Statement of the Austrian Haemophilia Society

Labelling of NAT testing of plasma products

More than 500 people in Austria suffer from haemophilia A or B, which also means that some thousand people are confronted with this chronic bleeding disorder.

Around 50% of the patients are treated with plasma- derived clotting factor- concentrates. Remembering the HIV- disaster in the late Seventies and early Eighties, which afflicted more than 150 boys and men with haemophilia (and their families) in Austria, the patients and their families are very suspicious concerning the substitution therapy of this chronic disease. Virus- inactivation- methods and the implementation of PCR- testing for viral material, as HIV, Hepatitis- viruses, and others were a late, but major success for this group of chronically ill people, depending on safe clotting factor- products.

Therefore all available Information about the product in use is a most important issue for the patient/ consumer and, last but not least, for the haemophilia-center and the medical staff providing the treatment.

Precise description of all methods used to provide safety of the product and the production- process, especially the complete “labelling” of clotting-factor-concentrates (vials), is of very high importance and value for the people receiving this products, and their families.

The Austrian Haemophilia Society informs all members on a regular basis about the progress in haemophilia- therapy as well as product safety. We strongly support all activities to enable medical staff, patients and their families to receive complete and comprehensive information about the use and safety of a medicinal product, as clotting- factor concentrates are.

Vienna, Jan. 21st, 2003



Hubert K.Hartl, M.D.   ......   Executive Dir.

Josef Weiss              ......  President


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