Foreword 3

Acknowledgements 4

Executive summary 8

1 EU supply chains of three medical countermeasures 11

  1.1. Objectives, selection of case studies, sources and methods 14

  1.2. Case study: Injectable systemic corticosteroids 21

  1.3. Case study: Influenza vaccines 38

  1.4. Case study: PCR tests for influenza 49

  References 64

  Annex 1.A. Detailed overview of data sources investigated 71

  Annex 1.B. IQVIA sales data coverage for influenza vaccines 82

  Annex 1.C. Manufacturers of CE-marked RT-PCR tests for influenza 84

  Annex 1.D. Use of ERVISS Surveillance system to evaluate the use of PCR tests for influenza 94

  Annex 1.E. Surveys conducted as part of the study 96

  Annex 1.F. Risk class classification for in vitro diagnostics under the IVDR 101

  Notes 102

2 Evaluation of existing and potential international co-operation instruments 105

  2.1. Identification of international co-operation instruments and evaluation framework 108

  2.2. Objective 1: Expanding and diversifying supply chains through international co-operation instruments 114

  2.3. Objective 2: Ensuring continuous and seamless trade of medical supplies and inputs 118

  2.4. Objective 3: Managing supply and enhancing security of supply 121

  2.5. Evaluation of O.3.1: Information sharing and supply chain monitoring (the “MedMIS” model)122

  2.6. Evaluation of O.3.2: Pooled procurement with international partners 141

  2.7. Evaluation of O.3.3: International co-operation on pooled pharmaceutical reserves 162

  2.8. Comparative assessment of the three instruments proposed to manage supply and enhance supply security (Objective 3) 180

  References 182

  Annex 2.A. Mutual recognition agreements 190

  Annex 2.B. MedMIS: Supporting evidence and technical specifications 193

  Annex 2.C. MedPPA: Supporting evidence and technical specifications 204

  Annex 2.D. RescPool: Supporting evidence and technical specifications 214

  Notes 227

3 New technologies and innovations to better monitor medical supply chains and forecast demand 228

  3.1. Introduction 230

  3.2. Public frameworks 233

  3.3. Private initiatives 238

  3.4. Key challenges in creating effective monitoring mechanisms for medical supply chains 245

  3.5. Recommendations for improving medical countermeasures supply chain monitoring and enhancing international co-operation 256

  3.6. Conclusion on new technologies and innovations to better monitor medical supply chains 263

  References 265

  Notes 272