Abstract
Over a period of some fifty years, society’s approach to the problem of ensuring the safety of medicines has become increasingly consistent and effective. During that same period, however, the community has repeatedly struggled to create a comparable system to deal with the challenge created by the need to supply safe blood for transfusion purposes. Human blood and its derivatives cannot be dealt with in the same manner as drugs. The fact that it is a material of human origin raises specific problems, both moral and technical. In particular, views differ as to whether blood should be sourced exclusively from volunteers who participate from altruistic motives and without financial reward, or whether an individual should be able to trade his or her blood against payment; in the latter situation, there is an evident risk that some donors may be tempted to give blood when their state of health does not in fact permit it, or to conceal data pointed to the fact that their blood is likely to be unusable, e.g. because of infection or other types of disorder. Similarly, the question has been much debated as to whether blood collected free of charge for transfusion purposes should be handled by commercial concerns working for profit or should be entrusted solely to official bodies or to non-profit organizations serving an idealistic purpose. The answers to these questions have varied from one country to another. In the United States, and a number of other countries, human blood can be traded, both at the donor and processing levels; in many other countries the entire system is operated on a non-profit basis, involving the Red Cross or state institutes. Over a long period, the supply system operated relatively quietly; incidental problems relating to blood grouping and storage were dealt with without a great deal of debate. All this began to change with the increasingly evident need to eliminate the transmission of viral infection through the system. Concerns initially related to the elimination of the hepatitis virus from the supply chain, but they became much more acute with the large-scale advent of HIV/AIDS. In large processing systems, the blood of a single donor is at an early stage mixed with that from many other sources. It is therefore clear than even a single bottle of infected blood entering the system will be capable of contaminating the entire supply chain, exposing a vast number of recipients to the risk of disease. In such a situation it is not sufficient to attain a “reasonable” level of safety; the entire system must in effect be watertight if disasters are to be involved. Nowhere have the problems in this connection come to the fore more severely than in Canada. Canada had for many years maintained a compromise system. Although at one time Canada itself had some 300,000 voluntary donors, the blood that they supplied was insufficient to meet all needs. Part of the blood entering the system therefore came from commercial firms in the United States, while the national system for its purchase, storage and distribution was for more than fifty years handled by the Canadian Red Cross, subject to control by the health authorities. In principle, therefore, there was the possibility
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More From: International Journal of Risk and Safety in Medicine
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