Title page 1

Contents 6

Foreword 4

Acknowledgements 5

Executive summary 9

1. EU supply chains of three medical countermeasures 12

1.1. Objectives, selection of case studies, sources and methods 15

1.1.1. Objectives 15

1.1.2. Selection of case studies 15

1.1.3. Overview of sources and methods to identify and analyse supply chains 17

1.2. Case study: Injectable systemic corticosteroids 22

1.2.1. Identification of products and manufacturers selling in the EU/EEA market 22

1.2.2. Demand for injectable corticosteroids in the EU/EEA market 27

1.2.3. Analysis of supply chains for injectable corticosteroids 29

1.2.4. Analysis of shortages 36

1.3. Case study: Influenza vaccines 39

1.3.1. Data sources for monitoring vaccine supply and production capacity 39

1.3.2. Identification of influenza vaccines and manufacturers selling in the EU/EEA market 40

1.3.3. Demand for influenza vaccines in the EU 41

1.3.4. Analysis of influenza vaccine supply chains 44

1.3.5. Analyses of shortages 50

1.4. Case study: PCR tests for influenza 50

1.4.1. Mapping of influenza PCR tests sold in EU Member States 52

1.4.2. Influenza PCR tests identified in the EU market 55

1.4.3. Analysis of the demand for influenza RT-PCR in the EU 56

1.4.4. Supply chains of manufacturers of CE-marked influenza PCR tests 57

1.4.5. Final remarks 64

References 65

Annex 1.A. Detailed overview of data sources investigated 72

Annex 1.B. IQVIA sales data coverage for influenza vaccines 83

Annex 1.C. Manufacturers of CE-marked RT-PCR tests for influenza 85

Annex 1.D. Use of ERVISS Surveillance system to evaluate the use of PCR tests for influenza 95

Annex 1.E. Surveys conducted as part of the study 97

Annex 1.F. Risk class classification for in vitro diagnostics under the IVDR 102

Notes 103

2. Evaluation of existing and potential international co-operation instruments 106

2.1. Identification of international co-operation instruments and evaluation framework 109

2.1.1. Identification of international co-operation instruments 109

2.1.2. Evaluation framework 110

2.1.3. Definition of criteria by objective category 112

2.2. Objective 1: Expanding and diversifying supply chains through international co-operation instruments 115

2.2.1. Impact of trade agreements and investments treaties on expansion of manufacturing capacity and diversification of supply 115

