Blood donation policies around the world

 

In one of the few articles to comprehensively calculate global blood collection, it was estimated that in the early 1980s, about 75 million units of blood were collected worldwide per annum [1]. Since then, updated statistics have been elusive to uncover, with factors such as political changes, poor record keeping and statistical difficulties preventing the compilation of data. However, if we use the reasonable assumption that blood collection has increased at about the same rate as that of world population growth, then it could be safely stated that at present, the total quantity of blood collected annually exceeds the 100 million unit level.

 

What this figure does not reveal is that like most economic indicators, there is a vast discrepancy in the international distribution of blood donations, with about 78% of all blood being collected in the developed world, even though less than 20% of the global population lives there [2]. In addition, there are major variations in the way that this blood is collected, for while voluntary unpaid donation is the norm in most developed states, the same can be said to occur for only about 15% of developing (middle income) countries and about 7% of lesser developed states [3] (who depend instead on other approaches, such as paid donation, to acquire blood). Despite these differences, a common problem is that very few countries have been able to become self sufficient when it comes to reconciling domestic blood usage with local collection efforts. Consequently, they have had to either endure some degree of shortage with their domestic stocks, or else they have had to import blood, with a system of international trade in blood products developing as a result. In the synopsis that follows, we look at how blood is supplied in different parts of the world, with commentary being provided on issues that may be of interest, in particular, on the applicable HIV situation in each region, as this has been the topic of greatest concern in the past two decades.

 

i) The United States

The largest single market in the world for blood products is the USA, where the responsibility for collecting blood lies primarily in the hands of thousands of community blood banks [4]. Most of these blood banks, which operate along non-profit lines, are affiliated to various national organisations, of which the most prominent are the American Association of Blood Banks (AABB), the American Red Cross (ARC) and Americas Blood Centers (ABC). While these national bodies do not usually collect blood themselves, they can, through the pooling of resources, offer a selection of specialist services to their members that would otherwise not be available. These range from lobbying legislators to pass laws that are in their interests to operating registries of donors with rare blood types and serving as clearing houses for the transfer of blood between different banks should some have major imbalances in their incoming and outgoing blood supplies.

 

As an examination of the discussion in Titmuss’ book reveals, getting an accurate estimate of the total quantity of blood collected and used in the USA during the 1960s was a tricky task, as there were many conflicting statistics available on this topic [5]. The situation has improved only slightly since then. This is because while some blood banks do not report their acquisition figures at all, others can belong to more than one national organisation at a time, leading to the possibility of double counting when examining how much blood each organisation claims that its members collect. Nevertheless, a reasonable estimate is that in 1999, about 8 million donors donated approximately 12 million units of whole blood, which was subsequently processed into about 23 million units of different blood products for use by about 4 million recipients [6].

 

In addition to these supplies, which are obtained from unpaid donors by the non-profit blood banks, there is also a substantial quantity of unaudited blood that is collected from paid donors by commercial blood banks, some of which are subsidiaries of pharmaceutical firms. This is because the USA, unlike many other nations, has no uniform laws that prohibit the acquisition of blood from donors who receive payment for their time and effort, with each state having separate policies on the issue. While whole blood obtained from such a source is allowed by the FDA to be used on patients, provided it is appropriately marked as being from “paid” donors, in recent years, commercial banks have tended not to collect such blood, preferring to leave this sector of the industry to the community banks. Instead, they have shifted their focus of operations on to the collection of components, such as plasma, where they can exploit economies of scale in order to efficiently produce products such as factor VIII concentrate at a relatively low price. As a result, these commercial firms have been able to corner a large share of the world market in such products, and have even been able to conclude sales in those countries where blood donation is limited to only unpaid, volunteers.

 

Despite playing a leading role in blood collection and use, the American blood industry has been beset with several problems, with one of its worst experiences relating to the HIV epidemic. Since the early 1980s, over 12,000 Americans, most of whom were haemophiliacs, have been infected with HIV obtained from infected blood products, of which over 10,000 have already died [7]. While this number is undoubtedly large in numerical terms, if we take into the context of the size of the American population and consider how prolifically blood is used in that country, then the numbers become relatively low. While various reasons could help to explain this relatively low incidence of infection, particular credit should go to the national health authorities who, despite the obfuscation of the Reagan administration on HIV when it first appeared, were prompt in ensuring that all measures that could be taken to prevent the spread of this disease were implemented. While some of these measures were admittedly instituted against commercial blood banks that were not operating according to proper safety procedures, such as those that collected blood from prison donors, other steps, such as the rapid introduction of blood screening and better donor selection policies, were applied to all blood banks regardless of how or from whom they collected blood. As a result, the number of blood related HIV infections in the USA has become negligible, although sometimes they still happen, with several incidents being reported of tainted blood being given by, amongst others, “safe” volunteers belonging to the American Red Cross.

