Pharmaceuticals Policy and Law - Volume 7, issue 0

Authors: Watters, David

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 179-182, 2006

Authors: Grifols, Victor

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 185-198, 2006

Authors: Rankin, Peter

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 199-207, 2006

Authors: Burnouf, Thierry

Article Type: Research Article

Abstract: Human plasma is used to prepare essential therapeutic products with unique features compared to traditional pharmaceutical products and other biopharmaceuticals. The raw material is inherently unique due to its human origin. The need to fulfill strict collection practices and testing, and the shrinking population of eligible donors, limit plasma availability and influence greatly the economics of the whole plasma industry. Consolidation in the industry has amplified and is making access to plasma, a highly valuable …natural commodity, more difficult. In this industry, plasma has become the single most important factor of the cost of end-products. In addition, the fractionation of human plasma is a "cracking" process where manufacturing technologies must allow extracting an economically balanced portfolio of products with appropriate quality, safety, and recovery profiles. Over the years, although the size of production batches has generally increased (within limits accepted by regulatory authorities), the manufacturing costs of plasma products have increased as production methods have become more complex (in particular with the introduction of viral reduction treatments) and product recovery has been affected negatively (especially for coagulation factors). Therefore (a) ensuring the production of at least 3 to 4 products from each batch of plasma and (b) economies of scale have been leading to major consolidation in this industry to ensure appropriate allocation of plasma and manufacturing costs. Efforts need to be pursued to improve the efficiency of the fractionation process, improve proteins recovery, and expand the universe of ailments treatable by niche plasma products to enhance plasma utilization and cost-sharing potentials. Historically, the supply of plasma products has never met the global needs and has averaged a 20–80% deficiency. To date, the inherent economical requirement to ensure a production balance of at least 3 or 4 products from plasma implies that with current fractionation technologies and current reimbursement practices, shortage of market-leading products, like immunoglobulins or alpha 1-antitrypsin, will continue if not worsen. Show more

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 209-218, 2006

Authors: Rautonen, Jukka

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 221-224, 2006

Authors: von Auer, Friedger

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 225-231, 2006

Authors: Betts, Jonathan P.

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 233-241, 2006

Authors: Rinaldi, Giovanni

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 243-253, 2006

Authors: Rouger, Philippe

Article Type: Research Article

Abstract: The French transfusion organization is based on principles and structures; the principles are: voluntary, anonymous, non-remunerated donations, focussing on self-sufficiency. There are three structures: the EFS (Etablissement Français du Sang – French Blood Establishment), for labile blood products; the LFB (Laboratoire Français du Fractionnement et des Biotechnologies – French Laboratory for Fractionation and Biotechnologies), for blood derivatives; the INTS (Institut National de la Transfusion Sanguine – Blood Transfusion National Institute) for …activities such as Reference, Research, Education & Training. The French health policy aims at defending ethics and self-sufficiency for all human blood derivatives. The French self-sufficiency is limited to cellular products as France is considered a rare user compared with other European countries � its annual growth rate is of about 1% only. Situation looks quite different with blood derivatives: between 2001 and 2004, consumptions of albumin, clotting factors, and immunoglobulins have shown an average annual increasement of 6.1% to 9.7%. All these elements have to be appreciated bearing in mind that beyond the 10 years ahead no substitute at all will be able to replace the human blood, making it a full necessity. Show more

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 255-259, 2006

Authors: Bult, Jan M.

Article Type: Research Article

Abstract: Plasma protein therapies are either manufactured using human plasma as starting material or through the use of alternative technologies to produce recombinant plasma protein therapies. Most of the chapter is written with a focus on the plasma that is used for the manufacture of stable therapies.

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 263-269, 2006

Authors: Prévot, Johan

Article Type: Other

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 273-282, 2006

Article Type: Other

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 285-289, 2006

Article Type: Other

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 291-310, 2006

Article Type: Other

Citation: Pharmaceuticals, Policy and Law, vol. 7, no. 0, pp. 311-327, 2006