Achieving self sufficiency in blood across EuropeBMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7130.489 (Published 14 February 1998) Cite this as: BMJ 1998;316:489
European countries should encourage unpaid donors and dismantle barriers
- Juhani Leikola, Director ()a
When the development of blood component therapy was in its infancy countries were by and large self sufficient for whole blood. Large scale export and import of plasma started in the 1960s and early 1970s, when both albumin and coagulation factor VIII became commercially available. The industry needed more and more plasma, and the development of plastic bags made plasmapheresis feasible. Large plasma donation centres were established, primarily in the United States but also in countries such as Nicaragua and Haiti. Exploitation of donors gained wide publicity, and the trade in “red gold” became an important international media event. In Europe self sufficiency in blood production has again become an important concern, but the picture is now more complicated and self sufficiency is often confused with the issue of the source of the blood—paid or unpaid donors.
Reacting to the bad publicity over exploited donors from developing countries, the assembly of the World Health Organisation in 1975 urged member states to “promote the development of national blood services based on voluntary non-remunerated donation of blood and enact effective legislation governing the operation of blood services and to take other actions necessary to protect and promote the health of blood donors and the recipients of blood and blood products.”1 Although national self sufficiency was not specifically mentioned, both the discussion and the decisions implied that developed countries should be able to meet their needs without importing plasma.
When this discussion about self sufficiency started, ethical considerations predominated. Industrialised countries were concerned that source plasma for the blood products they were using often came from poor donors living in deplorable conditions at a time when their own citizens should have been able to supply the necessary plasma. The AIDS epidemic, however, stimulated a new and more urgent concern about imported blood—its safety. Those countries that had been virtually self sufficient in the early 1980s, such as Norway, Belgium, and Finland, had a very low transmission rate of HIV to haemophiliac patients.2 Self sufficiency suddenly became more attractive and national health authorities more vigilant.
The European Community brought blood safety and self sufficiency on to its agenda in the late 1980s. Directive 89/381/EEC stipulates that member states should promote self sufficiency, and various actions by member states followed.3 A new impetus was given in September 1996 when the Irish presidency organised a colloquium which recommended further action to harmonise transfusion services within the European union, including the suggestion that there should be common criteria on selecting donors. The Dutch presidency in 1997 also promoted the concept of European Union self sufficiency, and under the Luxembourg presidency the commission organised an expert meeting on the subject last December.
The 1989 directive not only speaks of self sufficiency but also states that in order to promote self sufficiency, member states should encourage voluntary unpaid donations of blood and plasma.4 Therefore the question is not simply whether the European Union can reach self sufficiency but whether it can do so using voluntary unpaid donations. Unpaid donor populations carry fewer markers of infectious agents than paid ones.5 6 7 An all volunteer donor corps should not, of course, be an excuse for less stringent selection and testing of donors and treatment of products. Nevertheless, the question sometimes posed by representatives of the commercial plasma industry—“What is more important: safety or self sufficiency?”—is misguided, since additional safety is the goal in promoting voluntary unpaid donations.
Promoting voluntary unpaid donations may be easier than promoting European Union self sufficiency. Firstly, do we know what we mean by self sufficiency? Definitions might be thought to rely on an assessment of how much of a particular blood product is required. However, the clinical need for a blood product may not be the same as the market demand. For example, is the clinical need in Italy, where over 600 kg albumin per million population is consumed, so much greater than in Britain and Finland, where consumption is less than 200 kg? Similarly, a poor country that does not import blood products will be self sufficient, although its use may be considered inadequate by the standards of a more affluent one that imports (and exports) blood products. Recombinant products might provide an alternative to self sufficiency, but so far recombinant factor VIII has not replaced plasma derived factor VIII, but simply increased total consumption.
Secondly, self sufficiency within the union is a nice idea, but member states are still building barriers against the import of blood products. Testing for alanine aminotransferase is considered obsolete since the start of testing for hepatitis C,8 yet France and Germany still require all donations to be screened for alanine aminotransferase. The selection criteria for blood donors vary from country to country, despite the recommendations of the Council of Europe.9 Confidence in each other's blood and blood products is essential, and there should be practical measures to achieve this, as recommended in 1996.
Another problem is the cost of plasmapheresis. Many national health authorities have set standards and criteria for plasmapheresis which far exceed the European regulations, contributing to the high costs of plasma donation in Europe. If American plasma is available why should European fractionation laboratories buy European plasma that may be much more expensive? The costs are not related to whether the donors are paid or not.
To achieve self sufficiency, member states should accept European standards and remove barriers to receiving blood from other member states. But, as important, those countries that do not already do so should ensure that their blood donors are unpaid volunteers. The only reliable bases of blood services are voluntary donors: they help to ensure the integrity of the product, but they will volunteer only if they in turn trust the service and its standards and experience the donation as a gift.10