World Federation of Hemophilia
Statement on Proposed amendments to European Commission
Proposal for a Directive on Human Blood and Blood Components[1]
The World Federation of Hemophilia is an international not-for-profit organization representing 95 member countries, including 18 in Western Europe and 23 in Eastern Europe. It is recognized by the World Health Organization as an official non-governmental organization.
The WFH is dedicated to improving haemophilia care for the estimated 400,000 people around the world with haemophilia and working to ensure that they receive a sufficient amount of safe blood products for their treatment.
The World Federation of Hemophilia is very concerned about the amendments to the draft Blood Directive that have been proposed by the Parliament’s Committee on the Environment, Public Health and Consumer Policy. The amended Directive would prevent the remuneration of plasma donors within the European Union and prevent the importation of plasma and plasma products from remunerated donors.
Consider the following facts affecting the supply and safety of blood products today:
- Safe plasma-derived concentrates remain the lifeline for the majority of people with haemophilia.
- Much of the plasma used to manufacture concentrates in Europe is collected in the United States from well-screened, remunerated donors.
- There is currently a worldwide shortage of plasma products for treating people with haemophilia. This is a consequence of an unusually severe shortage of recombinant products; many patients who usually received these products have been switched to plasma-derived products.
- The current shortage is exacerbated by restrictions in the use of plasma from donors in the U.K. and elsewhere in Europe because of the theoretical risk of transmission of variant Creutzfeldt-Jakob disease (vCJD) by plasma products.
The proposed changes to the draft Blood Directive would have a severe impact on the supply of plasma-derived concentrates manufactured from remunerated donors at a time when people with haemophilia in Europe are increasingly reliant on such products.
The proposed amendments would have a great impact on the clinical freedom of haemophilia specialists to prescribe the optimum therapy for their patients and would effectively prevent the use of many factor concentrates that have been licensed for use by the European Agency for the Evaluation of Medicinal Products.
Implementing policies that reduce the pool of plasma donors will cause additional shortages in all countries, including those belonging to the European Union.
Fewer available products will lead to an increased number of deaths and disabilities because of:
- the unavailability of products to treat life-threatening bleeding episodes; and
- the replacement of safe products with unsafe local fresh frozen plasma and cryoprecipitate or products manufactured using lower quality plasma obtained from dubious sources.
Because of their tremendous worldwide impact, European policies for donors that further reduce the global availability of plasma products should be based on sound scientific knowledge or judgment that the safety obtained by the new policies will outweigh the risk of more people dying from lack of treatment products.
Careful assessment of the expected gain in risk reduction in this situation is absolutely mandatory.
Brian O’Mahony
President, World Federation of Hemophilia
Chairman, Irish Haemophilia Society
Paul Giangrande, MD
Vice-President Medical, World Federation of Hemophilia
Director, Oxford Haemophilia Centre
[1] Proposal for a European Parliament and Council Directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Council Directive 89/381/EEC.
August 2001
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