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November 7, 2026

Newsletter

The European Post

Policy • Diplomacy • strategic insight

LATEST
Teacher Shortages Put The EU Teachers Agenda To The TestKingspan Fine And KKR Charge Put EU Merger Control To WorkMEPs Near First Vote On EU Space Act In Parliament Industry CommitteeMercosur Safeguard Rules Let EU Curb Surges In Car And Goods ImportsMontenegro And Albania Receive EU Accession Roadmaps From CommissionHelsinki Presses Washington Over Paid-For Patriot InterceptorsMeloni Letter Exposes The EU Single Voice Problem On UkraineEmissions Trading Link Defines The EU-UK Summit Agenda For 20 NovemberAddis Ababa Talks Test The EU-African Union Partnership PlanDark Patterns Face Reform As Digital Fairness Act NearsLong-Term EU Budget Talks Face A December DeadlineReturn Hubs Plan Reshapes EU Deportation Rules After DealFishing Sector Gets Vision 2040 Fisheries Strategy With €2bn FloorNominations Open For The Next European Research Council PresidentInvestFrontier Launch Pulls Private Capital Into Humanitarian AidYoung Farmers Targeted By 10 Share In Post-2027 CAP PlanCOP17 Biodiversity Deal Leaves Nature Finance Gap OpenParliament Backs High-Speed Rail Network Linking CapitalsEnergy And Tyre Labelling Gets Simpler Rules In Council MandateEU Defence Readiness Goal For 2030 Slips Despite €418 Billion OutlayTeacher Shortages Put The EU Teachers Agenda To The TestKingspan Fine And KKR Charge Put EU Merger Control To WorkMEPs Near First Vote On EU Space Act In Parliament Industry CommitteeMercosur Safeguard Rules Let EU Curb Surges In Car And Goods ImportsMontenegro And Albania Receive EU Accession Roadmaps From CommissionHelsinki Presses Washington Over Paid-For Patriot InterceptorsMeloni Letter Exposes The EU Single Voice Problem On UkraineEmissions Trading Link Defines The EU-UK Summit Agenda For 20 NovemberAddis Ababa Talks Test The EU-African Union Partnership PlanDark Patterns Face Reform As Digital Fairness Act NearsLong-Term EU Budget Talks Face A December DeadlineReturn Hubs Plan Reshapes EU Deportation Rules After DealFishing Sector Gets Vision 2040 Fisheries Strategy With €2bn FloorNominations Open For The Next European Research Council PresidentInvestFrontier Launch Pulls Private Capital Into Humanitarian AidYoung Farmers Targeted By 10 Share In Post-2027 CAP PlanCOP17 Biodiversity Deal Leaves Nature Finance Gap OpenParliament Backs High-Speed Rail Network Linking CapitalsEnergy And Tyre Labelling Gets Simpler Rules In Council MandateEU Defence Readiness Goal For 2030 Slips Despite €418 Billion Outlay

Biotech Act Negotiations Weigh Patient Voices Against Patent Extension

Jóhannes Guðnason
Legislative Affairs Editor, Health and Wellbeing

Uppsala: The EU Biotech Act has entered a critical stage in Council and Parliament, and a patient group warned on 6 November that it is being left out of the talks. The European Patients’ Forum says the proposal’s patent extension for biotech medicines could delay cheaper biosimilars and raise costs.

The Commission presented the Biotech Act on 16 December 2025. It proposes a 12-month extension of the supplementary protection certificate for qualifying biotech medicines and advanced therapies. Eligibility requires a new active substance with a distinct mechanism, clinical trials in more than two member states and at least one manufacturing step in the EU. The Biotech Act also shortens clinical trial timelines, cutting multinational authorisation from 106 to 75 days.

In the Council, the Irish Presidency circulated compromise texts dated 28 and 29 October, after a first one on 8 and 9 October. The working party on pharmaceuticals and medical devices discussed them on 5 and 6 November. The 29 October text keeps the 12-month extension, allows it to combine with the six paediatric months for a maximum of 18 months, and lengthens the stockpiling period for biosimilar makers before a certificate expires, without yet stating the duration.

The text also keeps six-week assessments for strategic biotech projects, or eight weeks for those with significant sectoral impact. In cross-border projects one national authority coordinates, and other member states have 10 days to raise reasoned objections. If governments cannot agree, the promoter may amend its application to exclude the objecting state. Biosimilar rules could reduce comparative efficacy studies where the science allows, and the Biotech Act facilitates artificial intelligence in pharmaceutical research.

Patients want a larger role. The European Patients’ Forum told Members of the European Parliament Vytenis Andriukaitis and Stine Bosse that it wants stronger patient involvement in trial design, clearer consent rules and post-trial access. Claudia Louati, the forum’s head of policy and capacity building, said competitiveness should be measured not only by the investment Europe attracts. Supporters of the extension reply that few medicines would qualify, so the effect on biosimilars may be limited.

Research funding runs on a parallel track. The 2027 Horizon Europe health calls opened on 29 October with 14 topics, including innovative antimicrobials, and a deadline of 17 February 2027, which shows EU research money flowing while the legislation is negotiated.

Health Commissioner Olivér Várhelyi met MEPs Nicolás Casares and Stine Bosse as compromise amendment talks continued that week. No Parliament committee vote date or Council general approach date has been confirmed. The Biotech Act therefore faces months of bargaining between speed for researchers and affordability for patients.

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