Belgium - IPFA...Historical overview of donations (Flanders, Belgium) 4 0 50.000 100.000 150.000...
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Belgium Recent program to increase plasmapheresis for PDMP Philippe Vandekerckhove, MD, PhD Belgian Red Cross
Transcript of Belgium - IPFA...Historical overview of donations (Flanders, Belgium) 4 0 50.000 100.000 150.000...
BelgiumRecent program to increase plasmapheresis for PDMP
Philippe Vandekerckhove, MD, PhD
Belgian Red Cross
Facts & Figures: Belgian Blood Banking system
• 11,5 million inhabitants
• Separate legislation
• Labile blood products (100% self-sufficient)
• Stable blood products / PDMP (50% self-sufficient)
• Universal VNRD (whole blood, plasma, platelets)
• Responsibilities
• Federal Ministry of Health
• Competent authority: Federal Agency for medicines and health products
4 Licensed Blood Establishments
Blood Establishment % RBC
Flanders Belgian Red Cross – Flanders 62
Frenchspeaking part Belgian Red Cross - french
community
32
University Hospitals Charleroi 5
University Hospitals Mont-Godinne 1
Historical overview of donations (Flanders, Belgium)
40
50.000
100.000
150.000
200.000
250.000
300.000
350.000
400.000
1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020
Plasmapheresis
Whole blood
Historical overview of donations (Flanders, Belgium)
50
50.000
100.000
150.000
200.000
250.000
300.000
350.000
400.000
1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020
Phase 1 Phase 4Phase 3Phase 2
0
50.000
100.000
150.000
200.000
250.000
300.000
350.000
400.000
1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020
Plasmapheresis
Whole blood
• Aim
• risk mitigation for Belgian patients (access; price of end product)
• fairness
• Roles & responsibilities• Blood Establishments: collection
• + 5% / year over 4 years
• Commercial companies: fractionation & distribution & sales• on the basis of 4-yearly tender
• Belgian government: “honest” broker
• Tender for 50% of IVIG market (as driver) / 100 % albumin
• Specifications• Belgian plasma returns preferentially to Belgian patients
• mandatory use of PDMP by hospitals at prices set by the MOH (thus controlling price setting)
• surpluses (f.i. albumin) can be used abroad with approval of the MOH
• strategic stock of • plasma: 2 months (180.000/12= 15.000 x = 30.000 L)
• PMDP: 3 months
• Tender started 12/2017; won by CSL• new tender starts 12/2021
• evaluation by different stakeholders by government planned
Initiative Belgian Government: measures taken
Initiative Belgian Government: plasma budgeted
50.000
70.000
90.000
110.000
130.000
150.000
170.000
190.000
210.000
2 0 1 7 2 0 1 8 2 0 1 9 2 0 2 0 2 0 2 1
LITERS
total (budget) PF (budget)
50 % self-sufficiency
61 % self-sufficiency
Initiative Belgian Government: plasma collected 2018/19
50.000
70.000
90.000
110.000
130.000
150.000
170.000
190.000
210.000
2017 2018 2019 2020 2021
LITERS
total (budget) total (realised) PF (budget) PF (realised)
5 %
32 %
10 %
41 %
x
Similar pattern of PF donations in other countries
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50000
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16
Donors(BiD)
Tapninger(BiD)
France Denmark
Courtesy EFS – A. Volle Courtesy J. Georgsen
• introduction of EU common market for pharmaceuticals w/o accompanying measures
to ensure minimal levels of plasma sourcing from within EU • overlooked consequences that do not exist for chemical-derived pharmaceuticals:
• import of cheaper plasma from outside EU
• which led to erosion of the plasma donor base in many EU countries
• Belgian self-sufficiency• was/is 100 % for labile blood products that it legislates itself
• was 100 % for stable blood products till introduction of EU common market, then dropped to 50% • lost 30 years because of this: will reachieve 1990 level in ± 2022
• Belgian approach: possible to collect significant and increasing amounts of plasma • Without financial compensation or separate approaches
• i.e. by expanding collection capacity & by traditional communication
• but does require LT predictability of donor base management• regulatory conditions (re)created by Belgian government (50% of market & locally)
• achieving higher EU independence for PDMP requires derogation of EU common market legis-
lation to mandate minimal levels of sourcing from within EU (f.i. annual increase over 10 yrs)
Conclusions