2.2.2. The potential of strategic partnerships 117

2.3. Objective 2: Ensuring continuous and seamless trade of medical supplies and inputs 119

2.3.1. Regulatory harmonisation 119

2.3.2. Reduction or removal of trade barriers through trade agreements 122

2.3.3. Trade facilitation 122

2.4. Objective 3: Managing supply and enhancing security of supply 122

2.5. Evaluation of O.3.1: Information sharing and supply chain monitoring (the "MedMIS" model) 123

2.5.1. Objective, decision context and scope 123

2.5.2. Evidence and lessons from the Agricultural Market Information System (AMIS) 126

2.5.3. Structural feasibility of an AMIS-like system in pharmaceuticals 128

2.5.4. Operational feasibility: Minimum viable dataset and architecture 130

2.5.5. Testing the MedMIS proof-of-concept across tracer product categories 132

2.5.6. Impacts and standards 134

2.5.7. Participation incentives and geopolitical constraints 135

2.5.8. Risks and negative externalities 137

2.5.9. Implementation burden and value-for-money 138

2.5.10. Policy conclusions: Feasibility pre-requisites and operational conditions 139

2.6. Evaluation of O.3.2: Pooled procurement with international partners 142

2.6.1. Objective and rationale 142

2.6.2. Institutional models and global practice 143

2.6.3. Quality assurance, logistics and the "single buyer / single approver" logic 152

2.6.4. Implementation challenges and risks 154

2.6.5. Impacts on consumers, industry and environment 157

2.6.6. Product scope and alignment with the Union list of critical medicines 158

2.6.7. Implementation timeline and critical path 159

2.6.8. Opportunities and strategic value 159

2.7. Evaluation of O.3.3: International co-operation on pooled pharmaceutical reserves 163

2.7.1. Purpose, scope and strategic context 163

2.7.2. Instrument concept 167

2.7.3. Third-country participation tiers: Eligibility, reciprocal commitments and access modalities 170

2.7.4. Stress-testing on tracer archetypes 171

2.7.5. Operating model and design specifications 171

2.7.6. Expected effects 174

2.7.7. Risks: Moral hazard, crowd-out and political rationing 175

2.7.8. Legal architecture and feasibility 176

2.7.9. Impacts on consumers, industry and environment 178

2.7.10. Overall assessment and recommendations 180

2.8. Comparative assessment of the three instruments proposed to manage supply and enhance supply security (Objective 3) 181

References 183

Annex 2.A. Mutual recognition agreements 191

Annex 2.B. MedMIS: Supporting evidence and technical specifications 194

Annex 2.C. MedPPA: Supporting evidence and technical specifications 205

Annex 2.D. RescPool: Supporting evidence and technical specifications 215

Notes 228

3. New technologies and innovations to better monitor medical supply chains and forecast demand 229

3.1. Introduction 231

3.2. Public frameworks 234

3.2.1. EU Falsified Medicines Directive (FMD) 236

3.2.2. The US Drug Supply Chain Security Act (DSCSA) 237

3.2.3. Türkiye's pharmaceutical track-and-trace system (ITS) 238

3.2.4. Canada's community-led DataMatrix initiative 239

3.3. Private initiatives 239

3.3.1. Maersk/IBM 242

3.3.2. Pfizer 242

3.3.3. Johnson & Johnson 244

3.3.4. DHL 244

3.3.5. USP Medicine Supply Map 245

3.4. Key challenges in creating effective monitoring mechanisms for medical supply chains 246

3.4.1. Standardisation and international interoperability 246

3.4.2. Technological compatibility and infrastructure 249

3.4.3. Product and input coverage scope 250

3.4.4. Information requirements and data collection mechanisms 252

3.4.5. Incentives, obligations and public health benefits 254

3.4.6. Data privacy and security concerns 256

3.5. Recommendations for improving medical countermeasures supply chain monitoring and enhancing international co-operation 257

3.5.1. Limits of existing EU monitoring tools for medical countermeasures supply chains 258

3.5.2. Leverage and extend existing frameworks for the early detection of emerging supply chain risks 259

3.5.3. Evaluate alternative system architectures to integrate cross-border data sources 260

3.5.4. Translating signals into operational decision making: Enhancing predictive analytics and demand forecasting 263

3.6. Conclusion on new technologies and innovations to better monitor medical supply chains 264

References 266

Notes 273

Table 1.1. Data sources explored and information extracted 18

Table 1.2. Number of unique product presentations and MAHs for selected injectable corticosteroids in the EU/EEA market, 2024 23

Table 1.3. Market structure and supplier presence for selected injectable corticosteroids in EU/EEA countries, 2024 24

Table 1.4. Market concentration for presentations of injectable corticosteroids, 2024 26

Table 1.5. Parallel importers' share of total sales of injectable corticosteroids, 2024 26

Table 1.6. Assessment of IQVIA's coverage of influenza vaccine market by country 39

Table 1.7. Number of manufacturers and influenza vaccines for the EU/EEA market during the 2024/25 influenza season 41

Table 1.8. Location of bulk vaccine production sites for main manufacturers of influenza vaccines sold in the EU, as of 2023 45

Table 1.9. Types of influenza vaccines currently supplied or reserved for the EU market by CSL Seqirus 48

Table 2.1. List of international co-operation instruments considered in this report 110

Table 2.2. Assessment criteria for objective O1, potential data sources and feasibility for 1) past experiences in other domains and 2) for... 113

Table 2.3. Assessment criteria for objective O2 (trade facilitation) and potential data sources 113

Table 2.4. Assessment criteria for objective O3, potential data sources and feasibility 114

