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viii Plasma KCE Reports 120B En ce qui concerne la transparence des activités et des comptes des organismes subsidiés Une autorité subsidiante doit pouvoir contrôler l’utilisation des subsides qu’elle octroie directement ou indirectement. Par conséquent: • Il est recommandé de lier la poursuite de la subsidiation du prix du plasma vendu au CAF-DCF à une communication transparente o des flux financiers et en volumes relatifs au plasma et aux produits dérivés qui transitent par le CAF-DCF et ses partenaires étrangers o Des termes du contrat qui lie le CAF-DCF à ses partenaires concernant l’utilisation directe ou indirecte du plasma collecté en Belgique de manière à pouvoir vérifier l’utilité des subsides dans le cadre d’une politique d’auto suffisance clairement définie; • Il est également recommandé de mener un audit approfondi des comptes de la CR afin de déterminer avec précision la structure des coûts de l’activité de plasmaphérèse et d’en déduire le subside minimal éventuellement nécessaire pour assurer que cette activité soit financièrement en équilibre, et ainsi soutenir la collecte du niveau souhaité de plasma source.
KCE Reports 120 Plasma 1 Scientific summary Table of contents SCIENTIFIC SUMMARY ........................................................................................................... 1 GLOSSARY ................................................................................................................................. 3 1 INTRODUCTION ............................................................................................................ 5 1.1 CONTEXT ..................................................................................................................................................... 5 1.2 RESEARCH QUESTIONS ........................................................................................................................... 5 2 SUPPLY OF PLASMA DERIVATIVES .......................................................................... 6 2.1 COLLECTION OF PLASMA ...................................................................................................................... 6 2.1.1 Legal and ethical framework .......................................................................................................... 6 2.1.2 Plasma collection in Belgium ........................................................................................................ 12 2.1.3 Plasma collection in other countries .......................................................................................... 22 2.2 TRANSFORMATION OF PLASMA INTO PLASMA DERIVATIVES ............................................... 29 2.2.1 Quick overview of fractionation process .................................................................................. 29 2.2.2 The worldwide supply of plasma products .............................................................................. 32 2.2.3 The supply of plasma stable derivatives in Belgium ................................................................. 34 2.3 LIMITATIONS ............................................................................................................................................. 39 3 DEMAND FOR PLASMA DERIVATIVES: THE CASE OF IMMUNOGLOBULINS .......................................................................................................................................... 40 3.1 USE OF PLASMA DERIVATIVES IN BELGIUM .................................................................................... 40 3.1.1 Methods ............................................................................................................................................ 40 3.1.2 Results .............................................................................................................................................. 40 3.1.3 The case of immunoglobulins ...................................................................................................... 42 3.2 INDICATIONS FOR IMMUNOGLOBULINS ...................................................................................... 43 3.2.1 Recommendations for the use of immunoglobulins................................................................ 43 3.2.2 Evidence review on immunoglobulin effectiveness ................................................................. 49 3.3 CONSUMPTION OF IMMUNOGLOBULINS ..................................................................................... 70 3.3.1 Consumption in other countries ................................................................................................ 70 3.3.2 Consumption in Belgium ............................................................................................................... 74 3.3.3 Estimation of IG quantities to treat the main indications ...................................................... 86 3.3.4 Expected trends in consumption ................................................................................................ 97 4 SELF SUFFICIENCY OF BELGIUM ............................................................................ 98 4.1 WHAT ARE THE RISKS AT WORLDWIDE LEVEL ? ........................................................................ 98 4.1.1 Plasma collection: Key role of the North American Region ................................................. 98 4.1.2 Worldwide demand for plasma products / Focus on IVIG (2000-2008) .......................... 100 4.1.3 Potential changes in demand structure .................................................................................... 100 4.2 CONCEPT OF SELF SUFFICIENCY ..................................................................................................... 101 4.2.1 In Belgium ....................................................................................................................................... 101 4.2.2 In other countries ........................................................................................................................ 103 4.3 HOW TO STAY OR BECOME SELF SUFFICIENT .......................................................................... 111 4.3.1 Strategies to decrease IG use: lessons learned ...................................................................... 111 4.3.2 Strategies to decrease IG use: what could be applied in Belgium ...................................... 115 4.3.3 Increasing the capacities of collecting plasma ......................................................................... 115 4.3.4 Transparency and better control of the supply of derivatives ........................................... 116 4.4 CONCLUSIONS ....................................................................................................................................... 117 5 APPENDICES ............................................................................................................... 118 APPENDIX 1: ETHICAL DIMENSION OF DONATION: QUICK OVERVIEW .................................... 118 APPENDIX 2 : SEARCH TERMS ........................................................................................................................ 120 APPENDIX 3: GRADE CRITERIA FOR ASSIGNING GRADE OF EVIDENCE ...................................... 121 APPENDIX 4: IMMUNO-HAEMATOLOGICAL SURVEY ........................................................................... 122 APPENDIX 5: POTENTIAL CHANGES IN DEMAND VOLUME: FOCUS ON TWO EMERGING COUNTRIES .............................................................................................................................................. 124
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Page 5 and 6: KCE Reports 120B Plasma i PRÉFACE
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73. Financement du programme de soi
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