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The biggest rewrite of EU medicines law in twenty years, proposed in 2023: shorter default protection from generic competition with extensions for launching everywhere in the EU and for meeting unmet needs, faster assessments, and tighter orphan and paediatric rules, argued over by Parliament and Council since.
European Union, proposed directive and regulation. On 26 April 2023 the European Commission proposed a new directive and a new regulation to replace Directive 2001/83/EC and Regulation (EC) No 726/2004, as the legislative core of its 2020 Pharmaceutical Strategy for Europe. The European Parliament adopted its first-reading position in April 2024 and the Council agreed its negotiating position in June 2025, opening trilogue negotiations. Primary text: the Commission's reform page links the proposals and the co-legislators' positions.
What the Commission proposed: cut the standard regulatory data protection from eight years to six, with extensions for launching in all member states, addressing unmet medical need, running comparative trials or adding a new indication, up to a cap; modulate orphan market exclusivity in the same way and tighten the significant-benefit test; require paediatric plans based on mechanism of action; shorten EMA assessment to 180 days and Commission decisions to 46 days; create a transferable data exclusivity voucher for priority antimicrobials; broaden the Bolar exemption; add environmental risk assessment and shortage obligations. Parliament wanted seven and a half years of baseline data protection; the Council kept eight.
The arguments: industry associations warned the shorter baseline would drive investment to the United States and China and pointed to Europe's shrinking share of new medicine launches; generic makers, payers and health ministries argued that eleven years of combined protection is the world's longest and that the launch-everywhere incentive tackles the real access gap between western and eastern member states. For oncology, the orphan and paediatric changes and the treatment of new indications matter most, because many cancer medicines gain their value through successive indications.
Shares Regulation (EC) No 726/2004: the EU centralised procedure, European Medicines Agency and the tags law, eu.
Shares EU HTA Regulation (EU) 2021/2282: joint clinical assessments and the tags law, eu.
Shares the tags law, eu.
Shares Supplementary protection certificate (EU), EU data and market protection (8+2+1), US regulatory exclusivity periods, Prices and value and the tag law.
Shares Orphan drug designation, Regulation (EC) No 141/2000: EU orphan medicines, US regulatory exclusivity periods, Incentives reward me-too drugs and marginal gains and the tag law.
Shares Regulation (EC) No 1901/2006: EU paediatric medicines, Orphan drug designation, US regulatory exclusivity periods, Incentives reward me-too drugs and marginal gains and the tag law.
Shares Orphan drug designation, US regulatory exclusivity periods, EU HTA Regulation (EU) 2021/2282: joint clinical assessments, Biosimilar and the tag law.
Shares Supplementary protection certificate (EU), EU data and market protection (8+2+1), US regulatory exclusivity periods, Biosimilar and the tag law.