Towards Establishing an EU Real-World Evidence Generation Action Plan for Better Healthcare Systems & Patient Outcomes

The need for an EU Real-World Evidence (RWE) Generation Action Plan was a key conclusion from the 2020 RWE4Decisions Conference held under the auspices of the German EU Presidency. This call was taken up in the June EPSCO Council Conclusions on Access to Medicines under the Portuguese EU Presidency.  
Over the past year, RWE4Decisions has held payer-led multi-stakeholder workshops on outcomes-based managed entry agreements, seeking to align data collection requirements and identify appropriate sources to resolve decision-relevant uncertainties as outlined in the TRUST4RD tool and RWE4Decisions stakeholder actions

RWE4Decisions shared recommendations on how an EU RWE Generation Action Plan, defined through multi-stakeholder collaboration, can guide payers and HTA decision-makers, as well as industry, on the data required to address uncertainties at the time of launch of potentially transformative therapies for patients.


  • Frank Vandenbroucke, Belgian Deputy Prime Minister and Minister for Social Affairs and Public Health
  • Rui Santos Ivo, President, National Authority of Medicines and Health Products (INFARMED)
  • Flora Giorgio, Deputy Head of Unit, Unit for Medical Devices and Health Technology Assessment, DG SANTE, European Commission
  • Peter Arlett, Head of Data Analytics and Methods Taskforce, European Medicines Agency (EMA)
  • Jo De Cock, former CEO of the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV)
  • Diane Kleinermans, President of the Commission of Drugs Reimbursement, Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV)
  • Judith Fernandez, Coordinator – RWE unit, HTA division, Haute Autorité de Santé (HAS) 
  • Nicole Mittmann, Chief Scientist and Vice-President of Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH)
  • Aldo Golja, Senior Policy Advisor on Drug Pricing and Reimbursement, Ministry of Health, Welfare and Sports, The Netherlands 
  • Tuomas Oravilahti, Pharmacoeconomist, Finnish Medicines Agency (FIMEA)
  • Flemming Sonne, CEO, Amgros
  • Anna Nachtnebel, Senior HTA Expert, Austrian Social Insurances
  • Yann Le Cam, Chief Executive Officer, EURORDIS – Rare Diseases Europe
  • Karen Facey, Visiting Senior Research Fellow, Usher Institute, University of Edinburgh
  • Alexander Natz, Secretary-General, EuropeanConfederation of Pharmaceutical Entrepreneurs (EUCOPE)
  • Karen Coulton, Global Head of Payer Engagement, AstraZeneca  

The event was moderated by Jacki Davis.

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