The Dublin Consensus Statement on vital issues relating to the collection of blood and plasma and the manufacture of plasma products

Abstract

The requirement for plasma products manufactured from both source and recovered plasma for the treatment of many medical conditions is projected to increase substantially in the course of the next 5 years [1]. Patient organizations representing many thousands of patients with rare disorders who are dependant on products manufactured from plasma formed a coalition of plasma usersPLUSin 2009. PLUS represents the concerted views of seven organisations, the International Patients Organisation for Primary Immunodeficiency (IPOPI), the World Federation of Hemophilia (WFH), the European Haemophilia Consortium (EHC), Alfa Europe, Idiopathic Thrombocytopenic Purpura Support Organisation (ITP), Hereditary Angiodema International (HAEI) and Guillain Barre Syndrome Foundation International (GBS ⁄CIDP). Over the last thirty years, the manufacture from plasma of an increasing range of stable clinical products and the availability of plasmapheresis collection technology has led to the development of a commercial industry based on plasma-only donations from remunerated donors. In countries that do not permit a remunerated donor system, plasma collections are limited to those collected by blood establishments operating with nonremunerated donors. The growing global requirement for safe and effective plasma products [1] to meet the health needs of patients mean that plasma from both the commercial plasma and the blood sectors are essential to provide the range and quantity of plasma products required. IPOPI estimate that < 15% of persons with primary immune deficiency worldwide are diagnosed and treated [2]. In 2007, there was a total of 26AE5 million litres of plasma available for fractionation including 8AE6 million litres of recovered plasma and 17AE9 million litres of source plasma [1]. It is estimated that the global requirement for plasma for fractionation by 2015 may be 41AE7 million litres even in the absence of any new indications for IVIG [1]. Patients who are dependant on these life-saving therapies want to be reassured that they will have access to a sufficient supply of safe and effective therapy manufactured from the plasma of carefully selected and tested donors in the future. National policies in most cases only permit a non – remunerated system of blood and plasma collection. This means that commercial plasma collections are limited to a few countries which allow both remunerated and nonremunerated donations including the United States of America, Germany, Czech Republic and Austria. Most countries utilize domestic nonremunerated blood collection to fully satisfy their requirements for labile blood components. However, the vast majority of these countries also import additional products from the commercial plasma sector to fully meet their health needs. The plasma fractionation sector comprises both commercial and not for profit manufacturers, and these compete in both global and national markets. Where both commercial and not for profit plasma collection or manufacturing systems coexist or compete at a national level, there can be tensions and disagreements between the sectors on issues such as the relative safety profile of remunerated and nonremunerated donors, as well as competition for donors. Correspondence: Brian O. Mahony, Cheif Executive, Irish Haemophilia Society, Steering Group PLUS, Cathedral Court, New Street South, Dublin 8, Ireland E-mail: brian@haemophilia.ie Vox Sanguinis (2010)