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Dr Guy Rautmann Secretary to the CD-P-TS

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Sede Legale: 27, Bd. de Suisse – MC 98000 Monaco – Tel. +337 97 97 30 00 – C.F. 92064560706 – Tel. +39 333 70 52 571 www.fiods-ifbdo.org – Email: secretariatfiods@gmail.com / gianfrancomassaro@gmail.com

Dr Susanne Keitel EDQM Director

Dr Laurent Mallet Head of DBO, EDQM

Dr Guy Rautmann Secretary to the CD-P-TS

EDQM - Council of Europe Strasbourg, France

Cc:

Dr Claudio D’Amario Director General for Preventive Health

Dr Maria Rita Tamburrini Director, Office 7 Transplants, Blood and Blood Components

Directorate General for Preventive Health Ministry of Health, Rome, Italy

Dr Giancarlo Maria Liumbruno Director General Italian National Blood Centre

Rome, Italy

Dr Aldo OzinoCaligaris Coordinator of CIVIS Rome, Italy RE: Italian policy around the collection of plasma for manufacture

The considerations expressed by the Italian National Blood Centre and the National Coordinating Committee of voluntary Italian Blood Donors’ Associations/Federations (CIVIS), are shared by the International Federation of Blood Donor Organisations (FIODS/IFBDO), representing the blood donors’ organizations of 81 countries globally, 18 million blood donors in the world who donate around 25 million blood and plasma units yearly.

The FIODS notes that similar considerations for other systems based on voluntary unpaid blood and plasma donations have already been elucidated by itself and the countries concerned. These considerations confirm that the proposed increase of the donation frequency for plasmapheresis donors to sixty donations yearly is in variance with the voluntary blood donation sector and approaches more closely to the commercial collection of plasma, particularly in the USA. In the European volunteer-based environment, maintaining the current EDQM standard of 33 donations yearly will be compatible with the ethos of this environment. The FIODS is confident that application of this goal will contribute to ensuring that enough plasma can be collected to enhance the attainment of European self-sufficiency without generating unnecessary risks for donors and patients alike.

Rome, January 10

th

, 2020

Gian Franco Massaro,

President of FIODS/IFBDO

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