Safety and donor’s compensation

Since Titmuss’ 1971 book, The Gift Relationship,2 there has been a lingering concern that remunerated donors may compromise blood safety, because the expectation of a financial return may lead to unreliable personal information reporting and therefore increase the risk of transmissible diseases such as hepatitis or HIV. Titmuss reported American studies showing that hepatitis was more prevalent in blood supplied from paid than from unpaid donors. Generally, these studies were based on small samples and did not adequately account for potentially confounding factors that were unevenly distributed between compensated and non-compensated groups, such as the prevalence of first-time donors and the inclusion of inmates. Furthermore, the evidence predates the development of tests for the presence of hepatitis and HIV in the blood supply.3 Recent studies and reviews of the evidence over the last 40 years have concluded that the statistically sound, field-based evidence from large, representative samples shows that properly devised rewards increase supply without compromising the quality and safety of blood and blood components.4

Today, plasma-derived therapeutical products from both paid and unpaid donors are safe, thanks to stringent regulatory measures that rely on scientific advances in testing, require rigorous donor selection and mandate thorough inspections of collection and manufacturing facilities. These measures include production processes capable of inactivating or removing a range of known and unknown infective agents.5 Prevalent industry standards ensure that plasma originates from low-risk donors, for example, it is standard procedure not to use a person’s first donation but to use their plasma only if it passes tests starting from the second donation. These standards have made US plasma-derived products safe for decades.6

Moral concerns: coercion, exploitation, commodification

The WHO classifies donors into three categories: voluntary unpaid, family/replacement and paid.7 This classification is misleading: it implicitly assumes only unpaid donations to be ‘voluntary’, suggesting paid donations are coerced. The implication that compensation negates voluntariness is not only a potentially stigmatising claim; it is also at odds with common ethics and practice elsewhere, where not paying for a service is associated with exploitation, especially of those in more vulnerable socioeconomic conditions. To protect individuals from exploitation, labour laws around the world have introduced minimum compensation requirements rather than caps on earnings. To rely solely on altruism in these areas would be exploitative and eventually lead to a collapse in provision. In addition, payment bans on donors, even if intended to protect against undue inducements, raise concerns about price fixing to the benefit of non-donors.8

The commodification of the human body, that is, the transformation of a person or their parts into goods to be traded, is another ethical concern related to compensation for SoHOs. However, this can be immensely valuable to patients. For instance, approximately 1200 plasma donations are needed to produce the annual supply of clotting factor necessary for a single patient with haemophilia. This system of commodification has proved to be life-saving on a global scale.9 Vilifying certain types of donations overlooks the benefits that compensation together with careful regulation can bring to the efficiency and reliability of blood supply.

The goal of self-sufficiency and the burden on countries

The joint focus on self-sufficiency and unpaid donations poses a major tension. At least where plasma for fractionation is concerned, the unpaid-donor system has failed to meet demand. Table 1 indicates that in Europe, countries allowing monetary compensation for donors are the only ones achieving self-sufficiency in plasma collection for the production of immunoglobulin. The plasma sector in countries that compensate plasma donors, notably the USA, serves as supplier to many countries experiencing chronic shortages. The USA alone collects about 70% of the world’s plasma supply.10 A combination of a favourable regulatory environment, an extensive collection network and advanced technological infrastructure contributed to establishing the US position.11

More broadly, countries that allow some form of payment for plasma donations—including EU member states Germany, Austria, Hungary and the Czech Republic—account for nearly 90% of the global supply.12

The new EU regulation states that ‘Compensation may consist of the reimbursement of expenses incurred in connection with SoHO donation or on making good of any losses, preferably based on quantifiable criteria, associated with the donation of SoHO’. This potentially limits the existing practices of EU countries that allow compensation, as well as other schemes in other jurisdictions. However, national legislation may interpret this regulation with some flexibility, allowing for ‘fixed allowances’ or ‘non-financial forms of compensation’. This caveat potentially leaves individual countries the freedom to define what constitutes a quantifiable loss and to decide whether or not to include a form of ‘payment’ within these parameters. The new dispositions, however, still pose a risk because they do not allow any incentives beyond quantifiable losses, thus overlooking the practicalities of plasma donation—its time-consuming nature and the necessity for large quantities—making donor compensation not just a practical option but often a necessity to meet healthcare demands.

The most serious effects of these provisions will be for low-income countries; the increase in the shortage in the EU due to the reductions of donations following the new regulation would drive up international prices and reduce the affordability of plasma.13 Plasma supplies from the USA and some European save lives around the world. If this still represents a concern, it can be addressed by proper policies that discourage trade, but the current evidence suggests that this would make things worse for patients in poor countries.14

A false dichotomy

An underlying assumption in many discussions about compensation of donors is that it is an inherent feature of the private, for-profit sector, whereas unpaid donations characterise public and non-profit organisations. The opposition to delegating the provision of life-saving human products to for-profit companies may therefore coincide with an aversion to payments. However, nothing prevents publicly owned or non-profit collection agencies from offering economic incentives, with the achievement of social welfare as opposed to private economic return as the main organisational mission.