 

ii) The European Union

In the European Union, the collection of blood is managed mainly by NGOs, such as the Red Cross, or by the public health services run by national governments. While the provision of money or fringe benefits in exchange for blood was relatively common in many European states in the 1960s [8], this practise has gradually fallen away, as blood banks have shifted towards unpaid donation. Various factors have precipitated this change, with one of the most important reasons being the fact that blood banks, like many other institutions, have been forced to standardise their procedures and standards to be compatible with those of other member states. In particular, they have been affected by Directive 89/831, passed by the European Parliament, which states:

“Member states shall take the necessary measures to promote community self sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations [9]”. 

 

Despite having such impressive objectives, this piece of legislation has not been fully effective since, with the exception of some states such as Finland and the Netherlands, most European nations still have difficulties in meeting all their domestic blood requirements. Indeed, some countries that rely solely on unpaid donors, such as Ireland, have been forced to ration domestic blood consumption and import blood during periods of severe scarcity [10]. Furthermore, a number of states countries, most notably France and Ireland, have been beset by public scandals concerning the safety of donated blood. At the root of this crisis is the fact that European blood banks were extremely lax in responding to the spread of this disease, with the result being that by 1986, about 8,000 Europeans obtained HIV transmitted through contaminated blood products [11]. Particularly affected were the French, with about 3,000-4,000 such cases, who, despite being credited with first pinpointing HIV, were slow off the mark in introducing screening tests to detect this virus. Due to a combination of negligence, bureaucratic bungling, and political intrigue, the first (American designed) screening tests were only licensed in France about 6 months after gaining their FDA approval, at about the same time as the first local tests designed by the Pasteur Institute were introduced. As a result of this delay, many people who could otherwise have been saved during this crucial period were infected with HIV. While compensation has been offered in some countries to victims of this disease, a significant degree of distrust of blood banks still remains, with the collection of blood being severely affected as a result of these incidents.

 

One major European country not to suffer from such a scandal has been Germany, which operates a dual system where the substantial annual volume of 50 unpaid units donated per 1,000 people is supplemented by blood purchased from paid donors [12]. In this country, most unpaid volunteers donate their blood in urban collection centres run by the German Red Cross, while the paid donors are employed mainly by community and university blood banks on a “call” basis, where they are called upon by their contracting blood bank to give blood whenever the need arises. The rate of remuneration of these donors depends on the type of product they can offer, with the applicable rates in the early 1990s being DM 39-50 for whole blood, DM 35 for plasmapheresis donations, and up to DM 120 for attendance at cytapheresis sessions [13]. The key to the success of this system is that all paid donors are required to meet high medical standards, with entrance to the donation programme being strictly enforced and donor health being constantly monitored to ensure that the safety of blood recipients is not compromised. As a result, it is felt that paid donors have, on average, higher health standards than their unpaid counterparts. It also shows that despite the opinions of Titmuss, states that rely solely on altruistic donors will not necessarily have better run or inherently safer systems of blood collection than countries that allow for the payment of blood to take place. This is since the quality of management and the level of technological expertise available to blood banks can, more often than not, offset any weaknesses that may exist with the quality of the available donor pool [14].

 

iii) United Kingdom

In the UK, blood is collected by a set of regional blood banks reporting to a governing authority known as the National Blood Transfusion Service (NBTS), which operates under the auspices of the National Health Service (NHS) [15]. Since its inception in the aftermath of World War II, the NBTS has always depended solely on the goodwill of unpaid donors to meet its requirements, with the volume collected in the period 1997-1998 exceeding 2.2 million units of blood [16]. According to admirers such as Titmuss, the NBTS had the features of an ideal blood collection system, for not only was the way that it collected blood thought to involve a morally superior philosophy, but it was also believed to have superior safety standards and operate with an incomparable degree of efficiency (as evidenced by apparently negligible blood waste and the non-reliance on paid donors). Even today, the apparent validity of such claims continues to be reflected in statements such as “we are nationally self sufficient in blood” [17], and “from time to time … there may be a surplus of plasma … (which may be) offered abroad to those countries that are unable to meet their needs” [18]. With such convincing rhetoric, it is hardly surprising that many nations worldwide were persuaded to organise their domestic blood banking systems along similar lines to those of the NBTS.

