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134 Plasma KCE Reports 120 TIME MANAGEMENT AND COST STRUCTURE Tthe whole donation process (44 min) is divided into 4 steps - Step 1: Reception time Step 2: Medical interview - Step 3: Donation in donat. room Step 4: Plasma processing and data collection Cost Structure: see below Table 50: Cost Structure / Plasma Service Europe Budget Codes Average Costs Administrative Costs 4 € Renting and side costs 4.10 € - 5.50 € Personal / HR 23 – 28 € Advertising 1.70 € Maintenance Costs 2.30€ Capital Allowances 0.70€ Miscellaneous Expenses 2.60€ TOTAL 40.40 € – 46.80 € FINANCIAL COMPENSATION 16-20 € TOTAL COSTS 56.40€ - 66.80€ Smooth running of this industry implies a noticeable “investment” in financial compensation (28% of the costs) and Human Resources to recruit and retain donors. However, financial compensation does not prevent these centres from being financially profitable and sustainable. Figure 22: Plasma Service Europe: Cost structure for plasma collection Miscellaneous 4% Capital Allow. 1% Maintenance 4% Advertis. 2% Source : Corporate Data Fin.Compensati on 28% Admin. 13% Hum‐Res 40% Renting 8%
KCE Reports 120 Plasma 135 APPENDIX 8: AUSTRALIA: INSTITUTIONAL ASPECTS ROLE OF THE DIFFERENT STAKEHOLDERS IN AUSTRALIA National Blood Authority Overarching and steering institution in charge of the Australian National blood and plasma policy (see core report). Australian Red Cross Blood Service (ARCBS) CSL Limited The ARCBS is responsible for the collection of blood and plasma from donors and the distribution of fresh plasma and some imported plasma products, to the health system. This firm plays a key role in the supply chain, as it is responsible for fractionating the plasma supplied by the ARCBS and providing plasma products back to the ARCBS for further distribution. CSL Limited has to assume on many points public law obligations, as commissioned by the NBA (even if CSL is not a public law body). Other pharmaceutical firms More punctually, other firms can be responsible for the supply and distribution of specific range of products, whenever these products are not produced in Australia or when the Australian domestic capacity is not in the position to meet the patients’ needs. Therapeutic Goods Administration (TGA) The TGA is an independent body that is responsible for regulating the whole sector in the field of efficacy, safety standards, and quality of blood and blood products. It is also entrusted with auditing of Good Manufacturing Practice and product recalls (see below / Contract between CSL and the NBA). Health care professionals and suppliers The latter stakeholders also play a role, even informally, in advising the NBA a number of formal or informal working groups and fora on technical subjects (eg: Professional Community Forum, NBA Fellows Program, and Clinical Advisory Council). MANAGEMENT OF SUPPLY: QUICK OVERVIEW On a routine basis, the NBA notifies the Australian Red Cross Blood Service annually of the volume of plasma to be supplied to CSL for fractionation. Under the terms of the Plasma Products Agreement (PPA), the NBA must give CSL the Annual Supply Estimate for a particular financial year by no later than the preceding 30 November. Although these forecasts are not binding on the NBA, it is required under the terms of the PPA to purchase 95% of the plasma products produced in accordance with the Confirmed Quarterly Requirements that the NBA furnishes to CSL six months in advance of each quarter. The NBA also needs to make sure that suppliers actually maintain reserve holdings of products, in order to ensure that timely and adequate supplies are available to meet clinical needs.
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KCE Reports 120B Plasma i PRÉFACE
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KCE Reports 120B Plasma iii MÉTHOD
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KCE Reports 120B Plasma v En ce qui
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KCE Reports 120B Plasma vii RECOMMA
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KCE Reports 120 Plasma 3 GLOSSARY A
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