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Committee on Public Health Ordinary meeting Joint meeting Committee on the Environment, Climate and Food Safety

10 November 2026

Contents updated on 10 Nov 2026

Chairs open the joint SANT–ENVI meeting, introduce the Biotech Directive file, and lead the full voting sequence on compromises, amendments and the final report, which is adopted before closing the joint item and moving to SANT-only business.

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Opening and adoption of Biotech Directive report

00:07

Opening of joint SANT–ENVI meeting and agenda

00:07

Biotech Directive package — introduction and start of voting

03:12

Biotech file — compromises 1–9 and related amendments

04:41

Biotech file — compromises 10–20, remaining amendments and final adoption

08:23

Closure of joint Biotech item and shift to SANT business

10:59

Pharmaceutical package second reading and approval

17:07

Pharma package second reading — procedural context

17:07

Rapporteur Wölken: outcomes of pharma regulation

19:20

Second-reading votes on pharma regulation and directive; announcement of ATMP hearing

20:23

ATMP hearing — mandate, format and expert panel

26:25

Public hearing on ATMPs — objectives and scope

26:25

Chair — introduction of expert panel and agenda

27:28

Expert evidence — EU access gap and fast‑track needs

29:10

Dr. Gregorc — delayed EU access and shift of trials

29:10

Dr. Gregorc — advanced therapies gap and systemic causes

32:37

Dr. Gregorc — legislative asks on fast‑track, capacity and access

35:59

Expert evidence — CAR‑T access, hospital exemption and sustainability

38:26

Prof. Vaitiekus — small Member States’ CAR‑T access problem

38:26

Prof. Vaitiekus — hospital exemption CAR‑T model and safeguards

41:59

Prof. Vaitiekus — sustainability, EU support and policy requests

46:53

MEP–expert exchange — SPC, HTA, hospital exemption and innovation

49:10

Rapporteur and MEPs — SPC, HTA and early access questions

49:10

MEPs — scaling hospital exemption and broader innovation impact

53:23

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Committee on Public Health Ordinary meeting Joint meeting Committee on the Environment, Climate and Food Safety

10 November 2026

SANT, ENVI Tue, 10 Nov 2026 European Parliament

00:07 - 02:13

Speaker 3

Dear colleagues, we will start in a moment, please take your seats. Welcome to the full and substitute members of the SANT and ENVI committees. I inform you that interpreters for the following languages are present today: German, English, French, Italian, Dutch, Danish, Greek, Spanish, Portuguese, Swedish, Czech, Lithuanian, Hungarian, Polish, Slovak, Romanian and Croatian.

Speech-to-text automatic transcription and translation is available today for accessibility purposes. Scan the QR code on the posters and select the channel with the language being spoken. For translation you can choose your preferred language from the available options in the menu. Chair's announcements, none foreseen. Point three, amending directives

2001/18 and 2010/53 as regards the placing on the market of genetically modified microorganism and the processing of organs. Dear colleagues, please be informed that the following members will be replaced during today's vote: Bogdan Zdrojewski, substitute for Hanna Gronkiewicz-Waltz, Niclas Herbst, substitute for Stefan Köhler,

Borja Giménez, substitute for Dolors Montserrat, Jörgen Warborn, substitute for Jessica Polfjärd, Lena Düpont, substitute for Flavio Tosi, Paulius Saudargas, substitute for Oliver Schenk, Georgia Tramacere, substitute for Alessandra Moretti,

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European Parliament

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European Parliament

Read the full session, transcribed live

Try it free, or come back on 25 November: the transcript will be public.

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