Table 2.5. Potential impact of FTA and IT provisions on EU medical supply chains 116

Table 2.6. Assessment summary (scorecard) 141

Table 2.7. Comparative cost-effectiveness of security-of-supply tools 150

Table 2.8. Indicative award criteria for MedPPA security-of-supply tenders 151

Table 2.9. An indicative implementation timeline for MedPPA 159

Table 2.10. Net assessment of a MedPPA mechanism 160

Table 2.11. Comparative assessment of institutional configurations 162

Table 2.12. Indicative mapping and suitability of medicines included in the Union list 166

Table 2.13. Indicative RescPool implementation phases and pass/fail gates 178

Table 2.14. RescPool operational viability checklist: Hinge points, failure modes and verification 181

Table 2.15. Comparative assessment of the three Objective 3 instruments 182

Table 3.1. Summary of public frameworks reviewed 235

Table 3.2. Summary of private initiatives reviewed 241

Boxes 20

Box 1.1. Developments in EU regulatory frameworks with relevance to medical countermeasures supply chain monitoring 20

Box 1.2. Injectable corticosteroid manufacturing at a glance 29

Box 1.3. Key findings from a survey of injectable corticosteroid manufacturers (six respondents) 31

Box 1.4. Vaccine supply chains at a glance 44

Box 1.5. Insights from interview with influenza vaccine manufacturer CSL Seqirus 48

Box 1.6. RT-PCR workflow and components of an RT-PCR kit 50

Box 1.7. Key steps in viral acid nucleic extraction prior to RT-PCR testing 52

Box 1.8. Insights from interview with a procurement expert 57

Box 1.9. Risk certification process for IVDs under the IVDR 61

Box 2.1. The Critical Medicines Alliance 112

Box 2.2. Two modes of scarcity: Availability-driven and agency-driven crises 125

Box 2.3. Beyond early warning: How MedMIS could improve allocation of available stock 132

Box 2.4. Pooled procurement under scarcity: Three recurring failure modes 147

Box 2.5. Choosing the "right" reserve modality: A decision heuristic for assigning products to RescPool's hybrid architecture 171

Box 3.1. Digital technologies transforming supply chains 232

Box 3.2. Legacy national verification systems in Belgium, Greece and Italy 236

Box 3.3. Technologies supporting interoperability 243

Box 3.4. Global standards for product identification and tracing 247

Box 3.5. The European Shortages Monitoring Platform 253

Box 3.6. ATHINA: The EU operational platform for medical countermeasures preparedness and response 257

Box 3.7. Calculation of net stocks of medicines using FMD repositories 259

Annex Table 1.A.1. HS codes for injectable corticosteroids 76

Annex Table 1.A.2. Overview of sources and databases considered for the study 77

Annex Table 1.B.1. Estimated coverage of IQVIA sales data for influenza vaccines across countries 83

Annex Table 1.C.1. Overview of manufacturers of CE-marked PCR kits for influenza diagnosis as of 15 January 2026 85

Annex Table 1.F.1. Discrepancies on risk classification for influenza IVDs 103

Annex Table 2.A.1. Mutual recognition agreements between EU and non-EU countries for medical products, as of December 2025 191

Annex Table 2.B.1. Illustrative "minimum viable" operational indicator set for MedMIS 196

Annex Table 2.B.2. Stress-testing MedMIS: Feasibility assessment across tracer product categories 197

Annex Table 2.B.3. Budgetary benchmarks and indicative MedMIS cost envelopes (order-of-magnitude) 201

Annex Table 2.B.4. Scenario A cost decomposition (annual steady-state) 202

Annex Table 2.C.1. Comparator procurement mechanisms: Design features relevant to MedPPA 207

Annex Table 2.D.1. Summary: Stress-test findings by product type 220

Annex Table 2.D.2. Indicative RescPool performance monitoring framework 222

Annex Table 2.D.3. Indicative buffer obligations by product category 225

Annex Boxes 95

Annex Box 1.D.1. ERVISS Surveillance system types and case definitions 95