 

In truth, much of this rhetoric is misleading, as the arrival of HIV revealed several unpalatable truths about the true state of British blood banking, in particular, over the degree of national blood self-sufficiency and the safety of domestic blood. While there may have been some validity in the claim by Titmuss that the UK was self reliant for its whole blood needs, the same cannot be said about specialized blood products such as plasma derivatives. This is since the UK was an importer of such products, some of which were obtained from overseas blood banks that used paid donors. While Titmuss conceded that there were “serious difficulties in the technical production of the appropriate blood products” [19], he nevertheless glossed over this point by stating that “there is no shortage of blood” [20] and “the problems … are in no way comparable to those … in the United States” [21]. A retrospective analysis of past British plasma supply and demand records allows us, with hindsight, to realize how inaccurate his claims were, leaving us to deduce that he was either unaware of the full extent of British dependence on imported blood, or was guilty of misrepresenting the facts [22]. This is because as early as 1974, about one-third of the factor VIII concentrate used per annum in the UK was imported from paid donors, with the corresponding figure rising steadily over time to stand at about two thirds of annual consumption by 1985 [23] –even then, the UK had one of the lowest rates of factor VIII usage in the developed world [24].

 

While the NBTS always had its own plasma plants and had, from the late 1970s, undertaken to enhance local plasma processing capacity, the efforts taken to become self-sufficient were to suffer from a series of problems that were to mar the reputation of this service. In addition to cost overruns during construction and budgetary shortcomings that made products from these facilities uncompetitive in cost terms relative to those of commercial suppliers, there were also serious clinical safety breaches where unlicensed products were produced in manufacturing facilities that were deemed to be below acceptable standards [25]. As a result, it was several years before these facilities could approach anything near an efficient level of operational ability, with the interim solution being to continue importing “paid” plasma until the situation was stabilized, with such blood coming from, inter alia, Mexico, Lesotho [26] and the USA [27]. Along with problems concerning HIV, fears have also been expressed in the UK over the possible transmission via blood of Creutzfeld-Jakob disease. While such an issue was first raised in the late 1980s and early 1990, nothing was done as the transfusion authorities believed that this risk posed by this disease was only theoretical [28]. In recent years, this attitude has changed, with plasma provided by local donors no longer being used in the UK, with all plasma derived products being imported from countries with no recorded cases of Creutzfeld-Jakob disease and a low incidence of BSE [29]. In such a situation, it would be impossible to state with absolute confidence that blood products not originally from paid donors were being used in the UK.

 

In addition, what was to be a major shock was the discovery that just because the UK relied on unpaid donors did not mean that blood recipients would be immune to HIV infection. As in other countries, the main blood related victims of HIV were haemophiliacs, with informal surveys showing that in 1983, up to 75% of sampled patients receiving care from haemophilia support centres were HIV positive [30]. While it was generally expected that imported American plasma products could come from contaminated pools, locally manufactured products were assumed to come from a “safe” pool, with commentators only gradually realizing that quite possibly, “the size of the pool of National Health Service concentrates has been increased to a point where the benefit conferred by the use of volunteer donor plasma might have been lost” [31].

 

While the NBTS authorities were relatively prompt in ensuring that high risk donors, particularly homosexuals, were deferred from donating, in what must rank as one of their worst policy decisions ever, they were extremely lax in introducing routine tests to check donated blood for antibodies to HIV. While the FDA had granted approval for blood testing to commence in the USA from March 1985, in the UK, as in France, there was a half-year delay before the first standard screenings were introduced. This was even though Abbot Laboratories (makers of the first screening test) had actively solicited for the use of its product in the UK. The reason given for the delay was that the NBTS was unimpressed with the accuracy of the test on offer, for it was believed to provide a disproportionately high number of “false positive” results, thereby requiring an excessive amount of good, healthy blood to be destroyed. Frankly, this justification is not very acceptable, since if the test was deemed suitable for American use by the FDA, which was (and still is), the pre-eminent world authority on issues relating to the regulation of pharmaceutical products, then surely it should have been good enough in the UK too.

 

Furthermore, when dealing with something as dangerous as HIV, surely the better option for the NBTS would have been to adopt a risk averse approach and use the only test available, for at least a temporary period until better tests were available, rather than act like a risk taker and delay testing, thereby gambling with the lives of many blood recipients, who supposedly formed the heart of the system. Eventually, two other tests were introduced, of which one was developed, somewhat interestingly, by the UK-based Wellcome Foundation, which is now part of Glaxo SmithKline, one of the largest players in the global AIDS treatment industry. While there is no firm proof that the delay and ensuing test selection was attributable to commercial rather than scientific interests, questions have nonetheless been raised around the events of this period, especially since, unlike in France, no prosecutions were made or commissions of enquiry launched in the UK on this issue.

 

iv) Asia

In Asia, a general trend has been that as countries become wealthier, they have become able to radically overhaul all aspects of their healthcare systems, with one of the most popular changes involving a shift away from relying on paid blood donors in favour of unpaid collection systems.

