The Council of the European Union has adopted its first-reading positions on the regulation and directive forming the pharmaceutical package. The texts do not materially reopen the agreement reached with the European Parliament in December 2025 and endorsed by both sides in March. Parliament must still give its final approval.
Against current law, the protection model changes substantially. New medicines currently receive eight years of data protection, during which generic and biosimilar applicants cannot rely on the originator's regulatory dossier, followed by two years of market protection before competitors can launch. The new legislation retains eight years of data protection but reduces automatic market protection to one year. Further market protection becomes conditional on factors including unmet medical need, specified development and filing criteria, or a clinically beneficial new indication. The overall maximum remains 11 years.
Standard orphan market exclusivity falls from ten to nine years. A new breakthrough orphan category receives 11 years, while orphan medicines authorised through the well-established-use route receive four years. The general six-month supplementary protection certificate reward for completing an agreed paediatric investigation plan remains. The current two-year paediatric extension of orphan market exclusivity disappears, with eligible orphan products instead able to use the six-month certificate extension.
The Bolar exemption, which lets generic and biosimilar developers prepare for entry before patent or supplementary protection certificate expiry, is also widened. It will expressly cover HTA, pricing and reimbursement and procurement-tender applications. A new transferable voucher for priority antimicrobials can add 12 months to the regulatory data protection of a qualifying medicine. Member States also gain stronger powers to require protected medicines to be launched and supplied.
Although maximum combined regulatory protection can still reach 11 years, the baseline entitlement is reduced. A standard new medicine moves from eight years of data protection plus two years of market protection to eight plus one, with further market protection dependent on meeting specified criteria. Standard orphan exclusivity also falls from ten to nine years. Together with the wider Bolar exemption, the package therefore brings potential generic and biosimilar competition closer for products that do not qualify for additional protection, while preserving longer periods for medicines meeting the new incentive conditions.
Source: Council of the European Union
Link: ‘Pharma package’: Council adopts new rules for a fairer and more competitive EU pharmaceutical sector
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Source: Council of the European Union
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Source: Council of the European Union
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