countries have been a longstanding complaint, with some new medicines launched in large markets years before smaller ones.

How the package got here

The legislative path has taken more than three years:

• 26 April 2023: the Commission proposes a new directive and regulation.
• 10 April 2024: the European Parliament adopts its first-reading position with amendments.
• 4 June 2025: the Council agrees its negotiating mandate.
• 11 December 2025: the two institutions reach a provisional agreement.
• 6 March 2026: Coreper, the committee of member state ambassadors, endorses the compromise; the Parliament's public health committee approves it on 18 March.
• 28 September 2026: the Council adopts its first-reading position after legal and linguistic checks.
• 8 October 2026: the Parliament opens its second reading and refers the file to its public health committee.

The Council's statement of reasons, published in the Official Journal, says its position "fully reflects the compromise reached in the negotiations between the Council and the European Parliament, with the support of the Commission." That means the Parliament's second-reading vote is expected to approve the text without changes.

Supply safeguards

The Council's press release says the supply obligation comes with safeguards, so that it is used to meet patients' needs and does not facilitate parallel trade, meaning cheaper exports from one member state to another. Shortages of older medicines have been a recurring problem across the EU, and the package also includes measures on shortage prevention and security of supply.

What it means for clinical trials

Several parts of the package affect how and where trials are run:

• The extra protection year for multi-state trials and comparative trials rewards designs that compare a new medicine against existing treatment and spread sites across the EU.
• Faster EMA assessment shortens the gap between a trial's results and a decision.
• The antimicrobial voucher may draw more investment into antibiotic trials.
• The wider Bolar exemption lets generic makers run bioequivalence and other studies earlier.

The package sits alongside separate EU work on clinical trials. The proposed Biotech Act would change the Clinical Trials Regulation and the Clinical Trials Information System (CTIS), which we cover in our article on the Biotech Act and CTIS.

What it means for patients

For patients, the aims are faster access to new medicines across all member states, earlier arrival of cheaper generics, and more incentive to develop treatments for rare diseases and resistant infections. How much each aim is achieved will depend on national transposition, pricing decisions and company behaviour, none of which the package fixes on its own.

Our patient guide on how new medicines get approved explains the stages a medicine goes through after its trials end.

What happens next

The European Parliament must vote to adopt the texts at second reading. The indicative plenary date has moved from 11 November to 23 November 2026, according to the Parliament's Legislative Observatory as reported by trackers of the procedure. The texts will then be published in the Official Journal and enter into force.

The EMA has said it expects entry into force in 2026, followed by a transition period in which member states change national laws and the Commission, EMA and national regulators prepare implementing measures and guidance. The new framework is expected to apply generally from 2028. Companies with medicines already on the market or under review will need to check the transition rules carefully.

Related reading

• EU Biotech Act would rewrite most of CTIS
• MHRA Strategy 2030 targets faster approvals and trials

This article is for general information and is not medical advice. Please talk to your own doctor before joining a trial or changing any treatment.