 

The general evolution that has taken place in Asia can be demonstrated by looking at what happened in Japan as it prospered. While the first Japanese blood donors were probably unpaid volunteers, in the period following World War II, the emphasis of the national blood collection system had, with major American backing, switched decidedly to paid donation. By 1963, about 98% of all donated Japanese blood was said to come from paid donors known as tako (octopuses), who came from poor backgrounds and, if it can be believed, would “… visit two commercial banks a day, selling 200 c.c. at each bank” [32] in return for $1.40 per donation. In 1964, a decision was taken to switch solely to unpaid, voluntary blood donation, with the phasing out process starting in 1968 and being fully completed in 1973. The justification for this change was that the paid donor pool had an unjustifiably high prevalence of disease, with an estimated 50.9% of all Japanese patients acquiring post-transfusion hepatitis when using blood provided by paid donors. Following the changeover, the corresponding figure had fallen to 16.2%, with the incidence of infection being forced even lower to 14.3% of all recipients once HbsAg testing had been introduced [33].

 

Another wealthy Asian country to fully adopt voluntary blood donation was Taiwan, which had, until the early 1980s, relied mainly on the services of paid blood donors. By 1992, with major state funding and support, the entire blood acquisition system had been overhauled, with almost all national blood needs being met by volunteer donors, who made up about 5.5% of the population [34]. In contrast to this success story, one prosperous Asian state that has had difficulties in implementing a voluntary donation system has been South Korea, which has relied largely on imports of blood to meet its domestic needs. The flaw in this policy was demonstrated in the late 1990s, when the currency devaluation that took place meant that greater emphasis had to be placed on local, unpaid blood donation, since balance of payments difficulties meant that there were substantial problems in paying for blood imports [35].

 

The general experience of the wealthier Asian states is in marked contrast to that of their poorer neighbours, who remain largely dependent on paid donation. Arguably one of the worst performing voluntary systems is that of the Philippines, where unpaid volunteers provide only 20% of national blood needs. While an audit revealed that up to 4% of all donated blood in this country is contaminated by disease, there is no option but to continue relying on commercial sources, as only 1 in 500 Filipinos gave blood. Furthermore, it has been stated that if purchased blood supplies were eliminated, then up to 8,500 people would face the prospect of death due to a shortage of the products they required [36].

 

Another poor country to experience major problems with unpaid donation has been India. Selling blood has long been seen as a way of making a living for people with a low socio-economic status, with some even attempting to form unions that would protect their members’ interests and guarantee a minimum “wage” for their donation services [37]. In the mid-1990s, the Indian Supreme Court ruled that in addition to ensuring that paid donation was phased out within 2 years, the Indian government would also have to ensure that all blood banks were licensed (as 25% operated illegally) [38]. These measures were demanded due to safety fears, as over half of all blood collected in India was not screened for HIV, with about 15% of all Indian HIV positive individuals being either blood donors or former recipients. While a voluntary donation programme has been in operation for some time, with several regions being entirely reliant on unpaid donors [39], the reputation of the non-profit blood banks has also been sullied by embarrassing scandals. Most prominent of these was the discovery that a blood bank aligned to the Indian Red Cross supplied HIV positive blood to several leading Bombay hospitals, while workers had stolen substandard blood supplies and sold them to third parties in order to supplement their incomes [40]. As a direct result of such corruption and inefficiency, the ability of the non-profit sector to provide safer, higher quality blood than the commercial banks has been questioned.

 

v) Africa

While blood donation and transfusion is practised in most African states, quality levels are often poor and do not compare favourably to the standards of more developed nations. Unlike most parts of the world, where there are relatively benign disease profiles, many African states face unique problems arising from medical and environmental conditions that hamper the work of the local health services. For example, life threatening anaemia, which can be caused by infections such as sickle cell disease and drug resistant malaria, is common across a large swathe of the continent, with blood transfusions often being used as a cheaper and more effective treatment option than costly, imported drugs. The primary flaw with such widespread reliance on transfusion is that much blood goes untested for the presence of disease, as restrictions imposed by a lack of financial resources mean that such tests are deemed to be widely unaffordable. Indeed, in some African states, the cost of screening one unit of donated blood exceeds the annual per capita budget allocation to health care, with one survey revealing that as late as 1993, 8 out of 29 responding African states still had no policies in place with respect to the screening of HIV [41]. As such, it is hardly surprising that diseases are easily spread, with the number of transfusion related HIV infections in Africa possibly having exceeded the one million-person level already. Across the continent, a range of different approaches to the collection of blood exists. In many areas where formal donation infrastructure does not exist, a substantial portion of the blood collected is provided according to the lending and replacement system, where relatives and friends help ill patients to recover their blood costs. In many of these cases though, these people will not actually provide the required blood themselves, but will instead pay others to fulfil their obligations for them. In effect, this means that paid donation is a commonplace activity, even if in many instances it takes place in an indirect manner. While plans have been proposed to adopt voluntary, unpaid donation amongst a growing number of African states [42], it is not yet clear whether sufficient financial resources will be available, nor whether the shortages that exist in many areas will be alleviated as a result of appeals to people to give out of altruism [43].

 

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