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HMA/EMA multi-stakeholder workshop on shortages 1-2 March 2023, EMA, Amsterdam Hybrid meeting Background and objectives Improving the availability of human and veterinary medicines authorised in the EU is a key priority of the EU Network. An HMA/EMA Task Force was established by EU regulators in 2016 to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe. Shortages and availability problems are complex with no quick solutions. Medicine regulatory authorities are only one of the many actors involved in availability issues, however they play an important role in their prevention and management. By bringing together experts from various EU member states, the work of the task force lays the foundations for an improved and harmonised EU approach in addressing the problems of medicines’ availability issues. It is designed to function as a 'supply and availability hub', tracking progress on the medicine availability and shortage-related activities that the European medicines regulatory network is undertaking under the following EU projects: • the European medicines agencies network strategy to 2025 • the European Commission's Pharmaceutical Strategy for Europe • the 'Joint Action on Shortages', a three-year plan starting at the end of 2022 to enhance national systems in tackling medicines shortages in a harmonised way This aims to streamline processes, ensure synergies and avoid duplication of work within the network. In the meantime, the regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices entered into application on 1 March 2022. Complementary to the HMA/EMA Task Force, the regulation has prompted EMA to set up structures and processes for dealing with medicine shortages focusing on crisis situations. Under the new mandate, EMA will monitor events which might lead to a crisis situation, as well as with the reporting of shortages of critical medicines during a public health crisis. The Agency will also coordinate, after an initial transitional period, responses of EU countries on shortages of critical Medical Devices and in vitro diagnostics occurring in crisis situations. The aims of the workshop are to: • Inform stakeholders about the HMA/EMA Task Force activities on medicines shortages and availability and interfaces with other initiatives. • Update stakeholders on progress with the Task Force deliverables and identify areas of agreement as well as areas for further discussion. • Share stakeholders’ perspectives and (ongoing/planned) initiatives to address availability issues and discuss how these can contribute to the future deliverables of the Task Force. HMA/EMA multi-stakeholder workshop on shortages Chaired by Monica Dias (EMA) and Hugues Malonne (HMA) Day 1 - 1 March 2023, 13h00-17h45 (CET) 13:00 Joining and technical checks 13:15 Welcome and opening speech Welcome and introduction 10’ Emer Cooke (EMA) Outline of the day and objectives 10’ Hugues Malonne (HMA) 13:35 Session 1: Setting the scene Moderator: Karl Broich (HMA) EU initiatives on shortages and availability of medicines 15’ Sylvain Giraud (DG SANTE, EC) European Medicines Agencies Network initiatives 15’ Lorraine Nolan (HMA) Monitoring of events and preparedness for public 25’ health emergencies Agnes Marta Molnar (DG HERA, EC) Anthony Humphreys (EMA) What happened with the HMA/EMA Task Force on 15’ availability of authorised medicines (TF AAM) since 2018 Hugues Malonne (HMA) Monica Dias (EMA) Q&A 20’ 15:10 Coffee break 15:25 Session 2: Parallel breakout sessions Room 1A Room 1D Room 1G Immunoglobulins Biosimilars Medicines for veterinary use Room 1A Breakout session 2A: Immunoglobulins Facilitators: María Jesús Lamas (HMA) and Rui Santos Ivo (HMA) Rapporteur: Emilija Matelytė (EMA) Overview of immunoglobulins supply situation in the EU 15’ Klaus Kruttwig (EMA) EU legislation and policy on blood and blood components 15’ Stefaan van der Spiegel (DG SANTE, EC) SUPPLY project 15’ Fabio Candura (ISS) Daphne Thijssen-Timmer (Sanquin Bloodbank) Discussion on immunoglobulins shortages in the EU 60’ Tour de table Wrap up and key messages to report to plenary 25’ Room 1D Breakout session 2B: Biosimilars Facilitators: Steffen Thirstrup (EMA) Rapporteur: Rosa Gonzalez-Quevedo (EMA) Work plan of the HMA Biosimilar Working Group (BSWG) 15’ Esa Heinonen (HMA) Scientific rationale for interchangeability of biosimilars in the EU 10’ Elena Wolff-Holz (PEI, EMA BMWP) HMA/EMA statement on interchangeability of biosimilars 10’ Steffen Thirstrup (EMA) Discussion 