Product delivery in the developing world: options, opportunities and threats.
While many developed countries are moving to recombinant coagulation factors as their preferred modality for delivering haemophilia care, the cost of these products currently impedes their access by developing countries. A number of options are available to these countries for the provision of plasma-derived therapeutic products. The decreasing market for plasma-derived coagulation factors in the developed world is leading to the generation of a surplus of these products and an ability to offer them outside their traditional markets if prices are affordable. Current indications are that the commercial fractionation industry of the developed world has an excess capacity in both available plasma and fractionation plants. It would seem that accessing this capacity might have attractions for the developing world. Countries wedded to achieving self-sufficiency in haemophilia products may elect to develop a strategy for fractionating domestically sourced plasma. This may be achieved by the generation of a capacity to fractionate within the country or by contracting the fractionation to an external agency overseas. However, reliance on domestic plasma should not be allowed to impede access to sufficient and safe coagulation products. Irrespective of the route chosen, products need to attain satisfactory compliance to standards for safety, quality and efficacy. This is best done through alignment of the products with the requirements of credible regulatory agencies. While the approval of the mainstream regulators of the developed world affords considerable assurance regarding product quality, the increasing efforts made by fractionation agencies in the developing world to attain best practice is commendable and augurs well for the enhancement of haemophilia care in these countries.
Blood and Tissues Unit, Office of Devices, Blood and Tissues, Australian Therapeutic Goods Administration, Woden ACT, Australia 2606. albert.farrugia@bealth.gov.au
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D001779:Blood Coagulation Factors / Q000191:economics / Q000600:supply & distribution*; D005591:Chemical Fractionation / Q000379:methods; D003257:Consumer Product Safety; D003365:Costs and Cost Analysis; D003906:Developing Countries; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration; D006467:Hemophilia A / Q000188:drug therapy; D006801:Humans; D011994:Recombinant Proteins / Q000191:economics / Q000600:supply & distribution
D001779:Blood Coagulation Factors; D011994:Recombinant Proteins