The Dublin Consensus Statement 2011 on vital issues relating to the collection and provision of blood components and plasma‐derived medicinal products

Abstract

Following a conference in Dublin in 2010, a consensus statement was published in this journal (1). In January 2011, a follow-up conference was convened in Dublin under the auspices of the plasma users coalition (PLUS) to further consider the statement produced in Dublin in 2010. The goal was to negotiate a revised set of principles which could be potentially accepted by most stakeholders including global patient, donors, manufacturing and provider organisations. PLUS was eager to continue the constructive dialogue that commenced between key stakeholders in 2010. PLUS represents the concerted views of seven patient organisations, whose members are dependent on products manufactured from plasma. The goal of PLUS in this work is to help encourage the production of a sufficient supply of safe and effective plasma-derived medicinal products (PDMPs) to meet the global needs of patients. By recognising that the collection systems for blood components and PDMPs are interrelated in a number of countries, this meeting considered the collection of both blood and plasma and the manufacture of PDMPs from both the industry and not for profit sectors, and the views of national blood authorities, patient and donor organisations. The meeting was attended by the following persons representing organisations as follows: PLUS members: Brian O’Mahony (Convenor) -European Haemophilia Consortium (EHC) and Irish Haemophilia Society, David Watters-IPOPI, Larry Warren, Johan Prevot-IPOPI, Uwe Schlenkrich-EHC, David Page-WFH, Other participants: Mark Skinner-A-PLUS and World Federation of Hemophilia(WFH), Charles Waller and Albert Farrugia Plasma Proteins Therapeutics Association, Bob Perry and Theo EversInternational Plasma Fractionation Association (IPFA), Roger Dodd-International Society of Blood Transfusion, Niels MikkelsenInternational Federation of Blood Donor Organizations (IFBDO), Jim MacPherson-America’s Blood Centers, Alison Turner-National Blood Authority Australia, Patrick Robert-Marketing Research Bureau Cees van der Poel EDQM, Paul Strengers -ISBT ⁄ Sanquin, Gilles FolleaEuropean Blood Alliance (EBA). A number of other organisations were invited to send representatives, including WHO, Thalassemia International Federation and the International Federation of Red Cross and Red Crescent Societies but were unable to attend because of other commitments. The statement produced in 2010 had been fully endorsed by 22 patient organisations and was endorsed with qualification by a number of other key stakeholder organisations. The most consistent qualification raised by organisations related to the previous clause 2.11 which was interpreted by some as providing endorsement for paid donations. Organisations that operate within a framework that only supports unpaid donors were therefore unwilling to fully endorse the 2010 statement. Not unexpectedly, this issue occupied a significant amount of time at the 2011 meeting. The final wording agreed recognises that different organisations will operate within different policy and regulatory frameworks, but acknowledges that both systems are needed at the current time. Encouragingly, there has emerged an improved understanding and dialogue between paid and non paid system advocates of the need for both Correspondence: Brian O’Mahony, Irish Haemophilia Society, Steering Group PLUS, Cathedral Court, New Street South, Dublin 8, Ireland E-mail: brian@haemophilia.ie Vox Sanguinis (2011)