70’ Tour de table Wrap up and key messages to report to plenary 25’ Room 1G Breakout session 2C: Medicines for veterinary use Facilitators: Ivo Claassen (EMA) and Constance McDaniel (HMA) Rapporteur: Janos Kovacs (EMA) Selected presentations: 60’ Nancy de Briyne (FVE) Despoina Iatridou (FVE) Elsa Vecino (Accessvetmed) Rick Clayton (AnimalHealthEurope) Paule Carnat-Gautier (ANSES) Inke Reimer (BVL) Discussion 60’ Tour de table Wrap up and key messages to report to plenary 15’ 17:45 End of day 1 Day 2 - 2 March 2023, 09h00-16h45 (CET) 08:30 Joining and technical checks 09:00 Welcome and summary of day 1 Welcome and introduction 15’ Monica Dias (EMA) and Hugues Malonne (HMA) Reporting from breakout sessions 45’ Rapporteur session 2a: Emilija Matelytė (EMA) Rapporteur session 2b: Rosa Gonzalez-Quevedo (EMA) Rapporteur session 2c: Janos Kovacs (EMA) 10:00 Session 3: Prevention of shortages Moderator: Darren Scully (HMA) Short presentations by stakeholders 40’ Ancel.la Santos (BEUC) Stephan Roenninger (Industry) Jorge Batista (PGEU) Nancy de Briyne (FVE) Network priorities to 2025: TF AAM workplan 15’ Maria-Jesus Alcaraz Tomas (EMA) Discussion 40’ 11:40 Coffee break 11:55 Session 4: Permanent withdrawals from the market Moderator: Momir Radulovic (HMA) Flash statements by stakeholders 35’ Charlotte Roffiaen (EPHA) Mary McCarthy (UEMO) Sophie Dagens (Industry) Michael Ermisch (GKV-Spitzenverband) Matjaz Marc (JAZMP, SPOC WP) Network priorities to 2025: TF AAM workplan 15’ Joao Ferreira (EMA) Michael Berntgen (EMA) Discussion 30’ 13:20 Lunch 14:00 Session 5: Communication and transparency Moderator: Yngvil Knudsen (HMA) Short presentations by stakeholders 30’ Marko Korenjak (PCWP) Jean-François Duliere (Industry) Rosa Giuliani (HCPWP) Diego Pernas (AEMSP) Network priorities to 2025: TF AAM workplan 15’ Juan Garcia Burgos (EMA) Inga Abed (EMA) Discussion 30’ 15:20 Coffee break 15:30 Session 6: Work ahead to 2025 Panel discussion on: 45’ What have we learnt so far? What is missing? What needs to improve? 16:20 Closing remarks Wrap up: take-home messages and next steps 10’ Monica Dias (EMA) and Hugues Malonne (HMA) 16:30 End of meeting List of speakers Inga Abed Medical writer, Public and Stakeholders Engagement Department, EMA and member of the TF AAM Thematic Working Group on communication Jorge Batista Professional Affairs Advisor, Pharmaceutical Group of the European Union (PGEU) and member of EMA’s Healthcare Professionals' Working Party (HCPWP) Michael Berntgen Head of Scientific Evidence Generation Department, EMA Karl Broich President, Federal Institute for Drugs and Medical Devices, Germany (BfArM), Chairperson of the Heads of Medicines Agencies (HMA) Management Group and Co-chair of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) Fabio Candura Director, Plasma and Plasma-derived Medicinal Products Area, National Blood Centre (ISS), National Institute of Health, Italy Paule Carnat-Gautier Deputy Director, French Agency for Veterinary Medicinal Products (ANSES) Ivo Claassen Deputy Executive Director and Head of Veterinary Medicines Division, EMA, member of the TF AAM Rick Clayton Technical Director, AnimalhealthEurope Emer Cooke Executive Director, EMA Sophie Dagens Representative of industry associations Nancy de Briyne Executive Director, Federation of Veterinarians of Europe (FVE) Monica Dias Head of Supply and Availability of medicines and Devices, EMA and Co- chair of the TF AAM Jean-François Duliere Representative of industry associations Michael Ermisch Specialist for medicinal products at GKV-Spitzenverband, the National Association of Statutory Health Insurance Funds, Germany Joao Ferreira Supply and Availability of medicines and Devices’ specialist, EMA and secretariat of the TF AAM Juan Garcia Burgos Head of Public and Stakeholders Engagement Department, EMA and Co- Chair of the TF AAM Thematic Working Group on Communication Sylvain Giraud Head of Unit Medical Products: Quality, Safety, Innovation, European Commission (DG SANTE, EC) Rosa Giuliani European Society for Medical Oncology (ESMO) and Co-Chair of EMA’s Healthcare Professional Working Party (HCPWP) Rosa Gonzalez- Scientific Research Officer, Public and Stakeholders Engagement Quevedo Department, EMA Esa Heinonen Senior adviser, Finnish Medicines Agency (Fimea) and Chair of the HMA Working Group of Biosimilars (BSWG) Anthony Humphreys Head of Regulatory Science and Innovation Task Force, EMA Despoina Iatridou Senior Veterinary Policy Officer, Federation of Veterinarians of Europe (FVE) Maria Jesus