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26 Plasma KCE Reports 120 Legal Status and missions of the Laboratoire Français de Fractionnement et de Biotechnologie - LFB LEGAL STATUS In 2005, LFB (formerly public-law structure) has been transformed into a private-law firm (Edict of 28 July 2005) 13 . However, key members of the Board of Administration are representatives of public authorities (Department of Health, Ministry of Finance), and the majority of the LFB’s shares remains in the hands of public stakeholders only. In today’s form, LFB is a holding company that controls two subsidiary companies: • LFB Biomédicaments (specialized in plasma fractionation and marketing of plasma-derived products). • LFB Biotechnologies (specialized in Biotechnology R&D) THE MISSIONS OF THE LFB LFB is specialized in the following fields: • Immunology: primary immune deficiency, secondary immune deficiency, Kawasaki disease, Guillain-Barré syndrome, etc.. • Hemostasy / Clotting factors: mainly von Willbrand and haemophilia • Anaesthesia / Resuscitation products • RD activities in the field of Biotechnology: • International activities: as most private firms of this industry, LFB is also committed in international activities, especially in plasma fractionation. As described below in the report, it plays an important role on the Brazilian market, as it will assist Brazilian stakeholders in setting up plasma fractionation facilities, and a sustainable supply chain. Connection between the EFS towards the LFB As far as delivery of plasma is concerned, specific targets are fixed between EFS and LFB whereby, the volume of plasma to be delivered by EFS to the FFB is officially set out 14 . These targets are opposable to the EFS. Therefore, the key strategic objective of the latter is to keep up with the evolution of LFB supply needs. Delivery targets have evolved and will evolve as below (liters): Figure 3: EFS Delivery targets to LFB (2005-2011) Source: EFS Corporate data This key driver for the EFS is basically to increase its plasma supply in order to meet the EFS needs, which thus involves an in-depth reflection on the whole collection strategy and processes. Besides, the sale price of the plasma is fixed nationally by the Department of Health. Over the last years, it was reduced from 155 € to 135€ in 2007, and to 105€ in 2008. For all these reasons, the EFS steadily needs to improve its productivity (in terms of process) and also the total volume of collected plasma. In 2008:
KCE Reports 120 Plasma 27 • 73% of plasma delivered to LFB stems from traditional whole blood technique. • 27% from other techniques: plasmapheresis, combined apheresis, and mixed platelets concentrates (MPC). Cost control and EFS processes Costs Issues As mentioned above the EFS has to reach very demanding delivery targets, under strict constraints, especially unilateral sale prices fixing by the Departement of Health. Therefore, the EFS is compelled to deliver an increasing volume of blood to LFB 630 000 liters in 2006; 1,1 Millions liters scheduled for 2011. The main problems for EFS managers are obviously to ensure overall financial balance of collection activities, but also to avoid discrepancies between the collection costs of blood and plasma. One of main driver for EFS’s decision makers is to cut down apherese plasma production costs, step by step, thanks to an increased collection of actually collected plasma and a rationalization of collection techniques. DISTRIBUTION BETWEEN APHERESE PLASMA AND RECOVERED PLASMA In 2007, around 20% of plasma comes from apherese plasma whereas 80% remains recovered plasma. The objective of the EFS is to raise the share of apherese plama over the next year, for technical reasons (mainly increased frequency of donations). Frequency of donation is all the more important as the proportion of donors in the French population remains low (around 4% of the overall population). However, one must bear in mind that cost breakdown between apherese plasma and recovered plasma remains very different: • Costs of Apherese Plasma • 58% connected with collection step • 42% connected with processing, vigilance, and quality-control • Costs of Recovered Plasma • 22% connected with collection step • 78% connected with processing, vigilance, and quality-control Hence, this policy will call for specific efforts and rationalization of the collection step itself as it accounts for the major part of the costs mentioned above. Rationalization can be understood as a systematic use of accurate processes and techniques, but also a better use of human resources, as described below. CLINICAL PRACTICES AND HUMAN RESOURCES Volume of individual donations Across the country, clinical practices remain uneven, in the field of blood and plasma collection. As a practical matter, the volume of individual plasma collection may vary across donation centres and regions. Over the next years, one of the key issues (from a purely technical point of view) is to make sure that field practices are in line with official requirements set out by the EFS, and to standardize these practices. By doing so, the volume of individual collection could be raised significantly. Plasmapherese techniques Until now, 60% of apherese is performed is as a simple apherese and 40% is performed with an additive solution. Three measures will be implemented over the next years to maximize and to standardize the rentability of plasmapherese techniques: • The more intensive use of MPC as additive solutions • The automation of the production of the MPC
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