A breakthrough product in haemophilia treatment, which removes all human and animal proteins from the production process, has been licensed for sale by the European Commission. Joe Humphreys reports.
Advate, the first so-called third generation clotting agent for haemophiliacs, claims to completely eliminate the risk of viral infections being passed on through treatment.
Made by the multinational Baxter Healthcare, which employs 1,200 people at factories in Co Mayo, the product (Octocog Alfa Recombinant Coagulation Factor VIII) is being marketed throughout Europe.
However, it is unlikely to be used in the Republic until at least 2006 when a three-year contract lapses for the supply of a rival recombinant, or synthetic, product to Irish hospitals.
All products for haemophiliacs are now chosen by a selection group, comprising treating doctors and patient representatives, including the Irish Haemophilia Society (IHS).
The group was set up after the Lindsay tribunal, which investigated the infection of haemophiliacs with HIV and hepatitis C through blood products administered mainly in the 1980s.
Advate had yet to be licensed when the group sat last year to choose a product for the treatment of haemophilia A patients.
In its absence, two recombinant products called Kogenate and Helixate, made by the drugs firm Bayer, were selected. While neither product contains human or animal proteins, both use albumin made from such sources in the production process.
Mr Harry Keenan, general manager of Baxter Ireland, said Advate was the first treatment that was processed without adding plasma proteins, thereby "addressing current safety concerns."
Prof Claude Negrier, a leading European treater of haemophiliacs, said: "For years, the potential risk of viral transmission has been a considerable concern among haemophilia patients and this issue has continued to grow as new diseases have emerged over time... The significance of this development to haemophilia patients and their families cannot be underestimated."
Ms Margaret Dunne, administrator of the IHS, said the biggest advance in haemophilia treatment in recent years was the move from blood-based to recombinant products.
However, the new agent did involve "an extra step".
The licensing comes ahead of an expected announcement later this month of the creation of a statutory National Haemophilia Council, which will monitor the provision of all haemophilia treatment services.
The council has been operating on a non-statutory basis for the past 18 months.