Alcaraz Medicines and Medical Devices Shortages Specialist, EMA and Co-Chair of the TF AAM Thematic Working Group on availability and supply disruptions María Jesús Lamas Director, Spanish Agency for Medicines and Medical Devices (AEMPS), member of the TF AAM Steering Commitee Yngvil Knudsen Unit for Communication, The Norwegian Medicines Agency, and Co-Chair of the TF AAM Thematic Working Group on communication Marko Korenjak President of the European Liver Patient Association (ELPA) and Co-Chair of EMA’s Patient and Consumer Working Party (PCWP) Janos Kovacs Scientific Administrator, Veterinary Medicines Division, EMA Klaus Kruttwig Medicines and Medical Devices Shortages Specialist, EMA Hugues Malonne Federal Agency for Medicines and Health Products, Belgium (AFMPS), and Co-chair of the TF AAM Matjaz Marc Head of Division for pharmacoeconomics, market monitoring and HTA, Agency for medicinal products and medical devices, Slovenia (JAZMP) and member of the EMA Medicines Shortages Single Point of Contact (SPOC) Working Party Agnes Marta Molnar Deputy Head of Unit, Intelligence Gathering, Analysis and Innovation, European Commission (DG HERA, EC) Emilija Matelytė Medicines and Medical Devices Shortages Officer, EMA Mary McCarthy European Union of General Practitioners (UEMO) and alternate member of EMA’s Healthcare Professionals' Working Party (HCPWP) Constance McDaniel Head of Unit, Federal Office for Consumer Protection and Food Safety, Germany (BVL) and member of the TF AAM Steering Committee Lorraine Nolan Chief Executive, Health Products Regulatory Authority, Ireland (HPRA), EMA’s Management Board Chair and member of the TF AAM Steering Committee Diego Pernas Head of communications and PR, Spanish Agency of Medicines and Medical Products (AEMPS) and member of the TF AAM Thematic Working Group on Communication Momir Radulović Executive Director, Agency for Medicinal Products and Medical Devices, Slovenia (JAZMP), EMA Management Board member, Heads of Medicines Management Group member (HMA), and member of the TF AAM Steering Committee Inke Reimer Federal Office for Consumer Protection and Food Safety, Germany (BVL) Stephan Roenninger Representative of industry associations Charlotte Roffiaen European Policy Advisor at France Assos Santé (EPHA member) and Representative of EMA’s Patients' and Consumers' Working Party (PCWP) at the MSSG Ancel·la Santos Senior Health Policy Officer, European Consumer Organisation (BEUC), Member of EMA’s Patients' and Consumers' Working Party (PCWP) Rui Santos Ivo President of the National Authority of Medicines and Healthcare Products, Portugal (INFARMED), member of EMA’s Management Board and member of the TF AAM Steering Committee Darren Scully Medicine Shortages and Borderline Classification Manager, Health Products Regulatory Authority, Ireland (HPRA) and Co-Chair of the TF AAM Thematic Working Group on availability and supply disruptions Daphne Thijssen- Managing director of Tissues & Cells, Sanquin Bloodbank, Netherlands Timmer Steffen Thirstrup Chief Medical Officer, EMA Stefaan van der Team Leader - substances of human origin, Unit Medical Products: Spiegel Quality, Safety, Innovation, European Commission (DG SANTE, EC) Elsa Vecino Technical Director, Access VetMed Elena Wolff-Holz Medical Assessor, PEI, up to recently Chair of EMA’s Biosimilar Medicinal Products Working Party (BMWP) and Alternate member to the Scientific Advice Working Party (SAWP) Saatja: <[email protected]> Saadetud: 09.02.2023 13:14 Adressaat: <[email protected]> Koopia: Kruttwig Klaus <[email protected]>; <[email protected]>; <[email protected]>; VAN DER SPIEGEL Stefaan <Stefaan.VAN-DER- [email protected]> Teema: HMA/EMA multi-stakeholder workshop on shortages on 1 & 2 March 2023 Manused: image002.jpg; DRAFT Agenda - HMA_EMA Multi-stakeholder workshop on shortages.pdf Dear national competent authorities for blood and blood components, As you may already be aware, the HMA/EMA multi-stakeholder workshop on shortages will take place on 1 and 2 March 2023, the agenda is attached for your information. The workshop will be broadcast live, please note that for the parallel breakout sessions, the Agency will only broadcast the session on ‘Biosimilars’. All sessions will be recorded and published after the meeting. Should you wish to join the virtual room in Webex, please contact [email protected] for the joining instructions and specify the breakout session you would like to attend no later than 17 February. The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm