Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions : Synthese

38 p.ill.,SUMMARY 1 -- 1. INTRODUCTION, OBJECTIVE AND METHODOLOGY 3 -- 1.1. MARKET ACCESS IS REGULATED AT THE EUROPEAN LEVEL, WHILE REIMBURSEMENT IS DETERMINED BY THE MEMBER STATES. 3 -- 1.1.1. Medicinal products 4 -- 1.1.2. Medical devices 5 -- 1.1.3. Changes in the European regulations 5 -- 1.2. INITIATIVES THAT HAVE INCREASED THE EVIDENCE GAP AND INITIATIVES TO REDUCE THE EVIDENCE GAP 6 -- 1.3. OBJECTIVE OF THIS STUDY AND STUDY QUESTIONS 6 -- 2. ETHICAL AND LEGAL CONSIDERATIONS 9 -- 2.1. ETHICAL STANDARDS ON THE PROVISION OF EVIDENCE AND TRANSPARENCY 9 -- 2.2. EUROPEAN LEGISLATION ON MEDICINAL PRODUCTS 10 -- 2.2.1. Evidence requirements 10 -- 2.2.2. Procedure for the authorisation of clinical studies 10 -- 2.2.3. Transparency requirements 10 -- 2.3. EUROPEAN LEGISLATION ON MEDICAL DEVICES 10 -- 2.3.1. Evidence requirements 11 -- 2.3.2. Authorisation procedure for clinical research 11 -- 2.3.3. Transparency requirements 11 -- 2.4. EUROPEAN EVALUATION OF HEALTH TECHNOLOGY 12 -- 3. ANALYSIS OF THE INAMI/RIZIV DOSSIERS 12 -- 3.1.1. Results for the 18 assessment dossiers for medicinal products 13 -- 3.1.2. Results for the 18 assessment dossiers for medical devices 13 -- 4. LITERATURE STUDY 14 -- 4.1. MEDICINAL PRODUCTS 14 -- 4.2. MEDICAL DEVICES 15 -- 5. DISCUSSION AND POSSIBLE SOLUTIONS 16 -- 5.1. THE SEPARATION BETWEEN REGULATORY BODIES AND HTA BODIES; MORE COLLABORATION NECESSARY 16 -- 5.1.1. Study population requirements 19 -- 5.1.2. Requirements regarding the intervention 19 -- 5.1.3. Requirements regarding the comparator 19 -- 5.1.4. Requirements regarding outcomes 21 -- 5.1.5. Toward more efficient clinical studies; limitations of observational ‘real-world data’ 21 -- 5.1.6. Should the threshold of evidence for medical devices be lower? 22 -- 5.2. TRANSPARENCY REQUIREMENTS 23 -- 5.2.1. For medicinal products 23 -- 5.2.2. For medical devices 23 -- 5.3. PUBLISHED POLICY RECOMMENDATIONS 23 -- RECOMMENDATIONS 27 -- REFERENCES 3